ILI Surveillance Cold Chain Assessment ENGLISH_full.pdf - K4Health

ILI Surveillance Cold Chain Assessment Finding and Recommendation

January 2012

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

Laporan assessment cold chain

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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


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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


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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.


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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


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5 sentinel health centers:

5.

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

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


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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.


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Tim Assessment dan facilities visited No.

8.

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

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


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11.

Activity Timeline

No

Kegiatan

Nov.2011

1

Internal JSI/USAID Deliver preparation

2

Team development and discussions

3

4

5

Develop

assessment

design

Finalisation of assessment instrument

x

x

x

x

x

x

and training for usage by the field team Implementation of assessment in the

x

x

x

x

x

x

x

field Data tabulation and analysis

7

Report writing

8

File final Report

10

x x

and

Jan. 2012

instrument

6

9

x

Dec. 2011

x

x

x

x x

Design SOP on cold chain procedures

x

x

x

and management for the ILI samples Routine and incidental team meetings


x

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x

x

x

x x

x

x

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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.


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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. 1.

Regional Laboraty

Sentinel Health Center

Microbiology Laboratory of FK Universitas

Sudiang, Kota Makasar

Hasanuddin Hospital, Makasar 2. 3

Biomolecular Laboratory of FK Universitas

I

Udayana, Denpasar

Denpasar

Molecular

Diagnostic

Laboratory

of

FK

Denpasar

Selatan,

Kayu Putih Utara, Jakarta Timur

Universitas Indonesia, DKI Jakarta 4

Microbiology laboratory of

FK Universitas

Pandanaran, Kota Semarang

Diponegoro, Semarang Laporan assessment cold chain

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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.


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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.


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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.


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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 2

Biro Pusat Statistik 2010 1) BPS; Penduduk Indonesia per Propinsi, 2010


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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


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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.


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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. 1.

Regional Laboratory

Sentinel HC

Microbiology Laboratory of FK Universitas


Hasanuddin Hospital, Makasar 2.

Biomolecular Laboratory of FK Universitas

I Denpasar Selatan, Kota Denpasar

Udayana, Denpasar 3

Molecular Diagnostic Laboratory of FK

Kayu Putih Utara, Jakarta Timur

Universitas Indonesia, DKI Jakarta 4

Microbiology laboratory of

FK Universitas

Pandanaran, Kota Semarang

Diponegoro, 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. 1

Health Center

Average

Number of

number of

sample taken

visits per day

per day


150

Remarks

5-7

10

cases

(approx.

25% of all suspect cases) samping) 2

1 Denpasar Selatan

3

Utan Kayu Utara

4

Pandanaran


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150

4

20

3

130

2-5

Desember 2011

rejected

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.


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Table 1. Packaging equipment used at BTDK and regional labs. Type No.

Temp °C

Facility

Capaci

Maintenance/

ty

Temp. Recording

auto frost 1

Microbiology Lab, FK UNHAS Hospital Biomolecular Lab, FK Universitas Udayana

Clinical Microbiology Lab, FK Universitas Indonesia

Microbiology Lab, Universitas Diponegoro

Maintenance

Temp. Monitor Device

Freezer Deep Freezer

(-)80

Deep Freezer

Deep Freezer

None

recording

recording

but not updated Available

519 L

None

but not updated

(-)20

(-)80

482 L

519 L

Good, no temp

Domestic

(-)1- (-

recording

auto frost

)4.8

Good, no temp

Domestic

recording

auto frost

(-) 80

519 L

auto frost

Good, temp is recorded

Deep

(-) 80

519 L

Good, no temp.

Domestic

recording

auto frost

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


Temp.

Available

Good, no temp.

Freezer

5

ty to BTDK

Domestic 4

°C

N/A Freezer

3

135 L

Capaci

BTDK* Deep

2

2

Temp

Temporary storage for samples to be sent

Sample storage for testing and storage Domestic

Type

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135 L

Good

None

None Available

(-)1 – 5

135 L

Good

None

but not updated Available

4–5

135 L

Good

Available

and up to date * Available

(-) 80

519 L

Good

None

and up to date

1– 6.7

135 L

Good

None

None

Table 2. Sample storage equipment at HC Temp.

Type No.

