BUKOBA REGIONAL REFERRAL HOSPITAL LABORATORY

Document Title: Selecting and evaluating referral laboratories and consultants Procedure
Document No. PR-GM 05 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

RUBYA DESIGNATED DISTRICT

HOSPITAL LABORATORY

Selecting and evaluating referral

laboratories and consultants Procedure
(PR-GM 05)

Name Title Signature Date

Written by: Wilfrid Paschal Quality officer 16/06/2020

Rugarabamu

Reviewed by: Fulgence Donatian Laboratory Manager 18/06/2020

Ruharara

Approved by: Dr.Fr Leodigard Medical Officer In 20/06/2020

Mwesiga charge/ Laboratory
Director

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 BUKOBA REGIONAL REFERRAL HOSPITAL LABORATORY
Document Title: Selecting and evaluating referral laboratories and consultants Procedure
Document No. PR-GM 05 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

1. PURPOSE:

To provide guidance on evaluation and selection of referral laboratories and consultants for RDDH
laboratory to refer samples.

2. SCOPE:

This procedure applies to all laboratories to be evaluated and selected.

3. RESPONSIBILITY:

The Quality Officer and the Laboratory manager are responsible for evaluating and selecting referral
laboratories.

4. DEFINITIONS:

 Referral Laboratory: External laboratory to which a sample is submitted for a

supplementary or confirmatory examination procedure and report.
 Evaluation: The systematic collection and analysis of data needed to make decisions
 Selection: The act of choosing between or among a variety of options or alternatives.

5. DESCRIPTION OF ACTIVITIES

 Laboratory management shall identify the tests that need to be referred to other competent
laboratories

 The laboratory manager inform the Head of the referral Laboratory in writings the intentions to
evaluate them

 The two parts agree the date of the evaluation

 ISO 15189 Accredited laboratories shall be asked to provide current copies of their accreditation
certificates and scope of accreditation. Based on these documents laboratories shall be
approved as referral laboratories for the tests they are accredited in.

 In case the laboratory is not accredited, the following criteria shall be used to evaluate referral
laboratories:

a. A third party audit shall be conducted by the quality officer and/or sectional heads. The
audit shall focus on the technical competency aspects of ISO 15189 standards using the

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 BUKOBA REGIONAL REFERRAL HOSPITAL LABORATORY
Document Title: Selecting and evaluating referral laboratories and consultants Procedure
Document No. PR-GM 05 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

Referral Laboratory Checklists (FM 077). Those laboratories that satisfy most of the
requirements is 75% of the checklist shall be approved as referral laboratories.

b. Sending at least two samples with known target results (e.g. EQA, IQC or previously
tested samples) which the laboratories are required to test as a routine sample. Those
laboratories which their results are within the acceptable limits shall be approved as
referral laboratories

c. Evaluation of third party external audits by credible organization and reports if the
laboratory can avail them to RDDH laboratory. A good external assessment report will
make the laboratory acceptable.

 Approved laboratories shall be maintained on a register of approved referral laboratories

register (FM 008). A laboratory can only be registered after sufficient evidence of evaluation.

 A review of approved laboratories shall be conducted once in every two years to ensure their
continued fulfillment of the approval requirements.

Sending Samples and receiving of results from referral Laboratories

 The respective section head shall enter the details of all the samples identified for referral on
(FM 009) Sample Referral Log

 Samples shall be packed in the appropriate container for transportation and is sent to the
referral laboratory.
 The section head shall be responsible for making the follow-up with the referral laboratories to
ensure that results are received within the established Turn-around time by the referral
laboratory.

 When results are received, the responsible person receiving the results shall complete the
relevant row on which the original sample was entered on the Sample referral log.

 Upon receiving of HVL results from referral Laboratory, results are logged in HVL register book
(EXD/HVL register/Microbiology/001, Then results are dispatched into the envelope according to
requesting facilities. Before release of results to the spokes results are signed by TUTUME
program representative every Thursday and when they send samples to RDDH Laboratory.

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 BUKOBA REGIONAL REFERRAL HOSPITAL LABORATORY
Document Title: Selecting and evaluating referral laboratories and consultants Procedure
Document No. PR-GM 05 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

6. PROVISION OF EXAMINATION RESULTS

 RDDH laboratory takes all the responsibility for ensuring that examination results are provided
to the person making the request.

 The referral laboratory shall create the report according to the ISO 15189 requirements and this
report shall be given to the requesting clinician without alterations.

 In situations where the reports from referral laboratory do not satisfy the ISO15189
requirements, RDDH laboratory personnel involved in the test shall create the report.

 The report shall include all essential elements of the results reported by the referral laboratory
without alterations that could affect clinical interpretation.

 Any additional remarks made shall be identified in the new report by the person making the
remarks which should be initialed and then dated.

7. SUPPORTING DOCUMENTS:

 Sample Referral Log (FM 009)

 List of Approved Referral Laboratories (FM 008)
 Referral Laboratory evaluation checklist (FM 077)

8. REFERENCES

 ISO 15189: Medical laboratories — Particular requirements for quality and competence (2012)
International Organization for Standardisation.

9. RECORDS

RECORD TITLE RECORD ID CUSTODIAN/LOCATION

Sample referral log FM 009 Section heads
Register of approved laboratories FM 008 QO

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 BUKOBA REGIONAL REFERRAL HOSPITAL LABORATORY
Document Title: Selecting and evaluating referral laboratories and consultants Procedure
Document No. PR-GM 05 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

10. AMENDMENT RECORD

NAME DATE SUMMARY OF CHANGES

Idefonce Mkingule 27/12/2017 Reviewed the whole procedure to comply with ISO15189,
2012 version requirements
Wilfrid Paschal 30/07/2019 Reviewed the whole procedure to comply with ISO15189,
Rugarabamu 2012 version requirements
Wilfrid Paschal 20/06/2020 The documents prepared by quality officer, instead of
Rugarabamu safety officer, reviewed by laboratory manager instead of
quality officer and authorized by lab. director instead of
laboratory manager

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 BUKOBA REGIONAL REFERRAL HOSPITAL LABORATORY
Document Title: Selecting and evaluating referral laboratories and consultants Procedure
Document No. PR-GM 05 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

11. AGREEMENT RECORDS

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

No Name Signature Date

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