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The Role of External Quality Assessments(PT) in HIV Quality Assurance��

UMLTA CPD Webinar Session 22

29th August 2024

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Silence Zuriat

Uganda Virus Research Institute

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Presentation outline

Overview of EQA (Definition, EQA approaches, Benefits of EQA, characteristics & general cycle of EQA

EQA policy requirements, stakeholder roles

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Challenges and Recommendations

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Review performance in EQA schemes in the past year (HIV, UBTS & CD4 )

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  • External quality assessment is the objective assessment of a test site’s operations and performance by an external agency or personnel

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  • Method that allows for comparison of a laboratory/point of care testing to a source outside the laboratory.

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  • The comparison may be made to the performance of a peer group of laboratories or to the performance of a reference laboratory

(ref; WHO LQMS manual)

Definition of External Quality Assessment (EQA)

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EQA Comparisons are;

  1. Independently set by reference methods ( eg: HIV EQA/PT)
  2. Set by overall consensus data ( eg; CD4/CD8)
  3. Method peer group consensus data (consensus by methods, technologies, geographical location)
  4. Set by a panel of experts- common for complex test eg: histology

( ref: ISO 15189:2022,clause 7.3.7.3 (e)

Definition of EQA (2)

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( ref: ISO 15189:2022,clause 7.3.7.3 (f)

Approaches to EQA

Approaches

Proficiency Testing

Rechecking Re-testing

On-site Evaluation

Others include:

Interlaboratory comparison programme(s)

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  • Monitoring performance of examination methods; The laboratory shall monitor its performance of examination methods by comparison with results of other laboratories (ISO 15189:2022;7.3.7.3 (a), includes POCTs.
    1. Identifies training needs
    2. Indicates areas that need improvement
    3. Requirement for certification/Accreditation
    4. Provides objective evidence of testing quality
    5. Allows comparison of performance and results among different test sites and the testers
    6. Provides early warning mechanisms for systematic problems associated with kits or operations
    7. Competence assessment for laboratory staff

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Benefits of EQA to participating labs/POCTs

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Principle characteristics of EQA

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EQA general cycle

EQA sample received

Lab analyses EQA sample

Results sent to EQA provider

EQA Provider sends report

EQA report received

EQA report reviewed

CA taken if any

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EQA Policy requirements

1. National HTS Policy

2. Guidelines for the NEQAP

3. National Certification Framework.

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      • New guideline stipulates compulsory participation in PT
      • PT highlighted as major pillar for accreditation
      • To participate in HIV testing a tester should be certified; requires participation in PT

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HIV EQA/PT Program Stakeholders

    • Oversight by the Ministry of Health, STD/AIDS Control Program, National Quality assurance Program
    • Management by UVRI
  • Panel production done at UVRI
  • Panel distribution
    • the National Specimen Transport Network at NHLDS
    • Coordinates 100 hubs

- large volume facilities across the country

  • Coordination regional/District & facility
    • For return of results & corrective action
      • Regional RRHs/managers
      • Implementing partners
      • District health teams
      • Facility leadership and Laboratory personnel

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Scale up of PT Program

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Coverage of the HIV PT Program

Facilities

(n = 3759)

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    • 5.2% Hospitals
    • 65.2% Health Centers
    • 27.2% Private Clinics
    • 2.1% Specialized ART clinics/ labs

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Testing points

(n = 13,189)

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    • 6.6% ANC/PMTCT
    • 2.5% ART Clinic
    • 0.5% HCT
    • 54.5% Labs
    • 25.9% Other POCTS

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Testers

(n = 28,342 )

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    • 34.9% Lab personnel
    • 4.8% Clinical personnel
    • 44.1% Nurse/ midwife
    • 16.3% Lay tester

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Participation in PT Program

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HIV EQA Response by Cadre

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HIV EQA Pass rate by Cadre

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HIV EQA Pass rate (Apr-Jun 24)

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HIV EQA Ungraded results (Apr-Jun 24)

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CD4 EQA Performance

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UBTS EQA Performance

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Blood bank

Region

Quarter

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Apr-Jun '23

Jul-Sept '23

Oct-Dec '23

Jan-Mar '24

Apr-Jun 24

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Responded(Yes/No)

Passed (Yes/No)

Responded(Yes/No)

Passed (Yes/No)

Responded(Yes/No)

Passed (Yes/No)

Responded(Yes/No)

Passed (Yes/No)

Responded

Passed

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West Nile

No

NA

Yes

No(Failed Hep C serology)

Yes

Yes

Yes

Yes

Yes

Yes

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Mid west

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

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Mid north

Yes(Only submitted 2 parameters)

Yes

Yes

Yes

Yes

Yes

NS

NA

Yes

Yes

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Mid north

Yes(Only submitted 2 parameters)

Yes

Yes

Yes

Yes

Yes

Yes

No(Failed Rh factor typing)

Yes

Yes

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Mid East

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

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South West

Yes

Yes

Yes

Yes

Yes

No(Failed Rh factor typing)

Yes

Yes

Yes

Yes

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Kampala

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

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Kampala

Yes

Yes

Yes

Yes

Yes

No(Failed ABO blood grouping)

Yes

No(Failed Syphilis)

Yes

Yes

6 parameters are assessed including; HIV, syphilis, Hepatitis B and Hepatitis C serology; Rh factor typing; and ABO blood grouping

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Challenges

  • Challenges
    • Unsatisfactory performance
    • Delayed corrective action
    • Enforcement actions for non-participation

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    • Suggested Remedies
    • Continuous training and onsite mentorship
    • Work with DHTs and IPs to implement corrective action
    • Compulsory participation stipulated in revised HTS Guidelines

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Key Points

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  • EQA is one of the critical elements of a laboratory quality management system- key in monitoring test methods and competence of testers

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  • Mandatory to participate in EQA/pt

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  • EQA should not be punitive. It should be viewed as educational and used as a tool to help direct improvement efforts in the laboratory

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Contacts

UVRI Toll free:

Call: 0800100410

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WhatsApp:+256784269925

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SMS: 8227

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