°C

Facility

Capacity

Maintenance

Monitor

Temporary storage for samples to be sent to BTDK 1

2

3

Puskesmas Sudiang, Kota Makasar

Puskesmas 1 Denpasar Selatan

Puskesmas Utan Kayu Utara, East Jakarta Puskesmas

4

Pandanaran Semarang

Domestic auto

4

defrost

135 L

Dirty and fungi, molds

5.5

135 L

Thick frost

defrost Domestic auto defrost Domestic auto defrost

device

None Thermom

Domestic Manual

Temp.

eter Mueller & OneMed

Temp. recording

None

Available and up to date

(-) 2

135 L

Good

None

None

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.


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Tabel 3. Packaging devices and System for shipment of samples at regional labs and HCs. Devices and type No.

Facility

Container for

Temperature Cooler

shipment

monitor device

Sample container

Document

Frequenc

Mode of

on sample

y of

shipment

condition/

shipment

temp.

Regional lab Microbiology 1

Lab, FK UNHAS

1 x/week

Ice Cold box

Pack/

Thermometer

gel

Hospital Biomolecular 2

Lab, FK Universitas

Pralon tubing Pralon

Cold box

Ice Pack

Thermometer

Caraka/

None

None

Courier: Mega Cargo

1 x/week

tubing

Courier: Caraka

Udayana Clinical

Cold box

Microbiology 3

Ice

Thermometer

Pack

Pralon

None

1 x/week

tubing

Collected by BTDK

Lab, FK Universitas Indonesia Microbiology

4

Cold box

Lab,

Ice

Thermometer

Pack

Pralon

None

1 x/week

tubing

Courier: Caraka

Universitas Diponegoro Health Center Pralon

Puskesmas 1

Sudiang, Kota

Cold box

Makasar

Denpasar

Cold box

Selatan Puskesmas 3

Pack

Thermometer

1 x/week

tubing

Packed and send by Dinas staff to reg lab.

Puskesmas 1 2

Ice

None

Cold box

Utan Kayu

Ice Pack Ice

Thermometer

Pralon

(70% w/o

tubing

None

1 x/week

Caraka

thermometer) Thermometer

Pack

Utara

Clipped

Courier:

None

1 x/week

Packed and

Plastic

send by

bag

Dinas staff to reg lab

Puskesmas

Cold box

Pandanaran

Ice

Thermometer

Pack

4

capped

None

1 x/week

medicine

send by

plastic

Dinas staff to reg lab

bottle


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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


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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


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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


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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.


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-

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.


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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.

Specimen from Jayapura was received at the regional lab with warm ice packs and temperature on the thermometer showed 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


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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. Laporan assessment cold chain

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Desember 2011

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.

- Packaging equipment and devices: Equipment and devices used in ILI samples received at FK Unhas regional laboratory compose of the following: •

1 Cold box ± 6 L

•


•

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 capacity: 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 alreadytested 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


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Desember 2011

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.

- Supportive supervision: 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 subdistrict 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.


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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: •

1 Cold box ± 6 L

•


•

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.

- Supportive supervision: No routine supervision was obtained from the regional lab or Dinas regarding cold chain management of samples and ILI waste management. Laporan assessment cold chain

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Desember 2011

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.


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

- Packaging equipment and devices Equipment and devices used in ILI samples received at FK UNUD regional laboratory composes of the following: •

1 Cold box ± 6 L

•


•


•


•

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


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Desember 2011

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.


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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).

- Supportive supervision: 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.


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- Samples collection and shipment to regional lab.: 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.

- 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: •

1 Cold box ± 6 L

•

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

•

6 Cold packs ± 0.6 L

•


•



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Desember 2011

- Cold chain capacity: 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.

Thick frost in the

Refrigerator is recorded in the

refrigerator is need to be defrosted

temp. Monitoring graph

Refrigerator is monitored using thermometer

- 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.

- Supportive supervision: No routine supervision was obtained from the regional lab or Dinas regarding cold chain management of samples and ILI waste management.


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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 Laporan assessment cold chain

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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.

- Packaging equipment and devices Equipment and devices used in ILI samples received at FK UI regional laboratory usually composes of the following: •

1 Cold box ± 6 L

•


•


•

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


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Desember 2011

•


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.

- 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 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 capacity and condition 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.


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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.

- Supportive supervision: 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. Laporan assessment cold chain

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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.

- Samples collection and shipment to regional lab.: 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.

