CASE STUDIES:

QUALITY IMPROVEMENT

SHAIKH MUZAMMIL GHULAM MOHAMMED

DPGD/JA11/0316
SPECIALISATION: OPERATIONS

WELINGKAR INSTITUTE OF MANAGEMENT

DEVELOPMENT & RESEARCH

Year of Submission: December, 2012

ACKNOWLEDGEMENTS
It adds to my pleasure to acknowledge & express my deepest regards towards
those who have offered their invaluable support & guidance in completing this
project report.

I am thankful to them for the encouragement they gave me since the initial
phase of this project till its completion. I am highly oblige to Mr. Jayasheel
Hegde, my project guide, for his continuous support and for sharing with me
his rich experience in the field of Quality Control.

I would also like to express my sincere gratitude to Dr. T. F. Ashavaid, Head

of Laboratory Medicine section at P. D. Hinduja National Hospital Mumbai,
for having faith in me and helping me to complete this project in target time,
without her inspiration & guidance this project would have remained a dream.
I am also thankful to all my colleagues from the laboratory medicine &
biomedical engineering department for their guidance, advice and cooperation.

Last but not the least, I would also like to thank all my friends & family
memebrs who had directly or indirectly given their unconditional support &
encouragement.

(Shaikh Muzammil G. M.)

Place: Mumbai
Date:

PREFACE
Managing quality has a specific meaning within many business sectors.
Quality management therefore uses quality control and quality improvement
of processes as well as products to achieve more consistency in quality.
Through this project report on QUALITY IMPROVEMENT , I would like to put
before the readers the importance of quality improvement in healthcare
laboratories. This project report elaborates how the laboratories can raise the
level of accuracy, patient care & produce reliable results by implementing
internationally accepted methods of Good Laboratory Practice (GLP) and
following the guidelines of College of American Pathologists (CAP).

I have made sincere attempts and taken every care to present this matter
in in precise and compact form, the language being as simple as possible.

I am sure that the information contained in this report would certainly

prove useful for better insight in the scope & dimension of this project in its true
prospective.

This report focuses on one important element of the quality agenda: Quality
Improvement. It looks in particular at what are known as organizational or
industrial approaches to quality improvement, which focuses on bringing
about a measurable improvement by applying specific methods within a
healthcare environment.

INDEX

1. INTRODUCTION -------------------------------------------------------- 06

2. IMPORTANCE OF QUALITY IN
HEALTH CARE LABORATORIES ---------------------------------- 14

3. CAP (COLLEGE OF AMERICAN PATHOLOGISTS) ---------- 19

4. PLANNING FOR CAP ACCREDITATI-----------------------------

5.

28

BENEFITS TO THE HOSPITAL FROM

CAP ACCREDITATION ------------------------------------------------ 31

6.

GAP ANALYSIS ---------------------------------------------------------- 33

7. EQUIPMENT DOCUMENTS, PROCEDURES &

MANUALS ------------------------------------------------------------------ 39

8. NEW EQUIPMENT INSTALLATION -------------------------------- 42

9.

EQUIPMENT MAINTENANCE -------------------------------------- 45

10.

EQUIPMENT CALIBRATION --------------------------------------- 52

11.

CONCLUSION --------------------------------------------------------- 71

12.

APPENDIX -------------------------------------------------------------- 73

13.

BIBLIOGRAPHY ------------------------------------------------------- 82

1. INTRODUCTION
The basic definition of Quality Improvement states that it is the actions taken
throughout the organization to increase the effectiveness of activities and
processes to provide added benefits to both the organization and its
customers. In simple terms, quality improvement is anything which causes a
beneficial change in quality performance. The quality improvement techniques
can be applied for both improvements in products as well as improvement in
services provided by the organization.

I have been associated professionally with the healthcare field as a

Biomedical Engineer. With ten years of professional experience, providing
services for Laboratory Equipments, I am glad to present my project report on
the topic of Quality Improvement in healthcare related field. Hence the scope
of this report will be limited to quality improvement measures implemented to
improvise quality of clinical engineering services provided to a laboratory
medicine department in a hospital environment.

As we enter the new millennium, healthcare organizations are facing new

challenges and must continually improve their services to provide the highest
quality at the best cost. Pressures to increase the quality and lower the cost of
healthcare are coming from accreditation boards, the media, and comparisons
with other facilities and government agencies.

1.1 UNDERSTANDING QUALITY:

First of all let us understand what is meant by quality? Quality means meeting
the standards. The standards are predetermined requirements for a particular
substance or service.

Quality is also defined as the degree to which a set of inherent characteristics

of a product / service fulfills a customer need or expectation that is stated,
6

generally implied or obligatory. In simple word according to Philip Crosby,

quality means "conformance to requirements" (Crosby, 1979) which
ultimately means CUSTOMER SATISFACTION. Quality must be defined in
measurable and clearly stated terms to help the organization take action
based on tangible targets, rather than on hunch, experience, or opinions.

According to W. Edwards Deming, quality cannot be defined in a single

phrase. He asserts that the quality of any product or service can only be
defined by customer. Quality is a relative term that will change in meaning
depending on the customers needs e.g. the current and future needs of the
customer.
Lastly, Joseph M. Juran defined quality as fitness for use. He stresses a
balance between product features and products free from the deficiencies. As
used by Juran, the word "product" refers to the output of any process, and that
includes goods as well as services (Juran & Gryna, 1988).
Definition of quality by all the three Quality Gurus focuses on customer
satisfaction by meeting the pre-determined requirements. Anyone affected by
the product is considered a customer, according to Juran. This group includes
those who deal with the product during its developmental stages, the internal
customers, and those who deal with the finished product, the external
customers.

The foundation of Crosby's approach is prevention. His approach to quality is

best described by the following concepts: (1) "Do It Right the First Time"; (2)
"Zero Defects". There is no place in his philosophy for differing levels of
quality or categories of quality (e.g., high/low, good/poor). He believes there
should be no reason for planning and investing in strategies that are designed
in case something does not conform to requirements and goes wrong. He
stresses that the way to manage quality is by prevention, not detection and
testing.
7

Figure 1: The Prevention Process (Crosby ,1987)

Crosbys four absolutes of quality management, considered by him to be the
core concepts of the quality improvement process. The four absolutes are:
1. The definition of quality is conformance to requirements
(requirements meaning both the product and the customer's
requirements)
2. The system of quality is prevention
3. The

performance

standard

is

zero

defects

(relative

to

requirements)
4. The measurement of quality is the price of nonconformance
His belief was that an organization that established a quality program will see
savings returns that more than pay off the cost of the quality program: "Quality
is free".

1.2 QUALITY SYSTEM:

Quality is ensured through a well-defined quality system which is a part of
overall quality management aimed at ensuring consistency, reproducibility,
traceability and efficacy of the products or services. Accordingly, a quality
system is defined as the organizational structure and resources needed to
implement quality requirements.
8

The International Organization for Standardization (ISO) defines a quality

system

as

the

organizational

structure,

responsibilities,

procedures,

processes and resources for implementing quality management.

A quality system has the following five key elements:

Organizational management and structure
Documentation
Monitoring and Evaluation
Training
Quality standards

1.2.1 Organizational Management and Structure

The overall responsibility for the design, implementation, maintenance and

improvements in quality system rests with the laboratory management.
Quality is the responsibility of all the staff members of the organization.

1.2.2 Documentation

A document is a record whether in printed or electronic version, of any

information or instructions including policy statements, quality manuals,
procedures, specifications, calibration tables, reports, job description,
documents of external origin such as regulations, standards and examination
procedures etc.

1.2.3 Monitoring and Evaluation

The laboratory management develops and implements quality indicators to

systematically monitor and evaluate the laboratorys contribution to patient
care. When the program identifies opportunities for improvement within the
system, the laboratory management should take appropriate steps to address
9

them. Error management should be vigorously implemented. Assessment of

quality through audits (internal or external) and participation in external quality
assessment schemes are other tools, the results of which should guide the
management in further improving quality.

1.2.4 Training

The quality system is only as good as the staff who actually work for it. No
matter how good the quality system is on paper, if it cannot be translated into
practice, quality cannot be achieved. Training must also include an
understanding of why quality is important. Training should be competency
based and must be followed by post-training courses to provide a continuous
support.

