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NATIONAL PILOTNATIONAL PILOT

PROGRAM FOR HIVPROGRAM FOR HIV

(EEQ VIH Côte d’Ivoire)(EEQ VIH Côte d’Ivoire)

——

Quality Assurance Manager

CDC/ PEPFAR RETRO-CI

COTE D’IVOIRE

Quality Assurance Manager

CDC/ PEPFAR RETRO-CI

COTE D’IVOIRE

1

HIV/ AIDS IMPLEMENTERS MEETING

WINDHOEK, NAMIBIA JUNE 8-14, 2009

HIV/ AIDS IMPLEMENTERS MEETING

WINDHOEK, NAMIBIA JUNE 8-14, 2009

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PRESENTATION OUTLINEPRESENTATION OUTLINE

• Country backgroud• Country backgroud

• Ministry of health (MOH) organization• Contexte• Ministry of health (MOH) organization• Contexte

• CDC/ PEPFAR Laboratory branch

organization

• CDC/ PEPFAR Laboratory branch

organization• Methods

• Results

• Methods

• Results

• Constraints

• Lesson learned

• Constraints

• Lesson learned

2• Perspectives• Perspectives

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COUNTRY BACKGROUND (1)COUNTRY BACKGROUND (1)

• Cote d’Ivoire: West Africa

• Population: 20 Millions

• Cote d’Ivoire: West Africa

• Population: 20 Millions

• Yamoussoukro is the political capital

• HIV national prevalence is : 3,9% (UNAIDS, 2009)

’

• Yamoussoukro is the political capital

• HIV national prevalence is : 3,9% (UNAIDS, 2009)

’

• Health system structure is pyramidal

Primary level: District health facilities

• Health system structure is pyramidal

Primary level: District health facilities

Secondary level: Regional hospitals

Tertiary level: University teaching hospital, Specialized

Secondary level: Regional hospitals

Tertiary level: University teaching hospital, Specialized

• 1600 Health facilities w ith laboratories

300 have operational laboratory services

• 1600 Health facilities w ith laboratories

300 have operational laboratory services

3

101 lab equipped by PEPFAR and offering full lab

services (HIV, Hematology, Biochemistry, CD4)

101 lab equipped by PEPFAR and offering full lab

services (HIV, Hematology, Biochemistry, CD4)

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COUNTRY BACKGROUND (2)COUNTRY BACKGROUND (2)Mali

14

Guinée

18 1513

19

19

Regions

610

98

12 Ghana

4

3 2 1

5 7Libéria

44

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COUNTRY BACKGROUND (3):

-National Public Health Laboratory

- a ona are an rea menprogram

- National Public Health Pharmacy- National Blood Bank

Tertiar

y level

- 18 Regional hospitalsSecondary

level

72 Districts health facilities

- 56 District hospitals- 2 Specialised hospital1300 labs (Clinics, Maternity,TB centers, etc)

Primary level

5

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MINISTRY OF HEALTH ORGANISATIONMINISTRY OF HEALTH ORGANISATION

6

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CONTEXT (1)CONTEXT (1)’ ’

• The goal of PEPFAR program is to strengthen the national• The goal of PEPFAR program is to strengthen the national

a ora ory ne wor o o er qua y a ora ory serv ces o

support care and treatment program: care to 385,000patients, Treat 77,000 patients, prevent 265,655 new

a ora ory ne wor o o er qua y a ora ory serv ces o

support care and treatment program: care to 385,000patients, Treat 77,000 patients, prevent 265,655 new

infection

•

infection

•

the lab program in Cote d’Ivoire (supervision, training,

classic external quality assessment program (PT), re-

the lab program in Cote d’Ivoire (supervision, training,

classic external quality assessment program (PT), re-

…

• Since 2004 a national PT program for CD4 was initiated to

…

• Since 2004 a national PT program for CD4 was initiated to

7

support scaling up of ARTsupport scaling up of ART

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CONTEXT (2)CONTEXT (2), -

(CDC/ PEPFAR) initiated a MOU w ith the national

ublic health laborator LNSP and the HIV

, -(CDC/ PEPFAR) initiated a MOU w ith the national

ublic health laborator LNSP and the HIV

care and treatment program (PNPEC) to developa national PT program that w ill cover HIV,care and treatment program (PNPEC) to developa national PT program that w ill cover HIV,

