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Labcon 2009
'Lab Reports Should Not be Signed by Just Anybody'
A congregation to exchange knowledge on quality in clinical
laboratories
Labcon 2009, the first edition of conference on clinical diagnostic by Federation
of Hospital Administrators, took place in Meenakshi Mission, Madurai on 14-15
February. With over 1,00,000 clinical labs in the country and with only 150
having NABL accreditations, 'Quality in Clinical Laboratory' was the apt theme.
The conference started with an anthem of Meenakshi Mission, penned by its Chairman
Dr N Sethuraman. Then Dr Annabel DSouza Sekar, Organising Secretary, Labcon
and Head of Pathology in Meenakshi Mission, kick-started the day with the inaugural
speech.
Day 1
Dr Annabel DSouza Sekar |
Dr K Cheirmaraj |
Dr Pramila Samuel |
Dr K Cheirmaraj, Business Executive - Application Support,
Ortho Clinical Diagnostic, a division of Johnson and Johnson, spoke on 'Dry
slide technology: Away to eliminate pre-analytical errors'. According to him,
"The needs of the pathology laboratory is to enhance service levels, optimise
labour, ensure quality results and contain costs." While the sources of
error in laboratory arises from pre-analytical, analytical and post-analytical
stages, 48 per cent of laboratory errors arise from pre-analytical, he said,
citing J Kalra; Clinical Biochemistry study. And 68.2 per cent of pre analytical
errors occur from specimen collection.
He further added that pre-analytical errors mainly arose from insufficient sample,
sample handling and incorrect sample. Then he elaborated on why dry slide technology
is better than wet chemistry. "Wet chemistry involves water in every step
of reaction and the quality of water plays a key role in achieving quality results.
The advantages of dry slide technology is that it offers predictable costs,
minimum consummables to manage calibration frequency, less and no repeats of
samples and no water. It also has lowest turn-around-time, clinicians' confidence
in reports, extensive menu offering and 24/7 operations.
Dr Adarsh Pal Singh, Manager, Clinical Marketing, BD Diagnostics spoke on 'Pre-Variables
in view of Advanced Laboratory Diagnostic Investigations'. "Many pre-analytical
errors are difficult, if not impossible to detect. For example, specimen ID
errors, subtle changes in the specimen induced by poor blood collection technique,
improper specimen handling or inappropriate devices used. These errors pose
the greatest risk to patients and are most likely to have significant, adverse
cost implications for healthcare institutions."
Dr Suthanthira Kannan, Consultant Haemato-oncologist, GKNM
Hospital, Coimbatore, spoke on 'Flow Cytometry: Basics and quality control.'
The advantages of flow cytometry are that it gives information on the physical
and fluorescent properties of cells, is reproducible, quantitative and fast.
"The applications of flow cytometry are cell sorting, Immunophenotyping
(leukaemia/lymphoma), Immunemonitoring (T-cell subsets in HIV), leukocyte function
assays to determine the functional status of cells, DNA content cell cycle analysis,
detection of PNH (CD59 and CD55), hereditary spherocytosis EMA, CD34 enumeration,
apoptsis, MRD in leukaemia, foetal haemoglobin, MHC tetramer technology in combination
with functional cytokine release assays has enabled the study of highly specific
T-cell subsets and platelet function studies within the immune system,"
said Dr Kannan.
Dr Susheela Innah, Joint Director, Kerala State AIDS Control Society, Thiruvananthapuram
spoke on 'Quality control in transfusion services.' "Quality requirements
include quality control and proficiency testing, internal and external audits,
personnel and organisation, premises, equipment and materials, documentation,
blood processing, complaints and component recall and investigation of errors
and accidents? And quality control in blood ensures that blood and blood products
meet the needs of recipients and benefit, safeguard health of donors, recipients
and staff," she said.
The workforce responsible for QC are lab-tech (the person who performs testing),
supervisor (the person who is responsible for day-to-day activities, training,
delegation of work) and director (the person who is responsible for entire seamless
operation, planning and control of all activities). Emphasising on the need
for documentation, she said, "Adequate documentation prevent errors which
may result from communication. It includes all manufacturers' steps, data affecting
the quality of the component to be checked, from the donor to the recipient
of the blood component and vice-versa."
Suchita Dayanand, Senior Applications Specialist, Beckman Coulter, spoke on
'Analyser and Quality Management'. "QC is a process that monitors the accuracy
and precision of results through the use of control specimens. Daily QC verify
proper operation of major subsystems. Calibration is the basis of all quality
results. Inaccurate calibration leads to inaccurate patient results," she
said. She added that one needs to verify calibration, the results may vary between
instruments.
“A customer needs to verify calibration by performing the calibration procedure,
at completion of the installation process, after replacement of components dealing
with dilution or measurement,” she added. It is an unusual trend or considered
an outside limits, when room temperature of controls varies by more than 5.5
degrees C from the room temperature during the last calibration and as per their
laboratory inspection agency.
Dr Thuppil Venkatesh, Principal Advisor Quality Council of India, spoke on 'Registration
and accreditation of medical testing laboratory'. "Medical diagnostic testing
labs are not just restricted to testing of patient samples, it has great impact
based on quality of process. As of today, no Government established medical
college hospital testing labs are accredited," he said. He added that one
needs to comply with the particular requirements for quality and competence
as per the international standard ISO 15189 and specific requirement as per
NABL 112, only in the areas specified by the NABL, from time to time."
