INSTITUTE OF CONTINUING EDUCATION

DIPLOMA IN MEDICAL LABORATORY TECHNOLOGY

UNIVERSITY FIRST SITTING AND SUPPLIMENTARY EXAM

DML5213- QUALITY ASSESSMENT OF LABORATORY SERVICES

DATE: 16/10/2023 TIME:

3 HOURS

INSTRUCTIONS

A. Read this paper carefully.

B. This paper consists of seven (7) printed pages
C. This paper contains five (5) sections. Section A, B, C, D and E
D. Cellular Phone and any paper works outside the exams room is
prohibited.
E. Total Marks is 100
F. Use provided booklets for answering the questions.
G. Follow all the given instructions on each section.
 Section A: Multiple choice questions (MCQ)……(20 marks)
 Section B: TRUE/FALSE questions………………(10 marks)
 Section C: Matching items questions……………..(10 marks)
 Section D: Short answer questions…………….....(30 marks)
 Section E: Long answer questions………………..(40 marks)
H. Answer all Questions.

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SECTION A: MULTIPLE CHOICE QUESTIONS.
(20 marks)

1. Choose the most correct answer in the options provided and write the
letter in the answer sheet;
i. According to dictionary quality is degree of _________
A. Excellence
B. Agreement
C. Greatness
D. Validity
E. None of these
ii. An SOP is recognized abbreviation for?
A. Standard operating procedure
B. Surgical operating parameters
C. Student of pharmacy
D. Staffing of pharmacists
E. Standard operating practices
iii. Laboratory process where occurrence may be reported or
registered, which one is not;
A. Complaints
B. Process deviations
C. Errors and accidents
D. Phlebotomy
E. Instrument problems
iv. Analytic error is of 2 types:
A. Systematic and common
B. Random and systematic
C. Random and common
D. All of the above
E. None of the above
v. Log occurrence are used to capture, except;
A. Who was involved?
B. Which will be occurred?
C. What occurred?
D. When did it occur?
E. Where in the laboratory process did the problem occur?
vi. Reasons for ordering a laboratory test:
A. Diagnosis

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 B. Monitoring
C. Screening
D. Follow up
E. All of the above
vii. Factors affecting reference ranges are, except;
A. Age
B. Physical activity
C. Pregnancy
D. Sex
E. Colour

viii. Which is not true?

A. During blood collection needle cannot be in vein more than 1
minute
B. Release the tourniquet as the last tube is filling
C. Release the tourniquet before ending draw
D. Gloves are recommended tourniquet used
E. All of the above
ix. Pretend you are working in a medical lab and you are drawing a
blood sample from a patient. What phase of the medical lab are you
performing when you are taking this sample of blood?
A. Pre-analytical
B. Analytical
C. Examination
D. Post-analytical
E. Past analytical
x. One among the quality components for laboratory operations deals
with suggestions for possible causes of errors and remedies;
A. Enrolment
B. Management
C. Participation
D. Improvement
E. Feedback
xi. All of the following are uses of on-site evaluation, except;
A. Direct observation
B. Review QC & Documentation
C. Best utilized in high-volume settings

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 D. Collect & compare data from multiple sites
E. Opportunity for mentoring and evaluation of other programs
xii. Testing Personnel Responsibility is;
A. To communicate outcomes to supervisors
B. To Assigns responsibility
C. To Report results / trends
D. To Prioritize problems and assign to a process improvement
(PI) team
E. To Conduct focused audit to ensure resolution
xiii. Choice correct sequence on steps of the EQA procedure;
A. Receiving feedback, testing, receiving samples, submitting
report
B. Testing receiving samples, submitting report, receiving
feedback
C. Submitting report, receiving samples, testing, receiving
feedback
D. Receiving feedback, receiving samples, testing, submitting
report
E. Receiving samples, testing, submitting report, receiving
feedback
xiv. Which of the following is an external client complaints method of
detecting occurrences in laboratory operations?
A. Occurrence log, face-to-face and anonymous
B. Anonymous, feedback reports and suggestion box
C. Anonymous, occurrence log and face-to-face
D. Feedback reports, suggestion box and mails
E. Suggestion box, exit interview and face to face
xv. What is the most common laboratory error?
A. Collection error
B. Technical error
C. Transcription error
D. Releasing error
E. Customer care
xvi. Corrective action circle;
A. Act, Check, Do and Plan
B. Check, Do, Act and Plan
C. Do, Act, Plan and Check
D. Plan, Do, Check and Act

