Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
September 11, 2020

DEPARTMENT MEMORANDUM
No. 2020-_024|

FOR: CENTERS FOR HEALTH DEVELOPMENT DIRECTORS,

CHIEF HOSPITALS / MEDICAL CENTERS / SANITARIA,
COORDINATORS OF FOOD AND WATERBORNE DISEASE
PREVENTION AND CONTROL PROGRAM

SUBJECT: Implementation Guidelines for Cholera Rapid Diagnostic Test

(RDT) to Support Early Case Detection, Surveillance and
Outbreak Response

I. RATIONALE |

Cholera is an infectious disease that can be acquired through ingestion of food or water
contaminated by bacterium Vibrio cholera and causes severe acute watery diarrhea.
Worldwide, there are 1.3- 4 million estimated cholera cases and 21, 000 to 143,000
estimated cholera deaths annually!. It strikes fear as it rapidly spreads and lead to
immediate death if left untreated. Cholera remains a problem to people living in densely
populated urban-poor areas and evacuation centers, where people are displaced by war,
famine or natural disasters and access to clean water or sanitation is not available.

In the Philippines, cholera has annual outbreaks occurring in varying places and time and
is widely endemic. The Republic Act No. 11332 otherwise known as the Mandatory
Reporting of Notifiable Diseases and Health Events of Public Health Concern Act, orders
the mandatory reporting of cholera as one of the notifiable diseases under the “epidemic-
prone diseases category”. From 2015 to 2018, there are 25,264 reported suspected cholera
cases and 144 reported cholera deaths recorded by Philippines Integrated Disease
Surveillance and Response (PIDSR). The true burden of cholera, however, is
underestimated due to low reporting compliance, limited epidemiological surveillance
and lack of laboratory diagnostic capacity.

Early identification of cholera is essential for immediate containment of a possible

outbreak as it may lead to epidemic or pandemic. More often than not, laboratory culture
is limited or not available in areas where cholera prevalence is high and sending of
laboratory specimens to higher level laboratory is challenged by lack of funds or
unavailability of courier service in Geographically Isolated Disadvantaged Areas
(GIDA). These challenges result to delay outbreak detection, reactive implementation of
subsequent control measures, and unreliable estimates of cholera burden’. In fact, data
shows that on average only 35% of suspected cholera cases are laboratory tested and only
1% of suspected cholera cases are laboratory confirmed the Philippines yearly. in
In 2016, the World Health Organization (WHO) recommended use of Cholera Rapid the
Diagnostic Test as alternative to culture for confirmation of clinically suspected cholera
cases in situation where access to appropriate laboratory services is not readily available.

1
https://www.who.int/news-room/fact-sheets/detail/cholera
?
https://www.who.int/cholera/task force/Interim-guidance-cholera-RDT.pdf

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 1112, 1113
Direct Line: 711-9502; 711-9503 Fax: 743-1829 e URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph
 The Cholera RDT has 100% sensitivity and 100%specificity’. The use of Cholera RDT
can potentially augment the capacity of health centers and hospitals to rapidly detect
suspected cholera cases and thereby improve early detection, surveillance and outbreak
response’. The implementation of Cholera RDT supports the WHO global roadmap for
ending cholera by 2030 aiming to reduce cholera deaths by 90% at the country level °.

II. OBJECTIVE
This issuance aims to provide technical guidelines to health facilities for the use Cholera
Rapid Diagnostic Test (RDT) to support cholera early detection, surveillance and
outbreak response.

Ill. SCOPE
This policy shall cover selected health centers and hospitals in cholera endemic and non-
endemic areas.

IV. DEFINITION OF TERMS

a. Acute watery diarrhea - characterized by three or more loose or watery, non-bloody stool
within 24-hour period. (WHO Global Task Force on Cholera Control Surveillance
Working Group (GTFCC): Interim Guidance Document on Cholera Surveillance 2017)°
Cholera suspected case:
eIn area where cholera outbreak has not been declared: Any patient aged 2 years and
above presenting with acute watery diarrhea and severe dehydration or dying from acute
watery diarrhea.
eIn area where cholera outbreak is declared: Any person presenting with or dying from
acute watery diarrhea. (WHO GTFCC: Interim Guidance Document on Cholera
Surveillance 2017)
Probable cholera case - a suspected cholera case with positive cholera RDT result.
Cholera confirmed case - a suspected case that is laboratory confirmed, thru isolation of
V. cholerae 01 or 0139 from stools in
any patient with diarrhea (EB PIDSR MOP 2014)’
Cholera alert- is an alarm or signal that serves as a warning for a possible outbreak for
early activation of public health response and control measures.
Cholera endemic area- is an area where confirmed cholera cases, resulting from local
transmission, have been detected in the last three years. An area can be defined as any
subnational administrative unit such as purok, barangay, municipality, city, district or
province. (WHO GTFCC: Interim Guidance Document on Cholera Surveillance 2017)
Cholera non-endemic area- is an area with no reported cholera cases in the past 3 years.
Cholera hotspot area - a geographically limited area (i.e. city, administrative level 2 or
health district catchment area) where environmental, cultural and/or socio-economical
conditions facilitated the transmission of the disease and where cholera persists or
re-appears regularly. Hotspots play a central role in the spread of the disease to other areas.
(WHO GTFCC: Interim Guidance Document on Cholera Surveillance 2017)
Cholera outbreak:
eIn a non-endemic area, cholera outbreak is defined by the occurrence of at least one
confirmed case of cholera and evidence of local transmission.
e In area with sustained year-round transmission, cholera outbreak is defined by an

