My Num: CMLSSL/Gen/2020(03)

Date: 2020.02.03

The Chairman,
Parliament Oversight Committee for Health,
Sri Lanka Parliament,
Sri Jayewardenepura,
Kotte.

RE: UPGRADING THE HOSPITALS WHCIH ARE SELECTED TO ADMIT THE SUSPECTED PATIENTS WITH
SYMPTOMS OF CORONA VIRUS.

I would like to bring to your attention that the decision taken by the Ministry of Health, to admit and
administrate the suspected patients with the symptoms of corona virus in 12 hospitals island wide in addition
to the National Institute of Infectious Diseases.

Accordingly, it is essential that the patients at risk are admitted to hospitals and that their routine medical
examinations are performed in the respective hospitals. But in biosafety laboratories, which operate in very
limited facilities and often with very little space, it is not possible to analyses highly - infective specimens without
making necessary upgrades.

We acknowledge the difficulty to implement few laboratories with the recommended biosafety environment
immediately for this purpose, but there is room for optimum management of risks.

Hence, a formal proposal with detailed information relating to the upgrading the laboratories at a nominal cost
is attached herewith for your kind approval.

Appreciate, if you could grant us a time for further discussion with the participation of relevant stakeholders.

Thank you!
Yours faithfully,
CC:
1. His Excellency President
2. Hon. Prime Minister
3. Hon. Minister of Health Nutrition & Indigenous medicine
4. Secretary, Ministry of Health and Indigenous Medicine
Ravi Kumudesh
5. Director General of Health Services
President,
6. Deputy Director General (Medical Supplies)
College of Medical Laboratory Sciences.
7. Deputy Director General (Laboratory Services)
1.

No. 25/2, Norris Avenue, Colombo 08 1

 PROPOSAL TO ESTABLISH AN
ISOLATED LABOROTORY FOR
INVESTIGATIONS OF IVD
SAMPLES IN CORONA VIRUS
OUTBREAK SITUATION
As a Response to Virus Outbreak in China

College of Medical Laboratory Science Sri Lanka - Contact: 077 3077717

01. Background
Reference to the circular published by MOH on the management of suspected Corona
patients, following hospitals has been identified to admit and administrate patients with the
symptoms of fever, cough, shortness of breath, breathing difficulties & Fever.
TH Ragama, GH Gampaha, DBH Negombo, NH Kandy, TH Karapitiya, TH Anuradhapura,
TH Jaffna, PGH Kurunegala, PGH Rathnapura, TH Batticaloa, PGH Badulla and IDH.
The outbreak of Corona Virus in Sri Lanka poses a threat to the laboratory investigation
process due to lack of any containment levels to handle Biochemistry and hematology
investigations in the current laboratory infrastructure during such an outbreak. While the
confirmation test done in special high-risk Lab in MRI, Other biochemistry and haematology
tests to be done in the normal hospital laboratory.
In an environment which lack biosafety level 3/4 labs, this proposal is made to find a
compromised speedy solution to address the above requirement. It should be understood that
where time and infrastructure are limiting constrains the challenge in the objective is to
mitigate the risk level and this proposal does not address the ultimate solution.

To facilitate the laboratory requirements of the above hospitals to highly infective patients we
need to establish a special isolated laboratory located even in inside the Lab or outside the
Lab to avoid the contamination with latest technology. To do this we need to act immediately,
if the Ministry of Health facilitate the requirements, we will be able to implement the required
laboratories within 7 Days with the cost of Rs. 156Million
Following test are the important tests to be done for the patient management;
1. Full Blood Count
2. Renal Functions test
3. Liver Function tests
4. C- Reactive protein
5. Serum Electrolytes

02. Objective
To establish containment laboratories, in Ragama, Gampaha, Negombo, Kandy, Karapitiya,
Anuradhapura, Jaffna, Kurunegala, Rathnapura, Batticaloa & Badulla in addition to IDH in
Colombo where patient to be admitted and administrated for the Corona infection.
The objective is to use POCT instrumentation for Biochemistry to minimize the need for
sample centrifugation because the centrifugation is available inside the instruments and a five-
part haematology analyzer with CRP capability which has cap piercing and autoloader to
minimize the sample handling risk.

College of Medical Laboratory Science Sri Lanka - Contact: 077 3077717

03. Solutions proposed

1. Ideal is to have a BSL 3 Laboratory. But considering the current situation, we propose to have
an optimized isolated laboratory with operator and environment safety used by specialized
technology.
2. Identify a space inside the Lab or Hospital provided in a suitable location preferably at the
end of a corridor with restricted traffic flow, maintaining required Pressure Differentials and
Cleaning the air flow as per the safety standards and assurance of all surfaces of the space as
per the decontamination standards with hand washing and clothes changing facility for the
occupants.

