HOSPITAL
ADMINISTRATION – A LEGAL PERSPECTIVE
In
this period of management and technology, treatment also made into organized
activity, it may because of the challenges and difficulties confronted by the
profession in the evolutionary process. Actually treatment and related
activities are coming into the job description of Doctors, Nurses,
Pharmacists, Radiographers, etc. only. But enormous nature of work related
with the treatment led to the requirement of coordination of these activities
to provide qualitative and effective services to the stake holders. Based on
this requirement, Hospital Administration has changed into an essential and
responsible service provider related with the treatment. This essentiality
and responsibility made hospital authorities liable, for the negligent acts
of staff working in the hospital, based on the doctrine of respondeat
superior.
Applicability of this principle explained by
the court in the case of Scott
vs. London St. Katherine Docks Co.;
[(1865) as “Where the thing is shown
to be under the management of the defendant or his servants, and the accident
is such as in the ordinary course of things does not happen if those who have
the management, use, proper care, it affords reasonable evidence, in the
absence of explanation by the defendants, that the accident arose from want
of care.” And the same
reiterated by the Honourable Supreme Court of India in the case of Smt.
Savita Garg vs. Director, National
Heart Institute (2004) as: “Once an allegation is made that the
patient was admitted in a particular hospital and evidence is produced to
satisfy that he died because of lack of proper care and negligence, then the
burden lies on the hospital to justify that there was no negligence on the
part of the treating doctor or hospital. Therefore, in any case, the hospital
is in a better position to disclose what care was taken or what medicine was
administered to the patient. It is the duty of the hospital to satisfy that
there was no lack of care or diligence. The hospitals are institutions,
people expect better and efficient service, if the hospital fails to
discharge their duties through their doctors, being employed on job basis or
employed on contract basis, it is the hospital which has to justify and not
impleading a particular doctor will not absolve the hospital of its
responsibilities.”
Some other important verdicts of related subject are:
Mrs. Arpana Dutta vs Apollo Hospitals Enterprises
(2000) (Madras H C) (VICARIOUS
LIABILITY OF HOSPITALS)
Barnett
vs.
Cassidy vs. Ministry of Health [1951] (CONTRACT OF /FOR SERVICE& VICARIOUS LIABILITY)
V.
Chandrasekhar vs. Appollo Hospitals
Enterprises (
M. Chinnaiyan vs.
Collins vs. Hertfordshire County Council & Anr. [1947] (MISTAKE IN WRITTEN INSTRUCTION)
Gold vs.
Indian Medical Association vs.
V.P. Shantha & Ors (1996) (HOSPITALS – SERVICE)
Malay Kumar Ganguly vs. Sukumar
Mukherjee & Ors. (2009) (STEROIDS IN TREATMENT)
Martin
F.D’Souza vs. Mohd. Ishfaq, [(2009) (PRECAUTIONS BY DOCTORS / HOSPITALS)
Nizam
Institute of Medical Sciences vs. Prasanth S. Dhananka [2009] (NEGLIGENCE,
CONSENT, NEUROFIBROMA)
Pinnamaneni
Narasimha Rao vs. Gundavarapu Jayaprakasu, (1990) (NEGLIGENCE - ANAESTHETIST , SURGEON & HOSPITAL)
R vs. Yogasa Karan [1990] (
Prof. P.N. Thakur vs. Hans Charitable Hospital
(NCDRC) (UNQUALIFIED PHYSICIAN IN
HOSPITAL & LACK OF COORDINATION)
From the above it is very clear that judiciary
reckons very important role to the administration of the hospitals in the
treatment of patients by their staff. It is also very clear that the hospital
authorities are not directly doing these activities but get done the same
through their staff. This subject is explained in the case of Cassidy vs. Ministry of Health; [1951] as:
“Authorities
who run a hospital, be they local authorities, government boards or any other
corporation, are in law under the self same duty as the humblest doctor. The
hospital authorities cannot, of course, do it by themselves: they have no
ears to listen through the stethoscope, and no hands to hold the surgeon’s
knife. They must do it by the staff which they employ.” Actually
these responsibilities of the hospital authorities are done through the
Hospital Administrators. This gives way for the importance of hospital
administration in the effective management of activities of every hospital
upto the satisfaction of the consumers as well as that of the society as
measured by the judicial forums.
