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GUJARAT MEDICAL SERVICES CORPORATION LIMITED

(A Government of Gujarat Undertaking)

Regd. Office: Block No. 14/1, Dr. Jivraj Mehta Bhavan, Sector-10, Gandhinagar

079-23250767, 23250766, 23257696

Pre-Bid Meeting No. 17/2016-17

A Pre-Bid meeting for specifications of following items is organized in the Committee room of this Organization. Manufacturers, Authorized representatives / Dealers of this item are invited to attend this meeting. Only one authorized person from each company would be allowed to attend subject to the production of authorization letter, Valid photo ID Card and product literature of the company conforming that company manufactures the product for which pre-bid is being held. No. Name of item Date & Time

1 Fully auto blood grouping and cross match machine

: 08/09/2016 – 11:00 hrs.

2 HPLC Instrument for Hemoglobinopathy

: 08/09/2016 – 15:00 hrs.

3 Neonatal Ventilator : 16/09/2016 – 11:00 hrs.

Specification of above item can be downloaded free from web site: http://gmscl.gujarat.gov.in. Specifications are also available on this office's notice board.

INF- MANAGING DIRECTOR

Description of Reagent Rental System for Immuno-haematological tests. Reagent Rental System: It is a method in which any reputed multinational company supplys

required kits, calibrators, consumables, tips, reaction cuvettes/plates/Cards, reagents, etc. for performing the Immuno-haematological tests and supply latest model/version fully automatic immune-haematology analyzer/equipment free of cost with free maintenance &

calibration for the satisfactory performance of equipment- fully automatic immune-haematology analyzer.

The tenderer will be accountable & responsible for Performance of reagent, Stability of open & reconstituted Reagents, Calibrators, Precision & reproducibility. The Cold Chain must be maintained for all reagents, Controls and Calibrators during transport to the buyer. Location of placing System for Immuno-haematological tests with load of tests.

Location Total Blood

samples

Proposed test per years

patients &

Donors

ABO & RH Protocol-1

ABO & RH Protocol-2

Anti-body screening

Cross-matching

Jamnagar 50000 38000 12000 50000 25000

Rajkot 40000 32000 8000 40000 18000

Bhavnagar 45000 35000 10000 45000 25000

Surat 50000 38000 12000 50000 17000

Vadodra 38000 30000 80000 38000 25000

Total 223000 173000 50000 223000 110000

Part-1. Required specification of Immuno-haematological tests.

Par

t-1

Specification of immune-hematological tests Specification

available in

offered system

A ABO and Rh(D) Blood Grouping

Protocol-1

Forward Grouping

Reverse Grouping

Anti-A

Anti-B

Anti-AB

Anti-D1

Anti-D2

Control A cell

B cell

O cell

Critical

Protocol-2

Forward Grouping

Anti-A

Anti-B

Anti-AB

Anti-D1

Anti-D2

Anti-C

Anti-c

Anti-E Anti-e Anti-K

Reverse Grouping

Control A cell B cell O cell

Critical

B Antibody Screening with 3 cell panel

Cell Panel Results

Cell Panel 1

Cell Panel 2

Cell Panel 3

Critical

C Cross-matching AHG Critical

The tenderer must supply required kits, calibrators, consumables, tips, reaction cuvettes/plates/cards, reagents, etc. for performing Immuno-haematological tests as per specification mentioned in (A), (B) and (C)

Critical

Part-2. Required specification of Compatible Fully Automated Grouping, Cross

Matching & Antibody Screening System

Part

-2

Specification of equipment /analyzer Specification

available in

offered Model

1 Latest model/version of Fully Automated equipment

for ABO and Rh Typing, Rh phenotyping,

antibody screening and Patient /donor cross

matching must be supplied.

Critical

2. The analyzers/equipment must be latest

model/version of the company suppling the required kits, calibrators, consumables, tips, reaction cuvettes/plates/cards, reagents, etc. for performing Immuno-haematological tests as per specification mentioned.

