MAKERERE UNIVERSITY

REDUCING TURNAROUND TIME TO RETRIEVE A FROZEN SAMPLE IN

THE MYCOBACTERIOLOGY LABORATORY, MAKERERE SCHOOL OF

BIOMEDICAL SCIENCES

BY

GERMINE NAKAYITA (Bachelor of Biomedical Laboratory Technology)

HAPPY EDWARD (Bachelor of Biomedical Laboratory Technology)

MEDIUM – TERM FELLOWS

OCTOBER 2013

i

TABLE OF CONTENTS

TABLE OF CONTENTS ................................................................................................................................................I

LIST OF FIGURES ....................................................................................................................................................... II

LIST OF TABLES......................................................................................................................................................... II

DECLARATION ..........................................................................................................................................................III

FELLOWS’ ROLE IN PROJECT IMPLEMENTATION .......................................................................................... IV

ACKNOWLEDGEMENTS ........................................................................................................................................... V

ABBREVIATIONS AND ACRONYMS ...................................................................................................................... VI

EXECUTIVE SUMMARY ........................................................................................................................................ VIII

1.0 INTRODUCTION .................................................................................................................................................... 1

1.1 STATEMENT OF THE PROBLEM AND RATIONALE ......................................................................... 2

1.2 GENERAL OBJECTIVE ................................................................................................................ 2 1.3 SPECIFIC OBJECTIVES ................................................................................................................ 2

1.4 EXPECTED OUTCOMES .............................................................................................................. 2 1.5 LITERATURE REVIEW ................................................................................................................ 3

1.5.1 What is 5S? ....................................................................................................................... 3

2 METHODOLOGY ........................................................................................................................................... 6

2.1 BRIEFING MANAGEMENT AND WORK TEAM .............................................................................. 6

2.2 PROBLEM AREA IDENTIFICATION .............................................................................................. 6 2.3 ILLUSTRATIONS OF THE PROBLEM .............................................................................................. 7

2.4 PROJECT IMPLEMENTATION ..................................................................................................... 10 2.5 PLANNED ACTIVITIES .............................................................................................................. 10

3.0 PROJECT OUTCOMES ................................................................................................................................ 16

3.1 LESSONS LEARNT ...................................................................................................................... 18 3.2 CHALLENGES EXPERIENCED ...................................................................................................... 18

4.0 CONCLUSION ............................................................................................................................................... 19

4.1 RECOMMENDATIONS .................................................................................................................. 19 4.2 DISSEMINATION PLAN ................................................................................................................ 20

4.3 FOLLOW-UP STRATEGY ............................................................................................................ 20 4.4 FUTURE PLANS ....................................................................................................................... 20

5.0 REFERENCES ............................................................................................................................................... 21

6.0 APPENDIX ..................................................................................................................................................... 22

6.1 APPENDIX I MYCOBACTERIOLOGY LABORATORY GUIDELINES FOR SAMPLE STORAGE AND

RETRIEVAL............................................................................................................................. 22

ii

LIST OF FIGURES

Figure 1: Summary of Sample Retrieval in 72 hours ......................................................................................... 7

Figure 2: Sample storage in the -200C Freezers in February 2013 ...................................................................... 8

Figure 3: Flow chart showing baseline sample storage and retrieval procedure .................................................. 8

Figure 4: Fishbone diagram illustrating the problem analysis ............................................................................ 9

Figure 5: Applying 5S Principles of Sort and Setting in the Laboratory ........................................................... 13

Figure 6: FreezerWorks Software Installed in the Laboratory .......................................................................... 14

Figure 7: Labeling of -800C Freezer Compartments ........................................................................................ 14

Figure 8: Mycobacteriology Laboratory Sample Storage and Retrieval Flow chart .......................................... 15

Figure 9: Retrieval Time per sample in MakSBS TB Laboratory ..................................................................... 18

LIST OF TABLES

Table 1: Countermeasure Matrix ..................................................................................................................... 11

Table 2: Number of samples mapped and transferred to the -800C freezer. ...................................................... 17

iii

DECLARATION

We, Germine Nakayita and Happy Edward do hereby declare that this end-of- project report

entitled: “Reducing Turnaround Time to Retrieve Frozen Samples in the Mycobacteriology

Laboratory, Makerere School of Biomedical Sciences” 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.

Signature:………………… Date ………………..