3
RITM Cholera evaluation reported dated 16May2018
RDT

4 https://www.who.int/cholera/task_force/Interim-guidance-cholera-RDT .pdf
5 https://www.who.int/cholera/publications/global-roadmap-summary.pdf
6 https://www.who.int/cholera/task force/GTFCC-Guidance-cholera-surveillance.pdf?ua=1
7 https://www.doh.gov.ph/sites/default/files/publications/PIDSRMOP3ED VOLI1 2014.pdf
 unexpected increase in the magnitude or timing of suspected cholera cases over two
consecutive weeks, with some cases being confirmed by the laboratory. (WHO GTFCC:
Interim Guidance Document on Cholera Surveillance 2017)
Cholera elimination - any country that reports no confirmed cases with evidence of local
transmission for at least 3 consecutive years and has a well-functioning epidemiological
and laboratory surveillance system able to detect and confirm cases. (WHO GTFCC:
Interim Guidance Document on Cholera Surveillance 2017)
Alert threshold - refers to the level of a disease occurrence that serves as an early warning
for epidemics. An increase in the number of
cases above the threshold level should trigger
an investigation, check epidemic preparedness and implement appropriate prevention and
1
-
control measures. (PIDSR MOP Volume 2014).
Epidemic threshold refers to the level of occurrence of disease above normal which an
urgent response is required. The threshold is specific to each disease and depends on the
infectiousness, other determinants of transmission and local endemicity levels. (PIDSR
MOP Volume 1 2014).
Response
infection, - refers to the implementation of specific activities to control further spread of
outbreaks or epidemics and prevent re-occurrence. It includes verification,
contact tracing, rapid risk assessment, case measures, treatment of patients, risk
communication, conduct of prevention activities and rehabilitation.
Rapid response team - is composed of
experts who take the lead in conducting the initial
investigation of reported and suspected cases or outbreaks so as to confirm the nature of
the event under investigation. It is also the responsibility of the RRT to initiate the
preliminary control/ containment measures needed to
prevent further spread of the disease.
(WHO Guide for Rapid Response Teams for Cholera Outbreak investigation and initial
response)

GENERAL GUIDELINES
—
The Cholera RDT shall be integrated to selected health centers and hospitals as point-of-

care screening test to provide accurate and timely laboratory result for early case and
outbreak detection, to support surveillance and outbreak response.
The Cholera RDT shall be performed to stool sample of suspected cholera case only and
shall not replace culture in the confirmation of a cholera outbreak.
The Cholera RDT shall be available for free to all suspected cholera cases.
The Department of Health, Local Government Units (LGUs) and development partners
shall provide support and technical assistance in the conduct of capacity building
activities, advocacy and health promotion activities, implementation, courier service,
transportation, communication, printing of forms, etc.
Monitoring activities shall be conducted every quarter and evaluation shall be done after
one year of implementation.

VI. SPECIFIC GUIDELINES

A. Screening of Cases
a. Barangay health worker, midwife, nurse and physician in the health center or hospital
shall be trained to detect suspected cholera cases.
b. Thorough assessment of clinical status, clinical history and physical examination of

shttps://plateformecholera.info/attachments/article/ 672/RRT%20%20cholera%200utbreak™%20investigation%o2
Oguide.pdf
»

cases with acute watery diarrhea shall be performed by a physician.

