MAKERERE UNIVERSITY

REDUCING CONTAMINATED RESULTS OF LOWENSTEIN JENSEN

CULTURE METHOD AT THE NATIONAL TUBERCULOSIS

REFERENCE LABORATORY

CDC FELLOWS:

NSUBUGA RICHARD (BBLT Hons)

KASULE GEORGE WILLIAM (BBLT Hons)

SUPERVISORS:

MUSISI KENNETH – NATIONAL TB REFERENCE LABORATORY

ERIC IKOONA – MINISTRY OF HEALTH

MEDIUM TERM FELLOWSHIP

CONTINUOUS QUALITY IMPROVEMENT 2013

NOVEMBER 2013

i

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................................................ i

DECLARATION PAGE ............................................................................................................ ii

FELLOW’S ROLE IN PROJECT IMPLEMENTATION .......................................................... iii

ACKNOWLEDGEMENTS....................................................................................................... iv

ACRONYMS AND ABBREVIATIONS ....................................................................................v

ABSTRACT/ SUMMARY ....................................................................................................... vi

1.0 INTRODUCTION AND BACKGROUND ......................................................................1

1.1 Introduction ..................................................................................................................1

1.2 Background ...................................................................................................................1

2.0 LITERATURE REVIEW .................................................................................................2

3.0 Statement of the problem ..................................................................................................2

3.1 Problem statement .........................................................................................................3

3.2 Improvement target .......................................................................................................3

3.3 Justification/Rationale ...................................................................................................4

3.4 PROJECT OBJECTIVES..............................................................................................4

3.4.1 General Objectives ....................................................................................................4

3.4.2 Specific Objectives ....................................................................................................4

4.0 METHODOLOGY ...........................................................................................................5

4.1 Problem analysis ...........................................................................................................7

4.2 Activities implemented ............................................................................................... 10

5.0 PROJECT OUTCOMES ..................................................................................................... 11

6.0 LESSONS LEARNT ...................................................................................................... 15

7.0 CHALLENGES EXPERIENCED .................................................................................. 16

8.0 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS ..................................... 16

8.1 Conclusions ................................................................................................................ 16

8.2 Recommendations ....................................................................................................... 16

8.3 Dissemination plan ...................................................................................................... 17

8.4 Standardization ........................................................................................................... 17

9.0 FUTURE PLANS ........................................................................................................... 17

REFERENCES ......................................................................................................................... 18

ANNEX A Budget ..................................................................................................................... 19

ANNEX B. SOP........................................................................................................................ 22

ii

DECLARATION PAGE

We, Kasule George William and Nsubuga Richard do hereby declare that this end-of-project

report entitled reducing contaminated results of Lowenstein Jensen culture method at the

National Tuberculosis Reference Laboratory has been prepared and submitted in fulfillment

of the requirements of the Medium-term Fellowship Program at Makerere University School of

Public Health and has not been submitted for any academic or non-academic qualifications.

Signed ………………………………… Date…………………………………..

Kasule George William, Medium-term Fellow

Signed ………………………………… Date…………………………………….

Nsubuga Richard, Medium-term Fellow

Signed ………………………………… Date…………………………………..

Musisi Kenneth, Institutional Supervisor

Laboratory Manager

National TB Refrence Laboratory-Uganda

Signed ………………………………… Date…………………………………..

Dr. Ikoona Eric, Academic Supervisor

Ministry of Health

iii

FELLOW’S ROLE IN PROJECT IMPLEMENTATION

The two CDC fellows were part of this project from initiation, through proposal writing,

implementation and making the final report. The fellows were responsible for spearheading the

formation of a CQI team at NTRL. Together with the CQI team, they identified the problem and

analysed it to come with the root causes. They later implemented the practical methods of the

improvement project.

iv

ACKNOWLEDGEMENTS

We would like to first to thank the Lord Almighty who has given us the chance to be part of the

2012 medium term short term fellowship and guided us through the whole period of the

fellowship.

