5.1-03 SOP For Competency Assessment

Amhara Public Health Institute Dessie
Branch Regional Reference Laboratory
Standard Operating Procedure for

Competency Assessment
Compiled by : Abebe Eyasu Signature:
Approved by: Aynalem Mohammed Signature:
Effective date: December 15/ 2019 Version No. 02
Document No: APHIDBL -ALS- SOP5.1-03 Copy No. _____
Date of Discontinuation: _____________________________________

Amhara Public Health Institute Dessie Branch Regional Reference Laboratory
Title: Standard Operating Procedure for Document No: APHIDBL-ALS- SOP5.1-03
Competency Assessment Version No: 02
Section: All Laboratory Sections Page No: 1 of 6 Effective date: December 15/ 2019
A. Annual Review of Document

Reviewed by: Approved by:
Revision No. Review Date
Name Signature Name Signature
B. Version Change History/Description

Version. Effective Description of Version Change Name & Name &
No. Date Signature of Signature of
Reviewer approval
C. Amendment
Rev. Page Description of Amendment Amendment Effective Name &
No. No Date Date Signature
of approval
Authority for Issue: APHIDBL Authorized Date: November 15/2019
This is a controlled document for internal use only

1. Purpose:
To evaluate the competency of personnel and to assure that employees maintain their
competency to perform test procedures, report test results promptly and accurately and
exhibit proper skills as direct/indirect patient Care providers when applicable.
2. Scope
This procedure applies to all personnel that are working in APHIDBL.
3. Responsibility
The Laboratory director and Quality manager share the responsible of ensuring effective
implementation and maintenance of this procedure.
4. Definitions
 N/A
5. Abbreviations
 ALS All Laboratory Section
 APHIDBL Amhara Public Health Institute Dessie Branch Laboratory
 QA Quality Assurance
 SOP Standard Operating Procedure
6. Activity Description
Evaluation methods
Direct Observation
 Checklists
 Testing sample (witness)
Indirect Observations
 Review of records
 Proficiency Testing (if any)
 Blind sample analyzed (if any)
Theory/written examination
Essay/Short Answer
 Requires clear instructions
 Requires a scoring guide that includes everything expected in the answer
as well as distribution of credit.
True/False

 Construct short and easy to read statements

 Avoid double negative statements:
 Items must be 100% true or 100% false
 Responses should be circled or checked, not written •Include even
distribution of true and false items
Multiple Choice •
 Avoid negatively stated questions or statements

 Make the grammar consistent in the question and responses. •Include only
essential information in the question or statement
 Avoid absolute wording such as “always” or “never”.
 Address only one content area per item.
 When more than one response may be considered correct, the question must ask
for the best answer.
 Include words in the question that would otherwise be repeated in every response.
Materials
Sample
 Competency evaluation will be performed using at least two clinical specimens or

training materials.
 Serum, whole blood, or other clinical specimens or quality control material
appropriate for the procedure in question may be used.
 Refer to the specific written procedure in the laboratory manual.
Instruments:
 All instruments must be in working order and of the same type as used for routine
clinical determinations.
 Other necessary records
Who will evaluate?
 The APHIDBL Laboratory director will designate certain supervisory/managerial

personnel to be evaluators. The evaluator must be assessed for competency. Then they

will be responsible for assessing the competency of all other employees within the
laboratory.
Competency assessment program:

Competency evaluation must be performed according to the following schedules:
1. New personnel must demonstrate competency in performing each test procedure prior
to reporting patient results, one year later, and every year thereafter).
2. The laboratory has to perform the competency of all testing personnel before they
begin working.
3. If a new test method is added, or existing procedures substantially changed, all testing
personnel must demonstrate competency prior to the testing of clinical samples.
Procedure:
The evaluator will directly observe the entire testing procedure with special emphasis on the
following:
1. Specimen accession, handling and processing.

2. Test performance according to written protocols.
3. Appropriate QA checks must be performed and recorded.
4. Monitoring and recording of results according to written protocols.
5. Instrument maintenance and function checks are properly performed.
6. Assessment of problem solving skills by asking employees to respond orally or in
writing to simulated technical or procedural problems (perhaps in the form of case
studies) and assessing document actual employees performed problem-solving to
issues that they have handled in the laboratory within the last year.
7. Adherence to appropriate safety guidelines.
Result
Individual Competency Evaluation Worksheet
1. Make as many copies of the Individual Competency Worksheet as needed so that each
person has their own evaluation form.
2. Record the name of the individual and site location on each form.

3. The evaluator or designee will observe the person performing each clinical procedure.
4. Evaluation contains theoretical and Practical assessment.
5. The employee has to score above 80% to be scored as Satisfactory performance (PASS)
if <80% Unsatisfactory performance will be (FAIL) in each theoretical and practical
examinations.
6. In case of managing competency assessment, theoretical evaluation scores 30% and
practical evaluation scores 80%.
7. In both cases scoring 80% and above is a pass mark.
8. If an individual fails any portion of the assessment, any recommendation, corrective
action or retraining initiated must be documented.
7. Supportive Documents
S. No. Document Title Document No.
1 Orientation checklist APHIDBL-ALS- CL5.1-01
3 Competency form APHIDBL-ALS- F5.1-02
8. References:
1. Clinical Laboratory Improvement Amendments (CLIA) of 1988. Paragraph 144:
Technical Supervisor Responsibilities -- Highly Complex Laboratories.
2. Louisiana Clinical Laboratory Personnel Law -- Definitions; Licensure; Fees;
Penalties. Act. No. 396, Part 2, Section 1323, E. (2).
3. Susan E. Sharp1,* and B. Laurel Elder, July2004 .Competency Assessment in the
Clinical Microbiology Laboratory.ClinMicrobiol Rev.; 17(3): 681–694.
4. Sherry Curry, and et-al. Lsuhsc-Shereveport Laboratory Policy and information manual. May
1, 1995.

9. Declaration
I, the undersigned laboratory personnel, certify that I am conducting every steps of the
procedures incorporated in this SOP after a prior reading.
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Amhara Public Health Institute Dessie

Branch Regional Reference Laboratory

Standard Operating Procedure for

Approved by: Aynalem Mohammed Signature:

Effective date: December 15/ 2019 Version No. 02

Document No: APHIDBL -ALS- SOP5.1-03 Copy No. _____

Date of Discontinuation: _____________________________________

A. Annual Review of Document

B. Version Change History/Description

No. Date Signature of Signature of

No. No Date Date Signature

Authority for Issue: APHIDBL Authorized Date: November 15/2019

This is a controlled document for internal use only

Authority for Issue: APHIDBL Authorized Date: November 15/2019

This is a controlled document for internal use only

 Construct short and easy to read statements

 Avoid negatively stated questions or statements

 Competency evaluation will be performed using at least two clinical specimens or

 The APHIDBL Laboratory director will designate certain supervisory/managerial

Authority for Issue: APHIDBL Authorized Date: November 15/2019

This is a controlled document for internal use only

Competency assessment program:

1. Specimen accession, handling and processing.

Individual Competency Evaluation Worksheet

Authority for Issue: APHIDBL Authorized Date: November 15/2019

This is a controlled document for internal use only

3 Competency form APHIDBL-ALS- F5.1-02

Authority for Issue: APHIDBL Authorized Date: November 15/2019

This is a controlled document for internal use only

Authority for Issue: APHIDBL Authorized Date: November 15/2019

This is a controlled document for internal use only

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