- Packaging equipment and devices According to the HC staff, the equipment and devices used in ILI samples sent to FK UI regional laboratory compose of the following: •

1 Cold box ± 6 L

•

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.


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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 capacity 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. - Supportive supervision: No routine supervision was obtained from the regional lab or Dinas regarding cold chain management of samples and ILI waste management.

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).


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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. Then the sample IDs, temperature in the cold box when received will be registered in 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 – Laporan assessment cold chain

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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.

- Packaging equipment and devices 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


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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.

- Sample shipment from regional lab. to Pusat BTDK: 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 capacity and condition 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.


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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.

- Supportive supervision: 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) PCR-RT HC

SUBTYPING

Total Sample

Flu A

Flu B

Subty

Subty

Subty

Novel

Unsubty

pe H1

pe H3

pe H5

H1N1

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

673

53

101

4

11

0

28

14

(7.9%)

(15%)

(0.6%)

(1.6%)

(4.2%)

(2%)

Total


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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.

- Samples collection and shipment to regional lab.: 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.


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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.

- 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: •

1 Cold box ± 6 L

•

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 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. 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.

- Supportive supervision: No routine supervision was obtained from the regional lab or Dinas regarding cold chain management of samples and ILI waste management.


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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.


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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


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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).


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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 àmeasuring body temperature using digital thermometer

IDENTIFICATION à patient temp. ≥ 38◦C + cough or sore throat

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 àEntry into database NURSE àSample packed in coolbox àFill in sample delivery form

Form + Sample collected by courier Laporan assessment cold chain

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• • • • •

Swab Cryotube Tissue Parafilm Plastic clip

• 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.) Desember 2011

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

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).

• Thermometer • Daily temperature form

Bio safety cabinet

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

Dispatch sample Laporan assessment cold chain

to BTDK:55 of 61 • Sample packed in coolbox • Completness of document

recording

Bio safety cabinet

• • • •

Pralon and cover Cold box Ice packDesember 2011 Thermometer

Attachment B.I: Assessment Questionnaire for Regional Laboratory

See Attachment B below


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

See Attachment B.I I below


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Attachment C: Pictures of The Cold Chain Condition in Various ILI Facility

See Attachment C below


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Attachment D:

SHIPMENT/RECEIVE MONITORING CARD FOR ILI SAMPLE

Health Center::____________________

On No

Item

On Dispatch

Dispatch

On Arrival at

From Lab.

On Arrival

From Health

Regional Lab.

Regional to

at BTDK

Center

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


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

:

Assessment team

:

Province

:

District

:

Sub-district

:

Name of laboraty

:

Address

:

Tel/Fax

1 General information a Name of lab chief: Name of responsible person for sample lab testing and cold chain b management: 2 Collection of samples from HC (If samples were shipped by HC, go to section 3) a Period of sample collection

 Daily

b Average number of samples collected ?

 1 x /week

 1 x / month

____ /day

___ /week

 Racks

 Door shelves

__ / month

c Prior to collection, where were the samples stored?  Refrigerator, temperature  Freezer  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)

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

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 Was the sample temperature recorded in the shipping document on g collection? Yes

 Others: ___________  No

h How was the samples shipped ?  Courier

 car/motorbike

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

 Others: _____________________ _______ hours

1 - ILI Regional Laboratory

3 On Arrival of Samples at Regional Laboratory 3.1 At the General administration section of reg lab. a Average number of samples received/collected ? Was the condition and temperature of samples recorded in the b shipping documentfrom the HC? Is there a certain satff assigned to receive and check the condition of c the samples ?

___/day ____/week Yes

 No

Yes

 No

Yes

 No

___/month

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? 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

 Deep Freezer  Cold box If the facility is using domestic refrigerator which part of the i refrigerator are the specimens stored?

 Domestic fridge - auto defrost

 Freezer

 Vaccine Carrier  Others: ______________  Freezer

 Racks

Yes

 No

Yes Is there a staff assigned to receive and check the ILI sample condition at Yes b the lab.?

 No

 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: l

Were the packaging equipment/devices (cold box, cold packs etc.) returned to HC?

3.2 At the Virology Lab Section Is the condition and temp.of samples recorded in the shipping

a document from the HC?

 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

 Cold box

 Vaccine Carrier

 Others: _____________________

f Where are the specimen stored in the fridge?