(Refer to Philippine Clinical Practice Guidelines on the Management of Acute
Infectious Diarrhea in Children and Adults- A Pocket Guide )’.
c. Initial management of dehydration shall be initiated as soon as possible even without
the result of Cholera RDT. (Refer to Department Memorandum No.
2019-0172 Supplemental Guidelines for the Implementation of the Food and
Waterborne Disease (FWBD) Program Oral Rehydration Therapy (ORT) Corner
Utilizing the Clinical Practice Guidelines on Acute Infectious Diarrhea).
d. The cholera RDT shall be used to stool sample, collected before the initiation of
treatment, of suspected cholera case only.
e. The suspected cholera case shall be defined as follows:
e.1. In area where cholera outbreak has not been declared:
- Any patient aged > 2 years who has acute watery diarrhea and severe
dehydration or died from acute watery diarrhea. (WHO GTFCC: Interim
Guidance Document on Cholera Surveillance 2017)
e.2. In area where cholera outbreak is declared:
- Any person presenting with or dying from acute watery diarrhea.
(WHO GTFCC: Interim Guidance Document on Cholera Surveillance 2017)

Acute
watery
diarrhea

Suspect for —¥
other causative ;<
- Assess level of
—

agents or causes ~~~ Suspect -. dehydration

cholera
case?

mild
q
No Moderate to
dehydration Severe
1

I)Oe Collect stool

specimen
-
Advice __
on diet intake,
fluid replacement
Rehydrate and
advice on signs
and signs of of progressive
i
wv dehydration dehydration
Store stoo! samples
for other enteric
pathogen Hospital
surveillance Perform
Cholera
RDT
Rehydrate and
Send stool sample refer to the next Rehydrate &
to reference isolate patient
higher facility
laboratory

f. In the absence of a
physician, the attending nurse/midwife shall request Cholera RDT
provided that a trained medical technologist shall perform the testing.
g. Health education on cholera case definitions and signs and symptoms shall be
regularly conducted for health workers, patients and community to strengthen early
case detection.
Health facility with capacity of sending stool samples to RESU, sub-national
reference laboratories, sentinel sites or national reference laboratory shall submit
stool samples, positive or negative with Cholera RDT, regularly as part of other
enteric pathogen surveillance. |

9 https://www.doh.gov.ph/sites/default/files/publications/CPG%20AID_pocket™20guide.v7.pdf
to
B. Laboratory Testing Strategy

1. Non-endemic area |

a. In non-endemic area, the Cholera RDT shall be preposition to health centers and
hospitals to be used for early identification of probable cholera case and initiation of
cholera alert.

b. The Cholera RDT shall be utilized based on

the algorithm below:
Non-endemic

|
Definition 1: Suspected

|
} Area where cholera
_ outbreak hasnot
cholera case - any case 2 2
Perform
years old who has acute
| Cholera RDT
watery diarrhea & severe
:

been declared
dehydration or died from
La ee ee ee em mem acute watery diarrhea

YW

Negative
|

Treat
isolate patient
and
Positive”.

Declare
a
“cholera alert»
~
=
Inocu ate stool:
to Cary Blair
medium”
Invalid
. Repeat test
-c only once

Vv t
onde Bean [_entve_| Neate
ee
|)
|
2
patient
Report as implement. -
—

‘probable cholera Health public health

ae
wv

“ease to MESU/ -->1 -.. facilityto” outbreak Invalid

Coordinate
cEsu,
fF

‘trigger field:
4
gee ves
responses an oe to ESU &

ce
resuinesy vestigation raterone
|

"Tonwol
4
|
||
|

facility
|

peek
Health within 24 hours : measures” “Laborato Repeat specimen
&
-

—_______—_
send stool
collection
_

--sampleto
nearest sentinel
ae
CESU/PESU/
-RESU to
eee
Send specimen
Perform QC.

site or sub-
reference support y v v to reference
laboratory for . field — |].
Environmental! .

Data. Contact laboratory for

other enteric investigation investigation .
analysis — tracing
-
culture
pathogen (per request) confirmation
surveillance

c. A positive Cholera RDT result shall lead to three immediate actions:

1) treatment and isolation of patients;
2) declaration of cholera alert; and
3) sending of stool specimen reference laboratory. to
d. Treatment and isolation of patients
d.1. The health center shall facilitate referral of cases with moderate to severe level of
dehydration to the nearest hospital.
d.2. The hospital shall treat patient, provide intravenous rehydration and
antibiotics accordingly. (Refer to Philippine Clinical Practice Guidelines on
the Management of Acute Infectious Diarrhea in Children and Adults- A
Pocket Guide ):
d.3. Cholera patients shall be isolated from other patients and appropriate
infection control measures shall be implemented to prevent the spread of
disease.
d.4. Health education on cholera disease, transmission and prevention shall be
provided to patients and family members.

