Standard Operating Procedures and Shipping Guidelines for
Medical and Pharmaceutical Products:
General Information ......................................................................................................................... 2
Quality Management System (QMS) ............................................................................................... 3
Our role in developing a GDP with our Customers ......................................................................... 5
Routing and Station Information ...................................................................................................... 7
Pharmaceutical Products and Vaccines ........................................................................................ 15
Blood Products/Plasma ................................................................................................................. 18
Tissue and Transplant ................................................................................................................... 44
Shipping UN3373 and UN2814 ..................................................................................................... 48
Clinical Trials and Patient Specimen’s .......................................................................................... 58
Cold Chain, Distribution & Warehousing ....................................................................................... 59
Best Practice Solutions for Temperature Ranges and GDP ......................................................... 63
Chain of Custody ........................................................................................................................... 65
Temperature Control/Validation on site ......................................................................................... 76
Temperature Validation in transit................................................................................................... 78
Documentation and Local Regulatory Paperwork ......................................................................... 85
Qualified and Trained Personnel ................................................................................................... 90
MAJAX and Disaster Recovery ..................................................................................................... 92
MHRA/FDA .................................................................................................................................... 95
General Information
Purpose: This document is intended to establish detailed procedures and effective command
and control protocols for the shipping of Medical and Pharmaceutical products on behalf of
CitySprint clients.
Objectives: To ensure that proper handling/shipping techniques and transportation requirements,
including chain of custody and cold chains are established and maintained for the distribution of
various Pharmaceutical Products and Clinical Specimens.
CitySprint Medical Express provides specialist tailored transportation services to various
pharmaceutical manufacturers, clinical trial organisations, research labs and hospital sites
across the UK, Europe and North America, providing direct delivery of Temperature
controlled Clinical Specimens; bulk Pharmaceutical Products and Vaccines, Research
Samples, Biological Material, Hazardous Goods and Patient Samples from Clinical Trial
studies.
Quality Management System (QMS)
Purpose: CME has developed and will continue to develop an effective internal Quality
Management System (QMS).
Objectives: To ensure a well designed, structured and organised method of quality assuring the
provision of consistent, on-time, validated and effective delivery and clinical logistics services. To
provide a means of confirming to regulatory bodies, customers and management that the service
provision is in compliance with relevant regulatory and customer standards, and is also a basis
whereby improvement in quality systems may be demonstrated.
This QMS comprises of the following inter related elements:
Good Distribution Practice is the cornerstone of an effective QMS and provides the structure
upon which the elements of the quality system can be built. The objective of the GDP is to
ensure that the integrity of the product whilst in transit, for the safety of the product for Vaccines,
Blood Product and Plasma whilst ensuring clinical specimens for trials and analysis are still at
their optimum potency once delivered to the receiving lab for diagnosis.
For Transplant the GDP ensures that the tissue or bone marrow reaches it’s destination in the
shortest possible time and ensures that the necessary arrangements are in place to act
immediately, including the provision of charter aircraft, on-board couriers, arranging special
security clearance at the local airport of departure and arrival.
Documentation, effective documentation, whether in written or electronic format must be
accurate and informative and reviewed on a regular basis to ensure that it remains relevant.
It
must provide clear instructions on all aspects of the GDP and is there to prevent errors that may
occur. This document provides the SOP’s for the distribution of Pharmaceutical, Medical and
Clinical Specimens by CME and guidance on the many items described in various Local
Government documents for the effective transportation of Pharmaceutical Products and Clinical
Specimens.
Quality control, Temperature Validation and Traceability, are the most important areas when
shipping sensitive Pharmaceutical, Medical and clinical samples.
CME must be able to
demonstrate quality control and quality monitoring in all aspects of the shipping cycle, from initial
discussions with customer to arranging routing and temperature range to final delivery directly to
consignee and not the consignees mail facility or loading dock.
CME must be able to provide accurate Temperature Validation resources for Pharmaceutical and
Blood Products and work with each customer to ensure that we adhere to their audit processes
and shipping needs.
CME must be able to demonstrate a full audit trail when shipping temperature controlled
shipments that require validation; systems are in place with partners such as Sensitech who
provide electronic validation kits.
Temperature ranges and subsequent routings must be
discussed and agreed with the client prior to shipping.
Real time tracking must be available 24 * 7, 365 days a year. Tracking information can be viewed
on the web at www.citysprint.co.uk, verbal request for updates must be responded to within 60
minutes for all medical shipments (24 * 7, 365 days a year).
Resources and Staff Training, CME must have ensured that adequate resources are available
to staff at all times to ensure that the GDP is effectively managed and to continually improve its
effectiveness and satisfy customer requirements.
Staff must be qualified and competent to
ensure the work is of the required standard. The physical resources to undertake the work must
be suitable to attain the required standards; this will include equipment, consumables, work areas
and utilities.
Audit, quality audit of the GDP is a planned process of inspection conducted in an independent
and detailed way by competent trained individuals to ensure that our procedures and associated
quality assurance comply with the principles of our GDP contained within the document.
Our independent auditors would be:
-
Pharmaceutical and Blood Products – MHRA / Clients
-
Clinical Trials – MHRA / Clients
-
Clinical Specimens – ISO Auditors
-
Known Shipper Status - DTI
-
Airline Shipping and Dangerous Goods – IATA
-
Routing Set Up – Our Clients
Our Internal Auditor is:
-
Simon Baker
-
Tel: 1977
Our role in developing a GDP with our Customers
Purpose: This document is intended to establish working guidelines in conjunction with our
customers for the effective distribution of client samples and pharmaceutical products
Objectives: To ratify the many guidelines described in various Local Government documents for
the effective transportation of Pharmaceutical Products, Blood Products and Clinical Specimens,
whereby information is provided by the following organisations:
-
WHO
-
MHRA
-
DOT/FDA (US)
-
CDC (US)
-
USDA (US)
-
APHIS (Australia)
-
DEFRA (UK)
-
IATA/ICAO
CitySprint Medical express recognises the importance of effective and secure distribution of client
materials, and gives special attention to the integrity of clinical samples, blood, blood products
vaccines and other perishable items.
When integrating with clients we need to ensure that we are given guidance on the client’s
requirements and in turn develop an effective SOP with each customer.
There are four fundamentals that we focus on when agreeing the SOP:
-
Evaluation, CME must be brought into the planning process as early as possible, to
ensure that effective line of communication are open, to agree effective SOP’s, to confirm
the shipping requirements and temperature validation protocols and to plan the optimal
route for each shipment.
-
Packaging must be qualified and validated to ensure that it can maintain the correct
refrigerated or frozen temperature range.
Destination and routing will be business
critical and will determine the choice of packing used.
-
Routing, CME will need to clarify routing arrangements and schedules, liaising with its
commercial airline partners where the cold chain is utilised in flight and on the ground.
Agree tracking points and determine broker arrangements.
-
Documentation, International shipping requires extra diligence due to veryfing import
and export regulations between countries.
In particular documentation for US, Chinese
and Australian shipments must be 100% prior to shipping. Documentation should always
be in order before beginning shipping and explain the purpose of the shipment
When agreeing the shipping and cold chain SOP for each client it is imperative that the relevant
local country or competent organisations rules and guidelines are adhered to.
When shipping Pharmaceuticals and Vaccines in the UK attention must be paid to the “Rules and
Guidance for Pharmaceutical Manufacturers and Distributors 2002”, the “Orange Book” in
particular;
-
the “Guidelines on Good Distribution Practice (GDP) OF MEDICINAL PRODUCTS FOR
HUMAN USE (94/C 63/03)
When shipping whole blood, blood products and plasma in the UK attention must be paid to the
“Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002”, the “Orange
Book”.
Blood products must follow the Guidelines as per the “Guidelines for the Blood Transfusion
Services in the United Kingdom”
Routing and Station Information
Purpose: This document is intended to clearly demonstrate the global reach of CME and publish
the established communication lines globally with our Network of Integrated Partners.
Objectives: To provide a clear communication database globally for the provision of Import and
Export of Pharmaceutical Products, dry – ice top ups and chain of custody validation.
Global Network of over 200 Stations
CitySprint Medical Express has developed over time an effective “Integrated Partners” network
globally with access to over 200 local country stations and related Clearing Agent Partners.
Each consignment forwarded on behalf of our customers will not be grouped or consolidated with
any other material; we do not use any of the integrators such as FedEx, UPS, DHL or TNT.
Each and every shipment sent through our cool-chain medical network is sent directly to the
destination country on it’s own Master Airway Bill, with one of our approved commercial airline
partners, such as Virgin Atlantic, BA, Lufthansa, KLM, BMI, American Airlines, Thai, Singapore to
name a few.
Each consignment will fly directly to the destination country and will be handled individually
through customs, where necessary or available a “walk through” clearance will be assured to
attempt to clear the consignment within the shortest possible time frame.
Where necessary consignments, which are delayed, will be placed in Temperature controlled
storage if required, or a dry-ice replenishment will occur for Envirotainers or thermal control units.
