ILI Surveillance Cold Chain Assessment Finding and ... Surveillance Cold... · ILI Surveillance Cold Chain Assessment Finding and Recommendation January 2012 . ... SOP, and cold chain

ILI Surveillance Cold Chain Assessment

Finding and Recommendation

January 2012

Laporan assessment cold chain 1 of 61 Desember 2011

TABLE OF CONTENT

ACRONYM ................................................................................................................. 3

ACKNOWLEDGEMENT ............................................................................................. 4

I. COLD CHAIN ASSESSMENT TERM OF REFERENCE ................................... 5

1. Objective ...................................................................................................... 5

2. Specific Objective ........................................................................................ 5

3. Organization ................................................................................................ 5

4. Target .......................................................................................................... 5

5. Strategy ....................................................................................................... 6

6. Roles and Responsibilities of The Assessment Partners ............................ 6

7. Assessment Team ....................................................................................... 7

8. Outputs ........................................................................................................ 8

9. Finance ........................................................................................................ 8

10. Assessment Period ...................................................................................... 8

11. Activity Timeline ........................................................................................... 9

II. EXECUTIVE SUMMARY .................................................................................... 10

III. COUNTRY BACKGROUND ............................................................................... 15

IV. BACKGRAOUND ............................................................................................... 16

V. FINDING AND ANALYSIS OF RESULTS .......................................................... 18

VI. FINDING AND ANALYSIS OF RESULTS OF INDIVIDUAL FACILITIES

IN THE ILI SURVEILLANCE .............................................................................. 25

1. ILI National Referral Laboratory ................................................................... 25

2. Microbiology Laboratory of FK Universitas Hasanuddin Hospital ................ 27

3. Sentinel Health Center Sudiang, Makasar Municipality ............................... 31

4. Biomoleculer Laboratory of FK Universitas Udayana .................................. 33

5. Sentinel Health Center 1 Denpasar Selatan, Denpasar Municipality .......... 36


6. Clinical Microbiology of FK Universitas Indonesia ....................................... 39

7. Sentinel Health Center Utan Kayu Utara, East Jakarta ............................... 42

8. Microbiology Laboratory of FK Universitas Diponegoro .............................. 44

9. Sentinel Health Center Pandanaran, Semarang Municipality ...................... 49

VII. CONCLUSION .................................................................................................... 51

VIII. RECOMMENDATION ......................................................................................... 52

1. General Recommendation ........................................................................... 52

2. Recommendation for Regional Laboratory .................................................. 52

3. Recommendation for Sentinel Health Center .............................................. 53

ATTACHMENT:

A. Detection of Suspect Cases and Handling of Influenza Like Illness (ILI):

I. At Sentinel Health Center

II. At Regional Laboratory

B. Assessment Questionnaire for:

I. Regional Laboratory

II. Sentinel Health Center

C. Pictures of The Cold Chain Condition in Various ILI Facility

D. Shipment/Receive Monitoring Card for ILI Sample


ACRONYM

°C Temperature, degree, Celsius

Puslitbang BMF Center for Research and Development of Biomedic and Pharmacy

Puslit BTDK Center for Research on Biomedic and basic Health Technology,

MoH/ Pusat penelitian Biomedis dan Teknologi Dasar Kesehatan,

Kementerian Kesehatan

CDC Atlanta Communicable Disease Control Atlanta, USA

Ditjen P2P-PL Direktorat Jenderal Pengendalian Penyakit dan Penyehatan

Lingkungan

EVM Effective vaccine Management

FKUI Fakultas Kedokteran Universitas Indonesia, Jakarta

FK Unhas Fakultas Kedokteran Universitas Hasanudin, Makassar

FK Udayana Fakultas Kedokteran Universitas Udayana, Denpasar

FK Undip Fakultas Kedokteran Universitas Diponegoro, Semarang

ILI Influenza Like Illness

ILR Ice-lined Refrigerator

JSI John Snow, Inc.

KemenKes Kementerian Kesehatan

MoH RI Ministry of Health , Republic of Indonesia

PCR - RT Polymerase Chain Reaction – Reverse Transcriptase

Puskesmas/HC Pusat Kesehatan Masyarakat/Health Center

SOP Standard Operating Procedure

SPO Standar Prosedur Operasional/SOP

TOR Terms of Reference

USAID United States Agency for International Development

WHO World Health Organization


ACKNOWLEDGEMENT

USAID Deliver extends sincere thanks and appreciation to USAID for the opportunity to perform

this cold chain assessment in the ILI surveillance program at the regional laboratories and ILI

sentinel health centers.

USAID deliver is grateful for the initiative, and collaborative spirit shown Pusat BTDK Ministry of

Health RI, CDC Atlanta and head and staffs of the 5 regional laboratories in Jakarta, Makasar,

Denpasar and Semarang and ILI sentinel health centers in the region whose support enabled the

assessment to take place.

The activity was made possible through support provided by USAID through the USAID/DELIVER

GPO-1-00-06-00007-00 Task order 6 project 13244.2856.0001.


I. COLD CHAIN ASSESSMENT TERM OF REFERENCE

1. Objective

To guarantee reliability and accuracy of laboratory diagnosis of ILI specimens within the

scope of the ILI surveillance program in Indonesia.

2. Specific Objectives

1. To conduct an cold chain assessment at the ILI regional laboratories and ILI

sentinel health starting from the sample collection, storage, packaging and

shipment until the laboratory testing at the laboratories.

2. To assess the performance and availability various cold chain equipment and

ancillary supplies at the ILI regional laboratories and sentinel health centers.

3. To assess the use and availability and usage of temperature monitoring devices in

order to prevent excessive heat exposure towards the biological ILI specimens.

4. To assess the management and handling of infectious material and waste at the

ILI regional laboratories and sentinel health centers.

5. To assess tier wise supportive supervision performed to the ILI regional

laboratories and sentinel health centers.

6. To prepare recommendation and SOPs on the procedure and cold chain

management to enhance the quality of ILI samples.

3. Organization

This assessment is collaboration between Ministry of Health/ Pusat BTDK, Pusat

Biomedis dan Teknologi Dasar Kesehatan, USAID Deliver, and CDC Atlanta.

4. Target

Assessment was conducted at the 5 ILI regional laboratories i.e. :

1. Kota Semarang, Jawa Tengah (Microbiology Lab. FK UNDIP)

2. Denpasar, Bali ( Molecular Biology Lab FK Udayana)

3. Makasar (Microbiology Lab RS FK Hasanuddin)

4. DKI Jakarta (Microbiology Lab FK – UI) and

5. National ILI Referral Laboratory Pusat BTDK


5 sentinel health centers:

1. Pandanaran health center, Semarang

2. Sudiang health center, Makasar

3. 1 Denpasar Selatan health center, Denpasar

4. Utan Kayu Utara health center, DKI Jakarta

5. Strategy

Assessment was conducted through interviews with the relevant person in charge at

the regional laboratory and ILI sentinel health centers, observations on cold chain

practice starting from sample collection, storage, packaging and transportation, until

tested at the regional laboratories and or the national referral iLi laboratory.

6. Roles and Responsibilities of the Assessment Partners

Ministry of Health/Pusat BTDK, Pusat Biomedis dan Teknologi Dasar Kesehatan

• To coordinate assessment activities

• To serve as communications focal point the for assessment

• To provide suggestions on design and assessment instrument

• To appoint staff to be a member of the assessment team

• To conduct assessment field activity

• To provide suggestions in analyzing assessment results

• To provide suggestions on recommendation, SOP, and cold chain management to

improve ILI specimen quality

Regional Laboratories in Denpasar, Semarang, Makassar, DKI Jakarta

• To assist the coordination of assessment in the field and sentinel health centers

• To act as a communication focal point in the respective area

USAID through USAID Deliver

• To provide financial support for assessment implementation

• To provide suggestions related to assessment design and questionnaire

• To provide suggestions related to recommendation, SOP, and cold chain

management procedures to improve the ILI specimen quality


USAID/DELIVER


• To appoint consultant and staff who will become the member of the assessment

team

• To provide administrative and logistics supports for the assessment activity

• To conduct and coordinate the assessment activity in the field




CDC Atlanta – Jakarta office


• To appoint consultant and staff who will become the member of the assessment

team

• To participate in the assessment activity in the field




USAID Deliver Consultants

• To provide technical assistance and leadership in the assessment design,

coordination, and implementation

• To provide detailed activity plan of the assessment

• To coordinate design process and assessment instrument

• To conduct assessment activity in the field

• To analyze data resulted from the assessment

• To report the assessment results

• To prepare recommendation, SOP, and cold chain management procedures to

improve the ILI specimen quality

7. Assessment team

The Assessment team composes of representative members from collaborating

partners.


Tim Assessment dan facilities visited

No. Name of team members Institution//Organization

1 Dr. Vivi Setiawaty MSi Pusat BTDK - NIHRD

2 Dr. Krisna Nur Pusat BTDK

3 Dr. Mursinah Pusat BTDK

4 Eka Pratiwi SSi Pusat BTDK

5 Hartanti Dian Ikawati SSi Pusat BTDK

6 Anton Widjaya JSI/USAID Deliver

7 Juhartini JSI/USAID Deliver

8 Rio Chandra JSI/USAID Deliver

9 Febry Nova CDC Atlanta, kantor Jakarta

10 Esther CDC Atlanta, kantor Jakarta

8. Outputs

Data collected will be tabulated and analyzed to gain the following outputs:

1. Data on the situation and condition of the cold chain resources (equipment,

performance) to support the quality of samples collected at the sentinel health

centers and regional laboratory

2. Conclusion, technical recommendation, and SOP to improve the cold chain

performance related to ILI specimens.

9. Finance

The financial assistance for the assessment and SOP building, as well administrative

support is provided by USAID through USAID/Deliver

10. Assessment period

Assessment will be conducted between November 2011 and January 2012


11. Activity Timeline

No Kegiatan Nov.2011 Dec. 2011 Jan. 2012

1 Internal JSI/USAID Deliver preparation x x

2 Team development and discussions x x

3 Develop assessment design and

instrument

x x x

4 Finalisation of assessment instrument

and training for usage by the field team

x x

5 Implementation of assessment in the

field

x x x x

6 Data tabulation and analysis x x x x x

7 Report writing x x x

8 File final Report x

9 Design SOP on cold chain procedures

and management for the ILI samples

x x x x

x

x x

10 Routine and incidental team meetings x x x x x


II. Executive summary

Influenza virus infection is one of the diseases which cause health problems with potency

for causing epidemic and high mortality rate in Indonesia and other countries in the world.

Since September 2004, the Research Center for Biomedical and Pharmacy (now named

Pusat BTDK, Pusat Biomedis dan Teknologi Dasar Kesehatan) has collaborated with the

Directorate General for Disease and Environmental Control, Ministry of Health, CDC

Atlanta, and WHO to develop epidemiology and virology surveillance networks in seven

provinces in Indonesia, which at present was already extended into 22 provinces in

Sumatra, Java, Kalimantan, Sulawesi, Bali, Nusa Tenggara, and Papua.

This was followed by setting up a national referral laboratory, i.e. the central virology

laboratory at Pusat BTDK, Pusat Biomedis dan Teknologi Dasar Kesehatan, Ministry of

Health and 5 regional laboratories as the sites for examining PCR-RT (2 laboratories in

Jakarta, Semarang, Bali, and Makassar, respectively) on samples sent by sentinel health

centers.

Laboratory testing is important in supporting the epidemiological surveillance to determine

the control measures and prevent epidemic or pandemic of ILI virus infection that can

cause high morbidity and mortality such as with H1N1 and H5N1 cases.

Accurate laboratory diagnosis depends on various factors including how the cold chain for

samples is managed starting at the collection period , storage, transportation until testing of

the ILI specimens. All these are important factors to obtain reliable and accurate laboratory

results.

