Title- A Study of Clinical Laboratory Accreditation Processes.

Name of the Organization Ajanta Hospital & IVF center and RML
Mehrotra Pathology Pvt. Ltd.

Program Name- Post Graduate Diploma in Hospital and Healthcare

Management.

Academic Year- 2018-2019

Name of student- Jaimit Singh

Roll no-18200140
Ref.No:1215/SCHC/2018                                                                                                                  Date: 21/11/2018

                          

                                                                                                      

To 

MR. JAIMIT SINGH 

Roll No: 18500035

Subject: Project Title "A study on clinical laboratory accreditation process".

              

Dear MR. JAIMIT SINGH 

Thank you for sending your proposed Project Proposal. It has been approved. Please commence your project work
as soon as possible and attach this project approval letter along with the final dissertation/project report. The last date
for submission of the Project Report is 15th February, 2019.

Thanking you.           

Yours sincerely,

Dr. Rajendra Awate

MD(Community Medicine)

Head – DEP

Symbiosis Centre of Health Care

S. B. Road, Pune 411004, India

Tel: +91-20-25655023

Web: www.schcpune.org 

 
 DECLARATION

I hereby declare that the project work entitled “A Study of Clinical

Laboratory Accreditation Processes.” Submitted to the SCHC Pune, is
a record of an original work done by me under the guidance of Dr Anil
Khanna (Director Ajanta Hospital & IVF center) & Dr Sanjay Mehrotra,
(RML Mehrotra Pathology Pvt Ltd) and this project work is submitted
for fulfillment of the requirements for the award of the degree of Post
Graduate Diploma in hospital and healthcare management. This work has
not been submitted to any other University or Institute for the award of
any degree or diploma

Jaimit Singh

Roll No- 18200140

 CERTIFICATE-

This is to certify that Mr. Jaimit Singh, a student of PGDHHM, SCHC Pune was
assigned the following projects – “A Study of Clinical Laboratory Accreditation
Processes”
This is to certify that he has successfully completed the projects assigned to them
as project trainees at Ajanta Hospital & IVF Center and RML Mehrotra Pathology
Pvt Ltd.

Dr. Anil K Khanna

Ajanta Hospital & IVF center

Dr. Sanjay Mehrotra

RML Mehrotra Pathology Pvt Ltd
 Acknowledgement

The path towards this thesis is circuitous.Foremost, I want to offer this Endeavour
to our God Almighty for the wisdom he bestowed upon me. Its completion is
thanks to the large part to the people who challenged, supported, and stuck with me
along the way. I am extremely fortunate to have as my guides, Dr. Sanjay Mehrotra
and Dr. Anil Khanna, who brought a depth of knowledge that few could match. I
thank them for supporting this thesis and giving such thoughtful feedback, always
aimed at me moving forward. I would like to express my gratitude towards my
mother, Mrs. Pushpa Singh and my supportive wife, Supriya and my family .My
lovable daughter, Kaira, served as my inspiration to pursue this undertaking. My
thanks and appreciation also to my friend Priyanka who have willingly helped me
out with their abilities.
 Table of Contents

1. Title page 1

2. Letter of approval 2

3. Student’s declaration 3

4. Certificate from project guide 4

5. Acknowledgement 5

6. Introduction 6

7. Objective 8

8. Review of literature 9

9. Methodology 33

10.Results 34

11.Discussion 35

12.Summary and conclusion 39

13.Bibliography 40
Introduction
What is Accreditation?

Accreditation is the third party attestation related to a conformity assessment

body conveying the formal demonstration of its competence to carry out
specific conformity assessment task. Conformity Assessment Body (CAB) is
a body which includes Testing including medical Laboratory, Calibration
Laboratory, Proficiency Testing Provider, and Certified Reference Material
Producer.

Clinicians have customarily enjoyed a great deal of autonomy in their

practices. The mechanisms for monitoring and assuring quality of the care
provided have tended to be based on internal peer review. Time, however,
has torn away much of the curtain of professional mystique. The changing
health care environment with revised hospital accreditation guidelines have
sharpened the clinical and administrative hospital staff’s concern for
evaluating the quality of care they provide. Clinicians now see accreditation
standards as a framework by which organizational processes will be
improved and their patients will receive better care. Physicians and
administrators now must face the challenge of establishing comprehensive
and vigorous systems of quality assurance and learn to avoid the traps that
impede implementation of such systems. Quality assurance is a very simple
process that deals with finding problems and fixing them.

A comprehensive definition of quality health care would be, “The optimal

achievable result for each patient, the avoidance of physician-induced
(iatrogenic) complications, and attention to patient and family needs in a
manner that is both cost effective and reasonably documented.”
Objective
- To Study of Clinical Laboratory Accreditation Processes
- Accreditation is usually a voluntary program in which trained external peer
reviewers evaluate a healthcare organization's compliance and compare it
with pre-established performance standards. The aim of this study was to
evaluate the impact of accreditation programs on the quality of healthcare
services
Review of Literature
Accredited hospitals offer higher quality of care to their patients.
Accreditation also provides a competitive advantage in the health care
industry and strengthens community confidence in the quality and safety of
care, treatment, and services. Overall it improves risk management and risk
reduction and helps organize and strengthen patient safety efforts and creates
a culture of patient safety. Not only does it enhance recruitment and staff
education and development, it also assesses all aspects of management and
provides education on good practices to improve business operations.
International accreditation such as that from the Joint Commission
International (JCI), a nonprofit organization that is part of The Joint
Commission on Accreditation of Healthcare Organizations—aka JCAHO or
The Joint Commission—and founded in the late 1990s to survey hospitals
outside of the United States, creates a mark on the world map and increases
business through medical tourism.

Few quality accreditation programs for hospitals- There are

several quality standards, however, there are few to which hospitals are
commonly accredited. There is accreditation by the JCI, and accreditation to
the standard from the National Accreditation Board for Hospitals and
Healthcare providers (NABH)—part of the Quality Council of India. There
is also compliance to the Baldrige Criteria for Performance Excellence and
registration to ISO 9001—“Quality management systems—Requirements,”
from the International Organization for Standardization (ISO). Also, there is
more departmental-specific accreditation such as from the National
Accreditation Board for Testing and Calibration Laboratories (NABL).

Difference between the accreditation standards- The ISO 9001

standard is more process driven and is better for back-end departments, such
as accounting, human resources, etc., while NABH and JCI are clinically-
oriented standards that directly affect patient care.

Accreditation standards (NABH and JCI): Patient-centered standards—

functions related to providing patient care

Access to care and continuity of care—access, assessment, and continuity of

care

Patient and family rights—patient rights and education

Patient and family education

Assessment of patients—management of medication

Care of patients

Health care organization and management standards: Functions related to

providing a safe, effective, and well-managed organization

Quality improvement and patient safety—continuous quality improvement

Prevention and control of infection—hospital infection control

Governance, leadership, and direction—responsibilities of management

Facility management and safety

Staff qualifications and education—human resource management

The accreditation process- Begin with accreditation process by

education: Educate the leaders and the managers and explain the benefits,
advantages, process, timeline, etc., of the accreditation

Baseline assessment: Use knowledgeable and credible evaluators (either

internal or external consultants) who will critically and objectively assess
each area and conduct a detailed baseline assessment of the organization’s
current adherence to the standards and each measurable element. Score as
“Met,” “Partially Met,” or “Not Met” and cite specific findings and
recommendations. Also collect and analyze baseline quality data as required
by the quality monitoring standards (e.g., medication errors, hospital-
associated infection rates, antibiotic usage, surgical complications, etc.)
Establish an ongoing monitoring system for data collection (e.g., monthly,
with quarterly data analysis) to identify problem areas and track progress in
improvement.

Action planning: Using the findings of the baseline assessment, develop a

detailed project plan starting first with priority areas of the core standards.
Responsibilities, deliverables, and time frames should be assigned (e.g.,
revise informed consent policy, develop a new informed consent statement,
educate staff in the next two-month time period.)

Chapter assignment: Look for good people skills, time-management skills,

and consensus-building skills, and assign oversight of each chapter of
standards to a respected champion or leader who will identify team members
from throughout the hospital and carry out the process.

Policies and procedures: In addition to an overall project plan, it is often

helpful to compile a list of all required policies and procedures that will need
development and revision. Continue to monitor your progress in meeting the
standards, such as through a mini-evaluation of each chapter at regular
intervals (e.g., quarterly).

Final mock survey: Plan for a final “mock survey ” at least four to six
months in advance of the target date of the actual accreditation survey. Use
evaluators (internal or external consultants) who were not involved in the
baseline assessment and preparation, who will look at the organization with
a fresh and objective eye. Plan final revisions and corrections based on the
findings of the final mock survey.

The success of any quality assurance program depends almost entirely on the
commitment and interest of the administrators, nurses, paramedical staff,
and physicians. Leaders of quality assurance programs must be able to
generate interest and commitment without burdening clinical and
administrative staff with an activity they neither understand nor believe in.
This will help move quality assurance out of its current paralysis in some
hospitals. Quality assurance is to succeed in its goal to identify and correct
problems and to improve the quality of patient care.
Clinical Biochemistry

Clinical Biochemistryis a peer-reviewed scientific journal covering the

analytical and clinical investigation of laboratory tests in humans used for
diagnosis, molecular biology and genetics, prognosis, treatment and therapy,
and monitoring of disease ; the discipline of clinical biochemistry. It is the
official journal of the Canadian Society of Clinical Chemists.

Researchers at the University of North Carolina published an article in

Clinical Biochemistry , which found Baby wash products could cause false
drug test results. Newborn drug screening has significant implications in
both the healthcare and legal domains, on occasion resulting in involvement
by social services or false child abuse allegations. The accuracy of the
screening results is therefore essential. This research highlights reasons why
false positive cannabinoid (THC) screening results may have occurred.
Researchers identified commonly used soap and wash products used for
newborn and infant care as potential causes of false positive THC screening
results.

Hematology, alsospelled heamatology,is the branch of medicine

concerned with the study of the cause, prognosis, treatment, and prevention
of diseases related to blood. It involves treating diseases that affect the
productionof blood and its components, such as blood cells, hemoglobin,
blood proteins, bone marrow, platelets, blood vessels, spleen, and the
mechanism of coagulation. Such diseases might include hemophilia, blood
clots, other bleeding disorders and blood cancers such as leukemia, multiple
myeloma, and lymphoma. The laboratory work that goes into the study of
blood is frequently performed by a medical technologist or medical
laboratory scientist. Many hematologists work as hematologist-oncologists,
also providing medical treatment for all types of cancer. The term is from
the Greek αἷμα, haima meaning "blood," and -λoγία meaning study.

Physicians specialized in hematology are known as hematologists or

haematologists. Their routine work mainly includes the care and treatment of
patients with hematological diseases, although some may also work at the
hematology laboratory viewing blood films and bone marrow slides under
the microscope, interpreting various hematological test results and blood
clotting test results. In some institutions, hematologists also manage the
hematology laboratory. Physicians who work in hematology laboratories,
and most commonly manage them, are pathologists specialized in the
diagnosis of hematological diseases, referred to as hematopathologists or
haematopathologists. Hematologists and hematopathologists generally work
in conjunction to formulate a diagnosis and deliver the most appropriate
therapy if needed. Hematology is a distinct subspecialty of internal
medicine, separate from but overlapping with the subspecialty of medical
oncology. Hematologists may specialize further or have special interests, for
example, in:

• treating bleeding disorders such as hemophilia and idiopathic

thrombocytopenic purpura

• treating hematological malignancies such as lymphoma and leukemia

(cancers)

• treating hemoglobinopathies

• the science of blood transfusion and the work of a blood bank

• bone marrow and stem cell transplantation

Starting hematologists complete a four-year medical degree followed by

three or four more years in residency or internship programs. After
completion, they further expand their knowledge by spending two or three
more years learning how to experiment, diagnose, and treat blood disorders.
When applying for this career, most job openings look for first-hand
practical experience in a recognized training program that provides practice
in the following: Cause of abnormalities in formation of blood and other
disorders, diagnosis of numerous blood related conditions or cancers using
experimentation, and the proper care and treatment of patients in the best
manner.
Microbiology

Microbiology (from Greek μῑκρος, mīkros, "small"; βίος, bios, "life"; and
-λογία, -logia) is the study of microorganisms, those being unicellular
(single cell), multicellular (cell colony), or a cellular (lacking cells).
Microbiology encompasses numerous sub-disciplines including virology,
parasitological, mycology and bacteriology.

Eukaryotic microorganisms possess membrane-bound cell organelles and

include fungi and protests, whereas prokaryotic organisms—all of which are
microorganisms—are conventionally classified as lacking membrane-bound
organelles and include Bacteria and Achaea. Microbiologists traditionally
relied on culture, staining, and microscopy. However, less than % of the
microorganisms present in common environments can be cultured in
isolation using current means. Microbiologists often rely on molecular
biology tools such as DNA sequence based identification, for example s
rRNA gene sequence used for bacteria identification.

Viruses have been variably classified as organisms, as they have been

considered either as very simple microorganisms or very complex
molecules. Prions, never considered as microorganisms, have been
investigated by virologists, however, as the clinical effects traced to them
were originally presumed due to chronic viral infections, and virologists
took search—discovering "infectious proteins".

The existence of microorganisms was predicted many centuries before they

were first observed, for example by the Janis in India and by Marcus
Terentius Varro in ancient Rome. The first recorded microscope observation
was of the fruiting bodies of moulds, by Robert Hooke in, but the Jesuit
priest Athanasius Kircher was likely the first to see microbes, which he
mentioned observing in milk and putrid material in. Antoine van
Leeuwenhoek is considered a father of microbiology as he observed and
experimented with microscopic organisms in , using simple microscopes of
his own design. Scientific microbiology developed in the century through
the work of Louis Pasteur and in medical microbiology Robert Koch.

The existence of microorganisms was hypothesized for many centuries

before their actual discovery. The existence of unseen microbiological life
was postulated by Jainism which is based on Mahavira’s teachings as early
as th century BCE. Paul Dundas notes that Mahavira asserted the existence
of unseen microbiological creatures living in earth, water, air and fire. Jain
scriptures describe nigodas which are sub-microscopic creatures living in
large clusters and having a very short life, said to pervade every part of the
universe, even in tissues of plants and flesh of animals. The Roman Marcus
Terentius Varro made references to microbes when he warned against
locating a homestead in the vicinity of swamps "because there are bred
certain minute creatures which cannot be seen by the eyes, which float in the
air and enter the body through the mouth and nose and thereby cause serious
diseases."

he field of bacteriology (later a subdiscipline of microbiology) was founded

in the th century by Ferdinand Cohn, a botanist whose studies on algae and
photosynthetic bacteria led him to describe several bacteria including
Bacillus and Beggiatoa. Cohn was also the first to formulate a scheme for
the taxonomic classification of bacteria, and to discover end spores. Louis
Pasteur and Robert Koch were contemporaries of Cohn, and are often
considered to be the father of microbiology 0 and medical microbiology,
respectively. Pasteur is most famous for his series of experiments designed
to disprove the then widely held theory of spontaneous generation, thereby
solidifying microbiology’s identity as a biological science. One of his
students, Adrian Certes, is considered the founder of marine microbiology.
Pasteur also designed methods for food preservation (pasteurization) and
vaccines against several diseases such as anthrax, fowl cholera and rabies.
Koch is best known for his contributions to the germ theory of disease,
proving that specific diseases were caused by specific pathogenic micro-
organisms. He developed a series of criteria that have become known as the
Koch's postulates. Koch was one of the first scientists to focus on the
isolation of bacteria in pure culture resulting in his description of several
novel bacteria including Mycobacterium tuberculosis, the causative agent of
tuberculosis.

Applications

While some fear microbes due to the association of some microbes with
various human diseases, many microbes are also responsible for numerous
beneficial processes such as industrial fermentation (e.g. the production of
alcohol, vinegar and dairy products), antibiotic production and act as
molecular vehicles to transfer DNA to complex organisms such as plants and
animals. Scientists have also exploited their knowledge of microbes to
produce biotechnologically important enzymes such as Taq polymerase,
reporter genes for use in other genetic systems and novel molecular biology
techniques such as the yeast two-hybrid system. Citation needed

Bacteria can be used for the industrial production of amino acids.

Corynebacteriumglutamicum is one of the most important bacterial species
with an annual production of more than two million tons of amino acids,
mainly L-glutamate and L-lysine. Since some bacteria have the ability to
synthesize antibiotics, they are used for medicinal purposes, such as
Streptomycin to make amino glycoside antibiotics.

A variety of biopolymers, such as polysaccharides, polyesters, and

polyamides, are produced by microorganisms. Microorganisms are used for
the biotechnological production of biopolymers with tailored properties
suitable for high-value medical application such as tissue engineering and
drug delivery. Microorganisms are for example used for the biosynthesis of
xanthenes, alginate, cellulose, cyanophycin, poly (gamma-glutei acid), liven,
hyaluronic acid, organic acids, oligosaccharides polysaccharide and
polyhydroxyalkanoates.

Microorganisms are beneficial for microbial biodegradation or

bioremediation of domestic, agricultural and industrial wastes and
subsurface pollution in soils, sediments and marine environments. The
ability of each microorganism to degrade toxic waste depends on the nature
of each contaminant. Since sites typically have multiple pollutant types, the
most effective approach to microbial biodegradation is to use a mixture of
bacterial and fungal species and strains, each specific to the biodegradation
of one or more types of contaminants.

Symbiotic microbial communities confer benefits to their human and animal

hosts health including aiding digestion, producing beneficial vitamins and
amino acids, and suppressing pathogenic microbes. Some benefit may be
conferred by eating fermented foods, probiotics (bacteria potentially
beneficial to the digestive system) or prebiotics (substances consumed to
promote the growth of probiotic microorganisms). The ways the micro
biome influences human and animal health, as well as methods to influence
the microbiome are active areas of research.

Research has suggested that microorganisms could be useful in the treatment

of cancer. Various strains of non-pathogenic clostridia can infiltrate and
replicate within solid tumors. Clostridia vectors can be safely administered
and their potential to deliver therapeutic proteins has been demonstrated in a
variety of preclinical models.
Cytopathology

Cytopathology (from Greek κύτος, kytos, "a hollow"; πάθος, pathos, "fate,
harm"; and -λογία, -logia) is a branch of pathology that studies and
diagnoses diseases on the cellular level. The discipline was founded by
George Nicolas Papanicolaou in . Cytopathology is generally used on
samples of free cells or tissue fragments, in contrast to histopathology,
which studies whole tissues.

Cytopathology is commonly used to investigate diseases involving a wide

range of body sites, often to aid in the diagnosis of cancer, but also in the
diagnosis of some infectious diseases and other inflammatory conditions.
For example, a common application of cytopathology is the Pap smear, a
screening tool used to detect precancerous cervical lesions which may lead
to cervical cancer.

Cytopathologic tests are sometimes called smear tests because the samples
may be smeared across a glass microscope slide for subsequent staining and
microscopic examination. However, cytology samples may be prepared in
other ways, including cytocentrifugation. Different types of smear tests may
also be used for cancer diagnosis. In this sense, it is termed a cytologic
smear.

Cytopathology is frequently, less precisely, called cytology, which means

"the study of cells".

Cell collection

There are two methods of collecting cells for cytopathologic analysis:

exfoliative cytology, and intervention cytology.
Exfoliative cytology

A micrograph of an exfoliative cytopathology specimen (Pap test, Pap stain)

In this method, cells are collected after they have been either spontaneously
shed by the body ("spontaneous exfoliation"), or manually scraped/brushed
off of a surface in the body ("mechanical exfoliation"). An example of
spontaneous exfoliation is when cells of the pleural cavity or peritoneal
cavity are shed into the pleural or peritoneal fluid. This fluid can be
collected via various methods for examination. Examples of mechanical
exfoliation include Pap smears, where cells are scraped from the cervix with
a cervical spatula, or bronchial brushings, where a bronchoscope is inserted
into the trachea and used to evaluate a visible lesion by brushing cells from
its surface and subjecting them to cytopathologic analysis. Liquid-based
cytology collects the samples in the same way but places them in liquid that
is then treated to allow for improved results.4

Intervention cytology

Brushes used to collect samples for cytology.

In interventional cytology the pathologist intervenes into the body for

sample collection.

Fine-needle aspiration

Main article: Fine-needle aspiration

Fine-needle aspiration, or fine-needle aspiration cytology (FNAC), involves

use of a needle attached to a syringe is to collect cells from lesions or masses
in various body organs by microcoring, often with the application of
negative pressure (suction) to increase yield. FNAC can be performed under
palpation guidance (i.e., the clinician can feel the lesion) on a mass in
superficial regions like the neck, thyroid or breast; FNAC may be assisted
by ultrasound or CAT scan for sampling of deep-seated lesions within the
body that cannot be localized via palpation. FNAC is widely used in many
countries, but success rate is dependent on the skill of the practitioner. If
performed by a pathologist alone, or as team with pathologist-
cytotechnologist, the success rate of proper diagnosis is higher than when
performed by a non-pathologist.5 This may be due to the pathologist's ability
to immediately evaluate specimens under a microscope and immediately
repeat the procedure if sampling was inadequate.

Fine needles are 23 to 27 gauge. Because needles as small as 27 gauge can

almost always yield diagnostic material, FNAC is often the least injurious
way to obtain diagnostic tissue from a lesion. Sometime a syringe holder
may be used to facilitate using one hand to perform the biopsy while the
other hand is immobilizing the mass. Imaging equipment such as a CT
scanner or ultrasound may be used to assist in locating the region to be
biopsied.

FNAC has become synonymous to interventional cytology.

For cytology of sediment, the sample is collected from the fixative that was
used for processing the biopsy or autopsy specimen. The fixative is mixed
properly and taken into a centrifuge tube and is centrifuged. The sediment is
used for smearing. These sediments are the cells that are shed by the autopsy
and biopsy specimen during processing.
Parameters

The nucleus of the cell is very important in evaluating the cellular sample. In
cancerous cells, altered DNA activity can be seen as a physical change in the
nuclear qualities. Since more DNA is unfolded and being expressed, the
nucleus will be darker and less uniform, larger than in normal cells, and
often show a bright-red nucleolus.

While the cytologist's primary responsibility is to discern whether cancerous

or precancerous pathology is present in the cellular sample analyzed, other
pathologies may be seen such as:

Microbial infections: parasitic, viral, and/or bacterial

Reactive changes

Immune reactions

Cell aging

amyloidosis

autoimmune diseases

Various normal functions of cell growth, metabolism, and division can fail
or work in abnormal ways and lead to diseases.

Cytopathology is best used as one of three tools, the second and third being
the physical examination and medical imaging. Cytology can be used to
diagnose a condition and spare a patient from surgery to obtain a larger
specimen. An example is thyroid FNAC; many benign conditions can be
diagnosed with a superficial biopsy and the patient can go back to normal
activities right away. If a malignant condition is diagnosed, the patient may
be able to start radiation/chemotherapy, or may need to have surgery to
remove and/or stage the cancer.

Some tumors may be difficult to biopsy, such as sarcomas. Other rare

tumors may be dangerous to biopsy, such as pheochromocytoma. In general,
a fine-needle aspiration can be done anywhere it is safe to put a needle,
including liver, lung, kidney, and superficial masses.

Proper cytopathology technique takes time to master. Cytotechnologists and

cytopathologists can assist clinicians by assisting with sample collection. A
"quick read" is a peek under the microscope and can tell the clinician
whether enough diagnostic material was obtained. Cytological specimens
must be properly prepared so that the cells are not damaged.

Further information about the specimen may be gained by

immunohistochemical stains and molecular testing, particularly if the sample
is prepared using liquid based cytology. Often "reflex" testing is performed,
such as HPV testing on an abnormal pap test or flow cytometry on a
lymphoma specimen.

Body regions

Cytopathologic techniques are used in the examination of virtually all body

organs and tissues:

Gynecologic cytology – concerning the female reproductive tract

Urinary tract cytology – concerning the ureters, urinary bladder and urethra.
See Urine cytology.
Effusion cytology – concerning fluids collections, especially within the
peritoneum, pleura and pericardium

Breast cytology – principally concerning the female breast

Thyroid cytology – concerning the thyroid gland

Lymph node cytology – concerning lymph nodes

Respiratory cytology – concerning the lungs and airways

Gastrointestinal cytology – concerning the alimentary tract

Soft tissue, bone and skin cytology

Kidney and adrenal cytology

Liver and pancreas cytology

Central nervous system cytology

Eye cytology

Salivary gland cytology

Genetics

Genetics is a branch of biology concerned with the study of genes, genetic

variation, and heredity in organisms.

Gregor Mendel, a scientist and Augustinian friar, discovered genetics in the

late 19th-century. Mendel studied "trait inheritance", patterns in the way
traits are handed down from parents to offspring. He observed that
organisms (pea plants) inherit traits by way of discrete "units of inheritance".
This term, still used today, is a somewhat ambiguous definition of what is
referred to as a gene.

Trait inheritance and molecular inheritance mechanisms of genes are still

primary principles of genetics in the 21st century, but modern genetics has
expanded beyond inheritance to studying the function and behavior of genes.
Gene structure and function, variation, and distribution are studied within
the context of the cell, the organism (e.g. dominance), and within the context
of a population. Genetics has given rise to a number of subfields, including
epigenetic and population genetics. Organisms studied within the broad field
span the domains of life (archaea, bacteria, and eukarya).

Genetic processes work in combination with an organism's environment and

experiences to influence development and behavior, often referred to as
nature versus nurture. The intracellular or extracellular environment of a cell
or organism may switch gene transcription on or off. A classic example is
two seeds of genetically identical corn, one placed in a temperate climate
and one in an arid climate. While the average height of the two corn stalks
may be genetically determined to be equal, the one in the arid climate only
grows to half the height of the one in the temperate climate due to lack of
water and nutrients in its environment.

Mendelian and classical genetics

Morgan's observation of sex-linked inheritance of a mutation causing white

eyes in Drosophila led him to the hypothesis that genes are located upon
chromosomes.

Further information: Mutationism and Modern synthesis (20th century)

Modern genetics started with Mendel's studies of the nature of inheritance in

plants. In his paper "Versuche über Pflanzenhybriden" ("Experiments on
Plant Hybridization"), presented in 1865 to the Naturforschender Verein
(Society for Research in Nature) in Brünn, Mendel traced the inheritance
patterns of certain traits in pea plants and described them mathematically.14
Although this pattern of inheritance could only be observed for a few traits,
Mendel's work suggested that heredity was particulate, not acquired, and that
the inheritance patterns of many traits could be explained through simple
rules and ratios.

The importance of Mendel's work did not gain wide understanding until
1900, after his death, when Hugo de Vries and other scientists rediscovered
his research. William Bateson, a proponent of Mendel's work, coined the
word genetics in (the adjective genetic, derived from the Greek word genesis
—γένεσις, "origin", predates the noun and was first used in a biological
sense in 1860. Bateson both acted as a mentor and was aided significantly by
the work of female scientists from Newnham College at Cambridge,
specifically the work of Becky Saunders, Nora Darwin Barlow, and Muriel
Wheldale Onslow.18 Bateson popularized the usage of the word genetics to
describe the study of inheritance in his inaugural address to the Third
International Conference on Plant Hybridization in London in 1906.19

After the rediscovery of Mendel's work, scientists tried to determine which

molecules in the cell were responsible for inheritance. In 1911, Thomas
Hunt Morgan argued that genes are on chromosomes, based on observations
of a sex-linked white eye mutation in fruit flies.20 In 1913, his student
Alfred Sturtevant used the phenomenon of genetic linkage to show that
genes are arranged linearly on the chromosome.

Molecular genetics

DNA, the molecular basis for biological inheritance. Each strand of DNA is
a chain of nucleotides, matching each other in the center to form what look
like rungs on a twisted ladder.

Although genes were known to exist on chromosomes, chromosomes are

composed of both protein and DNA, and scientists did not know which of
the two is responsible for inheritance. In 1928, Frederick Griffith discovered
the phenomenon of transformation (see Griffith's experiment): dead bacteria
could transfer genetic material to "transform" other still-living bacteria.
Sixteen years later, in 1944, the Avery–MacLeod–McCarty experiment
identified DNA as the molecule responsible for transformation.22 The role
of the nucleus as the repository of genetic information in eukaryotes had
been established by Hämmerling in 1943 in his work on the single celled
alga Acetabularia.23 The Hershey–Chase experiment in 1952 confirmed that
DNA (rather than protein) is the genetic material of the viruses that infect
bacteria, providing further evidence that DNA is the molecule responsible
for inheritance.24

James Watson and Francis Crick determined the structure of DNA in 1953,
using the X-ray crystallography work of Rosalind Franklin and Maurice
Wilkins that indicated DNA has a helical structure (i.e., shaped like a
corkscrew).2526 Their double-helix model had two strands of DNA with the
nucleotides pointing inward, each matching a complementary nucleotide on
the other strand to form what look like rungs on a twisted ladder.27 This
structure showed that genetic information exists in the sequence of
nucleotides on each strand of DNA. The structure also suggested a simple
method for replication: if the strands are separated, new partner strands can
be reconstructed for each based on the sequence of the old strand. This
property is what gives DNA its semi-conservative nature where one strand
of new DNA is from an original parent strand.
Accreditation benefits all stake holders. Patients are the biggest beneficiary.
Accreditation results in high quality of care and patient safety. The patients get
services by credential medical staff. Rights of patients are respected and protected.
Patient satisfaction is regularly evaluated.

The staff in a accredited health care organisation are satisfied lot as it provides for
continuous learning, good working environment, leadership and above all
ownership of clinical processes.

Accreditation to a health care organisation stimulates continuous improvement. It

enables the organisation in demonstrating commitment to quality care. It raises
community confidence in the services provided by the health care organisation. It
also provides opportunity to healthcare unit to benchmark with the best.

Finally, accreditation provides an objective system of empanelment by insurance

and other third parties. Accreditation provides access to reliable and certified
information on facilities, infrastructure and level of care.
METHODOLOGY:

We did a systematic review of the literature to evaluate the impact of accreditation

programs on the quality of healthcare services. Several databases were
systematically searched, including Medline, Embase, Healthstar, and Cinhal.
RESULTS:

Twenty-six studies evaluating the impact of accreditation were identified. The

majority of the studies showed general accreditation for acute myocardial
infarction (AMI), trauma, ambulatory surgical care, infection control and pain
management; and subspecialty accreditation programs to significantly improve the
process of care provided by healthcare services by improving the structure and
organization of healthcare facilities. Several studies showed that general
accreditation programs significantly improve clinical outcomes and the quality of
care of these clinical conditions and showed a significant positive impact of
subspecialty accreditation programs in improving clinical outcomes in different
subspecialties, including sleep medicine, chest pain management and trauma
management.
DISCUSSION

Accreditation is usually a voluntary program, sponsored by a non-governmental

organization (NGO), in which trained external peer reviewers evaluate a healthcare
organization's compliance and compare it with pre-established performance
standards.The aim of this study was to evaluate the impact of accreditation
programs on the quality of healthcare services. Another recently published review
of the literature related to accreditation had several limitations. It was not limited
to health services accreditation, but also included heterogeneous types of
accreditation programs, including medical education accreditation programs. In our
review, we limited our search to health services accreditation. Second, the period
covered in the search in the other review was only up to May 2007 and several
important publications have been published since May 2007. Third, several
important papers relevant to accreditation were missed in the other review.

The impact of general accreditation programs on the overall performance of

hospitals

About 2 years after accreditation began; intervention hospitals significantly

improved their average compliance with accreditation standards, while no
appreciable increase was observed in the control hospitals. However, with the
exception of nurse perceptions of clinical quality, the independent research team
observed little or no effect of accreditation on 7 other indicators of quality,
including patient's satisfaction (n=1923), which was not found improved among
accredited hospitals compared to non-accredited hospitals.6 In a large analysis of
the Zambia Hospital Accreditation Program (n=79 hospitals), accreditation was
associated with significant improvement in compliance with standards in the
overall scores, and in 7 out of 13 important functional areas. In a longitudinal study
of 23 hospitals in Australia, hospitals were monitored over 2 years for their
response to accreditation requirements and the general changes in accreditation in
the hospital's environment. There was an increase and improvement in the structure
of medical staff organization, nursing organization and physical facilities and
safety.8 In another study conducted in Copenhagen on 51 units (38 surgical and 13
anesthetic), significantly more accredited units had guidelines in place compared to
non-accredited units. The improvement on the Systematic Development Scale was
significantly higher in accredited than in non-accredited units.9 In an analysis of
the National Committee on Quality Assurance (NCQA) and Health Plan Employer
Data and Information Set (HEDIS) databases, accredited plans had higher HEDIS
scores, but similar or lower performance on patient-reported measures of health
plan quality and satisfaction. A substantial number of the plans in the bottom
decile of quality performance were accredited, suggesting that accreditation does
not ensure high-quality care.10 In an analysis of data from 742 hospitals using 7
performance measures against JCAHO accreditation scores, Joint Commission
measures were found to be not correlated with outcome measures.11 In another
large analysis of JCAHO accreditation scores and the Agency for Healthcare
Research (AHRQ), Inpatient Quality Indicators (IQI) and Patient Safety Indicators
(PSI) (n=2116 institutions), worse performance on the PSI factor was associated
with worse performance on JCAHO scores (P=.02). In a large data analysis of 216
state psychiatric hospitals, there was a weak relationship between accreditation and
indicators of quality of care.13 In a large Egyptian study involving 30 units already
submitted for accreditation and 30 pair-matched units not programmed for
accreditation, the overall satisfaction score of providers was significantly higher
among accredited health units. Most of the checked standards had compliance
above 90% in accredited units and were significantly higher than compliance in
non-accredited units. In a cross-sectional survey (n=145) conducted in the
Philippines, using vignettes or case scenarios scores, the quality of clinical care
was significantly higher among accredited physicians compared to non-accredited
physicians.

The impact of general accreditation programs on a single aspect of a hospital's

performance

In a large analysis of data from Centers for Medicare and Medicaid Services
(CMS) in US (n=134 579 patients from 4221 hospitals), patients treated at
accredited hospitals were more likely to receive higher quality of care for the
management of acute myocardial infarction (AMI) than those treated at non-
accredited hospitals. In this study, the mortality rate was lower post AMI in
accredited hospitals than in non-accredited hospitals.16 In a cross-sectional survey
conducted in the US in 1988 (n=5172), 1990 (n=5140), 1995 (n=5116), 2000
(n=5150) and 2005 (n=5146), methadone maintenance facilities accredited by
JCAHO were more likely to adhere to the recommended dosage guideline of
methadone, compared to non-accredited hospitals.17 In a large cross-sectional
survey of outpatient substance abuse treatment programs conducted in the US
(n=1137), JCAHO accreditation was positively associated with two elements of
treatment comprehensiveness: the percentages of clients receiving physical
examinations and mental health care.18 In an American prospective study (n=36
institutions), medication error rates were similar between accredited and non-
accredited hospitals. In this study, 5 non-accredited hospitals achieved
accreditation during the study. In a large cross-sectional survey conducted in Japan
over 2 consecutive years (n=638 hospitals), the overall infection control
performance score was significantly associated with accreditation status. In a
retrospective analysis at 24 accredited trauma centers in the , accreditation was
significantly associated with higher survival rates for patients presenting with six
types of trauma injuries. In an analysis of huge data from ambulatory surgical
centers in the US, there was a significant reduction in unexpected hospitalizations
in patients undergoing colonoscopy (n=315 070) in accredited ambulatory surgical
centers (ASC) compared to non-accredited ASC. In this study, there was also a
reduction in unexpected hospitalizations in patients undergoing cataract surgery
(n=245 154; P=.08) in accredited ASC compared to non-accredited ASC. In a large
cross-sectional survey of acute care hospitals (n=85), the number of newly
employed full-time or part-time infection control nurses (ICNs) and the number of
new infection control service (ICS) organizations increased sharply from 1994 to
1996 with the accreditation of medical care services in 1995, and then decreased
until 1998. In a retrospective chart review (n=1082), JCAHO pain initiatives on
opioids use significantly improved perioperative pain management without a
visible increase in adverse effects.
SUMMARY AND CONCLUSIONS:

There is consistent evidence that shows that accreditation programs improve the
process of care provided by healthcare services. There is considerable evidence
to show that accreditation programs improve clinical outcomes of a wide
spectrum of clinical conditions. Accreditation programs should be supported as
a tool to improve the quality of healthcare services.
BIBLIOGRAPHY
a) Based upon presentations made in the Intercountry Meeting on Establishment of Quality
Systems and Accreditation in Health Laboratories held in Thailand from 9-13 October
2006 (SEA-HLM-393, WHO Regional Office for South-East Asia, New Delhi) 2006

b) Director, WHO Collaborating Centre on Strengthening Quality System in Health

Laboratories, Department of Medical Sciences, Ministry of Public Health, Nonthaburi,
Thailand

c) https://icmr.nic.in/sites/default/files/guidelines/GCLP.pdf

d) In India, medical laboratories can volunteer for accreditation of one or more services

offered ...projects submitted by individual researchers and institutes. ... staff
includes pathologists, microbiologists, cytotechnicians, laboratory technicians,.

e) https://www.who.int/ihr/training/.../11_cd_rom_publications_sea_hlm_394.pdf?ua=1

f) P Silva - Cited by 2 - Related articles

g) The major constraints to accreditation in India include the absence of a national ...

Chemistry,Pathology and Immunology, and imparts technical training for laboratory
project on national and international standards for medical laboratories.

h) index.about.com/Pathology India

i) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2423316/

j) https://www.jointcommission.org/assets/1/6/2013_Lab_Overview.pdf