ICAP-NY DATA DISSEMINATION

WEBINAR

Bereket Alemayehu, Clinical & Training Unit

Charon Gwynn, SI Unit

Laboratory Program and Facility Characteristics Tracking System:

Round One Findings

Please fill out webinar series survey!!!!

http://www.surveymonkey.com/s/WG5JTTG

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information–Health System Strengthening– Quality Assurance–Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

ICAP’S LABORATORY PORTFOLIO

ALGERIA

MAURITANIAMALI

NIGER

LIBYA

CHAD

EGYPT

SUDAN

ETHIOPIA

KENYA

TANZANIA

DEMOCRATIC

CENTRAL

RWANDA

GABON

NIGERIABENIN

SENEGAL

GHANA

CAMEROON

ZAMBIA

MOZAMBIQUE

ZIMBABWE

BOTSWANA

SWAZILAND

LESOTHO

NAMIBIA

ANGOLA

UGANDA

OF THE CONGO

REPUBLIC

COTE

BURKINAGUINE

A

SOUTH

REPUBLIC

AFRICAN

THE

AFRICA

D’IVOIRE

Turkmenistan

Uzbekistan

Kyrgyzstan

Tajikistan

Kazakhstan

LABORATORY PORTFOLIO…..ORGANOGRAM

Clinical &

Training Unit-

NY

Regional lab advisors

Country lab lead & teams

LABORATORY PORTFOLIO …. PROGRAM FOCUS AREAS

System strengthening• Policy & strategy

development• QA/QC• Lab networking• Accreditation

Service strengthening• Physical infrastructure• Equipments• Supplies

Human resource capacity building• Trainings• Mentorship• Supportive

supervisions

LABORATORY PORTFOLIO ….. INTEGRATION OF SUPPORT

HIVTB

Other OIs

Malaria

LABORATORY PFACTS• Laboratory survey that targets all labs across

the tiered levels • Provides information on the scope, diversity,

and comprehensiveness of laboratories

• Qualitative/quantitative information - implementation of lab quality essentials(QEs)– infrastructure and equipment - human resources– quality assurance activities - Facility safety– Supply chain management

RATIONALE FOR LABORATORY PFACTS

• Specific facility laboratory:– Laboratory’s capacity and progress toward

accreditation– Gap analysis and laboratory specific

improvement plan

• ICAP national laboratory program:– Aggregate information to assess capacity and

identify major gaps in implementing QMS across supported labs

– Lab support prioritization and strategy – Program planning and implementation of

improvement plans

PEPFAR DEFINITION OF CLINICAL LABORATORY

Laboratory that has the capacity to:

Perform testing for the diagnosis of HIV infection with either rapid test, EIA or molecular methods; and

Has dedicated laboratory personnel

Perform clinical laboratory tests in any of the following areas:Hematology - Clinical chemistry - Serology Microbiology - CD4 testing - HIV viral loads TB diagnostic - Malaria diagnosis - OI diagnosis

IMPLEMENTATION

Pilot

• Sept 2009• 6 countries and 51 laboratories• Survey tool revised, database developed

Survey

• July - November 2011• 8 countries and 521 ‘PEPFAR clinical labs’• Interview of lab-in-charge by country lab advisors

Report • Data reviewed and entered into the URS with help from country

M&E teams

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information–Health System Strengthening– Quality Assurance–Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings–General Information–Health System Strengthening– Quality Assurance–Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

PROPORTION OF ICAP SUPPORTED LABORATORIES PARTICIPATING IN LABORATORY PFACTS BY

COUNTRY

0

20

40

60

80

100

86

100 100 100 100 9491

7163

% o

f la

bora

tori

es

ICAP SUPPORTED LABORATORIES BY FACILITY TYPE AND COUNTRY (n=521)

Kenya

Tanza

nia

Ethiop

ia

Mozam

bique

Rwanda

Nigeria

Cote d'