Laboratory diagnosis by PRT-RT or virus isolation is believed to be the most reliable and

accurate method for confirming ILI infection in suspected cases.

To obtain a reliable and accurate laboratory result, it is important to guarantee the quality of

the samples and the maintaining the optimal temperature of 4°C of the samples starting

from specimen collection, storage, packaging, and shipment to regional laboratories or

national referral laboratories.

Many guidelines and SOPs are available on the collection, packaging, and shipment of

samples that stresses the need to always maintain the temperature of the samples at 4°C,

but there is no detailed guideline on how to arrange and to monitor the equipment and

support devices to achieve that optimal temperature besides of the preparation and training

of the implementers in managing the cold chain.


Considering its importance, an assessment was conducted to assess the cold chain

procedures and performance of cold storage, including also the temperature monitoring

equipment in use. Besides of cold chain issues, assessment also collect information on

supportive supervision conducted and the practice on safe management of infectious waste

based on universal precaution protocols currently implemented at the sample collection

sites and ILI laboratories.

An assessment on cold chain management on the samples was conducted to assess the

practice in the field for maintaining the optimal temperature, situation and condition of the

equipment and devices, the human resources and knowledge and skill of the

implementers. Besides of cold chain issues, the assessment also covers the practice of

waste management for the samples and the supportive supervision conducted within the

ILI surveillance program.

Five regional laboratories and five sentinel HCs in the area were targeted for the

assessment which was conducted between (end) November 2011- January 2012 by an

assessment team composing of personnel from Pusat BTDK, USAID Deliver and CDC

Atlanta.

Results obtained from the field is hoped to give an idea on the actual situation and

condition in the field to design a recommendation on how to maintain and improve the cold

chain management for the ILI samples.

Analysis of the assessment results indicates that more improvement is needed for the cold

chain management at the related facilities.

The assessment team has performed cold chain assessment in 4 out of 5 regional

laboratories and 4 out of 24 sentinel health centers that are participating in the ILI

surveillance project.:

No. Regional Laboraty Sentinel Health Center

1. Microbiology Laboratory of FK Universitas

Hasanuddin Hospital, Makasar

Sudiang, Kota Makasar

2. Biomolecular Laboratory of FK Universitas

Udayana, Denpasar

I Denpasar Selatan, Kota

Denpasar

3 Molecular Diagnostic Laboratory of FK

Universitas Indonesia, DKI Jakarta

Kayu Putih Utara, Jakarta Timur

4 Microbiology laboratory of FK Universitas

Diponegoro, Semarang

Pandanaran, Kota Semarang


Number of samples collected ranges between 2 – 10% of the average 20 – 150 patient

visits per day at the HC. Samples were collected by a lab technician or a nurse. .

Collection, storage in cryotube filled with Hank’s VTM, covering with parafilm and tissue

paper, and storing in plastic clipped bag andthe storahe in a cold storage were done

according to procedure. But not all refrigerators showed a temperature between 2-8 °C as

recommended.

Almost all health centers and regional labs use an auto-defrost refrigerator without placing

a thermometer inside the refrigeartor. Except in HC Denpasar Selatan and FKUI , all other

facilities di not perform daily refrigerator temperature monitoring and recording. Recording

of freezer temperature is conducted in FK UNUD Denpasar (not updated) and FKUI

regional labs.

During the assessment, real time temperature measured on domestic refrigerators showed

a range (- )1.5 °C to (+) 8°C, but no information obtained regarding the history before the

assessment and the effect of heater activation in auto defrost fridges when activated during

defrosting.

Maintenance of refrigerator still need attention, some refrigerators were found in a dirty

condition and full with dirt, fungi and mold at the door rubber seals and other parts of the

fridges.

Sample packaging for shipment to regional labs varies, some HC did the packaging until

collected by courier but there are 2 HCs who only handed over the samples in clipped

plastic bag and the surveillance form to the collecting Dinas staff who brought packaging

materials (cold box, pralon pipe, cold packs, and ?? thermometer) from dinas kesehatan.

Dinas staff will take the samples to the regional lab. Forty to fifty percent of shipments did

not have thermometers attached to the samples because the HC did not have spare

thermometers or because it was not stressed in the procedure.

Documents accompanying the shipments only consisted of the surveillance form regarding

patient’s condition etc. But no form on sample condition and temperature upon dispatch

from HC.

Lead time of shipmentfrom HC to regional lab ranged between 1-5 days or more

specifically if the samples arrived beyond working hours or on weekends so that it has to

wait until Monday before delivered.


The shipment schedule of Wednesday or Thursday frequently changes dependingon the

performance of the courier service and flight schedule from the other provinces.

Received samples at the regional lab were not checked for its temperature because most

of them did not have thermometer attached. At FKUI, 60 – 70 % of those having a

thermometer attached showed that the temperature on arrival ranged between 13 - 17 °C.

One among the shipment observed at RS FK Unhas was the shipment from Papua where

the temperature on arrival was 28 °C and not known how long this has happened.

Samples were divided in 2 aliquots for testing at BTDK and for local testing. Aliquot for

BTDK were stored in a 2-8 °C . At FKUI, when shipment to BTDK was delayed more than 1

day then the samples will be moved to a freezer. The aliquot for testing at the regional lab

was stoed in a (-) 20° C or (-) 80° freezer for 1-7 days until tested for PCR.

Daily monitoring of refrigerator temperature and recording in a temperature graph need to

be stressed. Some regional laboratories and HCs has already performed temperature

recordings but frequently not continously updated

Information on the received samples recorded in the sample logbook did not always

concurred inter regional labs. And no recording of the condition and temperature of the

received sample and the lag period between dispatch and arrival

Shipment of samples from the regional lab to BTDK used the packaging material originating

from HCs and if not complete or thermometer or pralon pipe were broken there will be no

resupply because the regional lab does not have spare devices in stock.

Shipment from regional lab to BTDK can take 2-3 days.

At BTDK, data and temperature of samples (if a thermometer was accompanied) were

recorded in a logbook and samples stored in a (-) 80° C freezer until sent to the virology lab

where it will be stored in a domestic refrigeratopr until tested for PCR. BTDK did not

record the temperature of their domestic refrigerator and freezers on a daily basis. Also no

recording on the lag period between sample dispatch and arrival.


Medical waste handling at BTDK and regional labs already meet the minimal requirement

but in some HCs still need attention and guidance.

Since the beginning of the project in 2005 , 2007 and 2009 there was no system for

performing routine supervision on cold chain issues at the health center, regional lab and

also at BTDK.

Based on the assessment results it is important to review the SOP and procedure of cold

chain management for ILI samples starting from HC level until BTDK and cold chain issues

need to be incorporated in the monitoring list.

Training or on the job training need to be performed for all ILI surveillance implementers.

It is also important to evaluate the relationship between samples shipped beyond 2-8 C

and the PCR , subtyping and isolation results.

Provision of cold chain devices such as thermometer, pralon containers need to be

reviewed for the sending of specimens as well as for replacing broken devices and

monitoring of the temperature in domestic refrigerators so that supply is sufficient at each

level.


III. COUNTRY BACKGROUND

Indonesia is an archipelago country composing of many islands, with a population of 238

million people in 2010 1, the 4th most populated country in the world, where approximately

65 % are living in Lampung, Java and Bali.

Administratively Indonesia composes of the Central Government in Jakarta, and 33

provinces, 399 districts and 99 municipalities, 6,543 sub-districts and 75,226 villages2.

Health services are provided through 8,737 static health centers where 6,033 are health

centers with inpatient care. Besides there are 6,253 mobile HCs using cars or motorboats

and 22,171 sub- HCs . In average each HC serves 25,000 – 50,000 or more population.

Hospital services are provided by 18 MOH- managed hospitals and 1,175 hospitals owned

by local governments, armed forces, non MoH ministries and private enterprises.

Picture 1: Map of Indonesia

1 Biro Pusat Statistik 2010

2 1) BPS; Penduduk Indonesia per Propinsi, 2010


IV. BACKGROUND

Communicable diseases are still prominent in Indonesia and diseases caused by virus

influenza infection is one of the diseases among the newly emerging diseases manifesting

in public health problems with potency for causing epidemics with high morbidity and

mortality in Indonesia and other parts of the world3.

Since September 2004 Puslitbang BMF, NIHRD-MOH (now Pusat Biomedis dan Teknologi

Dasar Kesehatan) in collaboration with the D.G. for Disease Control and Environmental

Health – MOH, CDC Atlanta and WHO has developed an epidemiological and virological

surveillance network in seven provinces in Indonesia which was then expanded to cover

22 provinces in Sumatera, Jawa, Kalimantan, Sulawesi, Bali, Nusa Tenggara and Papua.

Surveillance activity was conducted to detect ILI suspect cases and collection of nasal or

nasopharyngeal swabs at 20 HCs and 8 sentinel hospitals.

Epidemiological and virology surveillance are important to determine the causative virus

and to support the control measures and prevention of epidemic and possible pandemic

with potency for high morbidity and mortality such as in H1N1, H5N1 cases.

To support the surveillance activity a national referral laboratory i.e. the Virology Laboratory

at Pusat BTDK – MOH and five regional laboratory (2 in Jakarta, and one each in

Semarang, Denpasar-Bali, and Makassar) was assigned to be the central referral

laboratories for the PCR-RT testing on samples collected by sentinel hospitals and sentinel

HCs.

Laboratory diagnosis by PRT-RT or virus isolation is believed to be the most reliable and

accurate method for confirming ILI infection in suspected cases.

To obtain a reliable and accurate laboratory result, it is important to guarantee the quality of

the samples and the maintaining the optimal temperature of 4°C of the samples starting

3 Profil kesehatan Indonesia 2010, Kementerian Kesehatan, 2011


from specimen collection, storage, packaging, and shipment to regional laboratories or

national referral laboratories.

Many guidelines and SOPs are available on the collection, packaging, and shipment of

samples that stresses the need to always maintain the temperature of the samples at 4°C,

but there is no detailed guideline on how to arrange and to monitor the equipment and

support devices to achieve that optimal temperature besides of the preparation and training

of the implementers in managing the cold chain.

So far, HC and regional laboratory have collected and tested specimens routinely but there

is only limited information on the actual practice on cold chain management and the

availability and condition of cold chain and cold chain support equipment that are practiced

or used. Also there is limited information regarding the infectious waste management and

guidance or supportive supervision conducted for or by the facilities. Staffs generally

consider that cold chain equipment and the support devices automatically performed well to

meet the SOP on cold chain management for ILI samples and do not need any further

arrangement or monitoring.

Considering its importance and possible shortfalls, an assessment was conducted to

assess the cold chain procedures and performance of cold storage, including also the

temperature monitoring devices in use. Besides of cold chain issues, assessment also

collect information on supportive supervision conducted and the practice on safe

management of infectious waste based on universal precaution protocols currently

implemented at the sample collection sites and ILI laboratories. This assessment is hoped

to discover shortfalls and make recommendation for maintaining and improving the cold

chain management in the ILI surveillance program.

Five regional laboratories and four sentinel HCs in the area were targeted for the

assessment which was conducted between October-December 2011 by an assessment

team composing of personnel from Pusat BTDK, USAID Deliver and CDC Atlanta.


V. FINDINGS AND ANALYSIS OF RESULTS

General Findings

The assessment team had assessed the cold chain management of ILI samples in 4 out of

24 sentinel HCs and 4 out of 5 regional laboratories:

No. Regional Laboratory Sentinel HC

1. Microbiology Laboratory of FK Universitas

Hasanuddin Hospital, Makasar Sudiang, Kota Makasar

2. Biomolecular Laboratory of FK Universitas

Udayana, Denpasar I Denpasar Selatan, Kota Denpasar

3 Molecular Diagnostic Laboratory of FK

Universitas Indonesia, DKI Jakarta Kayu Putih Utara, Jakarta Timur

4 Microbiology laboratory of FK Universitas

Diponegoro, Semarang Pandanaran, Kota Semarang

The 4 regional laboratories and HCs are ILI surveillace project implementers.