 Freezer

 Deep Freezer  Racks

 Door shelves

g How long are the samples stored until being tested:  ______ days

 _____________________


h How is the sample handled when arriving at:  outside work hours:  weekends/holidays: Are the shipment equipment/devices (cold box,cold packs etc.) i returned to HC?

Yes

 No

4 Storage at Virology Lab. a Type of cold storage used:  Top opening fridge/ILR


 Domestic fridge - auto defrost

 Deep Freezer

 Cold box

 Vaccine Carrier  Others: ______________

b Where are the specimen stored in the fridge? c Refrigerator used:

Condition (clean/no frost, good rubber seal karet seal, etc.)

Type and amount

 Freezer

 Racks

Effective capacity (L)

d Is electricity supply continous:

Temp. range

Yes

e If not, how frequent power blackouts : ____X_/month

 Freezer  Door shelves

Source of supply

 No

How long: _________

f Does the facility havs a generator set? g Are the refrigerators connected to the generator during blackouts?

Yes

 No

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? b How is monitoring done?  Temp. monitor device

 Others: __________________________

c Type of temp. monitor device: Amount in stock

Type

Source of supply

Last 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 Who is the responsible person to monitor & to record the temp. ?


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

Dimension (cm)

Capacity (L)

Source of supply

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 Type of Container Cold box Vaccine carrier Thermos c.

Cooling device used Type Ice pack Solid ice cubes in plastic bag d Was temp monitor put in the sample package?

Yes

 No

e If Yes, what type of temp. monitoring device used: f How to prepare/freeze cold ice packs g Time to freeze the cold packs

7 Shipment a Number of samples sent to national lab.?

____/day

b Frequency of sample shipment per month to the national lab.? Are the number and temperature of samples recorded in the shipment c document from the reg. lab? Yes

____ /week

____/month

 No

e Mode of sample shipment?  Courier services



car/motorbike

 Others: _____________________

f Time between shipment by reg lab until recived by national lab.? g

Were the packaging devices (cold box, cold packs etc. ) returned to Regional laboratory?

Yes

 No


8 Waste management a Containers used for waste ? Type

Amount in stock

Consumption per month

Source 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 Is there a staff assigned for testing the ILI samples?

Yes: _________________

 No

b Is there a staff assigned for handling the cold chain for ILI samples?

Yes: _________________

 No

c If yes, was he/she trained on sample cold chain management?

Yes

 No

Was there guidance/supportive supervision on sample collection d performed by the national referal lab/other institution?

Yes

 No

e If yes, how many times per year? Was there guidance/supportive supervision on sample cold chain f management performed by the national lab/other institution?

Yes

 No

Yes

 No

Yes

 No

g If Yes, How many times per year?

h Done by whom/which institution ? 10 Problems/Constraints a Are there problems/constraints with the ILI sample collection ? b If Yes, desribe:

c

Are there other problems/constraints on collection/shipment of ILI samples?

d If Yes, describe (equipment, temp. monitoring and recording, sample storage, packaging, shipment,etc):


Attachment B.I I Cold Chain ILI Assessment ILI Surveilance Program (Influenza Like Illness) at Sentinel Health Center/ Sample Collection Site Date of Assessment

:

Assessment team

:

Province

:

District

:

Sub-district

:

Name of Health Center

:

Address

:

Tel/Fax

:

1 General information a Name of HC chief: Name of responsible person for sample collection and cold chain b management: c Type of HC:



w/ inpatient care

 Ambulatory patient care

d Inpatient bed capacity

bed

e Average ILI suspect cases hospitalized at HC/month: f Average # of patients visiting HC/month

________________

g Average ILI suspect cases (ambulatory) visit /month: h Average # of samples collected /period

____ /day

___ /week

____ / month

2 Preparation for sample collection a Preparation of cold chain equipment/devices  Cool box Number frozen: _________ b Sample container

 Ice pack, capacity _____L

Amount.: _____

 Others:  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.  temporarily stored at HC ( go directly to c section)

b If directly sent, how is the sample packed:

1 - ILI Health Center

c If temporarily stored, where stored? :  Top opening fridge/ILR


 Domestic fridge - auto defrost  Freezer

 Deep Freezer

 Cold box


If the facility is using domestic refrigerator which part of the d refrigerator are the specimens stored?