1.2.5 Quality Standards

The quality standards are an integral part of the quality system. These aim at
ensuring safety and consistency. These need to be followed strictly to meet
the regulatory requirements as well as to monitor the functioning of the
laboratory. Both management and technical standards need to be followed to
ensure quality. These must also conform to the local laws.

We have looked at what we mean by quality, and quality improvement, and

have seen where quality improvement approaches have come from. We now
go on to look at the theory in practice, by identifying some of the best known
approaches to quality improvement. These are approaches, rather than tools.
This means that they can and often are used simultaneously, and are
underpinned by a common set of principles.

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1.3 QUALITY IMPROVEMENT APPROACHES

The most common approaches to quality improvement are:
Business process re-engineering

Fundamental rethinking of how processes are designed, with change

driven from the top by a visionary leader, and organizations set up
around key processes rather than specialist functions.
Collaboratives

Groups of hospitals or health economies addressing the same

problems as each other, and learning from each others experience.
Lean

A quality management system developed by the Japanese car

manufacturer Toyota, focusing on value, flow and waste reduction.
Plan, Do, Check, Act (PDCA)

An approach to continuous improvement where changes are tested in

small cycles.

Fig. 2 The PDCA cycle / Demings Ring

11

 Six Sigma

A process or product improvement approach that focuses on reducing

what customers would define as defects.

Fig. 3 Six Sigma -The DMAIC Cycle

Statistical process control

Examines the difference between natural variation (common cause)

and special cause variation, and enables data to be collected over time
to show whether a process is within control limits.
Total quality management (TQM)

Also known as continuous quality improvement. Emphasizes the need

for leadership and management involvement to understand work
processes.

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1.4

ESSENTIAL CHRECTARISTICS OF QUALITY

IMPROVEMENT & MANAGEMENT:

Top management support and commitment are essential

Education and training must be continuous

Measurement is critical

Improvements are not viewed in terms of final achievements

Implementation is applicable to any organization

Effective communication and teamwork at all levels are essential

There are no shortcuts to quality

Suppliers must be involved in the quality effort

The pursuit of quality must be a continuous effort

After studying the importance of quality and quality improvement let us shift
our focus now to Quality Improvement in healthcare field. Specifically sticking
to the laboratory medicine section, which also is our region of interest for this
project.

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2. IMPORTANCE OF QUALITY IN HEALTH CARE

LABORATORIES
Improving quality is about making healthcare safer, effective, patient centered,
timely, efficient and equitable. Improving the quality of services in healthcare
sector is now a key requirement within the organization and it is further
supported by enrolling in quality control programs, quality validation and going
through various national & international accreditation programs such as:

1. ISO - International Organization for Standardization

2. CAP - College of American Pathologists
3. JCAHO - The Joint Commission on Accreditation of Healthcare
Organizations
4. CLIA - Clinical Laboratory Improvement Accreditation
5. NCCLS - National Committee for Clinical Laboratory Standards
6. NABL - National Accreditation Board for Testing and Calibration
Laboratories

Fig. 4 Health Care Laboratory

14

Quality is of paramount importance in health laboratories. Reliable results

produced by a laboratory, improve the decision making capacity of the
clinicians as well as public health physicians. The consequences of poor
quality could be serious. It could lead to inappropriate action or inaction
leading to over treatment, over investigation or mistreatment, lack of treatment
or inadequate investigations. Delayed or sub-optimal responses as a result of
poor quality of laboratory services & could adversely affect the credibility of
the laboratory.

For the sake of studying quality improvement in healthcare laboratories, I

have chosen the organisation named, P. D. Hinduja National Hospital,
Mumbai. I have provided my services as Biomedical Engineer taking care of
various sections of laboratory medicine department. I used to assist the
pathologists as well as medical technologists in solving issues related to
medical instruments (e.g. maintenance and continuous performance checks,
etc.) used in various types of lab. diagnosis. Let us know the organisation in
more details in next section,

15

2.1 P.D. HINDUJA NATIONAL HOSPITAL, MUMBAI:

Established in the early 1950's under the leadership of the late Shri P.D.
Hinduja, this organisation has followed a vision is to deliver quality healthcare.
As an ultramodern tertiary care hospital in India, this organisation has always
been motivated to lead the pathway to medical excellence with world-class
healthcare treatments and services.

Fig. 5 P.D. Hinduja National Hospital, Mumbai

Let us learn more about the organisation,

2.1.1 Specialities

- Allergy
- Anesthesiology
- Cancer Chemotherapy
16

- Cardiology
- Clinical Genetics
- Interventional Radiology
- Lab. Medicine
- Neurosurgery
- Orthopaedics
- Plastic Surgery & others

2.1.2 Accreditation

- CAP (College of American Pathologists)

- NABH (National Accreditation Board for Hospitals & Healthcare Providers)
- HACCP (Hazard Analysis & Critical Control Points)
- ISO 27001: 2005 Certification

2.1.3 Achievements

- The Twin Speed MRI, a revolutionary technology in neurovascular and

cardiology imaging
- The Gamma Camera / PET Scan redefines treatment in cancer
management, orthopedics, neurology and cardiology
- Gamma Knife, a gold standard in radio surgery, a non-invasive surgical tool
(first such unit in South Asia)
- Digital Linear accelerator Clinac 2300 C/D with MLC, micro MLC and portal
vision along with CT simulator, dedicated 3D computerised planning
system for achieving a high tumour dose and increased cure rate and a low
normal tissue dose to reduce toxicity
- First hospital laboratory in India and SAARC countries to be accredited by
College of American Pathologists

During year 2006 Hinduja Hospital decided to enroll for CAP accreditation.
This accreditation requires all the laboratory procedure as well the hospital
environment to be strictly adhering to the CAP guidelines. As a representative
17

from the Biomedical Engineering services I was chosen as the team leader to
develop the techniques and implement new quality improvement strategies
under the guidance of my project guide Mr. Jayasheel Hegde & Dr. T F.
Ashavaid (Head Lab. Medicine).

Before proceeding to understand the techniques implemented for quality

improvements, let us first understand the organisation CAP in details.

18

3. CAP (COLLEGE OF AMERCIAN PATHOLOGISTS)

College of American Pathologists is a medical society serving more than
17,000 physician members and more than 6,000 laboratories that are
accredited by CAP throughout the world. It is the world's largest association
composed exclusively of pathologists and is widely considered the leader in
laboratory quality assurance.

3.1 ABOUT THE CAP ACCREDITATION PROGRAM:

The CAP Laboratory Accreditation Program is an internationally recognized
program and the only one of its kind that utilizes teams of practicing laboratory
professionals as inspectors. Designed to go well beyond regulatory
compliance, the program helps laboratories achieve the highest standards of
excellence to positively impact patient care.

The program is based on rigorous accreditation standards that are translated

into detailed and focused checklist requirements. The checklists, which
provide a quality practice blueprint for laboratories to follow, are used by the
inspection teams as a guide to assess the overall management and operation
of the laboratory.

The CAP Laboratory Accreditation Program meets the needs of a variety of

laboratory settings from complex university medical centers to physician office
laboratories. The program also covers a complete array of disciplines and
testing procedures. Because of its comprehensive nature, CAP accreditation
can help achieve a consistently high level of service throughout an institution
or healthcare system.

19

The Centers for Medicare and Medicaid Services (CMS) has granted the CAP
Laboratory Accreditation Program deeming authority. It is also recognized by
the Joint Commission, and can be used to meet many state certification
requirements. The CAP also provides laboratory accreditation to forensic
urine drug testing and reproductive laboratories, co-sponsored with the
American Society for Reproductive Medicine (ASRM).

3.1.1 What is an accredited laboratory?

An accredited laboratory is one that is inspected by a private not-for-profit

accrediting organization that has been approved by the Centers for Medicare
and Medicaid Services (CMS) and its requirements deemed as equivalent to
or more stringent than CMS's regulatory requirements. An approved
accrediting organization can inspect a laboratory in lieu of CMS.

20

3.1.2 What is CAP accreditation?

The goal of the CAP Laboratory Accreditation Program is to improve patient

safety by advancing the quality of pathology and laboratory services through
education, standard setting, and ensuring laboratories meet or exceed
regulatory requirements. Upon successful completion of the inspection
process, the laboratory is awarded CAP accreditation and becomes part of an
exclusive group of more than 7,000 laboratories worldwide that have met the
highest standards of excellence.

