Components of Standards Development

1
Components of Standards Development

• Multiple Information Sources
• Scientific literature
• JCI Standards
• UK Healthcare Quality Standards
• Thailand Standards
• AHA Draft Standards
• JCI Survey compliance data
• Research Findings
• Individual input from field experts and key
  stakeholders
• ISO 9001-2000

2
Hospital Standards

• Organized around important functions
• Focus on patient and staff safety
• Set standards that all organizations must pass
• To be revised periodically and raise the bar
• Achieve International recognition

3
NABH Standards

• 10 Chapters
• 100 Standards
• 503 Objective Elements

4
Standards and Objective Elements

• A standard is a statement that defines the
  structures and processes that must be
  substantially in place in an organization to
  enhance the quality of care
• Objective element is a measurable component of a
  standard
• Acceptable compliance with objective elements
  determines the overall compliance with a standard

5
Section IPatient-Centered Standards

• STD OE
• Access, Assessment and Continuity of Care
  (AAC) 15 78
• Patients Rights and Education (PRE) 5 29
• Care of Patients (COP) 18 105
• Management of Medications (MOM) 13 61
• Hospital Infection Control (HIC) 9 44

6
Section II Health Care Organization Management
Standards

• STD OE
• Continuous Quality Improvement (CQI) 6 37
• Responsibilities of Management (ROM) 5 20
• Facility Management Safety (FMS) 9 41
• Human Resource Management (HRM) 13 47
• Information Management Systems (IMS) 7 41
• 100 503

7
NABH STANDARDS
8
Introduction

• NABH standards for hospitals have been prepared
  by Technical Committee of NABH and contain
  complete set of standards for evaluation of
  hospitals for grant of accreditation. The
  standards provide framework for quality assurance
  and quality improvement for hospitals
• NABH Standards contains 10 chapters,100 standards
  and 503 objective elements.

9
Details of chapters.

1. Access ,Assessment and continuity of care (AAC)
2. Patient Right and Education (PRE).
3. Care of Patients(COP).
4. Management of Medication (MOM).
5. Hospital Infection Control (HIC).
6. Continuous Quality Improvement(CQI)
7. Responsibility of Management (ROM).
8. Facility Management and Safety (FMS).
9. Human Resource Management (HRM)
10. Information Management System (IMS).

10
Chapter 1.ACCESS,ASSESSMENT AND CONTINIUITY OF
CARE (AAC)
11
AAC.1The organization defines and displays the
services that it can provide

• Objective Elements
• The services being provided are clearly defined.
• The defined services are prominently displayed.
• The staff is oriented to these services

12
AAC.2The organization has a well defined
registration and admission process

• Objective elements
• Standardized policies and procedures are used
  for registering and admitting patients
• The policies and procedures address out-
  patients, in-patients and emergency patients

13
Cont

• Patients are accepted only if the organization
  can provide the required service
• The policies and procedures also address managing
  patients during non availability of beds
• The staff is aware of these processes

14
AAC.3There is an appropriate mechanism for
transfer or referral of patients who do not match
the organizational resources

• Objective elements
• Policies guide the transfer of unstable
  patients to another facility in an appropriate
  manner
• Policies guide the transfer of stable patients
  to another facility

15
Cont

• Procedures identify staff responsible during
  transfer
• The organization gives a summary of patients
  condition and the treatment given

16
AAC.4During admission the patient and /or the
family members are educated to make informed
decisions

• Objective elements
• The patients and/or family members are
  explained about the proposed care
• The patients and/or family members are
  explained about the expected results

17
Cont

1. The patients and/or family members are
   explained about the possible complications
2. The patients and/or family members are explained
   about the expected costs.

18
AAC.5Patients cared for by the organization
undergo an established initial assessment

• Objective elements
• The organization defines the content of the
  assessments for the outpatients, in-patients and
  emergency patients.
• The organization determines who can perform the
  assessments.

19
cont

• The organization defines the time frame within
  which the initial assessment is completed.
• The initial assessment for in-patients is
  documented within 24 hours or earlier as per the
  patients condition or hospital policy.
• Initial assessment includes screening for
  nutritional and psychosocial needs.

20
Cont

1. The initial assessment results in a documented
   plan of care.
2. The plan of care also includes preventive aspects
   of the care

21
AAC.6All patients cared for by the organization
undergo a regular reassessment

• Objective elements.
• All patients are reassessed at appropriate
  intervals.
• Staff involved in direct clinical care document
  reassessments.
• Patients are reassessed to determine their
  response to treatment and to plan further
  treatment or discharge.

22
AAC.7Laboratory services are provided as per the
requirements of the patients

• Objective elements
• Scope of the laboratory services are commensurate
  to the services provided by the organization
• Adequately qualified and trained personnel
  perform and/or supervise the investigations.

23
cont..

1. Policies and procedures guide collection,
   identification, handling, safe transportation and
   disposal of specimens.
2. Laboratory results are available within a defined
   time frame.
3. Critical results are intimated immediately to the
   concerned personnel.
4. Laboratory tests not available in the
   organization are outsourced to organization(s)
   based on their quality assurance system.

24
AAC.8There is an established laboratory quality
assurance programme

• Objective elements
• The laboratory quality assurance programme is
  documented.
• The programme addresses verification and
  validation of test methods.
• The programme addresses surveillance of test
  results.