Germine Nakayita, Medium- term Fellow

Signature:………………………………… Date …………………

Happy Edward, Medium- term Fellow

Signature:……………………………………………. Date ……………………

Carolyn Namaganda (Institution Supervisor)

Signature:……………………………………………. Date ……………………

Dr. Sarah Byakika (Academic Supervisor)

iv

Fellows’ role in project implementation

The two Fellows Germine Nakayita and Happy Edward were actively involved right from project

conceptualization to implementation, evaluation and project dissemination. We occasionally altered

roles of team leadership and facilitator depending on the circumstances i.e. chairing meetings to check

progress, initiating purchasing orders and communications to management. We both participated in the

Sorting and Setting exercise of samples, their transfer to the -800C freezer as well as resolving errors

in the FreezerWorks database entries. It is one of the Fellows who labeled the -800C freezer’s

compartments, racks and rows. We both participated in the amendment of the Sample Storage and

Retrieval SOP having been part of the team that visited other TB laboratories to borrow a leaf on their

sample storage practices. One of the Fellows participated in the evaluation of the retrieval time at

intervals of project implementation. One of the Fellows has been assigned as the Freezer storage

supervisor to oversee proper documentation of sample storage and retrieval after project

implementation.

v

ACKNOWLEDGEMENTS

We would like to express special thanks to our team members (Kayiza Carol, Mboowa Gerald,

Nassolo Maria, Kiyimba Anthony, Bugumirwa Eric, Mudhasi Raymond and Nasuuna Jacent) with

whom we identified the problem of Inefficient Freezer storage system and conceptualized this project

entitled “Reducing Turnaround Time to Retrieve Frozen Samples in the Mycobacteriology

Laboratory” and continually and persuasively conveyed team spirit in accomplishing the above

project.

Secondly, we would like to express our deepest appreciation to our supervisors; Carolyn Namaganda

(Institution Supervisor as well as team member) and Dr. Sarah Byakika (Academic Supervisor) who

have shown the attitude and substance of genius in Continuous Quality Improvement. Without their

supervision and constant help, this report would not have been possible.

In addition, we would like to thank the Mycobacteriology Laboratory Management for their support

throughout this Fellowship program right from approval to undertake the Fellowship, time off from

work to attend classroom lectures, project implementation, institutional results’ dissemination and

final report production. We are truly grateful.

We are indebted to the Makerere University School of Public Health (MakSPH)- Centres for Disease

Control (CDC) Fellowship Program Staff in particular the training coordinator, Joseph Matovu and

the Mentorship team of Continuous Quality Improvement for their contributions towards

accomplishment of the Fellowship requirements. We thank the Fellowship Program Management for

the financial support. We are indeed grateful and May the God Lord reward them abundantly. We are

also thankful to (MakSPH) - for the collaboration between CDC that brought forward the Fellowship

Program.

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ABBREVIATIONS AND ACRONYMS

CDRC Centre for Disease Research Control

CQI Continuous Quality Improvement

0C Degrees Centigrade

FDA Food and Drug Administration

FIND Foundation of Innovation New Diagnostics

GLP Good Laboratory Practices

IDI Infectious Diseases Institute

IRB Institutional Review Board

MakSBS Makerere University School of Biomedical Sciences

Myco-Lab Mycobacteriology Laboratory

MOTT Mycobacteria Other than Tuberculosis

MTBC Mycobacterium Tuberculosis Complex

QA/QC Quality Assurance/ Quality Control

QI Quality Improvement

SBS School of Biomedical Sciences

SOP Standard Operating Procedure

SRL Supra-National Reference Laboratory

TB Tuberculosis

UNCST Uganda National Council of Science and Technology

WHO World Health Organization

vii

OPERATIONAL DEFINITIONS

Collaborators Funders of the laboratory and other organizations that have an understanding

with the laboratory.

FreezerWorks Software used for freezer inventory, sample labeling, tracking, and sample

management for laboratories. It offers a complete solution, meeting Good

Laboratory Practices (GLP), Food and Drug Administration requirements

(FDA) including 21 Code of Federal Regulations (CFR) part 11 requirements.

Map Arranging samples in vial boxes according to the freezer’s compartment, rack,

row box numbers and their positions within the vial box.

Samples This encompasses processed sputum sediments, laboratory identified

Mycobacterium Tuberculosis Complex (MTBC) and Mycobacteria Other than

Tuberculosis (MOTT).

viii

EXECUTIVE SUMMARY

As of March 2013, a technologist took on average 600 minutes to retrieve a sample in the

Mycobacteriology Laboratory of Makerere University School of Biomedical Sciences (MakSBS) as

compared to the expected 5 minutes using FreezerWorks software. This led to delays in availing

samples on time when requested from the laboratory by the Research students or collaborators for

further tests. This not only frustrated students but also affected the time of completion of the further

tests and hence the time they graduated. The collaborators had to incur more costs as they had to

review their protocols with the Uganda National Council of Science and Technology (UNCST).

The general objective of this project was to reduce the time taken to retrieve a sample from the -80

0C

freezer in the Myco-lab, from 600 minutes in March 2013 to 15 minutes by October 2013 so as to

increase sample usability for all clients. Specifically the project aimed at improving the freezer storage

system, operationalizing the FreezerWorks software and developing a comprehensive Standard

Operating Procedure (SOP) to guide freezer storage and usage in the Mycobacteriology laboratory.