Critical

3 The required proof for being latest model/version

should be provided. (The detail list of models,

mentioning their dates /year of launching in market

by the company, their brouchers etc. The

information should be available on the web –site

.(Please mentioned the web-site)

Critical

4. The analyzer/equipment should be based on the

principal of column agglutination/solid phase red

cell adherence assay /Erythro-magnetic Technology

Critical

5. It should be able to perform blood grouping,

compatibility testing and antibody screening

simultaneously.

Critical

6 The loading sample capacity should be at least of

100 samples at a time

Critical

7 It should be able to perform at least 60 blood

grouping & 80 antibody screening tests per hour.

Critical

8 It shall have the random access and continuous

sample loading & analysis capability.

Critical

9 It should be able to detect the sample abnormality

such as clots, haemolysis and lipemia

Critical

10 It should accept blood sample tube of any standard

size with ability to load whole blood, packed RBS’s

Red cell suspension, serum/plasma for all immune

haematological analysis.

Critical

11 It shall have the facility to read bar-coded reagents

and samples and calculator for counter

Critical

12. It shall have the facility for the preparation of

required amount and concentration of red cell

suspensions and reagent dilution automatically.

Critical

13 It shall have the facility for auto reading, capturing

and interpreting test results using a suitable device

and password protection for security results

Critical

14. It shall have the on board quality control package

system to monitor the process and the quality of the

results obtained.

Critical

15 It shall have continuous process verification to

ensure precise and accurate results & should have

auto alert for any deviation of process and/or result.

Critical

16. It shall have Bi-directional interface facility to the

LIS or HIS system for fetching data for all the

immune-hematological tests which is responsibility

of the tender/supplier during the contract period.

The LIS or HIS interfacing should be done during

time of installation, and then after as and when

required by the user.

Critical

17 The maintenance and repair of equipment/analyzer

is the responsibility of the tenderer without any cost

for any reason of break down at any time. The

calibration of equipment/analyzer is also the

responsibility of the tenderer without any cost as and

when required.

Critical

18 The additional equipment/analyzer of same loading

capacity and through put of each test should be

supplied by the tenderer if required for completing

daily testing work-load of the department.

Critical

19 The supplier should provide the same

model/versions immediately in case of the analyzer

is not repaired within 48 hours at the cost of

supplier.

Critical

20 The back-up equipment/analyzer of same loading

capacity and through put of each test should be

suppied by the tenderer.

Critical

21 The necessary IQ, OQ, PQ and calibration

certificate should be provided time to time as and

when necessary by the supplier during the contract

period.

Critical

22 The Consumables/reagents for at least 2000 tests for

blood grouping (ABO & RH D, Rh phenotyping),

antibody screening and compatibility testing should

to be provided free of cost during comprehensive

training for lab staff and support service to make

them familiar with the system.

Critical

23 List of users-(1) Place/Location (2) Name of user

and contact number (3) Year of installation and

detail of installed Model/version.

Critical

24 Platelet cross matching and platelet antibody

screening

Non-critical

25 It shall have capabilities with function of performing emergency/priority (stat) sample without affecting ongoing process.

Non-critical

Method of Commercial Bid Evaluation: The tenderer must quote the rates/CPRT ( Cost per reportable test) should be inclusive of the cost of all the kits, calibrators, consumables, tips, reaction cuvettes/plates/Cards, reagents, etc. for performing the tests as per the specification and also should be inclusive of all taxes & F.O.R bases. The rates/CPRT once accepted will be freezed for the RC period. No other cost/charges will be given for supply /maintenance of two compatible equipment during the RC period.

The projected numbers of each test/parameter is given as per the last year data. The projected numbers of test/parameter is given as per year of five location is given are not mandatory for the five departments to perform, but which is taken into consideration of commercial bid evaluation. The price evaluation will be done on the basis of total expenditure on total work load & CPRT quoted for the test/parameters.

.

