Components of Standards Development
Multiple Information Sources
n Scientific literature
n JCI Standards
n UK Healthcare Quality Standards
n Thailand Standards
n Apollo Draft Standards
n AHA Draft Standards
n JCI Survey compliance data
n Research Findings
n Individual input from field experts and key stakeholders
n ISO 9001-2000
Organized around important functions
n Focus on patient and staff safety
n Set standards that all organizations must pass
n To be revised periodically and raise the “bar”
n Achieve International recognition
n 10 Chapters
n 100 Standards
n 513 Objective Elements
Standards and Objective Elements
n 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
n Objective element is a measurable component of a standard
n Acceptable compliance with objective elements determines the overall compliance with a standard
Health Care Organization Management Standards
n Non-compliance 0
n Partial compliance 5
n Full compliance 10
n Orientation of Surveyors to the Organization’s Services
n Document Review
n Assessment Activities
n Functional Interviews
n Visits to Patient Care Areas
n Visits to Selected Departments
n Facility Tour
Infection Control Interview:
n Assesses processes to identify, prevent, and manage nosocomial infections
n Uses other information obtained from other survey activities
n Facility tour
n Visits to inpatient and outpatient care areas
n Visit to Pathology and Laboratory Services
n Document Review
n Patient Record Review
n Visit to Pharmacy
Information Management Interview:
n Evaluates hospital’s ability to meet information needs of
n Clinical staff
n Those outside the organization who require data/information
Staff Qualifications and Education Interview
n Reviews processes for
n Evaluation of staff
n Privileging of medical staff
Quality Improvement Interview:
n Evaluates effectiveness of quality improvement and patient safety activities
n Organization gives a presentation of an improvement process
n Provides evidence of data collection, analysis and improvements
Visits to Patient Care Settings: Inpatient and Ambulatory:
n Anesthetizing Areas
n Ambulatory/Outpatient Clinics
n Emergency Services
n Inpatient Units
n Imaging/Radiology Services
n Pathology and Clinical Laboratory Services
n Rehabilitation Services
Visits to Patient Care Settings:
n Evaluates the processes for caring for patients in different settings across the organization
n A sample selected of inpatient and outpatient areas
n Usually 100% of anesthetizing locations scheduled
n Surveyors may visit any other unit or location not on the agenda.
n Addresses issues related to
n Physical facility
n Medical and other equipment
n Hazardous waste
n Fire safety
n Utility systems
n Patient and visitor safety
n Infection control
The Final Question:
• No standard can have more than one zero
• No zero is acceptable in legal/regulatory requirements.
• The average for a standard should not be less than 5
• The average score of a chapter should not be less than 7
• The overall average score must exceed 7.
n 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 513 objective elements
n Details of chapters
1) Access ,Assessment and continuity of care (AAC)
2) Care of Patients (COP).
3) Management of Medication (MOM).
4) Patient Right and Education (PRE).
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).
ACCESS, ASSESSMENT AND CONTINIUITY OF CARE (AAC)
The organization defines and displays the services that it can provide
a) The services being provided are clearly defined and are in consonance with the needs of the community.
b) The defined services are prominently displayed.
c) The staff is oriented to these services
The organization has a well defined registration and admission process
a) Standardized policies and procedures are used for registering and admitting patients
b) The policies and procedures address out- patients, in-patients and emergency patients
c) Patients are accepted only if the organization can provide the required service
d) The policies and procedures also address managing patients during non availability of beds
e) The staff is aware of these processes
There is an appropriate mechanism for transfer or referral of patients who do not match the organizational resources
a) Policies guide the transfer of unstable patients to another facility in an appropriate manner
b) Policies guide the transfer of stable patients to another facility
c) Procedures identify staff responsible during transfer
d) The organization gives a summary of patient’s condition and the treatment given
During admission the patient and /or the family members are educated to make informed decisions
a) The patients and/or family members are explained about the proposed care
b) The patients and/or family members are explained about the expected results
c) The patients and/or family members are explained about the possible complications
d) The patients and/or family members are explained about the expected costs.
Patients cared for by the organization undergo an established initial assessment
a) The organization defines the content of the assessments for the out–patients, in-patients and emergency patients.
b) The organization determines who can perform the assessments.
c) The organization defines the time frame within which the initial assessment is completed.
d) The initial assessment for in-patients is documented within 24 hours or earlier as per the patient’s condition or hospital policy.
e) Initial assessment includes screening for nutritional and psychosocial needs.
f) The initial assessment results in a documented plan of care which is monitored.
g) The plan of care also includes preventive aspects of the care
All patients cared for by the organization undergo a regular reassessment
a) All patients are reassessed at appropriate intervals.
b) Staff involved in direct clinical care document reassessments.
c) Patients are reassessed to determine their response to treatment and to plan further treatment or discharge.
Laboratory services are provided as per the requirements of the patients
a) Scope of the laboratory services are commensurate to the services provided by the organization
b) Adequately qualified and trained personnel perform and/or supervise the investigations.
c) Policies and procedures guide collection, identification, handling, safe transportation and disposal of specimens.
d) Laboratory results are available within a defined time frame.
e) Critical results are intimated immediately to the concerned personnel.
f) Laboratory tests not available in the organization are outsourced to organization (s) based on their quality assurance system.