ema o ogy an oc em s ry

• A pilot program was initiated w ith 2 PT panels

ema o ogy an oc em s ry

• A pilot program was initiated w ith 2 PT panelsdistribution in February-March, 2008 and Dec-

January, 2009

distribution in February-March, 2008 and Dec-

January, 2009

• 98 testing sites participated to the EQA pilotprogram for HIV

• 98 testing sites participated to the EQA pilotprogram for HIV

8

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CDC/ PEPFAR LABORATORY

BRAN H R ANI ATI N

CDC/ PEPFAR LABORATORY

BRAN H R ANI ATI NLABORATORYBranch Chief

• CDC/ PEPFAR lab isorganized in 4 units

• CDC/ PEPFAR lab isorganized in 4 units

AdministrativeAssistant

QA unit Clinical Diagnostic

unit

QA unit Clinical Diagnostic

unit

Serology unit

MolecularDiagnostic unit

Serology unit

MolecularDiagnostic unit

QualityAssurance

Unit

ClinicalDiagnostic

Unit

SerologyUnit

MolecularDiagnostic

Unit

• Staff = 26

• Qualif ied : 6 biologist,

• Staff = 26

• Qualif ied : 6 biologist,

13 me icatechnologist and 7various support team

13 me icatechnologist and 7various support team

- EQA- Monitoring & Evaluation

9

• QA unit: EQA section• QA unit: EQA section - Secretariat- Informatique

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CDC/ PEPFAR LABORATORYCDC/ PEPFAR LABORATORY

10

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METHODS (1)METHODS (1)

• Participant selection

Inclusion criteria: To perform HIV testing and

• Participant selection

Inclusion criteria: To perform HIV testing and

run at least 100 samples a month Exclusion criteria: not performing HIV testing

run at least 100 samples a month Exclusion criteria: not performing HIV testing

• Participant : 98 sites (63 VCT and PMTCT, 35 labs)

• Participant : 98 sites (63 VCT and PMTCT, 35 labs)

17 RH labs (Secondary level) 17 RH labs (Secondary level)

the NRL (LNSP)

02 Private labs

the NRL (LNSP)

02 Private labs

1111

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METHODS (2)METHODS (2)•

Training•

Training 84 lab technicians trained in 2 sessions

including QA regional focal points

84 lab technicians trained in 2 sessions

including QA regional focal points

• EQA panel (caracterization source material) HIV- P lasma bag (200-250mL) from the

• EQA panel (caracterization source material) HIV- P lasma bag (200-250mL) from the

a ona oo an ; nega ve or an

HIV+ Plasma bag (200 to 250 ml) from the

a ona oo an ; nega ve or an

HIV+ Plasma bag (200 to 250 ml) from the

Highly positive samples are diluted

Stock material is aliquoted in Falcon tubes

Highly positive samples are diluted

Stock material is aliquoted in Falcon tubes

(50ml) and stored at – 40°C

Aliquots vials (2,5ml) of plasma for sero-status

(50ml) and stored at – 40°C

Aliquots vials (2,5ml) of plasma for sero-status

12

c arac er za on , an rap es s,

routinely used at RETRO-CI)

c arac er za on , an rap es s,

routinely used at RETRO-CI) 12

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METHODS (3)METHODS (3)• •

Perform segregated aliquoting to reduce a risk of

contamination between samples

Perform segregated aliquoting to reduce a risk of

contamination between samples

Retesting aliquots of stock material Serostatus rechecked, 1 sample per batch

Retesting aliquots of stock material Serostatus rechecked, 1 sample per batch

Dried Tube Specimen (DTS):