3.2 OBJECTIVES OF CAP:

The objectives of the CAP are:

To foster the highest standards in education, research, and the practice

of pathology;

To advance the science of pathology and to improve medical

laboratory service to patients, to physicians, to hospitals, and to the
public through study, education, and improvement of the economic
aspects of the practice of pathology;

To enhance the dignity, scientific basis, and efficient practice of the

specialty of pathology for the service of the common good.

3.3 BENEFITS OF CAP ACCREDITATION:

3.3.1 Comprehensive Evaluations

All laboratory test results need to be accurate-every time-no matter where

they are performed. The CAP accommodates all different types of labs so that
the labs can maintain a consistently high level of service across entire
organization

21

3.3.2 Expert Inspection Teams

The CAP Laboratory Accreditation Program is the only one of its kind that
utilizes multi-disciplinary teams of practicing lab professionals as inspectors.
Because they deal with lab issues on a daily basis, these inspectors are
uniquely qualified to provide labs with a thorough inspection that is specific for
each section of the lab.

3.3.3 Compliance with Regulations

The CAP Laboratory Accreditation Program helps labs meet and exceed
requirements of the Centers for Medicare and Medicaid Services (CMS) as
well as those of other national and state regulatory bodies.

3.3.4 Unparalleled Educational Opportunities

Lab. professionals are involved on both sides of the inspection process, so

there is always a healthy exchange of ideas and discussion of the latest lab
techniques that goes beyond regulatory requirements. There is something
valuable to take away from every inspection.

3.3.5 Useful Inspection Tools

The inspection Checklists constantly evolve to reflect current practices and

technologies and therefore serve as living documents on good laboratory
practice. Adhering to the Checklists provides assurance that practicing lab. is
doing all it can to produce the highest quality test results.

3.3.6 Recognition as a Top Performer

Over 83% of the top major teaching and large community hospitals choose
the CAP as their accrediting agency. By achieving the highest standards in
the industry labs. not only gain the confidence and trust of their community but
22

also distinguish themselves as a leader who is committed to quality patient

care.

3.4 HOW CAP INSPECTION WORKS:

A CAP inspector follows a patient specimen through the laboratory. He follows
a patient specimen from collection to test result. An inspector can cover
multiple checklist questions in the Laboratory General checklist, questions on
the specimen collection manual, phlebotomy, verbal orders, identification of
patients and specimens, accessioning and result reporting, including
appropriate reference ranges, retention of test records, maintaining
confidentiality of patient data and proper handling of critical values and
revisions to reports.
3.4.1 CAPS tools/techniques for quality improvement
Proficiency testing (PT): It is defined as determination of laboratory
testing performance by means of inter-laboratory comparisons, in
which a PT program periodically sends multiple specimens to members
of a group of laboratories for analysis and/or identification; the program
then compares each laboratorys results with those of other
laboratories in the group and/or with an assigned value
CAP checklists

CAP provides checklists for all types of test procedures performed in

various sections of the lab. These checklists help the labs to evaluate
their current procedure and implement steps to meet the requirement &
thus improving the over all quality of the lab. results.

23

The following gives a basic idea about the checklist:

-

Is there a documented hard copy of the Standard Operating

Procedures (SOPs)

Was the written procedure followed?

Was instrument maintenance performed on schedule?

Were quality control results acceptable?

Was the most recent calibration acceptable and within established

stability limits at the time testing was performed?

ROAD

During a CAP inspection, the CAP inspector follows a four step

inspection procedure as mentioned below:

READ Read/ review documents that must be

looked at during the inspection

OBSERVE

Observe

laboratory practices

by

looking at what the laboratory personnel are actually

doing and note if practice deviates from the
documented policies / procedures.
ASK Ask open-ended, probing questions that start

with phrases such as Show me how.., or Tell me

about..,or What would you do if... Ask follow up
questions for clarifications.
DISCOVER Discover or follow as specimen from

collection to reporting to cover multiple checklist

requirements

simultaneously.

Choose

representative specimen & track the specimen

through the lab. or section of the lab., reviewing
appropriate records in the pre-analytic and post24

analytic categories. Examples of the discovery

opportunities are describes throughout the checklist.

3.5

AREAS WHERE THE CAP PROVIDES GUIDELINES:

CAP provides guidelines to be followed for the following areas in a healthcare

lab.
Infrastructure
Personnel, training and development
Equipment
Reagents and materials
Specimen collection
Requisition form
Accession list
Worksheet
Reporting test results
Specimen rejection record
Data management

This project report is based on how the biomedical engineering department

can improve the quality of services provided to various lab. medicine sections
by following the guidelines formed by internationally recognized accreditation
organisation CAP.

Below mentioned are some of the general guidelines stated by CAP for
keeping the laboratory equipments in good & healthy working condition:
Each laboratory should prepare an exhaustive list of equipment and
consumables required and available for general functioning of the
laboratory and specialized equipment for special tests.

25

 Laboratory equipment should be of adequate capacity to meet work

load requirement.
Equipment should be suitably located in the laboratory so as to allow
accessibility and sequential utilization thus minimizing the need for
frequent movement of specimens or reagents.
All equipment should be in good working condition at all times. Periodic
inspection, cleaning, maintenance of equipment should be done. An
equipment log book should be maintained for all major equipment.
Laboratories should maintain necessary instructions for operation and
maintenance of equipment in the form of Standard Operating
Procedures (SOPs). A copy of SOP should be readily available.
Maintenance contracts including warranty cards, telephone numbers of
staff to be contacted in case of equipment malfunction should be kept
safely. User manual should be available readily for reference. The staff
should be aware of trouble shooting measures to be adopted for
preventing equipment malfunction.
New equipment should be calibrated and validated before routine use.
AMR (Analytical Measurement range) should be verified, manufacturer
can be consulted for verification and selection of range
Periodic performance check/calibration check for all equipment should
be done using reference standard/reference material. The frequency of
performance check should be based on the day-to-day performance of
the equipment.
Equipment performance should be verified from Internal Quality Control
results and External Quality Assessment results. Outlier parameter
trend analysis record should be maintained in respect of its effect on
the equipment.
All analytical equipment should be calibrated and calibration certificate
provided by equipment company. Non-analytical equipment such as
pipette, thermometer, weighing balance and centrifuge should be
calibrated by accredited calibration laboratory or done in-house with
traceability to National Physical Laboratory (NPL) or any other national
26

or international standards (e.g. NIST). For in-house calibration,

laboratories should use :
-

Calibrated tachometer - for centrifuge

Calibrated digital temperature sensor - for checking temperature of

refrigerator, incubator, etc.

Calibrated glass thermometer- for temperature checking of room, oven,

water bath etc.

Calibrated weights - for balance

Equipment measuring pressure, temperature, humidity etc. should be

checked by using suitable reference standards (One that is traceable to
national/international standards).

27

4. PLANNING FOR CAP ACCREDITATION

The CAP Laboratory Accreditation Program is an internationally recognized
laboratory

inspection

program,

the

only

one

of

its

kind

utilizing

multidisciplinary teams of practicing laboratory professionals as inspectors.

Because they deal with laboratory issues on a daily basis, these inspectors
are uniquely qualified to provide you with a thorough inspection that is specific
for each section of the laboratory. A laboratory inspection occurs every two
years. In the years when an on-site inspection does not occur, the laboratory
must perform a self-inspection using materials provided by the CAP. The
accreditation program is voluntary and helps laboratories achieve the highest
standards of excellence in patient care. The program is based on
requirements. These requirements are included in documents called
checklists, which are used both by the laboratory to prepare for inspections
and by the inspection team as a guide to assess the overall quality of the
laboratory.

4.1 CAP ACCREDITATION CYCLE:

28

4.2 CAP ACCREDITATION STAGES:

The entire accreditation process can be divided in three major stages as
mentioned below;
STAGE I Pre-Assessment:
In this phase the laboratory;

Must submit
-

A CAP application request form

Laboratory section pages for each section

Personnel forms for Lab. Directors, Pathologists, QA/QC personnel,

etc.

Supplemental material: CV, Organisation chart, etc.

Must enroll in Proficiency Testing (PT) program for each patient reportabletest and for affiliated labs.

Must list all lab. disciplines in the application

-

Laboratory General

Transfusion Medicine

Chemistry

Hematology

Microbiology

Immunology

Cytogenetic, etc.

