PROMOTING STANDARDS IN THE PRIVATE HEALTH SECTOR A Self-Assessment Guide for Health Care Organizations QUALITY, SAFETY, ETHICS IFC's Mission IFC, a member of the World Bank Group, creates opportunity for people to escape poverty and improve their lives. We foster sustainable economic growth in developing countries by supporting private sector development, mobilizing private capital, and providing advisory and risk mitigation services to businesses and governments. For more information, visit www.ifc.org. Contents Foreword 2 Acknowledgements 3 1. INTRODUCTION 5 About IFC 6 Purpose of this Guide 6 Why are Standards Important? 7 Governance and Standards 7 Principles of Quality Improvement 8 Where to Begin 9 Resources 9 2. PREPARING FOR THE SELF-ASSESSMENT 11 STEP 1: Get Organized 12 STEP 2: Orient the Team 12 STEP 3: Conduct the Assessment 12 3. THE SELF-ASSESSMENT TEMPLATE 15 Clinical Governance and Leadership (CGL) 17 Ethics and Patient Rights (EPR) 24 Quality Measurement and Improvement (QMI) 39 Patient Safety (PS) 55 Facility Safety and Emergency Management (FSE) 63 4. AFTER THE SELF-ASSESSMENT – NEXT STEPS 75 STEP 4: Score Performance and Identify Gaps 76 STEP 5: Develop an Action Plan 85 STEP 6: Communicate the Findings/Actions 85 STEP 7: Sustain the Gain 86 APPENDICES 89 Appendix I: IFC Code of Conduct for Health Care Organizations 90 Appendix II: Outline Terms of Reference for Key Committees in Health Care Organizations 92 Appendix III: Glossary 94 IFC Self-Assessment Guide for Health Care Organizations 1 2 IFC Self-Assessment Guide for Health Care Organizations ACKNOWLEDGEMENTS The original guide was developed with support from the Joint Commission International (JCI). We would like to also thank the review panel who were: Name Position Organization Location Dr. Alejandro J. Ayón L. Medical Director Hospital Managua, Metropolitano Nicaragua Vivian Pellas Dr. Francisco Balestrin Vice-President ANAHP (National São Paulo, Brazil of Board and Association of Coordinator of Private Hospitals) Information and Quality Committee Dr. K. S. Bhimwal Medical Director Rockland Hospital New Delhi, India Dr. Sneh Khemka Medical Director BUPA International London, UK Dr. Ajibike Oyewumi Consultant O&G Lagoon Hospitals Lagos, Nigeria and Head of Quality Improvement Dr. Arati Verma Chief, Quality and Max Healthcare New Delhi, India Training (Medical) Dr. Hazem Zagzoug Deputy Chairman Andalusia Hospitals Jeddah, Saudi Arabia IFC Self-Assessment Guide for Health Care Organizations 3 4 IFC Self-Assessment Guide for Health Care Organizations introduction IFC Self-Assessment Guide for Health Care Organizations 5 Introduction ABOUT IFC PURPOSE OF THIS GUIDE The International Finance Corporation (IFC) is part of theWorld This Guide is designed to assist health care organizations in emerging Bank Group. Our mission is to promote sustainable private sector markets to reach “international standards” of quality and patient safety. It investment in developing countries in order to reduce poverty and will enable them to conduct an organizational self-assessment to identify improve people’s lives. how well they are meeting defined standards in five key areas: IFC fosters sustainable economic growth in developing countries • Governance and Leadership by financing private sector investment, mobilizing capital in the • Ethics and Patient Rights international financial markets, and providing advisory services to • Quality Measurement and Improvement businesses and governments. • Patient Safety • Facility Safety and Emergency Management In recent years IFC has become increasingly active in the private health sector in developing countries. We are now the la rgest multi-lateral The Guide will help them to gauge how much effort they need to make investor in the private health sector worldwide. Since 2000 we have – and in which areas – to reach international standards. committed over US$2.9 billion of financial support (mainly through debt and equity financing) to over 140 projects in health services and life The assessment is not, in itself, intended for use as an accreditation tool, schiences in more than 30 countries. although it is likely to be a useful tool for organizations that are actively considering international accreditation. If the organization has already Health care organizations supported by IFC provide employment for an attained international accreditation, the Guide may serve to reinforce its estimated 35,000 people and treat 5.5 million patients annually. About commitment to the process of continual improvement. one third of our health care clients are based in IDA countries (mainly poorer developing countries). And about one fifth have achieved some The document provides information regarding key principles underlying form of internationally recognized accreditation. quality improvement initiatives. And it guides users through the important steps of undertaking a quality self-assessment. These include: Our clients include private hospitals and other types of health care getting organized, collecting data, identifying gaps and developing plans organizations including diagnostic centers, eye care chains, polyclinics, for meeting key standards. medical waste management firms and HMOs. More information is available at: www.ifc.org/health 6 IFC Self-Assessment Guide for Health Care Organizations Why are Standards Important? These groups share the responsibility of setting the strategic direction for the organization and for achieving its goals. They are accountable for the Why should private health care providers be interested in promoting quality of services and the safety of the patients, visitors and staff. standards of quality, safety and ethics? The leaders of health care organizations carry out the responsibilities of Of course, the consequences of poor standards can be disastrous. Stories governance through their planning, decision-making, and performance of unethical business practices are increasingly common in the news management functions. media and have resulted in the demise of individuals and whole health care organizations. No hospital executive wants to find their hospital or one of their staff in the news because of a patient being caused serious Principles of good governance injury or death. Principles of good governance include1: Ethical and responsible conduct is not only important for public relations, but it is also a necessary element in risk management. The reputation of a health care organization is critical in influencing patients seeking Stakeholder Stakeholders include investors and employees, as well as patients, services. And, for those organizations aspiring to attract medical tourism, rights: community members and a good reputation is imperative. Hospitals with good reputations also organizations, and vendors. Some rights are accorded by law and others benefit from lower recruitment and orientation costs, as staff retention may be established by the is high and the most qualified professionals tend to seek jobs with them. organization. Stakeholders should know their rights and have a means Solid, supportive leaders who work closely with the staff to improve of redress for violation of their rights. standards also find that patient and staff satisfaction increase. These outcomes create a sense of achievement and pride in the organization. Integrity & Decisions are based on the values held by an individual or organization. It is Quality improvement is linked to performance improvement because ethical behavior: important, then, that the organization defines and agrees on a improving quality tends to reduce costs. For example, when clinicians are shared set of values and code of uncertain about the best course of action to take, they tend to do more – conduct2, such that decisions are e.g. more tests, more procedures and more observation. Therefore, health based on a common understanding. care organizations that undertake more analysis and promote evidence- based medicine are more likely to reduce waste. In fact, some health professionals state that “the opposite of quality is waste” — and waste Disclosure & The organization implements procedures to independently verify reduction requires removing process flaws and non-value adding processes. transparency: and safeguard the integrity of its operating and reporting systems. Disclosure of material matters From a commercial perspective, all of these outcomes can translate into concerning the organization should financial dividends. be timely and balanced to ensure that investors and other stakeholders have access to clear, factual information. Governance and Standards What is governance? Performance The organization should establish indicators to determine whether goals Good governance is of fundamental importance to improving standards orientation: and objectives are being met. All of quality and safety. aspects, including financial, management, and clinical Governance is defined as the rules, processes and laws by which an performance, should be measured to organization is operated. Typically, there are two groups that make up provide an overall assessment of the the governance structure of an organization: organization. • the governing body (e.g. board), and Responsibility & The leadership of a health care facility is ultimately responsible for providing • the chief executive officer (or president) and senior managers. accountability: safe, high quality care. It is accountable for its actions to the In the case of health care organizations, clinicians (e.g. medical and relevant stakeholders, e.g. investors, nursing staff) also play a key role in governance. For example, physicians health authorities, community, and who provide care in a health care facility are normally supervised by individual clients. a licensed medical practitioner; accordingly hospitals have medical directors to fulfill this senior management oversight role. By driving Mutual respect: Leaders should demonstrate mutual the clinical decisions of the organization, physicians also control the use respect and civility with a goal of building trust.3 of resources — such as medications, procedures and tests — thereby making a significant impact on the business. 1 OECD (2004) OECD Principles of Clinical Governance, OECD Publications: Paris. Available at www.oecd.org/dataoecd/32/18/31557724.pdf 2 IFC’s proposed Code of Conduct for Health Care Organizations is included in Appendix I. 3 The Governance Institute. (2009) Leadership in Health Care Organizations: A Guide to Joint Commission Leadership Standards. A Governance Institute White Paper. The Governance Institute: San Diego, Ca. IFC Self-Assessment Guide for Health Care Organizations 7 Governance Structure for Client-focus Client-focused care is directed toward Health Care Organizations meeting the needs of patients and their families. Some factors to take There is no “right” governance structure for hospitals and other health into consideration are: care organizations. The structure will be based on the size and complexity of the organization. However, there are some basic elements that are Dignity and respect: recommended. • Taking into account the values, beliefs and cultural backgrounds of patients during the planning and First, all leaders should have a job description outlining their roles and delivery of care. responsibilities. • Resolving complaints and conflicts as soon as possible. Each individual has their own job to do and each leader has a responsibility to collaborate with the other leaders to make sure that the operations Information sharing: • Encouraging patients to share their of the organization function smoothly. Achieving this aim requires thoughts and questions. a structure and process of communication through which leaders can share information and make decisions. Meetings and committees are two • Health care professionals providing information regarding illness and primary means of gathering the right people together to make decisions. treatment options in ways that each patient can understand. Management meetings need to be held frequently enough to communicate Participation: information and to make decisions. Top management teams, e.g. the • Preparing and supporting patients chief operating officer, administrator, nursing director (or matron) and and their families to participate in medical director, may meet on a weekly basis; whereas, meetings that care at the level they choose. include all department heads may meet monthly. These types of meetings Continuity: are usually referred to as “standing” meetings as they are scheduled on a • Providing care across the regular basis. It is customary to make a yearly calendar marking these continuum of care, e.g. between dates in advance. home, hospital, primary health care, and the community. Committees, on the other hand, are organized around key tasks or functions. Most health care providers should have at least the following Teamwork Quality improvement activities are committees4: best carried out in multidisciplinary teams. Each member of the staff is valuable in the care and treatment • Quality and Patient Safety of patients and each member has a • Infection Prevention and Control role in providing quality care for the • Pharmacy and Therapeutics patient. Additionally each team • Safety (environmental) brings a different set of knowledge, experiences and skills, providing • Medical Records better understanding of an issue or • Clinical Privileging process. Teams are capable of providing a greater number of ideas Illustrative terms of reference for each of these committees are set out in for solutions than individuals. And, Appendix II. when people work together, they are usually more committed to the solutions agreed upon. Therefore involving all levels of staff in quality Principles of Quality improvement initiatives creates a Improvement sense of accountability and ownership. Several principles guide quality improvement efforts: client-focused care, teamwork, leadership, systems, and data. These principles should be applied when developing policies and procedures and implementing quality improvement activities. 4 Institute for Healthcare Improvement. Some Questions To Ask When Forming A Board Quality Committee. Available at: www.ihi.org/NR/rdonlyres/FD638477-AB4A-43B1-A9D9-35486E931C45/7339/JimReinertsenQuestionsforBoardQualityComm.pdf 8 IFC Self-Assessment Guide for Health Care Organizations Utilization/workload measures Leadership Effective leadership is critical to the • No of inpatients success of quality improvement • No of outpatients efforts. Leaders provide the direction and support required to create a • No of procedures (surgical etc) culture of quality. Leadership must • No of tests incorporate “Quality” into the mission, vision and values of the Efficiency measures organization. Leaders must be • Average length of stay “present” and participate in quality improvement efforts, such as • Bed occupancy rate participating in quality-related • Day case rate training, committees, making • Operating theater utilization rounds5, showing interest (e.g. by asking questions about activities and Quality/outcome measures results), including Quality Improvement reports in meeting • Unplanned readmission rates < xx days agendas, and giving recognition to • Infections (e.g. MRSA and Clostridium Difficile) individuals and groups. • Patient falls • Unplanned returns to operating theater Systems Hospital services are provided within • Needle-stick injuries a system. The focus must be on • Pressure sores improving the overall system and the • Complications rate processes within it to create an • Caesarian rate environment that meets the needs of the staff and patients. Quality • Deaths standards assist the staff in looking • Sentinel events at the various processes that affect • Patient complaints the quality of care. For example, the • Patient satisfaction process of maintaining an inventory has a direct effect on the availability of drugs. The focus is not on Often, data such as these are collected, but frequently they are not individual staff members but rather aggregated, analyzed and used for decision-making. Thus, the first place on how well the system is working to start is with the data that exist. Collating this basic information helps and finding ways to improve it. the organization to understand its patient population and provides a basis for planning service delivery and improvement. Data Sound decisions are made with the appropriate information. Therefore, quality improvement efforts rely on Resources collecting data to assess performance, to identify strengths Organizations committed to Quality Improvement should familiarize and gaps in performance, and to themselves with the latest Patient Safety Guidance from the World Health find solutions to improve Organization (WHO). This covers important issues such as Safe Surgery performance and meet set standards. and Hand Hygiene – and can be found at: www.who.int/patientsafety. The measure of success is based on comparing the baseline measurement with the measurement And many useful materials can be found on websites such as that of the after an improvement has been Institute for Healthcare Improvement: www.ihi.org implemented. Throughout this Guide, useful information sources are identified. These include publications and websites, that may be used to learn and to build Where to Begin staff capacity. All online resources that are referred to are accessible free of charge. When asked, health care staff can usually list the types of problems they face daily in providing patient care. However, often they do not believe that they have the accountability or power to do anything about it. And in many organizations, staff members have not been trained in the Quality Improvement approaches used to investigate and solve problems. Nonetheless, Quality Improvement methodology is increasingly being used effectively in many developing countries to help health care teams to identify problems and to find and implement solutions. The key factor in this process is the use of data to support decisions. The type of data collected will vary from place to place, but commonly includes or relates to: 5 Patient Safety First, UK. Leadership for Safety, Supplement 1: Patient Safety Walkrounds. Available at: www.patientsafetyfirst.nhs.uk/ashx/Asset.ashx?path=/How-to-guides-2008-09-19/How%20to%20Guide%20for%20Leadership%20WalkRounds%20(pdf) IFC Self-Assessment Guide for Health Care Organizations 9 10 IFC Self-Assessment Guide for Health Care Organizations Preparing for the self-assessment IFC Self-Assessment Guide for Health Care Organizations 11 Preparing for the Self-Assessment STEP 1: Get Organized STEP 3: Conduct the Assessment The first step towards improving standards of care and services is What areas does the Assessment cover? to form a Quality Assessment Team (or committee). Management The Self-Assessment Template that follows is based on a defined set of should write the terms of reference for the team to provide the team 31 standards, covering five key areas: members with the expectations for their work. Clinical Governance and Leadership (CGL) A team leader needs to be appointed who is responsible for organizing • Governance documents the group, assigning tasks and coordinating the effort. Several • Management responsibility for operations characteristics have been identified for an effective team leader; • Oversight of contracts this is a person who is interested, respected by others, an effective • Departmental scope of services and policies and procedures facilitator, and can devote the necessary time required. This person is • Space and equipment planning not necessarily a manager. • Staff recruitment, retention and development All main categories of staff (e.g. medical, nursing, pharmacy, Ethics and Patient Rights (EPR) housekeeping, and security) should participate on the team. A team • Verification of professional staff credentials of six to eight individuals is often considered to be most effective. • Processes to support patient and family rights • Informed consent • Framework for ethical management STEP 2: Orient the Team • Organ and tissue donation Who conducts the assessment? • Reproductive health policies/IVF The Quality Assessment Team is responsible for conducting the • Termination of pregnancy services assessment. And they may also ask for assistance from any member • Clinical research of the staff. The assessment should be a participative process, so that ownership of the quality improvement process spreads throughout Quality Measurement and Improvement (QMI) the organization. Community members also may be invited to • Clinical practice guidelines and pathways participate. These might be individuals who hold specific positions, • Leaders’ involvement and support such as members of a community health committee (if one exists), • Infection prevention and control parent-teachers’ association, local council or non-governmental • Medications use organization (NGO). Or they may be individuals who have had • Sentinel events recent experiences in the hospital, as these individuals can provide insights from the users’ perspective. When conducting assessments of Patient Safety (PS) the fire systems, the Civil Defense may be consulted with. • Patient identification • Effective communication Team orientation • High alert medications The team needs to be oriented to its purpose and objectives, as well as • Correct site, procedure, and patient for surgery to key quality principles and methodologies. An introduction to the • Health care associated infections importance of quality improvement by the head of the facility will • Risk of falls lend credence to the team’s work. The team leader is a likely person to review the quality standards and assist the team in understanding how to conduct the assessment. If the organization has individuals who have been trained in Quality Improvement methods, they could be helpful in training the team. 12 IFC Self-Assessment Guide for Health Care Organizations Facility Safety and Emergency Management (FSE) • Environmental safety and security Table 1: Assessment Scoring Key • Hazardous materials plan • Emergency management planning 0 = Not met • Fire/smoke plans 5 = Some of the elements are in place, but the • Medical equipment maintenance • Utilities management criteria is not fully satisfied 10 = The element fully meets the criteria Note. These standards were adapted from the JCI Accreditation Standards for Hospitals, 3rd Edition6. Thus, for those organizations seeking international accreditation; these standards will help set them on a path toward meeting internationally recognized standards. What methods can be used to conduct the assessment? How is the Self–Assessment Several methods may be used for gathering information to complete the assessment. Some are outlined below. Template organized? The Self Assessment Template lists each standard and an “intent 1. Observation Observation is typically used to monitor statement” to help the team understand the standard and why it is staff carrying out their duties. For example, important. observation is frequently used to assess infection control practices, counseling Compliance with each standard is evaluated against several techniques and performance of treatment “measurable elements”. There are 160 measurable elements in total procedures. Observations can be made during and for each one there are four columns: safety rounds to establish that safety practices are carried out, e.g. management of hazardous materials. Observation is also used to assess 1) What is The first column describes the condition of the facilities, the availability required? the measurable element. of space for performing services efficiently, and the safety of the environment. (It is generally recommended that management and staff make safety rounds together weekly.) 2) How is This question indicates what to look for when assessing 2. Interviews One-on-one interviews may be conducted this element the measurable element. with managers, staff and clients. Discussions assessed? might also be held with groups, such as the Infection Control or Pharmacy and Therapeutics committees (if these exist). 3) Score The team will score each of These interviews should be guided by a set the elements to establish of questions but tend to be less formal. More a baseline and to measure formal interviews/questionnaires are intended ongoing progress. (See Table to answer a specific set of questions – using a 1 below for scoring key). structured questionnaire or survey tool. Such tools are often used, for example, to collect data regarding staff and patient satisfaction7, 8. 4) Observations This column provides space for writing comments 3. Review of Some information needs to be obtained by or observations that are documents reviewing documents, e.g. patient registers, made, which is particularly patient records, personnel files, policies, useful when determining guidelines and protocols, reports, plans, and what action is needed minutes of meetings. to meet the standard. References and free online resources that may be useful for meeting the standards are cited in the footnotes. 6 Joint Commission International (2007) Joint Commission International Accreditation Standards for Hospitals, 3rd Edition, Oakbrook Terrace, IL, USA. 7 A range of patient survey questions can be found at: www.nhssurveys.org/Filestore/documents/Inpatient_2009_Core_Questionnaire_v5.pdf 8 Staff survey questions available at: www.cqc.org.uk/_db/_documents/quest_acute.pdf IFC Self-Assessment Guide for Health Care Organizations 13 14 IFC Self-Assessment Guide for Health Care Organizations The self -assessment template IFC Self-Assessment Guide for Health Care Organizations 15 The Self-Assessment Template STEP 1: Get Organized Self-Assessment – Quality and Safety Date _______________________________________________________________________________________________________ Name of facility _______________________________________________________________________________________________ ____________________________________________________________________________________________________________ Location: (town, district/province) _________________________________________________________________________________ ____________________________________________________________________________________________________________ Name(s) of assessor(s) __________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ 16 IFC Self-Assessment Guide for Health Care Organizations Clinical Governance and Leadership (CGL) Standard CGL.1 [Governance documentation] Governance responsibilities and accountabilities are described in bylaws, policies and procedures, or similar documents that guide how they are to be carried out. Intent of CGL.1 There is an entity (e.g. a holding company, a foundation, an owner), or a group of individuals (e.g. a board) that is responsible for overseeing the organization’s operation and is accountable for providing quality health care services to its community or to the population that seeks care. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization’s A document or set of documents governance structure is describes the mission, vision and ........................................................ described in written values, purpose and goals, and documents. structure of the organization ........................................................ (including the organizational chart). Also roles/responsibilities of ........................................................ the Chief Executive Officer, Board, etc. The title of the document may be “bylaws”, “administrative ........................................................ manual”, etc. The organization’s mission is made public, e.g. posted. ........................................................ 2) Strategic and Strategic and operational plans are management plans and written. The approval of the ........................................................ operating policies and strategic and operational plans is procedures are developed documented in the minutes of the ........................................................ and approved by the governing body. (The governing organization’s governing body may be the Board of ........................................................ body. Directors, or other such group). 3) An annual budget is An annual budget is developed. developed and approved The approval of the budget is ........................................................ to allocate the resources documented in the minutes of the required to meet the governing body. ........................................................ organization’s mission. 4) A license to operate A license to operate the facility, the organization, as and any other licenses that are ........................................................ required, is obtained and required, are displayed in public posted. view. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 17 Standard CGL.2 [Senior manager responsible for operations] A designated senior manager or director is responsible for managing the organization and ensuring compliance with applicable laws and regulations. Intent of CGL.2 Effective leadership is essential for a health care organization to be able to operate efficiently and fulfill its mission. A senior manager or director is responsible for the organization’s overall, day–to-day operations. These include the procurement and management of essential supplies, maintenance of the physical facilities, financial management, quality management, patient safety, and other responsibilities. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) A senior manager or A job description outlines the roles director manages the and responsibilities of the senior ........................................................ organization’s day-to-day manager/director. Routine operations, including management meetings are held ........................................................ human, financial and other and the minutes show resources. collaboration with department ........................................................ directors/managers in overseeing resource planning, financial management and quality ........................................................ improvement. ........................................................ 2) The senior manager or Documents show that policies director ensures approved by the governing body ........................................................ compliance with approved have been implemented. These policies. may include implementation plans, ........................................................ minutes of meetings, monitoring activities and reports to the ........................................................ governing body. 3) The senior manager or Copies of applicable laws and director ensures regulations are available. ........................................................ compliance with applicable Compliance with laws and laws and regulations. regulations is documented, e.g. ........................................................ reporting of notifiable contagious diseases, radiology safety logs. ........................................................ 4) The senior manager or Reports from inspecting or director responds to any regulatory agencies, e.g. ........................................................ reports from inspecting accreditation, Civil Defence or and regulatory agencies. Radiation Safety Councils, are kept ........................................................ on file. Minutes of meetings or reports show that actions have ........................................................ been taken to rectify any issues arising. ........................................................ 18 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 5) The organization’s Documents demonstrate leaders plan services with involvement of community leaders ........................................................ recognized leaders in the and other health care community and other organizations in planning services, ........................................................ health care organizations. e.g. strategic or program planning. Standard CGL.3 [Oversight of contracts] The organization’s leaders provide oversight of contracts for outsourced clinical and support services. Intent of CGL.3 Organizations frequently have the option to either provide services directly or to arrange services through referral, consultation, contractual arrangements, or other agreements. Such services may range from diagnostic imaging services to financial accounting services. In all cases, there is leadership oversight for such contracts, or other arrangements to ensure that the services meet patients’ needs. They are monitored as part of the organization’s quality management and improvement activities. Department managers receive and act on regular reports from contracting agencies and ensure the reports are integrated into the organization’s quality monitoring process when appropriate. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Contracts and other Contracts with any vendor (e.g. arrangements are housekeeping, laboratories) include ........................................................ monitored, as appropriate expectations for quality and how it to the nature of the will be monitored. Documents ........................................................ contract, as part of the show that quality monitoring is organization’s quality done, results are communicated to ........................................................ management and leadership and actions are taken as improvement program. needed. ........................................................ All independent contractors providing clinical services (e.g. ........................................................ diagnostic, consultation or treatment) have been formally ........................................................ awarded documented privileges by the organization to provide such services. ........................................................ 2) Services provided Results of patient satisfaction under contracts and other surveys or complaints regarding ........................................................ arrangements meet contracted services are documented patients’ needs. and followed up. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 19 Standard CGL.4 [Departmental services specification] The directors of each clinical department identify, in writing, the scope of services to be provided, policies and procedures for carrying out work, and the criteria for the department’s professional staff. Intent of CGL.4 Each department has a document called a “Scope of Services” that describes the goals and services provided by the department. The scope also includes the types of staff required to assess and meet patient care needs. The document describes how clinical services are coordinated within each department as well as with other departments and services. Unnecessary duplication of services is avoided or eliminated to conserve resources. Policies and procedures are written to standardize clinical care. A consistent format is used for departmental documents. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The scope of service Each department has a written and policies/procedures scope of services that describes the ........................................................ describe the current services provided in the services provided by each department, hours of operation, ........................................................ department. main diagnoses and procedures, support services available, ........................................................ organizational structure (management, medical, nursing), etc. ........................................................ Each department has a set of ........................................................ policies and procedures specific to their departmental functions and ........................................................ processes. In clinical departments, these processes address patient assessments, admission and ........................................................ discharge criteria, discharge planning, transfer and referrals, ........................................................ and coordination with other departments. ........................................................ Organization-wide protocols are ........................................................ incorporated in the department manuals, such as fire safety, adverse event handling, infection control, ........................................................ emergency preparedness etc. ........................................................ 20 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 2) There is coordination Coordination is described in the of services: departmental scope of services and ........................................................ policies/procedures. This could a. within each include regular staff meetings, ........................................................ department (e.g. grand rounds, interdisciplinary through regular staff team meetings; reporting processes meetings, reporting ........................................................ (e.g. shift reports). Coordination mechanisms, between key departments is also development of ........................................................ described, e.g. between an admission/ transfer/ orthopedic unit and a discharge criteria), and physiotherapy department, or ........................................................ b. between departments. these might include outside services, e.g. the emergency ........................................................ department describes their process for coordinating with ambulance ........................................................ services. Admission and discharge criteria are written for each inpatient department. ........................................................ 3) The department Job descriptions describe director develops and education, skills and knowledge ........................................................ applies criteria related to required. A library of recognized the required level of medical qualifications is developed. ........................................................ education, skills, Annual performance appraisals knowledge and experience document staff competency. This ........................................................ of the department’s information is used to plan staff professional staff. training and development. ........................................................ 4) The director ensures A list of the clinical privileges for that there is a process for each physician is available in the ........................................................ authorizing all medical departments and other areas professionals to admit and where they work. ........................................................ treat patients, commensurate with their ........................................................ training and qualifications (clinical privileges). ........................................................ IFC Self-Assessment Guide for Health Care Organizations 21 Standard CGL.5 [Departmental resource planning] Departmental directors/managers recommend space, equipment, staffing, and other resources needed by the department or service. Intent of CGL.5 Each department’s leader communicates their human resources and other resource requirements to the organization’s senior managers. This helps ensure that adequate staff, space, equipment, and other resources are available to meet patients’ needs at all times. As these resource needs may change or may not be fully met, the departmental leaders need to have plans to respond to resource shortages to ensure safe and effective care for all patients. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Department directors/ A staffing plan is developed, based managers recommend on the organization’s strategic plan ........................................................ numbers and qualifications and the department’s scope of of staff, space, and services. The plan describes the ........................................................ equipment required to methods used to ensure an provide services. adequate number and mix of staff. ........................................................ Staffing levels are based on appropriate utilization/workload information which is recorded ........................................................ periodically (e.g. daily patient census). ........................................................ A periodic assessment is ........................................................ undertaken to determine space and equipment needs. ........................................................ 2) Department directors/ Policies and procedures outline managers have a process to steps that are taken when shortages ........................................................ respond to resource occur, e.g. of drugs or staff. shortages. ........................................................ 22 IFC Self-Assessment Guide for Health Care Organizations Standard CGL.6 [Staff recruitment, retention and development] Organization leaders ensure that there are uniform programs for the recruitment, retention, development, continuing education, and health and safety of all staff. Intent of CGL.6 An organization’s ability to care for patients is directly related to its ability to attract and retain qualified, competent staff. Leaders recognize that staff retention, more than recruitment, provides greater long-term benefit. Retention is increased when leaders support staff advancement through continuing education. Thus, the leaders plan and implement programs related to recruitment, retention, development, and continuing education for each category of staff. The organization’s recruitment program considers published guidelines such as those from the WHO, the International Council of Nurses, and the World Medical Association. The health and safety of an organization’s staff are critical for maintaining staff security, satisfaction, and productivity. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) There is a formal Job descriptions are written for process for staff each category of staff, outlining the ........................................................ recruitment and retention. required educational qualifications, skills, knowledge and experience. ........................................................ The Human Resources department has a recruitment and retention plan ........................................................ that is developed collaboratively with department directors, and is updated annually. The effectiveness ........................................................ of the plan is measured, e.g. by monitoring staff turnover, absence ........................................................ and vacancy rates. ........................................................ 2) Each department has A general orientation program is established an orientation conducted for all new employees. A ........................................................ program for new staff. department-specific orientation is conducted as well as a job-specific ........................................................ orientation. The orientation program is documented, ........................................................ attendance is monitored, and successful achievement is recorded in each employee’s personnel file. ........................................................ 3) There is a formal Each department determines program for staff personal staff training needs on an annual ........................................................ development and basis and develops a training continuing education. plan. The plan may include in- ........................................................ service training/coaching as well as targeted outside education. ........................................................ Participation is documented in personnel files. ........................................................ 4) The organization The program addresses both urgent provides a staff health and and non-urgent health-related ........................................................ safety program. needs through direct treatment and referral. The program includes ........................................................ immunizations and vaccinations and appropriate follow-up care for ........................................................ staff exposed to infectious diseases and work-related injuries. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 23 Ethics and Patient Rights (EPR) Standard EPR.1 [Verification of credentials of professional staff] The organization has an effective process for gathering, verifying, and evaluating the credentials (e.g. licenses, education, training, and experience) of those professional staff permitted to provide patient care. Intent of EPR.1 Physicians, dentists, nurses, pharmacists and others who are licensed to provide clinical services represent those primarily responsible for patient care and care outcomes. Thus, the organization has the highest level of accountability to ensure that each of these practitioners is qualified to provide safe and effective care and treatment to patients. The organization assumes this accountability by: • understanding the applicable laws and regulations that identify those permitted to work in these positions; • confirming that the organization will only permit such practitioners to work within it; • gathering all available credentials for each practitioner including: –– at least evidence of education and training and evidence of current licensure, –– evidence of current competence through information from other organizations at which the practitioner practiced, –– letters of recommendation, and/or –– other information the organization may require such as health history, pictures/ID, etc.; • verifying of essential information such as: –– current registry or licensure, especially when such documents are periodically renewed, –– any certifications, and –– evidence of completion of postgraduate education. The organization needs to make every effort to verify essential information, especially when the education took place in another country and/ or a significant time ago. Secure web-sites, documented phone confirmation from sources, written confirmation, and verification by trusted third parties, such as designated official governmental or nongovernmental agencies, may be used. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Licensure, education A policy/procedure describes the and training are verifie d process for verifying licensure, ........................................................ according to the education and training. The parameters in the intent verification is documented in each ........................................................ statement above. personnel file. 2) There is a separate A policy/procedure lists the record maintained of the required contents of personnel ........................................................ credentials of every files. Personnel files contain the professional staff member required documents. ........................................................ that contains copies of any required license, ........................................................ certification, or registration and other documents required by the ........................................................ organization. ........................................................ 3) There is a standardized A system is in place to verify that all procedure to review each licensure, certification and ........................................................ record at least every three registrations are current. A years to assure current Credentialing and Privileging ........................................................ licensure, registration, etc. Committee is one means of carrying out this function. ........................................................ 24 IFC Self-Assessment Guide for Health Care Organizations Standard EPR.2 [Patient and family rights] The organization implements processes that support patients’ and families’ rights during care. Intent of EPR.2 An organization’s leaders are primarily responsible for how the organization treats its patients. Thus, the leaders need to know and understand patient and family rights and their organization’s responsibilities as identified in laws and regulations. The leaders provide direction to ensure that staff members throughout the organization assume responsibility for protecting these rights. To effectively protect and advance patient rights, the leaders work collaboratively and seek to understand their responsibilities in relation to the community served by the organization. The organization respects the right of patients (and in some circumstances the rights of the patient’s family) to have the prerogative to determine what information regarding their care would be provided to their families or others, and under what circumstances. For example, some patients may not wish to have a diagnosis shared with their family. Policies and procedures are developed and implemented to ensure that all staff members are aware of and respond to patient and family rights issues when they interact with and care for patients throughout the organization. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Policies and procedures Policies and procedures are written guide and support patient and implemented regarding the ........................................................ and family rights in the rights of patients and their families. organization. These may be based on a Patient ........................................................ Rights Charter. Specific expectations for each “right” need ........................................................ to be described. The rights should include at a minimum: • respect for personal dignity and ........................................................ privacy during examinations, treatments and procedures, ........................................................ • informed consent, ........................................................ • information regarding cost of services, ........................................................ • access to medical records, and • information about their health ........................................................ care needs. ........................................................ Patients and their families need to be informed about their rights in a form and language that they can ........................................................ understand. ........................................................ 2) Vulnerable groups Policies and procedures regarding (e.g. children, disabled vulnerable groups outline how to ........................................................ individuals, the elderly, and protect patients against possible others identified by the abuse and what actions are taken ........................................................ organization) are when cases of abuse are suspected. protected against abuse. Cases of reported or suspected ........................................................ abuse and actions taken to intervene are documented. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 25 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 3) The organization Policies and procedures describe respects patients’ health how patients’ health information is ........................................................ information as protected and how breaches of confidential. confidentiality are dealt with. ........................................................ Incidents of breaches and actions taken are recorded. ........................................................ 4) The organization Interviews with patients indicate informs patients and that they were provided with ........................................................ families about their rights information regarding their right to refuse or discontinue to refuse treatment. This ........................................................ treatment and the information might be provided in a available care and written document or verbally. ........................................................ treatment alternatives in a When a patient has refused manner that they can treatment, documentation on the understand. medical record shows that they are ........................................................ provided information about available care and treatment ........................................................ alternatives. 5) Patients are aware of Interviews with patients show that their right to voice a they are aware of their right to ........................................................ complaint and the process make a complaint and how to do to do so. so. (This may also include the use of ........................................................ a suggestion box). 26 IFC Self-Assessment Guide for Health Care Organizations Standard EPR.3 [Informed consent] Patients’ informed consent is obtained through a process defined by the organization and is carried out by trained staff. Intent of EPR.3 One of the main ways that patients are involved in their care decisions is by granting informed consent. To consent, a patient must be informed of those factors related to the planned care required for an informed decision. Informed consent may be obtained at several points in the care process, e.g. when a patient is admitted for inpatient care, and before undertaking certain procedures or treatments for which the risks may be high. The consent process is clearly defined by the organization in policies and procedures. Relevant laws and regulations are incorporated into the policies and procedures. Patients and families are informed as to what tests, procedures, and treatments require consent and how they can give consent (e.g. verbally, by signing a consent form, or through some other means). Patients and families understand who may, in addition to the patient, give consent. Designated staff members are trained in how to inform patients and in how to obtain and document their consent. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization has a Policies and procedures define the clearly defined informed process for obtaining informed ........................................................ consent process described consent. in policies and procedures. ........................................................ 2) Designated staff are Staff training for implementing the trained to implement the informed consent policy is ........................................................ policies and procedures. documented. This may be part of staff orientation. ........................................................ 3) Patients give informed Consent forms are completed and consent consistent with the located on the patient’s medical ........................................................ policies and procedures. record. Interviews with patients Patients are informed of: indicate that they have received all ........................................................ of the information required for a. their condition, informed consent. b. the proposed ........................................................ procedure(s) and treatment(s) and who ........................................................ is authorized to perform them, ........................................................ c. potential benefits and drawbacks to the ........................................................ proposed treatment(s) and possible problems ........................................................ related to recovery, d. possible alternatives to ........................................................ the proposed treatment(s) and ........................................................ possible results of non-treatment, ........................................................ e. the likelihood of successful treatment(s), ........................................................ and f. the identity of the ........................................................ physician or other practitioner ........................................................ responsible for care. IFC Self-Assessment Guide for Health Care Organizations 27 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 4) The organization has a The policies and procedures process for when others indicate who may grant consent ........................................................ can grant informed when the patient is unable to do consent. so, e.g. for children or comatose ........................................................ patients. Signed consent forms show that the proper individuals ........................................................ have provided consent. 5) Consent is obtained The policies and procedures include before high-risk procedures a list of high- risk procedures and ........................................................ and treatments are treatments for which consent is undertaken. required. A consent form/record is ........................................................ located on records of patients who have undergone these procedures. ........................................................ 28 IFC Self-Assessment Guide for Health Care Organizations Standard EPR.4 [Ethical management] The organization establishes a framework for ethical management that ensures that patient care is provided within business, financial, ethical, and legal norms and that protects patients and their rights. Intent of EPR.4 A health care organization has an ethical and legal responsibility to its patients and its community. The leaders understand these responsibilities as they apply to the organization’s business and clinical activities. They create guiding documents to provide a consistent framework to carry out these responsibilities. The organization operates within this framework to: • disclose ownership and any conflicts of interest; • honestly portray its services; • provide clear admission, transfer, and discharge policies; • accurately bill for its services; and • resolve conflicts when financial incentives and payment arrangements could compromise patient care. The framework also supports the organization’s professional staff when confronted by ethical dilemmas in patient care such as disagreements between patients and their families, and between patients and their care providers, regarding care decisions, and inter-professional disagreements. These documents are readily available to provide such support. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization’s A relevant policy, Code of Ethics, or leaders establish ethical Code of Conduct is established. ........................................................ and legal norms that protect patients and their ........................................................ rights. 2) The organization Ownership of the organization is discloses its ownership. publically displayed. ........................................................ 3) The organization Services available are made known honestly portrays its to the public, with no documented ........................................................ services. cases of misrepresentation. The scope of services is clearly defined. ........................................................ Transfer arrangements are in place for patients who do not match the ........................................................ organizations resources. ........................................................ Admission and discharge criteria, and registration processes are ........................................................ clearly defined. 4) The organization A price-list is available. Internal and accurately bills for services. external audits demonstrate ........................................................ accurate billing practices. IFC Self-Assessment Guide for Health Care Organizations 29 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 5) The organization The organization’s Code of Ethics discloses and resolves and/or policies and procedures ........................................................ conflicts when financial describe expectations and actions incentives and payment to be taken when posed with such ........................................................ arrangements may conflicts. Situations that arise are compromise patient care reviewed for consistency in carrying ........................................................ (e.g. payment of referral out the policy. fees, informal or “under the table” payments, ........................................................ bribes or kickbacks). ........................................................ 6) Staff are supported An ethics committee or other when confronted by ethical structure is in place that oversees ........................................................ dilemmas in patient care and provides guidance in dealing and professional ethical with ethical issues. ........................................................ issues. 7) The organizational The organization’s policies and structure(s) and processes procedures describe mechanisms to ........................................................ support safe reporting of allow for safe reporting of ethical ethical and legal concerns. and legal concerns, e.g. hot lines. ........................................................ 30 IFC Self-Assessment Guide for Health Care Organizations Standard EPR.5 [Organ and tissue donation and transplantation] The organization implements safeguards to ensure compliance with international guidelines. Intent of EPR.5 Transplant services raise many important ethical issues. For organizations involved in or with links to organ donation and transplant programs: • The organization supports the choice of patients and families to donate organs and other tissues for research or transplantation. • Information is provided on the donation process. • Policies and procedures are developed to guide the procurement and donation process and the transplantation process. • The policies are consistent with laws and regulations and take account of social and ethical issues. • Staff are trained in implementing the policies and procedures to support patient and family choices. • The organization complies with recognized international guidelines on organ donation and transplantation9, 10, 11. Staff are trained in these guidelines and in related contemporary concerns and issues. These include, for example information on organ and tissue shortages, the illegal trade in organs, the harvesting of organs without consent from dead patients (or executed prisoners). The organization has a responsibility to ensure that valid consent is received from live donors. It ensures that adequate controls are in place to prevent patients from feeling pressured to donate. Controls also identify instances where there may be commercial arrangements between donors and recipients, including via third parties, e.g. agents and intermediaries. It cooperates with other organizations and agencies responsible for all or a portion of the procurement, banking, transportation, or transplantation process. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization Medical records show family supports patient and family requests for donation are ........................................................ choices to donate organs carried through. Data of and other tissues. potential candidates and rates of ........................................................ procurement are kept. ........................................................ 2) Policies and Policies and procedures describe procedures guide the procurement, donation and ........................................................ procurement, donation transplant processes. These comply and transplantation with the WHO guidelines on organ ........................................................ processes. transplantation. ........................................................ 3) Staff are trained in Training records of staff in targeted the relevant policies and areas, e.g. ICU, are maintained. ........................................................ procedures and in ethical issues pertinent to organ ........................................................ transplantation. ........................................................ 4) Valid informed consent Appropriate checks, including is obtained from live interviews with potential donors, ........................................................ donors. are conducted by trained staff. 9 WHO Guiding Principles on Human Organ Transplantation (1989). Available at: www.who.int/ethics/topics/transplantation_guiding_principles/en/index.html 10 Joint Commission (2004) Health Care at the Crossroads: Strategies for Narrowing the Organ Donation Gap and Protecting Patients. Available at: www.jointcommission.org/NR/rdonlyres/E4E7DD3F-3FDF-4ACC-B69E-AEF3A1743AB0/0/organ_donation_white_paper.pdf 11 World Medical Association Statement on Human Organ Donation and Transplantation. (2006) Available at: www.wma.net/e/policy/wma.htm IFC Self-Assessment Guide for Health Care Organizations 31 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 5) The organization Minutes of meetings, memos, or cooperates with relevant reports indicate cooperation with ........................................................ organizations and agencies relevant community organizations in the community to and agencies. ........................................................ respect and implement choices to donate. ........................................................ 6) Staff are supported An ethics committee or other when confronted by ethical structure is in place that oversees ........................................................ dilemmas in patient care and provides guidance in dealing and professional ethical with ethical issues. ........................................................ issues. 7) The organizational The organization’s policies and structure(s) and processes procedures describe mechanisms to ........................................................ support safe reporting of allow for safe reporting of ethical ethical and legal concerns. and legal concerns, e.g. hot lines. ........................................................ 32 IFC Self-Assessment Guide for Health Care Organizations Standard EPR.6 [Reproductive health practices/IVF] The organization sets policies and oversees practices relating to fertility treatment. Intent of EPR.6 Organizations providing fertility services develop and implement reproductive health policies for fertility treatment (e.g. IVF), which take account of legal, social and ethical considerations. IVF services raise many important ethical issues that should be addressed in the policies. For example: • When embryos are formed outside the body, what should be done with those that are not transferred? –– Is it acceptable to use them for research? –– Could they be donated to another infertile couple? –– Should they be frozen for future use? Or should they be destroyed? –– And who has the right to make these decisions? • Donation of gametes (egg and sperm) –– What criteria are used to determine who may donate and who may receive gametes (e.g. age, relationship status, family size, etc?) –– What procedures are followed for recruiting, counseling and treating donors? –– What rules apply to the compensation of donors? –– What are the rules determining anonymity, or otherwise, of donors? • Ethical questions concern the practice of transferring several embryos in order to increase the likelihood of pregnancy. (If all the embryos successfully implant, the woman faces the prospect of a high order multiple pregnancy, with its attendant increased risks of obstetric complications, premature birth and disability12). Sex selection using IVF techniques presents a wide range of important ethical, legal and social implications. A significant ethical concern is that sex selection for non-medical reasons may reinforce discrimination, particularly against women and girls.13 Informed consent by women for all reproductive services is required. Services are carried out based on standardized procedures by qualified practitioners. And, a registry is kept to track the outcomes. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Fertility treatment is Fertility treatment is a part of the integrated into a wider local maternal health scope of ........................................................ reproductive and child services. health package of ........................................................ services.14 2) The organization has Policies and procedures address written policies regarding assisted reproductive health ........................................................ assisted reproductive technologies, including IVF. These health technologies that should address key ethical issues ........................................................ ensure that the rights of (e.g. including those outlined women as users of these above) – especially in countries ........................................................ technologies are within the where regulations are not boundaries of legal and well-defined. ethical considerations. ........................................................ Policies must include the rights of women, including egg donors ........................................................ (where applicable). 12 WHO. (2003) Assisted reproduction in developing countries-facing up to the issues. Progress in Reproductive Health Research. No. 63. Available on: www.who.int/reproductive-health/hrp/progress/63/63.pdf 13 WHO Genomic Resource Center. Available at: www.who.int/genomics/gender/en/index4.html 14 See a discussion of policy regarding infertility treatment in India, available at: www.searo.who.int/LinkFiles/Reporductive_Health_Profile_infertility.pdf IFC Self-Assessment Guide for Health Care Organizations 33 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 3) Health care providers Clinical practice guidelines, at each level are trained to protocols and procedures are ........................................................ perform screening, developed. Training records show examination, diagnosis, that the staff performing the ........................................................ referral and treatment procedures have been deemed services as appropriate. competent. ........................................................ 4) Procedures and The equipment and procedures equipment for the used to carry out these techniques ........................................................ techniques are are standardized. standardized. ........................................................ 5) Prior to treatment, Verbal explanations and written health personnel provide information are made available to ........................................................ patients with full patients. Patient interviews show information of the risks that they received and understood ........................................................ and implications of the the information. procedures.15 ........................................................ 6) Where applicable, Verbal explanations and written donors are provided with information are made available to ........................................................ full information of the risks donors. and implications of the ........................................................ procedure. (These may Request to see written information relate to physical and/or provided to donors. ........................................................ emotional implications and issues relating to confidentiality) ........................................................ 7) A registry is kept of A register or log is kept of all the results of direct fertility treatments. Quality and ........................................................ treatment (e.g. pregnancy outcome indicators are identified. rates), pregnancy The data are aggregated monthly. ........................................................ outcomes, child Minutes of departmental meetings development and side show that the data are reviewed ........................................................ effects of treatment for the and actions taken as required. women. ........................................................ 8) Registries are linked, If a national registry is kept, the where possible, with organization contributes its data. ........................................................ national health registries. WHO. Current Practices and Controversies in Assisted Reproduction. Report of a meeting on “Medical, Ethical and Social Aspects of Assisted Reproduction” WHO 15 headquarters, Geneva, Switzerland, 17-21 September 2001. Available at: www.who.int/reproductive-health/infertility/36.pdf 34 IFC Self-Assessment Guide for Health Care Organizations Standard EPR.7 [Termination of pregnancy services] The organization sets policies and procedures relating to termination of pregnancy services. Intent of EPR.7 Organizations providing termination of pregnancy services take account of legal, social and ethical considerations. Informed consent by women is required. Services are carried out based on standardized procedures by qualified practitioners. Sex selection using termination of pregnancy presents a wide range of important ethical, legal and social implications. A significant ethical concern is that sex selection for non-medical reasons may reinforce discrimination, particularly against women and girls. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Termination of Termination of pregnancy is a part pregnancy is integrated of the local reproductive health ........................................................ into a wider reproductive scope of services. package of services16. ........................................................ 2) The organization has Policies and procedures guide the written policies regarding organization’s provision of ........................................................ termination of pregnancy termination of pregnancy services. that ensure that the rights These must include the rights of ........................................................ of women as users of these women. technologies are within the ........................................................ boundaries of legal, social and cultural considerations. ........................................................ 3) Staff at each level are Clinical practice guidelines, trained to perform protocols and procedures are ........................................................ examination, referral and developed. Training records show treatment services as that the staff performing the ........................................................ appropriate. procedures have been deemed competent. These may be checklists ........................................................ or other performance based training documentation. ........................................................ 4) Clinical procedures and The equipment and procedures equipment are used to carry out these services are ........................................................ standardized17. standardized. 5) Prior to treatment, Verbal explanations and written health personnel provide information are made available to ........................................................ patients with full patients. Patient interviews/records information of the risks show that they received the ........................................................ and implications of the information. procedure18. ........................................................ 16 Marie Stopes International. Resources for planning reproductive health services. www.mariestopes.org/Publication.aspx?rid=1 17 WHO. Preventing unsafe abortion: www.who.int/reproductivehealth/topics/unsafe_abortion/en/index.html 18 Marie Stopes International. Information for Women. www.mariestopes.org.uk/Womens_services/Abortion/Download_our_leaflets_on_abortion.aspx IFC Self-Assessment Guide for Health Care Organizations 35 Standard EPR.8 [Clinical research] The organization informs patients and their families about how to gain access to clinical research, investigations or trials involving human subjects. Intent of EPR.8 An organization that conducts research, investigations, or clinical trials involving human subjects provides information to patients and families about how to gain access to those activities when relevant to the patient’s treatment needs19. The organization does not commence trials until their purpose and benefits are clear and pertinent ethical issues have been fully considered. When patients are asked to participate, they are given information upon which to base their decision. Patients are informed that they can refuse to participate or withdraw participation and that their refusal or withdrawal will not compromise their access to the organization’s services. The organization has policies and procedures for providing patients and families with this information. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Prior to Details of trials are documented. commencement, the Objectives and purported benefits ........................................................ purpose of any clinical trial are clearly specified. Minutes of and its purported benefits meetings of a clinical trial ........................................................ are clear. Ethical issues committee (and/or ethics relating to the trial are also committee) record discussion of ........................................................ fully considered. An ethics ethical aspects, including formal committee including approval to proceed. independent external ........................................................ experts may be formed to approve trials. ........................................................ 