- 20µl of HIV+ or HIV- plasma samples

Dried Tube Specimen (DTS):

- 20µl of HIV+ or HIV- plasma samples

temperature in BSC

temperature in BSC

- 300µl/ 500µl of HIV+ and HIV- aliquoted in

vials and stored at – 40°C

- 300µl/ 500µl of HIV+ and HIV- aliquoted in

vials and stored at – 40°C

13

Composition of panel: 5 frozen plasma and 5

(DTS)

Composition of panel: 5 frozen plasma and 5

(DTS) 13

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Frozen plasma DTS

- ac ag ng

• Ziplock bags

• Aqui-Pak 6 Bay absorbent

• TearTeach tube shuttle

separates up to 6 transporttubes

pouch

• Biohazard labels (+/ -)

• Cold Chain

•

• Biohazard labels

•Ambiant temperature Ice pack

Cooler bags

Mails

• Administrative su ort: 1 Cover sheet

2 Information sheet,

3 Form to acknowledge samples,

14

,

5 Questionnaire,

6 Results form)

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2- Shipping:2- Shipping:

• se s pp ng ca en ar o s an a

commodities of the Public health pharmacy(PSP)

• se s pp ng ca en ar o s an a

commodities of the Public health pharmacy(PSP)

• PSP delivered drugs and commodities to

health facilities on a monthly basis and this

• PSP delivered drugs and commodities to

health facilities on a monthly basis and thiscover the whole countrycover the whole country

• CDC Ve ic e is use to eserve participantsites located in Abidjan

• CDC Ve ic e is use to eserve participantsites located in Abidjan

15

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EQA FORMSEQA FORMS

16161 2

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EQA FORMSEQA FORMS

3

4

5

17

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PANEL PACKAGING MATERIALPANEL PACKAGING MATERIAL

2- Packaging for DTS1- Packaging for frozen plasma

Distribution number

a b

Panel ID

c

d

Distribution date

Or

resultats

1818

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TRANSPORTATION MATERIALTRANSPORTATION MATERIAL

1- Frozen plasma (2- 4°C) 2- DTS (25-40°C)

a

Distribution date and

Deadline for resultatsb

1919

a- Cooler bags (up country sites)

b- Cooler bags (Abidjan sites)

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COMMUNICATIONCOMMUNICATION

• Communication and transmission of EQA

results

• Communication and transmission of EQA

results

Fax Fax

-ma

Private transport

-ma

Private transport Directly to RETRO-CI EQA admin support or

to the sites

Directly to RETRO-CI EQA admin support or

to the sites

• Corrective actions

Phone

• Corrective actions

Phone

20

On-site visits On-site visits

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RESULTS (1)RESULTS (1)First EQA panel distribution• Effective participation: 96% (94 participants/98

First EQA panel distribution• Effective participation: 96% (94 participants/98

• 91 (97% ) participants scored 100%•

• 91 (97% ) participants scored 100%•

Level of NB of Score Scorehealth facility

(N)

participants

=100%

<100%

Primary (68) 65 62 3

Secondary (17) 17 17

Tertiary (11) 10 10

2121

Total (98) 94 91 3

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RESULTS (2)RESULTS (2) econ pane str ut on

• Effective participation: 94% (92

econ pane str ut on• Effective participation: 94% (92

• 71 (77% ) participants score 100%• 21 23% artici ants score < 100%

• 71 (77% ) participants score 100%• 21 23% artici ants score < 100%

Level of

health facility

NB of

participants

Score

=100%

Score

<100%

Primary (62) 62 48 14

Secondar 17 17 12 5

Tertiary (11) 11 9 2

Private 02 02 2

22

Total (98) 92 71 21

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RESULTS (3)RESULTS (3)• Reasons for underperformance

On the two panel a total of 24 sites had

• Reasons for underperformance On the two panel a total of 24 sites had

Pi ettin Ra id Test Mislabelin of

rr

error SOP notfollowed

panel

Primary 1 (DTS) 16 (1 FP & -DTS, 15 DTS)