Must Provide Labs activity menu

-

Scope of testing

List of all reportable assays

After processing the application, CAP will send the customized checklists to
the laboratory, which will be used by the CAP inspector during inspection.
29

STAGE II Assessment:
The inspector will look at all type of documentation
-

QC records

PT records

Instrument maintenance records

Procedure manuals

The inspector will ask open-ended questions as starting point to

-

Obtain large amount of information

Help understand the documentation

Assess the laboratorys understanding of the requirements

Eliminate the need to focus on checklist

Follow the R.O.A.D. guideline as described earlier

STAGE III Post-Assessment:
Responding to deficiencies discovered in earlier stages

Accreditation

Maintaining accreditation
-

PT participation

Monitoring PT scores

Self-inspection

Anniversary of inspection

30

5. BENEFITS TO THE HOSPITAL FROM CAP

ACCREDITATION
It is the best Laboratory Accreditation Program which is useful for
demonstrating and improving quality
It certifies that the lab is committed to quality patient care and
achieving excellence
It helps in quickly adapting to changing needs of the laboratory
procedures
It helps to improve standards of tests and reports generated by
laboratory
It gives opportunity to learn new methods and techniques to implement
in the laboratory
It helps to achieve excellence and quality patient care
CAP accredited labs benefit from an efficient process that saves time,
promotes standardization, and helps in attaining accuracy in patient
care

Fig. 6 Quality Improvement in Healthcare Laboratories

31

Hence it can be said that in a healthcare laboratory environment, going for

CAP accreditation is equivalent to enrolling in a continuous QUALITY
IMPROVEMENT program.

Now that we have studied the organisation and the quality improvement path
to be followed, let us now go through some of the major changes
implemented in the biomedical department with respect to the globally
recognized CAP guidelines for laboratory equipments.

32

6.GAP ANALYSIS
Providing the best patient care requires laboratories to strive for the highest
performance. The CAP instrumentation program provides labs with useful
information about the performance of various laboratory instruments (manual
and automated) which ultimately leads to determine if the laboratory is
providing the most accurate patient results.

In this step, called Gap Analysis, the organisation attempts to find areas for
improvement which could be located in any section of the lab. or any level
during the whole process from sample collection to result reporting.

Definition of Deficiency: Non-compliance to a mandatory requirement of the

accreditation checklist. i.e. the lab. fails to meet one or more than one
compulsory requirement as described in the checklist given by CAP. This
deficiency could be associated to any procedure like in specimen collection or
specimen transportation or equipment maintenance, etc.

The best way to find out deficiency in the present system is to hire an external
consultant who is well experienced & has sound knowledge about the
complete accreditation and quality control implementation.

Consultant: A consultant is usually an expert or a professional in a specific

field and has a wide knowledge of the subject matter.
External Consultant - Someone who is employed externally (either by a firm or
some other agency) whose expertise is provided on a temporary basis. As
such this type of consultant generally engages with multiple and changing
clients.

It was my honour to work with Mr. Jayasheel Hegde who was appointed as
the external consultant for this project by the head of Lab. Medicine section
Dr. T. F. Ashavaid at P. D. Hinduja National Hospital.
33

Under the expert guidance of Mr. Hegde, I was able to find the right path and
discover the areas which needed improvement in biomedical engineering
department. With his advice I was able to implement new ideas with respect
to various procedures performed by engineers as well as the documentation
of the same.

Since this project work is concerned with different quality improvement

techniques implemented in the biomedical engineering department, for
providing their services to lab. medicine section in a hospital environment. Let
us study the scope of work for a biomedical engineering department in a
hospital.

6.1 SCOPE OF BIOMEDICAL ENGINEERING DEPARTMENT

SERVICES IN A HOSPITAL:
We may divide the services of biomedical engineering department in following
major categories:

1. Equipment Documents, Procedures & Manuals

2. New Equipment Installation
3. Break Down Calls
4. Equipment Maintenance
5. Equipment Calibration
6. Equipment Data Management

Once the management has taken their decision on Organization, Facility, and
Personnel, the laboratory medicine section needs to acquire the equipment
necessary for delivering its desired testing services.

34

The biomedical dept. should assist lab. medicine in selecting the criteria for
each piece of equipment needs to be acquired, and should assure which
vendors can meet those criteria. Before equipment is selected / purchased the
biomedical dept. needs to verify that the laboratorys physical facility can meet
the equipments needs for space and load bearing; electricity, ventilation,
humidity, and temperature, water type and quality; and any other special
requirements. After arrival, and before use, each piece of equipment needs to
be installed and initially verified as meeting the manufacturers stated
performance characteristics.

After the onset of the actual testing, the equipment must also be verified as
functioning as intended in the actual work processes in which it is used.
Finally schedules and procedures that follow manufacturers instructions are
prepared for ongoing preventive maintenance, calibrations, and calibration
verification. Performance records provide objective evidence of outcomes of
these required activities. Troubleshooting, service, and repair records are also
required. Reconstruction of the history of each piece of equipment from
acquisition to decommission should be traceable from the equipment records.

35

6.2 CAP GUIDELINES FOR LABORATORY INSTRUMENTS &

EQUIPMENT:
A variety of instruments and equipment are used to support the performance
of analytical procedures. All instruments and equipment should be properly
operated, maintained, serviced, and monitored to ensure that malfunction of
these instruments and equipment do not adversely affect the analytical
results. The procedures and schedules for instrument maintenance must be
as thorough and as frequent as specified by the manufacturer.

Given below are some of the specific guidelines by CAP for laboratory
instruments & equipment:

6.2.1 Thermometric Standard Device

An appropriate thermometric standard device of known accuracy (guaranteed

by manufacturer to meet NIST Standards) is available.

NOTE: Thermometers should be present on all temperature-controlled

instruments and environments and checked daily .Thermometric standard
device should be recalibrated or recertified prior to the date of expiration of
the guarantee of calibration.

Evidence of Compliance: Thermometer certificate of accuracy

6.2.2 Non-Certified Thermometers

All non-certified thermometers in use in the laboratory are checked against an

appropriate thermometric standard device before placed in service.

36

Evidence of compliance:
- Written procedure defining criteria for verification of non-certified
thermometers AND
- Record of verification prior to being placed in service

6.2.3 Temperature Checks

The temperature of water baths and/or heat blocks, refrigerators and other
temperature - dependent equipment is checked and recorded daily.

6.2.4 Mechanical Timer

Mechanical timers on serologic centrifuges, and the speed of the centrifuges,

are checked for accuracy every 6 months.
Evidence of Compliance: Record of serologic centrifuge checks documents at
defined frequency.

6.2.5 Routine Maintenance Schedule

All instruments are on a routine maintenance program.

6.2.6 Instrument Repair Record

Instrument maintenance, service and repair record (or copies ) are promptly
available to, and usable by the technical staff operating the equipment.

6.2.7 Automatic Pipette Accuracy

Automatic & adjustable pipetting devices are checked at least annually for
accuracy & reproducibility & results recorded.

37

Evidence of Compliance:
- Written procedure detailing method for checking the accuracy &
reproducibility of automatic pipettes AND
- Records of initial & periodic pipette verification documented at defined
frequency

6.2.8 Analytical Balance

Balances are cleaned, serviced & checked at least annually only be qualified
service personnel.
Evidence of Compliance:
- Records of balance maintenance
- Written record of periodic accuracy checks

Now our task was to implement necessary changes in each of the biomedical
engineering procedure / field which should match to the above stated CAP
guidelines and ultimately help the organisation in gaining the objective of
accreditation & quality improvement.

ESTABLISH
REQUIREMENTS

IMPLEMENT
CHANGE

COMPARE WITH
CHECKLIST

To begin the process, we started with developing documentation for each of

the procedures mentioned in the list above which then should be placed in a
properly named file.

38

7. EQUIPMENT DOCUMENTS, PROCEDURES &

MANUALS
The Biomedical department should have a quality management policy and a
written and documented procedure pertaining to all types of services carried
out by the department to ensure the quality of the results generated by the
laboratory equipments ultimately leading to patient safety, care and
improvement in quality.

To solve this issue we prepared standard operating procedure (S.O.P.) for

each of the laboratory equipment describing the procedure in detail. To
prepare these documents help was taken from the equipment operating
manual & service manual provided by the manufacturer, the biomedical
engineering department policies & internet.

Let us have some explanation to understand the term SOP.

