Components of Standards Development

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

Organized around important functions
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

NABH Standards 10 Chapters 100 Standards 503 Objective Elements

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

Section I: Patient-Centered Standards
STD OE Access, Assessment and Continuity of Care (AAC) Patients Rights and Education (PRE) Care of Patients (COP) Management of Medications (MOM) Hospital Infection Control (HIC)

Section II: Health Care Organization Management Standards
STD OE Continuous Quality Improvement (CQI) Responsibilities of Management (ROM) Facility Management & Safety (FMS) Human Resource Management (HRM) Information Management Systems (IMS)

NABH STANDARDS

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.

Details of chapters. Access ,Assessment and continuity of care (AAC)
Patient Right and Education (PRE). Care of Patients(COP). Management of Medication (MOM). Hospital Infection Control (HIC). Continuous Quality Improvement(CQI) Responsibility of Management (ROM). Facility Management and Safety (FMS). Human Resource Management (HRM) Information Management System (IMS).

Chapter 1. ACCESS,ASSESSMENT AND CONTINIUITY OF CARE (AAC)

AAC.1 The 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

AAC.2 The 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

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

AAC.3 There 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

Cont… Procedures identify staff responsible during transfer
The organization gives a summary of patient’s condition and the treatment given

AAC.4 During 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

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

AAC.5 Patients cared for by the organization undergo an established initial assessment
Objective elements The organization defines the content of the assessments for the out–patients, in-patients and emergency patients. The organization determines who can perform the assessments.

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 patient’s condition or hospital policy. Initial assessment includes screening for nutritional and psychosocial needs.

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

AAC.6 All 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.

AAC.7 Laboratory 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.

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

AAC.8 There 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.

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

AAC.9 There is an established laboratory safety programme
Objective elements. The laboratory safety programme is documented. This programme is integrated with the organization’s safety programme.

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.

AAC.10 Imaging 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.

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.

AAC.11 There 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

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

AAC.12 There is an established radiation safety programme
Objective elements The radiation safety programme is documented. This programme is integrated with the organization’s safety programme. Written policies and procedures guide the handling and disposal of radio-active and hazardous materials.

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

AAC.13 Patient care is continuous and multidisciplinary in nature
Objective elements During all phases of care, there is a qualified individual identified as responsible for the patient’s care. Care of patients is coordinated in all care settings within the organization.

cont… Information about the patient’s 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 patient’s 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.

AAC.14 The organization has a documented discharge process
Objective elements The patient’s discharge process is planned. Policies and procedures exist for coordination of various departments and agencies involved in the discharge process (including medico-legal cases

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)

AAC.15 Organisation 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 patient’s condition at the time of discharge.

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

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

Chapter .2 PATIENT RIGHT AND EDUCATION (PRE)

PRE.1 The 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

cont… The organization’s leaders protect patient’s rights
Staff is aware of their responsibility in protecting patients rights Violation of patient rights is reviewed and corrective/preventive measures taken

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

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

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

PRE.3 A 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

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.

PRE.4 Patient 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

cont… Patient and families are educated about immunizations
Patient and families are educated about their specific disease process, complications and prevention strategies Patient and families are educated about preventing infections Patients are taught in a language and format that they can understand

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

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

Chapter 3. Care of Patients (COP)

COP.1 Uniform 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

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

COP.2 Emergency 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

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

COP.3 The 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

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

COP.4 Policies 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

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

COP.5 Policies 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

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

COP.6 Policies 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

cont… Adequate staff and equipment are available
Defined procedures for situation of bed shortages are followed Infection control practices are followed The unique needs of end of life patients are identified and cared for A quality assurance program is implemented

COP.7 Policies 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

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

COP.8 Policies 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

cont… High risk obstetric patient’s assessment also includes maternal nutrition The organization has the facilities to take care of neonates of high risk pregnancies

COP.9 Policies 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

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

cont… The children’s family members are educated about nutrition, immunization and safe parenting and this is documented in the medical record

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

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

COP.11 Policies 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

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

cont… Each patient’s post-anesthesia status is monitored and documented A qualified individual applies defined criteria to transfer the patient from the recovery area All adverse anesthesia events are recorded and monitored

COP.12 Policies 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

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

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

COP.13 Policies 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

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

COP.14 Policies 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

COP.15 Policies 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

COP.16 Policies 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

cont… Patient’s 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 organization’s services

COP.17 Policies 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

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

COP.18 Policies 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

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

Chapter4. MANAGEMENT OF MEDICATION (MOM)

MOM.1 Policies 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

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

MOM.2 There is a hospital formulary
Objective elements A list of medication appropriate for the patients and organization’s 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

MOM.3 Policies 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

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

MOM.4 Policies 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

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

MOM.4 Policies 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

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

cont… Medication is verified from the order prior to administration
Dosage is verified from the order prior to administration Route is verified from the order prior to administration Timing is verified from the order prior to administration

cont… Medication administration is documented
Polices and procedures govern patient’s self administration of medications Polices and procedures govern patient’s medications brought from outside the organization

MOM.7 Patients 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

MOM.8 Patients 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

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

MOM.9 Policies 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

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

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

cont… Chemotherapy is prepared and administered by qualified personnel
Chemotherapy drugs are disposed off in accordance with legal requirements

MOM.11 Policies 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

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

MOM.12 Policies 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

cont… The batch and serial number of the implantable prosthesis are recorded in the patient’s medical record and the master logbook

MOM.13 Policies 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

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

Chapter 5 HOSPITAL INFECTION CONTROL (HIC)

HIC.1 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.