25
cont

1. The programme includes periodic calibration and
   maintenance of all equipments.
2. The programme includes the documentation of
   corrective and preventive actions

26
AAC.9There is an established laboratory safety
programme

• Objective elements.
• The laboratory safety programme is documented.
• This programme is integrated with the
  organizations safety programme.

27
cont

• Written policies and procedures guide the
  handling and disposal of infectious and hazardous
  materials.
• Laboratory personnel are appropriately trained in
  safe practices.
• Laboratory personnel are provided with
  appropriate safety equipment / devices.

28
AAC.10Imaging services are provided as per the
requirements of the patients

• Objective elements
• Imaging services comply with legal and other
  requirements.
• Scope of the imaging services are commensurate to
  the services provided by the organization.
• Adequately qualified and trained personnel
  perform and/or supervise the investigations.

29
cont

• Policies and procedures guide identification and
  safe transportation of patients to imaging
  services.
• Imaging results are available within a defined
  time frame.
• Critical results are intimated immediately to the
  concerned personnel.
• Imaging tests not available in the organization
  are outsourced to organization(s) based on their
  quality assurance system.

30
AAC.11There is an established Quality assurance
programme for imaging services

• Objective elements
• The quality assurance programme for imaging
  services is documented.
• The programme addresses verification and
  validation of imaging methods
• The programme addresses surveillance of imaging
  results

31
cont

1. The programme includes periodic calibration and
   maintenance of all equipments.
2. The programme includes the documentation of
   corrective and preventive actions

32
AAC.12There is an established radiation safety
programme

• Objective elements
• The radiation safety programme is documented.
• This programme is integrated with the
  organizations safety programme.
• Written policies and procedures guide the
  handling and disposal of radio-active and
  hazardous materials.

33
cont

1. Imaging personnel are provided with appropriate
   radiation safety devices
2. Radiation safety devices are periodically tested
   and documented.
3. Imaging personnel are trained in radiation safety
   measures.
4. Imaging signage are prominently displayed in all
   appropriate locations.
5. Policies and procedures guide the safe use of
   radioactive isotopes for imaging services.

34
AAC.13Patient care is continuous and
multidisciplinary in nature

• Objective elements
• During all phases of care, there is a qualified
  individual identified as responsible for the
  patients care.
• Care of patients is coordinated in all care
  settings within the organization.

35
cont

• Information about the patients care and response
  to treatment is shared among medical, nursing and
  other care providers.
• Information is exchanged and documented during
  each staffing shift, between shifts, and during
  transfers between units/departments.
• The patients record (s) is available to the
  authorized care providers to facilitate the
  exchange of information.
• Policy and procedures guide the referral of
  patients to other department / specialty.

36
AAC.14The organization has a documented
discharge process

• Objective elements
• The patients discharge process is planned.
• Policies and procedures exist for coordination of
  various departments and agencies involved in the
  discharge process (including medico-legal cases

37
cont

• Policies and procedures are in place for patients
  leaving against medical advice
• A discharge summary is given to all the patients
  leaving the organization (including patients
  leaving against medical advice)

38
AAC.15Organisation defines the content of the
discharge summary

• Objective elements
• Discharge summary is provided to the patients at
  the time of discharge
• Discharge summary contains the reasons for
  admission, significant findings and diagnosis and
  the patients condition at the time of discharge.

39
cont

1. Discharge summary contains information regarding
   investigation results, any procedure performed,
   medication and other treatment given
2. Discharge summary contains follow up advice,
   medication and other instructions in an
   understandable manner.

40
cont

• Discharge summary incorporates instructions about
  when and how to obtain urgent care
• In case of death the summary of the case also
  includes the cause of death.Patient records also
  contain a copy of the discharge /case summary

41
Chapter .2PATIENT RIGHT AND EDUCATION (PRE)
42
PRE.1The organization protects patient and
family rights during care

• Objective element
• Patient and family rights are documented.
• Patients and families are informed of their
  rights in a format and language that they can
  understand

43
cont

1. The organizations leaders protect patients
   rights
2. Staff is aware of their responsibility in
   protecting patients rights
3. Violation of patient rights is reviewed and
   corrective/preventive measures taken

44
PRE.2.Patient rights support individual beliefs,
values and involve the patient and family in
decision making processes

• Objective elements
• Patient rights include respect for personal
  dignity and privacy during examination,
  procedures and treatment
• Patient rights include protection from physical
  abuse or neglect

45
cont

• Patient rights include treating patient
  information as confidential
• Patient rights include refusal of treatment
• Patient rights include informed consent before
  anesthesia, blood and blood product transfusions
  and any invasive / high risk procedures /
  treatment

46
cont

• Patient rights include information and consent
  before any research protocol is initiated
• Patient rights include information on how to
  voice a complaint
• Patient rights include information on the
  expected cost of the treatment
• Patient has a right to have an access to his /
  her clinical records

47
PRE.3A documented process for obtaining patient
and / or families consent exists for informed
decision making about their care

• Objective elements
• General consent for treatment is obtained when
  the patient enters the organization

48
cont

• Patient and/or his family members are informed of
  the scope of such general consent
• The organization has listed those procedures and
  treatment where informed consent is required
• Informed consent includes information on risks ,
  benefits, alternatives and as to who will perform
  the requisite procedure in a language that they
  can understand
• The policy describes who can give consent when
  patient is incapable of independents decision
  making.