Our sincere thanks also go to goes to our supervisors, Mr. Musisi Kenneth, the Institutional

supervisor, and Dr. Eric Ikoona, the Academic supervisor for their guidance and advice on the

CQI project implementation, proposal and report writing.

We acknowledge the contribution of the CQI team at NTRL for their sparing their time to be part

of this project, their advice and practical contribution especially during the implementation of the

CQI project is greatly noted. Therefore, we acknowledge the contributions of Kenneth Musisi,

Mbeiza Phiona, Nansubuga Christine, Matovu John, Byabajungu Henry and Sam Eyanu

We also acknowledge the Makerere University School of Public Health-CDC (MakSPH-CDC)

Fellowship program for giving us this opportunity to be part of this medium term fellowship and

sponsoring this project. Our sincere thanks go to the coordinators of the fellowship program; Mr.

Joseph Matovu, Stella and Faridah.

v

ACRONYMS AND ABBREVIATIONS

CDC – Centre for Disease Control

CQI – Continous Quality Improvement

EQA – External Quality Assessment

LJ - Lowenstein Jensen

NaoH – Sodium Hydroxide

NTRL – National TB Reference Laboratory

QC – Quality Control

SOP – Standard Operating Procedure

TB - Tuberculosis

WHO – World Health Organization

vi

ABSTRACT/ SUMMARY

Issue: The acceptable contamination rate of cultures at the National TB Reference Laboratory

(NTRL) for baseline samples is 2–5%. The NTRL contamination rate of baseline samples is

within the acceptable range but that of follow up samples (which is unkown and therefore CQI

used that of baseline sample as a standard reference for improvement) is high which makes the

general contamination high. The average general contamination rate at NTRL was 10.5% (Sept

2012 -Feb 2013). This high rate led to delay of patient results and in return delay to start

treatment. The root causes identified were; few days of quality control (QC), gaps in SOPs,

deviation from SOPs , poor planning and stock management. Therefore a CQI team planned to

work upon the causes in order to reduce the contamination from 10.5% to 6% in 6 months

(March 2013-Aug 2013).

Intervention description: All the personnel at NTRL were trained in how to plan their

laboratory work. They were mentored on how to manage media stock. Meetings were organized

to discuss the contamination progress. We reviewed the media preparation SOP. The

decontamination SOP was also changed and now they start with mucoid samples. Provided

evidence of deviation from sample processing SOP and mentored staff. Data was collected per

month and analyzed using excel

Intervention out comes: There is now proper planning of work through use of stock cards and

preparation of buffer media to be used after passing quality control checks of 3 weeks. SOPs

reviewed. No more harsh decontamination.

Lessons learnt: We learnt that, proper planning of work, high sterility procedures in media

preparation, careful decontamination of mucoid sputum and good use of reagents reduce

contaminated results at the NTRL.

Recommendation: Developed SOPs should always be strictly followed to reduce

contamination. Only quality control (QC) passed media should be used. Work should always be

planned. NTRL should buy an automatic dispenser.

Conclusion

The average contamination rate reduced to from 10.5% to 8.2%.

1

1.0 INTRODUCTION AND BACKGROUND

1.1 Introduction

The mission of the Uganda National TB Reference Laboratory (NTRL) is “To provide quality

laboratory services and to strengthen the national tuberculosis laboratory diagnostic network

through leadership and expert guidance in support of the National Tuberculosis and Leprosy

Control Program to reduce the burden of TB and leprosy in Uganda.One of the objectives of the

National Tuberculosis Reference Laboratory is to provide laboratory diagnosis of pulmonary and

extra pulmonary tuberculosis disease conditions by performing smear microscopy of stained

suspect specimens and culture in order to harvest TB organisms.

Culturing of Acid Fast Bacilli at NTRL involves decontamination and growing the organisms on

artificial sterilized egg rich media called Lowenstein Jensen media. Despite the fact that sputum

is decontaminated and organisms are cultured on sterilized media, there was still a very high

average general contamination rate in the last 6 months (10.5%) This led to delay of patient

results since the samples were re-decontaminated leading to delayed treatment, continuous TB

transmission by the patient to others, wastage of resources and finally death of some patients.