At the HCs, sample collection were conducted by a laboratory technician or a HC nurse.

No. Health Center

Average

number of

visits per day

Number of

sample taken

per day

Remarks

1 Sudiang, Kota Makasar 150 5 - 7 10 cases (approx.

25% of all suspect

cases) rejected

samping)

2 1 Denpasar Selatan 150 4

3 Utan Kayu Utara 20 3

4 Pandanaran 130 2-5


Collection, containing in a cryotube, wrapping with parafilm and tissue paper and clipped

plastic and the storage in the refrigerator already followed the procedures, but what was

not known is whether the temperature in the refrigerator was in the range of 2-8°C (at HC

Utan Kayu samples were placer in the chiller compartment which has a sub-zero

temperature /below 0°C).

In general the refrigerator used are the auto defrost type domestic refrigerator without

having a thermometer inside. Except in HC I Denpasar Selatan and at FKUI all the other

sites did not conduct monitoring and recording the daily refrigerator temperature. See tabel

1 & 2.

At time of assessment the real time temperature were at the range of (- ) 1.5° to (+) 8°C,

but the history before that was not known, especially the effect of heating that happened

when the autodefrost sytem was activated for defrosting.

Maintenance of refrigerator still need improvement and in some sites it was observed that

the rubber seal and other parts of the fridge was dirty and filled with fungi and molds.


Table 1. Packaging equipment used at BTDK and regional labs.

No. Facility

Type Temp °C Capaci

ty

Maintenance/

Temp. Recording Type

Temp

°C

Capaci

ty Maintenance Temp.

Monitor

Device

Temp.

recording Sample storage for testing and storage

Temporary storage for samples to be sent

to BTDK

1 BTDK*

Domestic

auto frost 2 135 L

Good, no temp.

recording

N/A

None

Available

but not

updated

Deep

Freezer (-)80 519 L None

Available

but not

updated

2 Microbiology Lab,

FK UNHAS Hospital Freezer (-)20 482 L

Good, no temp

recording

Domestic

auto frost

(-)1- (-

)4.8 135 L Good None None

3

Biomolecular Lab,

FK Universitas

Udayana

Deep

Freezer (-)80 519 L

Good, no temp

recording

Domestic

auto frost (-)1 – 5 135 L Good None

Available

but not

updated

4

Clinical Microbiology

Lab, FK Universitas

Indonesia

Deep

Freezer (-) 80 519 L

Good, temp is

recorded

Domestic

auto frost 4 – 5 135 L Good Available

Available

and up to

date

Deep

Freezer (-) 80 519 L Good None

* Available

and up to

date

5

Microbiology Lab,

Universitas

Diponegoro

Deep

Freezer (-) 80 519 L

Good, no temp.

recording

Domestic

auto frost 1– 6.7 135 L Good None None

*Temperature is recorded based on temperature display that build in on the freezer


Table 2. Sample storage equipment at HC

No. Facility Type

Temp.

°C Capacity Maintenance Temp.

Monitor

device

Temp.

recording Temporary storage for samples to be sent to BTDK

1 Puskesmas Sudiang,

Kota Makasar

Domestic auto

defrost 4 135 L

Dirty and

fungi, molds None None

2 Puskesmas 1

Denpasar Selatan

Domestic

Manual

defrost

5.5 135 L Thick frost

Thermom

eter

Mueller &

OneMed

Available

and up to

date

3 Puskesmas Utan Kayu

Utara, East Jakarta

Domestic

auto defrost (-) 2 135 L Good None None

4

Puskesmas

Pandanaran

Semarang

Domestic

auto defrost 3.8 135 L Good None None

Packaging of samples for sending to regional lab varies , there are HC who did complete

packaging until collected by courier and there are HCs who only provide the samples in

clipped plastic bag and the surveillance form to Dinas staff who then packed them with

devices (cold box, ice packs etc) taken from dinas and send it to regional lab.

Approximately 40 – 50 % sampleshipment were not accompanied with a thermometer in

the cold box and samples because HC does not have spare thermometers – some has not

rceived the returned devices from previous shipments- or because it was not stressed that

each shipment has to be accompanied with a thermometer.

Documents accompanying the shipment only composed of the surveillance form without a

form informing the condition and temperature upon leaving the HC and futher to be used

upon arrival at higher levels.

Lag time between sending from HC till arrival at regional lab ranges 0 – 5 days especially if

ample sariived beyond working hours or on Saturdays/holidays so that it was kept at room

temperature until the next day or at the following working day. This is happening mostly

with shipments from out of the province. The determined schedule for courier to pick up on

Wednesdays/Thursdays were often trespassed depending on the performance of the

courier or flight schedule.


Tabel 3. Packaging devices and System for shipment of samples at regional labs and HCs.

No. Facility

Devices and type Document

on sample condition/

temp.

Frequenc

y of

shipment

Mode of

shipment Container

for

shipment

Cooler

Temperature

monitor

device

Sample container

Regional lab

1

Microbiology

Lab, FK

UNHAS

Hospital

Cold box

Ice

Pack/

gel

Thermometer Pralon

tubing None

1 x/week Courier:

Caraka/

Mega Cargo

2

Biomolecular

Lab, FK

Universitas

Udayana

Cold box Ice

Pack Thermometer

Pralon

tubing

None 1 x/week Courier:

Caraka

3

Clinical

Microbiology

Lab, FK

Universitas

Indonesia

Cold box Ice

Pack

Thermometer Pralon

tubing None 1 x/week Collected by

BTDK

4

Microbiology

Lab,

Universitas

Diponegoro

Cold box Ice

Pack

Thermometer Pralon

tubing None 1 x/week Courier:

Caraka

Health Center

1

Puskesmas

Sudiang, Kota

Makasar

Cold box Ice

Pack Thermometer

Pralon

tubing None 1 x/week Packed and

send by

Dinas staff

to reg lab.

2

Puskesmas 1

Denpasar

Selatan

Cold box Ice

Pack

Thermometer

(70% w/o

thermometer)

Pralon

tubing None 1 x/week

Courier:

Caraka

3

Puskesmas

Utan Kayu

Utara

Cold box Ice

Pack

Thermometer Clipped

Plastic

bag

None 1 x/week Packed and

send by

Dinas staff

to reg lab

4

Puskesmas

Pandanaran

Cold box Ice

Pack

Thermometer capped

medicine

plastic

bottle

None 1 x/week Packed and

send by

Dinas staff

to reg lab


Samples received at regional lab will be checked regarding its condition but temperature

was not recorded becuse there was frequently no thermometer accompanied with the

samples.

At FKUI, 60 – 70 % among yhose having a thermometer attached, showed that on arrival

the samples temperature were in the range of 13 – 17° C . This was also observed in one

of the samples sent from Papua to regional lab RS FK Unhas in Makassar where the

temperature upon arrival was 28°C and not known how long this has been happening.

Samples were aliquoted in 2 parts, one for BTDK and stored in the 2-8°C domestic

refrigerator. The other aliquot for testing at regional lab were stored in (-) 20°C or (-) 80°C

freezer for 1-7 days until tested for PCR, depending on number of samples available

The information recorded in the logbook did not always record the condition and

temperature upon arrival and also not the lag time between sending and arrival. The model

and information recordred also varies between laboratories. At FKUI the assessors only

see the computerized log book and not a manual filled one.

Shipment of samples from regional lab to BTDK used packaging devices that was used to

ship the samples from HCs to regional labs . Ice packs were refrozen or changed but not

the broken thermometers or broken pralon covers were not replaced/resupplied because

the regional labs did not have extra stock. At BTDK, we were informed that broken or

missed devices will be resupplied by BTDK when sending back the devices to HCs. Length

of time between regional labs to BTDK usually took at least 2-3 days.

Samples received by BTDK were recorded in a logbook including the temperature on

arrival if there was a thermometer accompanying the samples . Sample will then be stored

in a (-) 80°C deep freezer at the sample receipt section until sent to the virology lab.

At the virology lab the samples were stored in an auto defrost domestic refrigerator or a

freezer until tested for PCR etc. No continous temperature monitoring of domestic

refrigerator and freezers were conducted at BTDK ( last update was of March 2010).

Medical waste management at the regional labs and BTDK were already following the

good waste handling procedures but HCs still need attention and improvements


Throughout the surveillance project course since 2005, 2007 and 2009 there was no

system for a supportive supervision on cold chain management of ILI samples for HCs,

regional labs and Also BTDK and also not incorporated in other routine supervision

performed


VI. FINDINGS AND ANALYSIS OF RESULTS OF INDIVIDUAL FACILITIES IN THE ILI SURVEILLANCE

1. ILI National Referral Laboratory/Regional Laboratory Pusat BTDK, Jakarta

- Organization:

Pusat BTDK virology laboratory serves as the National ILI Reference Laboratory to

perform parallel testing on all aliquot samples received from other regional labs and

also performs further virus cultures when necessary, as well as a regional

laboratory for testing samples from their catchment health centers i.e. 4 health

centers in Palu, Ambon, Bengkulu, Palangkaraya which were just assigned as ILI

sentinel HCs in September 2011.

- Samples received:

In average Pusat BTDK receives:

à 4 x 5-8 samples = 20 -32 samples per month from their 4 catchment HCs.

à 5 x 5-8 samples = 25 – 40 aliquot samples from 5 regional labs. for parallel

testing

Upon arrival samples were taken out from the pralon pipe containers and checked

for its condition and staff will read the Mueller thermometer. Then the sample IDs,

temperature in the cold box when received will be registered in a logbook for

samples. Samples were then stored in a rack into a deep freezer (temp – 80oC) at

the reception compound until send to the virology lab. There is no routine recording

of the deep freeze temperature monitoring except the display temperature shown by

the build in digital thermometer.

- Sample shipment to Pusat BTDK:

Samples were packed by sentinel health centers and regional labs in cold box with

6 ice packs with a Mueller thermometer put inside the cold box. Samples were

stored in cryotubes and put in pralon (polyvinyl) pipes about 15 cm long and 2.5

inch diameter. Along with the samples patient’s ID and clinical history forms were

attached. Only from Banjarmasin –although not completely filled in - do sometimes


attach a form containing temperature condition of the samples (Kartu monitoring

suhu ILI).

In theory the contracted courier service (Caraka for Western Indonesia regions and

Mega cargo for East Indonesia) will collect the cold boxes from HCs and regional

labs on a weekly basis. Lately there are internal problems with Caraka so that they

could not perform weekly collection and shipment. Because of that, some HCs will

instead ship the samples using TIKI courier service.

- Sample handling at the virology lab.:

Samples are stored in an auto defrost domestic laboratory w/o a thermometer

placed inside the fridge. A temperature recording sheet is attached to the fridge but

no routine daily recording was recorded. Last recording was of March 2009 (deep

freezer) and March 2010 (domestic refrigerator) seen.

An aliquot of the samples is used for testing and the other aliquot stored in a deep

freezer of 70o- 80oC at the virology lab.

- Packaging equipment and devices:

Equipment and devices use in ILI samples received at BTDK compose of the

following:

• 1 Cold box ± 6 L

• 1 Pralon pipe with cover 15 cm long and 2.5 inch diameter

• 6 Ice packs ± 0.6 L

• 1 Thermometer Mueller

• Form containing sample’s ID

• Form containing temperature condition of the samples (Kartu monitoring suhu

ILI).