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.

HIC.2 The 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.

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

Cont… Kitchen sanitation and food handling issues are included in the manual Engineering controls to prevent infections are included Mortuary practices and procedures are included as appropriate to the organization

HIC.3 The 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.

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

HIC.4 The 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.

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.

HIC.5 Proper 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.

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

HIC.6 The 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

HIC.7 There 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

HIC.8 Statutory 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.

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).

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

HIC.9 The 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.

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

Chapter 6 CONTINUOUS QUALITY IMPROVEMENT (CQI)

CQI.1 There 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.

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

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.

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

CQI.2 The 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.

Cont… Monitoring includes adverse drug events.
Monitoring includes use of anaesthesia. Monitoring includes use of blood and blood products. Monitoring includes availability and content of medical records. Monitoring includes infection control activities. Monitoring includes clinical research.

CQI.3 The 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.

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.

CQI.4 The 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

CQI.5 There 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.

CQI.6 Sentinel 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

Chapter 7 RESPONSIBILITIES OF MANAGEMENT (ROM)

ROM.1 The 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

Cont… The organization complies with the laid down and applicable legislations and regulations Those responsible for governance address the organization’s social responsibility

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

ROM.3 The 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 organization’s ethical management The organization discloses its ownership

Cont… The organization honestly portrays the services which it can and cannot provide The organization accurately bills for it’s services

ROM.4 A 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.

ROM.5 Leaders 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.

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.

Chapter 8 FACILITY MANAGEMENT AND SAFETY (FMS)

FMS.1 The 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.

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

FMS.2 The organization’s 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.

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

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

FMS.3 The 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.

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.

FMS.4 The 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.

FMS.5 The 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.

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

FMS.6 The 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

FMS.7 The 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.

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

FMS.8 The 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.

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.

FMS.9 The 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.

Cont… 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. Inspection reports are documented and corrective and preventive measures are undertaken. There is a safety education programme for all staff.

Chapter9 HUMAN RESOURCE MANAGEMENT

HRM.1 The 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.

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.

HRM.2 The 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 organization’s mission and goals.

Cont… Each staff member is made aware of hospital wide policies and procedures as well as relevant department / unit / service / programme’s 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

HRM.3 There 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.

HRM.4 Staff 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.

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

HRM.5 An 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.

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.

HRM.6 The 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.

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

HRM.7 A 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

HRM.8 The 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 organization’s policy.

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

HRM.9 There 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

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

HRM.10 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

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.

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

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.

HRM.12 There 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.

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

HRM.13 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

Objective elements The clinical work assigned to nursing staff is in consonance with their qualification, training and registration. The services provided by nursing staff are in accordance with the prevailing laws and regulations. The requisite services to be provided by the nursing staff are known to them as well as the various departments / units of the hospital

Chapter.10 INFORMATION MANAGEMENT SYSTEM (IMS)

IMS.1 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

Objective elements 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 Policies and procedures to meet the information needs are documented. These policies and procedures are in compliance with the prevailing laws and regulations.

Cont… All information management and technology acquisitions are in accordance with the policies and procedures. The organization contributes to external databases in accordance with the law and regulations

IMS.2 The organization has processes in place for effective management of data
Objective elements Formats for data collection are standardized Necessary resources are available for analyzing data

Cont… Documented procedures are laid down for timely and accurate dissemination of data Documented procedures exist for storing and retrieving data Appropriate clinical and managerial staff participates in selecting, integrating and using data.

IMS.3 The organization has a complete and accurate medical record for every patient
Objective elements Every medical record has a unique identifier. Organization policy identifies those authorized to make entries in medical record.

Cont… Every medical record entry is dated and timed.
The author of the entry can be identified The contents of medical record are identified and documented The record provides an up-to-date and chronological account of patient care

IMS.4 The medical record reflects continuity of care
Objective elements The medical record contains information regarding reasons for admission, diagnosis and plan of care. Operative and other procedures performed are incorporated in the medical record

Cont… 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 The medical record contains a copy of the discharge note duly signed by appropriate and qualified personnel

Cont… In case of death, the medical record contains a copy of the death certificate indicating the cause, date and time of death. Whenever a clinical autopsy is carried out, the medical record contains a copy of the report of the same. Care providers have access to current and past medical record.

IMS.5 Policies and procedures are in place for maintaining confidentiality, integrity and security of information Objective elements Documented policies and procedures exist for maintaining confidentiality, security and integrity of information

Cont… Policies and procedures are in consonance with the applicable laws The policies and procedures incorporate safeguarding of data/ record against loss, destruction and tampering The hospital has an effective process of monitoring compliance of the laid down policy

Cont… The hospital uses developments in appropriate technology for improving, confidentiality, integrity and security Privileged health information is used for the purposes identified or as required by law and not disclosed without the patient’s authorization

Cont… 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.

IMS.6 Policies and procedures exist for retention time of records, data and information
Objective elements Documented policies and procedures are in place on retaining the patient’s clinical records, data and information The policies and procedures are in consonance with the local and national laws and regulations

Cont… The retention process provides expected confidentiality and security The destruction of medical records, data and information is in accordance with the laid down policy

IMS.7 The organization regularly carries out medical audits
Objective elements The medical records are reviewed periodically The review uses a representative sample The review is conducted by identified care providers.

Cont… The review focuses on the timeliness, legibility and completeness of the medical records The review process includes records of both active and discharged patients The review points out and documents any deficiencies in records Appropriate corrective and preventive measures undertaken are documented.

Thank you

Components of Standards Development

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