The 5S (Sort, Set, Shine, Standardize and Sustain) Quality Improvement (QI) approach was applied by

the team members to sort, set and shine all frozen samples in the different -20

0C freezers and the -80

0C

freezer by use of freezer storage forms and the FreezerWorks database. The -800C freezer was well

labeled for easy identification of its compartments, racks and rows. The freezer storage SOP was

revised to fix timelines of storage in the -200C and -80

0C freezers as well as return of samples to

original positions after retrieval. From this SOP guidelines were adapted and put up to guide the team

members on the storage system and thus attaining the Standardization level under 5S. At the end of

the project, retrieval time had reduced to 3minutes on average beating both the improvement target

and the FreezerWorks standard of 5 minutes.

With the FreezerWorks database, sample management is made easy right from receipt, storage and

retrieval. It has been proved that a frozen sample can be retrieved in less than 5 minutes on average.

We recommend all laboratories handling big volumes of samples to explore and utilize the

FreezerWorks software. The 5S approach proved very useful in the initial organization of the

workplace and the principles can be applied to maintain an organized work place.

1

1.0 INTRODUCTION

The Mycobacteriology laboratory is located in the Department of Medical Microbiology, MakSBS,

College of Health Sciences. The laboratory has existed since 2009 and therefore still relatively new.

The laboratory’s vision is to stop Tuberculosis (TB) and improve medical research through quality

research, training and diagnostics. A number of services are provided in the laboratory which includes:

sputum smear microscopy, GeneXpert, solid culture (Lowenstein Jensen LJ), Liquid culture

(Mycobacterial Growth Indicator Tube MGIT), Drug sensitivity/ resistance testing and Blood culture.

These services are offered on diagnostic, research, training and consultancy basis. The major

customers are Research students from Makerere University and collaborators such as TB Centre for

Disease Research Control (CDRC), Supra-National Reference Laboratory (SRL) - Uganda, Infectious

Diseases Institute (IDI), Foundation of Innovation New Diagnostics (FIND) and a few private patients

from in and outside Mulago National Referral Hospital.

Most if not all samples received in the laboratory are obtained from patients attending TB clinics in

Mulago hospital. It is costly acquiring patients to participate in different research studies to provide

sputum at the TB clinic in Mulago Hospital because there is competition for patients by different

studies. In addition, TB testing is also expensive right from screening and culturing the organisms to

obtain samples. Therefore losing a single sample from a given patient is already a setback for the

researchers.

Mycobacterial samples require an organized freezer storage system to be retrieved in real time for

further tests. At the inception of this project, the Mycobacteriology Laboratory’s freezer storage

system was inefficient. The situation analysis conducted in March 2013 -found that 57% of the sample

boxes were stored in different -200C freezers yet they were supposed to be mapped in the -80

0C

freezer. This meant searching the different -200C freezers to retrieve the samples of interest and as a

result it would on average take 600 minutes to retrieve a sample. This project was therefore

implemented to reduce the sample retrieval time and establish a good freezer storage system to meet

our customer expectations.

The Project Implementers (Fellows under the MakSPH-CDC- Medium-term Fellowship program)

from the MakSBS first attended two classroom modules on the concepts of Continuous Quality

Improvement (CQI) from which the 5S approach and other QI concepts were introduced. Following

2

this, a proposal was prepared and the budget approved for the identified project entitled “Reducing

Turnaround Time to retrieve a Frozen Sample in the Mycobacteriology laboratory”. The project was

then implemented from May to October 2013. This report is therefore prepared and submitted as a pre-

requisite to completion of the Fellowship Program Funded by CDC in collaboration with the MakSPH.

1.1 Statement of the problem and Rationale

As per World Health Organization (WHO) standards, Mycobacterial samples can remain viable when

stored at -200C for several years (less than a decade). When stored at -80

0C these organisms remain

viable for decades (permanent storage). However as of March 2013, 57% of the total samples

generated in the laboratory were stored at -200C and some in inappropriate packages. Due to this,

retrieving a frozen sample would take on average 600 minutes contrary to the expected 5 minutes

using FreezerWorks software since there was a lot of disorganization in the different -200

C freezers.

This led to delay in availing samples on time when requested from the laboratory by the Research

students or collaborators. This not only frustrated students but also affected the time of completion of

the further tests and hence the time they graduated. For the collaborators, it had financial implications

as they had to review the protocol with the UNCST. It also led to loss of customers (Research students

and collaborators) due to dissatisfaction with the laboratory services.

1.2 General objective

To reduce the turnaround time to retrieve a sample from the -80

0C freezer from 600 minutes on

average as of March 2013 to 15 minutes on average by October 2013 so as to increase usability to all

clients.

1.3 Specific objectives

1. To establish a freezer storage management system.

2. To operationalize the FreezerWorks software.

3. To develop a comprehensive Standard Operating Procedure (SOP) to guide Freezer storage and

usage in the laboratory.

1.4 Expected outcomes

Time taken to retrieve a sample from -80

0C freezers reduced to 15 minutes.