49
PRE.4Patient and families have a right to
information and education about their healthcare
needs

• Objective elements
• When appropriate, patient and families are
  educated about the safe and effective use of
  medication and the potential side effects of the
  medication
• Patient and families are educated about diet and
  nutrition

50
cont

1. Patient and families are educated about
   immunizations
2. Patient and families are educated about their
   specific disease process, complications and
   prevention strategies
3. Patient and families are educated about
   preventing infections
4. Patients are taught in a language and format that
   they can understand

51
PRE.5. Patient and families have a right to
information on expected costs

• Objective elements
• There is uniform pricing policy in a given
  setting (out-patient and ward category)
• The tariff list is available to patients
• Patients are educated about the estimated costs
  of treatment

52
cont

1. Patients are informed about the estimated costs
   when there is a change in the patient condition
   or treatment setting

53
Chapter 3.Care of Patients (COP)
54
COP.1Uniform care of patients is guided by the
applicable laws and regulations

• Objective elements
• Care delivery is uniform when similar care is
  provided in more than one setting
• Uniform care is guided by policies and procedures
  which reflect applicable laws and regulations

55
cont

1. The care and treatment orders are signed, named,
   timed and dated by the concerned doctor
2. The care plan is countersigned by the clinician
   in-charge of the patient within 24 hours
3. Evidence based medicine and clinical practice
   guidelines are adopted to guide patient care
   whenever possible

56
COP.2Emergency services are guided by policies,
procedures, applicable laws and regulations

• Objective elements
• Policies and procedure for emergency care are
  documented
• Policies also address handling of medico-legal
  cases
• The patients receive care in consonance with the
  policies

57
cont

1. Policies and procedures guide the triage of
   patients for initiation of appropriate care
2. Staff is familiar with the policies and trained
   on the procedures for care of emergency patients
3. Admission or discharge to home or transfer to
   another organization is also documented

58
COP.3The ambulance services are commensurate
with the scope of the services provided by the
organization

• Objective elements
• There is adequate access and space for the
  ambulance(s)
• Ambulance(s) is appropriately equipped
• Ambulance(s) is manned by trained personnel

59
cont

• There is a checklist of all equipment and
  emergency medications
• Equipment are checked on a daily basis
• Emergency medications are checked daily and prior
  to dispatch
• The ambulance(s) has a proper communication
  system

60
COP.4Policies and procedures guide the care of
patients requiring cardio-pulmonary resuscitation

• Objective elements
• Documented policies and procedures guide the
  uniform use of resuscitation throughout the
  organization
• Staff providing direct patient care is trained
  and periodically updated in cardio pulmonary
  resuscitation

61
cont

1. The events during a cardio-pulmonary
   resuscitation are recorded
2. An analysis of all cardiac arrests is done
3. A multidisciplinary committee monitors the
   effectiveness of cardio-pulmonary resuscitation

62
COP.5Policies and procedures define rational use
of blood and blood products

• Objective elements
• Documented policies and procedures are used to
  guide rational use of blood and blood products
• The transfusion services are governed by the
  applicable laws and regulations

63
Cont

• Informed consent is obtained for donation and
  transfusion of blood and blood products
• Informed consent also includes patient and family
  education about donation
• Staff is trained to implement the policies
• Transfusion reactions are analyzed for preventive
  and corrective actions

64
COP.6Policies and procedures guide the care of
patients in the Intensive care and high
dependency units

• Objective elements
• The organization has documented admission and
  discharge criteria for its intensive care and
  high dependency units
• Staff is trained to apply these criteria

65
cont

1. Adequate staff and equipment are available
2. Defined procedures for situation of bed shortages
   are followed
3. Infection control practices are followed
4. The unique needs of end of life patients are
   identified and cared for
5. A quality assurance program is implemented

66
COP.7Policies and procedures guide the care of
vulnerable patients (elderly, children,
physically and/or mentally challenged)

• Objective elements
• Policies and procedures are documented and are in
  accordance with the prevailing laws and the
  national and international guidelines

67
cont

1. Staff is trained to care for this vulnerable
   group
2. Care is organized and delivered in accordance
   with the policies and procedures
3. The organization provides for a safe and secure
   environment for this vulnerable group
4. A documented procedure exists for obtaining
   informed consent from the appropriate legal
   representative

68
COP.8Policies and procedures guide the care of
high risk obstetrical patients

• Objective elements.
• The organization defines and displays whether
  high risk obstetric cases can be cared for or not
• Persons caring for high risk obstetric cases are
  competent

69
cont

• High risk obstetric patients assessment also
  includes maternal nutrition
• The organization has the facilities to take care
  of neonates of high risk pregnancies

70
COP.9Policies and procedures guide the care of
pediatric patients

• Objective elements.
• The organization defines and displays the scope
  of its pediatric services
• The policy for care of neonatal patients is in
  consonance with the national/ international
  guidelines
• Those who care for children have age specific
  competency

71
cont

• Provisions are made for special care of children
• Patient assessment includes detailed nutritional,
  growth, psychosocial and immunization assessment
• Policies and procedures prevent child/ neonate
  abduction and abuse

72
cont

• The childrens family members are educated about
  nutrition, immunization and safe parenting and
  this is documented in the medical record

73
COP.10  Policies and procedures guide the care
of patients undergoing moderate sedation

• Objective elements
• Competent and trained persons perform sedation
• The person administering and monitoring sedation
  is different from the person performing the
  procedure