There is an established laboratory safety programme
n Objective elements
a) The laboratory quality assurance programme is documented.
b) The programme addresses verification and validation of test methods.
c) The programme addresses surveillance of test results.
d) The programme includes periodic calibration and maintenance of all equipments.
e) The programme includes the documentation of corrective and preventive actions.
There is an established laboratory safety programme
a) The laboratory safety programme is documented.
b) This programme is integrated with the organization’s safety programme.
c) Written policies and procedures guide the handling and disposal of infectious and hazardous materials.
d) Laboratory personnel are appropriately trained in safe practices.
e) Laboratory personnel are provided with appropriate safety equipment / devices.
Imaging services are provided as per the requirements of the patients
a) Imaging services comply with legal and other requirements.
b) Scope of the imaging services are commensurate to the services provided by the organization.
c) Adequately qualified and trained personnel perform and/or supervise the investigations.
d) Policies and procedures guide identification and safe transportation of patients to imaging services.
e) Imaging results are available within a defined time frame.
f) Critical results are intimated immediately to the concerned personnel.
g) Imaging tests not available in the organization are outsourced to organization (s) based on their quality assurance system.
There is an established Quality assurance programme for imaging services
a) The quality assurance programme for imaging services is documented.
b) The programme addresses verification and validation of imaging methods
c) The programme addresses surveillance of imaging results
d) The programme includes periodic calibration and maintenance of all equipments.
e) The programme includes the documentation of corrective and preventive actions.
There is an established radiation safety programme
a) The radiation safety programme is documented.
b) This programme is integrated with the organization’s safety programme.
c) Written policies and procedures guide the handling and disposal of radio-active and hazardous materials.
d) Imaging personnel are provided with appropriate radiation safety devices
e) Radiation safety devices are periodically tested and documented.
f) Imaging personnel are trained in radiation safety measures.
g) Imaging signage are prominently displayed in all appropriate locations.
h) Policies and procedures guide the safe use of radioactive isotopes for imaging services.
Patient care is continuous and multidisciplinary in nature
a) During all phases of care, there is a qualified individual identified as responsible for the patient’s care.
b) Care of patients is coordinated in all care settings within the organization.
c) Information about the patient’s care and response to treatment is shared among medical, nursing and other care providers.
d) Information is exchanged and documented during each staffing shift, between shifts, and during transfers between units/departments.
e) The patient’s record (s) is available to the authorized care providers to facilitate the exchange of information.
f) Policy and procedures guide the referral of patients to other department / specialty.
The organization has a documented discharge process
a) The patient’s discharge process is planned in consultation with the patient and/or family
b) Policies and procedures exist for coordination of various departments and agencies involved in the discharge process (including medico-legal cases)
c) Policies and procedures are in place for patients leaving against medical advice
d) A discharge summary is given to all the patients leaving the organization (including patients leaving against medical advice)
Organization defines the content of the discharge summary
a) Discharge summary is provided to the patients at the time of discharge
b) Discharge summary contains the reasons for admission, significant findings and diagnosis and the patient’s condition at the time of discharge.
c) Discharge summary contains information regarding investigation results, any procedure performed, medication and other treatment given
d) Discharge summary contains follow up advice, medication and other instructions in an understandable manner.
e) Discharge summary incorporates instructions about when and how to obtain urgent care.
f) In case of death the summary of the case also includes the cause of death.
g) Patient records also contain a copy of the discharge /case summary
Care of Patients (COP)
Uniform care of patients is provided in all settings of the organization and is guided by the applicable laws, regulations and guidelines.
a) Care delivery is uniform when similar care is provided in more than one setting
b) Uniform care is guided by policies and procedures which reflect applicable laws and regulations
c) The care and treatment orders are signed, named, timed and dated by the concerned doctor
d) The care plan is countersigned by the clinician in-charge of the patient within 24 hours
e) Evidence based medicine and clinical practice guidelines are adopted to guide patient care whenever possible
Emergency services are guided by policies, procedures, applicable laws and regulations
a) Policies and procedure for emergency care are documented
b) Policies also address handling of medico-legal cases
c) The patients receive care in consonance with the policies
d) Policies and procedures guide the triage of patients for initiation of appropriate care
e) Staff is familiar with the policies and trained on the procedures for care of emergency patients
f) Admission or discharge to home or transfer to another organization is also documented
The ambulance services are commensurate with the scope of the services provided by the organization
a) There is adequate access and space for the ambulance(s)
b) Ambulance(s) is appropriately equipped
c) Ambulance(s) is manned by trained personnel
d) There is a checklist of all equipment and emergency medications
e) Equipment are checked on a daily basis
f) Emergency medications are checked daily and prior to dispatch
g) The ambulance(s) has a proper communication system
Policies and procedures guide the care of patients requiring cardio-pulmonary resuscitation
a) Documented policies and procedures guide the uniform use of resuscitation throughout the organization
b) Staff providing direct patient care is trained and periodically updated in cardio pulmonary resuscitation
c) The events during a cardio-pulmonary resuscitation are recorded
d) An analysis of all cardiac arrests is done
e) A multidisciplinary committee monitors the effectiveness of cardio-pulmonary resuscitation
Policies and procedures define rational use of blood and blood products
a) Documented policies and procedures are used to guide rational use of blood and blood products
b) The transfusion services are governed by the applicable laws and regulations
c) Informed consent is obtained for donation and transfusion of blood and blood products
d) Informed consent also includes patient and family education about donation
e) Staff is trained to implement the policies
f) The organization defines the time frame within which blood must be available for emergency use
g) Transfusion reactions are analyzed for preventive and corrective actions
Policies and procedures guide the care of patients in the Intensive care and high dependency units
a) The organization has documented admission and discharge criteria for its intensive care and high dependency units
b) Staff is trained to apply these criteria
c) Adequate staff and equipment are available.