Cold gel packs will also be replenished where necessary.
Once cleared, arrangements are made with the consignee to ensure delivery is made directly to
the receiving lab or facility and not the mailroom or loading dock.
Prompt Customs Clearance and Correct Packing, Labelling and Paperwork
CitySprint Medical Express will handle all elements of the shipment including pre-shipping checks
such as:
-
Check whether local country import permit required
-
Prepare Advance notification (if required)
-
Prepare Commercial Invoice, cut MAWB or DGN if required & MSDS
-
Check that shipment is fit to travel by air as per ICAO/IATA
-
Check routing and on forwarding to ensure adequate cooling capability
-
Prepare outer labelling, add required shipping documents & complete NES entry
-
Check cool-chain requirement against shipping time & organise replenishment
alerts, ensure Temptale is correctly validated
-
Check Packing List attached (if required)
-
Check if Vaccine Arrival Report attached (if required)
-
Check Airwaybill is correctly completed
In addition to the key elements listed above CitySprint will continually manage the shipments
progress through local country customs 24 hours a day.
Because CitySprint Medical Express operates 24 hours a day, 365 days a year, all local country
customs issues are dealt with in real time either in the UK or in the local country, this ensures that
all shipments incur ZERO delay in assisting with clearance.
Many of our nearest rivals do not
operate on a 24*7 basis, which for time and temperature sensitive shipments can be disastrous,
potential clients may incur a 24-hour delay waiting for the UK arm of their shipping agent to
handle issues within a different time zone.
Through our UK clearing body, “Consortium Sea Company – DGV” we are able to promptly clear
all inbound items quickly and effectively.
This is evident with the increase of North American Clinical Trial companies electing to use
CitySprint to “Collect, Clear and Deliver” within the UK and Europe their Temperature Controlled
Vaccines and Investigative Trial drugs.
Routing Information
Stage 1
The screen shot below captures the initial booking screen. CME utilises booking codes, which
are aligned to specific services.
The example below is a shipment of vaccines to a consignee in
Spain, shipped at 2 - 8c.
For instance:
HAZ
- Hazardous Material
MED
- Dry Ice shipment (Packing Supplied and Ice supplied by customer)
MED+ - Dry Ice shipment (Packing and Ice supplied by CitySprint)
MED1 - Temperate Samples
MED2 - Samples at 2 –8 (Requires Temperature monitor)
MED3 - Infectious Material UN2814
MED4 - UN3373 Diagnostic or Clinical Samples/Specimens
Stage 2
Once the shipment is booked, the bar-coded House AWB is created. This contains the delivery
details and any special instructions.
Stage 3
The shipment is then booked onto a direct flight with a major airline partner. The shipment will
be booked directly with the Airline on its own Master Airway bill. We will never consign a
shipment to any of the major integrators such as TNT, UPS, DHL or FedEx.
Once the shipment has been booked with the Airline we will then “cut” (complete) the MAWB
(Master Airway bill).
Once complete the shipment is then manifested to the local country delivery station and a serious
of pre-alerts are then forwarded by email and by fax.
Local Delivery Station Manifest
Stage 3 (continued)
In addition to the local delivery station manifest, the system also produces a MAWB pre alert,
which is also forwarded to the local delivery station.
Stage 3 (continued)
Accompanied with the Manifest and Pre alert will be any relevant paperwork including:
-
Scan of MAWB
-
Transportation Schedule
-
Commercial invoice
-
Import Permit if required
-
MSDS if required
-
Packing List
-
Letter of Credit Paperwork (if required)
-
Advance notification (if required)
-
VAR if (required)
Pharmaceutical Products and Vaccines
Purpose: This document is intended to establish working guidelines in conjunction with our
customers for the effective distribution of client samples and pharmaceutical products
Objectives: To ratify the many guidelines described in various Local Government documents for
the effective transportation of Pharmaceutical Products and Clinical Specimens. Information is
provided by the following organisations:
What are the key elements of the Service Provision?
Dedicated Client Customer Support Team
CME provides a dedicated pharmaceutical/cool chain team to handle the transportation of
Pharmaceutical products and Vaccines. This dedicated team will be able to provide customers
advice on global routing options, cool chain integrity solutions and any specific packing
requirements. This team will be solely responsible for maintaining the integrity of the cool chain
and delivering bespoke global logistics solutions for the client. They will not be working on behalf
of any other non medical divisions within CitySprint and will be available 24 hours a day, 365
days a year.
The team will also include a senior account manager from our US team based in Atlanta to assist
with the North American element of the client requirements.
Transportation of Vaccines, General considerations:
-
Temperature validation must be agreed and implemented into the SOP before
shipping begins, agree the temperature validation system and prepare routing
schedule.
Vaccines should be transported by a secure system using transit
containers supplied by the client. The client must ensure that packing materials
and procedures have been validated for the purpose to ensure the component
surface temperature can be maintained within the prescribed correct ranges during
transport.
-
Monitoring of routine transport temperatures should be performed periodically.
-
Transit containers should be equilibrated to a component’s storage temperature
prior to filling.
-
Transport containers should be appropriately labelled and should be secure and
protect components and samples from damage during transit.
-
Where prescribed a Vaccine Arrival Report (VAR) should be forwarded.
-
Where prescribed an Advance Notification should be sent to the consignee with
the following information
-
o
Type of Vaccine
o
Total number of vials and number of doses per vial in the shipment
o
Number of cartons
o
Gross weight
o
Value of Shipment in (US$)
o
Flight number, ETA and Consignee ETA
o
House AWB and MAWB umber
o
Special instructions and collection details
Documentation should accompany components in transit to permit their
identification.
-
Transport containers should not be exposed to temperatures beyond the range the
range and time for which they have been validated.
-
Refrigerants should not come into direct contact with the components nor the
TempTale.
-
Dead air space in packaging containers should be minimised.
Blood Products/Plasma
Purpose: This document is intended to establish working guidelines in conjunction with our
customers for the effective distribution of Blood Products and Plasma.
Objectives: To ratify the many guidelines described in various Local Government documents for
the effective transportation of Blood Products and Plasma.
To ensure that all Blood Products
and Plasma are
What are the key elements of the Service Provision?
Dedicated Client Customer Support Team
CME provides a dedicated Blood Products and Plasma/cool chain team to handle the
transportation of Blood Products and Plasma.
This dedicated team will be able to provide
customers advice on global routing options, cool chain integrity solutions and any specific packing
requirements. This team will be solely responsible for maintaining the integrity of the cool chain
and delivering bespoke global logistics solutions for the client. They will not be working on behalf
of any other non medical divisions within CitySprint and will be available 24 hours a day, 365
days a year.
The team will also include a senior account manager from our US team based in Atlanta to assist
with the North American element of the client requirements.
Transportation of blood components, General considerations:
-
Donated blood and blood components should be transported by a secure system
using transit containers supplied by the NBS, packing materials and procedures
which have been validated for the purpose to ensure the component surface
temperature can be maintained within the prescribed correct ranges during
transport.
-
Monitoring of routine transport temperatures should be performed periodically.
-
Transit containers should be equilibrated to a component’s storage temperature
prior to filling.
-
Transport containers should be appropriately labelled and should be secure and
protect components and samples from damage during transit.
-
Documentation should accompany components in transit to permit their
identification.
-
Transport containers should not be exposed to temperatures beyond the range the
range and time for which they have been validated.
-
Where melting ice is used to achieve an appropriate storage temperature, it should
not come into direct contact with the components.
Neither should frozen gel
packs.
-
Dead air space in packaging containers should be minimised.
NATIONAL BLOOD AUTHORITY
Local Courier Work Instructions:
1
INTRODUCTION
2
HEALTH AND SAFETY
3
COURIER SERVICE
4
INVOICING
5
PENALTIES/KEY PERFORMANCE INDICATORS
6
PERFORMANCE REVIEW MEETINGS
7
TRAINING
8
AUDITING
NATIONAL BLOOD AUTHORITY
Local Courier Work Instructions:
1
INTRODUCTION
1.1
This document defines the services, which are to be delivered by the Courier. It also sets
out the respective roles and responsibilities of the Courier and the National Blood Service (NBS)
in facilitating and undertaking the delivery of those services.
1.2
Operation procedures relating to the practical application of these instructions by the NBS
will be maintained and controlled by the NBS. The Courier will have operational procedures in
respect of the processes associated with implementing and undertaking its responsibilities
relating to the work instructions.
2
HEALTH & SAFETY
2.1
General Requirements
2.1.1
At the point of collection the driver shall inspect the consignment to ensure that the
shipping units show no signs of damage.
2.1.2
The consignment shall be secured on the vehicle to prevent any damage and ensure that
it is delivered in the correct condition. The vehicle load compartment doors shall be locked at all
times and the drivers doors shall be locked when the vehicle is unattended.
2.1.3
All vehicles must be road worthy with a valid MOT if applicable, road
insurance
and
be fully taxed.
2.1.4
All drivers must adhere to any legislation affecting them
in their
duty of
delivering/collecting as an agent of the National Blood Service (NBS).
2.1.5
At all times the driver must adhere to the site health and safety rules both at collection
and delivery points.
2.1.6
No passengers unless engaged by the courier or on accredited Courier work, must be
carried whilst on NBS work.
2.1.7
No driver or member of the vehicle crew shall open a package unless authorised to do so
by an NBS employee or by a nominated person at the delivery point.
2.1.8
Donations collected from donor sessions will be in a container with an outer thermal
container therefore any spillage will be contained within the unit. Samples collected from a donor
session will be in boxes and crates and require extra care when loading and unloading from the
vehicle.
2.1.9
The collection of blood from Donor sessions will carry a very minor risk of infection should
a spillage occur. This is due to a new donor’s blood being included, for which the NBS will not yet
have any information. The majority of the blood will be from known donors and will have been
tested previously. Products for delivery to Hospitals will consist of tested whole blood, platelets
and frozen products and emergency pharmaceutical products. All products will be enclosed in an
NBS approved container. The frozen product will also contain a small amount of dry ice pellets
and there is a minimal risk of the dry ice giving off CO2 gas as it dissolves all boxes containing
dry ice must be labelled as such.