74
cont

1. Intra-procedure monitoring includes at a minimum
   the heart rate, cardiac rhythm, respiratory rate,
   blood pressure, oxygen saturation, and level of
   sedation
2. Patients are monitored after sedation
3. Criteria are used to determine appropriateness of
   discharge from the recovery area
4. Equipment and manpower are available to rescue
   patients from a deeper level of sedation than
   that intended

75
COP.11Policies and procedures guide the
administration of anesthesia

• Objective elements
• There is a documented policy and procedure for
  the administration of anesthesia
• All patients for anesthesia have a pre-anesthesia
  assessment by a qualified individual

76
cont

• The pre-anesthesia assessment results in
  formulation of an anesthesia plan which is
  documented
• An immediate preoperative reevaluation is
  documented
• Informed consent for administration of anesthesia
  is obtained by the anesthetist
• During anesthesia monitoring includes regular and
  periodic recording of heart rate, cardiac rhythm,
  respiratory rate, blood pressure, oxygen
  saturation, airway security and patency and level
  of anesthesia

77
cont

1. Each patients post-anesthesia status is
   monitored and documented
2. A qualified individual applies defined criteria
   to transfer the patient from the recovery area
3. All adverse anesthesia events are recorded and
   monitored

78
COP.12Policies and procedures guide the care of
patients undergoing surgical procedures

• Objective elements
• The policies and procedures are documented
• Surgical patients have a preoperative assessment
  and a provisional diagnosis documented prior to
  surgery

79
cont

1. An informed consent is obtained by a surgeon
   prior to the procedure
2. Documented policies and procedures exist to
   prevent adverse events like wrong site, wrong
   patient and wrong surgery
3. Persons qualified by law are permitted to perform
   the procedures that they are entitled to perform
4. An operative note is documented prior to transfer
   out of patient from recovery area

80
cont

• The operating surgeon documents the
  post-operative plan of care
• A quality assurance program is followed for the
  surgical services
• The quality assurance program includes
  surveillance of the operation theatre environment
• The plan also includes monitoring of surgical
  site infection rates

81
COP.13Policies and procedures guide the care of
patients under restraints (physical and / or
chemical)

• Objective elements.
• Documented policies and procedures guide the care
  of patients under restraints
• These include both physical and chemical
  restraint measures

82
cont

• These include documentation of reasons for
  restraints
• These patients are more frequently monitored
• Staff receive training and periodic updating in
  control and restraint techniques

83
COP.14Policies and procedures guide appropriate
pain management

• Objective elements
• Documented policies and procedures guide the
  management of pain
• The organization respects and supports the
  appropriate assessment and management of pain for
  all patients
• Patient and family are educated on various pain
  management techniques

84
COP.15Policies and procedures guide appropriate
rehabilitative services

• Objective elements
• Documented policies and procedures guide the
  provision of rehabilitative services
• These services are commensurate with the
  organizational requirements
• Rehabilitative services are provided by a
  multidisciplinary team

85
COP.16Policies and procedures guide all research
activities

• Objective elements.
• Documented policies and procedures guide all
  research activities in compliance with national
  and international guidelines
• The organization has an ethics committee to
  oversee all research activities
• The committee has the powers to discontinue a
  research trial when risks outweigh the potential
  benefits

86
cont

• Patients informed consent is obtained before
  entering them in research protocols
• Patients are informed of their right to withdraw
  from the research at any stage and also of the
  consequences (if any) of such withdrawal
• Patients are assured that their refusal to
  participate or withdrawal from participation
  will not compromise their access to the
  organizations services

87
COP.17Policies and procedures guide nutritional
therapy

• Objective elements
• Documented policies and procedures guide
  nutritional assessment and reassessment
• Patients receive food according to their clinical
  needs
• There is a written order for the diet
• Nutritional therapy is planned and provided in a
  collaborative manner

88
cont

1. When families provide food, they are educated
   about the patients diet limitations
2. Food is prepared, handled, stored and distributed
   in a safe manner

89
COP.18Policies and procedures guide the end of
life care

• Objective elements
• Documented policies and procedures guide the end
  of life care
• These policies and procedures are in consonance
  with the legal requirements
• These also address the identification of the
  unique needs of such patient and family

90
cont

• These also include sensitively addressing issues
  such as autopsy and organ donation
• Staff is educated and trained in end of life care

91
Chapter4.MANAGEMENT OF MEDICATION (MOM)
92
MOM.1Policies and procedures guide the
organization of pharmacy services and usage of
medication

• Objective elements
• There is a documented policy and procedure for
  pharmacy services and medication usage
• These comply with the applicable laws and
  regulations

93
cont

• A multidisciplinary committee guides the
  formulation and implementation of these policies
  and procedures

94
MOM.2There is a hospital formulary

• Objective elements
• A list of medication appropriate for the patients
  and organizations resources is developed
• The list is developed collaboratively by the
  multidisciplinary committee
• There is a defined process for acquisition of
  these medications
• There is a process to obtain medications not
  listed in the formulary

95
MOM.3Policies and procedures exist for storage
of medication.

• Objective elements
• Documented policies and procedures exist for
  storage of medication
• Medications are stored in a clean, well lit and
  ventilated environment
• Sound inventory control practices guide storage
  of the medications

96
cont

• Medications are protected from loss or theft
• Sound alike and look alike medications are stored
  separately
• There is a method to obtain medication when the
  pharmacy is closed
• Emergency medications are available all the time
• Emergency medications are replenished in a timely
  manner when used