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 E. Check, Act, Do and Plan
xvii. The assessment process following implementation of corrective
actions involves the following, except;
A. Observe
B. Implement
C. Monitor
D. Document
E. Give feedback)
xviii. EQA programmes features includes the following, except;
A. Every laboratory must take part in one
B. It must not involve every section of the laboratory
C. It must involve as many test methods as possible
D. Survey samples must be processed as if they were patient
samples
E. Return results as quickly as possible
xix. Occurrence management system;
A. Is any problem or event that interferes with laboratory
operations or patient care services
B. Is an action taken to eliminate the cause of a detected
nonconformity or other undesirable situation
C. Is a process for documenting and addressing problems that
occur in the laboratory
D. Is to brainstorm the problem by asking why and to keep
asking why? until the underlying issue(s)/problem(s) is/are
found
E. Take note of areas corrective actions to be taken to solve
system or people issues identified
xx. Identification of corrective actions to occurrences in laboratory
operations involves, except;
A. Use problem-solving team
B. Implement corrective actions
C. Examine effectiveness
D. Read all documents within the laboratory
E. Record all actions and findings

SECTION B: TRUE/ FALSE QUESTIONS.

(10 marks)

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2. Write TRUE (T) for correct statement and FALSE (F) for incorrect
statements on your booklet provided;
i. The problems identified during assessment become opportunities
for improvement.
ii. On-site evaluation is usually done when it is difficult to conduct
traditional proficiency testing or to use the rechecking/retesting
method.
iii. Nonconformity may not be categorized as major (complete) or minor
(partial).
iv. To prevent errors in the laboratory, individual responsibilities must
be burden.
v. Staff needs to be trained in how to conduct the procedures and, if
this training is not neglected, errors can result.
vi. Both external and internal audits yield useful information.
vii. EQA is important for improvement of the laboratory quality
management system, as it is an obstacle of laboratory performance.
viii. Obtain information from occurrence log, investigate occurrence, try
to determine how it occurred by asking “HOW” questions.
ix. External proficiency testing program usually involves only a few
specimens.
x. Feedback is the process by which a laboratory is involved in EQA by
either applying or being selected and registered

SECTION C: MATCHING ITEMS QUESTIONS.

(10 marks)
3. Match the items of column A and column B and write the letter of true
answer from Column B on your booklet provided;

COLUMN A COLUMN B

I. Certification A. Conducts evaluations

II. Accreditation B. Failure to fulfill the requirements of a
III. Regulatory body specified process, structure or service
IV. Management C. Enrolment
responsibility D. 4%
V. Laboratory E. Results negative impact on an
responsibilities organization
VI. Nonconformity F. Authoritative body gives formal
VII. Occurrence recognition
VIII. Pre-examination error G. 26%

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 IX. Post-examination error H. Medical Laboratory Scientists
X. Examination error Association of Tanzania (MeLSAT)
I. ISO 2022
J. Participate in the EQA program
K. Log occurrence
L. Process by which errors or near errors
are identified and handled
M. 39%
N. Independent body gives written
assurance
O. Participation

SECTION D: SHORT ANSWER QUESTIONS. (30

marks)

4. Mentions five (5) reports which are parts of the EQA scheme?
5. List down five (5) errors/problems may occur throughout the testing
process?
6. Draw specimen transfer form?
7. a) Define the external quality assessment (EQA)?
b) State four (4) importance of EQA?
8. Define the following terms;
a) Quality
b) Preventive action
c) Remedial action
d) Corrective action
e) Laboratory

9. a) What is monitoring?
b) Mentions the importance of monitoring?

SECTION E: LONG ANSWER QUESTIONS.

(40 marks)
10. Quality management is not new; it grew from the work of innovators
who defined quality over a span of 80 years. Quality management is as
applicable for the medical laboratory as it is for manufacturing and
industry. Describe six (6) essential elements of quality management
system? (20 marks)

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11. Write an essay focusing on;
a) Definition of laboratory workflow?
(1 marks)
b) The phases of laboratory workflow?
(5 marks)
c) Common errors on each phase of laboratory workflow?
(5 marks)
d) Preventive measures to be taken to overcome errors on each phase of
laboratory workflow?
(5 marks)
e) Consequences of laboratory error?
(4 marks)

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