In the event of an accident/incident en route, which results in damage or spillage, the courier
must follow the emergency information which must be carried on the vehicle at all times. The
courier must phone the NBS centre that placed the order and immediately advise them of the
incident.
2.1.11Deliveries are to be made where practicable with vehicles containing a bulkhead between
the driver and the cargo carrying space.
2.2.1
Blood, which has been collected for the purpose of blood transfusion or for the
preparation of blood products, and blood products and any tissues or organs for use in
transplants, are not regarded as dangerous goods for carriage. Material which maybe classified
as dangerous according to the Carriage of Dangerous Goods (Classification, Packaging and
Labelling) Regulations 1996 are set out in Table 1.
2.2.2
Infectious substances carried are in risk group 3 or below and as such are transport
category 1. Therefore, the full provisions of the Carriage of Dangerous Goods by Road
Regulations 1996 will be required to be complied with when receptacles are over 1 litre or
kilogram and the total load is over 20 litres or kilograms. Information regarding the consignment
and the statutory declaration will be provided where the individual receptacle exceeds 1 litre or
kilogram.
2.2.3
All infectious substances will be packaged in accordance with the requirements of the
Carriage of Dangerous Goods (Classification, Packaging and Labelling) Regulations 1996.
2.2.4 In the first instance product to be carried will only be as points 2.1.8 and
2.1.9,any
product that falls into the category of Dangerous Goods (as per table 1), will only be carried after
both parties agree to it and have consulted with the consignor(s) and both parties dangerous
goods advisors.
Table 1 Classification of Dangerous Goods for Road Transport (excluding specialised activities
e.g. genetic, radioactive materials)
Transport
Description
Risk
Types of Materials
CDG
Streams
Apply
Stream
1
Samples/units
tested
H
Rare known infected, life saving,
Known
and confirmed positive
bone marrow (e.g. for re-infusion)
Infectious
for
from confirmed infected patients
Material
similar*
HIV,
hepatitis
or
Y
Confirmed biohazards **
Repeat
donor
samples
from
confirmed donations
Stream
Samples/units
2aProbable
and
/possible
screening
infectious
(unconfirmed)
tested
reactive
M
to
Unconfirmed, screen positive units
Y
(bio-hazards)**
test
Unconfirmed,
screen
positive
samples sent for confirmation
material
Repeat
donor
screen
positive
samples
from
(unconfirmed)
donations
Stream
2b
Samples for diagnostic
M/L
Diagnostic
purposes
Specimens
patient/donor is known
screening,
or
match
greater
than
100ml
Stream
suspected
unless
Samples of bone marrow typing,
to
Y
tissue or platelet typing, ante-natal
be
phenotyping,
cross
infected (see stream 1)
2c
Samples for diagnostic
Samples of bone marrow typing,
Diagnostic
purposes
Specimens less
patient/donor is known
screening,
than 100ml ##
or
match
suspected
unless
L
to
be
N
tissue or platelet typing, ante-natal
phenotyping,
cross
infected (see stream 1)
* HIV, Hepatitis and other agents for which NBS routinely screens and tests blood are hazard
Group 3
** Units to be denatured before transport by road. Obviously not possible when units/specimens
where infection is being investigated or tested for. Units recalled from hospital or NBS centre (e.g.
NAT pos) may need special handling.
## Exemption from CDG Road Regs available until 31 st December 2003
THE COURIER SERVICE.
3.1
Outline
3.1.1
A courier service shall be provided as per the agreed and documented by both parties,
this should outline periods of cover and period when no cover is available.
3.1.2
Jobs will consist of ad hoc short notice, urgent collections and deliveries as required, and
pre-planned and notified collections and deliveries.
3.1.3
The type of job can vary from issues from an NBS centre to collection of waste from a
remote session’s team. The NBS must communicate what the type of job is when placing the
order.
3.1.4
If at any stage the consignment is lost or damaged, the relevant person at the issuing
NBS site must be informed immediately, and if required to do so the courier must provide a
suitable replacement driver and vehicle at the requested time and site to transport any
replacement product.
3.1.5
Biohazard material includes blood, bone, human tissue -all handling and transport of
biohazard materials, including blood, bone and human tissue must be secure and the vehicles
must be locked when unattended.
3.1.6
Samples from or to hospitals or other centres will be packaged to; The Carriage of
Dangerous Goods (Classification, Packaging and Labelling) and use of Transportable Pressure
Receptacles Regulations 1996.This point will be amended when the NBS has completed its
review of packaging.
3.1.7
The use of motorcycles for the transportation of blood products will be subject to approval
by the Authority and can only be used if express permission is obtained from the NBS for each
specific instance that one is offered.
3.1.8
The courier must employ all drivers; they must carry ID cards, with photographs and
names on them, and be equipped with suitable working mobile phones.
3.1.9
Vehicles exterior must be clean (taking into consideration weather conditions) if it is not it
will be rejected and the courier must provide a replacement ASAP, and any service failures
following will be deemed to be the courier’s fault.
3.1.10 No sub-contracting of the job may take place without NBS authority.
3.1.11 If at any time the Courier wishes to provide a driver who has not been fully trained on any
aspect of the NBS work they must inform NBS at the booking stage to clarify as to whether the
job entails doing work for which the driver has not been trained.
3.1.12 The vehicle interior must be clean, with no spillages, odours or dirty equipment in it, the
customer has the right to reject any vehicles not up to standard and the courier must provide a
replacement up to standard and be liable for any service failures.
All drivers must be fully aware of any special local working practices deemed necessary by the
NBS, and have all necessary contact names and telephone numbers whilst performing
collections/deliveries on behalf of the customer.
No animals may be carried in vehicles engaged on NBS work.
3.1.15 At all times the driver must adhere to the site health and safety rules, both at collection
and delivery points.
3.1.16
As patient confidentiality is covered by the data protection act, all the couriers employees
and agents are bound by this not to reveal any patient details to any body. Therefore no
disclosures or information can be released regarding;
-
The service, its staff or its procedures.
-
The identity of any patient at any hospitals or other establishments.
-
The medical condition, tests undergone or treatment of any patient.
3.1.17 The vehicle is not allowed to carry any product other than that issued by the NBS to it.
Under no circumstances may it carry product for any other SOE customers whilst it is engaged on
work for the NBS.
3.1.18 No courier’s staff shall enter any NBS property without invitation.
3.1.19
The courier must employ for the purposes of these work instructions only such persons
as are careful, skilled and experienced in the duties required of them and must ensure that every
such person is properly and sufficiently trained and instructed and carries out the services with
regard to:
-
The tasks that person has to perform.
-
All relevant provisions of the contract.
-
All relevant rules, policies, procedures and standards of the service.
-
Fire risks and fire precaution.
-
The need for those working in the National Health Service to observe the highest
standards of hygiene, courtesy and consideration.
-
The requirements of the Health and Safety at work Act 1974 and other relevant
legislation and codes of practice.
3.1.20 The courier shall remove from the premises any of its staffs where the service requests
this on the grounds of efficiency or public interest.
3.1.21 The courier shall not advertise or publicly announce that it is supplying a service
or
undertaking work for the NBS without the prior written consent of the service, such consent not to
be unreasonably withheld.
3.2.
COMMUNICATION/ORDERING
3.2.1
Order receiving centre phones must be answered within 1 minute.
3.2.2
Only orders from the NBS that quote an accredited order number may be accepted.
3.2.3
If the booking is for a future date it requires confirmation as soon as it has been arranged.
3.2.4
The Courier shall respond i.e. with a suitable vehicle within the locally agreed response
period, to each request made by the NBS at all times during each 24 hour period.
3.2.5
The delivery should take place within 15 minutes either side of the requested delivery
time.
3.2.6
Whilst carrying out NBS work a non smoking policy shall apply on NBS/NHS sites and in
any vehicle engaged on NBS work.
3.2.7
Whilst delivering to hospitals any requests to turn off mobile phones made by the hospital
must be obeyed for the duration it takes to make the delivery.
3.2.8
If at any time the delivering vehicle is running late for its delivery the NBS department
who placed the order must be informed immediately.
3.2.9
If there any problems at the delivery point the vehicle may not leave until authorised to do
so by a NBS employee after resolving the issue.
3.2.10 All delivery notes issued by the NBS must be left at the delivery point.
3.2.11 Any delays above 10 minutes must be communicated to the NBS department who issued
the order, to ensure that a fast resolution is achieved.
3.2.12 If upon arrival at a delivery/collection the relevant consignor/consignee can not be located
the issue should be immediately communicated to the controlling NBS centre.
3.2.13 If at any time vehicles/drivers/mobile numbers change during a job the customer must be
informed to ensure that consignment traceability and process audibility are maintained.
3.2.14 If the vehicle is involved in an accident the NBS centre that made the booking must be
informed immediately.
3.3 Collection Point.
3.3.1
Upon arrival at the collection site the driver must report to the nominated collection point,
and give their name, vehicle registration and order number issued by NBS and delivery point as
nominated by the NBS.
3.3.2
The driver is responsible for case counting on and off all shipping units and ensuring that
they agree with the quantities shown on issued paperwork. If it not possible to count the product
due to manner in which the customer packages it, the driver must check along with a nominated
NBS employee that the correct packages are being loaded and that they are correctly marked up.
3.3.3
The consignment shall be secured on the vehicle to prevent any damage and ensure that
it is delivered in the correct condition.
3.3.4
The driver must check all paperwork issued to them against shipping units issued to
them, and ensure that they are aware of delivery locations, order of deliveries and required
delivery times.
3.3.5
In the case of product being collected from a donor session for delivery to an NBS centre,
the blood donations should be counted by number of shipping units and the blood samples by
number of individual samples. This count should take place at the collection point and at the
delivery point and must be done in conjunction with the NBS employee issuing/receiving the
product and the respective quantities agreed before being signed for.
3.4 Delivery Point.
3.4.1
Arrival at delivery point to be within 15 minutes either side of quoted ETA.A 100%
achievement is required on this. Allowances will be made for extraordinary condition i.e. major
road traffic accidents, weather etc. Reasons to be agreed between both parties. This must be
communicated at the time and recorded against any such incident.
3.4.2
Any issues occurring at collection point or delivery point in normal working hours of
0830hrs to 1700hrs Monday to Friday with the exception of Bank Holidays must be reported to
the customers transport department who will have placed the order (see contact appendix for