e. Declaration of cholera alert

e.1. One positive cholera RDT result shall be enough to declare a cholera alert. The
cholera alert shall also be triggered if the given circumstances are present:
 - One case of acute watery diarrhea testing positive for cholera by rapid diagnostic
test
(RDT)in an area that has not yet detected a confirmed case of cholera, including
those at risk for extension from a current outbreak. (WHO GTFCC: Interim
Guidance Document on Cholera Surveillance 2017)
- Two or more people > 2 years of age linked by time and place (from the same area
within one week of one another) with acute watery diarrhea and severe
dehydration, or dying from acute watery diarrhea. (WHO GTFCC: Interim
Guidance Document on Cholera Surveillance 2017)
- One death from severe watery diarrhea in a person > 5 years of age. (WHO
GTFCC: Interim Guidance Document on Cholera Surveillance 2017)
e.2. The cholera alert shall be immediately reported (within 24 hours) by the attending
physician or designated surveillance officer to the next higher level health authorities
(MESU/HESU/CESU/PESU/RESU/EB).
e.3. The health center shall organize a rapid response team to conduct field
investigation. The rapid response team shall be composed of medical officer, nurse,
surveillance officer, sanitary inspector, medical technologist and health promotion
officer. (Refer to WHO Guide for Rapid Response Teams (RRTs) for Cholera
Outbreak investigation and initial response) !°.
e.4. If the health center has no capacity for field investigation, it shall request
assistance from CESU/ PESU/ RESU.
e.5. Environmental investigation shall be performed to
identify source of transmission
and risk factors, by collecting data on rainfall, water and food samples, drinking water
supply, sanitation, irrigation projects and environmental contamination as appropriate.
e.6. Contact tracing and active surveillance shall be carried out at community level,
with support of community health workers, using case definition of suspected cholera
cases.
e.7. Data analysis shall include creation of spot map and description of area;
determining the population at risk; plotting of epi-curve; characteristic of affected
persons by age,
sex, religion, etc; formulation of hypothesis based on cause of disease, mode of
transmission, incubation period and other risk factors; recommendations and lesson’s
learned; etc.
e.8. Appropriate public health responses and control measures shall be instituted based
on field investigation findings. Control measures shall not be delayed pending culture
confirmation result. Refer to Section VI.C. Control Measures.
e.9 A medical emergency team shall by organized by nearby hospitals as necessary
for
possible increase of hospital admissions.

f. Sending of stool specimen to reference laboratory

f.1. Cary Blair transport medium and triple packaging system shall be used for sending
of stool samples to a reference laboratory for bacterial culture.
f.2. The arrangement of specimen transport shall be coordinated by a health facility
to CESU/PESU/RESU and/or reference laboratory.

10https://plateformecholera.info/attachments/article/67 2/RRT%20%20cholera%20o0utbreak%20investigation%
20guide.pdf
 f.3. Appropriate assistance shall be provided by provincial, regional or national
authorities to the health facility to ensure that the stool specimen reaches the reference
laboratory.

. Declaration of cholera outbreak

g.1. Bacterial culture shall be the only basis for declaration of cholera outbreak. Below
algorithm shall be followed:
Non-endemic
i
Area where cholera i

outbreak has not

been declared Microbial
elite eee
f .. i
ince cease. Seen culture
confinnation
Negative Positive

NN?

RESU to inform RESU to Inform

referring referring
institution/CESU Iinstitution/CESU
/PESU/MESU /PESU/MESU

~ MESU/CESU/PESU to
assess laboratory result and
Stop cholera field investigation report to
atert confirm the outbreak

SOH/LCE to
declare cholera
outbreak

g.2. For each new municipality, province or region affected by an outbreak, an official
bacterial culture confirmation result shall be required. |

g.3. Only qualified tertiary laboratory, qualified regional laboratory, qualified sub-
national reference laboratory or national reference laboratory that passed the
bacteriology NEQAS shall be recognized to perform bacterial culture.
g.4. Official result shall only be released by the laboratory to regional or national
authority (RESU, EB). Hard copy, electronic email or fax result is acceptable, except
result send through SMS message or
phone call.
g.5. Dissemination of bacterial culture result to concerned stakeholders and partners at
the national level (i.e. DPCB, WHO, etc.) shall be done by the Epidemiology Bureau,
while dissemination of bacterial culture result to provincial, city, hospital and
municipal levels shall be done by the Regional Surveillance Unit.
g.6. A positive culture result shall be validated by field investigation report. If there is
evidence of local transmission, an outbreak shall be declared.
g.7. The Secretary of Health or the Local Chief Executive shall declare an outbreak.
g.8. Extensive public health response and control measures in the affected area shall
be implemented in coordination with DOH and/or partners. Refer to Section VLC
Control Measures.
g.9. Sufficient and available stocks of drugs and logistical supplies shall be ensured by
the health facility, otherwise it shall request assistance from higher health authorities.
There shall also be mechanism in place to report consumption and ordering of new
supplies.
g.10. If the culture is negative, the cholera can be ruled out and cholera alert shall
be stopped.
g.11. Indeterminate Cholera RDT result shall only be repeated once. the result is If
invalid again, report the result as invalid. Perform quality assurance or request for
repeat collection.
2. Area with Cholera Outbreak
©

a. In non-endemic area, a cholera outbreak shall be defined by the occurrence of at

least one confirmed case of cholera and evidence of local transmission. (WHO
GTFCC Cholera Surveillance Guidelines 2018)
b. All succeeding individuals with acute watery diarrhea shall be treated as suspected
cholera cases once an outbreak is declared. Individual Choler RDT result shall not
be required prior to clinical management.
c. The Cholera RDT shall be used for monitoring of outbreak. Periodic sampling shall
be performed based on the algorithm below:

A
Outbreak

nT ete | Dg
Areas where cholera
3
| Perform
Definition 2: Suspected
-
cholera case “6 wv Shin, f
presen mB wi or eying
trom
declared:
outbreak Is
1
Cholera RDT
acute infectious watery
ae ea
vie
eae esa ee

ered diarrhea

Perform Cholera RDT to

maximum of 10 samples
per day

| Negative

Monitor the
number of RDT
Vv
|
| Positive

v
Inoculate stool!
| | indeterminate

‘
|

Repeat Cholera
n i mol
samples to Cary Blair
medium
ROT
only once
¢

Allsamples turned
negative for atleast

~
2 weeks Vv

|
Send minima oF
RDT positive samples

Consider outbreak
has ended
to higher laboratory a wv

Invalid

NJ

Monitor antibiotic
Repeat specimen
Resume to susceptibility profile and
circulating strains
collection &
routine Cholera Perform QC
RDT testing

d. A maximum of ten randomly selected suspected cholera cases per day in a span of
two weeks shall be tested using Cholera RDT. In a small outbreak, the number of
samples collected and tested shall depend on laboratory capacity and extent the of
an outbreak.
e. A minimum of five RDT positive samples per health facility, collected per day,
shall be sent to the reference laboratory weekly for determination of antibiotic
susceptibility profile and to continuous monitoring of strains.
f. Periodic sampling shall be done once a week after two weeks.
g. A line list of suspected cholera cases shall be secured by nurse or midwife in each
health facility. The line list shall contain minimum demographic, clinical and
laboratory information such as name, age, sex, place of residence, symptoms, date
of onset, hospitalization, level of dehydration, treatment plan, laboratory result and
treatment outcome.
h. The number of
cases and deaths, both registered at the health facility and occurring
in the community, shall be reported daily (first two weeks) or weekly (after two
weeks). Refer to Annex 6. Consolidation Report Form.
 i. The outbreak shall be declared over when no new suspected cholera cases are
reported and all samples are negative by RDT or culture for at least two
consecutive weeks.
j. The Secretary of Health or the Local Chief Executive (LCE) shall announce the
end of an outbreak.
k. Recording of cases shall be done from start to end of an outbreak.

3. Endemic Area

a. In endemic area or area with sustained year-round transmission, a cholera

outbreak shall be defined by unexpected increase in magnitude or timing of
suspected cholera cases over two consecutive weeks, with some cases being
confirmed by the laboratory. (WHO GTFCC Cholera Surveillance Guidelines
|

2018)
b. The Cholera RDT shall be available as routine laboratory test in health centers and
hospitals for early outbreak detection, as tool for initial alert, and monitoring of
seasonal peaks especially in hotspot areas.
c. A cholera outbreak shall be declared if the number of suspected cholera cases
exceeded the epidemic threshold over two consecutive weeks.
d. Preventive actions in these areas shall focus on enhancing prevention and
preparedness activities, improving water and sanitation, strengthening social
mobilization, establishing early warning system with active surveillance, ensuring
access to health facilities, adequate case management and implementation of
preventive Oral Cholera Vaccine (OCV) campaigns. |

e. An outbreak shall be declared over when no suspected cholera cases are reported
and laboratory result test negative by RDTor culture over two-week period.
f. Cholera cases shall be reported to International Health Regulations (IHR) if the
outbreak is deemed a public health emergency of international concern.