39

7.1 STANDARD OPERATING PROCEDURE (SOP):

SOP is a document, which contains detailed, written instructions
describing the stepwise process and technique of performing a test or
procedure on a laboratory equipment. e.g. Periodical Equipment
Maintenance, Calibration, etc. In other words,
SOP is a procedure for performing an operation (i.e., any work done
by any employee. e.g. Conveying a report through is also an
operation). SOP describes a standardized procedure.
SOP helps to ensure uniformity, consistency and control over the
processes carried out. It ensures that the procedures are done in
exactly the same way each time irrespective of the operator.
SOP should contain information on who can perform the test, their
qualification and training, how to carry out the test including preanalytical, analytical and post-analytical stages of test/procedure,
laboratory conditions required for the test/ procedure, routine care and
maintenance of equipment, precautions and safety instructions,
troubleshooting measures, waste disposal, etc.
SOP should be simple and written in an easy to understand language.
The procedure described in the SOP must be followed exactly by all
staff members to ensure high quality results.
It should be titled along with version number, dated and signed by an
authorized person and updated regularly.
It is important for the SOP document to be readily available in the
working area and is therefore also referred to as 'laboratory bench
work manual'.
SOPs are controlled documents and can be changed only with
approval of the laboratory quality manager and/or Head of the
laboratory

40

7.1.1 Format of SOP

The header of SOP should display the following information on all pages:
Title of SOP and Document number
Version number with dates of revision
Issue number and date of issue of the document
Page number/Number of pages

Following this common format the SOPs were written for various procedures
such as new installations, preventive maintenance schedule / plan, equipment
calibration, safety testing, equipment log book etc. These are explained in
detail in APPENDIX section of this project using examples.

41

8.NEW EQUIPMENT INSTALLATION

The SOP for new equipment installation guides the personnel to follow each
and every important step from the beginning to the end of installation process.
It provides information about formal checks and documentation to confirm that
the instrument and its components have been supplied as ordered and
properly installed in the lab environment.

Upon delivery, the shipment is visually inspected and reviewed for

completeness followed by installation of all hardware, software and
peripherals. Once completely installed, the system will be turned on to confirm
all modules and systems work correctly.

Finally, all information determined is then documented within the protocol.

Fig. 7 New Equipment Installation

42

Following points are considered important when a new installation is taking

place.
Compare & check that the equipment is received as per the purchase
order including software, accessories, spare parts, and documentation
such as tutorials, manuals and operating procedures.
Check equipment for any damage during shipping. (You may take help
from Tilt/Shock indicators pasted on the shipment box)
Check that the documentation supplied is of the correct issue
Establish

that

the

laboratory

environmental

requirements

are

appropriate for the instrument (as applicable for example power,

operating temperature in the lab, bench, lighting, LIS terminal,
accessibility etc.)
Review all hazards and safety precautions, including materials that
may come in contact with the instrument
Check that the installation of hardware including all software &
peripherals, e.g., printers and each equipment module is done
successfully.
Document equipment tutorials, manuals and operating procedures
Perform installation functionality checks, if applicable also perform the
safety tests, and prepare installation report
Record all relevant activities and actions and sign all required
documents.
Locate the certificates of conformity, warranty and place them in the
appropriate protocol appendices.
After the documentation & confirming that the installation is completed
successfully, generate asset no. for each newly installed system.
Submit place the original documents in the Biomedical department and
provide a copy of the same to lab. in-charge for reference.
Place hospital sticker on each equipment indicating Asset No., Date of
installation & Date to perform next Preventive Maintenance.

43

For larger laboratory analysers, this documentation is divided in three parts,

which is:

1) INSTALLATION QUALIFICATION (IQ)

Installation qualification establishes that the instrument is received as
designed and specified, that it is properly installed in the selected
environment, and that this environment is suitable for the operation and
use of the instrument.

2) OPERATIONAL QUALIFICATION (OQ)

Operational qualification is the process of demonstrating that an
instrument will function according to its operational specification in the
selected environment.

3) PERFORMANCE QUALIFICATIO (PQ)

Performance Qualification is the process of demonstrating that an
instrument

consistently

performs

appropriate for its routine use.

44

according

to

specification

9. EQUIPMENT MAINTENANCE
Lab equipment that functions efficiently enhances the efficiency of laboratory
procedures. However, routine use in busy labs may result in operational
defects. Timely repair and maintenance services are therefore needed to
keep equipment running smoothly and ensure their durability.

Fig. 8 Equipment Maintenance

There are many established & certified laboratory equipment dealers

providing quality repair and maintenance services to meet the needs of
research

laboratories

in

universities,

government

institutions,

private

organizations and healthcare facilities. Such services are now widely available
for all kinds of medical equipment, ranging from coagulation analyzers,
immunoassay analyzers, centrifuges and flow cytometers to microscopes,
mixers & shakers.

45

Many labs underestimate the value of preventive maintenance (PM). When

weighing the value of PMs, it is important to consider that preventive
maintenance offers these benefits:
Reduces lost time or down time due to equipment failure
Instrument downtime is costly, especially during critical workloads.
Continuous care and preventive maintenance reduces the risk that a
critical instrument is offline when needed.
Safeguards your labs Good Laboratory Practices (GLP)
GLP requires that instruments in a lab subject to regulatory oversight have
a documented Preventive Maintenance (PM) program. Missed PMs are
easily found in an inspection / audit. If multiple PMs are missed, a pattern
of non-compliance could lead to an enforcement action.
GLP requires that lab equipment operates within manufacturers
specifications. Instrument performance declines over time as parts wear
and components age. Scheduled Preventive Maintenance protocols are
designed to keep equipment operating within specifications.
Extends the life of an instrument
Instruments subject to intermittent and inconsistent maintenance have a
shorter working life. Ongoing preventive maintenance is more cost
effective and more easily managed - compared to emergency repairs and
capital equipment replacement.
Cost saving
Preventive Maintenance program saves on the expenses that would be
needed to buy new devices.

46

 Accuracy
Serving by expert, factory-trained technicians ensure that the job is done
right. They can identify potential issues and take timely action to prevent
further damage.

Keeping in mind all these above mentioned points for quality improvement in
equipment maintenance, we focused on preparing by following the CAP
guidelines:

1) Preventive maintenance schedule

2) SOPs for preventive maintenace
3) Preventive maintenance check list for each laboratory equipment

Next section elaborates these 3 points in details;

9.1 PREVENTIVE MAINTENANCE SCHEDULE:

The Biomedical Engineering Department shall be responsible for ensuring
that all laboratory equipments are maintained in good working condition. They
shall periodically issue updated maintenance schedule assignments as per
the equipment installation database & the check list that states what actions
are to be taken at what time and by whom to maintain equipment. Every
organization must have a master plan for Calibration and PM which includes
all equipments. Check APPENDIX section of this report for PM schedule
specimen.

The engineer assigned for the PM job, shall be responsible for adhering to
the routine maintenance schedule and carrying out other special maintenance
tasks as required by the lab and mentioned in the SOPs.

Each maintenance job performed shall be entered in the maintenance log and
updated the same day. If the PM was missed or the date needs to be
47

changed it shall be brought to the notice of section manager and same shall
be updated in the master schedule.

9.2 SOPs FOR PREVENTIVE MAINTENACE:

As discussed before, SOPs are very important because:

It contains detailed, written instructions step by step

It gives complete idea about the technique

It contains information on who & how the procedure can be performed

Most importantly, it helps to ensure uniformity, consistency and control

over the processes carried out.

Please find a general SOP format for laboratory equipment maintenance

on the next page.

48

XYZ (Name of the Hospital)

Laboratory Standard Operating Procedures
Laboratory Equipment Maintenance
Lab SOP No.: _____________

Version No.: ______________

Equipment name:

Equipment Sr. No.: _________

_________________
Lab. Medicine Section:

Page No.: ________________

_____________
Date prepared: _____________

Date adopted: _____________

I. PRINCIPLE

Brief description on principle of the equipment, purpose of use.

II. FUNCTIONAL VERIFICATION

A. Check for functional performance

B. Check various modules/ parts
C. Check peripherals
D. Check as applicable power, operating temperature, water supply, waste
drain, LIS terminal.