local customer details).
3.4.3
Any issues occurring at collection point or delivery point outside normal working, between
1700hrs to 0830hrs Monday to Friday and all day Saturday and Sunday and Bank Holidays must
be reported to the customers issues department who placed the order.
3.4.5
During transportation, all packages must be secured to avoid damage and or
contamination and carried in a safe and secure manner to prevent accidental damage/loss....
3.4.6
All deliveries will be made to relevant Blood Banks at each Hospital or to predetermined
delivery points as instructed by NBS staff who gave instructions at the time the goods were
collected.
3.4.7
All deliveries will be made directly to the nominated delivery points by the quickest route
available. No deviations or other third party work to be performed whilst undertaking work for the
NBS will be allowed, unless requested to do so by the NBS.
3.4.8
In an event of a Vehicle breakdown, the Courier must ensure the product carried is
delivered by alternative arrangements within the time scales and conditions agreed.
3.4.9
In the event of an accident/incident en route, which results in damage or spillage, the
courier should not attempt to stem the spillage or clean it up at the roadside. The courier must
phone NBS Issuing centre immediately and advise them of the incident.
3.4.10 The NBS must be notified immediately of any disruption/delay to the delivery service.
3.4.11 Upon return to the NBS centre arrangements will be made to remove and dispose of the
consignment.
3.4.12 Within 48 hours of the event, you should notify NBS in writing, with a full explanation of
the incident.
INVOICING
4.1
All invoices will be sent to designated member of National Blood Service staff at the
location which has issued the work.
4.2
Each job must show order number, name of person booking the job (first and second
name), collection point, delivery point, collection date and time and if more than one delivery was
on this job they must be grouped together, and the actual delivery date and time.
4.3The-delivery point format should show hospital name and location by town or in the case of
central London by postcode.
4.4.The invoice should break down by collection site, delivery site, job type, date, time and order
number.
7 PERFORMANCE REVIEWS.
7.1 Regular review meetings will occur on at an agreed frequency.
All aspects of the provision of service
7.2 Any variation to these local instructions must have the agreement of the NBS National
transport and Logistics Resource Planning Manger.
7.3 If it is found that problems are taking place at a local level and an immediate solution is not
forthcoming; the NBS has the right to call a local meeting at short notice to seek to rectify the
issues.
7.4 Any complaints raised by the NBS regarding the provision of service will have to be
investigated by the courier and responded to within 3 working days.
8 TRAINING.
8.1 All personnel involved on NBS work to be trained to agreed standards.
8.2 Personnel at the Couriers sites responsible for operation of service to visit local sites and
meet NBS staff.
8.3 The Couriers staff need to be familiar with their local sites delivery points and routes from
NBS centre to sites.
9 AUDITING.
9.1
The Courier must maintain a list of all drivers trained to do NBS work; this list must be
kept updated.
9.2 Trained list to be in a modular format, to allow training on fresh work instructions as issued.
9.3 The NBS has the right to check this list to ensure that drivers doing work on their behalf are
fully trained.
9.4 Vehicle service records should be available to ensure that checks can be made on their
suitability for the job.
On behalf of the National Blood Service
Name in capitals
Job title in capitals
Signature
Date
On behalf of CitySprint (UK) Ltd
Name in capitals
Job title in capitals
Signature
Date
NBS – Transport Contact Numbers
Transport Contact Numbers.
Centre
Name
Role
Mobile Phone
Fax
0121253 4166
0771144 (377) 7648
0121253 4169
0121253 4166
0771144 (377) 7528
0121253 4169
0121253 4167
0771144 (377) 7688
0121253 4149
0121253 4166
0771144 (377) 7519
0121253 4149
0127730 6019
0776428 (377) 0928
0127730 6087
Desk Phone
Birmingham
Alistair Lovie
Transport CoOrdinator
Birmingham
David Mitchell
Transport
Administrator
Birmingham
Neville Robinson
Transport and
Logistics
Manager
Birmingham
David Smith
Assistant
Transport and
Logistics
Manager
Brentwood
Jill Broughton
Transport and
Logistics
Manager
Brentwood
Gill Harding
Clerical
0127730 6023
0127730 6087
Assistant
Brentwood
Brentwood
Stephen
Transport Co-
Oakham
ordinator
Brian Payne
Assistant
0127730 6072
0776428 (377) 0644
0127730 6087
0127730 6090
0771144 (377) 7220
0127730 6087
0117991 2080
0771144 (377) 7507
Transport and
Logistics
Manager
Bristol
Andy Chapman
Assistant
Transport and
Logistics
Manager
Bristol
Carole Harbridge
Transport
0117991 2082
Administrator
Bristol
Cambridge
0117991 2081
Martin Harris
Transport and
Also covers
Logistics
Plymouth
Manager
Alan Hawkes
Assistant
01223 246 542
Jill Broughton
Transport and
Non
TLM Brentwood
Logistics
Featurenet
is also TLM for
Manager
0771144 (377) 7063
01223 413 782
Non Featurenet
Cambridge.
Colindale
Pearse Allen
Transport &
0208258 2934
0771144 (377) 7548
0208258 2897
0771144 (377) 7054
Logistics
Manager
Colindale
Bill McKeown
Assistant
Transport &
Logistics
Manager
Colindale
Julie Taylor
Transport Co-
0208258 2990
ordinator
Lancaster
Colin Richardson
Assistant
Terry Cain TLM
Transport and
Manchester is
Logistics
also TLM for
Manager
0152430 6204
0780890 (377) 6306
0152430 7361
Lancaster
Leeds
Gemma Holroyd
Transport
0113214 8633
0113214 8700
Administrator
Leeds
Chris Thyer
Transport and
0113214 8760
0776428 (377) 0895
0113214 8700
0113214 8633
0776428 (377) 0609
0113214 8700
Logistics
Manager
Leeds
Wayne Young
Assistant
Transport and
Logistics
Manager
Liverpool
Ed Bond
0776428 (377) 0307
Senior
Resource
Planning Data
Analyst
Liverpool
Ged Caswell
0776428 (377) 0771
National
01925 724369
01925 791612
Resource
Non Featurenet
Non Featurenet
Planning
Number
Number
Manager
Liverpool
Phil Loy
Transport &
0151551 8807
0776428 (377) 0987
0151551 8804
0771144 (377) 7376
0161251 4282
0776428 (377) 0786
0161 253 1211
Logistics
Manager
Liverpool
Peter Smathers
Assistant
Transport and
Logistics
Manager
Manchester
Larry Bannon
National Fleet
Services
Manager
Manchester
Jeff Brandon
Fleet Engineer
0161251 1205
0771144 (377) 7273
0161 253 1211
Manchester
Terry Cain
Transport and
0161251 4248
0771144 (377) 7375
0161251 1222
0161251 4248
0772027 (377) 5319
0161253 1222
0161251 4397
0776428 (377) 0145
0161251 4350
Logistics
Manager
Manchester
Mark Hodgson
Assistant
Transport and
Logistics
Manager
Manchester
Ruth Hopwood
PA to National
Transport
Operations
Manager
(North)
Manchester
John Lowden
Fleet Controller
0161253 1206
Manchester
Avril Marshall
Fleet
0161251 4282
0776428 (377) 0163
0161 253 1211
0161 253 1211
Operations
Assistant
Manchester
Andrew O'Brien
National
0161251 4397
0780890 (377) 6463
0161251 4350
0191219 4445
0776428 (377) 0960
0191219 4597
0191219 4445
0776428 (377) 0662
0191219 4597
0186544 7924
0776428 (377) 0794
0186544 7924
0186544 0018
0776428 (377) 0772
0186544 0053
Transport
Operations
Manager
(North)
Newcastle
David Lowe
Transport and
Logistics
Manager
Newcastle
Duncan Wright
Assistant
Transport and
Logistics
Manager
Oxford
Brian Mitchell
Assistant
Pearse Allen
Transport and
TLM Colindale is
Logistics
also TLM for
Manager
Oxford
Oxford
John Hilton MBE
National
Science Park
MILT, whilst
Transport
John is on AFC
Operations
secondment
Manager
Geoff Thorngate
(South)
at Southampton
is covering his
role.
Plymouth
See Bristol
Sheffield
Ian Easton
Transport and
0114203 4822
0771144 (377) 7337
0114203 4822
0114203 4853
0771144 (377) 7325
0114203 4822
Logistics
Manager
Sheffield
Stephen Firth
Assistant
Transport and
Logistics
Manager
Sheffield
Pat Peckett
Transport
0114203 4853
0114203 4822
0238029 6796
0238029 6779
Administrator
Southampton
Carol Baker
Transport
Administrator
Southampton
Mel Callaway
Assistant
Whilst Geoff
Transport and
Thorngate is
Logistics
covering for
Manager
0238029 6744
0771144 (377) 7541
0238029 6779
0238029 6745
0771144 (377) 7511
0238029 6779
0208258 8389
0771144 (377) 7086
0208258 8539
John Hilton,Mel
Callaway is
acting TLM at
Southampton.
Southampton
Geoff Thorngate
Transport and
Also is covering
Logistics
for John Hilton
Manager
whilst he is on
Southampton
AFC, Mel
Callaway is
covering TLM
role at
Southampton.
Tooting
Chris Appleby
Assitant
Transport and
Logistics
Manager
Tooting
Jackie Butler
Transport and
0208258 8385
0771144 (377) 7087
0208258 8539
Logistics
Manager
Tooting
Philip Holden
Transport Co-
0208258 8580
0208258 8539
0208258 8579
0208258 8539
Ordinator
Tooting
Susan Holland
Transport
Administrator
Watford
Geoff Cotter
General
0192348 6848
0771815 (377) 5200
0192348 6802
Manager
Transport
Watford
Sarah Angus
PA to General
Manager
Transport
0192348 6809
0192348 6802
NBS Maps and Directions
Tissue and Transplant
CME regularly transport Tissue and Bone Marrow for Transplant.
This specialised service is maintained by Andrew Turner, ext 1588, mobile 07989 857 816.
All tissue or marrow must be hand delivered from pick up to final delivery and OBC couriers are
available 24*7.
Airline tickets are booked utilising the company credit card (see Andy Turner –
07989 857 816).
Patient specimens must not be passed through airport X-rays or Metal Detecting equipment.
A
prior notice of indented flight must be forwarded to BAA security who will arrange for the courier
to be hand searched.
If flying from City Airport all arrangements must be made through Adam Tally (020 7646 0088)
(Security Manager) who will arrange the prior notice paperwork.
City Airport are more flexible than LHR, where possible arrange OBC flights from City Airport
Piston Engine, Jet and Helicopter charters are arranged at City Airport through:
London City Airport Jet Centre
Royal Docks
London, E16 2PJ
Telephone: 020 7646 0400
Fax: 020 7646 0450
E-mail: jetcentre@lcy.co.uk
SITA LCYGAXH
Frequency: 131.475
Call sign "Jet Centre Ops"
Attached are sample documents that must travel with the shipment.
Fax pre alert:
Andrew Turner
Business Development Manager
CitySprint Transplant
58-62 Scrutton Street
London, EC2A 4PH
CitySprint Transplant
020 7880 1121
Direct Line:
Mobile:
Direct Fax:
URGENT PRE ALERT
+44 (0) 20 7880 1588
+44 (0) 7989 857 816
+44 (0) 20 7880 1991
Email: aturner@citysprint.co.uk
To:
Lisa Hall/ Adam Tally - LCY
Fax:
From:
Andrew Turner
Date:
Re:
Shipment of Bone Marrow
Pages:
 Urgent
 For Review
 Please Comment
Andy Turner
020 7646 6167
International Sales Director
CitySprint International
22nd November
2005
58-62 Scrutton
Street
London, EC2A 4PH
3
Direct Line:
+44 (0) 20 7880 1590
Mobile:
+44 (0) 7989 855 351
 Please Reply
Direct Fax:
+44 (0) 20 7880 1991
Email: aturner@citysprint.co.uk
Dear Lisa,
As discussed the job is now a definite go, please find enclosed the letter of exemption for the
shipment that must be hand carried on the BA8706, also attached is the booking itinerary for Mr
Marcus Kelly.
The samples are bone marrow cells for a patient that is suffering from Leukaemia. They cannot
be consigned to the cargo hold as this renders the cells ineffective for treatment.
The samples can not be x-rayed as this will kill the cells newly cured cells.
The transportation of these samples by hand is patient critical; we appreciate your assistant with
these.
Regards
Andy
Direct Line:
Mobile:
+44 (0) 20 7880 1588
+44 (0) 7989 857 816
Commercial Invoice:
Commercial Invoice
23rd November 2005
From:
To:
Dr Amanda Curran
Dr Joanna Mountford
Clinical Trial Manager
The Royal Infirmary
Dept of Gene and Cell Therapy
Alexandra Parade
National Heart and Lung Institute
Glasgow
Emmanuel Kaye Building
G31 2ER
Manresa Road
London
SW3 6LR
Full Description of Contents:
Covering 3 million bone marrow cells labelled with Indium-111 with an estimated dose of 10 Mbq x 4
aliquots. Bone Marrow cells for Leukaemia patient undergoing life saving therapy. The Cells are