If the ice packs are frozen well the samples are supposed to be in a good condition

until arrival at BTDK, If the shipment does not take more than 24 hours. In some

shipment to BTDK, the Mueller thermometer was broken. All the packaging

equipment and devices were returned to the sender and broken thermometer will be

replaced with a new one.


- Cold chain capacity:

Cold chain storage for ILI samples at BTDK composes of 1deep freezer (also use

for SARI) at sample reception division, 1 domestic refrigerator and 1 deep freezer at

virology lab.

Total capacity is quite enough for storing ILI samples (135 L for domestic

refrigerator and ± 350 L for each deep freezer).

- Waste handling:

Laboratory waste was collected in a black colour waste bag and autoclaved. The

bags are not marked or colour as recommended by WHO.

A contracted waste transportation company will take the waste at intervals from the

BTDK. No info where they were taken afterwards.

- Supportive supervision:

No routine supervision was carried out for the regional labs nor the sentinel HCs by

the pusat BTDK on cold chain management of samples.

2. Microbiology Laboratory of FK Universitas Hasanuddin Hospital (Hasanuddin Medical School University Hospital) functioning as an ILI Regional Laboratory in Makasar

- Organization:

Microbiology laboratory of FK UNHAS serves as the ILI regional laboratory in

Makasar to perform PCR-RT and virus isolation on samples received from 5

sentinel health centers in Sudiang (Makasar), Manado (North Sulawesi), Jayapura

and Merauke ( Papua) and Balikpapan (East Kalimantan). This laboratory also

performs further virus isolation testing on positive PCR tested samples.

This laboratory is a division of the new university hospital managed by the university

and functions since April 2011for providing services to the hospital. For students

education the medical school still have a Microbiology division at their old

compound. This lab uses some equipment moved from their old laboratory which is

still on going. Some big equipment such as deep freezers still can not be moved

due to limited lift facility at the hospital.


This laboratory has 4 divisions : Bacteriology, Virology, and Mycology and

Biomolecular sections. The virology lab has 2 technicians (Safri and Desi) to do the

ILI tasks.

- Samples received:

In average Microbiology laboratory of FK UNHAS Hospital receives:

à 5 sites x 5-10 samples = 25 -50 samples per WEEK from their 5 catchment HCs.

Samples should actually be received three times a week (Tuesday, Wednesday and

Thursday) but from out of province sentinels were often not received on time

depending on arrangement by the contracted courier ( Megacargo is considered

better than Caraka courier) , samples from Sudiang health center were collected

once a week and packed using packaging materials and cold packs prepared by the

Municipality Health Office staff (Mr. Samsul).

At many times samples were received after hours or on Saturdays resulting that

samples were kept at room temperature by the hospital security or kept until the

following Monday at the courier’s storage without changing the cold packs.

• During the assessment, samples from Jayapura were received and cold packs

were already warm, and temperature in the cold box showed a temperature of

28ºC.

Upon arrival samples were taken out from the pralon pipe containers and checked

for its condition and staff will read the temperature of the Mueller thermometer (not

all cold boxes have a thermometer accompanying the samples or sometimes

thermometer was broken on transportation). Volume of samples also varies, some

tubes were leaking possibly because the swab sticks are too long so that cap could

Specimen from Jayapura was received at the regional lab with warm

ice packs and temperature on the thermometer showed 28ºC


not close tightly. Some samples showed change of Hanks colour into yellowish

colour.

Then the sample IDs, temperature in the cold box when received will be registered in

a logbook for samples. Samples were then aliquot, one aliquot stored in original

cryotube for sending to Pusat BTDK and stored in an ILI domestic refrigerator until

sent to Pusat BTDK. The other aliquot were contained in an Eppendorf micro-tube

for local testing ( 300-400 ul taken depending on received sample volume) and then

stored in a (-) 20ºC freezer.

Temperature of the domestic refrigerator is in the 4-8 C range (1- 4.8ºC when

checked with a thermotracer) and the freezer temperature is (-)17 to (-)19ºC . The

domestic refrigerator does not have a thermometer and the freezer only have the

build-in temperature display. There is no routine recording of all the refrigerator and

freezers.

Received cold packs were placed in a (-) 20 C upon arrival for further use in the

shipment to BTDK.

- Sample shipment to Pusat BTDK:

Aliquot samples in the originally received cryotubes were re-packed by the

microbiology laboratory using the packing materials received from health centers:

The 15 cm long and 2.5 inch diameter pralon tube, 6 re-frozen cold packs and

thermometer (if any) ere reused and put inside the received cold box. Along with the

samples patient’s ID and clinical history forms were attached plus a locally designed

form (Formulir kondisi sample/Sample condition form) containing condition, colour

and temperature of samples when received by the regional lab and the condition

when dispatched to Pusat BTDK. Samples were then shipped by courier to BTDK.

Damaged and broken pralon pipes and broken thermometer were not replaced since the regional lab does not have spares.

- Sample handling at the virology lab.:

As mentioned above, samples for local testing stored in a freezer and the samples

for BTDK are stored in the auto-defrost domestic refrigerator but no monitoring and

recording of temperature because they do not have a thermometer.


Samples for local testing are stored in a freezer of (-) 20ºC. Since one month ago the

reg. lab could not perform the PCR-RT testing because they have no primer in stock.

They have sent their primers to BTDK for review and calibration but have not got

them back or re-supplied.

They also have problem with their safety cabinet obtained from the project that need

to be checked by an engineer.


Equipment and devices used in ILI samples received at FK Unhas regional

laboratory compose of the following:



• 6 Ice packs ± 0.6 L ( or gels or frozen water in plastic bags)

• 1 Thermometer Mueller (or none)

• Form containing sample’s ID (from FK Unhas they add another form describing

sample condition).

All the packaging equipment and devices were returned to the sender by BTDK and

broken thermometer will be replaced with a new one. All ILI sites have 2 sets of

packaging equipment but sometimes due to the transportation problem the

packaging equipment were returned late, so the schedule for shipping the samples

could not be performed as scheduled.


Cold chain storage for ILI samples at FK Unhas regional laboratory composes of 2

freezers (1 used to store samples and 1 for preparing cold packs and store already-

tested samples since the beginning of the project that were not yet disposed pending

to guideline from ILI coordinating team at BTDK. Total capacity is quite enough for

storing ILI samples (approx. 135 L for domestic refrigerator and 482 L for each

freezer).

Positive samples are stored in deep freezer (still at the old FK Unhas compound).

- Waste handling:

Laboratory non-infectious wastes were collected in a common waste bin using white

colored plastic bags provided by the hospital safety division and periodically


collected by the safety division of the hospital. The infectious waste used at the bio

safety cabinet are collected in a yellow waste lined with a red colored plastic bag

inside and collected by the hospital safety division for incineration at RS Wahidin or

RS Dadi.


No routine supervision was carried out for the regional labs by the pusat BTDK and

also no supervision to sentinel health centers by the regional lab regarding cold

chain management of samples.

3. Sentinel Health Center Sudiang in Makasar Municipality

- Organization:

Sudiang health center is an ILI sentinel lab. The health center is one of the sub-

district level primary health care providers managed by the municipal health office of

Makasar.

This health center is an outpatient care facility without inpatient care. Total visit is in

average 150 patients per day. Health center is headed by Dr. Muh. Sofyan and ILI

project implementer is the responsibility of Dr. Martha.

- Samples collection and shipment to regional lab.:

In average the samples collected were 5-7 nose and pharyngeal swabs per day

(i.e.75 % of approximately 10 suspect cases/day, the other 25% rejects). Total

outpatient visit is 150 per day, and approx 6% are suspect ILI cases).

Suspect cases were diagnosed by the outpatient section (Dr. Martha) and after

interviewed and signing the inform consent form patient(s) were referred to the

laboratory for swab collection. Lab staff will then store the samples collected in

cryotubes and wrapped in tissue paper were kept in small clipped plastic bags and

stored in the ILI auto defrost domestic refrigerator (not equipped with thermometer

and no temperature recording). Actually the HC routinely record the temperature of

their immunization fridge which has a Mueller thermometer inside besides of the

build-in display.


Samples were collected on a daily basis and collected and packed by the

municipality health office staff (Mr. Samsul) on a weekly basis (every Wednesday)

for sending to the regional lab by motorbike or car.

HC only attach the ILI standard surveillance form containing patient condition, and

Dina swill resume the amount of samples in their form for shipment purposes.

Assessors do not have access on the cold pack preparation and thermometer stock

and condition at the Dinas but so far there are no complaints by the reg. lab.

regarding the temperature of samples from sudiang HC.

- Packaging equipment and devices

According to standard procedure and information received from regional lab, the

equipment and devices used in ILI samples sent to FK Unhas regional laboratory

compose of the following:



• 6 Ice packs ± 0.6 L ( or gels or frozen water in plastic bags)



• All the packaging equipment and devices were returned to the sender and

broken thermometer will be replaced with a new one.

- Cold chain capacity

Cold chain storage for ILI samples at the HC, an auto defrost domestic refrigerator

has a total capacity of approx.135 L, which is quite enough to store the samples.

- Waste handling:

Laboratory non-infectious and infectious wastes were all collected in a common

household small waste bin without plastic lining and burned (open fire burning)

along with other domestic and clinical waste at the HC yard.


No routine supervision was obtained from the regional lab or Dinas regarding cold

chain management of samples and ILI waste management.


4. Biomolecular Laboratory of FK Universitas Udayana Denpasar, functioning as an ILI Regional Laboratory

- Organization:

Biomolecular Laboratory of FK Udayana is a laboratory designed to conduct

biomolecular research activities which serves as the ILI regional laboratory in

Denpasar to perform PCR-RT. Samples are received from 3 sentinel health centers

i.e. HC I Denpasar Selatan (Denpasar), Mataram (NTB and Kupang (NTT).

Besides of PCR=RT testing this laboratory also performs further virus sub-typing on

positive PCR tested samples.

The biomolecular lab is headed by Dr. Nyoman Sri Widayanti, SPMK.

The responsible staffs working on ILI project are:

1. Nyoman Sri Handayani, SSi as coordinator

2. I Ketut Sucipta, responsible for specimen receipt, storage and packaging for

shipment to BTDK.

3. Wahyu Hidayati SKM and Ketut Nani Astuti, technicians performing the lab

testing

- Samples received:

In average the Biomolecular laboratory of FK UNUD receives:

à 3 sites x 5-10 samples = 15 – 30 samples per WEEK from their 3 catchment

HCs.

Samples reception was arranged as follows:

1. Wednesday: from HC I – Denpasar Selatan

2. Thursday – Saturday: from Kupang and Mataram

All samples were transported by Caraka courier service and most of the time the

schedule was followed by the courier service. The lab is ready to receive the

samples 7 days in a week upon notice from Caraka courier.

In the beginning of the project the reg lab frequently received sample leakage

because the swab sticks were too long or not using enough parafilm, but currently

this condition did not happen anymore.

Some pralon pipe covers were broken.


Upon arrival at the reg. lab samples were taken out from the pralon pipe containers

and checked for its condition and staff will read the temperature if they were

accompanied by a Mueller thermometer.


a logbook for samples. Samples were then aliquoted, one aliquot stored in original

cryotube for sending to Pusat BTDK and stored in an ILI domestic refrigerator (4 –

8ºC) until sent to Pusat BTDK. The other aliquot were contained in an Eppendorf

micro-tube for local testing ( 300 ul) and stored in the (–) 80ºC deep freezer.

Cold packs were stored in another(–) 20º C freezer specially for storing cold packs.


Equipment and devices used in ILI samples received at FK UNUD regional

laboratory composes of the following:





• Form containing sample’s ID, but not accompanied by a form stating the

condition of samples during dispatch from HCs.