C. Control Measures
1. Control Measures shall aim to reduce mortality and control the spread of the disease.
Control measures shall be implemented which may include setting up cholera
treatment units and oral rehydration points, ensuring early detection and transfer of
severe cases, training of additional health professionals as needed, applying standard
case-management protocols, strengthening epidemiological and laboratory capacity
for surveillance, ensuring access to water in quantity and promote hygiene conditions
and practices.
Health promotion and education activity shall include teaching of good hygiene
practices such as hand-washing, safe preparation of food, safe burials, improve
sanitation and proper excreta disposal.
In the case of a large outbreak, the use of cholera vaccine shall be considered in
preemptive situations (prevention before an outbreak starts) as part of comprehensive
cholera control plans depending on the local epidemiology and feasibility of
conducting vaccination. Refer to Department Memorandum 2017-0357 Guideline in
the Administration of Oral Cholera Vaccine in Evacuation Centers for the Displaced
Population and Health Care Providers Following Humanitarian Crisis.
D. Recording and Reporting
1. For reporting of laboratory result, a positive Cholera RDT result shall be written and
released as “Cholera RDT positive”. The negative Cholera RDT result shall be
written and released as “Cholera RDT negative”. The second indeterminate result
shall be written and released as “Cholera RDT invalid”.
. For reporting to PIDSR, a case > 2 years old positive with Cholera RDT
shall be
reported as “Probable Cholera Case” and the case > 2 years old negative with
Cholera RDT shall be reported as “Suspected Cholera Case”. Note in the “Remarks”
section that the laboratory test done is Cholera RDT.
No. Test Result Laboratory Reporting PIDSR Reporting
1 Positive Cholera RDT positive Probable Cholera Case
2 Negative Cholera RDT negative Suspected Cholera Case
|

3 Invalid Cholera RDT invalid Invalid

3. The Cholera RDT laboratory request form and result form shall be in accordance to
the health facility laboratory request and result forms.
4. All laboratories performing Cholera RDT shall keep laboratory record and shall submit
consolidated report to the Food and Waterborne Prevention and Control Program of
the Department of Health every quarter.

E. Collection, Storage and Transport of Specimen

1. Fecal specimens (liquid stool or rectal swabs) shall be collected within the first four
days of illness, and ideally before appropriate antibiotic therapy has been started.
Specimen collection may be done at
any time of rehydration.
Specimen shall be collected in a clean, appropriately labelled, leak-proof container at
room temperature and transported within two hours.
. If more than 2 hours delay in laboratory testing is expected, the Cary-Blair transport
medium shall be used.
All specimens shall be accompanied by laboratory request form and shall follow triple
packaging system.

F. Quality Assurance
1. Lot Testing
a. The Research Institute for Tropical Medicine- National Reference Laboratory
(RITM-NRL) Bacterial Enteric Diseases (BED) shall perform lot validation of
for
Cholera RDTs before shipment to
health facilities.
b. Consolidated report shall be submitted by NRL BED to Disease Prevention and
Control Bureau (DPCB) for every lot number tested.

2. External Quality Assurance

a. All laboratories providing Cholera RDT shall participate in the External Quality
Assurance (EQA) for Food and Waterborne Diseases (FWBD) as provided by the
National Reference Laboratory.

VII. ROLES AND RESPONSIBILITIES

A. Disease Prevention and Control Bureau (DPCB)

1. Formulates policy and provides policy direction for the implementation of
Cholera RDT;
 Together with RITM develops minimum standards and technical requirements for
the use of Cholera RDT;
Oversee the creation of pool of trainers to implement decentralize training and
other capability building activities for health workers;
Provides cholera RDT commodities to health centers and hospitals through DOH
Regional Offices;
mn Develop health promotion and advocacy activity for cholera RDT service; and
Conduct monitoring, supervision and evaluation activities of cholera RDT
implementation;

. Environmental Related Diseases Division (ERDD)

1. Provide technical assistance to CHDs and LGUs to comply with provisions and
requirements of the Sanitation Code of the Philippines;
2. Formulate and promote policies and guidelines in promoting increased access to
safe food, water and sanitation services;
3. Augment logistics for good and safe water, sanitation and hygiene practices
during outbreak; and
4. Coordinate with the Department of Environment, Natural Resources (DENR) and
Department of Agriculture (DA) and partners for interventions that will support
the public heath interventions for prevention of cholera.

. Epidemiology Bureau (EB)

1. Generate timely cholera surveillance reports and disseminate to concerned DOH
offices and other agencies;
2. Inform/communicate to FWBD and other concerned offices any impending

in
cholera outbreaks;
3. Provide technical assistance to RESU, PESU, CESU and MESU the
investigation, declaration and termination of outbreaks; and
4. In coordination with FWBD, as the International Health Regulations National
Focal Point Office, EB shall immediately notify the WHO when the assessment
of an event indicates that the cholera outbreak is notifiable pursuant THR 2005.
to

. Health Emergency and Management Bureau (HEMB)

1. Provide technical assistance in developing plans in times of emergencies and
disasters;
2. Coordinate the mobilization of WASH resources to ensure adequate and safe
water through water quality surveillance, disinfection/treatment in coordination
with DPCB-ERDD; and
Support in the augmentation of logistics to FWBD to respond to emergencies,
disaster and outbreaks.

. Health Promotion and Communication Services (HPCS)

1. Formulate and design health promotion and communication plan to address
cholera outbreak; and
2. Develop key messages for various groups of audiences relative to the prevention
and control of FWBDs.