Therefore a problem analysis was done and interventions identified. These will be implemented

in the next six months using Plan-Do-Check continuous quality improvement method.

1.2 Background

According to the World Health Organization (WHO) standards, the contamination rate for the

National TB Laboratories should be between 2-5% for baselines but it does not specify that of

follow up samples. The Uganda NTRL SOP also recommends a contamination rate of 2-5% of

baseline samples, but that of follow up samples is high and majorly contributes to the general

contamination rate. The general contamination rate and that of follow up samples is unknown.

Therefore, the CQI team used the baseline contamination rate as our standard rate for

improvement. The average general contamination rate was 10.5% for the last 6 month. There is

therefore an urgent need to understand the reasons behind this dismal performance so that

strategies to reduce the contamination rate to 6% are instituted.

2

2.0 LITERATURE REVIEW

Tuberculosis (TB), caused by bacteria of the Mycobacterium tuberculosis complex (MTBC),

remains a global threat to human health, which causes an estimated 2 million deaths annually

(WHO, 2007). For clinical management of TB, the length of anti-TB therapy (six months of

directly observed therapy) has negative implications for patient adherence, which in turn puts

pressure on health-care systems in developing countries. Globally more than 1.3 million people

die of the disease every year. Nearly one third of the world’s population is infected with TB

bacilli, approximately 10% of them have a life time risk of developing TB disease (TB India,

2010). The incidence of tuberculosis (TB) in Uganda was 179 per 100,000 people in 2012

(WHO, 2012). Like most of sub-Saharan Africa, Uganda has a high prevalence of HIV

(Mbulaiteye et al, 2002) and tuberculosis infection (Migliori et al, 1994). Health care managers

and tuberculosis control authorities in the country believe that the prevalence of the disease is

much higher than revealed by notification figures because of underreporting and due to poor

access to health care. Uganda also has one of the lowest TB cure rates (32%) and high drug

default rate (WHO, 2009), which may lead to an increase in drug resistance mutations.

M. tuberculosis culture is still the cornerstone on which definitive diagnosis of TB relies. Egg-

based Lowenstein-Jensen media has been used for cultivation of mycobacteria for several

decades. Contamination rates <2% indicates overly harsh decontamination, which means that too

many tubercle bacilli are killed. If the laboratory is experiencing delays in delivery of specimens

the contamination rate may be greater than 5% (Revised National TB Control Programme

manual, 2009). After inspissation, the whole media batch of the media bottles should be

incubated at 35o C-37

0C for 24 hours as a check for bacterial sterility. After 24 hours 5% of the

slopes should picked up randomly and continued for incubation for 14 days to check for fungal

sterility. In both the cases the contamination rate should not be > 10 % (Revised National TB

Control Programme manual, 2009).

3.0 Statement of the problem

The policy guidelines of NTRL and Standard Operating procedure (SOP) of LJ Culture

diagnostic method at NTRL states that the contamination rate of baseline samples should be 2-

5%. But, that of follow up is unknown (so the CQI team used that of baseline samples as the

standard for improvement) and yet contributes more to the general contamination rate at NTRL.

3

Data from the Data team at NTRL showed that the average contamination rate for the last six

months of 2013 has been 10.5%.

A high contamination rate effects patients directly in the following ways; one patients delay to

get results and hence starting treatment in case of a positive patient (any positive patient whose is

not treatment infects about 15 people annually) and secondly to the institution through wastage

of resources .

Figure 1: The graph below shows the contamination rate of LJ culture method at NTRL (Sept 2012 –

Feb 2013)

3.1 Problem statement

For the last 6 months (September 2012 – February 2013), the average contamination rate of LJ

TB culture method at the National TB Reference Laboratory was 10.5% which is above the

standard rate of 5% hence leading to delayed patient results and in return delay to start TB

treatment

3.2 Improvement target

To reduce the general contamination rate of LJ culture method from 10.5 to 6% (average) in 6

months (March – August 2013).