At many times no thermometer accompanies the samples:

During the project period from August 2011 till December 15, 2011 the following

situation was observed:

Out of 41 shipments, 21 shipments (> 50%) were not using thermometers

(Denpasar Selatan 3 out of 16, Mataram 6 out of 12 and Kupang 12 out of 13

shipments did not have a thermometer attached in the shipment. This might be

caused by insufficient numbers of thermometer available at HCs because they were

broken or late return from BTDK to HCs.

As a result the reg lab could not record the samples on arrival on all shipments in

their logbook.

Upon sending samples from reg lab to BTDK, the reg lab will use the packaging

material received from HCs including the broken thermometers or broken pralon


covers because the reg lab does not have spare devices. Reg lab will replace with

frozen cold packs form the reg lab.

- Sample shipment from regional lab. to Pusat BTDK:

Aliquoted samples in the originally received cryotubes were re-packed by the reg

laboratory using the packing materials received from health centers: The 15 cm long

and 2.5 inch diameter pralon tube, 6 re-frozen cold packs and thermometer (if any)

were reused and put inside the received cold box. This means that > 50 % shipment

did not use a thermometer. Along with the samples patient’s ID and clinical history

forms were attached. We suggested that the reg. lab will also attach a form on

sample condition upon received from HC and upon dispatch from the regional lab. It

will be good if the project coordinator at BTDK can supply the forms and enforce it

use at all ILI sites starting from the HCs and reg. labs. situation.

Samples were then shipped by courier to BTDK.

Damaged and broken pralon pipes and broken thermometer were not replaced

since the regional lab does not have spares.

- Cold chain capacity and condition

Cold chain storage for ILI project at FK UNUD regional laboratory composes of 1 (-)

80º C (used to store samples and a 250 L capacity (-) 20º C freezer (used to store

tested samples and for preparing cold packs). Both freezers are almost fully loaded.

The (-) 20º C freezer is used to store already-tested samples since the beginning of

the project that were not yet disposed pending to guideline from ILI coordinating

team at BTDK and also other projects samples,

Capacity of the domestic refrigerator ((approx 135 L) is for storing ILI samples.

Refrigerator is clean and looks well maintained. The question is regarding the use of

this auto defrost type because during the auto defrosting we do not know how long

and at what temperature the build – in heater is working.

Some biological materials are stored at the door racks, which are actually not

recommended to prevent overheating.


Temperature of the domestic refrigerator is in the 4-8ºC range [ (-1) to (+) 5ºC when

checked with a thermo-tracer] and the freezer temperature range is between (-) 20º

to (-)26º C.

The auto-defrost type domestic refrigerator does not have a thermometer inside so

temperature is not monitored or recorded in a temperature recording graph.

As for the freezers, monitoring of the temperature was recorded on a temperature

graph although not performed daily. Temperature reading is done by reading the

build-in display.

- Waste handling:

Laboratory infectious wastes were collected in a small plastic waste box with plastic

bag inside and if full will be disinfected by placing 1 hour under the laminar flow UV

light before placed in a big plastic bag for incineration at Sanglah hospital (charged

Rp 9.000/kg).


No routine supervision on cold chain management were carried out to the regional

labs by the pusat BTDK and also no supervision to sentinel health centers by the

regional lab regarding cold chain management of samples.

5. Sentinel Health Center I Denpasar Selatan in Denpasar Municipality.

- Organization:

Denpasar Selatan I is an ILI sentinel lab. The health center is one of the sub-district

level primary health care provider managed by the municipal health office of

Denpasar.

This health center is an outpatient care facility without inpatient care. Total visits at

the policlinic are in average 150 patients per day. Health center is headed by Mr.

Ketut Pawarte and ILI project implementer is the responsibility of Dr. Wulan Putri and

the staff lab Tarmanta.



In average the samples collected were 4 nose and pharyngeal swabs per day). Form

an average of 150 total outpatient visit per day (approximately 2% are suspect ILI

cases).

Suspect cases were diagnosed by the outpatient section (Dr. Wulan Putri) and after

interviewed and signing the inform consent form, patient(s) were referred to the

laboratory for swab collection. Lab staff will then store the samples collected in

cryotubes were kept in small clipped plastic bags and placed inside the pralon pipe

container and stored in the ILI manual defrost domestic refrigerator (equipped with

borrowed thermometer from the immunization section. The temperature was

monitored daily and recorded in a temperature graph.

Samples were collected on a daily basis and packed on each Wednesday by the HC

for sending to the regional lab by Caraka.

During the last 3 shipments they do not attached a thermometer with the shipment

because their thermometer was broken and do not have extra spares. They have

bought some One-Med spring thermometers but they were also easily got broken.

The 6 cold packs used in each shipment were frozen in a freezer owned by the

Immunization section.

HC only attached the ILI standard surveillance form containing patient condition.

We suggested that the HC design and use a form which records the condition and

temperature of samples upon despatch to the regional lab. and also add columns for

next step use at the regional lab and BTDK regarding condition upon receipt and

dispatch of samples.






• 1 Pralon pipe with cover, 15 cm long and 2.5 inch diameter

• 6 Cold packs ± 0.6 L





Cold chain storage for ILI samples at the HC, a manual defrost domestic refrigerator

has a total capacity of approx. 135 L, which is quite enough to store the samples.

Refrigerator maintenance is needed to be improved since we found thick frost in the

freezer compartment. They put thermometer inside the refrigerator and the

temperature is monitored. The HC immunization division also has a Modena freezer

with a total capacity of 100 L, which are they use to freeze the ice packs for both the

immunization and ILI use.

- Waste handling:

Laboratory non-infectious and infectious wastes were all collected in a common

household small waste bin with plastic lining and then the bags were sent to

Wangaya hospital for incineration.




Thick frost in the

refrigerator is need to be

defrosted Refrigerator is monitored using

thermometer

Refrigerator is recorded in the

temp. Monitoring graph


6. Clinical Microbiology Laboratory of FK Universitas Indonesia, Jakarta, functioning as an ILI Regional Laboratory

- Organization:

Clinical FKUI Microbiology laboratory composes of the following divisions:

Bacteriology (environmental and clinical), Virology, Mycology, Serology and

Molecular Diagnostic divisions.

This laboratory performs research as well as services to the RSCM Hospital and

other hospitals in Jakarta.

The Molecular Diagnostic division is a laboratory assigned to serve as the ILI

regional laboratory in Jakarta in performing PCR-RT testing and subtyping of PCR

positive Influenza A samples since 2009.

Samples were received from 6 sentinel health centers i.e. HC Utan Kayu Utara

(Jakarta Timur), and from sentinel health centers from provinces outside Jakarta i.e.

Tangerang (Banten), Banda Aceh (Aceh), Bandung (West Java), Pontianak (West

Kalimantan), and Banjarmasin (South Kalimanatan).

The Microbiology Laboratory is headed by Dr. Anis Karuniawati PhD.

The responsible staffs working on ILI project are:

1. DR. Andi Yasmon, head of the Molecular Diagnostic Division and coordinator for

the ILI project.

2. Alfian AMD, responsible for overall specimen receipt, documentation, storage

and packaging for shipment to BTDK. And also for PCR and subtyping testing.

3. Nila and Lolita, technicians to assist in the sample receipt, storage aliquoting

and lab testing of the received ILI samples.

- Samples received:

In average the Microbiology Laboratory of FK UI receives 6 - 20 samples per WEEK

from their 3 catchment HCs and all were shared with Pusat BTDK.

Samples reception was arranged that all samples should arrive at the regional

laboratory between Thursday and Friday during working hours.

All samples from other provinces were transported by contracted courier service and

most of the time the schedule was followed by the courier service. Exception is for


samples from Utan Kayu and Tangerang (Banten) that were collected and

transported from HCs/Dinas to the regional laboratory by Mr. Santono from BTDK. In

the beginning of the project the regional lab has experienced receiving sample

outside the mutually agreed days but this did not happen nowadays.

Upon arrival at the regional lab samples were taken out from the pralon pipe

containers (not always used) and checked for its condition and staff will read the

temperature (if they were accompanied by a Mueller thermometer).

Then the sample IDs, will be registered in a computer used for ILI samples. Assessor

did not find a manually written log book. We suggested that the computerized

records be added with columns recording the date of arrival and condition and

temperature when sample were received and if possible also the length of time

between dispatches from HC unit received at the regional laboratory.

Samples were then aliquoted, one half aliquot stored in original cryotube for sending

to Pusat BTDK and the other half for testing at the regional lab.

Aliquots for BTDK were then stored in an ILI domestic refrigerator (4 – 8ºC) until sent

to Pusat BTDK for one day, and if they were not yet sent to BTDK after one day the

samples will be stored in a (-) 800 C freezer along with the samples to be tested at

regional lab.

The other aliquot for testing at the regional lab (approx. 300 - 400 ul) were stored for

4-7 days in the (–) 80ºC deep freezer until tested for PCR RT.

Cold packs were stored in another(–) 20º C freezer specially for storing cold packs.


Equipment and devices used in ILI samples received at FK UI regional laboratory

usually composes of the following:




• 1 Thermometer Mueller (60 – 70% without thermometer).




Leakage from the cryotube was noted in only one event because the swab sticks

were too long or not using enough parafilm but it did not happen again at present.

Pralon pipe and thermometers (if any) were received intact.

Approximately 30 - 40 % of shipments did not have thermometers accompanying the samples.

In 60 – 70 % samples received, the temperature of the samples upon receipt

was between 13 – 170C. As a result the reg lab could not record the samples on

arrival on all shipments in their logbook. No data available regarding the length of

time between dispatch from health center and receipt at the regional lab.

In sending samples from regional lab to BTDK, the regional lab will use the

packaging material received from HCs Cold packs will be replaced with frozen cold

packs from the reg lab.

Samples for BTDK will be collected by BTDK on a weekly basis.


Aliquoted samples in the originally received cryotubes were re-packed by the reg

laboratory using the packing materials received from health centers: The pralon

tube, 6 re-frozen cold packs and thermometer (if any) were reused and put inside

the received cold box. This means that > 60 % shipment to BTDK did not use a

thermometer. Along with the samples the surveillance form containing patient’s ID

and clinical history forms were attached. We suggested that the reg. lab will also

attach a form on sample condition upon received from HC and upon dispatch from

the regional lab.


Cold chain storage for ILI project at FK UNUD regional laboratory composes of 1 (-)

80º C used to store samples and to store tested samples. The (-) 80ºC freezer is not

overloaded. The temperature is recorded on daily basis (only once a day in the

morning or afternoon) by reading the build-in thermometer display and recorded on a

temperature graph form.


A 2-80 C auto-defrost 2-door refrigerator is used for temporary storage of samples

for BTDK.

Capacity of the domestic refrigerator (approx 90 L refrigerator and 40 L freezer

compartment). Refrigerator is clean and looks well maintained and they recorded the

daily temperature on a temperature graph form. During the assessment the

temperature was (+) 4 - 50 C for the refrigerator and (-) 12 – 130C for the freezer

compartment. The question is regarding the use of this auto defrost type because

during the auto defrosting we do not know how long and at what temperature the

build – in heater is working.

Some biological materials are stored at the door racks, which are actually not

recommended to prevent overheating.

- Waste handling:

Laboratory infectious wastes were collected in a small plastic waste box with

biohazard plastic bag inside containing 1% chorine solution and if full will placed in a

big biohazard plastic bag for autoclaving at the microbiology kitchen and further

incinerated at RSCM hospital.


No routine supervision on cold chain management was received by the regional labs

and also no supervision to sentinel health centers by the regional lab regarding cold

chain management of samples.

7. Sentinel Health Center Utan Kayu Utara in East Jakarta.

- Organization:

Utan Kayu Utara is an ILI sentinel lab. The health center is one of the village level

(kelurahan) primary health care provider under the coordination of the sub district

Health center Matraman and managed by the East Jakarta health office.

