February 2018

Session 14: Viral Load Scale-Up and Laboratory Instrument Mapping and

Optimization

Prefabs / Renovations

Instruments

DISA Lab / DISA Link

Introduce Plasma

Hire New Staff

Training / Mentorship

Sample Transport

VL Specimens

Backlog – MoH

Backlog Register

DISA - Total # of

Viral Load

Performed /

Target / Monthly

TAT for Viral

Testing - DISA LAB

Increase

Testing

Capacity to

Meet Country

VL Need

Reduce Viral

Load TAT

Inadequate

Testing

Capacity to

Meet VL

Demand

High TAT for

Viral Testing

Results

Low

Coverage

and Access

to VL Testing

Problem Strategic Objectives ApproachMonitoring / Partner

Management

Current State

4

Current Viral Load Testing Capacity

Equipment

Total Fleet

(EID/VL)

Current # Equip. for EID

Current # Equip. for VL

VL Capacity at 100% (tests/year)

VL Capacity at 70% (tests/year)

8h 12h 24h 8h 12h 24h

Abbott m2000 8 0 8 178,560 357,120 489,600 133,920 267,840 367,200

Cobas TaqMan 96 11 2.5 8.5 299,880 403,200 642,600 224,916 302,400 481,956

Biomerieux 1 0 1 26,400 36,960 63,360 19,800 27,720 47,520

Total 20 2.5 17.5 504,840 797,280 1,195,560 378,636 597,960 896,676

Daily VL Capacity 8h 12h 24h

Abbott m2000 93 186 255

Roche Cobas TaqMan 96 147 210 315

Biomerieux 110 154 264

Roche Cobas 8800 960

Annual EID Capacity

2.5 Cobas TaqMan96 EID Conventional 56,400

45 AlereQ EID POC 64,800

EID Total Capacity 121,200

5

Location of Molecular Labs, GeneXpert, and POC EID, Mozambique 2018

• 11 Molecular Labs now running• 4 more to be added this year• Adding two high throughput Roche 8800• Adding Plasma Strategy

• GeneXpert• 76 current• 96 additional planned (GF&WB)

• POC EID (Alere Q)• 45 current• 93 more planned

• 30 Zambézia (PEFPAR)• 63 Non-PEPFAR

6

Viral Load Testing, FY 17 + F18 Q1

8,9

98

14

,30

2

15

,12

0

19

,45

6

23

,50

4

22

,68

7

26

,33

6 32

,97

6

32

,08

8

28

,77

0

38

,52

7

39

,13

4 4

6,7

83

58

,07

0

52

,23

2

-

10,000

20,000

30,000

40,000

50,000

60,000

70,000

Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17

FY17 = 301,898

FY18 Q1 = 157,085

7

Need to Actively Manage Pre-Analytic & Analytic Phases

0

10

20

30

40

50

60

70

80

Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan

T1 @ HF T2 Lab to registration T3 Arrival to testing T4 Testing to results release

Average TAT for Viral Load Testing in Days(Oct 2016 – Jan 2018)

8

FY17 testing targets, results and utilization

FY17 instrument testing capacities and unutilized capacities

FY17 Target FY17 Result (%)

LMIS DISA PANORAMA

VL304,121

320,757 (105%)

190,196(62.5%)

122,581(40%)

EID 89,849106,230(118%)

NA71,176(79%)

TB 456,809349,467 (76.5%)

NA NA

Instrument CapacityUnutilized Capacity

VL 378,636 0

EID121,200 (56,400 Conv; 64,800 POC)

0

TBXpert and Microscopy Capacity:1,319,880• GeneXpert: 218,880• TB Microscopy: 1,101,000

Xpert: 109,931 (50%)

9

Integration: GeneXpert for TB & EID

• Maximizing in-country instrument platform is shared vision

• Prioritizing GeneXpert for TB testing is critical

• Anticipated growth in case finding

• Ministerial stakeholder engagement to address multiplexing

• Immediate plans to conduct forecasting of TB needs and available instrument capacity

• Quantification will inform implementation guidelines on multiplexing EID and other tests

10

Specimen Referral Network

Referral network varies by partner and geography.

Standardizing the specimen referral system• Network Optimization regardless of political boundary• Learning from the Zambézia Sample Referral Program• Expanded DISA and technology for data capture• Monitoring and Evaluation Framework

11

77499

24942

151444823

32%

61%

32%

0%

10%

20%

30%

40%

50%

60%

70%

0

10000

20000

30000

40000

50000

60000

70000

80000

90000

Patients eligiblefor VL

VL samples sent VL resultsreturned

Tests VL>1000

Viral Load Results Reporting, FY17, Q4

*Data available from Inhambane, Maputo City, Nampula and Zambezia; Phase 1 and 2 Test and Start districts only ; sites > 1,000 ART patients

12

LIS Deployment – Current DISA Network

• 12 DISA sites nationwide

• 56 DISALink sites

13

LIS Deployment – FY18 DISA Network

• 16 DISA sites nationwide

• 96 additional DISALink sites • Total 152

Improved monitoring of TAT

Faster return of results

15

VL Capacity and Targets

• FY 18• 11 Laboratories• 70 % of eligible receiving VL• Labs operating 8h/day

16

VL Capacity and Targets

• FY 18• 14 Laboratories• 90 % of eligible receiving VL• Labs operating 12h/day

17

VL Capacity and Targets

• FY 19• 14 Laboratories• 90 % of eligible receiving VL• Labs operating 12h/day

18

VL Capacity and Targets

• FY 20• 14 Laboratories• 90 % of eligible receiving VL• Labs operating 12h/day

Planning for VL scale up

20

VL Forecasts

Key assumptions:

- 1 VL test per patient

- VL scale up 90% PLHIV

- Aligned with T&S expansion

- Instrument capacity/contribution & utilization rates:

Year VL Tests CD4 Tests

FY18 673,552 1,078,534

FY19 1,327,653 647,667

FY20 1,900,717 512,348

Instrument Tests/8 hours Run/day # Tests/monthWorking days

per month

Biomerieux 84 2 3,696 22

Cobas/Taqman 96 168 2 3,696 22

Cobas 8800 960 2 21,120 22

Abbott m2000 186 2 4,092 22

VL Reagent Financial Needs

FY19 FY20

Number of Tests 1,327,653 1,900,717

Funding Need $25,704,358 $36,799,307

Funding $22,000,027

Remaining Need $(3,704,331) $(36,799,307)

21

Equipment Maintenance

• Vendor strategy in place for appropriate equipment maintenance

• Routine preventive maintenance

• Roche reagent rental (64% of network and growing)

– Financial incentives for the vendor to respond quickly

• Abbott maintenance contract

– Challenges with response and repair time

• Training or refresher training for lab personnel

• Super users

• Regular review of errors and causes of breakdowns to determine root causes

• Challenges with electrical systems

22

Instrument Planning

COP18

23

Equipment Deployment Timeline Viral Load

Equipment Deployment Timeline

DEC 2016-JULY 2017: BID/TECH EVAL/APPROVAL BY

USAID WSIGNATURE RRA BY GHSC-PSM

1- HP QUELIMANE;_12- CARMELO_1

3- DREAM SOFALA_14- MACHAVA_1

5- NAMPULA_26- MACHAVA_2

7- CS EDUARDO MONDLANE_18- HOSP MILITAR_1

9- HP QUELIMANE_210- CARMELO_2

11- UEM_1

12- TETE_1 13- HP CHIMOIO_1

14- HOSPITAL MILITAR_215- INS_2

16- HP CHIMOIO_217- CARMELO_3

18- UEM_219- DREAM SOFALA_2

20- TETE_221- CS EDUARDO MONDLANE_2

22- QUELIMANE_323- DREAM SOFALA_3

24- HP QUELIMANE COBAS 880025- HP CHIMOIO_3

Equipment approved and installed in green

Equipment approved and installation ongoing in yellow

Equipment not yet approved and integration ongoing in blue

Equipment not yet approved in red

24

Infrastructure and HR Needs For COP18

Province Infrastructure Instruments Human Resources

Lab Techs Clerks

C. Delgado 1 0 0

Sofala 1 (Dream) 1 4 2

Manica 1 2 2

Gaza 1 (Xai-Xai) 1 2 2

Maputo Cidade 2 (Expand Machava) 1 (Cobas 8800) 4 2

Total 5 14 10

Way Forward: Learning from Experience

26

Addressing Laboratory Backlogs

0

10000

20000

30000

40000

50000

60000

70000

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan

2017 2018

EID Samples Tested VL Samples Tested VL Samples Backlogged

May 2017:

Site visit revealed significant backlog of samples in lab freezers

November 2017

• Minister determined backlog crisis could be handled in country

May-November 2017

• VL backlog emergency plan implemented

• Total backlog 42K

• Backlogs sent to SA

27

Viral Load Backlog Emergency Plan

Change management

Weekly VL monitoring

SOP for backup testingMoU between in-country labs to

support each other

HRH Laboratory technicians shifted, hired, trained

Introduction of block shifts; Increased # hrs

Payment of overtime & weekends

Technical assistance from experienced

mentors

Supply Chain

Accelerated installation of instruments

Comprehensive re-evaluation of infrastructure

Closer coordination on increased reagent needs to

test backlogs

28

Best Practice: Weekly VL Backlog Monitoring

0

500

1000

1500

2000

2500

3000

3500

CSU PontaGêa

Hosp Carmelo HG JoséMacamo

DreamMaputo

HC Nampula HP Xai-Xai HG Machava INS Dream Beira HG Quelimane

EID Samples Tested VL Samples Tested VL Samples Backlogged

Viral Load and EID Testing, Feb ‘18

29

Lessons Learned: Viral Load Sample Backlog

• Maximum capacity lab network 67%; 12 hours /day

• Routine monitoring with visual inspections: Bi-weekly monitoring of VL indicators

• SOPs essential for harmonized implementation

• Lab technical task shifting between in-country labs needed

• Laboratory mentorship critical to improve technical capacity

• Mapping of supply chain including auxillary equipment key to improving long term network optimization

• Expansion of DISA link to improve accountability

30

Best Practice - Lab Champions

2042

3158

5438

4929

68%1387

82%2592

70%3791

112%5521

0

1000

2000

3000

4000

5000

6000

Q2 FY17 Q3 FY17 Q4 FY17 Q1 FY18

Viral Load samples processed (DISA) Viral Load results entered in OpenMRS at the HF

Increase in number of VL results registered in patient records after introduction of Lab/clinic admin staff

31

Improved VL testing

coverage

Standardized specimen

management and referral

HRH

Lab: More technicians, extended shifts

HF: results reporting

Weekly monitoring of performance

Supply chain plan for instruments &

commodities

Plasma in high demand provinces

Increased mentorship in labsInfrastructure

32

Lab Continuous Quality Improvement

Continuous Quality

Improvement

Auditing

Mentoring

Laboratory CQIExternal quality

assessment

International accreditation

33

Summary of Concerns: Increasing demand on lab system

• Mozambique context: Ground up lab support• Test & Start scale up• Future backlogs• Tight budget of 1 test per/person• Lab site readiness• HRH gaps• Turn around times• Results reporting