Ivoire

DR Con

go0

50

100

150

200

135

76

2641 37

0 51

40

34

46 10 7

32 11 5

0

1

5

2

00 0

1

3

3

Primary Secondary Tertiary Reference lab

Num

ber

of la

bora

tori

es

TYPE OF SUPPORT PROVIDED BY ICAP (n=521)

0

20

40

60

80

100 97

8580 77

6961 58

44 4136 31 31

18

% o

f la

bora

tori

es

TYPE OF HIV-RELATED TESTS PERFORMED (n=521)

0

20

40

60

80

100 96 94 93

71

50 47 4742

31

2420%

of

labo

rato

ries

AVAILABILITY OF HIV RELATED TESTS BY FACILITY

TYPE

Primary (n=321) Secondary (n=185)

Tertiary (n=8) Reference lab (n=7)

0

20

40

60

80

100 96 97

88

57

5

70

100

88

4

46

3843

9297

100

57

0 0

13

57

HIV Rapid test CD4 cell counts CD4 percent TB test (AFB)

% o

f la

bora

tori

es

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

3%

8%

90%

All equip-ment sep-arateSome equipment separateAll equip-ment to-gether

LOCATION OF ICAP SUPPORTED EQUIPMENT (n=378)

Micropipette (n=114) Chemistry analyzer (n=228)

Hemotology analyzer (n=230)

0

20

40

60

80

100 9895 94

% o

f la

bora

tori

es

EQUIPMENT USED FOR HIV AND NON-HIV PROGRAMS

INVENTORY SYSTEMS USED FOR HIV AND NON-HIV

PROGRAMS

0

20

40

60

80

100

84

98 97 97

84

66 66 64

43

% o

f la

bora

tori

es

REQUISITION FORMS USED FOR HIV AND NON-HIV

PROGRAMS

0

10

20

30

40

50

60

70

80

90

100

87

100 10096

9188

79 79 77

% o

f la

bora

tori

es

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) FOR KEY HIV-

RELATED TESTS

Rapid test (n=500)

CD4 cell counts (n=160)

ALT (n=241)

Creatinine (n=247)

0

20

40

60

80

100 96 99 98 99

14

2720 20

53

85

27 24

Testing against internal controls Internal proficiency testingExternal proficiency testing

% o

f la

bora

tori

es

QA/QC FREQUENCY FOR HIV RAPID TEST (n=498)

Testin

g aga

inst i

nter

nal c

ontro

ls

Inter

nal p

roficie

ncy t

estin

g

Extern

al pr

oficie

ncy t

estin

g0

20406080

100

3

8646

94

31 2

1

19

3

10 10

49

None Daily Weekly Monthly Quarterly Yearly

% o

f la

bora

tori

es

QA/QC FREQUENCY FOR CD4 CELL COUNT TEST (n=159)

Testin

g aga

inst i

nter

nal c

ontro

ls

Inter

nal p

roficie

ncy t

estin

g

Extern

al pr

oficie

ncy t

estin

g0

20406080

100

75

723 52 15

372

14

1

82

0 1

None Daily Weekly Monthly Quarterly Yearly

% o

f la

bora

tori

es

QA/QC FREQUENCY OF ALT TEST (n=247)

Testin

g aga

inst i

nter

nal c

ontro

ls

Inter

nal p

roficie

ncy t

estin

g

Extern

al pr

oficie

ncy t

estin

g0

20406080

100

2

80 7391

75 12 111 26

1

None Daily Weekly Monthly Quarterly Yearly

% o

f la

bora

tori

es

QA/QC FREQUENCY OF CREATININE TEST (n=247)

Testin

g aga

inst i

nter

nal c

ontro

ls

Inter

nal p

roficie

ncy t

estin

g

Extern

al pr

oficie

ncy t

estin

g0

20406080

100

1

80 7691

75 10 1

24

None Daily Weekly Monthly Quarterly Yearly

% o

f la

bora

tori

es

AVAILABILITY OF STANDARD OPERATION PROCEDURES FOR

HIV RELATED TESTING

Rapid test (n=495)