This health center is an outpatient care facility without inpatient care. Total visits at

the policlinic are in average 20 - 40 patients per day.

Health center is headed by drg. Rosalina and assisted by Dr. Rahadini.


This HC participated since 2007 in the ILI project.

ILI project implementation is the responsibility of Nurse Nurhaeni and assisted by

nurse Choti from the sampling, sampling, documentation and storage of samples.


In average the samples collected were 3 nose and pharyngeal swabs per day out of

approx 20 patients visits (approximately 10.% are suspect ILI cases).

Suspect cases were diagnosed by the outpatient section (Dr. Rahadini) and after

interviewed and signing the inform consent form, patient(s) were referred to nurse

Nurhaeni for swab collection.

Samples were collected in cryotubes and using parafilm and tissue paper samples

were put into a clip plastic bag and stored in an ILI manual defrost domestic

refrigerator equipped with one of the two Mueller thermometers provided by the

project. (they do not know that the thermometers should accompany the samples

during shipment so they use one for the refrigerator and store the other one.

Samples were placed in the chiller compartment in the refrigerator (temperature is (-)

110 C when assessed).

Samples were collected on a daily basis and on each Wednesday or Thursday will

be collected by the Dinas staff for sending to the regional lab.


According to the HC staff, the equipment and devices used in ILI samples sent to

FK UI regional laboratory compose of the following:


• 6 Cold packs ± 0.6 L


Packing materials (cold box, cold packs – but no thermometer and pralon tubes –

was brought by Dinas staff during the collection day.

HC only attached the ILI standard surveillance form containing patient condition

without form on sample condition and temperature during dispatch from the HC.


We suggested that the HC from now on attach a form which records the condition

and temperature of samples upon despatch to the regional lab.

The assessment team have no access or information regarding the materials really

used by the Dinas staff in sending to the regional lab.


Cold chain storage for ILI samples at the HC, is an auto-defrost 1-door domestic

refrigerator with a total capacity of approx. 135 L, which is quite enough to store the

samples. On checking the team found that the temperature of the freezer

compartment and the chiller compartment is (-) 110 to (-) 180C while the refrigerator

compartment is (-) 1.50 to 50 C. We detected that the thermostat was set at

maximum (level 7) so we re-set it to level 3 to get a temperature of 2-80 C.

The temperature of refrigerator was not recorded because the staff did not

understood that the refrigerator need to be monitored and recorded.

- Waste handling:

Laboratory non-infectious and infectious wastes were all collected in a medical waste

bag and once in 2 days will be taken to the sub district HC for further incineration.




8. Microbiology Laboratory of FK Universitas Diponegoro, Semarang, functioning as an ILI Regional Laboratory

- Organization:

Microbiology laboratory of FK Universitas Diponegoro, Semarang is a laboratory

designed to serve as the ILI regional laboratory in Semarang to perform laboratory

testing of collected ILI specimens. Samples were received from 3 sentinel health

centers i.e. HC Pandanaran (Semarang), HC Dinoyo Malang (East Java), HC Kota

Gede I in Yogyakarta (DIY).


Besides of PCR-RT testing this laboratory also performs further virus sub-typing on

positive A PCR tested samples.

The Microbiology department performs activities in Bacteriology, Mycology, Virology

and Serology chapters and functions as an education department to train medical

students and residents. They also have a Clinical Microbiology division at the Dr.

Kariadi Central General Hospital with the main task to conduct clinical microbiology

services for patients of the hospital.

The Microbiology Department is headed by Prof.DR.dr.Hendro Wahyono,

MscTropMed,DMM, SpMK(K), and the Virology section where ILI specimens are

tested is coordinated by Dr. Purnomo Hadi, MSi assisted by:

1. Ms. Irma Dewinovita, Senior lab technician as the day to day ILI main staff,

2. Dr. Vincentio Rezke resident at the Microbiology lab.,

3. Mr. Bambang, technician performing the lab testing, sample receipt, packaging,

storage of samples

- Samples received:

In average the Microbiology laboratory of FK UNDIP receives 10 – 17 samples per

week originating from the 3 Catchment HCs sites: 1-3 samples from Yogya and 8 –

14 samples from Malang and Semarang HCs.

Samples reception was arranged as follows:

1. Tuesday: from HC Pandanaran

2. Wednesday: from HC Kota gede, DIY and

3. Thursday: from HC Dinoyo, Malang.

Tolerance is given until Saturdays where the lab is open, but not on holidays and

Sundays.

All samples were transported by Caraka courier service (except from HC Pandaran

samples were brought by Dinas staff. Most of the time the schedule was followed by

the courier service.

Upon arrival at the regional lab samples were taken out from the pralon pipe

containers (or sometimes plastic cans) and checked for its condition and staff will

read the temperature if they were accompanied by a Mueller thermometer.


a logbook for samples. Samples were then aliquoted, one aliquot stored in original

cryotube for sending to Pusat BTDK and stored in an ILI domestic refrigerator (4 –


8ºC) until sent to Pusat BTDK. The regional lab will send samples to BTDK 3 times a

week, sometime on the same day the samples were received from HCs or the next

day. The other aliquot were contained in a micro-tube for local testing and stored in

the (–) 80ºC deep freezer.

Cold packs were stored in another (–) 20º C freezer specially for storing cold packs

and tested samples.

According to the reg lab, yellowish Hanks were received mostly from Malang and

Semarang so they thought it might be due to Hanks quality.


Equipment and devices used in ILI samples received at FK UNDIP regional

laboratory composes of the following:

• 1 Cold box ± 6 L, sometimes not the standard provided cold boxes.


• 6 Ice packs or gel packs of various capacity




At many times no thermometer accompanied the samples:

During the project period from November 2011 till December 2011 the following

situation was observed:

Out of 24 shipments, 7 shipments from the 3 HCs (30%) were not using

thermometers. This might be caused by insufficient numbers of thermometer

available at HCs because they were broken or late return from BTDK to HCs.

As a result the reg lab could not record the samples on arrival on all shipments in

their logbook.

In the logbook they recorded that for November – December 2011, the temperature

of those samples received with a thermometer attached were between 4-10°C when

received.

For sending samples from reg lab to BTDK, the reg lab will use the packaging

material received from HCs including without thermometers or using the broken


thermometers because the reg lab does not have spare devices. Re cold packs, reg

lab will replace with frozen cold packs form the reg lab.


Aliquoted samples in the originally received cryotubes were re-packed by the

regional laboratory using the packing materials received from health centers: pralon

tube container or plastic capped bottle, 6 re-frozen cold packs and thermometer (if

any) were reused and put inside the received cold box. This means that also 30%

shipments did not use a thermometer. Along with the samples patient’s ID and

clinical history forms were attached. We suggested that the reg. lab will also attach a

continuous form on sample condition and temperature starting from HC dispatch and

upon received and dispatch from the regional lab. to BTDK so that the temperature

history can be reviewed.


Cold chain storage for ILI project at FK UNDIP regional laboratory composes of a

519 L capacity (-) 80ºC (used to store samples) and a 482 L capacity (-) 25º C

freezer (used to store tested samples and for preparing cold packs). Both freezers

are almost fully loaded with old samples already tested and not knowing when it can

be discarded.

The (-) 20º C freezer is used to store already-tested samples since the beginning of

the project in 2007 that were not yet disposed pending to guideline from ILI

coordinating team at BTDK.

They have 3 auto-defrost type domestic refrigerators with the capacity of approx 135

L each which are used to store samples for BTDK and also used to gradually thaw

the labs samples from ((-) 80°C to (-) 25°C and then in the domestic refrigerators of

2-8°C

Refrigerator is clean and looks well maintained. The question is regarding the use of

this auto defrost type because during the auto defrosting we do not know how long

and at what temperature the build – in heater is working when defrosting was

activated.


Temperature of the domestic refrigerator is in the 4-8ºC ranges between (+)1° to

(+)6.7ºC when checked with a thermo-trace and the freezer temperature range is

between (-)25ºC and to (-)77ºC.

The auto-defrost type domestic refrigerator does not have a thermometer inside so

temperature is not monitored or recorded in a temperature recording graph.

As for the freezers, monitoring of the temperature was not recorded on a

temperature graph. Temperature reading is done by reading the build-in display.

The freezers actually have thermograph build –in to the freezers but they do not

know how to replace and where to get the thermograph paper discs.

- Waste handling:

Laboratory infectious wastes were collected in a small plastic waste box with red

plastic bag inside and if full will be autoclaved at the Microbiology Department and

then put in a big bag for further weekly incineration at the hospital’s incinerator. Non

medical waste was placed in a marked black colored bag for hospital disposal.


No routine supervision on cold chain management were carried out to the regional

labs by the pusat BTDK and also no supervision to sentinel health centers by the

regional lab regarding cold chain management of samples.

- Results of PCR and Sub-typing (July 2010 – July 2011)

HC Total

Sample

PCR-RT SUBTYPING

Flu A Flu B Subty

pe H1

Subty

pe H3

Subty

pe H5

Novel

H1N1

Unsubty

pe

Yogyakarta 141 15 14 3 7 0 4 5

Malang 221 21 31 1 1 0 13 6

Semarang 311 17 56 0 3 0 11 3

Total 673 53

(7.9%)

101

(15%)

4

(0.6%)

11

(1.6%)

0 28

(4.2%)

14

(2%)


9. Sentinel health center Pandanaran in Semarang

- Organization:

HC Pandanaran is a ILI sentinel lab. since 2009. The health center is one of the 37

sub-district level primary health care provider managed by the municipal health

office of Semarang.

This health center is an outpatient care facility without inpatient care (their maternity

ward was closed a few months ago because lack of patients). Total visits at the

policlinic are in average 130 patients per day.

Health center is headed by Dr. Antonia and ILI project implementer is the

responsibility of Dr. Wiwik Nugrawati and nurse Eko Suprianto.


In average the samples collected were 2-5 nose and pharyngeal swabs per day.

From an average of 130 total outpatient visit per day (approximately 2 - 4.% are

suspect ILI cases but approx 1% are willing to be taken samples or staff could not

take the swabs.

Suspect cases were diagnosed by the outpatient clinic and after interviewed and

signing the inform consent form, patient(s) were taken nose and pharyngeal swabs

at the clinic. Staff will then store the samples collected in cryotubes that were kept in

small clipped plastic bags and placed inside the pralon pipe or plastic

bottles/container and stored in the ILI manual defrost domestic refrigerator.

Temperature was not checked or recorded because they do not have a

thermometer.

Samples were collected on a daily basis and packed on each Tuesday by the HC for

sending to the regional lab by Mr. Ashudi, SKM from Dinas Kesehatan composing of

approx. 10 – 15 samples per week.

This week they have no stock of cold box, container, cold packs because they have

not received back the devices from BTDK after sent 2 weeks ago. Usually it was

already returned to HC in less than 1 week.

In the cold box, HC only attached the ILI standard surveillance form containing

patient condition.


We suggested that the HC design and use a form which records the condition and

temperature of samples upon dispatch to the regional lab. and also add columns for

next step use at the regional lab and BTDK regarding condition upon receipt and

dispatch of samples.






• 1 Pralon pipe with cover, or substituted with a capped medicine plastic bottle.

• 6 Cold packs ± 0.6 L of various types or gel packs.




Cold chain storage for ILI samples at the HC, an auto defrost domestic refrigerator

has a total capacity of approx. 135 L, which is quite enough to store the samples.

The HC freeze their cold packs in the freezer compartment. During the assessment,

the temperature of the refrigerator was 3.8°C and (-) 1°C at the chiller compartment.

Refrigerator is clean and well maintained.

- Waste handling:

Laboratory medical infectious wastes were all collected in a waste bin with inner

lining using plastic bags which were weekly brought to the Dinas medical waste

disposal compound at Tambak Aji for incineration.