Reduction in the proportion of samples in the -200C freezer.

The FreezerWorks software installed and is operational.

A functional Freezer storage management system.

3

A comprehensive SOP to guide freezer storage and usage put in place.

1.5 Literature Review

The storage and maintenance of mycobacterial reference strains and clinical isolates is an important

part of the GLP in a Mycobacteria laboratory. The storage of reference and control strains facilitates a

reliable control on intra- and inter-test reproducibility (1, 2). Furthermore, to study various aspects of

the epidemiology of TB it is important to be able to study serial isolates of individual patients (3) or of

patients associated with particular place or time factors (4).

It is possible to maintain mycobacterial cultures by re-culturing on solid medium, like Lowenstein

Jensen medium. There are, however, many examples of marked genetic re-arrangements in

mycobacterial strains during in-vitro culturing (5, 6). It is therefore of the utmost importance to

preserve reference strains and clinical isolates under circumstances with the lowest metabolic activity.

Previously, lyophilization was the most frequently used approach to preserve cultures. Because the

viability of the lyophilized bacteria drops dramatically within a few years, storage of cultures in -800C

freezers is increasingly applied. In the Netherlands a 15 years-experience with latter method for

storage has shown that this method is highly efficient to maintain the viability of mycobacterial

cultures.

1.5.1 What is 5S?

5S is a management tool, which originated from the Japanese manufacturing sector. It is used as a

basic, fundamental, systematic approach for productivity, quality and safety improvement in all types

of organizations.

5S is literally five abbreviations of Japanese terms with five initials of S. These are Seiri, Seiton,

Seiso, Seiketsu, and Shitsuke. In English, 5Ss were translated as Sort, Set, Shine, Standardize, and

Sustain. These are explained briefly below:

Sort: Remove unused stuff from your venue of work; and reduce clutter (Removal / organization)

Set: Organize everything needed in proper order for easy operation (orderliness)

Shine: Maintain high standard of cleanness (Cleanness)

4

Standardize: Set up the above three Ss as norms in every section of your place by use of Standard

Operating Procedures and checklists (Standardize)

Sustain: Train and maintain discipline of the personnel engaged. (Discipline)

The five steps of Sort-Set-Shine-Standardize-Sustain are a sequence of activities to improve the work

environment to be as convenient and comfortable as possible and thereby also improve service

contents with respect to preparedness, standardization, and timeliness. The 5S Principles are reliable

instruments to make a break-through in the work environment and staff attending to various types of

jobs in an Institution. This is not only a concept but also a set of actions, which has to be conducted

systematically with the full participation of the staff serving the institution. 5S activities are practiced

in a real participatory effort to improve the quality of both the work environment and the service

contents that are delivered to clients using the improved environment.

Targets of 5S principles are:

Zero changeovers leading to product/ service diversification

Zero defects leading to higher quality

Zero waste leading to lower costs

Zero delays leading to on time delivery

Zero injuries from promotion of safety

Zero breakdowns bringing better maintenance

Zero customer complaints i.e. customer satisfaction

Zero red ink i.e. betterment of organization’s image

Further, introduction of 5S is expected to instill a team culture, increase morale and motivation and

improve job satisfaction. They are simple but effective methods to organize the workplace. In the

long-term the implementation of the 5S principles also helps in creating positive altitude in the

workforce (7).

Tracking valuable samples and specimens is critical for research and biotech laboratories. The

FreezerWorks product line offers a complete solution; meeting GLP and FDA Guidelines, including

21 CFR part 11 requirements, for individual laboratories in universities, clinics, biotech, and

pharmaceutical companies. FreezerWorks Unlimited offers unparalleled time-saving features that will

streamline sample tracking and management workflow in high-volume laboratories. With

FreezerWorks Unlimited, entering a large number of similar samples is made simple, and updating

5

groups of samples, aliquots, or transactions can be done in one easy step. Shipping samples to other

sites is streamlined and straightforward. FreezerWorks Unlimited combines the power of a user-

definable information management system with the solid foundation of a relational database. It tracks

what is being stored, moved, and tested across the organization, down to the precise location in the

freezer. All of this comes with a fully automated user name and date input system that offers

unprecedented user and freezer security (8, 9).

6

2 METHODOLOGY

2.1 Briefing Management and Work Team

The project inception began after completing a two weeks intensive course on CQI at MakSPH. On

return the Fellows briefed the Laboratory Management and the workmates about the Fellowship

Program and need to identify and implement a CQI project as a requirement for the Program. All were

willing to support and participate in the CQI project.

2.2 Problem Area Identification

The team organized a meeting on the 28th

February 2013 for identifying the problem and through

brainstorming the following were identified:

1. Sometimes culture results take too long to be disseminated to the customers.

2. Inefficient freezer storage systems for processed specimen sediments and TB culture isolates.

3. Limited laboratory information system.

4. A lot of time taken to completion of assigned action points from laboratory audits and weekly

meetings.