Average contamination rate

4

Figure 2: The graph shows the improvement target

3.3 Justification/Rationale

The LJ method is one of the traditional phenotypic methods used in diagnosis of TB. It is used to

confirm TB disease following microscopy results and monitoring TB treatment outcome of

patients. A positive result of LJ takes 2-8 weeks, negative results is 8 weeks and contaminated

results as early as 2 days. A contaminated result requires one to re-decontaminate the sample

which means that patient’s results and treatment are delayed and furthermore wastage of

resources like reagents.

3.4 PROJECT OBJECTIVES

3.4.1 General Objectives

To reduce the contamination rate of LJ culture at NTRL from 10.5% to 6% on average from

March – August 2013) in order to improve the quality of patient care.

3.4.2 Specific Objectives

1. To analyse the current performance levels in order to understand the reasons for

suboptimal performance

2. To improve media preparation procedure and quality control

3. To improve the decontamination procedure.

4. To improve the inventory management of media preparation and use at NTRL

Current average

contamination rate

Improvement target

5

4.0 METHODOLOGY

A continuous quality improvement (CQI) presentation was done to introduce the whole NTRL

staff to the fellowship program and solicit members to join the NTRL CQI team. All meetings

were held at the NTRL training room and the selected CQI team met afterwards to carryout

problem identification and analysis. Problem analysis was done using the root cause analysis

strategy. A Plan –Do- Check –Act (PDCA) methodology was used to implement the

interventions every after 2 months.

Team members

This team comprised of Kasule George William (CDC Fellow), Nsubuga Richard (CDC Fellow),

Kenneth Musisi (Laboratory Manager), Byabajungu Henry (Laboratory Supervisor), Nansubuga

Chrsitine (Quality Manager), Eyanu Sam (NTRL Quality team), Matovu John Baptist

(Laboratory Technologist) and Mbeiza Fiona (Administrative Assistant).

The CQI team brainstormed on various quality improvement projects and voted on one that CDC

fellow would handle for their study project. Below is the list of quality improvement projects

identified during the meeting and a theme number coded to each for multi voting purposes.

Table 1: Quality improvement projects

Quality Improvement Project Theme No

Delay to complete action points from audits 1

Reducing the contamination rate of LJ culture 2

Increased number of incomplete patient request forms 3

All Customer complaints are not captured and few are resolved 4

Irregular performance of Fluorescent microscopy by EQA sites 5

Insufficient knowledge of root cause analysis 6

After coming up with the list of proposed quality improvement projects, each member was

requested to explain why a particular theme was a problem and to make it more clear to all the

members before the voting session.

6

Below is a table showing the multi voting of the NTRL CQI team which identified reducing the

contamination rate of LJ Culture method as the quality improvement project of the CDC CQI

fellows.

Table 2: Showing voting of identified problems

Theme code 1st Vote 2

nd Vote 3

rd Vote

1 3

2 6 5 5

3 3

4 4 1

5 4 3

6 4 2

7

1

Do not start with thick samples

4.1 Problem analysis

LJ

contamination

rate above the

acceptable 5%

Management

Media

Environment

Personnel

Process

Unsterile media

Insufficient sterilization and cleaning

No process plan (lack inventory

management skills)

Non-sterile media preparation process

Manual media dispensing

Chemical contamination

Insuficient decontamination

Insufficient QC of media

SOP states 2 days

Insufficient supervision of surbodinates

Lack training of

inventory management

Harsh decontamination

Media used before passing QC

Media not enough

Lack of supervision skills

Lack of capacity building

within NTRL Lack of appraisals

Deviate from SOP

Lack of planning skills

SOP not address

starting with them.

Not tested in local setting

SOP lacked the

manual media

procedure and sorting.