VII. Conclusion

1. Procedure for the cold chain management in storage and shipment of samples still

varies among facilities in the ILI surveillance. There are also discrepencies between

those participating in 2007 and 2009.

2. Implementers were not fully exposed on the operational and maintenance of cold

storage equipment

3. Implementers were not fully exposed on the daily monitor and record the temperature of

the cold storage equipment and also the appropriate placement of sample storage in

the refrigerator

4. The domestic refrigerator used are of the auto-defrost type which can affect the stability

of inside the fridge’s temperature.

5. Packaging devices was not/not sufficiently provided at HCs and regional labs especially

to replace broken thermometers and pralon pipe covers and also thermometers for use

in the domestic refrigerators or the equipment is not returned yet because of variety of

shipment time.

6. Temperature monitoring device for freezer and refrigerator are not procured so

refrigerator can not be monitored.

7. No standarization for log book for recording sample receive, sample shipment,

temperature and sample condition.

8. Shipment and arrival schedule of samples at the higher level varies and not always

followed by the contracted courier service which can cause a risk for the samples

quality.

9. In general the medical waste handling already meets the guideline for medical waste

handling. Improvement is still needed in some HCs on the medical waste handling..

10. No guidance nor supportive supervision was performed by the higher level on the cold

chain management for ILI samples at all ILI surveillance facilities.


VIII. Recomendation

1. General Recomendation

a. A review on the procedure for ILI sample handling and cold chain measures

needed starting from sample collection until testing at BTDK among those

participating in the surveillance in 2007, 2009 etc. including at what temperature

and where to store samples need to be handled. At HCs and regional labs.

b. A more detailed SOP on cold chain management of ILI samples is needed.

c. Training on ILI samples cold chain management or on the job training (OTJ) for HC

and regional lab staffs is needed.

d. Document accompanying the shipments need to be uniformed and also what need

to be recorded in the log book at each facility.

e. Schedule, procedure and resposible party for packaging and shipment of samples

need to be re-designed.

f. A review is needed on the need and provision of appropriate equipment and

devices (type and amount) for local storage and for sample transportation

especially thermometers, ILR refrigerators or auto-defrost domestic refrigerator etc.

g. A sufficient supply of packaging materials is needed for HCs and regional labs is

needed also to replace broken devices and for monitoring local refrigerators.

h. Rescheduling of shipment is needed to avoid risk of room temperature /heat

exposure on samples for several days which affects the quality of samples.

i. Waste handling in the some health centers are need to be improved.

j. Routine guidance or supportive supervision on cold chain management for ILI at all

ILI facility as a separate activity or incorporated as a component surveillance

supervision element.

2. Recomendation for regional laboratories

a. A manual filled log book is needed a part from the computerized one containing

also the date, condition and temperature of the specimens received and sent.

b. All domestic refrigerators need to have a thermometer placed inside and all cold

storage facilities need to be maintained.

c. All cold storage facilities ( refrigertaor and freezers) temperature need to be

monitored and recorded daily


3. Recomendation for sentinel health centers

a. Log book for sample need to also record the date and temperature on dispatch and

on arrival of samples.

b. Need to check availability of packing material completeness especially thermometer

for shipment and also to attach a documents containing date and temperature of

specimen upon shipment.

c. Need to place a thermometer in the fridge and conduct daily monitoring and

recording of the temperature.

d. Refrigerators need to be maintained routinely especially cleaning from floating

water and defrosting (in manual defrost system).


Attachment A.I:

FLOWCHART: DETECTION OF SUSPECT CASES AND

HANDLING OF

INFLUENZA LIKE ILLNESS (ILI) AT SENTINEL HEALTH

CENTER

DOCTOR/NURSE Identification of ILI Patient à anamnesis àmeasuring body temperature using digital thermometer

NURSE

Record in ILI register book

DOCTOR/NURSE

Informed Consent

• Fill in ILI case form

• Nose swab and throat swab collection

• Waste handling follow the SOP

• ILI case form à Deliver to surveillance staff

• Sample à store in refrigerator

SURVEILLANCE STAFF /MEDICAL RECORD àEntry into database NURSE àSample packed in coolbox àFill in sample delivery form

Form + Sample collected by courier

• Swab • Cryotube • Tissue • Parafilm • Plastic clip

IDENTIFICATION à patient

temp. ≥ 38◦C + cough or sore

throat

• Refrigerator 2-8oC • Thermometer • Daily temperature

recording form

• Pralon and cover • Cold box • Ice pack • Thermometer

• Dispatch letter • Condition & temperature

sample form • Survailans form (patient

ID, patient condition, etc.)


Attachment A.II:

FLOWCHART: DETECTION OF SUSPECT CASES AND

HANDLING OF

INFLUENZA LIKE ILLNESS (ILI) AT REGIONAL

LABORATORY

Sample receive from health center • Check completness of document • Check condition and temperature

sample

Record in the ILI log Book

Sample aliquot: 1. Sample store at refrigerator 2-8ºC for

sending to BTDK 2. Sample for reg reg store at freezer or

deep freezer

Sample testing: 1. Extraction 2. PCR-RT testing if positive A continue

with sub typing

Dispatch sample to BTDK: • Sample packed in coolbox • Completness of document

• Thermometer • Daily temperature recording

form

• Pralon and cover • Cold box • Ice pack • Thermometer

• Dispatch letter • Condition & temperature

Document completness: • Dispatch letter • Condition & temp. sample form • Survailans form (patient ID,

patient condition, etc)

Check condition and temperature sample: • Check temperature à look at

thermometer • Check packaging equipment

(pralon & cover, ice pack, thermometer, cool box).

Bio safety cabinet

Bio safety cabinet


Attachment B.I:

Assessment Questionnaire for Regional Laboratory

ghunter

Text Box

See Attachment B below


Attachment B.I I: Assessment Questionnaire for Sentinel Health Centers

ghunter

Text Box

See Attachment B.I I below


Attachment C:

Pictures of The Cold Chain Condition in Various ILI Facility

ghunter

Text Box

See Attachment C below



Attachment D:

SHIPMENT/RECEIVE MONITORING CARD FOR ILI SAMPLE

Health Center::____________________

No Item

On Dispatch

From Health Center

On Arrival at Regional Lab.

On Dispatch From Lab.

Regional to BTDK

On Arrival at BTDK

1 Shipment date

2 Shipment time

3 Shipment temp °C °C °C °C

4 Sample amount pcs pcs pcs pcs

5 Sample color

6 Thermometer: Yes/No

7 Ice pack amount pcs pcs pcs pcs

8 Pralon amount pcs pcs pcs pcs

9 Staff name

10 Staff signed

1 - ILI Regional Laboratory

Date of Assessment :

Assessment team :

Province :

District :

Sub-district :

Name of laboraty :

Address :

Tel/Fax

1 General information

a Name of lab chief:

b

2 Collection of samples from HC (If samples were shipped by HC, go to section 3)

a Period of sample collection Daily 1 x /week 1 x / month

b ____ /day ___ /week __ / month

c Prior to collection, where were the samples stored?

Refrigerator, temperature Freezer Racks Door shelves

Cold box, temperature: ____ºC

At room temperature

d Equipment/device used in collection of samples ?

1st line packaging:

Type of container Dimension (cm) Capasity (L)Source of

supply

Clip plastic bag

Palstic box w/cryotube rack

Pralon pipe w/cover

2nd line packaging:

Type of container Dimension (cm) Capasity (L)Source of supply

Cold box

Vaccine carrier

Termos

e Use temp. monitoring device ? Yes No

f If yes, describe type:

Thermometer Digital thermometer Dial Termometer Others: ___________

g Yes No

h How was the samples shipped ?

Courier car/motorbike Others: _____________________

i _______ hours

Cold Chain ILI Assessment ILI Surveillance Program (Influenza Like Illness) at the Regional Laboratory/ ILI Sample Testing Site

Name of responsible person for sample lab testing and cold chain management:

Average number of samples collected ?

Was the sample temperature recorded in the shipping document on collection?

Length of time between collection at HC until arrival at Reg. lab.?

ghunter

Text Box

Attachment B


3 On Arrival of Samples at Regional Laboratory

3.1 At the General administration section of reg lab.

a ___/day ____/week ___/month

b Yes No

c Yes No

d Condition of samples upon arrival ?

Samples in good packaging, still cold and cold box intact

Samples in good packaging, not cold and cold box intact

e Is the condition & temperature of samples recorded upon arrival? Yes No

f if yes, where recorded?

g After received, how were the samples handled prior to testing at the Virology lab.?

Directly sent to Virology lab section ( go directly to section 3.2)

Temporarily stored in cold storage until sent/collected by Virology lab staff

h Where were samples stored temporarily:

Top opening fridge/ILR Domestic fridge - manual defrost Domestic fridge - auto defrost Freezer

Deep Freezer Cold box Vaccine Carrier Others: ______________

i Freezer Racks Door shelves

j How long stored until handed to virology testing lab:

______ days Others: _____________________

k How was the samples handled if arriving at:

Outside working hours

Weekends /holidays:

lYes No

3.2 At the Virology Lab Section

a Yes No

b Yes No

c How is the condition of samples when received at virology lab ?

Sample in good packaging, ice pack still cold, cold box intact

Sample in good packaging, ice pack warm/not cold, cold box intact

d Is the condition and temp of samples on arrival recorded? Yes No

If Yes, where recorded?

e If samples are not directly tested, where at the virology lab are the samples stored ?

Top opening fridge/ILR Domestic fridge Freezer Deep Freezer

Cold box Vaccine Carrier Others: _____________________

f Where are the specimen stored in the fridge? Freezer Racks Door shelves

g How long are the samples stored until being tested:

______ days _____________________

Is there a staff assigned to receive and check the ILI sample condition at the lab.?

Average number of samples received/collected ?

If the facility is using domestic refrigerator which part of the refrigerator are the specimens stored?

Was the condition and temperature of samples recorded in the shipping documentfrom the HC?

Is the condition and temp.of samples recorded in the shipping document from the HC?

Is there a certain satff assigned to receive and check the condition of the samples ?

Were the packaging equipment/devices (cold box, cold packs etc.) returned to HC?


h How is the sample handled when arriving at:

outside work hours:

weekends/holidays:

iYes No

4 Storage at Virology Lab.

a Type of cold storage used:



b Where are the specimen stored in the fridge? Freezer Racks Door shelves

c Refrigerator used:

Type and amountCondition (clean/no frost, good rubber

seal karet seal, etc.) Effective capacity

(L) Temp. range Source of supply

d Is electricity supply continous: Yes No

e If not, how frequent power blackouts : ____X_/month How long: _________

f Does the facility havs a generator set?

g Are the refrigerators connected to the generator during blackouts? Yes No

h What measures taken during power cuts:

5 Temperature Monitoring devices and temp. recording

a Is the temp.of the cold storage monitored routinely? Yes No

b How is monitoring done?

Temp. monitor device Others: __________________________

c

Type Amount in stock Source of supplyLast date calibrated

Mercury/Liquid thermometer

Dial termometer

Termometer digital

d Was the fridge temp. recorded? Yes No

e If Yes, when recorded:

5 days per week 7 days per week Occasionally

Morning Late afternoon Morning and late afternoon

f Where was the temp. recorded?

g

Type of temp. monitor device:

Who is the responsible person to monitor & to record the temp. ?

Are the shipment equipment/devices (cold box,cold packs etc.) returned to HC?


6 Packaging (only if samples from regional lab is referred or for paralel testing at national referral lab)

If no shipment to national referral lab --> go to Q 8

a Device used in the 1st line packaging

Type of Container Dimension (cm) Capacity (L)Source of

supply

Clip plastic bag

Plastic box w/ cryotube rack

Pralon tube w/ cover

b Device used in the 2nd line packaging


supply

Cold box

Vaccine carrier

Thermos

c. Cooling device used

Type Dimension (cm) Capacity (L)Source of

supply

Ice pack

Solid ice cubes in plastic bag

d Yes No

e

f How to prepare/freeze cold ice packs

g Time to freeze the cold packs

7 Shipment

a ____/day ____ /week ____/month

b

c Yes No

e Mode of sample shipment?