d) Defined procedures for situation of bed shortages are followed.
e) Infection control practices are followed
f) A quality assurance program is implemented.
Policies and procedures guide the care of vulnerable patients (elderly, children, physically and/or mentally challenged)
a) Policies and procedures are documented and are in accordance with the prevailing laws and the national and international guidelines
b) Staff is trained to care for this vulnerable group
c) Care is organized and delivered in accordance with the policies and procedures
d) The organization provides for a safe and secure environment for this vulnerable group
e) A documented procedure exists for obtaining informed consent from the appropriate legal representative
Policies and procedures guide the care of high risk obstetrical patients
a) The organization defines and displays whether high risk obstetric cases can be cared for or not
b) Persons caring for high risk obstetric cases are competent
c) High risk obstetric patient’s assessment also includes maternal nutrition
d) The organization has the facilities to take care of neonates of high risk pregnancies
Policies and procedures guide the care of pediatric patients
a) The organization defines and displays the scope of its pediatric services
b) The policy for care of neonatal patients is in consonance with the national/ international guidelines
c) Those who care for children have age specific competency
d) Provisions are made for special care of children
e) Patient assessment includes detailed nutritional, growth, psychosocial and immunization assessment
f) Policies and procedures prevent child/ neonate abduction and abuse
g) The children’s family members are educated about nutrition, immunization and safe parenting and this is documented in the medical record
Policies and procedures guide the care of patients undergoing moderate sedation
a) Competent and trained persons perform sedation
b) The person administering and monitoring sedation is different from the person performing the procedure
c) Intra-procedure monitoring includes at a minimum the heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, and level of sedation
d) Patients are monitored after sedation
e) Criteria are used to determine appropriateness of discharge from the recovery area
f) Equipment and manpower are available to rescue patients from a deeper level of sedation than that intended
Policies and procedures guide the administration of anesthesia
a) There is a documented policy and procedure for the administration of anesthesia
b) All patients for anesthesia have a pre-anesthesia assessment by a qualified individual
c) The pre-anesthesia assessment results in formulation of an anesthesia plan which is documented
d) An immediate preoperative reevaluation is documented
e) Informed consent for administration of anesthesia is obtained by the anesthetist
f) During anesthesia monitoring includes regular and periodic recording of heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, airway security and potency and level of anesthesia
g) Each patient’s post-anesthesia status is monitored and documented
h) A qualified individual applies defined criteria to transfer the patient from the recovery area
i) All adverse anesthesia events are recorded and monitored
Policies and procedures guide the care of patients undergoing surgical procedures
a) The policies and procedures are documented
b) Surgical patients have a preoperative assessment and a provisional diagnosis documented prior to surgery
c) An informed consent is obtained by a surgeon prior to the procedure
d) Documented policies and procedures exist to prevent adverse events like wrong site, wrong patient and wrong surgery
e) Persons qualified by law are permitted to perform the procedures that they are entitled to perform
f) An operative note is documented prior to transfer out of patient from recovery area
g) The operating surgeon documents the post-operative plan of care
h) A quality assurance program is followed for the surgical services
i) The quality assurance program includes surveillance of the operation theatre environment
j) The plan also includes monitoring of surgical site infection rates
Policies and procedures guide the care of patients under restraints (physical and / or chemical)
a) Documented policies and procedures guide the care of patients under restraints
b) These include both physical and chemical restraint measures
c) These include documentation of reasons for restraints
d) These patients are more frequently monitored
e) Staff receive training and periodic updating in control and restraint techniques
Policies and procedures guide appropriate pain management
a) Documented policies and procedures guide the management of pain
b) The organization respects and supports the appropriate assessment and management of pain for all patients
c) Patient and family are educated on various pain management techniques
Policies and procedures guide appropriate rehabilitative services
a) Documented policies and procedures guide the provision of rehabilitative services
b) These services are commensurate with the organizational requirements
c) Rehabilitative services are provided by a multidisciplinary team
Policies and procedures guide all research activities
a) Documented policies and procedures guide all research activities in compliance with national and international guidelines
b) The organization has an ethics committee to oversee all research activities
c) The committee has the powers to discontinue a research trial when risks outweigh the potential benefits
d) Patient’s informed consent is obtained before entering them in research protocols
e) Patients are informed of their right to withdraw from the research at any stage and also of the consequences (if any) of such withdrawal
f) Patients are assured that their refusal to participate or withdrawal from participation will not compromise their access to the organization’s services
Policies and procedures guide nutritional therapy
a) Documented policies and procedures guide nutritional assessment and reassessment