CD4 count (n=160)

Hemoglobin (n=488)

ALT (n=247)

0

20

40

60

80

100 95 9891 94

% o

f la

bora

tori

es

REJECTION CRITERIA FOR HIV RELATED TEST FORMS AND

SAMPLES BY COUNTRY

0

20

40

60

80

10090

100 10096

9389

86

25

0

% o

f lab

orat

orie

s

USE OF SAMPLE VALIDATION SYSTEMS BY COUNTRY

0

20

40

60

80

100

31

100

55

34 33

2114

6 6

% o

f la

bora

tori

es

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

STAFF RECEIVING TRAINING FOR HIV RELATED TESTS

HIV rapid test

(n=499)

CD4 count (n=160)

CD4 percent (n=104)

ALT (n=246)

Hemoglobin (n=489)

CBC (n=259)

0

20

40

60

80

100 91

6168

7380

76

47

26

34

24

38

20

Ever Last 12 month

% o

f sta

ff

STAFF RECEIVING TRAINING FOR HIV RELATED TESTS BY COUNTRY

0

20

40

60

80

100

91

100 100 10096

86

71

5552

60

97 95

61

78

57

34

23

31

73

96100

73

96

53

3642

33

80

100 100 10096

67

25

1420

Rapid test CD4 ALT Hemoglobin

% o

f st

aff

STAFF RECEIVING KEY LABORATORY SKILLS TRAINING (n=520)

QA/QC Inventory/supply management

Data management Biosafety0%

20%

40%

60%

80%

63

55

49 48

4035

28

39

Onsite

% o

f st

aff

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

TRACKING OF SPECIMENS AND TEST RESULTS BY COUNTRY

0

20

40

60

80

100

30

41

13

50

63

15

81

0

88 91

100 97 100

88

100

25

100

paper documentation

% o

f la

bora

tori

es

APPROACHES TO TRANSFER TEST RESULTS TO PATIENT CLINICAL RECORDS BY COUNTRY

All cou

ntries

(n=

520)

Tanza

nia (

n=11

2)

Mozam

bique

(n=

53)

Ethiop

ia (

n=80

)

DR Con

go

(n=6)

Kenya

(n=

174)

Nigeria

(n=

32)

Cote d'

Ivoire

(n=

16)

Rwanda

(n=

47)

0

20

40

60

80

100

52

9887

7450

29

0 0 0

24

12

0

1746

59 5032

17

0 11

4 1716 41

4468

4 1 0 6 17 8 0 6 0

Patient retrieves result from labsData capurer from clinic retrieves result from labsLab technician brings resutls to the clinicData capturer from labs transcribes results into patient clinical recordsOther

% o

f la

bora

tori

es

POWER OUTAGE FREQUENCY (n=520)

Daily Weekly Monthly Yearly Less frequently0

20

40

60

80

100

% o

f la

bora

tori

es

BACKUP GENERATOR AVAILABILITY BY POWER

OUTAGE FREQUENCY

Daily (n=177) Weekly (n=149) Monthly (n=143) Yearly (n=12)0

10

20

30

40

50

36

32

16

0

% o

f la

bora

tori

es

LABORATORIES HAVING AT LEAST MONTHLY POWER OUTAGES BY COUNTRY

0

20

40

60

80

10090

100 99 98 96

8374 71

50

% o

f la

bora

tori

es

BACKUP GENERATOR AVAILABILITY AMONG LABORATORIES HAVING POWER OUTAGE AT LEAST MONTHLY BY COUNTRY

0

20

40

60

80

100 90100 99 98 96

8374 71

50

29

97

11

39

13

60

10

74

25

Have power outage at least monthlyHave generator among labs having power outage at least monthly

% o

f la

bora

tori

es

AVERAGE NUMBER OF SUPPLY SHORTAGES IN YEAR BY COUNTRY

0

1

2

3

4

5

6

7

4.7

6.4 6.2

5.35

3.73.3

1.8 1.7

Ave

rage

SUPPLY SHORTAGES BY KEY COMMODITY AND FREQUENCY (n=519)