packed in 1 approved fibreboard shipper specifically designed for shipping bone marrow samples.
This package conforms to the conditions and limitations specified in section 10.5.9, Excepted
Packages of the IATA Dangerous Goods Regulations 47th Edition.
This package is also exempt from being x-rayed as per the NASP regulations, chapter 18,
Annex F, Item 5, which in summary states that: “ bonafide consignments of life saving nature,
other essential medical supplies, human organs, blood plasma” are exempt from being x-rayed.
This shipment must not travel in the cargo hold because the pressure and temperature will
destroy the cells rendering them ineffective for the patient’s treatment.
These samples are being hand carried by Mr Marcus Kelly on flight number BA8706. Mr Kelly’s
passport number is 029040972, Mr Kelly’s ticket number is ZWXFTX, the security seal number on the
shipping box is X25B.
The material does not come from a facility where work with exotic viruses affecting livestock and avian
species is conducted.
The material is not recombinant.
I hereby certify that the contents of this consignment are fully and accurately described above by the
proper shipping name and are classified, packed, marked, and labelled, and in proper condition for
carriage by air according to applicable national governmental regulations, IATA and DFT regulations
Certified true and correct.
Dr Amanda Curran
Royal Brompton Hospital
Shipping UN3373 and UN2814
Purpose: This document is intended to establish working guidelines in conjunction with our
customers for the effective distribution of client samples and pharmaceutical products
Objectives: To ratify the many guidelines described in various Local Government documents for
the effective transportation of Pharmaceutical Products and Clinical Specimens. Information is
provided by the following organisations:
CitySprint Medical Express
FACT SHEET - Shipping Biological Materials & Dry Ice
The International Air Transport Association (IATA) and many local Government Agencies,
including DEFRA (UK), ADR (UK), Centers for Disease Control and Prevention (CDC - US), the
Department of Transportation (DOT - US) have requirements regarding shipment of hazardous
materials, which are termed, “dangerous goods".
Dangerous goods are articles or substances
which are capable of posing a risk to health, safety, property or the environment. Infectious
substances, diagnostic specimens, genetically modified microorganisms and dry ice are listed as
dangerous goods and must be packaged and shipped accordingly.
Implementation of the IATA
requirements ensures compliance with all of the other agencies’ requirements. IATA requirements
are updated annually, are complex and may be non-intuitive. This fact sheet provides only an
overview of the current requirements regarding training, packaging, labeling and transportation
regulations.
You will also need to know UN codes, specific packing instructions and other
information from the IATA Dangerous Goods Regulations Manual to properly prepare your
shipment.
2005 Regulatory Update
Shipping regulations have changed significantly in 2005. The major updates include:
Infectious agents and diagnostic specimens have been classified into lists known as “Category A
agents” and “Category B agents.”
-
Category A agents are infectious materials that have the potential to cause serious/life
threatening disease or disability.
-
Category B agents are generally diagnostic specimens which pose a low risk during
transportation.
-
Diagnostic and clinical specimens must be labeled with UN3373 and be marked
“Diagnostic Specimen” or “Clinical Specimen.”
-
Airway bills for diagnostic specimens will need to include the text “Diagnostic Specimen”
or “Clinical Specimen,” and the packaging will require the UN3373 label.
Training Requirements
IATA (by air) and ADR (by road) training is required for all CME personnel who:
-
Prepare shipping documentation
-
Mark and label packages
-
Repack items that are received in poor or damaged condition
-
Accept packages
-
Supervise transport of packages.
Training is required initially and must be refreshed within 24 months of the previous training. The
training will describe the shipper’s responsibilities and provides the necessary guidelines and
references to ensure the safe and compliant transport of dangerous goods. Similar training is
also required for authorization to ship other dangerous goods, including chemicals and
radioactive materials.
IATA Shipping Terms
INFECTIOUS SUBSTANCES are class 6.2 Dangerous Goods. IATA defines infectious
substances as materials known or reasonably expected to contain pathogens. Pathogens are
defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, or fungi) and other
agents such as prions, which have the potential to cause disease upon exposure to humans or
animals. Infectious substances are assigned to UN classes based on the following definitions:
-
Category A, is an infectious substance which is transported in a form that is capable of
causing permanent disability, life threatening or fatal disease in humans or animals.
Category A infectious substances require Packaging Instruction 602 and are assigned to
either UN2814 (infectious substances affecting humans) or UN2900 (infectious
substances affecting animals). Examples of Category A materials are listed in Table 1.
-
Category B: An infectious substance which does not pose a risk of causing permanent
disability, life threatening or fatal disease to humans or animals. Most diagnostic or
clinical specimens are considered Category B and are assigned UN 3373 and follow
Packaging Instruction 650.
-
CULTURES & LABORATORY STOCKS are materials that have been amplified or
propagated in order to generate high concentrations or organisms. This definition of
cultures and stocks refers to items prepared for the intentional generation of pathogens
and does not include cultures intended for diagnostic and clinical purposes. Cultures that
meet the criteria of Category A or B infectious substances must be handled accordingly.
-
GENETICALLY MODIFIED ORGANISMS (GMOs) are class 9 Dangerous Goods. GMOs
are defined as an organism in which genetic material has been purposely altered in a
way that does not occur naturally. These materials are assigned UN 3425 and should be
packed according to Packing Instruction 602. The maximum quantity in a primary
receptacle must not exceed 100 ml. or 100 g. If GMOs meet the definition of Category A
or B infectious substances, they must be handled accordingly.
-
DRY ICE is a class 9 Dangerous Good. Packages containing dry ice must always be
declared as such by proper marking and labeling. A shipper’s declaration form is not
required if no other dangerous goods are in the shipment. Dry ice must be packaged to
permit the release of carbon dioxide gas and to prevent a build-up of pressure that could
rupture the packaging. Packaging Instruction 904 must be used. A dry ice shipper’s
checklist is in the warehouse.
-
Special packaging and arrangements must be made with the carrier for packages
containing liquid nitrogen, except in the case of “Dry Shippers”.
-
BIOLOGICAL PRODUCTS may be considered dangerous goods and are divided into two
groups.
o
Products manufactured and packaged in accordance with the requirements of
appropriate national authorities (such as FDA). These products must be planned
for use for personal health care by medical professionals or individuals. If these
items are being transported for the purposes of final packaging or distribution
they are not subject to dangerous goods regulations. However, Packaging
Instruction 650 is recommended.
o
Examples of non-regulated biological products may include vaccines; licensed
diagnostic kits; experimental product distributed prior to licensing; investigational
new drugs; items used for prevention, treatment, or diagnosis of disease
in
humans or animals; and items used for development, experimental or
investigational purposes.
Substances which are not described above and are known or reasonably believed to contain
infectious substances may meet the criteria for inclusion in Category A or Category B. If
substances meet the definition of Category A or B materials, then they must be handled as an
infectious substance.
TABLE 1: CATEGORY A INFECTIOUS SUBSTANCES
UN Number & Proper Shipping Name
Organism Name
UN 2814:
Bacillus anthracis (cultures only)
Infectious substances
Brucella abortus (cultures only)
affecting humans
Brucella melitensis (cultures only)
Brucella suis (cultures only)
Burkholderia mallei - Pseudomonas mallei – Glanders (cultures only)
Burkholderia pseudomallei – Pseudomonas pseudomallei (cultures only)
Chlamydia psittaci - avian strains (cultures only)
Clostridium botulinum (cultures only)
Coccidioides immitis (cultures only)
Coxiella burnetii (cultures only)
Crimean-Congo hemorrhagic fever virus
Dengue virus (cultures only)
Eastern equine encephalitis virus (cultures only)
Escherichia coli, verotoxigenic (cultures only)
Ebola virus
Flexal virus
Francisella tularensis (cultures only)
Guanarito virus
Hantaan virus
Hantaviruses causing hantavirus pulmonary syndrome
Hendra virus
Hepatitis B virus (cultures only)
Herpes B virus (cultures only)
Human immunodeficiency virus (cultures only)
Highly pathogenic avian influenza virus (cultures only)
Japanese Encephalitis virus (cultures only)
Junin virus
Kyasanur Forest disease virus
Lassa virus
Machupo virus
Marburg virus
Monkeypox virus
Mycobacterium tuberculosis (cultures only)
Nipah virus
Omsk hemorrhagic fever virus
Poliovirus (cultures only)
Rabies virus
Rickettsia prowazekii (cultures only)
Rickettsia rickettsii (cultures only)
Rift Valley fever virus
Russian spring-summer encephalitis virus (cultures only)
Sabia virus
Shigella dysenteriae type 1 (cultures only)
Tick-borne encephalitis virus (cultures only)
Variola virus
Venezuelan equine encephalitis virus
West Nile virus (cultures only)
Yellow fever virus (cultures only)
Yersinia pestis (cultures only)
UN 2900:
African horse sickness virus
Infectious substances
African swine fever virus
affecting animals only
Avian paramyxovirus Type 1 - Newcastle disease virus
Bluetongue virus
Classical swine fever virus
Foot and mouth disease virus
Lumpy skin disease virus
Mycoplasma mycoides - Contagious bovine pleuropneumonia
Peste des petits ruminants virus
Rinderpest virus
Sheep-pox virus
Goatpox virus
Swine vesicular disease virus
Vesicular stomatitis virus
Required Steps for Shipping Dangerous Goods.
Shippers are responsible for following the steps below when shipping dangerous goods:
1. Classify. The materials must be classified according to hazard class 1-9 (ex. infectious
substances are class 6.2, GMOs are class 9). Any additional hazards present such as
dry ice or flammable materials must also be identified.
2. Identify. From the IATA Dangerous Goods Manual, identify a proper shipping name, UN
ID number, hazard class, packing group, cargo/passenger air limitations and special
provisions.
3. Select the Proper Packaging. The IATA Dangerous Goods manual sets out which
packing instructions should be used.
An example of a triple-packaging system for
packaging infectious, diagnostic or biological shipments is shown on page 5.
4. Pack. Follow the directions provided by the packing material manufacturer. Make sure
all of the components are included. Ensure a leak proof seal. Be sure to tape the screw
cap of the primary containers. (Please note that all samples should be packed within
the lab environment by the customer, CME staff, do not re-pack UN2814).
5. Mark and Label. Labels identify that packages contain dangerous goods & give a broad
indication of the type of material inside the box. Mislabeling or misrepresenting package
contents is illegal.
6. Complete the Documentation.
All shipments of dangerous goods must be
accompanied by an airway bill or shipper’s declaration that describes the consignment in
detail. For an infectious substance, both a
shipper’s
declaration
and
a
24-hour
emergency response telephone number are required.
7. Forward Pre Notification of Shipment Arrival. Check if there are any special handling