Poor stock

management

Poor planning of Work

No training in

planning

Figure 3: Problem analysis; Fish born analysis

Deviation from the

Processing SOP

Not trained in

management.

8

Flowchart showing media preparation process at NTRL

with possible bottlenecks

Flowchart showing specimen reception and processing at

NTRL with possible bottlenecks

Figure 3: Flowchart showing specimen reception and processing at

NTRL Figure 4: Flowchart showing media preparation process

9

Figure 5: Countermeasure matrix

LJ

contamination rate

above the

acceptabl

e of 5%

Gaps in media

preparation and

sample

processing SOPs

Days of media

QC not tested

in local setting

Tested QC days

in NTRL setting

Problem Root cause Countermeasure Practical methods used

Incubated media for 2 days and 3 weeks

Incorporated;

- manual media dispensing procedures,

- Sorting media at 3 stages

- 3 weeks of QC

- Hired trainers

-Trained 30 staff on planning, delegation,

coordination and team work

Poor planning

and stock

management

skills - Stock cards introduced

- Minimum stocks determined

- Prepared buffer media stocks

Process thick (mucoid) samples first

Reviewed SOP

Leadership and

management

training

Deviation from

sample

processing SOP

CQI team

provided

evidence based

information

Demonstrated effects of harsh processing

procedure

Mentored personnel

on inventory

management

10

4.2 Activities implemented

Through the above CQI story, the baseline performance and root causes for sub-optimal

performance identified.

To improve media preparation and quality control ,the following were done

(i) Tested the sterility check in our local NTRL setting by incubating the media for two days

and three weeks and observed the contamination rates before media was used.

(ii) Media preparation SOP was also reviewed and incorporated manual dispensing

procedure and a three stage sorting mechanism; during sterility check ( after 2 days), after

viability check(after 3 weeks) , and before inoculation. A three week quality control

procedure was also incorporated in the SOP(Since it had been proved to be working in

our local setting)

To improve the decontamination procedure, the following activities were done

(i) The decontamination SOP was adjusted to start with thick samples (since most of the

contaminated samples were thick).

(ii) Furthermore we met the processing team and discussed the effects of harsh

decontamination (a cause of chemical contamination). They were also advised to read

the labels on reagents before making a digestion mixture and decontaminating for

strictly 20 minutes in order to prevent harsh decontamination

(iii)The process was also supervised

To improve inventory management of media preparation and use the following were done

(i) The fellows with personnel in the media preparation section prepared media buffer

stocks. This was done to ensure that there is enough media to be used and give ample

time to the other to pass QC before being used.

(ii) Stock cards were used to monitor the media inventory

(iii) A Leadership and management training course was conducted for all staff at NTRL by

ACLAIM Africa. This focused on leadership and management, team building and

dynamics, communication and delegation were NTRL staff obtained various skills

including proper planning of their work.

11

Fig:Management training for NTRL staff

(iv) The fellows worked with personnel using media and showed them how to fill in the stock

cards on a daily basis or whenever it was used. The documentation on the stock cards

included media lost due to contamination before it was used.

5.0 PROJECT OUTCOMES

5.1 Established major root causes of contamination

The problem of high general contamination rate is has been persistent at NTRL and its causes

have been suggestions and assumptions. This project brainstormed and also produced evidence

based information to the probable major causes of contamination (see root cause analysis above).

And from this major emphasis has now been put in place and SOP revised to this effect.

The project identified that the major causes were; use of media before passing internal QC (since

the sterility check had not been tested in our local setting), un revised media preparation and

decontamination SOPs, deviation the decontamination SOPs, poor planning skills and inventory

management.

12

The sterility check (media QC) was tested in our local setting.

We found that the contamination of of media before use in two days was less than 1 % yet that

after 3 weeks was higher than 5%(from the table below).It was also observed that some of the

spotted media turned contaminated after 3 weeks.

Table 3. Showing the trend of contamination rates of different media batches before use

after three weeks of incubation.

