ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

WHO/AFRO Stepwise Laboratory Quality

Improvement Process Towards Accreditation

(SLIPTA)

ASLM 2012 Satellite Session

December 1, 2012

Cape Town, South Africa

Teferi MekonenAccreditation Officer/SLIPTA Focal Point

African Society for Laboratory Medicine

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

Guidance for the WHO/AFRO SLIPTA Implementation

� Guidelines and Policy for

implementation of WHO/AFRO

SLIPTA was finalized and approved in

July 2011 in Nairobi, Kenya.

� Has catalytic effect to enable

countries develop their national

laboratory strategic and operational

plans

� Established to bring laboratory

quality improvement process in a

stepwise manner

� Country owned program

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

WHO/AFRO SLIPTA Checklist

� WHO/AFRO SLIPTA Checklist is based on ISO 15189:2007 and CLSI Quality Management System: Approved Guideline (GP26-A4: 2011)

� Developed to monitor the progress and improvement of laboratory quality system

� Directly applicable to all laboratory settings and disciplines

� Based on 12 sections of Quality System Essentials (QSE)

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

• Commendations, challenges and recommendations

• Notes for Improvement plan

Remarks & Recommendations

Main Parts of the WHO/AFRO SLIPTA Checklist

• Scoring and summary of findings

•Review, observe, ask open-ended questions, follow specimen, IQC and PT, evaluate supporting work areas, talk to clinicians

• Space

• Personnel

• Equipment

• Supplies

• Infrastructure, etc Provides laboratory

profile

Provides an auditing method

Summary of Findings

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

Scoring

Audit Sections Score

Section 1: Documents and Records 25

Section 2: Management Reviews 17

Section 3: Organization & Personnel 20

Section 4: Client Management & Customer Service 8

Section 5: Equipment 30

Section 6: Internal Audit 10

Section 7: Purchasing & Inventory 30

Section 8: Process Control and Internal & External Quality Assessment 33

Section 9: Information Management 18

Section 10: Corrective Action 12

Section 11: Occurrence Management & Process Improvement 12

Section 12: Facilities and Safety 43

Total Score 258

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

Star Levels

No Stars

(0 – 142 pts)

< 55%

1 Star

(143 – 165 pts)

55 – 64%

2 Stars

(166 – 191 pts)

65 – 74%

3 Stars(192 – 217 pts)

75 – 84%

4 Stars

(218 – 243 pts)

85 – 94%

5 Stars

(244 – 258 pts)

≥95%

Stepwise Process

1 Star

5 Star

2 Star

3 Star

4 Star

65-74 %

75-84 %

85-94 %

≥ 95 %

0 Star

End Point

Link to

Accreditation

Body

55-64 %

Certificate of Recognition

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

SLIPTA Auditor Training

� Developed a Standardized Training Curriculum

- In collaboration with US-CDC, CLSI and Vijay Consulting

� Content includes, but not limited to:

• SLMTA and SLIPTA

• Introduction to accreditation and ISO 15189:2007 Standards

• Audit techniques

• WHO/AFRO SLIPTA Checklist

• Identification of Nonconformities (Major/Minor)

• Reporting

• Professional Ethics

� Five days Program – 3 days for lectures & 2 days on lab audit practicum

� Post training practicum of 3-5 shadowed audits

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

SLIPTA Auditor Database

Country Time Language Number of

Participants

Successfully

Completed

Collaborative

Organization

Tanzania Sept/11 English 16 12 SADCAS

Cote d’Ivoire July/12 French 16 16 CRESAC

Botswana July/12 English - 17 *

Kenya Aug/12 English - 11 * + KENAS

Tanzania Oct/12 English 17 16 ECSA-HC

Cameroon Oct/12 French 11 11 GHSS

Ethiopia Oct/12 English 17 13 CLSI

Nigeria Nov/12 English 23 21 MLSCN

South Africa Dec/12 English 20 - NHLS

Total 117 (27) ASLM Certified

* A Global Healthcare Public Foundation

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

WHO/AFRO SLIPTA Implementation

Key Message:

o WHO-AFRO communicated 47 Countries in early Oct/2012.

o Encourage, support and recognize the implementation of QMS

o Indicates that ASLM in collaboration with CDC-US will implement WHO-AFRO SLIPTA

o Requests MoHs in countries to designate a National SLIPTA Focal Point to coordinate and support the implementation in the country

Observations in October/November:

- The documents are in E-publication

- MoHs notify the nomination of SLIPTA Focal Point

- Over 250 laboratories in 20 countries have contacted for the implementation of SLIPTA

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

Number of Laboratories Applied/Enrolled and Audited

Country Applied/Enrolled Audited Time

Tanzania 4 4 2012

Kenya 4 4 2012

Mozambique 1 1 2012

Lesotho 4 � 2012

Nigeria 6 � 2012

Cameroon 4 � 2012

Ethiopia 5 � 2012

Cote d’Ivoire 4 � 2012

ASLM Vision by 2020:

� 2,500 laboratories will be enrolled for SLIPTA

� 10% (250) laboratories will be accredited by accrediting body

WHO AFRO Stepwise Laboratory Quality

Improvement Process Towards Accreditation

Certificate of Recognition

Issued to the Xxxxxxx Hospital Laboratory

Unit/Section: Xxxxxxxxxx

has been audited per the WHO AFRO SLIPTA Checklist and has met the

requirements for the following star recognition level:

Valid: 10/18 /2012 - 10/17/2014

The African Society for Laboratory Medicine accepts no liability for the

laboratory testing conducted in facilities enrolled in SLIPTA.

The laboratory has achieved a star ranking on the SLIPTA Tier of Recognition

of Laboratory Quality Management and is not a certificate of accreditation.

Tsehaynesh Messele, Ph.D.

Chief Executive Officer, ASLM

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA

• Application for SLIPTA can be sent to: SLIPTA@aslm.org

• For More Information please visit us at: www.aslm.org

• Or contact me at: tmekonen@aslm.org

Thank You!