5. Re-occurrence of corrective actions.

6. Poor management of private patients.

7. Inadequate space for files storage.

8. No Evacuation plan for the laboratory.

9. Lack of management support as regards minor equipment breakdowns.

10. Uncertainties as regards staff remuneration.

11. Arising complaints and dissatisfaction from customers.

By using clarification and evaluation, the QI team eliminated issues that were beyond our limits to

influence.

The following were agreed upon as problems that the QI team had ability influence change;

1. Sometimes culture results take too long to be disseminated to the customers.

2. A lot of time taken to retrieve sediments and TB culture isolates from the freezers.

3. Limited laboratory information system.

7

4. A lot of time taken to completion of assigned action points from laboratory audits and weekly

meetings.

Through consensus the QI Team identified and prioritized the process problem of “a lot of time taken

to retrieve a frozen sample’’. This has for a long time been a complaint from our customers. Some

research students have failed to graduate on time due to the delay to retrieve frozen samples for further

tests to complete their projects. Review of records showed that by March 2013 it took 600 minutes to

retrieve a sample in the Mycobacteriology Laboratory as compared to the expected 5 minutes using

FreezerWorks software. The team agreed that the problem could be worked upon within the given

fellowship time.

2.3 Illustrations of the problem

The list of all Mycobacterial samples as of March 2013 was obtained from the data team. Twenty

samples were randomly selected and out of the twenty samples selected, only seven (35%) were

retrieved within 72 hours (4,320 minutes) and the thirteen (65%) never retrieved.

Figure 1: Summary of Sample Retrieval in 72 hours

It was tedious retrieving these samples because out of 234 samples boxes 43% were mapped in the -

800C freezer by use of the freezer storage form and 57% were stored in different -20

0C freezers

instead of the -80

0C freezer. This meant looking through the different

-20

0C freezers to retrieve the

samples of interest. It was noted that some retrieved frozen samples were never taken back to their

rightful positions. Frozen sample boxes were distributed in different -20

0C freezers with no

documentation tracking them and some in inappropriate packages.

35%

65%

retrieved not retrieved

8

Figure 2: Sample storage in the -200C Freezers in February 2013

The baseline sample storage and retrieval procedure in the Mycobateriology Laboratory is shown in

the flowchart below.

Figure 3: Flow chart showing baseline sample storage and retrieval procedure

Yes

No No

Yes

Yes

No

Sputum

processing

Is it

positive?

Store in sample

vial

Incubate for 3days in

the incubator

Transfer to -200C

freezer

Need to

retrieve

Retrieve

the

sample

Subculture

the sample

Sputum

sample

Leave in -

800C freezer

Transfer to -800C

freezer

Discard

culture

Sample for further tests

Culture on

MGIT &

LJ

Store sample

sediment

9

Problem analysis using “Fishbone diagram” was carried out and a number of contributing factors including personnel, storage system,

equipment and ICT System were identified (Figure 4).

Figure 4: Fishbone diagram illustrating the problem analysis

Storage not done in a timely manner No order of storage

Staff are reluctant in all freezers

No supervision

FreezerWorks software not utilized Disorganization in the freezers

Not fully installed and configured Freezers’ compartments not labeled

A lot of time taken to

retrieve a frozen sample

Personnel Storage system

ICT Equipment

No one assigned to

oversee freezer

storage

No comprehensive SOP to guide storage

and retrieval of samples

Lacked service provider

to configure FreezerWorks software

No one has been

assigned the task

10

2.4 Project implementation

The Project Implementation Team was comprised of the two Fellows, five laboratory technologists, two data

administrators, the supervisor (QA/QC Officer) and the laboratory manager.

2.5 Planned activities

The project activities were aimed at implementing the countermeasures identified using the matrix as

shown below (Table 1).

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Table 1: Countermeasure Matrix

Root Causes Countermeasures Planned activity Expected Outputs Timing Actual

Output M J J A S O

No one assigned to

supervise freezer

storage.

Assign a staff to

supervise freezer storage

in the laboratory.

Convene a

meeting to select

the personnel.

Define his/ her

roles as regards

freezer storage and

usage supervision.

Personnel to oversee

freezer storage

assigned with clear

roles

Freezer

storage

supervised

No comprehensive

SOP to guide

storage and

retrieval of samples

from the freezers.

Develop a

comprehensive SOP to

guide storage and

retrieval of samples from

the freezers.

Convene a

meeting to

brainstorm on the

amendments to be

made in the

available freezer

storage SOP.

Develop a frozen

sample retrieval

form, amend the

freezer storage

form and develop

a sample storage

tracking form.

Revised Freezer

storage SOP

Revised freezer

storage form

Sample storage

tracking form

SOP utilized

to guide

storage and

retrieval of

samples

Lack of a service

provider to fully

install and

configure

FreezerWorks

software for the

electronic system to

be utilized in

sample storage and

frozen sample

Operationalize

FreezerWorks software

to be used to store and

retrieve samples from

the -80

0C freezer.