. Bureau of Quarantine (BOQ)

1. Ensure compliance to protocol and field operation guidelines on entry/exit
management of specimens incoordination with airport and/or port of entries.
G. Research Institute for Tropical Medicine (RITM) and National Reference
Laboratories (Parasitology, Bacterial Enteric Diseases, Rotavirus and Other
Enteric Viruses and Surveillance and Response Unit)
1, Perform confirmatory laboratory testing for human samples referred for the
cholera surveillance and outbreak investigation;
2. Provide technical support for collection, transport and storage of specimen for the
disease reporting unit;
3. Provide training on laboratory diagnosis for Cholera RDT and quality assurance
to participating laboratories;
4. Provide line-list of laboratory result to EB and RESU, and individual laboratory
results to the RESU,in the form of transmittals (for distribution to the DRUs);
5. Perform further studies to determine other etiologies of diarrhea;
6. Conduct laboratory surveillance for the cholera; and
7. Conduct Cholera RDT validation.

H. Department of Health - Centers for Health Development (CHD) Infectious

Disease Prevention and Control Cluster
1. Disseminate this issuance to different stakeholders and partners;
2. Support the advance implementation of Cholera RDT by inclusion of budgetary
requirements to their respective FWBD work and financial plans;
3. Lobby with Local Chief Executives to support capacity building, cholera RDT
implementation, compliance with quality assurance and outbreak response
activities (as necessary) in identified areas with high prevalence of cholera or
where cholera is endemic;
> Assist RESU, HEMB and in
EOH cholera outbreak investigation and response;
Augment logistics support to health centers and hospitals during outbreak;
An
Together with RITM, organizes training, mentoring and coaching activities for
health workers following Cholera RDT guidelines;
Provides cholera RDT kits and other consumables to health facilities;
Conducts monitoring, supervision and evaluation activities of cholera RDT
implementation; and |

Regularly collects and analyzes regional supply inventory reports, monitoring

and supervision reports; and provides feedback to DPCB.

I. Department of Health - Regional Epidemiological and Surveillance Unit (RESU)

technical assistance to LGUs Surveillance Unit (ESUs)
1. Provide Epidemiological
in the conduct of outbreak investigation;
2. Coordinate and facilitate the submission of stool samples to qualified laboratory
or reference laboratory;
3. Facilitate immediate reporting to ESR if there is an outbreak or clustering of
Cases;
4. Conduct weekly analysis of cholera data and submit weekly report to EB on
notifiable diseases; and
5: Notify EB if there is a Public Health Emergency of International Concern.

J. Qualified Laboratories
1. Perform bacterial culture of stool samples referred by disease reporting units, as
well as from health facilities for outbreak investigations;
2. Participate in the Cholera RDT quality assurance system;
3. Provide laboratory results to the National Reference Laboratory and RESU, and
coordinate with NRL for technical concerns (i.e. specimen collection, transport,
storage, testing and troubleshooting)
Send isolates to NRL for antibacterial testing, etc.
 K. Hospital
1. Diagnose, manage and treat cholera cases based on approved Clinical Practice
Guidelines (CPG);
2. Provide health promotion and education about cholera disease, transmission and
prevention such as proper sanitation and good hygiene practices, etc. to patient
and relatives;
RY
Report cholera cases to local epidemiological and surveillance unit;
Conduct regular death review of cholera cases;
Ensure availability of adequate supplies and commodities during outbreak;
Ensure the creation of emergency medical team as needed;
SAM

Ensure sending of stool specimen to a qualified culture laboratory for |

bacteriological culture confirmation; and

8. Provide IEC materials to patients.

L. Health Center
1. Diagnose, manage and treat cholera cases based on approved CPG;
2. Conduct field investigation including environmental, contact tracing and data
analysis.
|

3. Implement public health responses and control measures when there is cholera
alert or confirmed cholera outbreak;
Provide health promotion and education about cholera disease, transmission and
prevention such as proper sanitation and good hygiene practices, etc. to patients
and community;
wn Report cholera cases to local epidemiological and surveillance unit;
Ensure sending of stool specimen to a qualified culture laboratory for
bacteriological culture confirmation;
oN
Refer patients appropriately to hospital as needed; and
Provide IEC materials to patients.

For your guidance and strict compliance.

By Authority of the Secretary of Health:

A C. CABOTAJE, MD, MPH, CESO III

Undersecretary of Healt
Public Health Services’Team
 Republicof the Philippines _
Department of Health —

CHOLERA PATIENT REFERRAL FORM

Name of Receiving Unit:

Address:

Name of Patient: Last Name First Name M.I.

Age: Sex ID No.