TOTAL

NUMBEROF

SLANTS MADE

PER BATCH

CONTAMINATION

OF SLANTS

AFTER THREE

WEEKS

FATE OF SPOTTED MEDIA SLANTS

AFTER THREE WEKS

CONT

RATE

OF MEDIA

BEFORE

USE

BATC

H NO.

TOTAL

NO.

SLANT

S

MADE

INITIAL

NO.CON

T

CONT

RATE(%

)

NO. OF

SPOTED

SLANTS

NO.

TURNED

CONT

CONT

RATE FOR

SPOTED

SLANTS

GENENERA

L SLANT

CONT

RATE(%)

48 1310 226 17.3 116 56 48 21.5

49 1320 75 5.7 528 142 27 16.4

50 1320 83 6.3 125 33 26 8.7

51 1320 100 7.5 48 12 25. 8.4

This implied that the sterility check of 2 days was insufficient for the media quality control since

there is a high contamination rate after 3 weeks. The decreasing trend in red was due to our

interventions ie revising media preparation SOPs.

5.2 Revision of SOPs

The SOPs of plain LJ media preparation and sample processing have been revised. The Plain LJ

media preparation SOP now reflects the need of Internal QC being done for three weeks before it

is used; this is to allow slow contaminants to appear so that they are sorted out. In addition, the

sample processing SOP reflects the need of starting with mucoid samples when processing.

13

5.3 Adherence to SOP

The decontamination team has adhered to the decontamination SOP. They use the right reagents

and decontaminate in strictly 20 minutes. Harsh decontamination has reduced

5.4 Documentation of stock cards

The use of stock cards has been adopted in the media preparation and sample processing

sections. Through these stock cards, the use of media is monitored so that more is prepared when

it reached the minimum stock which allows media to pass QC before use.

5.5 Laboratory personnel trained

All laboratory personnel were trained in proper planning of laboratory work

5.6 Reduction of average contamination rate

The average general contamination rate for the period of September 2012 to February 2013 was

10.5%. With the intervention of the CQI fellows, this has reduced 7.2% from March 2013-

August 2013.

Average general contamination rate before the interventions

Acceptable average cont rate

Baseline

contamination

rate rate

Improvement target

14

Fig. Average contamination after the interventions (Mar-Aug)

The average contamination rate reduced to 8.2%. the contamination rate in June 2013 increased

beyond compared to rest of the months. During the CQI project, it was discovered that it was due

to harsh processing (redecontamation) procedure in the sample processing section. Due to this,

the inoculated media appeared whitish and therefore interpreted as contaminated yet in the real

sense they were not. More so, was due to use hands to dispense media since the automatic

dispenser had broken down(manual dispensing) yet the SOP had not been revised.

The CQI team held meetings with the processing section and advised them about the effect of the

harsh processing procedure. We also revised the media preparation SOP to cater for manual

dispensing. With this, the contamination rate reduced in the subsequent months of July and

August.

Acceptable cont rate (2-5%)

Previous Average cont rate –

10.5% (Sep 2012 – Feb

2013) Current Average cont rate

– 8.2% (Mar 2013 – Aug

2013)

Acceptable average cont rate range

Contamination rate

before intervention

Improvement target

15

6.0 LESSONS LEARNT

We learnt the following lessons

The major causes of contamination at NTRL were; use of media before passing internal

QC (since the sterility check had not been tested in our local setting), un-revised media

preparation and decontamination SOPs, deviation the decontamination SOPs, poor

planning skills and inventory management.

Incubating media for three weeks enables all organisms on the contaminated slants to

grow and therefore easily sorted out which later reduces rate of contaminated results

Revision of the media preparation SOP to include the manual/hand dispensing procedure

and various sorting stages enables one to obtain sterilize slants for inoculation hence

reduced contaminated results.

Revision of SOP to start with thick samples and break the mucous thoroughly reduces

contamination.

Adherence to the decontamination SOP by using right reagents, right concentrations and

processing for strictly 20 minutes reduces chemical contamination since there is no harsh

decontamination.

Training personnel in management improves planning, delegation and team work skills

hence the amount of media to be prepared and the dates are planned hence media gets

enough time for quality control. More-so the lab does not run out of quality controlled

media since there is proper delegation of work and team work and there for only sterile

media used hence reduced rate of contaminated results.

Proper inventory/stock management using stock cards leads to good monitoring of media

stocks hence more is prepared when the minimum stock is reached which allows media

to pass QC before use and finally reduced result contamination rates.

16

7.0 CHALLENGES EXPERIENCED

The major challenge faced was the personnel were not consistent in implementing it the

interventions identified. There was a major challenge of not implementing the SOP by

everyone in the laboratory.

The below shows the other challenges faced and solutions implemented.

Challenges Solutions

(i) Nonfunctional Automatic dispenser

(ii) Contamination increased in June due to

harsh decontamination i.e. excessive use of

NaOH solution

(iii) One autoclave functional for both

infectious waste and media utensils

(i)-Hand dispensing done, SOP revised,

- prepared many batches, flow chart

desighned

(ii) - Held a meeting to discovered root

cause (i.e. use of excessive NaOH)

(iii) Discussed with team in processing

section; reconstitute digestion mixture

according the SOP.

(iv) autoclaving infectious and non-

infectious them separately

8.0 SUMMARY, CONCLUSIONS AND RECOMMENDATIONS

8.1 Conclusions

The average contamination rate reduced from 10.5% (September 2012-Feburay 2013) to 8.2%

(March - August 2013)

8.2 Recommendations

• At the institution, we recommend that the management enforces the strict following of

the SOP put in place especially those with interventions of the CQI team.

• Continuous improvement should now focus on follow up samples

• Strict adherence to SOPs including interventions

• Procure another or repair non-functional autoclave

17

8.3 Dissemination plan

The project outcomes have been presented at the Institution (NTRL) where the whole laboratory

was present. The CQI project and its outcomes will also be disseminated at the MakSPH-CDC

Fellowship Program and other sister laboratories and institutions.

8.4 Standardization

The project interventions have been adopted into the NTRL SOPs. With subsequent days, the

interventions will be followed by all personnel in the laboratory and become daily routine. The

NTRL SOPs may be adopted by other culture laboratories in Uganda.

9.0 FUTURE PLANS

The CQI team and management of NTRL will continue with the improvement process to reach

the acceptable range. The remaining problems which were generated will also be worked upon

18

REFERENCES

Mbulaiteye S.M., C Mahe, J.A. Whitworth, et al. (2002): Declining HIV-1 Incidence and the

associated Prevalence over ten years in a rural population in south-west Uganda: A Cohort

Study, Lancet, 360:41-6

TB India (2010): RNTCP Status Report [Internet]. 2010 [cited 2010 Jun 1]. Available from:

http://tbcindia.nic.in/ pdfs/TB%20India%202010.pdf

Revised National TB Control Programme (2009): Training Manual for Mycobacterium

tuberculosis Culture & Drug susceptibility testing. Ministry of Health and Family Welfare,

Nirman Bhawan,New Delhi 110011.

19

ANNEX A Budget

CQI PROPOSAL BUDGET Activity code Activities

Unit of Measure

Units

Unit Cost (Ug. Shs)

Total (Ug.Shs) Justification

ACTIVITY 1: TRAINING STAFF IN PLANNING AND CORDINATION SKILLS (Three times)

1.1

Trainer Persons

3

800,000 x 3 2,400,000

From our root cause analysis, NTRL has major gaps in coordination, planning and inventory management. Therefore there is need of a management training which will focus at all these aspects. Training facilitation for a consultant trainer, quotation from one of the firms indicates $320 per day per trainer. Training will carried out on 3 occasions (each session last one day), every 2 months during the implementation of the CQI project