b) Patients receive food according to their clinical needs
c) There is a written order for the diet
d) Nutritional therapy is planned and provided in a collaborative manner
e) When families provide food, they are educated about the patients diet limitations
f) Food is prepared, handled, stored and distributed in a safe manner
Policies and procedures guide the end of life care
a) Documented policies and procedures guide the end of life care
b) These policies and procedures are in consonance with the legal requirements
c) These also address the identification of the unique needs of such patient and family
d) These also include sensitively addressing issues such as autopsy and organ donation
e) Staff is educated and trained in end of life care
MANAGEMENT OF MEDICATION (MOM)
Policies and procedures guide the organization of pharmacy services and usage of medication
a) There is a documented policy and procedure for pharmacy services and medication usage
b) These comply with the applicable laws and regulations
c) A multidisciplinary committee guides the formulation and implementation of these policies and procedures
There is a hospital formulary
a) A list of medication appropriate for the patients and organization’s resources is developed
b) The list is developed collaboratively by the multidisciplinary committee
c) There is a defined process for acquisition of these medications
d) There is a process to obtain medications not listed in the formulary
Policies and procedures exist for storage of medication
a) Documented policies and procedures exist for storage of medication
b) Medications are stored in a clean, well lit and ventilated environment
c) Sound inventory control practices guide storage of the medications
d) Medications are protected from loss or theft
e) Sound alike and look alike medications are stored separately
f) There is a method to obtain medication when the pharmacy is closed
g) Emergency medications are available all the time
h) Emergency medications are replenished in a timely manner when used
Policies and procedures guide the prescription of medications
a) Documented policies and procedures exist for prescription of medications
b) The organization determines who can write orders
c) Orders are written in a uniform location in the medical records
d) Medication orders are clear, legible, dated, timed, named and signed.
e) Policy on verbal orders is documented and implemented
f) The organization defines a list of high risk medication
g) High risk medication orders are verified prior to dispensing
Policies and procedures guide the safe dispensing of medications
a) Documented policies and procedures guide the safe dispensing of medications
b) The policies include a procedure for medication recall
c) Expiry dates are checked prior to dispensing
d) Labeling requirements are documented and implemented by the organization
There are defined procedures for medication administration
a) Medications are administered by those who are permitted by law to do so
b) Prepared medication are labeled prior to preparation of a second drug
c) Patient is identified prior to administration
d) Medication is verified from the order prior to administration
e) Dosage is verified from the order prior to administration
f) Route is verified from the order prior to administration
g) Timing is verified from the order prior to administration
h) Medication administration is documented
i) Polices and procedures govern patient’s self administration of medications
j) Polices and procedures govern patient’s medications brought from outside the organization
Patients and family members are educated about safe medication and food-drug interactions
a) Patient and family are educated about safe and effective use of medication
b) Patient and family are educated about food-drug interactions
Patients are monitored after medication administration
a) Patients are monitored after medication administration and this is documented
b) Adverse drug events are defined
c) Adverse drug events are reported within a specified time frame
d) Adverse drug events are collected and analysed
e) Policies are modified to reduce adverse drug events when unacceptable trends occur
Policies and procedures guide the use of narcotic drugs and psychotropic substances
a) Documented policies and procedures guide the use of narcotic drugs and psychotropic substances
b) These policies are in consonance with local and national regulations
c) A proper record is kept of the usage, administration and disposal of these drugs
d) These drugs are handled by appropriate personnel in accordance with policies
Policies and procedures guide the usage of chemotherapeutic agents
a) Documented policies and procedures guide the usage of chemotherapeutic agents
b) Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect of chemotherapy
c) Chemotherapy is prepared and administered by qualified personnel
d) Chemotherapy drugs are disposed off in accordance with legal requirements
Policies and procedures govern usage of radioactive drugs
a) Documented policies and procedures govern usage of radioactive drugs
b) These policies and procedures are in consonance with laws and regulations
c) The policies and procedures include the safe storage, preparation, handling, distribution and disposal of radioactive drugs
d) Staff, patients and visitors are educated on safety precautions
Policies and procedures guide the use of implantable prosthesis
a) Documented policies and procedures govern procurement and usage of implantable prosthesis
b) Selection of implantable prosthesis is based on scientific criteria and national /internationally recognized approvals
c) The batch and serial number of the implantable prosthesis are recorded in the patient’s medical record and the master logbook
Policies and procedures guide the use of medical gases
a) Documented policies and procedures govern procurement, handling, storage, distribution, usage and replenishment of medical gases.
b) The policies and procedures address the safety issues at all levels
c) Appropriate records are maintained in accordance with the policies, procedures and legal requirements.