Address of Patient:
No. Street Barangay

City/ Municipality Province

Vital Signs: BP: Temp: RR: PR: Weight: Height: BMI:

Pertinent Findings:

Intervention/Laboratory Work ups:

Impression:

Reason for Referral:

Name of Referring Unit: _Date:

Address:
:

Time:
Contact No: Email address:
|

Name of Physician: Signature:

Cholera Patient Referral Reply Slip

From: |
Date: ___
Time:
To: Address:
Name of Patient:
Laboratory Result:
Action/s Taken:
Admitted For Follow-up
_
Sent Home
|

For Observation
_
__ Against
Medical Advice Referred to other facility
Died Others, specify:
__

Name of Physician: Signature:

 of the Philippines
Republic
Department of Health
CHOLERA RDT
MONTHLY SUPPLY INVENTORY FORM

Nameof Facility:
Address:
|
Month: Quarter/ Year:

Prepared by: Designation:

Commodity: Brand Name/Supplier:
(1) (2) (3) (4) (5) (6) (7) (8) (9)
Day Date of Quantity Quality Lot Expiration No. of Kit No. of Kit T
Receipt Number Date Used Remaining AM
|
bo

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ON

|B]

00

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me
jem pam

jem BO

foe
2
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16
ee SI

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OO

|
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LN

QO

JN BR

PN On

PY ON

ND

COTS

ND

ND
[|
Gd S
Cod

|
 of the Philippines
Republic
of Health
Department
SPECIMEN RECEIVING FORM

Name of Facility: Date:

Address:

Prepared by: Designation: Contact No:

(1) (2) (3) (4) (5) (6) (7) (8)

No Name Case Type of Date Quantity/ Date Remarks

Number Specimen Collected Quality Received
—

N|

BB!

B&B)

a
HD

NE

CGC)

So,

a" oS

ay rv

pond nN

pm eo

jh ea.

jh an

jh Nn

jum

|
pac Ge

pooh \©

nN oS

TOTAL

Received by: Date: Contact No.

 Republic of the Philippines
Department of Health
SPECIMEN REFERRAL FORM

Name of Facility: Date:

Address:

Prepared by: Designation: Contact No.

_

(1) (2) (3) (4)

SO) (6) (7) (8)

No Name Case Type of Date Quantity/ Date Remarks

Number Specimen Collected Quality Received

NHN!

|)

RB]

a
AL

NY

CO)

Oo!

jum oS

md pond

—" ho

—" 7)

pom
>

poh an

—v ON

pam
~
jvomh
CO

ry \O

nN oS

TOTAL

Received by: Date: Contact No.

 of the Philippines
Republic
Department of Health
CHOLERA RDT
CONSOLIDATION REPORT FORM
(Please tick reporting level)
[_] Region: Province: L] Hospital: Daily/Weekly/Month/Quarter/Year Date Submitted:
Period Covered:

(1) (2) (3) (4) (5) (6) (7) (8)

Name ofCity/ Total no. Sex Age Group Total Cholera Total Culture Total Case Classified Remarks
Municipality/ Facility of RDT Result Result
(Hospital) Dengue mM F <i 1-4 5-9 10- 15- 25- 40-| 65& Neg Pos Inv Neg Pos Ind Probable Confirmed
Case 14 24 39 64 UP

TOTAL

PERCENT

Prepared by: Name & Signature: Noted by: Name & Signature:
Position: Position:
Contact Number: Contact Number:
Abbreviation: Neg- negative; Pos- positive; Inv- Invalid
 Republic of the Philippines
Department of Health
CHOLERA RDT LABORATORY REGISTRY

Name of Facility: Region: Municipality/Province:

Trained Laboratory Personnel: Contact Number: Month/Quarter/Year Covered:

(1)
No
(2)
Date of
(3)
Case No. |
4)
Name
CR)Sex
Age
(7)
Address & Contact Number
(8)
Stool
(9)
Result of
(10)
Result of
(11)
Case
(12)
Examined
(13)
Remarks
Collection/ (year-xxxx) (Last Name, First Name, M.1) (M/F) (street, barangay, municipality) Quality Cholera Culture Classification by
Examination (watery, RDT Positive
( mm/dd/ yy) bloody, hard, se Py
Negative (N),
Suspect ey
Probable (P)
etc) Novative ny) Indeterminate (I) Confirmed (C)/
/
Invalid (I) (If available)
1.

2.

3,

4.
5.

6.
=
7. 7

fs
8. 2

9,

10.

1. No. Cholera RDT Positive: 5. Monthly Total: 1. Suspect Cholera:

CHOLERA RDT No
MONTHLY C ONSOLID ATION 2. No. Cholera RDT Negative: 2. No. Probable Cholera:

3. No. Cholera RDT Invalid: 3. No. Confirmed Cholera:

4. No. Cholera RDT Repeat Test:
4. Monthly Total: