ACCREDITATION AND CERTIFICATION

fhe word accredit Is related to the same root word as

credible, or believable. A11 accredited \nstitution is one
that can be believed. Accreditation can be defined as a
voluntary process by whlch organizations are certified
by an Independent company that they comply with
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 189

ecifiC requireme2nts, lt is a means of showing and EN 45001:1989 as the contemporary standar~ to

spnfidence in an organiLation's performance. In the ISO be adhered to by all testing and calibration laboratories.
~em, the independent certifying company Is the one It integrated to requirements of ISO 9001 and ~002
that is also accredited, meaning that this company must (1994) and embodied the extensive experience gamed
be checked and recognize~ by other specialized authority over a time span of 10 years of laboratory systems
b()dies in order to be cons1dere? capable to certify other implementation.
companies. The process by which a company is audited
bY the certifying body is called certification and 190/IEC 17026:2006
compliance is usually demonstrated by certificates. The
companies that meet the requirements specified in ISO/IEC 17025 is recognition of laboratory com?~tency,
international standards are called certified. while ISO 9001 alone is simply recogn 1t1on of
conformance to a quality system. ISO/IEC 17025:2~05
1s0 Standard, has been revised to align the ISO 17025: 1999 version
with ISO 9001 :2000. Thus, ISO harmonized laboratory
The word ISO originates from the Greek word "isos '~ system accreditation by recognizing the ISO 9001:2000
meaning equal. According to ISO, its idea is to contribute standard as the basis for sound management of
to making the development, manufacturing and supply laboratory systems. This is now found in Clause 4. of
of products and services more efficient safer and cleaner. ISO/IEC 17025. The technical part, in clause 5 contains
all of the requirements that testing and calibration
The International Organization for Standardization (ISO) laboratories have to meet if they wish to demonst rate
is a non-governmental organization with members from that they operate a management system, that are
International institutes of more than hundred countries, technically competent and are able to generate
coordinated by a central office in Geneva, Switzerland. technically valid results.
The main purpose of ISO is to develop standards
Internationally recognized. Accreditation to ISO/IEC 17025 means-
• The laboratory has a quality syst em meeting
ISO Background
requirements of ISO 9001.
Customer satisfaction, profitability and market • The laboratory has adequate equipment to perform
leadership are driven in large part by delivering quality its testing or calibration tasks.
products and services to customers. Today, there is a
• The laboratory facility has adequate laboratory
worldwide trend towards increasingly stringent customer
personnel with the competence to perform t he
expectations regarding quality. Accompanying this trend
calibration and testing.
has been a growing realization that continuous quality
improvements are often necessary to achieving and • Laboratories have proficiency testing facilities.
sustaining excellent economic performance. This gave
rise to 150- the International organization for A methodical perusal of the industries and service
standardization. Located in Switzerland, ISO is the practice that exist in the global economy reveals that
specialized international agency for standardization and companies improve and stay competitive when they
employ the best business practices from around the
the source of ISO 9000. Established in 1947, it is
world. The new standards are benchmarks, gathering
comprised of 140 countries, working together to produce
and sharing these best-in-class systems. They reflect
more than 13,000 International standards for business,
the progression of organizations from compliance with
government and society. ISO is made up of standards to the adoption of a continuous improvement
approximately 180 technical committees. Each technical strategy for customer satisfaction. The new standards
committee is responsible for one of many areas of serve as implementation guides but also as the base
specialization. The object of ISO is to promote the for accreditation. ·
development of standardization and related world
activities with a view to facilitating international The comparative advantage of ISO/IEC 17025:2005
exchange of goods and services and to develop promotes cooperation between laboratories and other
cooperation in the sphere of intelligence, scientific, bodies to assist in the exchange of information and
technological and economy activity. The results of ISO experience and the harmonization of standards and
technical work are published as International standards. procedural goals.
ISO 9001:2000 is an International standard designed
to provide companies and organizations with a common Note
approach to apply a Quality Management System. Over
As a rule, within an organization any technology should
130 countries have adopted the standard since Its
be -subjected to calibration and testing and measured
Inception in 1987. by a sampling scheme that results in data collection
and analysis. It is then possible to gauge the effect on
1S0/IEC 17025:1999 replaced ISO/IEC Gulde 25:1990
. 190 TEXTBOOK OF MEDICA
L LABORATORY TECHNOLOGY
the ~ctivitles or goocJs rod ment cycle used in both ISO 14000 and ISO 90oo
for improvement. P uced and plan appropriately
standards.
ISO Definitions Policy: A definite course or method of act!on to
• .d nd determine present and future decision
• gui e a k. nder · s,
Accreditation· The It is a guide to decision ma ing u a given set
recognised b~d act whereby a nationally
operate an audity adppro~es ~n organization to
?f
of circumstances within the framework corporate
an reg1strat1on program objectives, goals and management philosophies.
• Accreditation bod· • M ·
• Process :· A set of interrelate~ resources and
organizations th ~es. ember countries have
activities that transform inputs into outp~ts With
reg . tr a are chartered to accredit
the aim of add ing va lue. Resources include
req~ ars. The ISO accreditation bodies publish the
irements that they set forth for registrars to personnel, facilities, equ ipment, technology,
beeome accredited. methodology and finances.
• A~dit stan~a~d: An authentic description of essential • Product: The result of activities or processes. A
cth aracthenst,cs of audits, which reflects current product can be tangible or intangible, or a
oug t and practice. combination of both.
• Auditee: The organization being audited . • Qualification: A documented determination that a
• Auditors: They work for or contract to registrars to product (and its associated software), component
perform registration assessment and surveillances. packaging or labelling, meets all prescribed desig~
• Certifi~tion: :he authoritative act of documenting and performance requirements .
compliance with agreed requirements. • Quality: The composite of all the characteristicsI
• Certific_a tion body: An impartial organization including performance of an item, product or service
pos~ess1~g the necessary competence to operate a that bear on its ability to satisfy stated or implied
certification program. needs. Quality is sometimes referred to as "fitness
• for use'~ "customer satisfaction", or "conformance
Clie~t: the person or organization requesting the
audit. to the requirements".

• Company: Term used primarily to refer to a business • Quality Assurance: A planned and systemic pattern
first party, the purpose of which is to supply a of a!I actions necessary to provide adequate
product or service. conf1d~nce that the product, its components,
packaging and labelling are acceptable for their
• Compliance: A judgement that a product or service intended use.
meets the requirements of a specified standard.
• Quali_ty ~udit: A systematic and independent
• Conformity: The fulfilment of specified
examination to determine whether quality activities
requirements.
and related results comply with planned
• Customer: Ultimate consumer, user, client, ~rrangements and ~hether these arrangements are
beneficiary or second party. im~le~ented effectively and are suitable to achieve
• Defect: The non-fulfilment of intended usage obJectives. One purpose of quality audit is to
requirements. The departure or absence of one or ev~luate th e need of improvement or corrective
more quality characteristics from intended usage action.

•
requirements.
Failure: An event in which a previously acceptable
• ~?
~~? 1 cothntrol: The operational techniques and
c 1v1·1ty1es at are used to fulfil requirements for
product does not perform one or more of its qua 1 •
required function within the specified limits under • Quality document· A d
specified conditions. requirements for · . ocument that conta ins
ISO: The International organization for products or serviceiuallty system elements for
•
Standardization. • Quality evaluation· As t .
• Non-conformance: A condition of any product or extent to which · ysematic examination of the
an entity (part p d .
component in which one or more characteristics organization) is c bl , ro uct, service or
do not conform to requirements. Includes failures, requirements. apa e of meeting specified
deficiencies, defects and malfunctions. • Quality Improvement· Th .
Organization: A company, corporation, firm, the value to the · e actions taken to increase
• enterprise, or institution, or part there of (whether effectiveness and et!ic~
st0
mer by improving t he
Incorporated or not, public or private) that has Its throughout the orga ~en~y of process and activities
own function(s) and administration that supplies • Quality manag nizat1onal structure.
products or services to other organizations. ement· All acr1 1 T II
management functio~ th v 1es of the overa
Plan-Do-Check-Act: The Process based Improve- policy, objectives / t determine the quality
• an respansib ilities I and
 191
, CHAPTER 6: TOTAL QUALITY MANAGEMENT

. plements th em by means such as quality ISO 15189: 2007: MEDICAL LABORATORIES

'~anning, quality control, quality assurance and
The duties of medical laboratories consist essentially of
~uality improvement. . analysing biological samples for purposes of screening,
Quality Manual_ : A_document sta_ti~g the quality diagnosis, follow-up, and for the treatment an_d
• •
011c1es and ob1ect1ves and describing the quality prevention of disease. The aim of clinical laboratory 1s
p . t'
system of an organiza 10n. . to provide accurate results within a reasonable turn-
, Quality policy:_ Th~ overall qua_lity_ objectives, around time and with traceability of all laboratory
intentions and d1rect1on of an organization regarding procedures, consideration of safety of patients and staff
quality, as formally expressed by top management. and due respect to ethics.
Quality system: The organizational structure,
• responsibilities, procedures, processes and In 2003, many in the worldwide clinical laborato_ry com-
resources for implementing quality management. munity felt the requirement of recognized and interna-
tional laboratory quality system standard for pathology
• Record: A document that furnishes objective laboratories. Although, ISO 17025:1999 was an excel-
evidence of activities performed or of results lent standard for the research and suitable for "indus-
achieved. trial" laboratory, it did not adequately address the unique
, Registrar: Organizations that issue ISO certificate. structure, operation and needs of medical and clinical
Also called "certification bodies" or "registration laboratories. Hence ISO 15189:2003 was created. ISO
bodies''. 15189:2007 replaced the earlier version.
, Specification: Documented detailed requirements
with which a product or service has to comply. When ISO 15189:2007 and ISO 17025:2005 are
compared, they have similar management requirements,
• Supplier: The organization that provides a product and quite different technical requirements. ISO
or service. 15189:2007 provides laboratories around the world a
• System: The principal functioning entities "harmonized" laboratory practice standard specific for
comprising the product, e.g. hardware, software Clinical and Medical laboratories.
and an organized and disciplined approach to
accomplish a task. In addition to setting standards for validation and
• Testing: The determination by technical or scientific interpretation of patient test results, a quality
means of the properties or elements of a product management system for laboratories sets standards for
or its components, including functional operation, the requisition of the analysis, patient identification and
and involving the application of established scientific preparation, collection, transportation , storage,
principles and procedures. processing and examination of patient samples.
• Traceability: The ability to trace the history, An ISO 15189 accredited Quality management System
application or location of a product and, in some (QMS) allows a laboratory to meet all customer quality
cases, service by means of recorded identifications. requirements, improve competitiveness of a pathology
Traceability may refer to a product, a calibration laboratory and also reduce laboratory costs by
and its relationship to the measuring equipment eliminating waste, reducing risk, and controlling process
and the national or international standards, variation . This working group included provision of
properties or reference materials. advice to users of the laboratory service, the collection
• Validated: The state of being confirmed by of patient samples, the interpretation of test results,
examination and provision of objective evidence acceptabl'e turnaround times, how testing is to be
that the particular· requirements for a specific provided in a medical emergency and the role of a
Intended use have been met. Validation Is normally laboratory in the education and training of health care
performed on the final product under defined staff.
operating conditions, and when necessary,
performed In earlier production stages. A medical laboratory's fulfilment of the requirements of
ISO 15189:2007 means the laboratory meets both the
• Verification: Confirmation by examination and technical competence requirements and the
Provision of objective evidence that specified management system requirements that are necessary
requirements have been met. In design and for it to consistently deliver technically valid results.
development, verification concerns the process of The management system requirements in ISO 15189
examining the results of a given activity to (Section 4) are written in a language relevant to a
determine conformity with the Input requirement medical laboratory operations and meet the principles
for that activity. of ISO 9001: 2008 Quality management systems-
• Waiver: A written authorization to release a product, Requirements and are aligned with its pertinent
Which does not conform· to the specified requirements (Joint IAF-ILAC-ISO Communique issued
requirement. In 2009).
192 TEXTBOOK OF MED
ICAL LABORATORY TECHNOLOGY
ISO 15189·2007 I t . urement procedure, for Which th
requireme~ts fo n e~~ational Standard specifies the by a given meas lsel claiming the absence Of e
laboratories Thi~ iuta ,ty a nd competence in medical probability of fa t Y is /3 given a probability a
medical laborat ~ ern~tional Standard is for use by component in a ma ena I ' u Of
management sy~r;es in developing the ir quality falsely claiming its presence.
competence. ems and assessing thei r own
Engineering Controls
The following refe ·solate or remove blood borne pathogen
for th • . rence d ocuments are indispensable These con t ro Is
'
,,
e app11cat1on of this document. hazards from the work place.

• ISO/IECS00OO (all parts), Quantities and units

Examination
• ISO ~001:2008, Quality management systems - having the object of determining the
Requirements Setof opera t ·ons
1
value or characteristics of a property.
• ISO/IEC 17025:2005, General requirements for the
competence of testing and calibration laboratories
Laboratory Director
ISO 15189: 2007:TERMS AND DEFINITIONS competent person(s) with responsibility for, and
Following terms and definitions are given in ISO 9000 authority over a laboratory.
ISO/IEC Guide 2, ISO 17000, ISO/IEC Guide 99:2007(
Laboratory Management
Note Person(s) who direct and manage the activities of a
For the following terms refer to specific chapters in laboratory.
this text book:
Matrix Effect
Clinical (Medical) laboratory (Chapter 1), Accuracy,
Precision, Sensitivity, Specificity, Validation, A constituent or artefact in the control material that
Accreditation (Chapter 6). causes a methodology or instrument to give consistently
higher or lower values (i. e. demonstrate a positive or
Automated Selection and Reporting of Results negative bias).
Process by which patient examination results are sent
to the laboratory information system and compared with Measurand
laboratory-defined acceptance criteria, and in which Quantity intended to be measured
results that fall within the defined criteria are
automatically included in patient report formats without Note
any additional intervention.
The specification of a measurand in laboratory medicine
Biological Reference Interval requires knowledge of the kind of quantity ( e.g., mass
concentration), a description of the matrix carrying
Specified interval of the distribution of values taken from the quantity (e.g., blood, plasma or serum), and the
a biological reference population. (related to old terms chemical entities involved (e.g., the analyte).
such as "normal range", "normal values", and "clinical
range"). Examples: In "mass of protein in 24-hour urine",
"protein" is the analyte and "mass" is the property. In
Competence "concentration of glucose in plasma", " glucose" is the
Demonstrated ability to apply knowledge and skills analyte and "concentration" is the property. In both
cases, the full phrase designates the measurand.
Crltlcal Values
Values obtained on a patient sample from a list of Measurement
selected laboratory tests that demand attention by a Process of experimentally obtaining one or more quantity
physician. values that can reasonably be attributed to a quantity.

Decision Value or Level Measurement Accuracy

A threshold value of a test result above or below which Accuracy of measurement
a physician will respond with an action.
Meaeurement Trueness
Detection Limit Trueness of measurement
. f detection measured quantity value, obtained
um,t o
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 193

..,asurernent Uncertainty Quality Indicator

uncertainty of measurement A measure of the degree to which a set of inherent
characteristics fulfils requirements.
"'8t,Ologlcal Comparability of Measurement Results
comparability of measurement results, for quantities of Example: If the requirement is to receive all urine
a given kind, that are metrologically traceable to the samples in the laboratory uncontaminated. The number
same reference. of contaminated urine samples received as a % of all
urine samples received (the inherent characteristic of
Example: M~a_surement_ results from two different the process) is a measure of the quality of the process.
commercial clinical chemistry measuring systems are
comparable when they are both metrologically traceable Quality Management System
to the same primary refer~nce standard, for example, Management system to direct and control an
acertified Reference Material for the mass concentration organisation with regard to quality
of serum uric acid.
Note
Metrological Traceability
The term "quality management system" referred to in
Property of a measurement result whereby the result this definition relates to general management activities,
can be related to a reference through a documented the provision and management of resources, the
unbroken chain of calibrations, each contributing to the preexamination, examination and post-examination
measurement uncertainty.
processes and evaluation and continual improvement.
Nonconformity
Quality Policy
Nonfulfillment of a requirement.
Overall intentions and direction of a laboratory related
to quality as formally expressed by laboratory
Postexamination Processes {Postanalytical Phase)
management. ·
Processes following the examination including review
of results; retention and storage of clinical material; Note
sampl~ (and waste) disposal; and formatting, releasing,
Generally the quality policy is consistent with the overall
reporting and retention of examination results.
policy of an organisation and provides a framework
for setting quality objectives.
Preexamination Processes (Preanalytical Phase)
Processes that start, in chronological order, from the Quality Objective
dinician's request and include the examination request,
Something sought, or aimed for, related to quality.
preparation and identification of the patient, collection
of the primary sample(s), and transportation to and
Note
within the laboratory, and ending when the analytical
examination begins 1 Quality objectives are generally based on the
laboratory's quality policy.
Primary Sample {Specimen) 2 Quality objectives are generally specified for
Discrete portion of a body fluid or tissue taken for relevant functions and levels in the organisation.
examination, study or analysis of one or more quantities
or properties to determine the character of the whole. Quantity
Property of a phenomenon, body or substance, where
Procedure the property has a magnitude that can be expressed as
Specified way to carry out an activity or a process. a number and a reference.

Process Referral Laboratory

Set of interrelated or interacting activities which External laboratory to which a sample is submitted for
transform inputs into outputs. examination.

Ouallty Remedial Action

Degree to which a set of inherent characteristics fulfils Action taken to rectify the effects of a detected
requirements. nonconformity.
 114 TEXTBOOK OF M
EDICAL. LAEO'"·il1·r, .9v TECHNOLOGY riate pre:i.edures to e"
approP . ,•Sur
Sample There are n samples, tissues, or rern . e11.,
•
sta
ff treat huma
ct
a1ris :i
~~
One or more parts due respe ·
taken from a primary sample.
Example• A 1 Director
volume of• vo ume of serum taken from a larger t
Labora ory hall be directed by a person or
serum.
The laboratorv s_ty and competence to be reste'S<Jrr
System with the au~hon rovided. onsi~
for the services p
Set of interrelated or Interacting elements
Ttaceablllty Note . nd respons1·b·1·t· f d.
I ' ,es o a •rector
The duties . a "Organization and Operation are
The abili~ to follow history of an activity by means of described,, i~n this chapter. of a
recorded information. Laboratory 1
Trueness t Responsibifity and Managen,
Managemen ent
~los~ness of agreement between the average of an Commitment
infinite number of replicate measured quantity values management shall provide evidence of .
and a reference quantity value. Labor~ttoryent to the development and implementa}s
comm, m t t u0r,
f the quality managemen sys em and continuait
lumaround Time ~prove its effectiveness by- I
Bapsed time between two points on the laboratory's • Establishing the quality policy.
path of work through preexamination, examination, and • Ensuring that quality objectives and planning are
postexamination processes.
established.
Verification • Defining authorities, responsibilities and
interrelationships of all personnel.
Confirmation, through provision of objective evidence, • Ensuring that _laboratory service~, including
that specified requirements have been fulfilled.
appropriate advisory and interpretative services,
meets the needs of patients and those using the
ISO 15189:2007, MEDICAL LABORATORIES:
R EQ UIREMENTS FOR QUALITY AND COMPETENCE
laboratory services.
• Ensuring that appropriate communication processes
Organization and Management Responsibility are established within the laboratory and that
The Oinical laboratory shall meet the requirements of communication takes place regarding the
ISO 15189:2007 International Standard when carrying effectiveness of the laboratory's preexamination,
out work at its permanent facilities, or in associated or examination, and postexamination processes and
mobile facilities. quality management system.
• Ensuing that laboratory management appoints a
Type of Laboratory quality manager who shall have, irrespective of
Small, medium or large (Refer to NABL guidelines) other responsibilities, delegated responsibility and
authority to ensure that the processes needed for
Legal Entity ~he quality management system are established,
implemented, and maintained.
The laboratory or the organization of which the
laboratory is a part shall be an entity that can be held
Documentation Requirements and Document Control
legally responsible for its activities.
A document is any information or instructions,
Ethlcal Conduct 1n c1udlng policy statements, procedures, specification~,
Laboratory management shall have arrangements to calibratlon tables, biological reference intervals and their
~rigln s, notices, memoranda, software, drawings, fioW
ensure the following:
dharts, charts, posters, plans agreements, and
There fs no Involvement In any activities that would
• diminish ocuments of external origin s~ch as regulatio_ ns,
confidence In the laboratory's competence, st nd rds
a a , text books from which examination
impartiality, Judgement, or operational Integrity. procedures are taken.
Management and personnel are free from any undue
• commercial, financial, or other pressures and The quality m . houid
Include: anagement system·documentat1on 5
Influences that may adversely affect the quality of
their work. • A statements of a quality policy and qualitY

___J
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 195
objectives its place in any parent organization.
A quality manual
• A description of the roles and responsibilities of
• procedures and records require d by this laboratory management (including the laboratory
• International Standard director and quality manage r) for ensurin g
oocuments, including records, determined by the compliance with this International Standard.
• laboratory to ensure t~e effectiv e plannin g, • A description of the structure and relationships
operation, and control of ,ts processes of the docume ntation used in the quality
copies of applicable regulations, standards and management system, and
• other normative documents. ' • The docume nted policies , process es and
, Record of document control and document reviews procedu res establis hed for the quality
management system (including management
Note activities, provision of resources, laborato ry
processes, and continual improvement).
1 Quality manual: The laboratory shall establish
and maintain a quality manual that includes, the 2 Record of reviews of service agreements: Reviews
quality policy with a description of the scope of of agreem ents to provide medical laborat ory
the quality management system; and a description services shall include all aspects of the agreement.
of the roles and respons ibilities of laboratory Records of these reviews shall include any changes
management (including the laboratory director and to the agreement and any relevant discussions. The
quality manager) for ensuring compliance with this following requirements are considered when the
International Standard. laboratory enters into an agreement to provide
medical laboratory services: The customers' and
2 All laboratory staff shall have access to and be
users' requirements, including the examination
instructed on the use and application of the quality
processes to be used, shall be defined, documented
manual and the referenced documents. and understood.
3 Document control: The laboratory shall control 3 Documented procedure for selecting, managing,
documents required by the quality management and evaluat ing the relation ship with referral
system and shall ensure that unintended use of laboratories as well as consultants who are to
any obsolete document is prevented . provide second opinions as well as interpretation
4 Documents are periodically reviewed and updated for complex testing in any discipline.
regularly. Personnel
5 Obsolete controll ed documents are dated and
4 Record of staff qualific ations, training and
marked as obsolete
competency records.
6 At least one copy of an obsolet e controll ed
5 Defined and documented responsibilities, authorities
document is retained for a specified time period . and interrel ationsh ips within the laborat ory
7 All documents, including those maintained in a organization. This shall include the appointment of
computerized system, issued as part of the quality person(s) responsible for each laboratory function
management system are reviewed and approved and appointment of deputies for all key functions.
by authorized personnel before issue. 6 Documents, including records, determined by the
laborato ry to ensure the effectiv e plannin g,
ISO 15189:2007, documentation requirements operati on, and control of its process es. A
documented procedure for personnel management
ISO 15189:2007, docume ntation requirem ents for
and to maintain records for all personnel that
medical laboratories are as follows: indicate compliance with requirements.
Organization and Quality management 7 Documents of personnel qualifications for each
1 Copy of a Quality manual which contains the position . The qualific ations shall reflect the
appropriate education, training, experience and
following aspects of quality management:
demons trated skills needed , and should be
• The quality policy of the laboratory. appropriate to the tasks performed.
• Statements of vision, mission, long term and 8 The job descriptions that describe responsibilities
short term goals of the laboratory and tasks for all personnel.
• A descrip tion of the scope of the quality 9 A documented programme to introduce new staff
management system (a specific aim of quality to the organization, the department or area in which
management system, which Is purposed to be the person will work; the terms and conditions of
reached or accomplished). employment; staff facilities; health and safety
• A presen tation of the organiz ation a nd requirements (Including fire and emergency); and
management structure of the laboratory and occupational health services.
 191
TEXTBOOK OF MEDICAL LACOR/\TO: n-' ' ff _-.,:·n i..OGY e or rejtction, and storage
·nspection, acceptancmable suoplies. Of
lO Record of staff training for assigned w",rk p, ocess, , nd consu . .
~ures, health, safety, ethics and confidentiality equipment a t and records: The mvento
nag em en h d. ~
of patient information. 22 Inventory ma hall include t e recor i~g of lo
control system s ts control materials ant
11 Record of competence assessment of staff after
training. numbers of re~~t~n of' receipt in the_ la?orato~
calibrators, the d the date the material 1s placed
12 Record of staff performance monitoring. the expiry date, an
13 Record of continuous education programs. in service. . . . a propriate storage space for
14 Rec?rd of professional development after 23 Document ind1cat1~g r~agent kits and equipment
continuous education programs. chemicals, reagen S, ·

15 Record of immunization status of employees . revention

Safety and f,re P
working in the laboratory. 24 Material safety data sheets (MSDS). .
laboratory and office facilities . procedures and equipment use
25 Fire prevention
16 Documentation related to the laboratory and manuals. t ff
~ ty classes for laboratory s a .
associated office facilities which have space and 26 Record of sa,e . .
provide an environment suitable for the tasks to be nts diagnostic kits and
Chemicals, reag e '
undertaken with following facilities:
equipment ,
• Access to areas affecting the quality of . t cords containing manufacturers name
examinations is controlled. Medical information, 27 Equ1pmen re . I b th ,
e, identification, and sena_ num ~r or o er
patient samples, and laboratory resources are ~Jque identification; contact mformat10~ _for the
safeguarded from unauthorised access.
supplier or the manufactur~r; date ot~ re~e1vindg·t~nd
• Documents indicating facilities (adequate date of entering. into service; 1oca ,on, ~o_n , ion
space, furniture, equipment and other when received (e.g. new, used, or recond1t1oned);
requirements) for staff members for breakfast, manufacturer's instructions; reco~?s that confirmed
lunch, dinner and adequate access to the equipment's initial acceptab1l1ty for use wh_en
washrooms, to a supply of drinking water, and equipment is incorporated in the laboratory; main-
to facilities for storage of personal protective tenance carried out and the schedule for preven-
equipment, clothing and, additional space for tive maintenance; equipment performance records
staff activities such as meetings and quiet study that confirm the equipment's ongoing acceptability
and a lounge area. for use; and damage to, or malfunction, modifica-
• Document indicating facilities, which allow tion, or repair of the equipment.
correct performance of examinations. These 28 List of "information systems" including the man-
include energy sources, lighting, ventilation, agement of data and information contained in both
noise, water, waste disposal, and environmental computer and non-computerized systems. Comput-
conditions. erized systems can include those integral to the
• Communication systems within the laboratory functioning of laboratory equipment and standalone
which are appropriate to the size and systems using generic software, such as word pro-
complexity of the facility to ensure the efficient cessing, spreadsheet, and database applications
transfer of information. that generate, collate, report, and archive patient
information and reports.
• Safety facilities and devices and record of their
regular verification. 29 A documented procedure for the calibration of
equipment.
• Document indicating library, list of laboratory
30 A documented programme of preventive
work books and work sheets.
maintenance which, at a minimum follows the
External services and supplies manufacturer's instructions. '
17 A documented procedure for the selection and 31 Equipment adverse incident reporting record.
purchasing of external services, equipment and 32 A docu_ mented procedure for receiving, storing and
consumable supplies. managing ~eagents and consumables. Records shall
18 A list of selected and approved suppliers. be malnta!ned for each reagent and consumable
and consumable t~at contributes to the performance of examina-
19 Record of purchased equipment tions: These records shall include the following:
supplies. . ldent!ty of th e reagent or consumable; manufac-
20 Verified record of all the requirements defined for turers name, batch code or lot number· contact
the preexamination, examination or Information _f~r th e supplier or the man~facturer;
postexaminatlon processes concerned. dat~ o_f receiving and date of entering into service;
21 A documented procedure and criteria for receipt, con Itron when received (e.g. acceptable or dam·
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 197

ed); manufacturer's instructions; records that The laboratory's instructions for collectio_n a~ivities
:nfirmed the reagent's or consumable's initial shall include the following : Determination of
acceptance for use, and performance records that identification of the patient from whom a pri~ary
confirm the reagent's or consumables' ongoing ac- sample is collected; verification that the pat~ent
ceptance for use. meets preexamination requirements (e.g., fasting,
Record of rea~ents ~~epared in-house. This records and duration of fasting etc.); instructions for
33 shall include, m add1t1on to the relevant information collection of primary sample (e.g. phlebotomy, skin
above, refere~ce to th~ person or persons puncture, blood and non-blood sam~les),
undertaking their preparation. descriptions of the primary sample contame_rs,
Record of adverse incidents and accidents caused information of additives; instructions for labelling
34
by reagents. of primary samples, recording of the collection time,
instructions for proper storage conditions; and safe
35 standard operation procedures for the use of disposal of materials used in the collection.
diagnostic kits, reagents and equipment with
appropriate safety precautions. 47 Standard operation procedures for appropriate
36 Record of calibration and validation of reagents and sample transportation.
diagnostic kits. 48 Listed criteria for sample reception: These include
37 Record of calibration and validation of equipment. criteria for sample acceptance and rejection;
38 Record of Equipment maintenance and repair. procedure of identification of samples, identification
of samples for urgent reports; identification of
39 Equipment adverse incident reporting.
grossly hemolysed samples, identification of clotted
40 Record of adverse incidents and accidents that can blood for routine hematological tests, record of
be attributed directly to specific equipment and identity of persons involved in sample reception;
reported documents to the manufacturer and the mechanism of transfer of the primary sample
appropriate authorities. to the examination area of the laboratory, any rapid
Specimen examination processes processing mode to be used, and any special
reporting criteria to be followed.
41 Record of advisory services for patients.
49 Record of validation of examination procedures: Per-
42 Documented procedures and information for formance characteristics of an examination proce-
preexamination activities to ensure the validity of dure may include: measurement trueness, measure-
the results of examinations. The identity of persons ment accuracy, measurement precision including
performing preexamination processes shall be
measurement repeatability and measurement re-
recorded.
producibility; measurement uncertainty, analytical
43 Documented information for patients and users: The specificity, including interfering substances, analyti-
information shall include- the location of the cal sensitivity, detection limit and quantitation limit
laboratory; types of clinical services offered by the (limits of linearity), diagnostic specificity and sen-
laboratory; hours of operation of the laboratory; sitivity.
the examinations offered by the laboratory,
including information concerning samples required, SO List of sources that contribute to the uncertainty of
primary sample volumes, special precautions, measurements, which include, sampling, sample
turnaround time, (which may also be provided in preparation, sample portion selection, reagents,
general categories or for groups of examinations), primary standards, input quantities, equipment
biological reference intervals, and clinical decision used, environmental conditions, condition of the
values; instructions for completion of the request sample and changes of operator.
form; instruction for preparation of the patient; 51 List of biological reference intervals or clinical
instructions for patient-collected samples; decision values of all the laboratory tests.
instructions for transportation of samples, Including 52 Documentation of all the sample examination pro-
any special handling needs; a list of factors known cedures (refer to any sop of an experiment in this
to significantly affect the performance of the "Text Book"). The examination test procedures in-
examination or the interpretation of the results; cludes various aspects such as, patient prepara-
and the laboratory's complaint procedure. tion, specimen collection, clinical significance, prin-
44 Documented procedures of sample collection and ciple of the test, standard operation procedure, ref-
handling. erence range, quality control, Interfering sub-
45 Doc.umented instructions for precollectlon activities: stances, precautions, references, etc.
These include all details of patient preparation, 53 List of "Quality control" (QC) procedures and
5Pecific order and requirements of anticoagulants, materials used for QC. These Include, use of primary
vacutainers and preparation of specimen collection standards, control sera, QC charts (e.g. L-J charts);
sectk>n with all the related requirements. participation In a suitable programme of inter-
46 List of instructions for specimen collection activities: laboratory comparisons; use of suitable certified
 1"£>ci-eoo1< o,: M
tefe EDICAL LABORATORY TECHNOLOGY
rence mater· I
another Ptoced •a s; examination or calibration by 71 Records of management reviews.
Which are Cle Ute; data of standards or methods 72 Record of feedback from t he users of
S1 Charactettzed. arly established, specified, and services. labor
ss Data of an inte a~,
73 Records of staff suggestions and acr
Data of Post e rn~I QC measures. the management. 10n take
Should estab~~~•nation processes: The laboratory 74 Record of quality indicators to monitor no,
identification s a_ documented procedure for
Performance throug hout critical andevai
storage mai~~llect,on, retention, indexing, access, · rIOn, and Post asp ects~ill.-~
preexamina t.,on, examma
sample~. enance and safe disposal of clinical
S6 Data of e-... processes. exatriinaro'
S'7 R ""oernal QC prorams. 75 Record of periodically evaluation of t 'Ori
ecord of rep0rt5, Th times for each of laboratory exarni lJ:nar0~
the follow· · e laboratory shall ensure that reflect clinical needs. nat,ons t~ni
communi •ng report attributes effectively •iat
needs. f~te laboratory results and meet the users' 76 Record of results of reviews by extern
1
tions that indicate the laboratory has n a 0tganis,i.
electmnic mat and medium of the report (i.e.
to be co or J:>aper) and the manner in which it is ties or potential nonconformities. onconforlll~
on mmun,cated from the laboratory· comments Audits
s~mple quality that might cdmpromise
examination results; interpretive comments on 77 Records of internal and external audits
results, Where applicable; "alert" or "critical" Authorities and responsibilities
58 ntervals and record of revised reports.
~ documented contingency plan to maintain services 78 Defined authorities and responsibilities f
management of the information system 0~ the
'" event of failures in information systems that
affects the laboratory's ability to provide service. laboratory including the maintenanc O the
59 modification to the information system(s) th:t and
Data of inter-laboratory comparisons. ·
60 affect patient care. may
~mented procedure of retention and storage of
chn1ca1 samples. 79 Defined authorities and resp?nsibilities of all
61 personnel who use the system, in particular tho
Documented procedure of sample disposal . · who access patient data and information ent:
62
Record of sample disposal incident records and patient data and examination results; ~hange
action taken.
patient data or examination results; and authorise
63 Records of accidents and action taken. the release of examination results and reports.
64 Data of Risk management system. Information system management
Detection of nonconformities 80 Validated and verified record of the system(s) used
65 A documented procedure for the resolution of for the collection, processing, recording, reporting,
complaints or other feedback received from storage, or retrieval of examination data and
dinidans, patients, laboratory staff, or other parties. information.
Records shall be maintained of all complaints and Resolution of complain
their investigation and the action taken.
81 Record of resolution of complaints.
66 A documented procedure that is implemented when
nonconformities are identified in any aspect of the Guidelines for operating collection centers
quality management system, including
preexamination, examination or postexamlnatlon 82 Record of guideline for operating collection centers
processes. of the main laboratory.
References
67 Record of corrective actions taken to get rid of
nonconformities, rec.ord of results of corrective actions 83 Record of references related to all the activities of
and reviews of effectiveness of the corrective actions. the pathology laboratory.
Continuous education of staff
68 Ust of continual improvement activities of staff and QUALITY COUNCIL OF INDIA (QCI) (FIG. 6.2S)
relevant record. QCI of India Is governed by a Council of 38 memb:
Quality Improvement activities With equal representations of government, induStry arne
consumers. Chairman of QCI is appointed by the Pnent
69 Records of quality improvement activities. Minister's office on recommendation of the governm_ble
70 ·nutes of meetings that record decisions made and Industry. Council Is the apex level body resp~;i~ion
.:1tout the laboratory's quality management for formulating the strategy, general policy, co~s~'iudin9
activities. and monitoring of various components o~ QCI 111 nsure
the accreditation boards with objective to e

◄
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 199

Council

I Govering body
,.._______J-,:,:_-_-_-_-_-_-_-_-_____-_,--- Secretarial
Accreditation Quality promotion
I
National accrediation National accrediation Quality Information
National board for
board for certiftcatiion board for education and enquiry service
quality promotion
bodies (NABCB) and training (NABET) (QIES)
(NBQP)

National accrediatation National accreditation

board for hospitals and board for testing and
healthcare providers calibration laboratories
(NABH) (NABL)

Fig. 6.28: Structure of quality council of India.

transparent and credible accreditation system. The It is necessary for laboratory owners in India to enrol
council through a Governing Body mo~itors the progress in QCI Medical Laboratory Program. QCI Medical
of activities and appeal mechanisms set by the Laboratory Program is for laboratories and si~ilar
respective boards. facilities (regardless of size, sophistication and locat!on)
that conduct biological, microbiological, immunological,
National Accreditation Board for Hospitals & chemical, hematological, pathological, cytological or
Healthcare Providers (NABH) is a constituent board other examination of materials derived from the human
of Quality Council of India, set up to establish and body for the purpose of providing information for the
operate accreditation. program for healthcare diagnosis, prevention and treatment of disease. This
organizations. The board Is structured to cater to much
includes laboratories that have only the most basic of
desired needs of the consumers and to set benchmarks
equipment (such as a microscope) and perform the most
for progress of health industry. NABH is an institutional
routine tests.
member of the International Society for Quality in Health
care (ISQUA). ISQUA is an international body which
grants approval to Accreditation Bodies in the area of The decision of laboratories to enrol in QCI's Essential
healthcare as mark of equivalence of accreditation Standards in Medical Laboratories in India (also called
program of member countries. So far hospital standards the QCI Med Lab Program) will place them on a path
of only 11 countries viz. Australia, Canada, Egypt, Hong that will positively change the status of that specific
Kong, Ireland, Japan, Jordan, Kyrgyz Republic, South laboratory and significantly improve impact on patient
Africa, Taiwan, United Kingdom were accredited by care. This laboratory will be recognized as among those
ISQUA. India becomes the 12th country to join in this laboratories in India, who have tried to set a higher
group. standard for medical laboratory practices, working
towards meeting an international standard of best
Accreditation of medical laboratories based on ISO practices.
15189 defines overall competencies needed in a
laboratory to deliver its intended outcome. However, The QCI's essential standards require information on
out of about 100,000 medical laboratories in India, the following aspects of a laboratory:
accredited laboratories are not even 100. In the absence • Organization and management
of any effective regulation, majority of medic~I
laboratories as such function with no assurance to their • Quality management
diagnostic outcome. Hence, in January 2007, the Quality • Management review
Council of India (QCI) created Essential Standards for • Personnel
Medical Laboratories in India in response to a request • Laboratory equipment and Instruments
from the Government of India, Ministry of Health In
2006. The Standards, created using a multi-stakeholder • Procurement and external supplies
approach, balance the needs of rural and urban settings • External services
and apply to all medical testrng facilities, regardless of • Process control
size, capacity, sophistication or location. The Standards • Laboratory space
reflect internationally accepted processes and
Procedures for clinical laboratories to consistently • Quality assurance
Produce accurate results. • Preexamination process
-
•
•
l'EXTBooK OF MF..DICA.L IAHO P.t,Ti)!W [ ,

Examination process
Postexamination process
1

. . . :··,
" ~ .
.
1
,. . . ~.1 to take active
._11C I IY- • -~ssi on s, comrnitt
~ ,
7
ee
• Reporting ~
f•
,.•. ' >!:
f, •
•

4,_I ' •~ f
··{(• I '.~,

> '· • •
i1 r;-· I-,r to ke::ip p;ice with the latest
• Document Control (' . ', J 'l"1P /i~-;,.

. d, ~dkc ·ill t'W ar:t1vit1es which shall promote

• Internal audit • 1o un P,l . · , • · - • I ·
uncir1 taking Bi • lateral/Mult1-laterad r,ecbogn1tion
• External audit etween NABL an a oratory
agrccmcn t s b t . th
• Control of non-conformities accreditation bodies in other coun nes _so at test
• Continual quality Improvement results of NABL accredited laboratories becorne
acceptable in all countries.
To enrol with QCI - Medical Laboratory Program, it is
necessary to fill out their specific form and send it to Note
the following Address: The laboratories are requ ired to c_omply with all the
requirements listed in the internati~nal standa~d ISO
Mailing Address:- 15189:2007 (Medical laboratories - Part1cu ~ar
QCI - Medical Laboratory Program requirements for quality and competence)_. The_Specific
C/0 Quality Council of India Criteria document must be used in c_onJunction with
A-3; TC 26/2127; Apoos Serene, ISO 15189. It provides an interpret~t1on of the latter
Tutor's Lane, Statue; Trivandrum document and describes specific requirements for those
Kerala ; India ; PIN:- 695001 clauses of ISO 15189 which are general in nature,
Further the laboratory shall follow the national,
National Board for Testing and Calibration regional and local laws and regulations as applicable
Laboratories (NABL)
Scope
During 1991-92, the accreditation program earlier known
as National Coordination of Testing and Calibration The scope of the accred itation is applicable to the
Facilities (NCTCF) scheme was renamed as National following medical laboratory services:
Accreditation Board for Testing and Calibration • Clinical Biochemistry
Laboratories (NABL). The accreditation criteria were then
• Clinical Pathology
aligned to latest prevailing international criteria i.e. ISO/
IEC Guide 25:1990. • Hematology and Immunohematology
• Microbiology and Serology
Aims and Objectives • Histopathology
• To promote, coordinate, guide, implement and • Cytopathology
maintain an accreditation system for laboratories • Genetics
suitable for the country in accordance with the relevant • Nuclear Medicine (in-vitro tests only)
national and international standards and guides.
• To encourage proficiency tests/inter-laboratory Note
comparisons in order to ensure accuracy, reliability 1 Immunological techniques are common to many
and reproducibility of test results. disciplines. Therefore, the immunological tests can
• To ensure that all measurements either during be listed under respective disciplines.
calibration or testing by accredited laboratories are 2 The accreditation shall be considered only for those
traceable to appropriate national/international tests, which the 1.aboratory is in itself equipped and
standards. competent to carryout.
• To ensure that the accredited laboratories adhere 3 In case of Histopathology, a laboratory may use
to all the conditions of accreditation, by periodic the services of another NABL-accredited laboratory
surveillance. for tissue processing (block making, sectioning and
• To organize awareness programs on all aspects of st aini ng). The reporting laboratory itself shall
laboratory accreditation for the laboratories by perform g_ross examination and tissue sampling.
various mean lnc.luding seminars, workshops and To be eligible for accreditation for Histopathology
labc,ratory-indu~try·ac.c.redltatlon body mPPts Ptc. and Cytopathology, a laboratory should receive at
To es.tat,lish and maintain strong linkages with least 300 specimens every year.
•
international and regional organt,atlons such as 4 The f acllity for primary sample collection at sites
International LaboralfJry Atuedltatlon Conference, other than Its main laboratory shall also comply
European Accreditation Cooperation for with the relevant requirements of ISO 15189 . A
Laboratories, Asia Pacific LaboriJtory Acuedltallon rt•presentative sample of these facilities shall be

J
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 201

assessed by NABL for their compliance with the • M.S. (Anatomy )/ Ph.D. with M.Sc. ~Hu~an
requirements. Anatomy)/ Ph.D. (Genetics)/ Ph.D. (Applied Biol-
5 The requirements given in this document are ogy): Genetics.
applicable to all medical laboratories applying for • Medical Degree with specialized (post graduate)
NABL accreditation regardless of the level at which qualification in nuclear medicine such as Diplo~a
they function (small/ medium/ large) or the place in Radiation Medicine (DRM), M.D./ Ph .D./ M.Sc. in
in which they are located (village/ district/ city) or Nuclear Medicine: Nuclear Medicine. It is neces-
whether they are private/ governmen t/ quasi- sary that the person concerned holds a certificate
government attached to a hospital/ stand-alone. from BARC on the use of radioisotopes and RIA.
6 Following classificat ion shall be used for M.D. in Lab Medicine: Clinical Pathology, Hematol-
determining fee structure: •
ogy, Clinical Biochemistry, Nuclear Medicine (in-vitro
• Small Laboratory: A laboratory receiving up tests), routine Microbiology and Serology.
to 100 patients per day
• DCP with 7 years experience: Histopathology, Cy-
• Medium Laboratory: A laboratory receiving up topathology, Clinical Pathology, Hematology, Clini-
to 101-400 patients per day cal Biochemistry, Nuclear Medicine (in-vitro tests),
• Large Laboratory: A laboratory receiving above routine Microbiology and Serology.
400 patients per day
7 A laboratory operating at more than one location
• MBBS with three years experience in medical labo-
ratory: Routine Clinical Biochemistry, routine He-
within a city having the same legal identity will be matology, routine Microbiology, Serology, and Clini-
considered as a single laboratory and will be is-
cal Pathology.
sued a single certificate. However, if the laborato-
ry requires separate certificates for individual lo- • M.Sc. in Medical Biochemistry with S years experi-
cations, the application for accreditation should be ence or M.Sc. in Biochemistry with 7 years experi-
submitted separately for each location. ence in Medical laboratory: Clinical Biochemistry,
8 The laboratory operating at more than one location Clinical Pathology, routine Hematology, routine Mi-
having separate legal identities will be treated as crobiology, and Serology.
independent laboratories even though they are part • M.Sc. in Medical Microbiology with S years experi-
of same organization. ence or M.Sc. in Microbiology with 7 years experi-
9 The laboratory having same legal identity but ence in Medical laboratory: Microbiology and Se-
operating in different cities will be treated as rology, Clinical Pathology, routine Clinical Biochem-
independent laboratories even though they are part istry, routine Hematology.
of the same organization.
Note
NABL Qualifica tion norms for authorize d
signatories and Disciplines for being authorized 1 DNB is equivalent to M.D./ M.S. in the respective
discipline as stated above.
signatory
2 D.M. in Haematological disciplines can be a su-
• M.D. (Pathology): Histopathology, Cytopathology, pervisor and authorized signatory for Hematolog-
Clinical Pathology, Hematology, Clinical Biochem- ical tests, Flow Cytometry and Molecular Biology.
istry, Nuclear Medicine (in-vitro tests), routine 3 NABL may relax qualifications in those exceptional
Microbiolo gy and Serology, Genetics, Flow cases where persons have demonstrated compe-
Cytometry and Molecular Biology. tence and established their credentials.
• M.D. (Microbiology): Microbiology and Serology, 4 In addition to the above, the persons supervising
Flow Cytometry, Molecular Biology, Clinical Pa- and performing the following tests should dem-
thology, routine Hematology and routine Bio- onstrate evidence of adequate training, compe-
chemistry. tence and experience: bone marrow examination ,
• Ph.D. (Microbiology) with M.Sc. (Medical Micro- tests for coagulation, flow cytometry, molecular
biology): Microbiology and Serology, Clinical Pa- biology, karyotyping, HLA typing and special bio-
thology, Flow Cytometry, Molecular Biology. chemistry.
• M.D. (Biochemistry): Clinical Biochemistry, Cllnl-
cal Pathology, Nuclear Medicine (In-vitro tests), Qualification Norms for Technical Staff
Flow Cytometry, Molecular Biology, Routine He-
The technical person performing the tests should have
matology, Routine Microbiology and Serology.
one of the following qualifications:
• Ph.D. (Biochemistry) with M.Sc. (Biochemistry):
Clinical Biochemistry, Clinical Pathology, Nuclear 1 Graduate In Medical Laboratory Technology.
Medicine (In-vitro tests), Flow Cytometry, Molecu- 2 Diploma In Medical Laboratory Technology with the
lar Biology. course of at least two years duration.
 -
TEXTBOOK OF MEDICAL LABORATORY TLL:1:-v~i ,:'.:, '·
. d b The ccrt~rs for Medicare &.
l
3 Diplom a/certlf icat 1 .
Technol . e n Medical La bo, ,jtory C:UA certificate~ issue MSY) or its aqent include th
Medic.aid Services (C - e
durati ogy with the course of at least one }'~:ir
otn and two years of experience in a medical following various types:
labora ory. . f mplianc e to a laboratory in
• Cer l ,f1cate o co d·t· ''
4 . 'th all applicable con 1 10n level
Gra~uate In Science with one year experience in a compliance wI
medical laboratory. requirements. .
5 Diploma in Medical Radiation and Radioisotope • Certificate for provider-perform ed_ ~ ,croscop y (PPM)
Technology (DMRIT). ~ h . •an midleve l practIt1 oner or dentist
,orrfa P. ys1cn10 te'sts other than PPM procedur es
6 Cytotechnologlst with additional certification in pe ormrng . . ·
• Certificate of accredita tion for accred1ta t1on by an
cytotechn~logy by the Indian Academy of Cytology
for screening of exfoliative cytology. accreditation organization approved by CMS.
7 A_ labo~atory may employ up to 25% of the staff • Certificate of registration enabling perf~rming
with ~ence_ in matriculation having at least 10 years moderate or high complexity labora~ory testing, or
experience in a medical laboratory. both, until the entity is determined to be in
compliance.
Note • certificate of waiver to perform only waived tests.
1 The qualific ations and experience for the
The Clinical Laboratory Improvement Amendments
phlebotomist shall be same as above. In addition,
(CUA) of 1988 is an amendment to the original Clinical
trained nurses may collect blood samples.
Laboratory Improvement Act of 1967. T~e purpose of
2 The laboratory shall have a system of imparting CUA '88 is to provide site-neutral quality (accuracy,
necessary training to technical staff at various reliability, and timeliness) of patient testing results. CUA
levels. There shall be a system so that a technical '67 covered only Medicare, Medicaid, and interstate
person receives adequate training in the operation commerce; but CUA '88 has a much broader scope.
of new analytical equipment and/ or performance
of new test before he/she is assigned such work. The Health Care Financing Administration (HCFA), now
known as the Center for Medicare and Medicaid Services
CLINICAL LABORATORY IMPROVEMENT (CMS), USA is responsible for implementation of CUA,
AMENDMENTS (CLIA) OF 1988 (USA) including laboratory registration, fee collection, surveys,
The Clinical Laboratory Improvement Amendments surveyor training and guidelines, enforcement,
(CUA) of 1988 (USA) establ1shes quality standards for proficiency test (PT) provider approval, accrediting
all applicable clinical laboratory testing to ensure the organizations and exempt states. CMS is responsible
accuracy, reliability and timeliness of patient test results. for developing the criteria for test waivers. The Food
and Drug Administration, USA, now has the responsibility
CUA covers "any facility which performs laboratory for test categorization (previously done by the Centers
testing on specimens derived from humans for the for Disease Control and Prevention).
purpose of providing information for the diagnosis,
prevention, treatment of disease, of impairment of, or The original "final" CUA regulations were published on
assessment of health.". Forensic testing is not included, Febr~ary 28, 1992. The "final" CLIA regulations were
nor is imaging (ultrasound, mammography, etc.) or skin publtshed on January 24, 2003, with an effective date
testing (TB, Candida, e.g.). Breath tests (alcohol, H. of April 24, 2003. The goal was to make the regulations
more "user friendly_" by organizing them in a more logical
pylori) are currently not covered but are under
sequence, following the specimen from collection
consideration for inclusion . Tests performed in the home through reporting.
by the patient are not covered. Tests done in the home
by healthcare workers to instruct the patient in doing
The new regulations refer to "waived" and "non-waived"
the test (e.g., glucose monitoring) are not covered.
tests. Mo~erate complexity tests now must meet the
Other tests done in the home by healthcare workers
same qualtty con~rol and quality assessment regulations
(e.g., blood gases) are covered. as high complexity tests (Refer to Chapter No 1 for
complexity tests, P3). ·
The FDA (USA) categorizes commercially marketed In
vitro diagnostic tests under CUA. categorization Includes Note
assigning commercially marketed In vitro diagnostic test
systems to one of three CUA regulatory categories,
based on their potential for risk to public health,
including waived tests, tests of moderate complexlty,
and tests of high complexity.
State and local regulations, as well as those of other
~ealthlcarle accredltln_g agencies (such as the Joint
omm ss on on American Health
may supercede CUA If th
. .
care Organrzat1ons),
ey are more stringent.
J
 CHAPTER 6: TOTAL QUALITY MANAGEMENT 203

CLINICAL AND LABORATORY STANDARD Effects Analysis (FMEA) and Failure Reporting Analysis
INSTITUTE (CLSI) and Corrective Action Systems (FRACAS). It is_neces_
s ~ry
revious NCCLS) is a World Health Organization to understand the following additional terms (m addition
cLSI ?rating center for Clinical Laboratory Standards to NABL terms):
collaA~creditation. It is a global, nonprofit, standards-
and loping organization that promotes the development Failure
deve e of voluntary consensus standards and guidelines It is a case when the system does not meet the user's
a~ih~~ the health care community. Their documents
expectation.
WI 'de invaluable tools which are useful to carry out
P~~~;ty control measures with efficiency, effectiveness,
Failure Mode
~nd global acceptance.
Manner by which a failure is observed .
the fall of 1967, 31 clinicians and laboratory scientists
Inpresenting 15 organizations met to discuss various ways Failure mode and Effect Analysis (FMEA)
~ improving quality control measures and to develop a Systematic review of an instrument system or process
~rmal consensus process for standardization. In 1977,
that examines, how failure can affect the instrument
CLSI was first accredited by the American National
system or process.
standards Institute (ANSI) as a voluntary consensus
standards organization. At about the same time, CLSI
l)eeame the home of the National Reference System for Note
the Clinical Laboratory (NRSCL), a collection of broadly FMEA involves identification of potential failure modes
understood reference systems intended to improve the and determines the consequences of each failure and
comparability of test results, consistent with the needs of also reviews the control measures implemented to
medical practice. CLSI actively promotes global prevent or detect the failure.
harmonization of standards through its own initiatives and
through direct communication links and cooperative Failure Reporting and Corrective Action System
programs with many standards-developing organizations (FRACAS)
around the world. Formal education program of CLSI
involves workshops designed to increase the effectiveness A process whereby a system is test ed and failures are
of laboratory standards and guidelines, and continues observed and classified by severity and frequency of
today with conferences, videos, and software programs occurrence.
aimed to support our products and services.
Note
Following are the vision and mission of CLSI: 1 The failures are ranked by criticality, severity and
Vision frequency of occurrence. The most severe problems
are corrected. FRACAS measures the failure rate.
To be the leader in clinical and laboratory standards to
improve the quality of medical care. 2 For both manufacturers and users FMEA and
FRACAS are important techniques to prevent
Mission failures.

To develop best practices in clinical and laboratory Corrective Action

testing and promote their use throughout the world,
using a consensus-driven process that balances the Action to eliminate the cause of a detected nonconfor-
viewpoints of industry, government, and the health care mity or other undesirable situation.
professions.
Uncertainty of a Measurement
CLSI: Risk Management Techniques to Identify and It is characterizes the dispersion of a set of distribution
Control Laboratory Error Sources of quality values (indicating inaacuracy) for a specific
In vitro diagnostic devices (IVDs) play a crucial role in measurand due to random and systematic effects.
Patient care. IVD results may be affected by
Prea~alytical, analytical and postanalytical err.ors. The Error Grid
relative importance and probability of a specific error It Is a graphical display of differences between an assay
cond_ition will vary with the devise design, the user, the and reference.
rnedical application and the operating environment.
Quality Assurance (QA) and Quality control (QC) Hazard
Proc~dures should be developed systematically using
quality management tools such as "Failure Modes and A situation with the potential to cause harm.
 11,nlQC),c OF MEDICAL LABORATORY 1 h ,1 ,;,:iLCGY
inattent:o~~. misjudgement
.. 1111...,... tors such as momenta~upation a,e the last and least
forgetfulness, and.preocchain
~ chains of cause and effect between identu1ed manageable links in a ·
lead and~ hazardous situation to which they might

.... u,e resulting harm.

:;-l)Ul'pose
IMPORTANCE OF FMEA AND FRACAS
ff t analysis (FMEA) and failure
Failure mode and e _ec action system (FRACAS) can
reporting and c_orrect~ve manufacturers and users to

•U:tlon for a hazard

of analysis Is to derive sufficient
the assessment of the risks involved
ldent1ftcatton of preventive measures.
be used effectively . y laboratory.
excellent QA and QC in a
, onsibilitV is to design the testing
Manufacture~ s_ resp or minimize significant sources of
llaltunctlon system to ehmh inate ossible and then list those which
Failure of the product to meet its performance error as muc as P · · d Th f
remain once the errors are ide~t1f1e f. e ma~u a~thurer
specifications or otherwise perform as intended. should develop recommendations or managing ose

Reaklual Risk sources of error.

Risk remaining after risk control measures have been User's responsibility is to devel~P a qu~!ity managem~nt
taken. system (described earlier) th~t Is spec1_
f1c t~ each testing
system and the setting in which ea~h I.s being used. For
Risk Analysis the test system to perform within performance
characteristics and limitations of use, the users must
Systematic use of available information to identify follow the manufacturer's directions.
hazards and to estimate the risk.
The FMEA table may be used as a tool to help identify
Risk Assessment potential errors in a testing system so that an
Overall process comprising a risk analysis and risk appropriate QA program can address_ them. Both FMEA
evaluation. and FRACAS are important techniques to prevent
failures. Their use is recommended as follows:
Risk Management
Manufacturers should use FMEA technique during the
Systematic application of management policies, designing of the product and testing it after the
procedures and practices to the tasks of analysis, completion of its designing. Potential errors are indicated
evaluation, controlling and monitoring risk. by the manufacturers in the product insert.

Severity of harm • Example: Developing Glucose ki t for the

Measure of the possible consequences of hazard. determination of plasma glucose by GOD/ POD
method.
Note • Use of FMEA technique by the manufacturer and
With respect to patient harm there are two possible observations: 1) This kit is stable at 2-8°C for six
month~ fr?m the day of manufacture; 2) After
effects: reconstItutIon with reagent grade water it is stable
1 Ari incorrect result, which could lead a clinician at 2-8°C for 7 days, 3) Limitation of the test
making an incorrect medical decision (linearity) u~ to 500 mg/di, 4) Significant amount
2 A delayed result. ?f hemoglobin or bilirubin or lipemia will interfere
in the test results. Laboratory users should use
3 Other non-patient harmful effects are: Increase In
the cost to the laboratory, threat to accreditation FRACAS technique for the product evaluation. They
should read carefully the product insert before
and incidenc.e of a complaint. teSt lng th e Prod uct. Similarly the product should
be tested before using sample~ of the patients using
Pareto Anafysla :iproprlate controls and any errors observed during
It is represented by either a table or chart. It Is a way e use of samples of the patients are recorded.
to shoW the most important problems. • of plasma Use of GIbucose k'it for the determination
Example:
91 ucose Y GOD/POD method
Human Error • Use of FRACAS techni ·
personal): 1) Confirm j~ie_ by_the user (laboratory
Human error is widely ac.knowledged as a major cause
reagent; 2) Note th ImIta_ t1_on of the GOD/POD
of quality and safety rl!>kS. Errors area Is a product chain
of causes in which the precipitating psychological fac-
number of the kit· )e st ability, date and batch
' 3 Use of grossly hemolysed, j