Hire a service

provider to fully

install & configure

FreezerWorks

software.

Purchase a new

laptop specifically

for the

FreezerWorks

database

Laptop procured

FreezerWorks

software installed

All staffed trained

in use of software

Consultant

installed

software

Trained 2

team members

on use

12

Root Causes Countermeasures Planned activity Expected Outputs Timing Actual

Output M J J A S O

retrieval.

Train all staff on

how to use the

FreezerWorks

software to store

and retrieve

isolates.

No one assigned the

task to label

freezers’

compartments and

racks

Assign staff to label the

freezers’ compartments

and racks.

Orient all

Laboratory staff

on the 5S approach

and its

implementation to

sort the

disorganization in

the freezers.

Convene a

meeting to assign

someone the task

of labeling

freezers’

compartments and

racks.

Purchase labels for

the freezers’

compartments and

racks.

All staff oriented

on 5S approach and

implemented

Freezer

compartments and

racks well labeled

11 team

members

sensitized

Sorting and

Setting done

13

Team members were sensitized on the 5S (Sort, Set, Shine, Standardize and Sustain) approach and

its implementation and the 5S exercise was scheduled. Members would come in over the weekends

to remove unwanted samples, sort samples according to sample type ( sediment or isolate) and

study cord putting into consideration proper packaging in sample boxes to reduce clutter in the

different -200C freezers. The ongoing samples were organized in order for easy operation and this

created order line in the laboratory. The team cleared the back log of the many samples in the

different -200C freezer and transferred them to the -80

0C freezer by mapping using the Freezer

storage forms. The work surfaces were cleaned on a regular basis.

Figure 5: Applying 5S Principles of Sort and Setting in the Laboratory

The FreezerWorks database was configured and became functional. All records on the Freezer

Storage form were entered in to the FreezerWorks database.

14

Figure 6: FreezerWorks Software Installed in the Laboratory

The -800C freezer compartments, racks and rows were labeled (Standardization) to ease the storage

and retrieval of samples from this freezer. Under the 5S approach labeling is useful for S2 “Set”

and S4 “Standardize” activities. This is used for the identification of each item and to organize them

properly.

Figure 7: Labeling of -800C Freezer Compartments

The freezer storage SOP was revised, guidelines to guide sample storage and retrieval adapted from

it and put up. These guided the technologists to store ongoing samples in the laboratory to prevent

disorganization as before. A new flow chart was developed to define timelines of storage in the

different freezers.

15

Figure 8: Mycobacteriology Laboratory Sample Storage and Retrieval Flow chart

No

Yes

No

No

Yes

Yes No

Sputum

Sample Sample processing Is it

positive?

Discard

culture

Store sample sediment at

20C to 80C for 5 days. Check for contamination and

viability of organisms for 21 days

Is it pure

growth?

Aliquot in a pre-

labeled sterile vial

Re-decontaminate

the culture

Need to

retrieve

Leave in -

800C freezer

permanently

Store at -200C for a week

(sediments) & a month (isolates).

Seek permission

from management

Fill the sample retrieval form

& retrieve from

FreezerWorks database.

Sub-culture sample on

7H10 media for 21 days

Sample

taken for

further tests

Transfer to -800C by filling the Freezer

storage form & FreezerWorks database.

Culture on LJ and

MGIT

16

3.0 PROJECT OUTCOMES

1) Established a functional freezer storage management system

All samples in the different -200C freezers were transferred to the -80

0C freezer and in appropriate

packaging by mapping using the freezer storage forms. The -800C freezer compartments, racks and

rows were well labeled to ease storage and retrieval practices. One personnel was assigned to

oversee/ supervise the freezer storage section of the laboratory.

-800C Freezer before (February 2013) -80

0C Freezer after (September 2013)

2) Operationalized the FreezerWorks software.

The FreezerWorks software was installed and configured and all entries in the freezer storage made

into the FreezerWorks database. From this all samples in the -800C freezer are tracked by the

FreezerWorks database and are easily accessible. By October 2013, a total of 13,083 samples in the -

800C freezer were mapped.

17

Table 2: Number of samples mapped and transferred to the -800C freezer

Month No. of samples in -800C mapped by

FreezerWorks database

Cumulative Total

March 0 0

April 0 0

May 0 0

June 2,100 2,100

July 4,750 6,850

August 4,805 11,655

September 1,059 12,714

October 324 13,083

3) Developed a comprehensive SOP

The Sample storage and retrieval SOP was revised to capture timelines of storage in the different

freezers and had all laboratory Technologists read and understand it. A sample retrieval form was

developed as well as a new flow chart for the process. Guidelines for sample storage and retrieval

(see Appendix I) were adapted from the SOP and put up to guide technologists in the sample storage

section. This SOP has been institutionalized.