3. A controlled ventilation system that maintains a unidirectional airflow into the laboratory
room with visual indication for assurance of same if possible.

4. For FBC: The current system is to use FBC is use of normal EDTA tubes, and the sample to
be feed to the instrument manually. But considering the risk level, we proposed to use
Vacutainers which will enable the instrument to pierce the cap, and the instrument with the
CRP testing capability to reduce the risk of opening and closing the tube many times.
(Specification Attached – Attachment I)

5. For Biochemistry test, normally the test to done by separating the serum by centrifugation
and which creates aerosol and increase the contamination risk. But, for the current scenario,
we propose a POCT instrument which has the inbuild centrifugation facility to avoid the
contamination. (Specification Attached – Attachment I)

6. Also, we propose a special training to the medical Laboratory Technologists who ever handles the
samples on the handling of high-risk samples and the risk allowance.

7. Personal protection equipment’s such as Clothing and accessories required as per following
table.

College of Medical Laboratory Science Sri Lanka - Contact: 077 3077717

04.Budget

Number of Budgeted Budgeted Total

Category Product
units Required Unit Price Rs. Price Rs.
Laboratory Develop the room to an
12 2,000,000.00 24,000,000.00
Infrastructure isolated Laboratory
5 Part Hematology
Analyzer with CRP 12 6,000,000.00 72,000,000.00
Laboratory
Capability
Equipment
POCT Biochemistry
12 2,000,000.00 24,000,000.00
Analyzer
Connecting the
IT Solution instruments to the 12 2,000,000.00 24,000,000.00
HHIMS

Safety Personal Protective

12 1,000,000.00 12,000,000.00
Equipment’s Equipment

GRAND TOTAL 156,000,000.00

College of Medical Laboratory Science Sri Lanka - Contact: 077 3077717

 Attachment I

Specification for 5-part Automated Haematology Analyzer with CRP

capability

1 2 3 4
Purchaser’s Requirements Bidder’s Offer

Prio Conformity Remarks

rity Yes No
The unit shall operate on the power supply of
1 C
230+10% 50 Hz single phases.
It shall be a Microprocessor based, fully automated
2 C
compact bench top model Analyzer.
If the unit is required a compatible uninterrupted
3 power supply the cost of such item shall be quoted C
separately.
The unit shall be able to operate in a tropical
4 environment. Operating temperature shall be 15 – C
30 C and humidity level up to 85%.
The unit shall be capable of measuring following 25
parameters from sample of undiluted whole blood.
WBC, Lym (#&%), Neu (#&%), Mon (#&%), Bas
5 (#&%),Eos (#&%), RBC, Hb, Hct, MCV, MCH, C
MCHC, RDW-CV, RDW-SD, Plt, MPV, Pct, PDW,
P-LCR, P-LCC with 4 research parameters And
quantitative CRP
The unit have autoloader with automatic cap piercing
6 C
facility.
The unit shall have CBC+ DIFF+ CRP throughput of
7 at least 60 samples per hour. Need to have pediatric C
sample handling capability.
There shall be a memory facility of storing at least
40,000 test results including histogram and scatter
8 C
grams. The histogram and scatter gram should be
displayed on screen.
It shall also consist of an error indicator for errors in
9 C
the recording and technical malfunctioning.
The unit shall have an automatic calibration quality
10 control facility, cleaning rinsing and bleaching of C
sample probes and valves.
Complete and detailed set of operation and service
11 C
manuals in English shall be supplied with the unit.
On-site training shall be provided for operation and
12 C
maintenance of the machine.
The equipment shall covered by a comprehensive
13 "Part & Labour" warranty for a period of not less than C
12 calendar months from the date of successful
 commissioning of the equipment at the respective
institutions.
The local representative shall be able to sign a service
agreement for four years after the period of warranty
and the cost of such contract shall be quoted
14 separately. The contract shall give all the required C
details such as number of preventive servicing, the
ability to provide a backup system on temporary basis
etc.
The CRP measurement should Latex Immuno
15 C
turbidimetric method.
The tenderer should submit details of other
16 supporting facilities offered by the distributors for the C
smooth functioning of the instrument.
A warranty shall include servicing and preventive
maintenance during this period. Details of this
17 C
together with information on how this warranty will
be implemented shall be given in your offer.
Proof of the unit being a Workable System
18 (Reference Installation List) in the Government C
Sector.
Precision, accuracy and linearity ranges of the
machine shall be clearly indicated and they shall be
within the ranges given in table below.
Linearity Range

WBC 0 -400(109/L)

19 RBC 0 – 8.0 (1012/L) C

HB 1-250 g/L

Platelet 0-5000 (109/L)