or permit requirements for the shipment. Ensure the consignee is aware of the package,
its contents, temperature requirement routing and ETA.
Prohibited Items and Prohibited Modes of Transportation
-
Certain items and substances are prohibited from transportation by Air; check the IATA
DG Regulations, also dangerous goods by hand or in luggage is only permitted if explicit
approval is given from the carrier. Dry ice, only if declared to the carrier and approved,
may be put in carry-on or checked baggage.
-
IATA regulations cover any dangerous goods that are carried or transported including
when boarding an airplane. Persons who violate IATA regulations and knowingly misdeclare items on a DG note are subject to fines and criminal prosecution.
Labels & Packaging
Infectious substances and other dangerous goods must be transported in appropriate containers.
UN approved packaging materials meet stringent “test” criteria ensuring that the package can
withstand leakage, shocks, temperature changes and pressure changes that can occur during
transport. These UN approved packaging materials are acceptable for transport of shipments in
motor vehicles, trains, boats and airplanes.
Labels: If package contains infectious materials, a class 6 infectious substance label must be
placed on the outer packaging. A new diamond shaped label printed with UN 3373 is required for
all diagnostic or clinical specimens. If dry ice is present in the shipment, a class 9 diamond label
must be on the outer packaging. When shipping over 50 ml or 50g of infectious substance, you
must also either split the shipment down into the appropriate number of boxes or put a “Cargo air
craft only” label on the outer package.
Receiving Dangerous Goods Packages
The following provisions are incorporated within the SOP for receipt of packages containing
infectious substances, diagnostic specimens or GMOs that require re packing.
CME staff must not open any inner packing’s, but will check for the following:
Proper paperwork and labelling:
-
The label and accompanying documentation should be examined.
Package integrity:
-
The package should not be leaking or appear damaged in any way. If it is, notify the PI
immediately. Disinfection & clean-up materials should be available for spills.
Leaking Packages:
-
Receiving warehouse staff should not handle a package that appears to be leaking or
damaged. Receiving personnel should isolate the area around the package, and then
notify the recipient and the 24 hour emergency contact.
If anyone has become
contaminated after handling the leaking package, they should wash the affected area for
15 minutes, and then visit the local (A&E at the Royal London Hospital, Whitechapel
Road E1) for additional medical follow-up. The trained representative or if in doubt local
authority (Fire brigade – dial 999) should clean up any spill and decontaminate the area
according to procedures listed below.
Clinical Trials and Patient Specimens
A Clinical Trial is an experiment on human beings and is controlled by local government.
Principle controls are the Declaration of Helsinki, which is designed to give protection to the
patient, or subject; and Good Clinical Practice, which drills down into more detail and additional
requires integrity of the data produced.
GCP overlaps with GDP in certain aspects and it is imperative that when CME is utilised to
provide logistics for clinical trials, we must be involved with the trail co-ordinator pre start up and
agree the SOP’S.
If storing clinical trial materials, protocols must be set up and agreed with the client prior to trial
commencement as it is a requirement of GCP that monitoring of packaging, distribution and
storage is approved by both regulatory and technical bodies.
CitySprint Medical Express have been chosen by various labs within UK University research
campuses to assist with the logistical set up and going support of Clinical Trials.
Many labs have been let down by the larger integrators, who simply have not collected the patient
samples, lost patient samples or in some cases have left patient samples on airport runways in
direct contact with sunlight for the samples to be rendered useless.
As part of our Clinical Trial Support, we work alongside the clinical trial managers or trial coordinators:
-
Contact the local collaborator or research nurse to understand how the samples are
presently stored (frozen, chilled, and ambient).
-
Forward to the collaborator the correct packing material and dry-ice arrange a predetermined time when the lab will be ready to hand over the samples Make the booking
to collect the samples, documenting collection time and ETA of arrival.
-
Provide on-site storage of samples collected in batches to be delivered to the study
coordinator in one hit Storage, call-off and forwarding of randomised drug trial kits.
All Clinical Trail activities must be handled (CME) by either:
-
Andrew Turner, 1588
-
David Potter, 1589
-
David Humby, 1590
Cold Chain, Distribution & Warehousing
Cool Chain Solutions
CitySprint is committed to maintaining, developing, controlling and ensuring the cold chain
environment for clients is our number one priority.
Our own internal auditors and scientific team will work closely in partnership with clients at the
outset to ensure that we understand the current requirements, prepare and agree auditable
SOPS; ensuring valid audits are undertaken by client staff to ensure that we jointly agree a Global
Shipping solution fully tailored to the requirements of the client.
Within the UK we operate our own fleet of temperature-controlled vehicles, which maintain preprescribed temperatures for each specific cargo.
Within the UK we also offer a vast range of temperature controlled packing options for smaller
items, ranging from Liquid Nitrogen, Dry-Ice, Wet-Ice solutions, and Chilled Gel solutions to small
controlled release shipping boxes with in-built temperature monitors.
For shipments overseas we have partnered with “Envirotainer” utilising their temperature
controlled shipping products, which maintain the integrity of chilled or frozen samples up-to 96
hours depending on the unit utilised.
The Envirotainer units are leased by CME and we handle the booking and return of each unit.
Outside of the UK we also offer a vast range of temperature controlled packing options for smaller
items, ranging from Liquid Nitrogen, Dry-Ice, Wet-Ice solutions, and Chilled Gel solutions to small
controlled release shipping boxes with in-built temperature monitors.
Envirotainer leases must be made at least 24 hours prior to requested shipping date.
Lease forms are attached and must be faxed to:
-
Lease form
-
Return form
-
Unit specifications
Best Practice Solutions for Temperature Ranges and GDP
Packing materials, thermal control units, dry-ice and refrigerants are held in stock in the Medical
Unit in the Warehouse.
We provide 3 main thermal control units, available for either PI650 or
PI602 materials.
These are our validated 96 Hour validated shipper, used for overseas samples to North America,
Asia, Australasia, India, Africa our 72 Hour validated shipper used for sending frozen or chilled
samples within Western and Eastern Europe and our 48 Hour validated shipper for use within the
UK.
The 48 Hour Shipper is priced at £15.95 plus vat, the 72 Hour Shipper is priced at £20.95 plus
vat, and the 96 Hour Shipper is priced at £35.95 plus vat.
Also available to clients are our Liquid Nitrogen Dry-Shippers, these are normally hired out to labs
for shipping samples in Liquid Nitrogen.
CitySprint Medical Express also stock a full range of UN approved packing materials for almost
any potential combination of ambient or temperature controlled shipment, for all packing groups
and classes. For further information and bespoke request please contact David Potter on 1589.
In addition we also utilise Envirotainer units for highly sensitive and high valuable items. We have
a working relationship with Envirotainer and their LHR hub is1 minute from CME’s LHR offices.
When agreeing an SOP with the client it is imperative that the destination is qualified to ensure
that the appropriate packing and cool chain environment is developed.
Temperature validation can be provided utilising a TempTale. Temp Tales are held in stock in
the Medical Room in the warehouse and are available in single or multi use units. The multi use
units are reserved for on going clinical trials.
Under no circumstances must a Temp Tale be
used without agreeing the Temperature range with the client and validating the cold chain
environment and routing.
Temp Tales must be ordered through Andy Turner, 1588 or David Potter 1589 only!
CME do not dictate the Temperature Range when shipping samples this must be done by
the client.
Chain of Custody
CME as part of the SOP for shipping Clinical or Pharmaceutical goods will agree an effective
Chain of Custody with each clinical trial or Pharmaceutical client.
Many precautions are taking in a typical research lab to ensure the integrity of biological
specimens, clinical trial investigative drugs and vaccines. Temperature and storage are tightly
controlled by our clients and as such CME must demonstrate similar controls within it’s SOP’s.
To ensure that CME adheres to the strict protocols adopted by our customer there are various
forms and manifest which are used when handling Pharmaceutical and clinical commodity’s
through our cold chain.
1. The cold chain begins at the client site and is handed over to CitySprint once the
collection is made from the client site, either in a refrigerated vehicle or a temperate
vehicle.
2. The shipment is manifested into the local warehouse where it is either on forwarded to
the destination country via a direct and specific routing or it is stored in a cold room,
fridge or freezer (if prescribed) for delivery the following day.
3. Electronic audit trail and hard coded collection and delivery information is captured and
can be viewed on line at www.citysprint.co.uk. CitySprint are able to provide On Line
Hard Copy Proof of Deliveries, instantly upon delivery.
4. Each of the drivers is tracked via satellite tracking and their exact whereabouts can be
viewed on line at www.citysprint.co.uk
5. Once in transit the temperature of certain items including vaccines, blood products and
plasma and clinical trial material should be monitored at regular pre determined internal
by utilising a Temp Tale unit.
6. For international shipment the Airline Check form should be completed where possible,
this is used in conjunction with THE Temp Tale readouts.
In most if not all cases this
information is collected by the clinical trail company and not by CME.
7. Final delivery POD is captured, and where possible the Temp Tale unit is sent back to
the client for analysis.
8. Job is closed off and temperature validation is documented and filed by client.
-
A custody manifest is enclosed over.
-
A full description of our tracking facilities is enclosed over
Custody Manifests
Booking and Tracking Capabilities
Our clients would be able to book our services, via the telephone and On-Line, via our On-Line
Booking Facility. Outlined below is a brief explanation of this process.
Telephone Booking:
Each booking would be made directly on to our CityTrak system. This involves the simple filling
in of a certain number of fields on one screen (see screen example overleaf). Once this process
is completed the job is confirmed and then electronically transferred to the relevant circuit for
allocation to a courier.
There are time saving features that can be used in this process including storage of regularly
used collection and delivery addresses which can be accessed with a single key stroke.
If the customer had any regular jobs/runs that occur at the same time each day, CitySprint would
be able to upload the job onto our CityTrak platform and it would automatically appear on the
controller’s screen for allocation. This means that the customer would not need to continually
contact our call centre to book the same job each day.
Security features can also be used in this process including:

Authorised user lists

Verification of cost centres and references

Delivery Procedure
On-Line Booking
On-Line Booking is a Java front end to our CityTrak IT Operating Platform and feeds information
directly into CityTrak. CitySprint’s On-Line Booking for SameDay Courier jobs is an extremely
robust system, over 15,500 jobs are booked monthly and it has been in operation for more than
three years. Our clients would access this system through our corporate web site,
www.citysprint.co.uk and log in using their account number and a unique password.
After logging in, clients’ staff would be transferred to the booking screen. Within this screen the
Our clients personnel would complete a series of fields with the relevant details of their job, some
of these fields are compulsory and the system will not let the booking progress until these fields
are completed, an error message is displayed.
The booking screen also has an address book facility. Our clients’ staff would be able to save
frequently used addresses; therefore, instead of continually typing in the same addresses, the
person booking can just scroll through and select the appropriate address.
Additionally, CitySprint can modify the department and reference fields to any preference, such
as purchase order number or departmental code.
The compulsory fields are highlighted with blue writing. An example of a booking screen is
displayed below.
NextDay Courier and International Courier jobs can also be booked On-Line via our On-Line
Booking system. Through this password protected system, customers are able to do the
following:

Access an On-Line quotation facility for specific services

Request a collection

Consignment information can be entered and a plain airway bill produced for the shipment

An end of day manifest can be produced to allow drivers to check and sign for all material
collected

Track their consignment

Invoices for prior shipments can be accessed and printed.
An example of a CityTrak International screen is shown below.
All shipments processed by CityTrak International travel on a bar-coded Airway bill.
These
airway bills are scanned at each leg of the journey from collection to final delivery and allow for
real time tracking to be provided On-Line at www.citysprint.co.uk
Tracking Capabilities
Monitoring:
From the time that a booking is made for the despatch of a consignment to the time that the
consignment is delivered, CityTrak maintains a full audit trail which is recorded automatically.
The points at which details are recorded are:

At booking

At allocation to courier

At collection

At delivery
At each point details are recorded of

The time

The operator name

The operation carried out
This information is collected by our mobile data units, CityTrakkers, which are carried by our
couriers. Details of the pick up are relayed directly to the unit by our CityTrak system. The courier
confirms that they have received the details and also confirms that they have picked up the
consignment. On delivery the recipient signs across the CityTrakker and the courier enters the
name of the signatory. This information along with the time the signature is entered and is
transmitted via the GPRS network back to our CityTrak operating platform this information is also
viewable over the internet, via our On-Line Booking facility.
Through our On-Line Booking system, the clients can also track the progress of their package,
this is enabled through the job reports and tracking page. Clients can track the progress of the
package through using either the job reference number given or the date the job was completed.
After selecting the job the journey is then displayed and at the bottom of the screen is a message
box detailing the latest information on the job, for example confirmation of booking and delivery
time. Additionally within this system, clients would also able to view the electronic signature of the
recipient. This information can be printed off and kept for future reference, an example of this
proof of delivery is shown overleaf.
Additionally, through the job reports and tracking page, the Our clients could access management
reports detailing the amount of jobs booked and the journey details, which can be either
downloaded in a CSV file or downloaded into a PDF format, which can be printed out. This
information can be used to analyse usage of the services. A screenshot of this screen is
displayed below.
CitySprint have also implemented a single job search facility, QuikTrak. QuikTrak is also available
via our corporate web site, but unlike On-Line Booking customers do not need to input a
password with an account number just input the account number and the unique job reference
number relating to the job, which is given at booking. The difference between this facility and our
On-Line Booking facility is that this system is designed for the tracking of a single job, whereas
On-Line Booking enables customers to search for more than one job undertaken within a certain
period and a report can also be downloaded detailing the number of jobs booked.
International Tracking and Tracing
Each shipment will be scanned at each leg of the journey to ensure that tracking information is up
to date. All tracking information is available on-line.
Proof of Delivery will be available On-Line:
Mobile Data and GPS Tracking
CitySprint have equipped our national fleet with CityTrakker units. CityTrakkers are XDA mobile
data units through which our control staff allocate jobs to our couriers. Once the job has been
allocated the driver then confirms that they have received the details and also confirms that they
have picked up the consignment. On delivery the recipient signs across the CityTrakker and the
courier enters the name of the signatory. This information along with the time the signature is
entered and is transmitted via the GPRS network back to our CityTrak operating platform and is
also viewable over the internet, via our On-Line Booking facility.
The CityTrakker units also have an industry first fail-over system through a GRPS and GSM
facility.
The CityTrakker can also double as a mobile phone if further communication is needed.
All CitySprint couriers will have a GPS unit connected to their CityTrakker XDAs. CitySprint
controllers are able to monitor the exact location of all couriers. Once a consignment has been
allocated to a courier, customers would be able to view the actual progress of the courier on line,
in terms of pinpointing the courier’s position on a map, until the delivery has been made and the
POD is available also on line in real time.
GPS mapping provides CitySprint Operations staff with full visibility of all couriers
from any location.
Customers can view the location of a courier allocated to their consignment from time of
allocation to time of delivery.
Temperature Control/Validation on site
CME has one 10’ x 6’ walk in cold room, which is set for a temperature range of 2 – 8˚. This is
used for the following clinical trials:
Cold Room Validation is implemented on regular basis by Sensitech. When implementing clinical
trials that require temperature validation this must be written in to the specific GDP/SOP for that
trial and original validation reports must be sent directly to the client.
-
-
-
Police Airwave Monitoring Study
o
Sponsor:
Home Office
o
Trial Coordinator:
Imperial College
Ministry of Defence
o
Sponsor:
MOD
o
Trial Coordinator:
DTMA compulsory drug testing (LGC Labs)
Ad hoc sample storage
o
MRC
o
Imperial College
o
Baxter
o
MRD Leukaemia Trial
o
St Thomas’s Hospital
o
Bart’s and The London Hospital
All samples for on-going trials must be pre-booked and all ad-hoc samples must be manifested in
and out. See manifest form on side of unit.
The units are leased from Ice Cool Trailers, 24 hour emergency response is available from 01653
250 950 or 07850 226839, account manager is Miles Atherton. Agreed SLA for call out engineer
is 120 minutes from call.
There is 1 Frigidaire domestic freezer and 1 Frigidaire fridge located in the medical unit in the
warehouse.
Temperature Validation in transit
CME has partnered with Sensitech to ensure accurate temperature monitoring whilst in transit.
Sensitech provides single or multi use Temp tale units that monitor a range of temperatures from
temperate and chilled units to units that are placed within dry-ice shippers.
All Temp Tales units must be ordered through Andy Turner, 1588 or David Potter 1589.
CME’s account manager is:
Simon Hartley
Regional Sales Manager
Sensitech UK Limited
167 - 169 Kensington High Street
London
W8 6SH
Tel:
+44 (0) 207 795 4420
Fax
+44 (0) 20 7937 0661
Mobile +44 (0) 791 757 7375
The following pages relate to the set up and SOP’s for each of the Temp Tale units.
TempTale 4 Instruction Sheet
A TempTale 4 temperature-monitoring device is included in this shipment. Refer to the ‘Receipt
of Study Vaccines at the Study Site’ Procedure in your Study Specific Manual for detailed
instruction.
Before stopping the TempTale 4 monitor: inspect the digital
display to ensure that there is a sun icon in the upper left-hand corner.
The sun icon ( ) is
visible when the
TempTale is recording.
Switch the TempTale 4 monitor off:
Press the red “Stop” button on
the TempTale monitor and hold
down for 3 seconds, to stop
temperature measurement.
The sun icon ( ) will
disappear when the
TempTale is stopped.
A “Stop” icon ( ) appears when the
TempTale is stopped.
If a bell icon ( ) is displayed
before / after stopping the
TempTale:
Vaccine must be quarantined!
To obtain the temperature readings for
the TempTale Receipt Form:
Press the “Start”
button to obtain brief
readings.
The readings are given in the following order:
• Mean temperature (C)
• Highest temperature (C)
• Total time above high temperature limit (minutes)
• Lowest temperature (C)
• Total time below low temperature limit (minutes)
S.O.P. s - Using TempTale4 2K Temperature Monitors:
I. Downloading a TempTale4 Monitor: Once you have removed a
TT4 monitor from a fridge, press the Stop button for 3 seconds. This will
ensure that the TT4 was stop. A small “Stop Sign” shaped icon should
appear on the top right corner of the LCD indicating the monitor has been
stopped.
1) From the Start-up Assistant dialog, or select Monitor; Download
TempTale Monitor or click on the Download a TempTale4 monitor
icon.
2) At the Download Monitor dialog connect the TempTale4 to the Interface
Plus by laying the TempTale4 facedown in the bracket of the Interface
Plus, so the LED lights are aligned. Than click OK to continue.
3) At the prompt disconnect the TempTale4 monitor and click OK. In the
case of Multi-Use monitors that are still actively recording data will
display “Would you like to stop this multi-use monitor now?”
4) Click Yes to transfer the data stored and stop recording additional data.
Click No to transfer the data stored and continue recording data when the
TempTale4 monitor is disconnected from the Interface Plus.
II.
Accessing the Data: To access the Graph, Summary or Tabular
views, download a TempTale4 monitor or open a stored file. Clicking
in the tabs, located at the bottom of the screen, will display the
Summary, Configuration, Tabular or Graph views for that file.
1)
Summary View: This view displays the start and stop time,
minimum temperatures recorded, average, standard deviation, time
above and below the programmed range, degrees minutes above and
below the programmed range and the number of events above and
below the programmed range as well as comments stored with the file.
TempTale4 & Software
Features and Benefits
Feature
LCD displays key decisionmaking information
Only monitor available that
displays cumulative time out
of range
Software allows multiple files
to appear on one display
Benefit
No need to download TempTale to view key
data; can download at convenience for further
analysis and documentation.
Assures customers of state-of-the-art
technology that competitors cannot offer.
Up to 15 files can appear at once as multiple
graphs overlaying and multiple tabular reports,
which will be useful when doing any
validation/qualification studies
Data cannot be overwritten
The data recorded on the unit will not be
overwritten. All records remain on the data
logger even after it is downloaded several
times.
Data cannot be altered
After downloading the data cannot be altered
Certificates of Calibration
Certificates of Calibration are provided with all
provided with both Single-Use units, which are traceable to NIST standards.
and Multiple-Use monitors free You do not need to calibrate the units in-house
of charge
or have them sent to a 3rd party calibration
company, which would cost as much as a new
monitor.
Customized Alarm Triggers
Alarm is very useful in making accept/reject
 Cumulative time above or
decisions.
below
No need to download monitor to make
 Single event above or below decision.
 Degree-minutes above or
below
Annual Trade-in for Multiple
All Multiple-Use monitors are traded-in
use monitors
annually. New units along with certificates
of validation will be provided for less
than half of the initial unit price.
Using a TempTale 4 Monitor
Starting the TempTale 4 Monitor
1. Hold down the start button (the green button on the monitor) until you see the sunshine icon (picture) on the upper
left corner of the LCD that confirms that the monitor has started. When the monitor is activated, the sunshine icon
will stay on until the monitor has been stopped. The monitor will begin recording data after the startup delay is
completed. Refer to the figure below:
TempTale 4 Monitor
Note: TTM software uses only temperature data to generate graphs, tables, and summary data.
- PROGRAMMING OPTIONS Catalogue Number:
Alarm Bell on LCD:
Certifcates:
Start-Up Delay:
Display Current Temp:
Choose one a Recording Period:
b Measurement Interval
High Alarm
Delay
Low Alarm
Delay
Launch Options:
LCD Panel Display
Start Key Options:
Stop Key Options:
Temperature Range:
Monitor Type: Single Use
Y/N
(mins)
Y/N
Days/Hours
International Certificate of Validation
30 mins
Yes
5 mins
C
(mins)
C
(mins)
C or F
8
0
2
0
Manual, 30 min delay
C
3 second delay
3 second delay
2-8C
Configuring a TempTale 4 Monitor
1. Open TTM software and select Start Up Assistant; Configure a TempTale Monitor. The ‘Monitor
Configuration’ dialog box will open.
2. Connect the monitor facedown on the Interface Plus and select OK.
3. If the Monitor is Single Use and has been used you will not be allowed to re-configure the unit.
4. Otherwise edit the configuration data in both fields General Configuration and LCD Alarm accessible
by the index tabs on top of the Monitor Configuration window.
5. Confirm new settings are correct as only one configuration change on Single Use loggers is permitted.
Then select OK. New data will be stored. When completed, remove logger and select OK. Screen on
TT4 should be blank, this is now ready for use.
Setting Alarm Criteria (TT4 monitors only)
Click on the index at the top of the screen for the LCD Alarm view. This menu is used to set the alarm
criteria for TempTale 4 monitors.
LCD Alarm View: Description of fields
- Alarm Criteria: If enabled, the alarm will utilize the user defined alarm settings.
- Temperature Limit: This is the temperature used for the low limit or high limit alarm. When setting the
low alarm, the alarm is triggered if it drops below this temperature for a set period, defined by the Alarm
Type and “Threshold” fields. When the high alarm, the alarm is triggered if it goes above this temperature
for a set period, defined by the Alarm Type and “Threshold “ fields. The temperature range is from –4 to
+158 degrees Fahrenheit or –20 to +70 degrees Celsius, in whole degrees only.
- Alarm Type: The user must select from a predefined list of two choices for this field: “Time-Single
Event” or “Time Cumulative”. Each of the four choices is described below in more detail.
- Time-Single Event: Alarm triggers if temperature is above/below ideal range for a single event of the
defined threshold.
- Time- Cumulative: Alarm triggers if temperature is above/below ideal range for the cumulative time of
the defined threshold.
Threshold: The range allowed is from 0 to 999 minutes.
Documentation and Local Regulatory Paperwork
The following documents are samples of the paperwork that is prepared on behalf of our
customers, and includes:
-
Commercial Invoices
-
Dangerous Goods Shippers Declaration
-
Import Permit Applications
Qualified and Trained Personnel
CitySprint representatives are on hand 24/7 to provide advice to clients on the appropriate
method of transportation for hazardous goods, non-hazardous patient samples, medical
instruments and biological samples.
The representatives would facilitate the collection of these consignments as well and be on hand
to answer any queries that the client’s personnel may have regarding proper packing instructions,
Dangerous Goods paperwork and the requirements for obtaining local country import/export
licences.
The IATA trained DG representatives will classify the samples and check the UN number(s) to
ensure they are appropriately packaged as per the correct IATA Packing Instruction:
For example:
UN3373 Diagnostic Specimens
= IATA PI650
UN2814 Infectious Substance affecting Humans
= IATA PI602
UN1230 Methanol
= IATA Y305/305/307
Or “Exempt Human Specimen” same packing instruction as PI650
The IATA/ADR trained CitySprint representatives available are:
Andrew Turner:
24 hour emergency contact number – 07989 857 816
David Potter:
24 hour emergency contact number – 07989 544 424
Paul Guerrier
24 hour emergency contact number – 07957 545 628
The CitySprint DGSA is:
Tracy Fletcher: 24 hour emergency contact number – 07930 481 009
CitySprint’s Competent Regulatory Contacts:
DEFRA:
Ms Kirsty Glover - 020 7904 6790
DEFRA:
Mr Paul Manser - 020 7904 6187
DOT:
Andrea Pearson - 020 7944 2763
Health Canada:
Ms Stacey Mantha, Head, Biosafety Services – 001 613 957 1779
IATA:
Mr Dave Brennan - 001 800 71 66 32 60
USDA:
Dr Morris - 001 301 734 3277
USDA:
CMDR Bill Burkhardt – 001 251- 690-3361
CDC:
Mr Mathew Jennings - 001 404 498 2260
DGSA
Our Dangerous Goods Safety Adviser service will offer advice on the following.
-
Monitoring compliance with the rules governing the transport of dangerous goods.
-
Advice on the transport of dangerous goods.
-
Ensuring that an annual report is prepared on the activities concerning the transport of
dangerous goods.
-
Monitoring the procedures for compliance with the rules governing the identification of
dangerous goods being transported.
-
Monitoring the procedures for checking the equipment used in connection with the
transport of dangerous goods.
-
Monitoring the proper training of employees and the maintenance of records of such
training.
-
Monitoring the implementation of appropriate measures to avoid the recurrence of
accidents, incidents or serious infringements.
-
Monitoring the account taken of the legal prescriptions and special requirements
associated with the transport of dangerous goods in the choice and use of subcontractors or third parties.
-
Verification that employees involved in the transport of dangerous goods have detailed
operational procedures and instructions.
-
Introduction of measures to increase awareness of the risks inherent in the transport of
dangerous goods.
-
Implementation of verification procedures to ensure the presence, on board the means of
transport, of the documents and safety equipment which must be accompanied during
transport and the compliance of such documents and equipment with health and safety
regulations.
-
The implementation of verification procedures to ensure compliance with legislation
governing loading and unloading dangerous goods.
MAJAX and Disaster Recovery
Purpose: This document is intended to establish working guidelines in conjunction with our
customers for the effective transition and business continuity in the event of a Major Incident or
Disaster.
Emergency Response Procedures
For detailed emergency response guidelines CitySprint Medical Express follow relevant
HSE/COSHH guidelines and as an aide-memoir CitySprint Medical Express prescribe to a US
Government publication, the Emergency Response Guidebook, which can be viewed at
http://hazmat.dot.gov/erg2000/erg2000.pdf. This document lists in detail emergency response
guidelines for Dangerous Goods.
Disaster Recovery:
CitySprint have invested heavily to ensure business continuity. All areas of our systems have
been analysed and appropriate disaster recovery procedures laid down.
The key areas covered are as follows:-

