Adama Public Health Research and

Referral Laboratory Center

Procedure for Service Agreement

Name Position Signature Date

Compiled by Mr. Bedada Teshome Laboratory expert 04/03/2007 E.C

Ms. Tizita Tsegaye Quality Manager 04 /03/2007 E.C

Reviewed by Haile Benti Quality Manager July 17, 2021

Approved by Mr. Daba Mulleta CEO August 9, 2021

Effective Date: August 9, 2021 Version No. 04

Document No: SSOP4.4-001 Copy No.
 Adama Public Health Research and Document No: SSOP4.4-001
Referral Laboratory Center Version No: 04
Page 2 of 7
Procedure for Service Agreements Effective Date: August 9, 2021

REVISION AND AMENDMENT

A. Annual Review of Document
Revision Review Date Reviewed by: Approved by:
No Name Signature Name Signature
04 July 16, 2021 Haile Benti Daba Mulleta

B. Version Change History/Description

Version Effective Description of Version Change Name & Signature Name & Signature of
No Date of Reviewer Approval

C. Amendment
Rev. Page Description of Amendment Amendment Effective Date Name &
No. No Date Signature of
approval
Updated to meet requirements of ISO 04 /03/2007 EC
15189:2012 04/04/2008 EC
More clarification on establishing and
review of service agreements provided
Quality assurance department changed to all 05/04/2009 E.C
section 12/3/2009 E.C
1. Name and logo of the organization changed July 17, 2021
August 9, 2021
from OPHRCBQAL to APHRRLC
2. The position ‘Laboratory director’ named as
 Adama Public Health Research and Document No: SSOP4.4-001
Referral Laboratory Center Version No: 04
Page 3 of 7
Procedure for Service Agreements Effective Date: August 9, 2021

Chief Executive Officer (CEO)

July 17, 2021 August 9, 2021

The amendment sheet at the end of the
document has omitted and the amendment of
the 2nd page of the document replaced
July 17, 2021 August 9, 2021
The document numbering System has
changed as indicated on Document control
procedure
 Adama Public Health Research and Document No: SSOP4.4-001
Referral Laboratory Center Version No: 04
Page 4 of 7
Procedure for Service Agreements Effective Date: August 9, 2021

1. Purpose

This procedure describes how service agreements are reviewed before providing laboratory
services.

2. Scope

This procedure applies to all service agreements for providing laboratory testing services at the
APHRRLC.

3. Abbreviation

APHRRLC- Adama Public Health Research and Referral Laboratory Center

4. Responsibility

It is the responsibility of the laboratory CEO to ensure effective implementation and

maintenance of this procedure.

5. Definitions

Service agreement: a scenario where one is making a request for a service and the other party is
accepting to provide it.

6. Activity description

6.1. Individual testing

1. The client submits a sample and test request form for medical laboratory services to the
APHRRLC laboratory personnel at the reception area.
2. The request is reviewed upon receipt to determine whether the APHRRLC has the
capacity and resources to proceed with testing.
3. When there is capacity and resources the sample will be accepted and processed
according to APHRRLC procedures.
 Adama Public Health Research and Document No: SSOP4.4-001
Referral Laboratory Center Version No: 04
Page 5 of 7
Procedure for Service Agreements Effective Date: August 9, 2021

4. If the APHRRLC is experiencing temporary service interruptions, the sample will be

accepted but the client will be informed that the test will be referred to a referral
laboratory.
5. If there is going to be any minor deviation to an earlier agreement, the client shall be
informed of the deviations and their effect to sample testing on the testing report.
6. If there is going to be any major change to an earlier agreement, the client shall be
informed within 24 hours of the changes and their effect to sample testing using the
quickest method of communication. The client shall instruct APHRRLC whether to
proceed with the testing process or not.
7. All communication with the client shall be recorded on the communication log (SF4.1-
005).

6.2. Large sample sizes

8. The client shall submit the service agreement protocol to the APHRRLC defining number
of samples involved, test(s) to be done, test method(s), expected result turnaround time,
method of reporting results, sample storage and duration of testing. The staff to be
involved and their roles and responsibilities shall be clearly defined and documented.
Either the organization requesting service may use its own format or SF4.4-001 can be
used to establish service agreement with APHRRLC.
9. The APHRRLC management shall review the service agreement protocol requirements
and compare them for adequacy against available resources as described on the service
agreement review form (SF4.4-001).
10. If there is need for further clarification, a meeting to discuss the protocol with the
prospective client is convened by the APHRRLC management.
11. When there is capacity and resources the samples will be accepted and processed
according to APHRRLC procedures or with minor deviations as agreed between the two
parties.
 Adama Public Health Research and Document No: SSOP4.4-001
Referral Laboratory Center Version No: 04
Page 6 of 7
Procedure for Service Agreements Effective Date: August 9, 2021

12. If the APHRRLC does not have capacity and resources, the service agreement will be
rejected. However, if it is a national public health emergency programme the samples
will be accepted and the tests will be referred to a referral laboratory.
13. If there is going to be any minor deviation to an earlier agreed contract, the client shall be
informed of the deviations and their effect to sample testing through a letter.
14. If there is going to be any major changes to an earlier agreement, the client shall be
informed within 24 hours of the changes and their effect to sample testing using
telephone. The client shall instruct APHRRLC whether to proceed with the testing
process or not.
15. All communication with the client shall be recorded on the communication form (SF 06).

7. References

• ISO 15189:2012 Medical laboratories — Particular requirements for quality and

competence.

8. Supporting documents

• Quality Policy Manual-QPM4.2-001

• Service agreement review form-SF4.4-001
• Memorandum of understanding Form-4.4-002
• Communication log-SF4.1-005
 Adama Public Health Research and Document No: SSOP4.4-001
Referral Laboratory Center Version No: 04
Page 7 of 7
Procedure for Service Agreements Effective Date: August 9, 2021

I have read, understood and agree to follow the procedure as documented:

No Name Signature Date