Test Specification CPRT

ABO &

RH Blood

Grouping

Protocol-1

Forward Grouping

Reverse Grouping

Anti-A

Anti-B

Anti-AB

Anti-D1

Anti-D2

Control A cell

B cell

O cell

ABO &

RH Blood

Grouping

Protocol-2

Forward Grouping

Anti-A

Anti-B

Anti-AB

Anti-D1

Anti-D2

Anti-C

Anti-c

Anti-E Anti-e Anti-K

Reverse Grouping

Control A cell B cell O cell

Anti body

Screening

Cell Panel Results

Cell Panel 1

Cell Panel 2

Cell Panel 3

Cross-

matching

AHG

Test CPRT Total projected test Total cost

ABO & RH

Blood

Grouping

Protocol-1

Rs.00.00 * 173000 =

ABO & RH

Blood

Grouping

Protocol-2

Rs.00.00 * 50000 =

Anti body

Screening Rs.00.00 * 223000 =

Cross-matching Rs.00.00 * 110000 =

Total cost

1. Dr. Jitendra Vachhani 2. Dr. Amrish Pandia 3. Dr. Milind Dighe Professor& Head Professor& Head Professor& Head Department of IHBT Department of IHBT Department of IHBT M.P. Shah Govt. Medical college Govt. Medical College Govt. Medical College Jammagar Surat Vadodara 4. Dr. Gauravi Dhruv 5. Dr. Pragnesh Shah Professor & Head Associate professor Department of Pathology Department of Pathology P.D.U. Medical College Sir T. Hospital and Medical college Rajkot Bhavnagar

Page 1 of 3

PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/F-379/RI-E-535/2016-17 DATE:

Name of Item : Neonatal Ventilator TIME: Hrs.

Manufacture________________ Brand______________ Model__________________

[A] Required Specifications Specifications

available in offered Model

(A) Advanced microprocessor based Pressure Limited Time constant (TCPL) ventilator for neonatal patients from 500 gms upto maximum 1O Kgs with innovative features (Critical)

(1) Suitable for patients from 500 gms body weight upto a maximum of 10 Kg in all modes (Critical)

(2) Machine should have electronic (High pressure sevo vlaves type) O2 – Air mixer. (Critical)

(B) The ventilator should have the following ventilation modes as below:

(1) IPPV (Pr. Control) (Critical)

(2) Assist Control (Critical)

(3) SIMV (Critical)

(4) CPAP with Apnea backup (Critical)

(5) Volume Guarantee (Critical)

(6) Pressure Support (Critical)

(C) Should have settings for :

(1) FiO2 : 21 – 100 percentage (Critical)

(2) Peak Inspiratory Pressure : 10 - 60 cmH2O (Critical)

(3) Flow independent PEEP : 0 - 15 cmH2O (Critical)

(4) Inspiratory Time : 0.1 - 2 sec (Critical)

(5) Expiratory Time : 0.2 - 30 sec (Critical)

(6) Maximum Rate (based on Insp. Time and Exp. Time) : 150 bpm (Critical)

(7) Automatic / Adjustable Inspiratory flow : 0-30 lpm (Critical)

(8) Automatic / Adjustable Base flow (VIVE) : 0-10 lpm (Critical)

(9) Slope control: 0-2second or graphical. (Critical)

(10) Leak Adapted Flow Trigger : 0.3 lpm or less (Critical) – 15 lpm (Non-Critical)

(D) Should have real time monitoring of :

(1) Pressure Monitoring (Critical)

(a) Peak Pressure / Plataue Pressure (Critical)

(b) Mean Pressure (Critical)

(c) PEEP/ CPAP PRESSURE (Critical)

(2) Volume Monitoring (Critical)

(a) Vte (Critical)

(b) MV (Critical)

(c) Leak percentage (Critical)

(3) Frequency Monitoring (Critical)

(a) F set (Critical)

(b) F total (Critical)

(c) Spontaneous percentage / rate (Critical)

(4) FiO2 set & measured (Should have integrated Monitoring) (Critical)

(5) Airway Temperature with active humidifier (Critical)

(6) Lung Mechanics (Non-Critical)

(a) Resistance R

(b) Compliance C

(c) C20/C

Page 2 of 3

PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/F-379/RI-E-535/2016-17 DATE:

Name of Item : Neonatal Ventilator TIME: Hrs.