 Freezer

e How long was the sample retained/stored:

___________days  Others: __________

 Racks

 Door shelves

4 Storage of samples a Type of cold storage used:  Top opening fridge/ILR


 Domestic fridge - auto defrost  Freezer

 Deep Freezer

 Cold box


b Where are the specimen stored in the fridge? c Cold storage used: Type and amount

 Freezer

 Racks

 Door shelves

Condition (clean/no frost, good rubber Effective capacity seal karet seal, etc.) (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 of temp. monitor device: Type

Amount in Stock

Source of Supply

Last 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

Who is the responsible person to monitor and to record the temp. ?

6 Packaging a Device used in the 1st line packaging Type of Container

Dimension (cm)

Capacity (L)

Source of supply

Dimension (cm)

Capacity (L)

Source of supply

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 Type of Container Cold box Vaccine carrier Thermos c

Cooling device used Type Ice pack Solid ice cubes in plastic bag d Was temp monitor put in the sample package?

Yes

 No

____ /day

___ /week

Yes

 No

e If Yes, what type of temp. monitoring device used: 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 Number of samples shipped per period of time ?

____ / month

c Frequency of shipment to reg. lab per month ? d Is there a shipment document used in the shipment?


e If Yes, what information contained in the document ? Sample ID

 Number of samples



Temperature on despatch

 Others: _________________________________________________________________________ f Mode of shipment?



car/motorbike

 Courier service

 Others: _____________________ Time between shipment from HC until recived g at Reg. Lab ?

______ hours

Were the packaging devices (cold box, cold packs etc. ) returned to h HC?

Yes

 No

8 Waste management a Containers used for waste ? Type

Amount in stock

Consumption per month

Source 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 Is there a staff assigned for collection of ILI samples? b

Is there a staff assigned for handling the cold chain for ILI samples?

c If yes, was he/she trained on sample cold chain management? Was there guidance/supportive supervision on sample collection d performed by the reg. lab/other institution?

Yes: _________________

 No

Yes: _________________

 No

Yes

 No

Yes

 No

Yes

 No

e If yes, how many times per year? f Was there guidance/supportive supervision on sample cold chain management performed by the reg. lab/other institution? g If Yes, How many times per year? h Done by whom/which institution ?


10 Problems/Constraints a Are there problems/constraints with the ILI sample collection ?

Yes

 No

Yes

 No

b If Yes, desribe:

c

Are there other problems/constraints on collection/shipment of ILI samples?

d If Yes, describe (equipment, temp. monitoring and recording, sample storage, packaging, shipment,etc):


Attachment C

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

•

Regional Labortory in Makasar: Microbiology Laboratory of Hasanuddin University Medical School Hospital.

(-)20°C freezer to store tested samples and ice packs freezer

(-)20°C freezer to store samples

Samples are stored in the drawer at the bottom of the rerigerator (temperature can be < 0 C).

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. .

Cold box used to ship the samples. 1

Arrival of samples from Jayapura during the assessment.

The temperature inside the box is (+) 28°C.

Aliquoting samples upon arrival health center.

The laboratory staff is opening the cold box from Jayapura

The arrangement inside the cold box.

One of the specimen showed a yellow colored virus transport media.

2

Small waste box with platic bag containing chlorine solution placed inside in the safety cabinet.

Fully loaded waste boxes put in a big plastic bag which will be incinerated at the Wahidin or Dadi Hospital.

Medical waste inside the waste box.

Non infectous waste were placed in a waste bin with plastic bag inside. Bag will be collected by hospital safety division for disposal.

3

• 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.

4

•

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.

Various types and capacity of cold packs used for cooling samples during transport.

Lab reagents placed at the doorside. ( Risk for overheating)

(-)20°C freezer for freezing and storage of ice packs.

Temperature monitoring form. Data not updated.

5

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.

6

• 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.

Correct: No items stored at door side.

Freezer for freezing and storage of ice packs.

Thick frost  need to be defrosted.

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.

Recorded and updated temperature monitoring graph at HC. 7

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.

•

Regional Labortory in Jakarta: Microbiology Laboratory of University of Indonesia Medical School Hospital.

8

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.

9

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.

• Sentinel health center Utan Kayu Utara, DKI Jakarta

10

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.

Regional Labortory in Semarang: Microbiology Laboratory of University of Diponegoro Medical School Hospital.

11

Domestic refrigerator uses in regional lab. The door side is full with items. Poor maintenance: mold on

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.

c

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.

12

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

13

• 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.

14