PATIENT RIGHT AND EDUCATION (PRE)
The organization protects patient and family rights and informs them about their responsibilities during care.
a) Patient and family rights and responsibilities are documented.
b) Patients and families are informed of their rights and responsibilities in a format and language that they can understand.
c) The organization’s leaders protect patient’s rights
d) Staff is aware of their responsibility in protecting patients rights
e) Violation of patient rights is reviewed and corrective/preventive measures taken
Patient rights support individual beliefs, values and involve the patient and family in decision making processes
a) Patient and family rights address any special preferences, spiritual and cultural needs.
b) Patient rights include respect for personal dignity and privacy during examination, procedures and treatment
c) Patient rights include protection from physical abuse or neglect
d) Patient rights include treating patient information as confidential
e) Patient rights include refusal of treatment
f) Patient rights include informed consent before anesthesia, blood and blood product transfusions and any invasive / high risk procedures / treatment
g) Patient rights include information and consent before any research protocol is initiated
h) Patient rights include information on how to voice a complaint
i) Patient rights include information on the expected cost of the treatment
j) Patient has a right to have an access to his / her clinical records
A documented process for obtaining patient and / or families consent exists for informed decision making about their care
a) General consent for treatment is obtained when the patient enters the organization
b) Patient and/or his family members are informed of the scope of such general consent
c) The organization has listed those procedures and treatment where informed consent is required
d) Informed consent includes information on risks , benefits, alternatives and as to who will perform the requisite procedure in a language that they can understand
e) The policy describes who can give consent when patient is incapable of independents decision making.
Patient and families have a right to information and education about their healthcare needs
a) When appropriate, patient and families are educated about the safe and effective use of medication and the potential side effects of the medication
b) Patient and families are educated about diet and nutrition
c) Patient and families are educated about immunizations
d) Patient and families are educated about their specific disease process, complications and prevention strategies
e) Patient and families are educated about preventing infections
f) Patients are taught in a language and format that they can understand
Patient and families have a right to information on expected costs
a) There is uniform pricing policy in a given setting (out-patient and ward category)
b) The tariff list is available to patients
c) Patients are educated about the estimated costs of treatment
- Patients are informed about the estimated costs when there is a change in the patient condition or treatment setting
HOSPITAL INFECTION CONTROL (HIC)
The 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
a) The hospital infection control programme is documented which aims at preventing and reducing risk of nosocomial infections.
b) The hospital has a multi-disciplinary infection control committee.
c) The hospital has an infection control team.
d) The hospital has designated and qualified infection control nurse(s) for this activity
The hospital has an infection control manual, which is periodically updated.
a) The manual identifies the various high-risk areas and procedures
b) It outlines methods of surveillance in the identified high-risk areas.
c) It focuses on adherence to standard precautions at all times.
d) Equipment cleaning and sterilisation practices are included.
e) An appropriate antibiotic policy is established and implemented.
f) Laundry and linen management processes are also included.
g) Kitchen sanitation and food handling issues are included in the manual
h) Engineering controls to prevent infections are included
i) Mortuary practices and procedures are included as appropriate to the organization
j) The organization defines the periodicity of updating the infection control manual.
The infection control team is responsible for surveillance activities in identified areas of the hospital.
a) Surveillance activities are appropriately directed towards the identified high-risk areas.
b) Collection of surveillance data is an ongoing process.
c) Verification of data is done on regular basis by the infection control team.
d) In cases of notifiable diseases, information (in relevant format) is sent to appropriate authorities.
e) Scope of surveillance activities incorporates tracking and analyzing of infection risks, rates and trends.
f) Surveillance activities include monitoring the effectiveness of housekeeping services.
The hospital takes actions to prevent or reduce the risks of Hospital Associated Infections (HAI) in patients and employees.
a) The organization monitors urinary tract infections.
b) The organization monitors respiratory tract infections.
c) The organization monitors intra-vascular device infections.
d) The organization monitors surgical site infections.
e) Appropriate feedback regarding HAI rates are provided on a regular basis to medical and nursing staff.
Proper facilities and adequate resources are provided to support the infection control programme
a) Hand washing facilities in all patient care areas are accessible to health care providers.
b) Compliance with proper hand washing is monitored regularly.
c) Isolation/ barrier nursing facilities are available.
d) Adequate gloves, masks, soaps, and disinfectants are available and used correctly.
The hospital takes appropriate action to control outbreaks of infections.
a) Hospital has a documented procedure for handling such outbreaks.
b) This procedure is implemented during outbreaks.
c) After the outbreak is over appropriate corrective actions are taken to prevent recurrence.
There are documented procedures for sterilisation activities in the hospital.
a) There is adequate space available for sterilization activities
b) Regular validation tests for sterilisation are carried out and documented.
c) There is an established recall procedure when breakdown in the sterilisation system is identified .
Statutory provisions with regard to Bio-medical Waste (BMW) management are complied with
a) The hospital is authorised by prescribed authority for the management and handling of Bio-medical Waste.
b) Proper segregation and collection of Bio-medical Waste from all patient care areas of the hospital is implemented and monitored.
c) 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.
d) Bio-medical Waste treatment facility is managed as per statutory provisions (if in-house) or outsourced to authorised contractor(s).
e) Requisite fees, documents and reports are submitted to competent authorities on stipulated dates.
f) Appropriate personal protective measures are used by all categories of staff handling Bio-medical Waste
The infection control programme is supported by hospital management and includes training of staff and employee health
a) Hospital management makes available resources required for the infection control programme
b) The hospital regularly earmarks adequate funds from its annual budget in this regard.
c) It conducts regular pre-induction training for appropriate categories of staff before joining concerned department(s).
d) It also conducts regular “in-service” training sessions for all concerned categories of staff at least once in a year.
e) Appropriate pre and post exposure prophylaxis is provided to all concerned staff members.
CONTINUOUS QUALITY IMPROVEMENT (CQI)
There is a structured quality improvement and continuous monitoring programme in the organization
a) The quality improvement is developed, implemented and maintained by a multi-disciplinary committee
b) The quality improvement programme is documented
c) There is a designated individual for coordinating and implementing the quality improvement programme
d) The quality improvement programme is comprehensive and covers all the major elements related to quality assurance and risk management.
e) The designated programme is communicated and coordinated amongst all the employees of the organization through proper training mechanism.
f) The quality improvement programme is reviewed at predefined intervals and opportunities for improvement are identified.
g) The quality improvement programme is a continuous process and updated at least once in a year.
The organization identifies key indicators to monitor the clinical structures, processes and outcomes which are used as tools for continual improvement.
a) Monitoring includes appropriate patient assessment.
b) Monitoring includes safety and quality control programmes of the diagnostics services.
c) Monitoring includes all invasive procedures.
d) Monitoring includes adverse drug events.
e) Monitoring includes use of anaesthesia.
f) Monitoring includes use of blood and blood products.
g) Monitoring includes availability and content of medical records.
h) Monitoring includes infection control activities.
i) Monitoring includes clinical research.
j) Monitoring includes data collection to support further improvements.
k) Monitoring includes data collection to support evaluation of these improvements.
The organization identifies key indicators to monitor the clinical structures, processes and outcomes which are used as tools for continual improvement.
a) Monitoring includes procurement of medication essential to meet patient needs.
b) Monitoring includes reporting of activities as required by laws and regulations.
c) Monitoring includes risk management.
d) Monitoring includes utilisation of space, manpower and equipment.
e) Monitoring includes patient satisfaction which also incorporates waiting time for services.
f) Monitoring includes employee satisfaction.
g) Monitoring includes adverse events and near misses.
h) Monitoring includes data collection to support further study for improvements.
i) Monitoring includes data collection to support evaluation of the improvements.
The quality improvement programme is supported by the management
a) Hospital Management makes available adequate resources required for quality improvement programme.
b) Hospital earmarks adequate funds from its annual budget in this regard.
c) Appropriate statistical and management tools are applied whenever required .
There is an established system for audit of patient care services
a) Medical and nursing staff participates in this system.
b) The parameters to be audited are defined by the organisation.
c) Patient and staff anonymity is maintained.
d) All audits are documented.
e) Remedial measures are implemented.
Sentinel events are intensively analysed
a) The organisation has defined sentinel events.
b) The organisation has established processes for intense analysis of such events.
c) Sentinel events are intensively analysed when they occur.
d) Actions are taken upon findings of such analysis
RESPONSIBILITIES OF MANAGEMENT (ROM)
The responsibilities of the management are defined
a) Those responsible for governance lay down the organization’s mission statement.
b) Those responsible for governance lay down the strategic and operational plans commensurate to the organization’s mission in consultation with the various stake holders.
c) Those responsible for governance approve the organization’s budget and allocate the resources required to meet the organization’s mission.
d) Those responsible for governance monitor and measure the performance of the organization against the stated mission.
e) Those responsible for governance establish the organization’s organogram.
f) Those responsible for governance appoint the senior leaders in the organization.
g) Those responsible for governance support research activities and quality improvement plans.
h) The organization complies with the laid down and applicable legislations and regulations.
i) Those responsible for governance address the organization’s social responsibility.
The services provided by each department are documented
a) Each organizational program, service, site or department has effective leadership
b) Scope of services of each department is defined
c) Administrative policies and procedures for each department is maintained
d) Departmental leaders are involved in quality improvement
The organization is managed by the leaders in an ethical manner
a) The leaders make public the mission statement of the organization
b) The leaders establish the organization’s ethical management
c) The organization discloses its ownership
d) The organization honestly portrays the services which it can and cannot provide
e) The organization honestly portrays its affiliations and accreditation.
f) The organization accurately bills for it’s services .
A suitably qualified and experienced individual heads the organisation
a) The designated individual has requisite and appropriate administrative qualifications.
b) The designated individual has requisite and appropriate administrative experience.