Secondary - 4 (1FP, 3 DTS) 1 (DTS)

Tertiary - 2 (DTS) -

Private - - -

23

Total 1 22 1

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Availability of fund (USG procedures)

Availability of fund (USG procedures)

Availability of coolers bags

(manufacturer)

Availability of coolers bags

(manufacturer) Delay in delivering of panels Panel transportation is not a priority

activit of PSP

Delay in delivering of panels Panel transportation is not a priority

activit of PSP

• Results transmission by participants Dela in results deliver to RETROCI

• Results transmission by participants Dela in results deliver to RETROCI

24

Some site do not have communication

means (Telephone, fax, internetconnectivit electricit roblems etc…

Some site do not have communication

means (Telephone, fax, internetconnectivit electricit roblems etc…

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Limited resources of the LNSP (HR, Limited resources of the LNSP (HR,

, ,

funds) impacted the collaboration w ith

-

, ,

funds) impacted the collaboration w ith

-

• National public health pharmacy(PSP) delivery schedule of drugs and

• National public health pharmacy(PSP) delivery schedule of drugs and

commodities Technical issues (new softwarecommodities Technical issues (new software

25

installation at PSP) has disturbed EQA

panel distribution

installation at PSP) has disturbed EQA

panel distribution 25

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Lesson learnedLesson learned• C te d’Ivoire has capacity to implement HIV

PT program

• C te d’Ivoire has capacity to implement HIV

PT program

• DTS is e or a e or any country ue to

many advantages

• DTS is e or a e or any country ue to

many advantages

Easy to prepare an to store

Less cost for materials used for packaging

Easy to prepare an to store

Less cost for materials used for packaging Easy to transport

No risk of sample spills

Easy to transport

No risk of sample spills

Reconstitued DTS is stable at 45°C during4 weeks

Reconstitued DTS is stable at 45°C during4 weeks

2626

Can be used at VCT and PMTCT sites as

internal quality control

Can be used at VCT and PMTCT sites as

internal quality control

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PERSPECTIVES (1)PERSPECTIVES (1)

• ur ng t e tw o years p ot

Rolled out of 200 sites (more VCT and PMTCT

• ur ng t e tw o years p ot

Rolled out of 200 sites (more VCT and PMTCT

Training of counselors on the DTS PT Use DTS PT anel as internal ualit control

Training of counselors on the DTS PT Use DTS PT anel as internal ualit control

at all HIV testing sites

• Develo a national PT roll-out lan to all HIV

at all HIV testing sites

• Develo a national PT roll-out lan to all HIVtesting sites

• Wide im lementation of E A for Chemistr and

testing sites

• Wide im lementation of E A for Chemistr and

Hematology (pilot include 25 sites out of 101)

Hematology (pilot include 25 sites out of 101)

27

for CD4 and HIV PT panel samples

for CD4 and HIV PT panel samples

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PERSPECTIVES (2)PERSPECTIVES (2)

• Continu to strengthen the NRL

(infrastructure, preparation of DTS panels,

• Continu to strengthen the NRL

(infrastructure, preparation of DTS panels,

on-site visit, )on-site visit, )

• Logistic issues:

Built capacity of the NRL : allocating fund

• Logistic issues:

Built capacity of the NRL : allocating fundthrough MOH (PT panel distribution and

on-sit visit

through MOH (PT panel distribution and

on-sit visit

s a s a par ners p w a pr va ecompany (Abidjan)

s a s a par ners p w a pr va ecompany (Abidjan)

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AKNOWLEGMENTSAKNOWLEGMENTS

• MOH representatives

• MOH representatives

National AIDS program (PNPEC)

National AIDS program (PNPEC)

National reference lab. (LNSP)

National reference lab. (LNSP)

Direction and Regional Direction)

Direction and Regional Direction)

• All participants

• All participants

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• .• .

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THANK YOU

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Documents

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