97
MOM.4Policies and procedures guide the
prescription of medications

• Objective elements
• Documented policies and procedures exist for
  prescription of medications
• The organization determines who can write orders
• Orders are written in a uniform location in the
  medical records

98
cont

• Medication orders are clear, legible, dated,
  named and signed
• Policy on verbal orders is documented and
  implemented
• The organization defines a list of high risk
  medication
• High risk medication orders are verified prior to
  dispensing

99
MOM.4Policies and procedures guide the safe
dispensing of medications

• Objective elements
• Documented policies and procedures guide the safe
  dispensing of medications
• The policies include a procedure for medication
  recall
• Expiry dates are checked prior to dispensing
• Labeling requirements are documented and
  implemented by the organization

100
MOM.5 There are defined procedures for
medication administration

• Objective elements
• Medications are administered by those who are
  permitted by law to do so
• Prepared medication are labeled prior to
  preparation of a second drug
• Patient is identified prior to administration

101
cont

1. Medication is verified from the order prior to
   administration
2. Dosage is verified from the order prior to
   administration
3. Route is verified from the order prior to
   administration
4. Timing is verified from the order prior to
   administration

102
cont

1. Medication administration is documented
2. Polices and procedures govern patients self
   administration of medications
3. Polices and procedures govern patients
   medications brought from outside the organization

103
MOM.7Patients and family members are educated
about safe medication and food-drug interactions

• Objective elements
• Patient and family are educated about safe and
  effective use of medication
• Patient and family are educated about food-drug
  interactions

104
MOM.8Patients are monitored after medication
administration

• Objective elements
• Patients are monitored after medication
  administration and this is documented
• Adverse drug events are defined
• Adverse drug events are reported within a
  specified time frame

105
cont

• Adverse drug events are collected and analysed
• Policies are modified to reduce adverse drug
  events when unacceptable trends occur

106
MOM.9Policies and procedures guide the use of
narcotic drugs and psychotropic substances

• Objective elements
• Documented policies and procedures guide the use
  of narcotic drugs and psychotropic substances
• These policies are in consonance with local and
  national regulations

107
cont

1. A proper record is kept of the usage,
   administration and disposal of these drugs
2. These drugs are handled by appropriate personnel
   in accordance with policies

108
MOM.10 Policies and procedures guide the usage
of chemotherapeutic agents

• Objective elements
• Documented policies and procedures guide the
  usage of chemotherapeutic agents
• Chemotherapy is prescribed by those who have the
  knowledge to monitor and treat the adverse effect
  of chemotherapy

109
cont

1. Chemotherapy is prepared and administered by
   qualified personnel
2. Chemotherapy drugs are disposed off in accordance
   with legal requirements

110
MOM.11Policies and procedures govern usage of
radioactive or investigational drugs

• Objective elements.
• Documented policies and procedures govern usage
  of radioactive or investigational drugs
• These policies and procedures are in consonance
  with laws and regulations

111
cont

• The policies and procedures include the safe
  storage, preparation, handling, distribution and
  disposal of radioactive and investigational drugs
• Staff, patients and visitors are educated on
  safety precautions

112
MOM.12Policies and procedures guide the use of
implantable prosthesis

• Objective elements.
• Documented policies and procedures govern
  procurement and usage of implantable prosthesis
• Selection of implantable prosthesis is based on
  scientific criteria and internationally
  recognized approvals

113
cont

1. The batch and serial number of the implantable
   prosthesis are recorded in the patients medical
   record and the master logbook

114
MOM.13Policies and procedures guide the use of
medical gases

• Objective elements
• Documented policies and procedures govern
  procurement, handling, storage, distribution,
  usage and replenishment of medical gases.
• The policies and procedures address the safety
  issues at all levels

115
Cont

1. Appropriate records are maintained in accordance
   with the policies, procedures and legal
   requirements.

116
Chapter 5HOSPITAL INFECTION CONTROL (HIC)
117
HIC.1The organization has a well-designed,
comprehensive and coordinated Hospital Infection
Control (HIC) programme aimed at reducing/
eliminating risks to patients, visitors and
providers of care.
118

• Objective elements
• The hospital has a multi-disciplinary infection
  control committee.
• The hospital has an infection control team.
• The hospital has designated and qualified
  infection control nurse(s) for this activity
• The hospital infection control programme is
  documented.

119
HIC.2The hospital has an infection control
manual, which is periodically updated.

• Objective elements
• The manual identifies the various high-risk
  areas.
• It outlines methods of surveillance in the
  identified high-risk areas.

120
Cont

1. It focuses on adherence to standard precautions
   at all times.
2. Equipment cleaning and sterilisation practices
   are included.
3. An appropriate antibiotic policy is established
   and implemented.
4. Laundry and linen management processes are also
   included.

121
Cont

1. Kitchen sanitation and food handling issues are
   included in the manual
2. Engineering controls to prevent infections are
   included
3. Mortuary practices and procedures are included
   as appropriate to the organization

122
HIC.3The infection control team is responsible
for surveillance activities in identified areas
of the hospital.

• Objective elements
• Surveillance activities are appropriately
  directed towards the identified high-risk areas.
• Collection of surveillance data is an ongoing
  process.

123
Cont

1. Verification of data is done on regular basis by
   the infection control team.
2. In cases of notifiable diseases, information (in
   relevant format) is sent to appropriate
   authorities.
3. Scope of surveillance activities incorporates
   tracking and analyzing of infection risks, rates
   and trends.