Courier services car/motorbike Others: _____________________

f

gYes No

Number of samples sent to national lab.?

Frequency of sample shipment per month to the national lab.?

Were the packaging devices (cold box, cold packs etc. ) returned to Regional laboratory?

Are the number and temperature of samples recorded in the shipment document from the reg. lab?

Was temp monitor put in the sample package?

Time between shipment by reg lab until recived by national lab.?

If Yes, what type of temp. monitoring device used:


8 Waste management

a Containers used for waste ?

Type Amount in stockConsumption

per monthSource of

supply

Waste bag

Ordinary palstic bag

Carton

b Mode for waste final disposal ?

Burried /landfill Incinerated Autoclaved Burned

Others: _____________________

c Type of equipment for waste final disposal?

Incinerator Furnace Others: _____________________

9 Human Resources and Supportive Supervision

a Yes: _________________ No

b Yes: _________________ No

c Yes No

d Yes No

e If yes, how many times per year?

f Yes No

g If Yes, How many times per year?

h Done by whom/which institution ?

10 Problems/Constraints

a Yes No

b If Yes, desribe:

cYes No

d If Yes, describe (equipment, temp. monitoring and recording, sample storage, packaging, shipment,etc):

Was there guidance/supportive supervision on sample collection performed by the national referal lab/other institution?

Was there guidance/supportive supervision on sample cold chain management performed by the national lab/other institution?

Are there other problems/constraints on collection/shipment of ILI samples?

Are there problems/constraints with the ILI sample collection ?

Is there a staff assigned for testing the ILI samples?

Is there a staff assigned for handling the cold chain for ILI samples?

If yes, was he/she trained on sample cold chain management?

1 - ILI Health Center

Date of Assessment :

Assessment team :

Province :

District :

Sub-district :

Name of Health Center :

Address :

Tel/Fax :

1 General information

a Name of HC chief:

b

c Type of HC: w/ inpatient care Ambulatory patient care

d Inpatient bed capacity bed

e

f ________________

g

h Average # of samples collected /period ____ /day ___ /week ____ / month

2 Preparation for sample collection

a Preparation of cold chain equipment/devices

Cool box Ice pack, capacity _____L Amount.: _____

Number frozen: _________ Others:

b Sample container Cryotube

Pralon pipe w/ cover

Plastic box w/cryotube rack

3 Following sample collection:

a What is done after the sample was collected: Directly send to regional lab.

b If directly sent, how is the sample packed:

Cold Chain ILI Assessment ILI Surveilance Program (Influenza Like Illness) at Sentinel Health Center/ Sample Collection Site

Name of responsible person for sample collection and cold chain management:

Average ILI suspect cases hospitalized at HC/month:

temporarily stored at HC ( go directly to c - section)

Average ILI suspect cases (ambulatory) visit /month:

Average # of patients visiting HC/month

ghunter

Text Box

Attachment B.I I


c If temporarily stored, where stored? :



d Freezer Racks Door shelves

e How long was the sample retained/stored: ___________days Others: __________

4 Storage of samples

a Type of cold storage used:



b Where are the specimen stored in the fridge? Freezer Racks Door shelves

c Cold storage used:

Type and amountCondition (clean/no frost, good rubber

seal karet seal, etc.) Effective capacity

(L) Temp. range Source of supply

d Is electricity supply continous: Yes No

e If not, how frequent power blackouts : ____X_/month How long: _________

f Does the facility havs a generator set?

g Are the refrigerators connected to the generator during blackouts?

h What measures taken during power cuts:

5 Temperature Monitoring devices and temp. recording

a Is the temp.of the cold storage monitored routinely? Yes No

b How is monitoring done?

Temp. monitor device Others: __________________________

c

Type Amount in Stock Source of SupplyLast Date Calibrated

Mercury/Liquid thermometer

Dial termometer

Termometer digital

d Was the fridge temp. recorded? Yes No

Type of temp. monitor device:

If the facility is using domestic refrigerator which part of the refrigerator are the specimens stored?


e If Yes, when recorded:

5 days per week 7 days per week Occasionally

Morning Late afternoon Morning and late afternoon

f Where was the temp. recorded?

g

6 Packaging

a Device used in the 1st line packaging


supply

Clip plastic bag

Plastic box w/ cryotube rack

Pralon tube w/ cover

b Device used in the 2nd line packaging


supply

Cold box

Vaccine carrier

Thermos

c Cooling device used

Type Dimension (cm) Capacity (L)Source of

supply

Ice pack

Solid ice cubes in plastic bag

d Yes No

e

f How to prepare/freeze cold ice packs

g Time to freeze the cold packs

7 Sample Shipment

a Collected by Reg. lab/Health Office, sent by HC

b ____ /day ___ /week ____ / month

c

d Yes No

If Yes, what type of temp. monitoring device used:

Number of samples shipped per period of time ?

Frequency of shipment to reg. lab per month ?

Was temp monitor put in the sample package?

Who is the responsible person to monitor and to record the temp. ?

Is there a shipment document used in the shipment?


e

Sample ID Number of samples Temperature on despatch

Others: _________________________________________________________________________

f Mode of shipment? car/motorbike Courier service

Others: _____________________

g ______ hours

h Yes No

8 Waste management

a Containers used for waste ?

Type Amount in stockConsumption

per monthSource of

supply

Waste bag

Ordinary palstic bag

Carton

b Mode for waste final disposal ?

Burried /landfill Incinerated Autoclaved Burned

Others: _____________________

c Type of equipment for waste final disposal?

incinerator Furnace Others: _____________________

9 Human Resources and Supportive Supervisiona Yes: _________________ No

bYes: _________________ No

c Yes No

dYes No

e If yes, how many times per year?

fYes No

g If Yes, How many times per year?

h Done by whom/which institution ?

Was there guidance/supportive supervision on sample collection performed by the reg. lab/other institution?

Were the packaging devices (cold box, cold packs etc. ) returned to HC?

Is there a staff assigned for collection of ILI samples?

Was there guidance/supportive supervision on sample cold chain management performed by the reg. lab/other institution?

Is there a staff assigned for handling the cold chain for ILI samples?

If yes, was he/she trained on sample cold chain management?

Time between shipment from HC until recived at Reg. Lab ?

If Yes, what information contained in the document ?


10 Problems/Constraints

a Yes No

b If Yes, desribe:

cYes No

d If Yes, describe (equipment, temp. monitoring and recording, sample storage, packaging, shipment,etc):

Are there other problems/constraints on collection/shipment of ILI samples?

Are there problems/constraints with the ILI sample collection ?

Pictures of The Cold Chain Condition in Various ILI

Facility

Cold Chain Assessment in ILI Surveillance Program at Regional Laboratories and Sentinel Health Centers

2011

ghunter

Text Box

Attachment C

1

• Regional Labortory in Makasar: Microbiology Laboratory of Hasanuddin University Medical School Hospital.

(-)20°C freezer to store tested samples and ice packs freezer

Poor maintenance: Mold and fungi at freezer door rubber seal

The arrangement of samples to be sent to be send to BTDK in the domestic refrigerator. .

Samples are stored in the drawer at the bottom of the rerigerator (temperature can be < 0 C).

(-)20°C freezer to store samples

Cold box used to ship the samples.

2

Arrival of samples from Jayapura during the assessment.

The laboratory staff is opening the cold box from Jayapura

The temperature inside the box is (+) 28°C. The arrangement inside the cold box.

Aliquoting samples upon arrival health center. One of the specimen showed a yellow colored virus transport media.

3

Small waste box with platic bag containing chlorine solution placed inside in the safety

cabinet. Medical waste inside the waste box.

Fully loaded waste boxes put in a big plastic bag which will be incinerated at the Wahidin or

Dadi Hospital.

Non infectous waste were placed in a waste bin with plastic bag inside. Bag will be collected by

hospital safety division for disposal.

4

• Sudiang ILI Sentinel Health Center in Makasar

Samples stored in the middle compartment of the refrigerator shelf.

Poor maintenance: Refrigerator is dirty and fungi and mold on door lining and rubber seal

Medical waste is placed in the trash bin without plastic bag and treated and disposed at HC as

ordinary domestic waste. The yellow safety box are supplied for immunization sharps waste and when full to be taken to Dinas for incineration.

5

• Regional laboratory in Denpasar, Bali : Molecular Biology of Udayana University Medical School

Arrangement inside the domestic fridge. Samples are placed the middle compartment

(-)80°C deep freezer where samples are stored.

(-)20°C freezer for freezing and storage of ice packs.

Lab reagents placed at the doorside. ( Risk for overheating)

Various types and capacity of cold packs used for cooling samples during transport. Temperature monitoring form. Data not

updated.

6

Small waste box with small biohazard plastic bag inside in the

safety cabinet.

Large biohazard plastic bag used to contain the filled small bags for incineration at sanglah

hospital.

7

• Sentinel health center I Denpasar Selatan , Denpasar

The arrangement of the samples in the domestic refrigerator (some samples are still

contained in the pralon pipe containers.

Thick frost need to be defrosted.

Correct: No items stored at door side.

Broken thermometer. The yellow colored are OneMEd brand purchased by health center to

replace the broken ones.This type is very fragile, all 3 lost their arrow pointers.

Freezer for freezing and storage of ice packs.

Recorded and updated temperature monitoring graph at HC.

8

• Regional Labortory in Jakarta: Microbiology Laboratory of University of Indonesia Medical School Hospital.

Waste is placed in the trash bin according to type of waste: organic or anorganic. Yellow colored safand the filled safety box

(sharp waste) wety box is used for sharps waste in the immunization program. Incineration of medical waste is

performed at Wangaya hospital.

9

The door side is full with items and the arrangement of the sample and lab medicine

is not corret.

Thermometer placement is not corret, they put it at the door side of the freezer. It should be

placed at the cool shelve part (2-8°C).

Temperature monitoring is recorded using temperature monitoring graph

Correct samples placement in deep freezer.

10

• Sentinel health center Utan Kayu Utara, DKI Jakarta

Broken termograph, it was used to monitor deep freezer. They can’t repair it because of

budget limitation.

Deep Freezer is monitored daily based on display temperature build in on the deep

freezer.

11

• Regional Labortory in Semarang: Microbiology Laboratory of University

of Diponegoro Medical School Hospital.

Refrigerator was empty because health center just moved to original place after renovation. Samples was put at the sub

district health center for temporary.

Thermometer showed temperature below 0° because thermostat was set on the maximum

setting. It has been changed to middle.

Domestic refrigerator uses in regional lab. The door side is full with items. Poor maintenance: mold on the rubber seal door.

12

c

Another domestic refrigerator and deep freezer use in regional lab. Thermometer is not available. The arrangement inside refrigerator is not correct: some item put at the door side and sample is stored

unorginaze at freezer.

Thermograph (continue temp. monitoring device) is installed on deep freezer, because of lack of knowledge staff so it’s not properly function. Paper to print temperature is not replaced.

Complete packaging equipment just arrived from Pandanaran health center. All the equipment is used as recommended except from pralon pipe, they replace it with ex medicine plastic bottle.

13

Neat arrangement for logistic that should be kept in the ambient temperature.

Waste red plastic bag is put in the safety cabinet and non infectious waste is put it in the black

plastic bag

14

• Sentinel health center Pandanaran, Semarang

Domestic refrigerator uses in the health center. The arrangement and maintenance is good. Voltage stabilazer is installed for stabilizing the electricity.