CRP 0.2- 300 mg/L

The Consumables & Reagent prices shall be valid for

a period of at least for 5 years (Euro or USD Price
20 C
list). These prices will be taken into consideration at
the time of evaluation.
In the event of the customer informing the supplier at
any time that the Equipment is out of order and the
supplier failing to restore the Equipment to
21 satisfactory working order within a period of 3 C
working days from the receipt of such information,
the local agent should agree to pay the cost of tests
that are done from any outside source.
The supplier should have the decentralized aftersales
22 support in proposed 11 hospitals such as Ragama, C
Gampaha, Negombo, Kandy, Karapitiya,
 Anuradhapura, Jaffna, Kurunegala, Rathnapura,
Batticaloa & Badulla to provide effective after sales
services.
The supplier to need provide proof of connectivity
and previous experience to connect to the ministry
23
developed HHIMs for result cross reference, Data
archiving and QC management.

Make & Model : ………………………………………………………………

Country of Manufacture : ………………………………………………………

Relevant catalogue & technical information attached

Information given under “Bidder’s offer” is true & correct

Bidder’s Name, Signature & Date : …………………………………………….

Company seal : ………………………………………….

 Attachment II

Specification for Point Care Biochemistry analyzer

1 2 3 4
Purchaser’s Requirements Bidder’s Offer

Prior Conformity Remarks

ity Yes No
The unit shall be capable of measuring Liver profile
and Renal profile simultaneously including TP, ALB,
1 C
TBIL, DBIL, ALT, AST, ALP, GGT, CRE, UREA,
UA, GLU, TG, CHOL, HDL and Electrolyte.
The instrument should be a Point-of-care instrument
2 with less hands-on to avoid or minimize the
contamination risk.
The reagents should be cartridge based, self-
3 contained reagent in dry form and no centrifugation
to be needed.
Instrument should have the centrifugation inside the
4 instrument with the easy sample processing steps.
The sample volume shall not exceed 100ul.
5 The unit should have the memory of at least 50000 sample C
The system should measure the parameters at body
6 C
temperature which is 37±0.1 °C for accurate results.
The instrument should be work with Whole blood,
7
Plasma (Heparinized) & serum.
General Conditions C
The unit shall operate on power supply of AC 100V-
240V, 50-60Hz, if the unit require special power
8 C
supply; the cost of such items shall be quoted
separately.
Each unit shall be supplied with an instruction
9 C
manual and a service manual in English.
Full graphic illustrated original technical literature in
English describing the equipment offered and
10 C
detailing the specifications shall be supplied with the
bid.
A detailed proforma invoice of the equipment
describing the parts and accessories offered as
requested by the specification together with their
11 make, model, country of origin, unit price, quantity, C
total price, ref. numbers of accessories and the period
of warranty offered etc. shall be compulsorily
provided with the bid.
12 The Consumables, Reagents & fast-moving spare C
 parts prices shall be quoted separately & shall be
valid for a period of at least for 5 years (Euro or USD
Price list).
The equipment should be covered by a
comprehensive “Parts & Labour” warranty for the
period of not less than 12 calendar months from the
date of successful Installation & commissioning.
13
Such a warranty should also include servicing and at
least 4 preventive maintenances per year during the
period of validity.

The quotation shall include the annual cost of

consumables including all applicable reagent
cartridges, calibrators and quality control samples &
consumables based on 1000tests/month for TP, ALB,
14
AST, ALT, TBIL, GGT, CRE, UREA & Serum
Electrolytes. Above cost will be considered for
5years Life cycle cost analysis in the technical
evaluation.
The bidder should quote separately for a
comprehensive service contract on full parts and
15
labor basis covering all items on the offer for a period
of 05 years after the warranty period.
Bidder shall furnish the documentary evidence to
meet the following financial requirement.
16 a. Annual Turnover not less than Rs. 100 million
Net profit shall not be negative for the last three years
Fast moving spare parts, consumables and reagent
17
shall be available ex-stock.
All standard accessories shall be supplied including
18 relevant software. Other relevant optional accessories
shall also be quoted separately.
The supplier should have the decentralized aftersales
support in proposed 11 hospitals such as Ragama,
Gampaha, Negombo, Kandy, Karapitiya,
19
Anuradhapura, Jaffna, Kurunegala, Rathnapura,
Batticaloa & Badulla to provide effective after sales
services.
The supplier to need provide proof of connectivity
and previous experience to connect to the ministry
20
developed HHIMs for result cross reference, Data
archiving and QC management.

Make & Model : ……………………………………………………

Country of Manufacture : ……………………………………………………

Relevant catalogue & technical information attached
Information given under “Bidder’s offer” is true & correct

Bidder’s Name, Signature & Date : ……………………………………………………

Company seal : ……………………………………………………