1.2

Facilitation costs

Persons

30

20,000 x 3

1,800,000

Each training session takes the one whole day hence the need to provide breakfast and Lunch to participants. 20,000 per person for Breakfast (5000=) and Lunch (15,000=) for attending participants at the institution. Rate determined by service providers usually utilized by the institution during workshops and trainings. (There will be three training sessions)

1.3

Markers

Box (10 markers each)

3 20,000

60,000

One box of markers to be used per day during the three training sessions. Price determined by external markets around Kampala

1.4 Note books books

30 2,000

60,000

Note books for participants during training sessions. Will be given out once during the first training session. Price determined by external markets around Kampala

1.5

Pens piece 30 500

15,000

Pens for participants during training sessions. Will be given out once during the first training session. Price determined by external markets around Kampala

1.6 Ream of papers ream

2 15,000

30,000

Reams of paper for printing training materials/handouts during the 3 sessions. Price determined by external markets around Kampala.

1.7 Flip charts chart

3 15,000

45,000

A flip chart will be used per training session hence three flip charts for the 3 sessions. Price determined by external markets around Kampala.

Sub Total

4,410,000

ACTIVITY 2 Improving stock taking and sterilization procedures

20

2.1

Laptop piece 1 - -

-For monitoring the stock. - Preparing presentation of CQI project progress and developing of CQI procedures. - To be provided by the institution.

2.2 Sub Total -

ACTIVITY 3: DEVELOPING A PROCEDURE FOR STERLISATION

3.1 Ream of papers ream

2 15,000

30,000 for printing and dissemination of procedures

3.2

Camera piece 1 500,000

500,000

According to our SOP, newly prepared media batch is sorted only once after incubation for 2 days at 37 0C to discard the slopes contaminated. But this only eliminates the fast growing contaminants .In practice we have observed contaminants after 2weeks.Therefore we are going to incubate media for 2weeks at 37

0C to discard more contaminated slopes before

using them. We would like to photograph all the contaminated slopes after 2weeks as evidence that there are also other slow growing contaminants which contaminate the media before samples are inoculated. This will provide a strong ground for changing our operating procedures but unfortunately we don’t have a camera at NTRL. More so this camera will be used to photo graph the current autoclaving procedures of over packing the autoclave with un sorted slopes rendering some bottles unsterile and our proposed procedures of sorting the contaminated slopes and autoclaving them separately at slightly higher temperatures. Price determined by external market around Kampala. .

Sub Total

530,000

ACTIVITY 4: Preparing culture media for the next six months

4.1

LJ Culture slants Bottles

1,000 2,000

2,000,000

NTRL reuses culture bottles for preparing media. There is need to procure more bottles to allow for enough time of recycling the used ones so that sterilization process is completed adequately. - To obtain 1000 supplementary cultures for preparing adequate media so

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that it is not used before passing QC.

Sub Total

2,000,000

ACTIVITY 5:WORKSHOP FOR DISSEMINATION OF CQI RESULTS

5.1

Facilitation costs

Persons

30 10,000

300,000

Dissemination meeting of project results and lesson learnt to the rest of the NTRL staff from 9.00 am – 12.30 pm in September or October 2013. Facilitation cost will be 10,000 per person which includes coffee/tea, snack and refreshments during the dissemination meeting.

Ream of paper Ream 1 15000 15,000

For printing handouts of CQI results and presentation to be distributed to the 30 persons attending the dissemination workshop above.

Projector

Training room at NTRL 1 - - -

For presentation of CQI results during the dissemination meeting. To be provided by the institution

Venue,

Training room at NTRL 1 - - -

For presentation of CQI results during the dissemination meeting. To be provided by the institution

5.2 Binding of report

booklet

10 10,000

100,000

Final Copies for dissemination to the School of Public Health (4 copies), NTRL institution (2 copies), CDC fellows (2 copies), to supervisors (2 copies)

Sub Total

415,000

GRAND TOTAL 7,355,000

Source of Funds

CDC MakSPH 6,250,000

NTRL 1,105,000

Total Amount 7,355,000

(NB. Exchange rate is 2500 USD)

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ANNEX B. SOP