4) Time taken to retrieve a sample from -800C freezers reduced

The turnaround time to retrieve a frozen sample was reduced from 600 minutes on average to 3

minutes on average at the end of project implementation surpassing both our improvement target of

15 minutes and the FreezerWorks standard of 5 minutes. This is because by October, all storage

entries had been fed in to the FreezerWorks database as shown in Table 2 above thus making it quick

to retrieve a given sample. The labeling of the -800C freezer as well a comprehensive SOP to guide

sample storage and retrieval practices also contributed to this time. In addition, being that the samples

were organized according to sample type and study cord in a particular sample box made it very easy

and fast to retrieve a given sample.

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Figure 9: Retrieval Time per sample in MakSBS TB Laboratory

3.1 Lessons Learnt

Some of the lessons learnt from our CQI project included;

Team work is key to successful QI project implementation.

Simple practical approaches like 5S can help improve service delivery and minimize financial

loses both to the customers and the laboratory.

Not all solutions in QI are as effective as may be expected but through continuous innovation,

the most effective countermeasure may be attained. However if all countermeasures are

implemented effectively, they yield better results.

Identification of the true root causes of a problem is critical for QI project development.

QI initiatives can be implemented using available resources.

3.2 Challenges Experienced

Not some many challenges were encountered however below are some of those that had a big

impact on the project implementation;

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The funds from MakSPH-CDC Fellowship Program were delayed for reasons we cannot

explain. This led to delay in implementing the most effective countermeasure however we

were able to beat time by tightening the Sorting and Setting schedule of samples.

Not all team members were trained to manipulate the FreezerWorks database because the

main equipment i.e. the FreezerWorks printer is faulty and non- functional at the moment.

However this has been addressed to the laboratory management that is trying its best to find a

solution.

The transcription error rate was high the fact that we have been using makers to label sample

tubes (cryo tubes). This remains a big challenge as the FreezerWorks printer is still faulty yet

it was meant to print labels for the sample tubes.

4.0 CONCLUSION

The Fellows were able to achieve the project objective as planned. The installation of the

FreezerWorks Software demonstrated to the organization that it makes sample management much

easier right from receipt, storage and retrieval. It has been proved beyond reasonable doubt that by

using the FreezerWorks database, a frozen sample can be retrieved in less than 5minutes on average.

And all this can be achieved if the laboratory has an established freezer storage management system.

4.1 Recommendations

At institution level we recommend the laboratory to maintain the FreezerWorks database to date by

subscribing for the FreezerWorks software license annually. It as shown great results at sample

management since the Department is in the process of building a strong bio-repository on behalf of

Makerere University. In addition, we recommend purchase of a second -800C freezer so as to have a

backup in case of equipment breakdown. Other Laboratories can improve on their sample

management by application of the QI principles and use of available technology.

To the MakSPH-CDC Fellowship Program, we recommend recruitment of more laboratory

professionals to increase their knowledge in CQI since they are also directly involved in health

services delivery. There is need for more accredited laboratories which can only be achieved through

gained knowledge in Quality Improvement.

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4.2 Dissemination Plan

The outcomes of this project have been disseminated at institution level i.e. to sister laboratories in

the Department of Medical Microbiology, MakSBS. These included; the Immunology laboratory,

Molecular Diagnostic laboratory and the Microbiology laboratory who are partners in the proposed

bio-repository for the College of Health Sciences spearheaded by the Department of Medical

Microbiology MakSBS. Further dissemination will be to the MakSPH-CDC Fellowship Program on

date yet to be communicated in November 2013.

We shall also look for opportunities to disseminate our results in QI and Scientific Research

conferences and publications like newsletters and websites.

4.3 Follow-up strategy

The Quality Assurance department has included the fridge and freezer storage section on the annual

internal Audit Schedule for purposes of monitoring quality. Turnaround time of sample storage is

monitored on monthly basis through reports discussed in the Quality meetings. In addition,

competence is to be checked on every laboratory Technologist semi-annually or when need be before

rotation into the freezer storage section just like the other sections. There is now a designated person

to supervise the freezer storage section. There is a plan to train all laboratory technologists on how to

manipulate the FreezerWorks database once the printer is available.

4.4 Future plans

Having identified a high transcription error as the remaining part of the problem, we are going to look

for the best way possible to reduce this error. The above lessons learnt are going to be used to solve

our limited laboratory information system problem.

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5.0 REFERENCES

1. World Health Organization. Global tuberculosis control: WHO report 2010. Geneva: World

Health Organization; 2010. Available from:

http://www.who.int/tb/publications/global_report/2010/en/index.html

2. Doveren RFC, Keizer ST, Kremer K, et al. A tuberculous microepidemic caused by a

endogenous reactivation eight years after infection; demonstrated by DNA finger-printing.

Ned Tijdschr Geneesk 1998; 142:189–192.

3. Schaaf HS, Gie RP, van Rie A, et al. Second episode of tuberculosis in an HIV-infected child:

relapse or reinfection? J Infect 2000; 41:100–103.