Building Damage - London
In the case where our Scrutton Street offices become inoperable we have a contract with NDR
that allows us to occupy floor space at any of their recovery centres. They have 2 separate sites
in London and 1 in the Midlands. At this centre NDR have prepared a range of facilities for
CitySprint. These facilities include

o
50 PC desk positions
o
50 Telephones
o
2 MB Internet connection
o
Telephony connections to all major telecom suppliers
o
Full range of servers for CitySprint to reload their key systems on
o
All numbers can be quickly diverted by our Telecom suppliers BT and MCI
Building Damage – Outside of London
All CitySprint offices operate a ‘buddy’ system. Should a building become inoperable the
telephone numbers are diverted to the ‘buddy’ office from where the customer can be cared for
until the office is re-instated.

Telecoms Failures
CitySprint have a 24 hour, 7 day a week, 52 week a year support contract with BT and MCI.
Extensive use of non-geographic numbers allows CitySprint to divert telephone numbers to any
other UK location within 24 hours. Standard geographic numbers are diverted by request with our
telecom suppliers
All key data communication lines are backed up by means of either 2 MB broadband connections
or ISDN-2 dial up connections, and in some cases both.

Power Supply Failure
Scrutton Street has a 3 tiered approach to power failure. All servers have an individual UPS
connected to them. The entire building is also protected by a single large UPS that will keep all
services running whilst our on site generator starts.
The generator is an F G Wilson P380 KVA, it is covered by 24 hour, 365 days a year call out
insurance, and if there are any issues our maintenance provider is on call to resolve the issue.
Our maintenance provider is Bills Control Ltd, who is based in Scrutton Street, just a few doors
down from our own premises. So if we needed to call the engineers out, they have a quick
response time. The generator has an engine capacity of 14 BMW 7 series cars, and has the
capacity to fulfil the building’s needs five times over.

System Hardware Failure
CitySprint have contracted CCE engineering to maintain all our hardware on a national basis. All
hardware is covered by next day fix, on site anywhere in the UK mainland, thereby limiting the
impact of a breakdown.
All servers have a 4 hour fix time associated with them.
Some key systems can never be unavailable and consequently we operate complete hardware
duplication. The systems duplicated are:
o
CityTrak Server
o
Web and On-Line Booking Server
o
Mobile Data Gateways

Data Loss
CitySprint are highly conscious of the importance of data backups. All servers and user data are
backed up every night with an incremental backup. A full system wide backup is taken every
weekend.
In order to ensure that the latest backups are not held on-site CitySprint have contracted Recall to
collect the latest backup tapes every day and return the previous week’s daily backup for that
day. The rota ensures that at anytime we keep a full copy of all our data off-site.
Daily backups are not always sufficient and on our CityTrak server we take a 2 hourly backup and
a full daily backup. Later in 2006 CitySprint will be upgrading CityTrak to a transactional backup
so every single transaction made is immediately copied to our duplicate failover server. This
mirroring ensures that CityTrak will never be off-line or lose data.
Similarly our On-Line system also has duplication that allows a seamless failover to the duplicate
server.
MHRA/DOT
CME follow closely the guidelines prescribed by the MHRA in the UK and by the DOT in the US.
Particular attention is paid to the DOT publication 49 CFR part 171 when shipping to the US.
US customs entry requirements are often complex and involve clearance from:
-
US Customs
-
CDC
-
USDA
-
FDA
The USDA and CDC websites contain informative information and list the requirements for
shipping into the US.
-
www.cdc.gov
-
www.usda.gov
It is imperative that all consignments to the US are properly prepared prior to forwarding.
You must not forward any medical samples to any country, especially the US without
checking if an import permit is required. Check the relevant Government website.
When importing back to the UK checks with DEFRA are required for Animal Samples or Human
Samples in any form of culture medium derived from animals.
-
www.defra.gov.uk