Responsibilities of Hospital
Administrator
For
the effectiveness of their responsibilities what are the duties a Hospital
Administrator supposed to do, so as to make it acceptable to the society?
While
going into the intricacies of the nature of job of a Hospital Administrator,
we can that some of the following activities shall become invariably
unavoidable for its effectiveness:
a.
Administration and coordination of
the developmental activities and implementation of various clinical practices
and services in the delivery of quality patient care;
b.
Monitoring of the standards and
values regulating the quality assurance of health care prescribed by the
accreditation boards and regulatory agencies;
c.
Maintaining of complete
administrative responsibilities of the organization for the optimum
utilization and effectiveness of various units;
d.
Planning, developing and
implementing of programs and services for various units of the organization;
e.
Evaluation of program effectiveness
and recommending reorganization strategies to ensure compliance with
regulations, that the needs of the targeted population are met and funding
guidelines are adhered to;
f.
Coordination of the activities of
hospital staff to ensure continuing efforts towards the accomplishment of
organizational goals;
g.
Investigation into complaints or
grievances and recommends corrective action according to the judicial tenants
upto the satisfaction of all involved;
h.
Developing, recommending and
implementing requisite changes in overall administrative policies and
procedures so as to enable it to carry out departmental programs and
objectives more effectively;
i.
Liaison with regulatory authorities
and agencies regarding standards of care and legal compliance;
j.
Utilization of computer applications
or other automated systems in Management Information Systems for the
effective storing and retrieval of data and performing work assignments;
Legal compliance
Observance of
legal tenants give way for discipline in the society because law prescribes
socially acceptable standards of behaviour to be followed in every situations
for the well being of the society. Compliance of legal provisions is
mandatory in most of the subjects related with the hospital administration
due to the involvement of dangerous chattels or activities. Meanwhile
observance of guidelines provides way for the qualitative delivery of service
to the consumers. There are so many enacted laws and guidelines; those
directly as well as indirectly regulate the activities of health care
organization. Knowledge of these laws and their applications are inevitable
for the effective function of the health care organization without any
hindrance. Some of them are:
* Safe Disposal of Radioactive Waste Rules,
Radiation Surveillance Procedure, Safety Code for Medical Diagnostic X-ray Equipment & Installations,
Atomic Energy (Radiation Protection) Rules, etc.
*
PC-PNDT Act & Rules
*
Clinical Establishment and Registration Act
*
Clinical practice guidelines
*
Emergency Severity Index (ESI)
*
Triage Scales (ATS & CTAS)
*
Prevention of hospital acquired infections - A Practical Guide by WHO
*
ACLS, BLS, PALS and NALS guidelines
*
AHA 2010 guidelines
*
OT Guidelines, “Safe Surgery Saves Lives” Initiative by WHO
* Anatomy Act
* Disaster Management Act
* Drugs and Cosmetics Act & Rules
* Drugs and Magical Remedies Act &
Rules
* Employers Liability Act, Employees
welfare Acts & Rules
* Companies Act,
Charitable Societies Act, Indian Trusts Act, Partnerships Act, Income Tax Act
& Rule, VAT Act & Rules, General Sales Tax Act & Rules, Excise
Act, etc.
* Ethical Guidelines for Biomedical
Research on Human Subjects
* Acts & Rules related with
Foreigners
* Indian Evidence
Act, I P C, Cr P C, Indian Contract Act, Consumer Protection Act, Torts Act,
Indian Explosives Act, General Clauses Act, Constitution of India,
Information Technology Act. etc.
* Motor Vehicles
Act & Rule, Inflammable Substances Act, Indian Boilers Act, Petroleum Act
& Rules, Gas cylinders Act, SMPV
Rules, The Explosive Substances Act & Rules, Batteries Rules,
* Blood Bank
Regulations, Clinical Thermometer Order, Epidemic Disease Act, Food Safety and
Standards Act, ICMR Guidelines, Indian Medical Council Act, M T P Act,
Regulations & Rules, NACO Guidelines, Narcotic Drugs & Psychotropic
Substances Act & Rules, etc.
* Environmental
Protection Act & Rules, Insecticides Act, Lifts & Escalators Act,
National Building Code, Air Act & Rules, Municipal Building Byelaws,
Ozone Depleting substances Act, Bio-Medical Waste Rules, Hazardous Substances
& Waste Rules, Noise Pollution Rules, Water Act & Rules, Hazardous
Micro organisms Rules, etc.
Documentation
Proper
documentation of its activities is considered as a vital sign of a successful
organization. Documents prepared at appropriate time are reckoned as genuine
evidence, which is a tool, to settle issues in a dispute, that may occur in
future. Generally doctors and other health care providers do everything with
the intention of curing the patient so as to get relief from the clutches of
diseases or disorders but due to some inadvertence or misfortune of
unavoidable circumstances that leads to inconvenience or difficulties to the
patient. Its after, whenever the dispute reaches in the court for perusal,
the doctors and other health care providers become helpless to prove their
‘good faith’ in the activities which led to negligence, in the absence of any
evidence to support their argument.
Importance of documentation is explained in the research paper titled
‘Medical Negligence: Law and
Interpretation’ by Anurag K.
Agarwal of IIM, Ahmedabad as: “Law requires evidence and documentary
evidence in the form of case papers has to be meticulously prepared. The duty
of the doctor is to treat the patient; however, it is also important to
document the treatment given and at times the reason why such treatment has
been given. The matters reach a court after several months and years and by
that time the only thing on which the parties can rely in the court is the
case file. The oral evidence of doctors and other staff also adds to the
evidence, however, the documentary evidence always gets precedence, until and
unless proved to be forged. It is also important to have transparency in the
system and give a copy of all the papers, reports, films, etc. to the
patient. In such a case the confidence of a patient in the hospital and its
system increases. There are, however, some doctors and hospitals who try to
keep the patient in the dark. The oft-repeated phrase is, “do you have trust
in me?” The patient is almost at the mercy of the doctor. An important
improvement in the paper work has been in the shape of electronic records,
which allow easy storage and retrieval. At the same time, several copies can
easily be made. There is also minimal chance of errors creeping in as most of
the items are to be selected from a drop-box. The issue of bad handwriting,
very common complaint with doctors, is also easily taken care of. All new
hospitals work with local network of computers and do not transfer papers
from one place to another. There is also no chance of losing a paper.”
This
concept has included in the “Accreditation
Standards for Hospitals”, 3rd Edition by National Accreditation Board for Hospitals and Healthcare
Providers (NABH) as important and
very essential requirement for accreditation. Eg. The Chapter, ‘Access Assessment and Continuity of
Care’ (AAC) provides as:
a. Documented
policies and procedures are used for registering and admitting patients.
b. The documented
procedures address out-patients, inpatients and emergency patients.
c. The documented
policies and procedures also address managing patients during
non-availability of beds.
d. Documented
policies and procedures guide the transfer-in of patients to the
organization.
e. Documented
policies and procedures guide the transfer-out/referral of unstable patients
to another facility in an appropriate manner.
f. Documented
policies and procedures guide the transfer-out/referral of stable patients to
another facility in an appropriate manner.
g. The documented
procedures identify staff responsible during transfer/referral.
h. The organization defines
and documents the content of the initial assessment for the out-patients,
in-patients and emergency patients.
i.
Documented procedure guide ordering of tests,
collection, identification, handling, safe transportation, processing and
disposal of specimens.
j. Laboratory
results are available within a defined time frame.
k. Critical results
are intimated immediately to the personnel concerned.
l.
The laboratory quality assurance programme is
documented.
m. The programme
addresses verification and/or validation of test methods.
n. The programme
addresses surveillance of test results.
o. The programme
includes periodic calibration and maintenance of all equipment.
p. The programme
includes the documentation of corrective and preventive actions
q. The
laboratory-safety programme is documented.
r. Written
procedures guide the handling and disposal of infectious and hazardous
materials.
s. Documented
policies and procedures guide identification and safe transportation of
patients to imaging services.
t. Imaging results
are available within a defined time frame.
u. Critical results
are intimated immediately to the personnel concerned.
v. The quality
assurance programme for imaging services is documented.
w. The programme
addresses surveillance of imaging results.
x. The programme
includes the documentation of corrective and preventive actions.
y. The
radiation-safety programme is documented.
z. Radiation-safety
devices are periodically tested and results documented.
aa. Information is
exchanged and documented during each staffing shift, between shifts, and
during transfers between units/departments.
bb.
Documented procedures guide the referral of patients
to other departments/specialties.
cc. Documented
procedures exist for coordination of various departments and agencies
involved in the discharge process (including medico-legal and absconded
cases).
dd.
Documented policies and procedures are in place for
patients leaving against medical advice and patients being discharged on
request.
In
the cases of Bolam vs. Friern Hospital
Management Committee, Queen’s Bench Division, [1957]; Dr. Suresh Gupta vs. Govt. of N.C.T. of Delhi (2004); Jacob
Mathew vs. State of Punjab (2005); Dr.
B N Gurudev vs. Dr. N Ramanna (2008);
Martin F. D’Souza vs. Mohd. Ishfaq
(2009); Dr. C P Sreekumar vs. S
Ramanujam (2009), court held hospitals and medical professionals are not
liable on the basis of documentary evidences maintained by them.
Importance of Manuals
Manuals
are made to provide advance information to the staff regarding the management
of situations as per the policies of the organization. Manuals also enable to
take reasoned decisions in the disciplinary proceedings without giving way
for arbitrariness. There shall be an Apex Manual with vision, mission,
objectives and organogram of the organization and could be distributed to all individuals
in the first rung of the organogram. In addition to the apex manual the
hospital shall introduce other manuals for the use of every units, viz.
Infection Control Manual, Quality Improvement manual which also incorporates
the quality assurance activities of lab, imaging, intensive care and surgical
services, Safety manual which also incorporates lab safety and radiation
safety, Front office manual, Critical care unit & Casualty manual, HR
manual, Security manual, Finance manual, Dietary services manual, etc.
Monitoring
of Sentinel Events
Sentinel
Events defined as “An unexpected
incident, related to system or process deficiencies, which leads to death or
major and enduring loss of function for a recipient of healthcare services.”
(Ref: NABH
Accreditation Standards for Hospitals, 3rd Edition) In which
Major and enduring loss of function refers to sensory, motor, physiological,
or psychological impairment not present at the time services were sought or
begun. The impairment lasts for a minimum period of two weeks and is not
related to an underlying condition. Sentinel events are classified as
follows:
1.
Surgical events
·
Surgery performed on the wrong patient
·
Surgery performed on the wrong body part
·
Wrong surgical procedures performed on the wrong
patient
·
Retained instruments in patient discovered after surgery/procedure
·
Patient death during or immediately post-surgical
procedure
·
Anesthesia-related event
2. Device or
product events patient death or serious disability associated with:
·
The use of contaminated drugs, devices, products
supplied by the organization
·
The use or function of a device in a manner other
than the device’s intended use
·
The failure or breakdown of a device or medial
equipment
·
Intravascular air embolism
3. Patient
protection events
·
Discharge of an infant to the wrong person
·
Patient death or serious disability associated with
elopement from the healthcare facility
·
Patient suicide, attempted suicide, or deliberate
self-harm resulting in serious disability.
·
International injury to a patient by a staff member,
another patient, visitor, or other.
·
Any incident in which a line designated for oxygen or
other came to be delivered to a
patient and contains the wrong gas or is contaminated by toxic
substances
·
Nosocomial infection or disease causing patient death
or serious disability
4. Environmental
events
Patient death or serious disability
while being cared for in a healthcare facility associated with:
·
A burn incurred from any source
·
A slip, trip, or fall
·
An electric shock
·
The use of restraints or bedrails
5.
Care management events
·
Patient death or serious disability associated with a
hemolytic reaction due to the administration of ABO-incompatible blood or
blood products
·
Maternal death or serious disability associated with
labour or delivery in a low-risk pregnancy
·
Medication error leading to the death or serious
disability of patient due to incorrect administration of drugs, for
example:
o
Omission
error
o
Dosage
error
o
Dose-preparation error
o
Wrong-time
error
o
Wrong rate of administration error
o
Wrong
administrative technique error
o
Wrong-patient error
·
Patient death or serious disability associated with
an avoidable delay in treatment or response to abnormal test results
6. Criminal events
·
Any instance of care ordered by or provided by an
individual impersonating a clinical member of staff
·
Abduction of a patient
·
Sexual assault on a patient within or on the grounds
of the healthcare facility
·
Death or significant injury of a patient or staff
member resulting from a physical assault or other crime that occurs within or
on the grounds of the healthcare facility.
Clinical Audit
Clinical
audit (CA) may be defined as “view
for evaluation of medical care through retrospective and concurrent analysis
of medical record.” (Ref: NABH Accreditation Standards for Hospitals, 3rd
Edition). The primary aim of
CA is to improve the quality of
healthcare services rendered to the patients. But it is not a fault-finding mission or a punitive action or
an external quality-control method. Generally it will be done by Clinical
Audit Committee,
* Set standards
* Measure practice through data Collection
and Analysis
* Assessment of Performance against standard
* Identify opportunity for improvement
* Suggest change
* Implement change
* Evaluate change
* Review standard
Methodology of
administration of Clinical Audit
a.
Simplest for the purpose
b.
Only essential data is collected
c.
Suitable sample size is to be selected
i.
Random sampling-generate
ii.
Stratified samples
iii.
Systematic sampling
iv.
Cluster sampling
d.
Probability of bias is to be considered
i.
Non-response to a survey
ii.
Unavailability of certain type of case note
iii.
Selective referral of certain types of patients
iv.
Failure of patient to turn up for follow up
Motives behind
Clinical Audit
·
Professional
* To identify deficiencies
* Educational need
* Self-correction & self-regulation
·
Social
* To ensure safety of public
* To protect patient from inappropriate
or suboptimal care
·
Pragmatic
* To reduce patients suffering
·
Legal
* Medical negligence related with
Consumer Protection Act & Civil Laws
* Criminal Negligence
* Malpractice
Benefits of
Clinical Audit
(a) Professional benefits
- Change in prescribing behavior
- Updating of clinical knowledge
- Increase in staff enthusiasm and satisfaction
- Teamwork
(b) Patient care and service delivery
- Improvements in patient care
- improved patient satisfaction
- Better patient feedback
- Reduction in disputes and grievances
Dangerous
materials
It
has become inevitable for every hospital to stack and use different types of
materials which may cause dangers to the users as well as other people who
come adjacent to it or by escaping from control. In such cases, the basis of
liability is the magnitude of the risk which is foreseeable. According to the
‘Rule of Strict liability’, as put
forth in the case of Rylands
vs. Fletcher (1868), the Plaintiff is not required to prove
negligence, lack of care or wrongful intention on the part of the defendant.
It was laid down that: “If a person
brings or accumulates on his land anything which, if it should escape may
cause damage to his neighbours, he does so at his peril. If it does escape
and cause damage he is responsible, however, careful he may have been, and
whatever precaution he may have to prevent the damage.” In such matters,
the Honourable Supreme Court of India took a hard and bold decision holding
that it was not bound to follow the 19th century rule and evolved
the ‘Rule of Absolute liability’,
suitable to the social and economic conditions prevailing in India at the
present day, in the case of M C Mehta
vs. Union of India (1987) and observed that: “We are of the view that an enterprise,
which is engaged in hazardous or inherently dangerous materials, which poses
a potential threat to the health and safety of the person working with it or
in the surrounding areas owes absolute and non- delegatable duty to the
community to ensure that no harm results to anyone on account of hazardous or
inherently dangerous activity which it has undertaken. The enterprise must be
held to be under an obligation to provide that the hazardous or inherently
dangerous activity in which it is engaged must be conducted with the highest
standards of safety and if any harm results on account of such activity the
enterprise must be absolutely liable to compensate for such harm and it
should be no answer to enterprise to say that it has taken all reasonable
care and that the harm occurred without any negligence on its part.”