124
HIC.4The hospital takes actions to prevent or
reduce the risks of Hospital Associated
Infections (HAI) in patients and employees.

• Objective elements
• The organization monitors urinary tract
  infections.
• The organization monitors respiratory tract
  infections.

125
Cont

• The organization monitors intra-vascular device
  infections.
• The organization monitors surgical site
  infections.
• Appropriate feedback regarding HAI rates are
  provided on a regular basis to medical and
  nursing staff.

126
HIC.5Proper facilities and adequate resources
are provided to support the infection control
programme

• Objective elements
• Hand washing facilities in all patient care areas
  are accessible to health care providers.
• Compliance with proper hand washing is monitored
  regularly.

127
Cont

1. Isolation/ barrier nursing facilities are
   available.
2. Adequate gloves, masks, soaps, and disinfectants
   are available and used correctly.

128
HIC.6The hospital takes appropriate action to
control outbreaks of infections.

• Objective elements
• Hospital has a documented procedure for handling
  such outbreaks.
• This procedure is implemented during outbreaks.
• After the outbreak is over appropriate corrective
  actions are taken to prevent recurrence

129
HIC.7There are documented procedures for
sterilisation activities in the hospital.

• Objective elements
• There is adequate space available for
  sterilization activities
• Regular validation tests for sterilisation are
  carried out and documented.
• There is an established recall procedure when
  breakdown in the sterilisation system is
  identified

130
HIC.8Statutory provisions with regard to
Bio-medical Waste (BMW) management are complied
with

• Objective elements
• The hospital is authorised by prescribed
  authority for the management and handling of
  Bio-medical Waste.
• Proper segregation and collection of Bio-medical
  Waste from all patient care areas of the hospital
  is implemented and monitored.

131
Cont

• The organization ensures that Bio-medical Waste
  is stored and transported to the site of
  treatment and disposal in proper covered vehicles
  within stipulated time limits in a secure manner.
• Bio-medical Waste treatment facility is managed
  as per statutory provisions (if in-house) or
  outsourced to authorised contractor(s).

132
Cont

1. Requisite fees, documents and reports are
   submitted to competent authorities on stipulated
   dates.
2. Appropriate personal protective measures are used
   by all categories of staff handling Bio-medical
   Waste

133
HIC.9The infection control programme is
supported by hospital management and includes
training of staff and employee health

• Objective elements
• Hospital management makes available resources
  required for the infection control programme
• The hospital regularly earmarks adequate funds
  from its annual budget in this regard.

134
Cont

• It conducts regular pre-induction training for
  appropriate categories of staff before joining
  concerned department(s).
• It also conducts regular in-service training
  sessions for all concerned categories of staff at
  least once in a year.
• Appropriate pre and post exposure prophylaxis is
  provided to all concerned staff members

135
Chapter 6CONTINUOUS QUALITY IMPROVEMENT (CQI)
136
CQI.1There is a structured quality assurance and
continuous monitoring programme in the
organization

• Objective elements
• The quality assurance programme is developed,
  implemented and maintained by a
  multi-disciplinary committee.
• The quality assurance programme is documented.

137
Cont

1. There is a designated individual for coordinating
   and implementing the quality assurance programme
   
2. The quality assurance programme is comprehensive
   and covers all the major elements related to
   quality assurance and risk management.

138
Cont

• The designated programme is communicated and
  coordinated amongst all the employees of the
  organization through proper training mechanism.
• The quality assurance programme is reviewed at
  predefined intervals and opportunities for
  improvement are identified.

139
Cont

• The quality assurance programme is a continuous
  process and updated at least once in a year.

140
CQI.2The organization identifies key indicators
to monitor the clinical structures, processes and
outcomes

• Objective elements
• Monitoring includes appropriate patient
  assessment.
• Monitoring includes diagnostics services safety
  and quality control programmes.
• Monitoring includes all invasive procedures.

141
Cont

1. Monitoring includes adverse drug events.
2. Monitoring includes use of anaesthesia.
3. Monitoring includes use of blood and blood
   products.
4. Monitoring includes availability and content of
   medical records.
5. Monitoring includes infection control activities.
6. Monitoring includes clinical research.

142
CQI.3The organisation identifies key indicators
to monitor the managerial structures, processes
and outcomes

• Objective elements
• Monitoring includes procurement of medication
  essential to meet patient needs.
• Monitoring includes reporting of activities as
  required by laws and regulations.

143
Cont

• Monitoring includes risk management.
• Monitoring includes utilisation of facilities.
• Monitoring includes patient satisfaction.
• Monitoring includes employee satisfaction.
• Monitoring includes adverse events.
• Monitoring includes data collection to support
  further study for improvements.
• Monitoring includes data collection to support
  evaluation of the improvements.

144
CQI.4The quality improvement programme is
supported by the management

• Objective elements
• Hospital Management makes available adequate
  resources required for quality improvement
  programme.
• Hospital earmarks adequate funds from its annual
  budget in this regard.
• Appropriate statistical and management tools are
  applied whenever required

145
CQI.5There is an established system for audit of
patient care services

• Objective elements
• Medical staff participates in this system.
• The parameters to be audited are defined by the
  organisation.
• Patient and clinician anonymity is maintained.
• All audits are documented.
• Remedial measures are implemented.