III. PRECAUTIONS

List of precautions to be taken while performing the maintenance with

respect to any of the following points as applicable;

A. Electrical safety for the personnel performing the PM as well for the
equipment
B. Chemical safety for the reagents/chemicals used
C. Fire safety
D. Taking care for the moving parts
49

IV. INSTRUMENT MAINTENANCE

Perform maintenace step by step as applicable

A. Cleaning
B. Decontamination
C. Lubrication
D. Electrical contacts
E. Defrost
F. Tubing/filter replacement

V. CORRECTIVE ACTION

Take the necessary corrective action if needed

A. Equipment repair
B. Equipment calibration
C. Equipment re-location
D. Spare part replacement
E. Data back-up
(Record the corrective action taken.)

VI. APPROVAL
The signature below constitutes the approval of this SOP for use in the
laboratory.

Biomedical Manager
Signed: ________________________

Date: ____________________

Full name: _____________________________

Lab. Medicine Section Supervisor

Signed: ________________________

Date: ____________________

Full name: _____________________________

50

Following the format explained & the points mentioned above, we developed
the SOPs in such a way that we combined it with check list as well as
mentioning the PM schedule i.e. when PM was done and the next due date.
One example for this SOP can be seen in the APPENDIX section of this
project report.

51

10. EQUIPMENT CALIBRATION

Equipment monitoring is specified as an essential element of quality
assurance for standard calibration in accordance with many international
standards. Test equipment monitoring must assure that all test equipment
used for assuring product quality measures correctly.

In order to ensure that this is the case, lab. equipment must be calibrated on a
regular basis, and must be retraceable to national standards. Obtained
measured values must be documented as well.

Instrument calibration is intended to eliminate or reduce bias in an

instrument's performance over a range for all continuous values. For this
purpose, reference standards with known values for selected points covering
the range of interest are measured with the instrument in question. Then a
functional relationship is established between the values of the standards and
the corresponding measurements.

Proper calibration of an instrument allows people to have a safe working

environment and produce valid data.

Fig. 9 Laboratory equipment calibration

52

10.1 IMPORTANT TERMS USED IN CALIBRATION PROCESS:

Test Equipment or Standards

Accredited Labs. must use master test equipment or standards that may
be used to calibrate various laboratory equipments. These pieces of
equipment must be appropriately marked or labeled, and must be
calibrated so as to be traceable to national / international standards where
possible.
Traceability

Test equipment must be appropriately marked or labeled, and must be

calibrated so as to be traceable to SI units where possible. Traceability
may be accomplished by having calibrations performed by:

Certified directly by NIST (National Institute of Standards and

Technology, USA) / NPL (National Physical Lab., India)

A Calibration laboratory accredited by an accrediting body that is a

signatory to the International Laboratory Accreditation Cooperation
(ILAC) Mutual Recognition Arrangement (MRA), or one of its
recognized Regions

Direct reference to a primary standard or to a natural constant, the

value of which in terms of the relevant SI unit is known and
recommended

Estimation of measurement uncertainty

Estimation of measurement uncertainty is a crucial portion of ensuring

traceability. Where it is possible to calculate uncertainty, the calculations
must be performed.

53

Uncertainties must be supported by an uncertainty budget and

represented as expanded uncertainties. Uncertainties are to be reported at
the 95 percent or higher level of confidence. Any lower level of coverage
must be supported by documented justification. The coverage factor (k) is
determined using degrees of freedom and the T-Tables. Uncertainty is
typically calculated at k=1.96 for 95% confidence. However, k=2 is
typically used in reporting. The use of k=2 is acceptable for reporting
uncertainty.

Calibration certificates and reports must provide statements of the

measurement results and the associated uncertainty. Such statements
must include the coverage factor and confidence level.

10.2 CALIBRATION PROCEDURES:

Calibration procedures must be both verified by ensuring that the instrument
is adequately calibrated and validated making sure that the calibration is fit for
intended use of the instrument. Calibration procedures may be obtained from
external sources such as the manufacturer, calibration service provider or if
possible may be performed internally.

Calibration procedures obtained from some external sources may be

considered already verified and validated.

Internally developed calibration procedures must be verified and validated.

Evidence of the verification and validation must be maintained for as long as
the procedure is considered valid for use. Associated uncertainties must be
documented as part of the evidence.

Environmental monitoring equipment is included as equipment whose function

has an effect on the calibration operations of the laboratory equipment, and
must be calibrated for example thermometer used to measure air temperature
or pressure meter, etc.
54

It is possible that a laboratory may use a calibration provider that is

accredited, but not for the specific calibrations required for the laboratory. In
those instances, they must verify the providers ability to perform the
calibrations and also ensure that the provider has trained staff & traceable
master test equipment or standards with a valid traceability certificate.

Basic calibration steps for correcting the instrument for bias

The method is the same for any of the situations stated above and
requires the following basic steps:
1. Selection of reference standards or master test equipment with known
values to cover the range of interest.
2. Measurements on the reference standards with the instrument to be
calibrated.
3. Functional relationship between the measured and known values of the
reference standards.
4. Correction as required.

In this project we decided to perform some of the equipment calibrations and

other equipments were handed over to a service provider for calibrations
making sure they are certified to carry out this job and have traceable
standards.

For the purpose of understanding the quality assurance measures taken to

ensure valid calibration for all laboratory equipments, let us study some of the
cases in more detail. i.e.

1. Thermometer
2. Centrifuge
3. Micropipette

55

10.3 THERMOMETER:
The mercury-in-glass or mercury thermometer was invented by German
physicist Daniel Gabriel Fahrenheit in 1714. It consists of a bulb containing
mercury attached to a glass tube of narrow diameter; the volume of mercury
in the tube is much less than the volume in the bulb. The volume of mercury
changes slightly with temperature; the small change in volume drives the
narrow mercury column a relatively long way up the tube. The space above
the mercury may be filled with nitrogen or it may be at less than atmospheric
pressure, a partial vacuum.

Fig. 10 Mercury-in-glass or mercury thermometer

56

Fig. 11 : Mercury in glass thermometer structure (medical grade)

Glass thermometers are remarkably stable and reliable indicating devices.

Nonetheless, changes in the indications of a given instrument do occur, as a
result of temperature cycling and day-to-day handling.

When a thermometer is heated, the liquid within the bulb expands and is
forced upward into the capillary where its level indicates the temperature
value. Each heating and cooling cycle imparts tremendous stress to the bulb.
After repeated use, even the highest quality liquid in glass thermometer will
undergo a slight change in bulb volume due to this expansion and contraction.
When a change of this type does take place, the indication of the thermometer
will also change.

Re-calibration of the certified thermometer updates the indications and thus

allows the user to maintain accurate, reliable and consistent results when
making temperature measurements. NIST recommends annual recalibration
for

liquid-in-glass

thermometers,

thermistors

and

PRTs.

The

Good

Measurement Practice (GMP) goes on to recommend six month calibration

intervals for liquid-in-glass thermometers used for temperature critical
parameters.

57

Re-calibration at regular intervals with document traceability to NIST

standards is an important part of most quality programs and international
standards, to assure that required levels of accuracy are being met.

In our quality improvement project we decided to approach a thermometer

supplier, who would provide us the thermometers matching the temperature
range as per our laboratory requirement. Secondly the supplier would provide
us a calibration certificate of the device indicating accuracy and traceability to
any national or international standard like NPL/ NIST.

Later at regular interval these thermometers will be checked and calibrated by

the staff following the procedure as mentioned in a sample SOP described in
next section.

Fig. 12 NIST calibrated thermometer with calibration certificate

58

10.3.1 Sample SOP for Lab. Thermometer Quality Control

XYZ (Name of the Hospital)

Laboratory Standard Operating Procedures
Thermometer Quality Control
Lab SOP No.: _____________

Version No.: ______________

Lab. Medicine Section:

Page No.: ________________

_____________
Date prepared: _____________

Date adopted: _____________

I. PRINCIPLE
Refrigeration of reagents is essential in ensuring shelf life and stability.
Room temperature monitoring is also important for the proper functioning of
equipment. Thermometers vary widely in their calibration accuracy.
Therefore, it is essential that all thermometers are calibrated against a
national or international traceable standard / reference thermometer for
proper temperature control of freezers, refrigerators, incubators, and room
temperature.

II. SCOPE
A. Thermometers will be calibrated when they are brought into service.
B. Existing thermometers will be calibrated yearly to assess accuracy.
All thermometers can be calibrated during a single month or
calibration can be staggered.

III. IDENTIFICATION
All thermometers will be uniquely identified. The identifier will be recorded in
a logbook located in the laboratory, along with the initial and all future
calibrations.