Dr Satheesh Kumar Amarnath, Medical Director, Manipal Cure & Care Private
Limited, Bangalore, spoke on 'Automated Microbiology Laboratory - A need'. "Automation
ensures that there is no problem that cannot be solved.' Dr Pramila Samuel,
Chief Quality Officer, SRL Religare Laboratories, spoke on 'Quality Management'.
"Quality covers quality assurance, quality control, quality improvement
and quality indicators, quality system and quality management," she said.
Speaking on why to perform quality control, she said, "To monitor the accuracy
and precision of the laboratory testing systems which will give the laboratory,
physician, customer/ patient confidence and satisfaction in the test results.
It provides a method of evaluation for new tests, reagents, kits, methods, instruments
and personnel on a quantitative basis and to develop historical records of testing
systems and to compare laboratory results with other outside laboratories, either
local and/ or worldwide." She added that daily QC involve recording of
temperature, equipment maintenance, records of reagents, calibration records,
daily QC values in the prescribed format, corrective action and LJ's with point
data and performance statistics (to be reviewed by section head).
"Quality is an investment and must be a delight to the customers,"
she said. The day also had Dr S Subramaniam, Consultant Biochemist, Apollo Hospitals,
Chennai, speak on '’Recent Advancements in Clinical Biochemistry' and S
Mohammed Nazeer, Applications Specialist, Tulip Diagnostics, Mumbai on 'Blood
Transfusion Facts.'
The day ended with an engaging debate on the pros and cons of out-sourcing labs,
which was moderated by Dr CN Srinivas, Chairman and Organising Secretary, Labcon.
Day 2
Suchita Dayanand |
Dr Susheela Innah |
Dr Satheesh Kumar Amarnath |
Dr VK Rama Desikan, Professor - Biochemistry, Madras Medical
College, spoke on 'Common Non - Conformances in Laboratory Accreditation'. "Non
Conformance (NC) is a departure of a quality characteristic from its intended
level or state that has a severity sufficient to cause the associated product
or service not to meet a specification requirement. The various types of NCs
are major, minor, observation and opportunity for improvement. NCs may be raised
against documentation and procedures, against processes, against staff qualification
and competency, against equipment, reagents, chemicals, kits and consumables,
against result reporting system and against non compliance to statutory and
legal requirements," he said. Lab reports just cant be singed by anybody.
The signatories should be either an MD Pathology, MD Microbiology, MD Biochemistry,
MS Anatomy, DCP with seven years experience, MBBS with three years lab experience,
MSc With PhD and MSc with five to seven years' experience," he added.
Dr Charulata Pamnani, Chief Laboratory Services & Blood
Bank, Jupiter Hospital spoke on 'Internal Audit and Technical requirements -
Instruments'. "Auditing is a means of gathering evidence about compliance
with the quality system. The various types of auditing are internal, horizontal,
external and vertical. The attributes of auditor are ethical, professional,
diplomatic, observant, decisive and perceptive. The audit report should contain
name of audit officer, date of audit, areas audited, details of aspects examined,
non compliance observed with category, corrective action with time period and
so on," she said.
Dr V Chitrasree, Associate Consultant - Lab Services, Madras Medical Mission,
Chennai, spoke on Quality Assurance in Clinical Laboratory. "It is important
to have a clear job description. The laboratory shall have a policy to assign
specific responsibilities to each individual: Laboratory Director, Laboratory
Manager, Technical Supervisor, Technicians and Lab assistants," she said.
Speaking on training, she said, "The laboratory shall have a system of
imparting regular training to technical staffs of all levels to keep them updated
in terms of latest technology and trends. There should be individual development
plan against each job profile. Education in required form (scientific, equipment,
computer skills etc and evaluation of the effectiveness of the training programme,
should be imparted," she said.
Dr Sujay Prasad, Consultant Pathologist/Quality Manager, Anand Diagnostic, Bangalore,
spoke on 'Role of Management in Accreditation.' "The role of management
in a laboratories accreditation status, be it preparing, successfully getting
it and thereafter maintaining status can never be over emphasised on. It has
a very global nature in providing the hospital laboratory with every piece of
support it needs, to deliver quality and competence. The management should be
like a guiding star for the laboratory leading it from the front. Technical
excellence can only follow good management support," he said.
The day also had Dr Sujatha Chandrasekaran, Chief Microbiologist, Global Health
City, Chennai, spoke on 'Accreditation Process.' "The accreditation certificate
issued has a unique number, fields, date of validity along with the scope of
accreditation. It has field of test, items/ materials/ products tested, specific
tests performed, specification/ standard methods or techniques used, range of
testing/ limit of detection, wherever applicable and MU / CV per cent,"
she said.
The day ended with a discussion on 'Sharing the Experience
of NABL Accreditation' by Dr Lalitha, Head - Microbiology, Aravind
Eye Hospital, Madurai, Dr Balambal, Head - Biochemistry, Sundaram
Medical Foundation, Chennai and Dr Angayarkanni, Head - Biochemistry,
Sankara Nethralaya, Chennai.
Express Healthcare was the media partner
for the event.
EH News Bureau
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