146
CQI.6Sentinel events are intensively analysed

• Objective elements
• The organisation has defined sentinel events.
• The organisation has established processes for
  intense analysis of such events.
• Sentinel events are intensively analysed when
  they occur.
• Actions are taken upon findings of such analysis

147
Chapter 7RESPONSIBILITIES OF MANAGEMENT (ROM)
148
ROM.1The responsibilities of the management are
defined

• Objective elements
• The organization has a documented organogram
• Those responsible for governance appoint the
  senior leaders in the organization
• Those responsible for governance support the
  quality improvement plan 

149
Cont

1. The organization complies with the laid down and
   applicable legislations and regulations
2. Those responsible for governance address the
   organizations social responsibility

150
ROM.2 The services provided by each department
are documented

• Objective elements
• Each organizational program, service, site or
  department has effective leadership
• Scope of services of each department is defined
• Administrative policies and procedures for each
  department is maintained
• Departmental leaders are involved in quality
  improvement

151
ROM.3The organization is managed by the leaders
in an ethical manner

• Objective elements
• The leaders make public the mission statement of
  the organization
• The leaders establish the organizations ethical
  management
• The organization discloses its ownership

152
Cont

• The organization honestly portrays the services
  which it can and cannot provide
• The organization accurately bills for its
  services

153
ROM.4A suitably qualified and experienced
individual heads the organisation

• Objective elements
• The designated individual has requisite and
  appropriate administrative qualifications.
• The designated individual has requisite and
  appropriate administrative experience.

154
ROM.5Leaders ensure that patient safety aspects
and risk management issues are an integral part
of patient care and hospital management

• Objective elements
• The organization has an interdisciplinary group
  assigned to oversee the hospital wide safety
  programme.

155
Cont

• The scope of the programme is defined to include
  adverse events ranging from no harm to
  sentinel events.
• Management ensures implementation of systems for
  internal and external reporting of system and
  process failures.
• Management provides resources for proactive risk
  assessment and risk reduction activities.

156
Chapter 8FACILITY MANAGEMENT AND SAFETY (FMS)
157
FMS.1The organization is aware of and complies
with the relevant rules and regulations, laws and
byelaws and requisite facility inspection
requirements

• Objective elements
• The management is conversant with the laws and
  regulations and knows their applicability to the
  organization.

158
Cont

• Management regularly updates any amendments in
  the prevailing laws of the land.
• The management ensures implementation of these
  requirements.
• There is a mechanism to regularly update
  licenses/ registrations/certifications

159
FMS.2The organizations environment and
facilities operate to ensure safety of patients,
staff and visitors

• Objective elements
• There is a documented operational and maintenance
  (preventive and breakdown) plan.

160
Cont

1. Up-to-date drawings are maintained which detail
   the site layout, floor plans and fire escape
   routes.
2. The provision of space shall be in accordance
   with the available literature on good practices
   (Indian or International Standards) and
   directives from government agencies.
3. There are designated individuals responsible for
   the maintenance of all the facilities.

161
Cont

• Maintenance staff is contactable round the clock
  for emergency repairs.
• Response times are monitored from reporting to
  inspection and implementation of corrective
  actions.

162
FMS.3The organization has a program for clinical
and support service equipment management

• Objective elements
• The organization plans for equipment in
  accordance with its services and strategic plan
• Equipment is selected by a collaborative process.
• All equipment is inventoried and proper logs are
  maintained as required. 

163
Cont

• Qualified and trained personnel operate and
  maintain the equipment.
• Equipment are periodically inspected and
  calibrated for their proper functioning.
• There is a documented operational and maintenance
  (preventive and breakdown) plan.

164
FMS.4The organization has provisions for safe
water, electricity, medical gases and vacuum
systems

• Objective elements
• Potable water and electricity are available round
  the clock.
• Alternate sources are provided for in case of
  failure.
• The organisation regularly tests the alternate
  sources.
• There is a maintenance plan for piped medical gas
  and vacuum installation.
•  

165
FMS.5The organization has plans for fire and
non-fire emergencies within the facilities

• Objective elements
• The organization has plans and provisions for
  early detection, abatement and containment of
  fire and non-fire emergencies.

166
Cont

1. Staff is trained for their role in case of such
   emergencies.
2. The organization has a documented safe exit plan
   in case of fire and non-fire emergencies.
3. Mock drills are held at least twice in a year

167
FMS.6The organization has a smoking limitation
policy

• Objective elements
• The organization defines its polices to reduce or
  eliminate smoking
• The policy has provisions for granting exceptions
  for patients and families to smoke

168
FMS.7The organization plans for handling
community emergencies, epidemics and other
disasters

• Objective elements
• The hospital identifies potential emergencies.
• The organization has a documented disaster
  management plan.

169
Cont

• Provision is made for availability of medical
  supplies, equipment and materials during such
  emergencies.
• Hospital staff is trained in the hospitals
  disaster management plan
• The plan is tested at least twice in a year.

170
FMS.8The organization has a plan for management
of hazardous materials

• Objective elements
• Hazardous materials are identified within the
  organization
• The hospital implements processes for sorting,
  handling, storage, transporting and disposal of
  hazardous material.

171
Cont

• Requisite regulatory requirements are met in
  respect of radioactive materials.
• There is a plan for managing spills of hazardous
  materials
• Staff is educated and trained for handling such
  materials.