HIV test kits

Reagents Controls Calibrators Specimen collection materials

Biosafety materials

0

20

40

60

80

100

2432

5674

63 6635

34

25

2026 25

16

2311

27 5

19

8 5 2 3 26 2 2 2 2 1

0 1 2 3 >3

% o

f la

bora

tori

es

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

AVAILABILITY OF BIOSAFETY EQUIPMENT (n=521)

Hand w

ash s

tation

Autoc

lave

Fire ex

tingu

isher

Biosafe

ty ca

binet

Shower

Eye w

ash

0

10

20

30

40

50

60

70

80

90

100 95

32

2115 13 11%

of

labo

rato

ries

AVAILABILITY OF KEY BIOSAFETY EQUIPMENT BY COUNTRY

0

10

20

30

40

50

60

70

80

90

10094

34

12 118 10

19

0

34 33

14

6 4 40 0

72

33

51

69

4

19

33

Fire Extinguisher Biosafety Cabinet Autoclave

% o

f la

bora

tori

es

HAZARDOUS WASTE DISPOSAL METHODS BY COUNTRY

0

20

40

60

80

100 96100 99 100 99 100

9488

83

74

100 98

88 90

36 36

54

0

Sharps Container Biohazard bag

% o

f la

bora

tori

es

HAZARDOUS WASTE INCINERATION METHOD BY COUNTRY

0

20

40

60

80

100

81

100 100

67

98 95 91

64

1317

0 0

31

2.5 3

26

87

2 0 0 1.1 2.3 2.56.3

9.4

0.0

Incinerator at facility Burned & buried Waste is disposed out of facility

% o

f lab

orat

orie

s

AVAILABILITY OF PERSONAL PROTECTIVE EQUIPMENT (n=521)

Lab coat Gloves Detergents/ antiseptics

Protective glasses

Respirator0

20

40

60

80

100100 99 97

20

7.7

% o

f la

bora

tori

es

OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety

• Summary• Implications

SUMMARY • ICAP supports a wide range of services and

capacity building activities in the countries where we work

• ICAP’s laboratory support contributes to overall health system strengthening through co-location and shared usage of equipment with non-HIV programs

• Routine QA/QC is conducted in most laboratories, however further efforts are required around routine internal and external proficiency testing and sample validation

SUMMARY (CON’T)• Training on HIV Rapid test procedures was

common, however several countries experience limited training on key HIV-related tests among laboratory staff

• Lack of back up generators and frequent shortages of key commodities compromise laboratory services in most ICAP supported laboratories

• Most countries have appropriate biohazard disposal methods available, however key biosafety and personal protective equipment are lacking at many laboratories

IMPLICATIONS• Aggregate findings from Laboratory PFaCTS should

be used to identify and address country level technical support area needs such as QA/QC, human resources and infrastructure

• Facility specific data should also be reviewed to ensure appropriate targeted technical assistance is provided to facilities

• Routine collection of Laboratory PFaCTS data is needed to allow for more rigorous monitoring and strategic planning towards building capacity of ICAP supported laboratories

• Laboratory PFaCTS results should be combined with routinely collected clinical indicators to examine impacts of laboratory capacity on patient outcomes (eg, completion of CD4 testing at baseline and follow-up)

COMING SOON…• PFaCTS Data Collection

– Combined surveys • Care and Treatment - Round 7• Laboratory - Round 2

– August 2012

• Final Laboratory PFaCTS Report• https://www.socialtext.net/icap_data_dissemination/Laboratory%

20PFaCTS%20July%202011

• URS2.0– Facility level and other user defined reports– https://urs2.mericap.columbia.edu/

ACKNOWLEDGEMENTS• Country Laboratory and M&E

Advisors• Amilcar Tanuri, Luis Felipe

Gonzalez, Stephania Koblavi• Abby Hahn, Yingfeng Wu, SI

Specialists

THANK YOU