Manufacture________________ Brand______________ Model__________________

[A] Required Specifications Specifications

available in offered Model

(d) Time constant t

(e) Rate Volume Ratio RVR

(E) Should have automatic alarm settings for all alarms. MV alarm can be manually adjusted along with alarms for:

(1) High / low Pressure (should be set automatically) (Critical)

(2) High / low Minute Volume (Critical)

(3) High Rate (Critical)

(4) High Tidal Volume (Non-Critical)

(5) APnoea / apnoea alarm time (Critical)

(6) High / low O2 percentage (automatic settings) (Critical)

(7) Oxygen line failure (Critical)

(8) Compressed air failure (Critical)

(9) Total electronic failure (with error code) (Critical)

(F) Graphical Interface - should be 8-12 inch color screen. (Critical)

(1) At least 3 curve from pressure, flow and volume (Critical)

(2) The curves should be filled curues for easy viewing at a distance (Critical)

(3) Waves form displays (Three curves f/T, P/T, V/T and two loops P-V. f-V) (Critical)

(4) It should be possible to freeze the loops and calculate with the inflection Points (Critical)

(5) It should be also possible to keep a reference point for loops (Critical)

(6) Integrated Graphical trend for 24 hours should be available for monitored parameters (Critical)

(G) Quality Standards and Support requirements

(1) The unit should comply with ISO 13485 and 9001 standards. Should have European CE Approval and USFDA approval for usage in Intensive Care Area. (Critical)

(2) The distribution / service organization in India should have a local (in customers city) trained service personnel and the company must have designated application support people to provide application training to our users. The Indian subsidiary should also have a quality system in place as per ISO 9001. (Critical)

(H) Non Invasive Ventilation/ nasal CPAP ventilation (standard) (Critical)

(1) The nasal CPAP unit should be self-contained with head strap, hood, nasal prongs, fixing unit. (Critical)

(J) Pressure Support / Volume Guarantee (standard) (Critical)

(1) lt should be possible to give pressure support to spontaneously breathing patients with a set volume guarantee(Critical)

(2) Volume guarantee should be regulated within the existing PIP(Critical)

(K) Medical Air Compressor (Critical)

(1) Dedicated Medical Air Compressor to provide quality air as per ISO standard (Critical)

(2) Snap fit or screw fit with the ventilator machine (Critical)

(3) Peak flow should be minimum 180LPM (Critical)

(4) lt should be of original company whose ventilator machine is quoted. (Critical)

Page 3 of 3

PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/F-379/RI-E-535/2016-17 DATE:

Name of Item : Neonatal Ventilator TIME: Hrs.

Manufacture________________ Brand______________ Model__________________

[A] Required Specifications Specifications

available in offered Model

(5) lt should be CE / US FDA certified (Critical)

(L) Scope of supply should include

(1) Basic Unit ( 220 - 240 V) (Critical)

(2) Medical Air Compressor (Critical)

(3) Servo Controlled Humidifier (Critical)

(4) Modular corrosion free Trolley (Critical)

(5) Silicon Hose set reusable for neonates (Critical)

(6) Reusable Flow sensor ( Total 2 nos.) (Critical)

(7) Nasal CPAP Kit (Support Tubings - 10 nos., Cap – 10 nos. Nasal Prongs – 5 Nos. and Masks - 5 nos.) (Critical)

(8) Disposable hose set - 10 nos. (Critical)

(9) Temperature sensor (Critical)

(10) Oxygen connecting Hose (Critical)

(11) Air connecting Hose (Critical)

(12) Hinged arm for rail (Support for patient circuit) (Critical)

(13) Instruction Manual (Critical)

(14) O2 Cell – Total 2 Nos. To be provided when asked. (Critical)

(M) Ventilator must have battery backup of at least 1 hour. (Critical)

Operation manual with user demonstration video CD.

Copy of Supply order (cost must not be disclosed), satisfaction report and contact details of at least 2 healthcare institutions in India must be provided for the quoted model.