Leaders ensure that patient safety aspects and risk management issues are an integral part of patient care and hospital management
a) The organization has an interdisciplinary group assigned to oversee the hospital wide safety programme.
b) The scope of the programme is defined to include adverse events ranging from “no harm” to “sentinel events”.
c) Management ensures implementation of systems for internal and external reporting of system and process failures.
d) Management provides resources for proactive risk assessment and risk reduction activities.
FACILITY MANAGEMENT AND SAFETY (FMS)
The organization is aware of and complies with the relevant rules and regulations, laws and byelaws and requisite facility inspection requirements
a) The management is conversant with the laws and regulations and knows their applicability to the organization.
b) Management regularly updates any amendments in the prevailing laws of the land.
c) The management ensures implementation of these requirements.
d) There is a mechanism to regularly update licenses/ registrations/certifications .
The organization’s environment and facilities operate to ensure safety of patients, staff and visitors
a) There is a documented operational and maintenance (preventive and breakdown) plan.
b) Up-to-date drawings are maintained which detail the site layout, floor plans and fire escape routes.
c) There is internal and external sign posting in the organization in a language understood by patient, families and community.
d) The provision of space shall be in accordance with the available literature on good practices (Indian or International Standards) and directives from government agencies.
e) There are designated individuals responsible for the maintenance of all the facilities.
f) Maintenance staff is contactable round the clock for emergency repairs.
g) Response times are monitored from reporting to inspection and implementation of corrective actions.
The organization has a program for clinical and support service equipment management
a) The organization plans for equipment in accordance with its services and strategic plan
b) Equipment is selected by a collaborative process.
c) All equipment is inventoried and proper logs are maintained as required.
d) Qualified and trained personnel operate and maintain the equipment.
e) Equipment are periodically inspected and calibrated for their proper functioning.
f) There is a documented operational and maintenance (preventive and breakdown) plan.
The organization has provisions for safe water, electricity, medical gases and vacuum systems
a) Portable water and electricity are available round the clock.
b) Alternate sources are provided for in case of failure.
c) The organisation regularly tests the alternate sources.
d) There is a maintenance plan for piped medical gas, compressed air and vacuum installation.
The organization has plans for fire and non-fire emergencies within the facilities
a) The organization has plans and provisions for early detection, abatement and containment of fire and non-fire emergencies.
b) Staff is trained for their role in case of such emergencies.
c) The organization has a documented safe exit plan in case of fire and non-fire emergencies.
d) Mock drills are held at least twice in a year.
The organization has a smoking limitation policy.
a) The organization defines and implement its policies to reduce or eliminate smoking
b) The policy has provisions for granting exceptions for patients and families to smoke.
The organization plans for handling community emergencies, epidemics and other disasters
a) The hospital identifies potential emergencies.
b) The organization has a documented disaster management plan.
c) Provision is made for availability of medical supplies, equipment and materials during such emergencies.
d) Hospital staff is trained in the hospital’s disaster management plan
e) The plan is tested at least twice in a year.
The organization has a plan for management of hazardous materials
a) Hazardous materials are identified within the organization
b) The hospital implements processes for sorting, labelling, handling, storage, transporting and disposal of hazardous material.
c) Requisite regulatory requirements are met in respect of radioactive materials.
d) There is a plan for managing spills of hazardous materials
e) Staff is educated and trained for handling such materials.
The hospital has system in place to provide a safe and secure environment
a) The hospital has a safety committee to identify the potential safety and security risks.
b) This committee coordinates development, implementation, and monitoring of the safety plan and policies.
c) Patient safety devices are installed across the organization and inspected periodically.
d) 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.
e) Inspection reports are documented and corrective and preventive measures are undertaken.
f) There is a safety education programme for all staff.
HUMAN RESOURCE MANAGEMENT
The organization has a documented system of human resource planning
a) The organization maintains an adequate number and mix of staff to meet the care, treatment and service needs of the patient.
b) The required job specifications and job description are well defined for each category of staff.
c) The organization verifies the antecedents of the potential employee with regards to criminal/negligence background.
The staff joining the organization is socialized and oriented to the hospital environment
a) Each staff member, employee, student and voluntary worker is appropriately oriented to the organization’s mission and goals.
b) Each staff member is made aware of hospital wide policies and procedures as well as relevant department / unit / service / programme’s policies and procedures.
c) Each staff member is made aware of his/her rights and responsibilities.
d) All employees are educated with regard to patients’ rights and responsibilities.
e) All employees are oriented to the service standards of the organisation
There is an ongoing programme for professional training and development of the staff
a) A documented training and development policy exists for the staff.
b) Training also occurs when job responsibilities change/ new equipment is introduced.
c) Feedback mechanisms for assessment of training and development programme exist.
Staff members, students and volunteers are adequately trained on specific job duties or responsibilities related to safety
a) All staff is trained on the risks within the hospital environment.
b) Staff members can demonstrate and take actions to report, eliminate / minimize risks.
c) Staff members are made aware of procedures to follow in the event of an incident.
d) Reporting processes for common problems, failures and user errors exist .