4. Van Rie A, Warren R, Richardson M, et al. Exogeneous reinfection as a cause of recurrent

tuberculosis after curative treatment. NEJM 1999; 341:117

5. Steenken, Jr., W., and Gardner, L. U. (1946) History of H37 strain of tubercle bacillus. Am.

Rev. Tuberc. 54, 62-66.

6. Behr, M. A., and Small, P. M. (1999) A historical and molecular phylogeny of BCG strains.

Vaccine 17, 915-922.

7. Ministry of Health Guidelines, 5S Implementation guide.

8. http://freezerworks.com/products.php?action=subitems&product_id=9&subitem_id=45.

9. http://freezerworks.com/products.php?action=read&product_id=8.

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6.0 APPENDIX

6.1 Appendix I Mycobacteriology Laboratory Guidelines for Sample Storage and Retrieval

1.1 Storing of positive cultures from MGIT

1.1.1 Collect and check for the presence of Acid Fast Bacilli by the identification method and rule out contamination

for the MGIT that are signaled as instrument positive.

1.1.2 Check the viability of organisms by sub culturing on 7H10/11 media and incubate at 370C for maximum

21 days. Check the purity by inoculating on blood agar plate and incubate for 24hrs.

1.1.3 Confirm pure Mycobacterium growth and aliquot the broth into one pre-labeled (with lab number, date of

storage and initials of technologist) sterile vial. In case one culture method was used, store two vials of the isolate. If

the culture is contaminated, re-decontaminate to obtain a pure growth.

1.1.4 Transfer the isolate vials into individual study storage boxes and keep t in the -200C freezer temporary for a

month. Transfer to the -800C freezer by mapping using the freezer storage form (FO-MYC-P012-A).

1.1.5 The final and complete transfer and mapping of samples in the -800C freezer is by the FreezerWorks

database. Entries are made using the information on the freezer storage form.

1.1.6 Turnaround time for storage of identified positive cultures is to be monitored on a monthly basis through

reports from the data team.

Note: While mapping samples by the freezer storage form, the laboratory number as well as date of sample

storage should be documented in the individual sample positions on the form.

1.2 Storing of positive LJ Mycobacteria cultures

1.2.1 The LJ media with growth will be examined and confirmed for growth of Mycobacterium Tuberculosis by the

laboratory’s identification method and contamination ruled out.

1.2.2 Aliquot 1ml of storage medium in a pre-labeled cryovials with sample laboratory number and date of

storage.

1.2.3 Add a loopful of growth, mix or vortex for 30 seconds and allow settling for 30minutes.

Then follow the procedure as in 1.1.4, 1.1.5 and 1.1.6.

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1.3 Procedure For Storing of Sediments after Inoculation on media

1.3.1 Label a new sterile cryovial with “Lab ID”, Date of processing (Date-MMDDYY). Place cryo vial in a rack

within the Biosafety Cabinet.

1.3.2 After inoculation of MGIT and LJ medium, keep the remaining sample in the refrigerator at 2-8 C for 5 days.

This is in case the sample is required to repeat the smear or re-inoculate the culture in case of the immediate

contamination of the MGIT and LJ.

1.3.3 If no contamination is seen in the inoculated medium, aseptically transfer the remaining sediment into a pre-

labelled sterile cryovial in individual study storage boxes.

1.3.4 Label the boxes, store in -20C temporarily for a week and then transfer to the -800C freezer by mapping using

the freezer storage form (FO-MYC-P012-A).

1.3.5 The final and complete transfer of samples in the -800C freezer is by the FreezerWorks database. Entries

are made using the information on the freezer storage form. Turnaround time for sediment storage will be

monitored on a weekly basis through reports from the data team.

1.4 Retrieval of frozen samples

1.4.1 Permission is to be sought from management before any isolates or sediments can be retrieved.

1.4.2 The freezer storage supervisor completes the sample retrieval form (FO-MYC-P012-B).

1.4.3 Delete the retrieved samples from the FreezerWorks database and capture their history. This is obtained

from the FreezerWorks’ database audit trail which entails who, how much and when the sample is retrieved.

1.4.4 Sub culture the isolate following retrieval. Here a portion of the isolate is inoculated on 7H10 media and

incubated at 370C for maximum 21days and store as in sections 1.2.

1.4.5 Return isolate vials to their original position no more than 6weeks from the retrieval date and 2weeks for

sediments (remaining portion) for future reference.

1.4.6 Re-enter the isolates into the FreezerWorks database and for any reason as to why they are not returned to

the freezer, state in the comment section.

1.4.7 The freezer storage supervisor must ensure all the above is ensured before signing off the form.

Note: For samples that require thawing, they should be thawed 3 times maximum.

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1.5 Fate of unsuccessfully stored samples

1.5.1 Some samples may be lost, contaminated or have no growth at all. Where possible the above processes

need to be repeated. For any unsuccessful repeats, document the final fate.