59

IV. PROCEDURE
A. Visually inspect thermometer for any cracks in the capillary or bulb.
Check the mercury or alcohol column for separations that may
have occurred. If no defects are found, continue with this
procedure.
B. Immerse the Standard / Reference thermometer into the same
glycerol/water bath as the thermometer that is being calibrated.
(NOTE: Allow the system to equilibrate for one hour.)
C. Read and record the temperature on both thermometers.

V. RESULTS
Temperature readings must be within 1 degree of each other.

VI. CORRECTIVE ACTION

Discard any thermometer that is broken, does not read within 1 degree
of the Standard / Reference thermometer, or contains bubbles. Notify
section supervisor so that a new thermometer may be ordered.

VII. APPROVAL
The signature below constitutes the approval of this SOP for use in the
laboratory.

Biomedical Manager
Signed: ________________________

Date: ____________________

Full name: ____________________________

Lab. Medicine Section Supervisor

Signed: ________________________

Date: ____________________

Full name: _____________________________

60

10.4 CENTRIFUGE:
The word centrifuge comes from the Latin word centrum which means centre
and fugere which means to escape. The centrifuge is designed to use the
centrifugal force generated in rotational movements to separate the
constitutive elements of a mixture. There is a wide range of centrifuges
capable of serving specific industry and research needs. This section focuses
on standing centrifuges normally used in health and clinical laboratories.

Fig. 13 Centrifuge
61

Centrifuge generally driven by an electric motor, that puts an object in rotation

around a fixed axis, applying a force perpendicular to the axis. The centrifuge
works using the sedimentation principle, where the centripetal acceleration
causes denser substances to separate out along the radial direction (the
bottom of the tube). By the same token lighter objects will tend to move to the
top (of the tube; in the rotating picture, move to the centre).

10.4.1 Purpose of the centrifuge

The centrifuge uses centrifugal force (the force generated when an object
rotates around a single point), for separating solids suspended in a liquid by
sedimentation, or liquids of diverse density. The rotational movements allow
forces much greater than gravity to be generated in controlled periods of time.
In the laboratory, centrifuges are generally used in processes such as the
separation of solid components from biological liquids through sedimentation
and in particular of blood components: red cells, white cells, serum & platelets
among others which is then used for conducting multiple tests and treatments.

There are several kinds of centrifuges. The most widely used in public health,
surveillance and clinical laboratories are the table-top centrifuge, the
ultracentrifuge, the haeamatocrit centrifuge and the standing centrifuge.

10.4.2 Components of the centrifuge

The most important components of a centrifuge are the following:

1. Power ON and OFF control, operation time control (timer), rotation speed
control (in some centrifuges), temperature control (in refrigerated
centrifuges), vibration control (safety mechanism) and brake system.
2. Refrigeration system (only in refrigerated centrifuges).
3. Vacuum system (in ultracentrifuges).
4. Base
5. Lid/cover
62

6. Casing
7. Electric motor
8. Rotor. There are different types of rotors. The most common are the fixed
angle, the swinging buckets, the vertical tube and the almost vertical tube
types.

10.4.3 Routine maintenance

The routine maintenance required by a centrifuge depends on multiple factors

such as the incorporated technology, usage intensity, training of users, quality
of the electrical feed and environmental conditions. The following are general
recommendations regarding adequate use and most common maintenance
for guaranteeing correct operation.

(Priority recommendation: Verify that only qualified personnel trained and

familiar with the use, care, risks and handling of the centrifuge operates it. It is
the laboratory directors responsibility to supervise and take necessary
precautions so that personnel operating centrifuges understand the
implications of working with such equipment)
Always disinfect the rotor bowl, centrifuge head, buckets and trunnion
rings as applicable before any servicing of centrifuges used to prepare
clinical or infectious samples.
Wash tubes adaptors and other accessories by hand using a 1:10 mild
detergent solution in water and a soft textured brush (not metallic).
Verify that the centrifuge external components are free of dust and
stains. Avoid aff -ecting the rotor with spills.
Clean the rotor compartment using a mild detergent.

63

 Test that the rotors connecting and adjustment mechanisms are in

good condition. Keep the points lubricated as the manufacturer
recommends.
Verify the locking /safety mechanism of the centrifuges cover. This is
fundamental in guaranteeing operators safety as this mechanism
keeps the cover of the centrifuge closed while the rotor is turning.
Check the lubrication state of elements such as for O-rings as the
manufacturer recommends. Always use lubricants according to the
manufacturers instructions (frequency and type of lubricants). In
recently manufactured centrifuges, there are sealed ball bearings
which do not require lubrication.
Verify the state of the motors brushes, if the centrifuge has a motor
with brushes. Substitute with new ones (with the same specifications
as the original) if necessary.
If the centrifuge is refrigerated, test the temperature by using an
electronic thermometer. The temperature must not vary by more than
+/- 3 C.
Examine the exactitude of the time controls. Use a timer. The time
measured must not vary by more than +/- 10 % of the programmed
time.
Verify the actual rotation speed against the selected one using a
normal load. The testing is done with a tachometer or a photo
tachometer. If the hatch is not transparent, the procedure indicated by
the manufacturer must be followed.

64

Fig. 14 Contactless tachometer Principle of operation

Confirm the functioning of the emergency brake system.

Keeping in mind above mentioned points and the standard format of SOPs,
we developed a combined SOP format which included also the PM CHECK
LIST as well the date scheduled for maintenance. This is attached for your
reference in the APPENDIX section of this project report.

10.5 MICROPIPETTE:
Accurate volumetric measurements and transfers are essential to all
laboratories concerned with maintaining high levels of quality and productivity.
The performance of pipettes varies substantially, and their accuracy cannot
be taken for granted.

Fig. 15 Micropipette used in healthcare labs

65

Mainly micropipettes, both adjustable & fixed volume, are used to accurately
measure small volumes of liquids (volumes typically vary from 1 to 1000 L).
The parts of typical micropipettes are shown below.

Fig. 16 Parts of lab. grade micropipette

10.5.1 Use of the micropipettes

The micropipettes are used for pipetting desired volumes for various lab
procedures. It is used with a suitable plastic tip (disposable) which is selected
keeping in mind the pipette & volume to be pipetted.

The plastic tip is used to avoid the liquid from being drawn into the barrel of
the micropipette itself. The tip should always be placed firmly on the end.
Since the principle by which the micropipette works is the creation of a
vacuum in the tip, causing liquid to be drawn up, it is critical that the tip be on
tight enough to make an air-tight seal.

66

Fig. 17 Adjustable Micropipette with Disposable Plastic Tips

Plunger is used to operate the micropipette. By using the plunger liquid can
be aspirated into the tip as well cab ne expelled out completely.

The volume to be taken up is set by turning the plunger or in some cases a

separate volume adjustment knob is provided as seen in fig. 16 above. The
user can also check the numerical settings displayed on the readout.

Although micropipettes are usually quite accurate when newly purchased,

they can eventually develop problems with use and require maintenance &
calibration to ensure that they are delivering a known volume of fluid.

10.5.2 Preventative Maintenance

Complete disassembly (as applicable), inspection, and cleaning of
instrument.
Replacement of Teflon seal and o-ring or grease, if the instrument
requires a seal, and as recommended by the manufacturer.
Calibration of instrument if required.
67

 Fix sticker/tag to pipette with date of service and service provider.

All measurement and test equipment used for calibration must be SI
through NIST traceable or other recognized standard.

10.5.3 Important points to remember

1) Tips Use high quality tips which optimize the pipettes performance be
used. A high quality tip is one that has a smooth uniform interior with straight
even sides that prevents the retention of liquids and minimizes surface
wetting. Also it should fix tightly to attachment.