Responsibilities
of Patients
Patients are the real
consumers of a hospital and their cooperation is very essential for the
success of each and every endeavor of organization but it is the
responsibility of the authorities to actively seek and procure the same by
enlightening them on their responsibilities for the benefit of them. Some of
the responsibilities towards this end are:
·
Provide complete and accurate information about
his/her health, including present condition, past illness, hospitalizations,
medications, natural products and vitamins, and any other matters that
pertain to his/her health.
·
Provide complete and accurate information including
full name, address and other information.
·
To ask questions when he/she does not understand what
the doctor or other member of the healthcare team tells about diagnosis or
treatment. He/she should also inform the doctor if he/she anticipates problems
in following prescribed treatment or considering alternative therapies.
·
Abide by all hospital rules and regulations.
·
Comply with the no-smoking policy.
·
Comply with the visitor policies to ensure the rights
and comfort of all patients.
·
Be considerate of noise levels, privacy, and safety.
·
Weapons are prohibited on premises.
·
Treat hospital staff, other patients, and visitor
with courtesy and respect.
·
To be on time in case of appointments. To cancel or
reschedule as far in advance as possible in case of cancellation or
rescheduling of the appointments.
·
Not to give medication prescribed for him/her to
others.
·
Provide complete and accurate information for
insurance claims and work with the hospital and physician billing offices to
make payment arrangements.
·
To communicate with the healthcare provider if
his/her condition worsens or does not follow the expected course.
·
To pay for services billed for in a timely manner as
per the hospital policies.
·
To respect that some other patient’s medical
condition may be more urgent than yours and accept that your doctor may need
to attend them first.
·
To respect that admitted patient and patients
requiring emergency care take priority for your doctor.
·
To follow the prescribed treatment plan and carefully
comply with the instructions given.
·
To accept, where applicable, adaptations to the
environment to ensure a safe and secure stay in hospital.
·
To accept the measures taken by the hospital to
ensure personal privacy and confidentiality of medical records.
·
To attend follow-up appointment as requested.
·
Not to take any medications without the knowledge of
doctor and healthcare professionals.
·
To provide correct and truthful history.
·
To understand the charter of rights and seek
clarification, if any.
In
the case of A.S. Mittal vs. State of
“Staff: The operations in the camp should only be performed by
qualified, experienced Ophthalmic Surgeons registered with Medical Council of
“There should be a pathologist to examine Urine, blood, sugar etc. It is preferable to have a Dentist to check the teeth for
sepsis and a Physician for general medical check-up.”
“Medication:
All medicines to be used should be
of standard quality duly verified by the doctor in-charge of the camp.”
“The necessity of maintenance of the highest standards of a septic and
sterile conditions at places where Ophthalmic surgery or any surgery is
conducted cannot be overemphasised. It is not merely on the formulation of
the theoretical standards but really on the professional commitment with
which the prescriptions are implemented that the ultimate result rests.
Government, States and
Again in the case of Martin F.D’Souza vs. Mohd. Ishfaq (2009)
laid down the precautions which
doctors/hospitals etc. should have taken, in the following terms, which are
very important and valuable for every health care organization in the administration:-
“(a) Current practices, infrastructure, paramedical
and other staff, hygiene and sterility should be observed strictly.
(b) No prescription should ordinarily be given without actual
examination. The tendency to give prescription over the telephone, except in
an acute emergency, should be avoided.
(c) A doctor should not merely go by the version of the patient
regarding his symptoms, but should also make his own analysis including tests
and investigations where necessary.
(d) A doctor should not experiment unless necessary and even then he should ordinarily get a
written consent from the patient.
(e) An expert should be consulted in case of
any doubt.”
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Tuesday, 17 June 2014
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