An appraisal system for evaluating the performance of an employee exists as an integral part of the human resource management process
a) A well-documented performance appraisal system exists in the organization.
b) The employees are made aware of the system of appraisal at the time of induction.
c) Performance is evaluated based on the performance expectations described in job description.
d) The appraisal system is used as a tool for further development.
e) Performance appraisal is carried out at pre defined intervals and is documented.
The organization has a well-documented disciplinary procedure
a) A written statement of the policy of the organization with regard to discipline is in place.
b) The disciplinary policy and procedure is based on the principles of natural justice.
c) The policy and procedure is known to all categories of employees of the organization.
d) The disciplinary procedure is in consonance with the prevailing laws.
e) There is a provision for appeals in all disciplinary cases.
A grievance handling mechanism exists in the organization
a) The employees are aware of the procedure to be followed in case they feel aggrieved.
b) The redress procedure addresses the grievance.
c) Actions are taken to redress the grievance
The organization addresses the health needs of the employees
a) A pre-employment medical examination is conducted on all the employees.
b) Health problems of the employees are taken care of in accordance with the organization’s policy.
c) Regular physical and medical checks are done at-least once a year and the findings / results are documented.
d) Occupational health hazards are adequately addressed.
There is documented personal information for each staff member
a) Personal files are maintained in respect of all employees.
b) The personal files contain personal information regarding the employees qualification, disciplinary background and health status
c) All records of in-service training and education are contained in the personal files.
d) Personal files contain results of all evaluations .
There 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 .
There is a process for authorising all medical professionals to admit and treat patients and provide other clinical services commensurate with their qualifications .
There is a process for collecting, verifying and evaluating the credentials (education, registration, training and experience) of nursing staff
a) The education, registration, training and experience of nursing staff is documented and updated periodically.
b) All such information pertaining to the nursing staff is appropriately verified when possible .
There 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
INFORMATION MANAGEMENT SYSTEM (IMS)
Policies and procedures exist to meet the information needs of the care providers, management of the organization as well as other agencies that require data and information from the organization
n Objective elements
a) The information needs of the organization are identified and are appropriate to the scope of the services being provided by the organization and the complexity of the organization
b) Policies and procedures to meet the information needs are documented.
c) These policies and procedures are in compliance with the prevailing laws and regulations.
d) All information management and technology acquisitions are in accordance with the policies and procedures.
e) The organization contributes to external databases in accordance with the law and regulations
n IMS.2 :The organization has processes in place for effective management of data
a) Formats for data collection are standardized
a) Necessary resources are available for analyzing data
b) Documented procedures are laid down for timely and accurate dissemination of data
d) Documented procedures exist for storing and retrieving data
e) Appropriate clinical and managerial staff participates in selecting, integrating and using data.
The organization has a complete and accurate medical record for every patient
a) Every medical record has a unique identifier.
b) Organization policy identifies those authorized to make entries in medical record.
c) Every medical record entry is dated and timed.
d) The author of the entry can be identified
e) The contents of medical record are identified and documented
f) The record provides an up-to-date and chronological account of patient care
The medical record reflects continuity of care
a) The medical record contains information regarding reasons for admission, diagnosis and plan of care.
b) Operative and other procedures performed are incorporated in the medical record
c) When patient is transferred to another hospital, the medical record contains the date of transfer, the reason for the transfer and the name of the receiving hospital
d) The medical record contains a copy of the discharge note duly signed by appropriate and qualified personnel
e) In case of death, the medical record contains a copy of the death certificate indicating the cause, date and time of death.
f) Whenever a clinical autopsy is carried out, the medical record contains a copy of the report of the same.
g) Care providers have access to current and past medical record.
Policies and procedures are in place for maintaining confidentiality, integrity and security of information
a) Documented policies and procedures exist for maintaining confidentiality, security and integrity of information
b) Policies and procedures are in consonance with the applicable laws
c) The policies and procedures incorporate safeguarding of data/ record against loss, destruction and tampering
d) The hospital has an effective process of monitoring compliance of the laid down policy
e) The hospital uses developments in appropriate technology for improving, confidentiality, integrity and security
f) Privileged health information is used for the purposes identified or as required by law and not disclosed without the patient’s authorization
g) A documented procedure exists on how to respond to patients / physicians and other public agencies requests for access to information in the clinical record in accordance with the local and national law.
Policies and procedures exist for retention time of records, data and information
a) Documented policies and procedures are in place on retaining the patient’s clinical records, data and information
b) The policies and procedures are in consonance with the local and national laws and regulations
c) The retention process provides expected confidentiality and security
d) The destruction of medical records, data and information is in accordance with the laid down policy
The organization regularly carries out review of medical records.
a) The medical records are reviewed periodically
b) The review uses a representative sample
c) The review is conducted by identified care providers.
d) The review focuses on the timeliness, legibility and completeness of the medical records
e) The review process includes records of both active and discharged patients
f) The review points out and documents any deficiencies in records
g) Appropriate corrective and preventive measures undertaken are documented.