2) Pre-Wetting/Pre-Rinsing Tips - Failing to pre-wet tips can cause

inconsistency between samples since liquid in the initial samples adhere to
the inside surfaces of the pipette tip, but liquid from later samples does not.
Also, if a new volume is dialed in on the pipettes micrometer, you will receive
better results at the new volume by taking the old tip off and placing a new
one on the shaft before you commence pipetting.
3) Temperature The volume delivery performance specifications of pipettes
have been referenced by most manufacturers at room temperature which is
defined as 20-25C. Any deviation from this specification can affect the
amount of liquid dispensed due to the expansion or contraction of the internal
components. Temperature is probably the most important factor that
influences pipette performance. In fact, the density of water in a gravimetric
analysis is calculated as a function of temperature
4) Equilibration Time It is recommended that the tip, the pipette, the liquid
being transferred, and the transfer container itself all be allowed to equilibrate
to the same temperature. This is done to lessen the effects of thermal
expansion which can dramatically impact the delivered volume.
5) Barometric Pressure Pressure is reduced by 1.06" Hg for every 1000' of
elevation, however, barometric pressure has only a small effect on the density
68

formula, so the error encountered in not correcting for elevation is often

ignored.
6) Relative Humidity This is the percentage of moisture in the air at a
measured dry bulb temperature compared to the amount of moisture that the
air can hold at that temperature if the air is 100% saturated. Relative humidity
exerts a major influence on taking accurate measurements of volume delivery.
Under dry conditions, which are defined as less than 30% RH, it is extremely
difficult to ensure an accurate measurement due to the rapid evaporation rate
of liquid.

10.5.4 Pipette calibration

Principle:

Under a constant temperature and atmospheric pressure, the density of

distilled water is constant. The volume of water can be determined by
weighting dispensed water. The calibration of pipette is carried out by
gravimetric method. When determining the volume of water, the accuracy
of measurements is effected by ambient temperature, atmospheric
pressure and relative humidity. These factors are usually combined to give
the Z factor, used in calculation of volume of water. Then the calculated
volume of water is compared with the theoretical volume to determine the
accuracy and precision of the pipette.
Material and equipment:

(1) Pipette and tips

(2) 50 ml beaker and plastic medicine cup
(3) Distilled water ( >=10MQ )
(4) Temperature meter ( 0.1 )
(5) Analytical balance ( 1.0 mg )
(6) Atmospheric pressure meter
69

(Items 4,5 & 6 must have a valid calibration certificate, traceable to

recognized standards)
Procedure:

1. Turn on the balance

2. Place aluminum foil (prepared to cup shaped) on the pan of balance
carefully
3. Zero the balance by tarring from its keyboard
4. Pipette out DW onto the foil and observe the weight of water on the data
display
5. Zero the balance by tarring from its keyboard, again
6. Pipette out DW with the same pipette onto the foil and observe again
the weight of water
7. Repeat steps 5 and 6 for more than 30 attempts
8. Calculate the Accuracy and % CV and compared with the specified
range
9. If the results are within the acceptable range, calibration procedure is
completed
10. Pipette should be calibrated every 6 months routinely

The College of American Pathologists (CAP) and National Committee for

Clinical Laboratory Standards (NCCLS) recommend that an initial pipette
calibration be performed on new pipettes, using 30 data points to estimate
within-run imprecision, or at least ten data points to estimate inaccuracy
alone. Thereafter, pipettes should be checked for accuracy and precision at
specified, periodic intervals, depending upon how pipettes are stored,
handled, and used in the laboratory.

70

11. CONCLUSION
Quality improvement is defined as a systematic approach that uses specific
techniques to improve quality. The most important ingredient in successful
and sustained improvement is the way in which the change is introduced and
implemented.

Quality improvement project can be summarized in three basic phases:

PHASE I : Study & Design
Plan target or an area they which requires improvement, collect
data to establish a starting point.
PHASE II : Implementation
Identify and implement specific actions to correct problems
described in previous phase.
PHASE III : Re-measurement and evaluation
Re-measure performance after implementing improvement
efforts into place and evaluate if they were successful.

Fig. 18 Quality improvement

71

In healthcare field, Quality Improvement (QI) is a proven, effective way to

improve care for patients, residents and clients, and to improve practice for
staff. Hence there are always opportunities to optimize, streamline, develop
and test processes. QI should be a continuous process and an integral part of
everyones work, regardless of role or position within the organization.
More specifically, QI in healthcare should be considered as A broad range of
activities of varying degrees of complexity and methodological and statistical
rigour, through which healthcare providers develop, implement and assess
small-scale interventions, identify those that work well and implement them
more broadly in order to improve clinical practice.

Hence we conclude that, Quality improvement (QI) involves a series of

activities undertaken to reduce the gap between current practice and desired
practice. QI offers a way to organise and harmonise the provision of care by
engaging service providers at the point of service delivery in reflecting and
assessing the performance of their programme and in deciding how they
could organise themselves to do their jobs better.

72

12. APPENDIX
12.1 EQUIPMENT LOG BOOK

EQUIPMENT LOG BOOK

Name & Model of Equipment: ______________

Department: _________________
Equipment Serial Number: _________________
Emergency Telephone No: ________________

No.

Date

Problem/ Event

Action taken

Remarks,
Signature

73

12.2 SOP FOR CENTRIFUGE MAINTENANCE WITH

CHECK LIST
Name of Hospital
Department: Biomedical Engg

Equipment: Centrifuge

Section:

Asset no:

Procedure No.:

Page No : 01

Title : Preventive Maintenance Procedure Check with Schedule

Sr. Procedure

P.M.

Next

Date:

P.M:

Preliminary Checks
1.

Check mains supply (230V AC) and power cord.

2.

Check LED display, timer & switches.

3.

Check lid locking mechanism

4.

Check machine body & lid for any damage or

defect
Remove & Clean

1.

Open and clean all internal parts.

2.

Check speed control rheostat wiper contact &

check for continuity.

3.

Remove & clean all tube holders for dust

deposition or sample spillage. (CAUTION! Wear
protective gloves)

4.

DECONTAMINATION: Spray the centrifuge

chamber & test tube holders for it may have
come in contact with dangerous biological
samples, using disinfectant detergent such as 10
% bleach solution. Repeat spray treatment &
leave solution on surfaces for approx. 10 min.
finally clean with paper towel soaked in water.

5. Re-fix all parts & test the m/c for proper spinning.
74

P.D. HINDUJA NATIONAL HOSPITAL AND MEDICAL RESEARCH

CENTRE
Department: Biomedical Engg

Equipment: Centrifuge

Section:

Asset no:

Procedure No.:

Page No : 02

Title : Preventive Maintenance Procedure Check with Schedule

Check / Clean / Replace

1.

Check the motor voltage supply (230 V AC)

2.

Check rubber cushion of tube holders for wear &

tear, carbon brush and replace with new if required.
Final Check & Calibration

1.

Give a dummy run & check for imbalance & stability.

2.

Check and verify the actual speed (RPM) against

the speed with a tachometer

3.

Machine tested fully operational.

Engineers Signature :
Name:

End Users Signature

Date:

Name:

Date:

Approved by:
______________________
(Manager - Biomedical Engg.)
Due Date

Signature:

January 2012

January 2013

Document
Reviewed

75

January 2014

12.3 GLASS THERMOMETER CALIBRATION

CERTIFICATE

76

12.4 MICROPIPETTE CALIBRATION CERTIFICATE

77

12.5 TRACEABILITY CERTIFICATE - SPECIMEN

78

Traceability Certificate Specimen.Continued

79

12.6 PREVENTIVE MAINTENANCE SCHEDULE

(SPECIMEN)

(NAME OF THE HOSPITAL)

LABORATORY MEDICINE SECTION
YEAR 2013
LAST REVIEW DATE: __________
PREVENTIVE MAINTENANCE MASTER SCHEDULE

No. ASSET J

NO.

XYZ

14

14

XYZ

XYZ

XYZ

15

15

XYZ

26

26

28

28

80

12.7 PREVENTIVE MAINTENANCE STICKER - SPECIMEN

81

13. BIBLIOGRAPHY
Books:
1.

Quality is free - Crosby, P. B.

2.

Jurans Quality Handbook Joseph M. Juran

3.

Quality Improvement Assessment Guide for Medi-Cal Managed

Care Plans Medi-Cal Managed Care Division , California
Department of Health Care Services

4.

Quality Improvement Made Simple - The Health Foundation, UK

5.

Quality Improvement Guide - Health Quality Ontario (HQO)

6.

Laboratory Quality Management, A Roadmap - Lucia M. Berte

7.

Handbook: Good Laboratory Practice (GLP) WHO

8.

Maintenance Manual for Laboratory Equipment WHO

9.

Pipette Standards Handbook TROEMNER

10.

Guidelines for Good Clinical Laboratory Practices (GCLP) ICMR,

New Delhi

Internet:
1. www.wikipedia.org
2. www.cap.org
3. www.us.mt.com (Mettler Toledo)
4. www.troemner.com
5. www.hindujahospital.com

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