CENTRAL PROCUREMENT & SUPPLIES UNIT
MINISTRY FOR HEALTH
UB 002 – Industrial Estate, San Gwann SGN 3000
Tel: (+356) 2592 4000
E-mail: [email protected]
Our Ref: CPSU0425/17
RFP Publication Ref: 020-14001/17
Request for Participation (Negotiated) for the Supply of Blood Glucose Meters and
compatible Test Strips
The Central Procurement and Supplies Unit within the Ministry for Health wishes to identify
Economic Operators interested in supplying blood glucose monitoring test strips and meters to
entitled patients
Through this Request for Participation the Ministry for Health intends to identify and enter into
an agreement with all eligible Economic Operators interested in participating in this scheme and
are able to provide in total:



45,000 Blood Glucose Meters, on loan, free of charge
65,000,000 Blood Glucose Test Strips with capillary strip technology
Patient education material for the patients during the duration of the contract
Interested Economic Operators must be willing to provide the service for a period of THREE (3)
years.
The Department of Health will equally distribute the number of patients between all successful
Economic Operators.
Prices will be capped at a maximum value of €2.50 per fifty test strips. Offers exceeding this
price will NOT be considered.
I. Eligibility
In order to participate, the Economic Operator has to have a minimum of four (4) outlets for
distribution one in each of the below areas:
- Malta North Area
- Malta South Area
- Malta Central Area
- Gozo Area
Ministry for Health
II. Documents required for Participation
Interested Economic Operators are to submit:
a) Details of distribution outlets;
b) Declaration of Conformity for the products being offered;
c) Blood glucose Meters user manual
d) Detailed literature and documentation about studies related to the offered meters
e) Sample: Economic Operators are to submit a functional Blood Glucose Meter with a
minimum 200 Blood Glucose Test Strips for statistical evaluation on diabetic patients
prior adjudication. A demonstration on how to use the device may be required prior
adjudication.
III. Technical Specifications
Specifications for Blood Glucose Test Strips and Blood Glucose Meters include:
Blood Glucose Test Strips
a) All Blood Glucose Test Strips must be the ‘capillary action’ type i.e. Blood is drawn up for
testing by capillary action
Blood Glucose Meters
a) All Blood Glucose Meters, should be factory set to mmol/L
b) Each Blood Glucose Meter should be capable of storing at least 300 test results with their
time and date in its memory. It should be capable of calculating averages from the saved
results (e.g. all results, for the last 7 days, 14 days , 30 days) and stored data should also
be downloadable to a PC system;
c) Blood Glucose Meters should have a tolerance for haematocrit level that ranges at least
between 20 to 65%. Furthermore the measuring range of the glucose should be at least
between 1.1 mmol/L (lower limit) and 33.3 mmol/L (upper limit) or of a wider range;
d) The Blood Glucose Meter should also have an in-built warning system for inadequate
sample application;
e) The mean imprecision of the Blood Glucose Meter should be between 2% to 4%
(coefficient of variation);
f) Blood Glucose Meters should be according to ISO 15197-2015: Clinical accuracy is defined
as the percentage of glucose monitors results within ±0.83mmol/L for glucose,
4.2mmol/L and within ±20% for glucose ≥4.2mmol/L of the reference method. A
statistical analysis may be carried out on patient samples to test that this criteria is met.
g) The reading time to issue a result should not exceed 10 seconds for every Blood Glucose
Test Strip;
h) The meter should keep track of the patient data for at least one month;
i) The tenderer MUST guarantee that there is no interference with products such as
Icodextrin (i.e. patients on Peritoneal dialysis), maltose, galacotose, xylose and with
certain types of intravenous immunoglobulin therapies e.g. Octagam 5%.
Ministry for Health
IV. Technical Conditions
a) The Blood Glucose Meters and Blood Glucose Test Strips must be available for a fully
functional system, within 8 weeks following the signing of the Contract Agreement.
V. Conditions of Participation
a) The tenderer must provide a user manual with each Blood Glucose Meter given.
b) The tenderer is to provide structured and comprehensive diabetes education modules for
patients and relatives throughout the contract period. The tenderer must also provide
diabetes education material and other educational consumables such as meal diaries and
testing brochures.
c) Blood Glucose Meters must be CE marked and certified (also known as European
Conformity mark / CE mark).
d) The tenderer may be requested to submit a copy of the Medical Devices Directorate
Evaluation Report for the instrument (obtained from HMSO, UK) or equivalent.
e) The tenderer is to guarantee a shelf life of 12 months or more, upon dispensing. Any
infringement in this respect will render the tenderer liable to penalties.
f) The meters are to operate on Li batteries for longer life. Batteries are to be supplied
free of charge. The supplier should provide battery chargers in case these meters are
supplied within inbuilt battery chargers.
g) Quality Control (QC) should be performed yearly by the supplier throughout the whole
duration of the contract period.
h) Tenderer will be responsible for the full servicing; as well as for the preventive and
corrective maintenance of the equipment throughout the whole duration of the contract
period. This full service must cover both the labour and parts required to repair a fault
and must be provided by the tenderer at no extra cost.
i) Tenderer must state the maximum guaranteed repair time required in order to service a
fault, especially in terms of delivery time for the procurement of parts or to exchange a
faulty meter. The Contracting Authority shall be notified of each breakdown with an
official report.
j) The tenderer must be in a position to repair the broken-down equipment within one
calendar week. In the event of repetitive breakdown, the tenderer is bound to replace
the equipment in question within 1 week from the 3rd breakdown.
k) Late delivery of any component of the instrumentation setup that delays delivery of the
service will be liable to late delivery penalties.
Ministry for Health
VI. Instructions to Interested Parties
Economic Operators are to submit their offer via email: [email protected] by not later
than Monday 8th May, 2017 at 10:00 hrs and should include:
-
Full name of Service Provider;
Address of Services Provider;
Full name of contact person;
Contact Telephone Number / Mobile Number & Fax Number;
E-mail Address;
VAT number;
All the information requested in Sections I-VI
Submissions must be provided in Word, Excel, pdf or jpg formats. No links are to be provided
for Technical Specifications. These should be attached with the offer. Other formats will NOT
be considered.
Please note that ALL submissions/documentation must include the Reference number. In cases,
where this information is not included, the Contracting Authority reserves the right NOT to
consider the quote.
Offers submitted that do not conform with specifications will not be considered.
Offers exceeding the price of €2.50 per 50 test strips will not be considered.
Economic Operators are to submit their offer via email: [email protected] by not later
than Monday 8th May, 2017 at 10:00 hrs clearly indicating the reference number of this call in
the subject of the email.
ANY SUBMISSIONS AFTER THIS DATE AND TIME WILL BE AUTOMATICALLY REJECTED.
Ministry for Health