172
FMS.9The hospital has system in place to provide
a safe and secure environment

• Objective elements
• The hospital has a safety committee to identify
  the potential safety and security risks.
• This committee coordinates development,
  implementation, and monitoring of the safety plan
  and policies.

173
Cont

1. Facility inspection rounds to ensure safety are
   conducted at least twice in a year in patient
   care areas and at least once in a year in
   non-patient care areas.
2. Inspection reports are documented and corrective
   and preventive measures are undertaken.
3. There is a safety education programme for all
   staff.

174
Chapter9HUMAN RESOURCE MANAGEMENT
175
HRM.1The organization has a documented system of
human resource planning

• Objective elements
• The organization maintains an adequate number and
  mix of staff to meet the care, treatment and
  service needs of the patient.

176
Cont

• The required job specifications and job
  description are well defined for each category of
  staff.
• The organization verifies the antecedents of the
  potential employee with regards to
  criminal/negligence background.

177
HRM.2The staff joining the organization is
socialized and oriented to the hospital
environment

• Objective elements
• Each staff member, employee, student and
  voluntary worker is appropriately oriented to the
  organizations mission and goals.

178
Cont

• Each staff member is made aware of hospital wide
  policies and procedures as well as relevant
  department / unit / service / programmes
  policies and procedures.
• Each staff member is made aware of his/her rights
  and responsibilities.
• All employees are educated with regard to
  patients rights and responsibilities.
• All employees are oriented to the service
  standards of the organisation

179
HRM.3There is an ongoing programme for
professional training and development of the
staff

• Objective elements
• A documented training and development policy
  exists for the staff.
• Training also occurs when job responsibilities
  change/ new equipment is introduced.
• Feedback mechanisms for assessment of training
  and development programme exist.

180
HRM.4Staff members, students and volunteers are
adequately trained on specific job duties or
responsibilities related to safety

• Objective elements
• All staff is trained on the risks within the
  hospital environment.
• Staff members can demonstrate and take actions to
  report, eliminate / minimize risks.

181
Cont

1. Staff members are made aware of procedures to
   follow in the event of an incident.
2. Reporting processes for common problems, failures
   and user errors exist

182
HRM.5An appraisal system for evaluating the
performance of an employee exists as an integral
part of the human resource management process

• Objective elements
• A well-documented performance appraisal system
  exists in the organization.

183
Cont

• The employees are made aware of the system of
  appraisal at the time of induction.
• Performance is evaluated based on the performance
  expectations described in job description.
• The appraisal system is used as a tool for
  further development.
• Performance appraisal is carried out at pre
  defined intervals and is documented.

184
HRM.6The organization has a well-documented
disciplinary procedure

• Objective elements
• A written statement of the policy of the
  organization with regard to discipline is in
  place.
• The disciplinary policy and procedure is based on
  the principles of natural justice.

185
Cont

1. The policy and procedure is known to all
   categories of employees of the organization.
2. The disciplinary procedure is in consonance with
   the prevailing laws.
3. There is a provision for appeals in all
   disciplinary cases.

186
HRM.7A grievance handling mechanism exists in
the organization

• Objective elements
• The employees are aware of the procedure to be
  followed in case they feel aggrieved.
• The redress procedure addresses the grievance.
• Actions are taken to redress the grievance

187
HRM.8The organization addresses the health needs
of the employees

• Objective elements
• A pre-employment medical examination is conducted
  on all the employees.
• Health problems of the employees are taken care
  of in accordance with the organizations policy.

188
Cont

1. Regular physical and medical checks are done
   at-least once a year and the findings/ results
   are documented.
2. Occupational health hazards are adequately
   addressed.

189
HRM.9There is documented personal information
for each staff member

• Objective elements
• Personal files are maintained in respect of all
  employees.
• The personal files contain personal information
  regarding the employees qualification,
  disciplinary background and health status

190
Cont

1. All records of in-service training and education
   are contained in the personal files.
2. Personal files contain results of all evaluations

191
HRM.10There is a
process for collecting, verifying and evaluating
the credentials (education, registration,
training and experience) of medical
professionals permitted to provide patient care
without supervision
192

• Objective elements
• Medical professionals permitted by law,
  regulation and the hospital to provide patient
  care without supervision is identified.
• The education, registration, training and
  experience of the identified medical
  professionals is documented and updated
  periodically.
• All such information pertaining to the medical
  professionals is appropriately verified when
  possible. 

193
HRM.11There is a process for authorising all
medical professionals to admit and treat
patients and provide other clinical services
commensurate with their qualifications
194

• Objective elements
• Medical professionals admit and care for patients
  as per the laid down policies and authorisation
  procedures of the organization
• The services provided by the medical
  professionals are in consonance with their
  qualification, training and registration.
• The requisite services to be provided by the
  medical professionals are known to them as well
  as the various departments / units of the
  hospital.

195
HRM.12There is a process for collecting,
verifying and evaluating the credentials
(education, registration, training and
experience) of nursing staff

• Objective elements
• The education, registration, training and
  experience of nursing staff is documented and
  updated periodically.

196
Cont

• All such information pertaining to the nursing
  staff is appropriately verified when possible

197
HRM.13There is a process to
identify job responsibilities and make clinical
work assignments to all nursing staff members
commensurate with their qualifications and any
other regulatory requirements
198

• Objective elements
• The clinical work assigned to nursing staff is in
  consonance with their qualification, training and
  registration.
• The services provided by nursing staf