19 A global register of clinical trials is maintained at: www.clinicaltrials.gov 36 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 2) The organization has a The terms of reference for a committee or other research oversight committee (e.g. ........................................................ mechanism to oversee all institutional review or ethics research within it. committee) include the required ........................................................ Oversight activities include: elements. Committee minutes demonstrate that the terms and a. a review process, ........................................................ policies and procedures are carried b. a process to weigh out. relative risks and ........................................................ benefits to subjects, c. processes to provide ........................................................ confidentiality and security of research ........................................................ information, d. ensuring that informed ........................................................ consent processes and other ethical aspects ........................................................ are appropriate, e. ensuring compliance ........................................................ with all regulatory aspects of clinical ........................................................ research, f. monitoring serious ........................................................ adverse events, and g. intervening in the ........................................................ interest of patient safety if required. ........................................................ ........................................................ 3) Appropriate patients Public announcements are made are identified and for planned research. Criteria are ........................................................ informed about how to established for patient selection gain access to research, based on research protocols. ........................................................ investigations or clinical trials relevant to their ........................................................ treatment needs20. 4) Policies and procedures There are written policies and guide the information and procedures for all clinical research ........................................................ decision process. processes. Resource for patients. Candid experiences of patients involved in different aspects of clinical trials in the UK are available at: 20 www.healthtalkonline.org/medical_research/clinical_trials IFC Self-Assessment Guide for Health Care Organizations 37 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 5) Written informed Research files demonstrate that all consent is obtained from patients were informed about the ........................................................ participants and includes required elements. Patient the following information: interviews could be used to ........................................................ validate this requirement. a. expected benefits, b. potential discomforts ........................................................ and risks, ........................................................ c. alternatives that might help them, ........................................................ d. procedures that they must follow ........................................................ e. process for reviewing research protocols, ........................................................ f. process for withdrawing ........................................................ participation, and g. process for weighing ........................................................ the benefits and risks to the subjects. ........................................................ 6) Patients are assured Written documentation of this that their refusal to right is located in the research file ........................................................ participate or withdraw for each patient. from participation will not ........................................................ compromise their access to the organization’s services. ........................................................ 38 IFC Self-Assessment Guide for Health Care Organizations Quality Measurement and Improvement (QMI) Standard QMI.1 [Clinical practice guidelines] Clinical practice guidelines and clinical pathways are used to guide clinical care. Intent of QMI.1 The goals of health care organizations include: • using evidence-based medicine; • standardizing clinical care processes; • reducing risks within care processes, particularly those associated with critical decision steps; and • providing clinical care in a timely, effective manner using available resources efficiently. The organization uses a variety of tools to reach these goals. It seeks to develop clinical care processes and make clinical care decisions based on the best available scientific evidence. Clinical practice guidelines are useful tools in this effort to understand and apply the best science to a particular diagnosis or condition. The organization seeks to standardize care processes. Clinical care pathways (protocols, algorithms, etc) are useful tools in this effort to ensure effective integration and coordination of care and efficient use of available resources. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Clinicians use Current evidence-based guidelines recognized and reputable are adopted for the care and ........................................................ clinical practice guidelines treatment of high-priority patient and pathways to guide groups (e.g. involving high volume ........................................................ patient care processes.21, 22, procedures, or high risk 23, 24, 25, 26, 27, 28, 29, 30, 31 procedures). These may be in the ........................................................ form of a document, protocol, poster, check-list and/or other job aide. ........................................................ 21 National Library for Health (NLH): www.library.nhs.uk 22 National Institute for Health and Clinical Excellence (NICE): www.nice.org.uk 23 eGuidelines: www.eguidelines.co.uk 24 Centre for Evidence Based Medicine: www.cebm.net 25 Health Information Research Unit: http://hiru.mcmaster.ca/hiru 26 Agency for Healthcare Research and Quality (AHCPR): www.ahrq.gov 27 National Guideline Clearinghouse: www.guideline.gov 28 Elsevier Clinical Decision Support: www.ClinicalDecisionSupport.com 29 New Zealand Guidelines Group: www.nzgg.org.nz 30 WHO and UNICEF Baby-friendly Hospital Initiative: www.who.int/nutrition/topics/bfhi/en/index.html 31 African Partnerships for Patient Safety: www.who.int/patientsafety/implementation/apps/en IFC Self-Assessment Guide for Health Care Organizations 39 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 2) The organization uses Policies and procedures outline the the following processes in process for developing and ........................................................ implementing clinical implementing the clinical practice guidelines and guidelines. Guidelines and ........................................................ clinical pathways: pathways that have been developed reflect key patient a. select from among ........................................................ populations. They are approved by those applicable to the identified authorities, e.g. services and patients of ........................................................ department head or medical the organization director, and dated. References are (mandatory national included on the documents that ........................................................ guidelines are included demonstrate recent evidence. in this process, ........................................................ b. if available);evaluate Select an aspect of the guidelines for their applicability to monitor to assure compliance. and science; For instance, for a protocol ........................................................ regarding use of antibiotic c. adapt when needed to ........................................................ prophylaxis, the timing of the dose the technology and or the amount and type of other resources of the organization or to antibiotic could be monitored. ........................................................ Monitoring is done until the accepted national protocol is effectively implemented ........................................................ professional norms; and sustained over time. d. formally approve or adopt by the An ongoing review process is ........................................................ organization; followed to check that the guidelines are up-to-date. The ........................................................ e. implement and review process is outlined in the monitor for consistent use and effectiveness; policies and procedure and the ........................................................ date of review is noted on the f. support with staff guidelines. ........................................................ trained to apply the guidelines or pathways; and ........................................................ g. update periodically. ........................................................ 3) At least one guideline It is more important to implement or pathway is adapted, a few guidelines well than many ........................................................ adopted or updated each done poorly. Thus, the staff will year. prioritize the guidelines and work ........................................................ on a few at a time. 40 IFC Self-Assessment Guide for Health Care Organizations Standard QMI.2 [Leaders’ collaboration] The organization’s leaders collaborate to carry out a Quality Improvement and Patient Safety program. Intent of QMI.2 The organization’s leaders play a key role in ensuring that the quality improvement and patient safety plans shape the organization’s culture and make an impact on every aspect of operations. Leaders ensure the program involves: • continuous system design and redesign in the quality improvement process; • a multidisciplinary approach, with all departments and services in the organization included; • coordination among the multiple organizational units concerned with quality and safety. These might include, for example, –– a clinical laboratory quality control program, –– a facility risk management program, or –– a patient safety program. (An inclusive program is necessary to improving patient outcomes because patients typically receive care from many different departments and services and/or types of clinical staff); and, • a systematic approach, i.e. employing similar quality processes to carry out all improvement and patient safety activities across the organization. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The Quality Quality and safety plans describes Improvement and Patient the quality improvement methods ........................................................ Safety Program (or similar) that are used (e.g. employs a systematic “Plan-Do-Study-Act”). ........................................................ approach to quality improvement and patient ........................................................ safety.32, 33 2) A multidisciplinary A committee has been formed and Quality Improvement and a leader assigned. It meets at least ........................................................ Patient Safety Committee34 monthly and keeps minutes. The meets on a regular basis to minutes show that data relating to ........................................................ provide guidance to the quality are discussed, decisions to quality improvement improve quality are made and ........................................................ process. progress is followed. 3) The leaders set An annual “Quality Plan” (or priorities for quality similar) outlines the quality ........................................................ improvement and patient objectives for the year. Minutes of safety activities and provide the Quality Improvement and ........................................................ technology and support, Patient Safety Committee (or consistent with the similar group responsible for ........................................................ organization’s resources. improvement) show the prioritization process and the participants involved. Senior ........................................................ management supports a budget for quality improvement and safety. ........................................................ 32 University Research Corp (2004) A Modern Paradigm for Improving Healthcare Quality. Bethesda, MD, USA. Available at: www.qaproject.org 33 Institute for Healthcare Improvement. www.ihi.org 34 Draft terms of reference for a Quality and Patient Safety Committee are included in Appendix II. IFC Self-Assessment Guide for Health Care Organizations 41 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 4) Those responsible for Leaders review the quality of governance regularly clinical and non clinical services on ........................................................ receive and act on reports a regular basis, e.g. at least of the Quality quarterly. Action is taken that is ........................................................ Improvement and Patient supported by data and objective Safety Program. measures of performance. Cost ........................................................ effectiveness is also part of this review. Leaders track clinical audit results and take actions as ........................................................ indicated. ........................................................ There is a defined process for notifying leaders when a sentinel ........................................................ event has occurred and there is evidence that they are actively involved in resolving such situations. ........................................................ 5) There is a training A training plan (which may be a program for staff that is one-page table) outlines the ........................................................ consistent with their role in quality training for different the Quality Improvement categories of staff. For instance, ........................................................ and Patient Safety leadership receives training in program. quality awareness, management ........................................................ indicators and data for decision making, general staff are provided basic quality/safety awareness ........................................................ training, and staff involved in quality committees/teams receive ........................................................ more in-depth training on quality improvement methodologies. ........................................................ 42 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 6) Leaders identify key The annual Quality Plan lists the measures (indicators) to indicators that are being measured ........................................................ monitor the organization’s for each of the required aspects of clinical structures, processes care. Minutes of the Quality ........................................................ and outcomes. These may Improvement and Patient Safety include the International Committee meetings indicate the ........................................................ Patient Safety Goals35 or prioritization process. The similar. Clinical monitoring organization carries out periodic includes: assessments of its structures, ........................................................ processes and outcomes based on a. aspects of laboratory the standards in this Plan. ........................................................ services, b. aspects of radiology ........................................................ and diagnostic imaging services, ........................................................ c. medication errors, adverse drug events ........................................................ and near misses, d. infection control, ........................................................ surveillance, and reporting, and ........................................................ e. clinical research (where applicable).36 ........................................................ 7) Managerial/ The annual Quality Plan lists the administrative monitoring indicators that are monitored for ........................................................ includes: each of the required aspects of management. (E.g. indicators for ........................................................ a. procurement of utilization management might routinely required include patient numbers, lengths of supplies and ........................................................ stay, bed occupancy etc). medications essential to meet patient needs, ........................................................ b. activities as required by law and regulation, ........................................................ c. risk management. ........................................................ 35 Information on International Patient Safety Goals available at: www.jointcommissioninternational.org/International-Patient-Safety-Goals/ 36 University Research Corp (2005) Health Manager’s Guide: Monitoring the Quality of Hospital Care. Bethesda, MD, USA. Available at: www.qaproject.org IFC Self-Assessment Guide for Health Care Organizations 43 Standard QMI.3 [Infection control] There is a designated coordination mechanism for all infection control activities that involves physicians, nurses, and others as appropriate to the size and complexity of the organization. Intent of QMI.3 Infection prevention and control activities reach into every part of a health care organization and involve individuals in multiple departments and services, e.g. in clinical departments, facility maintenance, food services, house-keeping, laboratory, pharmacy and sterilization services. There is a designated mechanism to coordinate the overall Infection Control program. That mechanism may involve a small working group, or a coordinating committee. Responsibilities include, for example, setting criteria to define health care–associated infections, establishing data collection and surveillance methods, designing strategies to address infection prevention and control risks, and reporting processes. Coordination involves communicating with all parts of the organization to ensure that the program is continuous and proactive. Whatever the mechanism chosen by the organization to coordinate the infection control program, physicians and nurses are represented and engaged in the activities with the infection control professionals. Others may be included as determined by the organization’s size and complexity of services (e.g. epidemiologist, data collection expert, statistician, central sterilization manager, microbiologist, pharmacist, housekeeping services manager, environmental or facilities services manager, operating theater supervisor). Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) There is a designated A staff member is assigned to mechanism for the oversee the infection control ........................................................ coordination of the program. This may be a full time infection control program post or an assigned role. Their job ........................................................ that is based on current description includes this scientific knowledge, responsibility. The terms of ........................................................ practice guidelines, and reference for an Infection Control laws/regulations. Committee describes the roles and responsibilities of various staff ........................................................ members in the program. ........................................................ The organization has policies and procedures to ensure that all ........................................................ aspects of the infection control program are comprehensively addressed. Process controls, physical ........................................................ infrastructure and other regulatory aspects are adequately addressed. ........................................................ 2) The organization’s Observation of the facility and leaders allocate adequate discussions with staff reveal that ........................................................ resources for the infection there are sufficient supplies, control program. equipment and human resources ........................................................ necessary to carry out the infection control program. ........................................................ 44 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 3) The infection control The infection control plan or program includes policies/procedures describe the ........................................................ systematic and proactive surveillance process. Surveillance surveillance activities to data are documented. ........................................................ determine usual (endemic) rates of infection and ........................................................ outbreaks of infectious diseases. ........................................................ 4) The organization has Hospital-associated infections are established the focus of routinely monitored, e.g. ........................................................ the infection control pneumonia (particularly ventilator program to prevent or associated), UTI, blood stream ........................................................ reduce the incidence of infections and surgical wound health care–associated infections. The data are collected ........................................................ infections, e.g: and rates of infection graphed. a. respiratory tract Comparisons are made across time and against regional or ........................................................ infections are included as appropriate to the international rates. ........................................................ organization,37 b. urinary tract infections ........................................................ (UTI) are included as appropriate to the organization,38 ........................................................ c. intravascular invasive ........................................................ devices are included as appropriate to the organization,39 ........................................................ d. surgical wounds are ........................................................ included as appropriate to the organization,40 ........................................................ e. epidemiologically ........................................................ significant diseases and organisms are included as appropriate to the ........................................................ organization and its community, and ........................................................ f. emerging or reemerging infections ........................................................ are included as appropriate to the ........................................................ organization and its community.41 37 Coffin SE, Klompas M, et. al Strategies to prevent ventilator-associated pneumonia in acute care hospitals. Infection Control and Hospital Epidemiology. vol. 29, supplement . Available at www.azdhs.gov 38 Lo E, Nicolle L, et.al Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infection Control and Hospital Epidemiology. vol. 29, supplement 1 39 Marschall J, Mermel LA, et al. (2008) Strategies to prevent central line–associated bloodstream infections in acute care hospitals. Infection Control and Hospital Epidemiology. vol. 29, supplement 1 40 Anderson DJ, Kaye KS, et al. (2008) Strategies to prevent surgical site infections in acute care hospitals. Infection Control and Hospital Epidemiology. vol. 29, supplement 1 41 Dubberke ER, Gerding DN, et al. (2008) Strategies to prevent Clostridium difficile infections in acute care hospitals. Infection Control and Hospital Epidemiology. vol. 29, supplement 1. Available at: www.wvidep.org/Portals/31/infection%20control/SHEA%20Prevent%20C%20dif%20in%20Acute%20Care%20Oct08.pdf IFC Self-Assessment Guide for Health Care Organizations 45 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 5) Equipment cleaning Policies and procedures for and sterilization methods sterilization are based on ........................................................ are appropriate for the manufacturer’s recommendations type of equipment.42 and current practice. Staff ........................................................ performing sterilization are trained (documented in their file) and ........................................................ competency verified. The effectiveness of sterilization is monitored. ........................................................ 6) Laundry and linen Laundry department policies and management are procedures include infection ........................................................ appropriate to minimize prevention practices. Staff are risk to staff and patients.43 trained (documented in their file). ........................................................ Compliance with these practices is recorded. ........................................................ 7) Disposal of infectious Policies and procedures describe waste and body fluids are the disposal of infectious waste. All ........................................................ managed to minimize staff that deal with waste are transmission risk.44 trained to carry out these ........................................................ procedures correctly (documented in their file). Observation and ........................................................ monitoring of compliance is recorded. ........................................................ 8) Sharps and needles are Observations made during safety collected in dedicated, rounds indicate that appropriate ........................................................ puncture-proof containers containers are used for sharps which are not re-used.45 disposal. These may be heavy ........................................................ plastic or thick cardboard containers. The opening does not ........................................................ allow withdrawal of items. The container is no more than 2/3 full. Containers are never emptied, but ........................................................ are sealed and put in a protected location until final disposal. ........................................................ 42 Center for Disease Control (2008), Guideline for Disinfection and Sterilization in Healthcare Facilities. Available at: www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf 43 Healthcare Laundry Accreditation Council (2006) Accreditation Standards for Processing Reusable Textiles for use in Healthcare Facilities. Frankfort, IL, USA. Available at www.hlacnet.org 44 Center for Disease Control (2003) Guidelines for Environmental Infection Control in Health-Care Facilities. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm 45 WHO Safe Injection Global Network. www.who.int/injection_safety/sign/en 46 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 9) Kitchen sanitation and Policies and procedures are written food preparation and for kitchen sanitation. Staff are ........................................................ handling are appropriate trained (document in file). to minimize infection risk. Observation monitoring shows that ........................................................ staff carry out the procedures according to policy. ........................................................ 10) The risks and impact Minutes of meetings regarding of any renovation or construction projects indicate that ........................................................ construction on air quality infection control is considered and and infection control actions planned to reduce the ........................................................ activities is assessed and potential for infection. During managed. construction, safety rounds are ........................................................ made to observe whether safety practices are adhered to. ........................................................ 11) Patients with known Isolation policies and procedures or suspected contagious are in place. Observation of ........................................................ diseases are isolated in practice indicates proper accordance with implementation of isolation ........................................................ organization policy and precautions. recommended guidelines.46 ........................................................ 12) Universal procedures, Observations show that staff use including for gloves, masks, gloves and masks etc according to ........................................................ eye protection and hand the defined policy and procedures. disinfection, are ........................................................ appropriately implemented.47, 48 ........................................................ 13) All staff are oriented Infection control procedures are to the policies, procedures, incorporated into the general ........................................................ and practices of the orientation program for staff. infection prevention and Annual training is provided for ........................................................ control program. targeted staff groups. 14) Patients and their Policies and procedures describe families are educated expectations for educating patients ........................................................ about reducing the and families regarding hygiene transmission of infectious measures. Informational materials ........................................................ diseases, e.g. are made available to them and immunizations, personal implementation of the policy is ........................................................ hygiene, hand washing, monitored. cough etiquette, as appropriate. ........................................................ 46 Coia JE, Duckworth GJ, et al. (2006) Guidelines for the control and prevention of methicillin-resistant Staphylococcus aureus (MRSA) in healthcare facilities. Journal of Hospital Infection, 63S, S1-S44. Available at: www.his.org.uk/_db/_documents/MRSA_Guidelines_PDF.pdf 47 Joint Commission (2009). Measuring Hand Hygiene Adherence: Overcoming the Challenges. Available at: www.jointcommission.org/NR/rdonlyres/68B9CB2F-789F-49DB-9E3F-2FB387666BCC/0/hh_monograph.pdf 48 WHO (2009). WHO Guidelines on Hand Hygiene in Health Care. Available at http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf IFC Self-Assessment Guide for Health Care Organizations 47 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 15) There is a There is a policy on the provision of comprehensive program staff vaccinations and ........................................................ and plan to reduce the risk immunizations and a policy on the of health care–associated evaluation, counseling, and follow- ........................................................ infections in health care up of staff exposed to infectious workers. diseases. ........................................................ Staff are able to receive urgent and non-urgent care through direct ........................................................ care or referral. Needle stick injuries are tracked, with post- ........................................................ exposure prophylaxis medications available. Hepatitis B vaccine is ........................................................ available to staff. 48 IFC Self-Assessment Guide for Health Care Organizations Standard QMI.4 [Medications use] Medications use complies with applicable laws and regulations and is efficiently organized to meet patient needs. Intent of QMI.4 Medications, as important resources in patient care, must be organized effectively and efficiently. Medication management is not only the responsibility of the pharmaceutical service but also of managers and clinicians. How this responsibility is shared depends on the organization’s structure and staffing. In those cases where a pharmacy is not present, medications may be managed on each clinical unit according to organization policy. In other cases, where a large central pharmacy is present, the pharmacy may organize and control medications throughout the organization. Applicable laws and regulations are incorporated into the operation of the medication management system. To ensure efficient and effective medication management and use, the organization conducts a systems review at least once a year. The review includes the medications selection and procurement, storage, ordering and transcribing, preparing and dispensing, administration and monitoring. The review considers evidence-based practices, monitoring activities, documentation of improvements, and safety systems. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Policies guide all A set of medication policies and phases of medication procedures address all the required ........................................................ management and elements. There is evidence that medication use in the the there is compliance with the ........................................................ organization, including: policies and procedures. A multidisciplinary team guides the a. when generic or brand ........................................................ formulation, implementation, names are acceptable review and improvement of or required, ........................................................ medication policies and procedures. b. the data necessary to accurately identify the ........................................................ patient, c. the required elements ........................................................ of the order or prescription, ........................................................ d. whether or when indications for use are ........................................................ required on a PRN (pro re nata, or “as ........................................................ needed”) or other medication order, ........................................................ e. special precautions or procedures for ........................................................ ordering drugs with look-alike or sound- ........................................................ alike names, f. actions to be taken ........................................................ when medication orders are incomplete, ........................................................ illegible, or unclear, IFC Self-Assessment Guide for Health Care Organizations 49 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? g. the use of verbal and telephone medication ........................................................ orders and the process to verify such orders, ........................................................ h. the types of orders that are weight based, ........................................................ such as for children, i. the types of orders ........................................................ that require additional information, such as ........................................................ vital signs or lab results, ........................................................ j. destruction of medications known to ........................................................ be expired or outdated, and ........................................................ k. special precautions and double verification ........................................................ while handling high risk medications - the ........................................................ list of which should include insulin, chemotherapy drugs, ........................................................ radioactive drugs, concentrated ........................................................ electrolytes, anti- coagulants, and ........................................................ sedatives.49 2) The pharmacy or A copy of applicable laws and pharmaceutical service and regulations are available in the ........................................................ medication use comply pharmacy. The pharmacists and with applicable laws and assistants are aware of the laws ........................................................ regulations. and regulations. These requirements are included in the ........................................................ policies and procedures. 3) An appropriately Personnel records indicate that a licensed, certified, and licensed pharmacist supervises the ........................................................ trained individual pharmacy. supervises all activities. ........................................................ Best Practice Committee of the Health Care Association of New Jersey, Medication Management Guideline. Hamilton, New Jersey, USA. Available at 49 www.hcanj.org/bestpractices.htm and at the National Guideline Clearinghouse: www.guideline.gov 50 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 4) A list of medications A formulary or other document lists for prescribing and the medications available. ........................................................ ordering is available and is appropriate to the ........................................................ organization’s mission, patient needs, and services ........................................................ provided. 5) There is a process A policy/procedure describes the established for when process to be followed when ........................................................ medications are not medications are not available, e.g. available that includes a notification of physician, ........................................................ notification to prescribers identifying alternatives. and suggested ........................................................ substitutions. 6) Medications are A policy describes how medications protected from loss or are managed to prevent loss or ........................................................ theft throughout the theft. organization. ........................................................ 7) Medications are stored Observations made in areas where under conditions suitable medications are kept show that ........................................................ for product stability. medications are stored properly. The temperatures of refrigerators ........................................................ are monitored daily; range limits are listed, and staff know what to ........................................................ do when the temperature is out of range. The “first in/first out” rule is applied to avoid wastage due to ........................................................ expiration. 8) Controlled substances A log/record is kept for managing are accurately accounted controlled substances. ........................................................ for according to applicable law and regulation. ........................................................ 9) Emergency During rounds, the emergency medications are available carts/boxes are found to be locked ........................................................ in the units where they will and the stocking sheets accurately be needed or readily completed. ........................................................ accessible within the organization to meet Adequate stocks of life critical medications are consistently ........................................................ emergency needs. maintained. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 51 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 10) Only those permitted A policy and procedure outline by the organization and by who by law, etc. are permitted to ........................................................ relevant licensure, laws prescribe/order medications. and regulations prescribe ........................................................ or order medications. ........................................................ 11) Medications Each patient has a medication prescribed or ordered are record and each dose of medication ........................................................ recorded for each patient is recorded. and dose. ........................................................ 12) Medications are During safety rounds, areas for prepared and dispensed in preparing and dispensing ........................................................ clean and safe areas; the medications are observed to be process adheres to law, clean and separate from potential ........................................................ regulation and professional contaminants. standards of practice. ........................................................ 13) Staff preparing Documentation in personnel files sterile products are trained shows that staff preparing sterile ........................................................ in aseptic techniques. products have been trained in aseptic techniques. Observation of ........................................................ practice confirms compliance. 14) There is a Observation and interviews with standardized medication staff indicate that the same process ........................................................ dispensing and distribution is used throughout the organization system in the organization for dispensing and distributing ........................................................ medications. A recall process is outlined, e.g. when medications are ........................................................ pulled from the market. 15) Medications are During rounds, medications are appropriately labeled after noted to be properly labeled. ........................................................ preparation. 16) Medication effects on Documentation on medical records patients are monitored, indicates the response to ........................................................ including adverse effects. medications. E.g. if pain medication is given, the patient’s pain relief is ........................................................ noted; if antibiotics are given, documentation indicates whether ........................................................ the infection resolves. 52 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 17) Adverse effects are A policy/procedure describes reported in the time frame reporting of adverse effects of ........................................................ required by policy. medications. Adverse effects are monitored, e.g. by completing an ........................................................ incident report. 18) Medication errors A policy/procedure defines and near misses are medication errors and near misses. ........................................................ reported in a timely A process for reporting and manner using an measuring error rates is ........................................................ established process. implemented. 19) The organization Data show that medication errors uses reported information are being reported, and actions ........................................................ on medication errors and taken to reduce risks. near misses to improve ........................................................ medication use processes. 20) An antibiotic policy is Policies and protocols are developed and developed to guide appropriate ........................................................ implemented by clinical use of antibiotics, e.g. antibiotic teams in collaboration with surgical prophylaxis. Adherence to ........................................................ microbiology staff. the policies are monitored. IFC Self-Assessment Guide for Health Care Organizations 53 Standard QMI.5 [Sentinel events] The organization uses a defined process for identifying and managing sentinel events. Intent of QMI.5 The organization’s definition of a sentinel event includes events as may be required by law or regulation, and those viewed by the organization as appropriate. All events that meet the definition are assessed by performing a credible root cause analysis50. When the root cause analysis reveals that systems improvements or other actions can prevent or reduce the risk of such sentinel events recurring, the organization redesigns the processes and takes whatever other actions are appropriate to do so. It is important to note that the term “sentinel event” does not always refer to an error or mistake, or suggest any particular legal liability. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization has A policy/procedure defines established a definition of “sentinel event” and includes the ........................................................ a sentinel event that required elements. Documents includes at least: show that a root cause analysis was ........................................................ done and actions taken to respond a. unanticipated death to a sentinel event. (As these events unrelated to the ........................................................ do happen in hospitals all over the natural course of the world, it would be unlikely that a patient’s illness or ........................................................ hospital did not have a record/ underlying condition; history of sentinel events.) b. major permanent loss ........................................................ of function unrelated to the natural course ........................................................ of the patient’s illness or underlying condition; and ........................................................ c. wrong-site, wrong- ........................................................ procedure, wrong- patient surgery. ........................................................ 2) The organization has A policy/procedure describes a a process by which it process for identifying high risk ........................................................ identifies high-risk areas areas/processes, e.g. pro-active risk in terms of patient and assessment. Plans, minutes of ........................................................ staff safety. meetings and reports demonstrate that the organization has identified ........................................................ potential risks and taken proactive actions to reduce them. ........................................................ 3) The organization’s Minutes, reports or other leaders undertake a formal documents show that the ........................................................ assessment of patient and organization has conducted a staff safety risks at least formal assessment of risks and the ........................................................ once per year. management of risks on an annual basis. ........................................................ 50 UK National Patient Safety Agency. A Guide to Root Cause Analysis. Available at: www.msnpsa.nhs.uk/rcatoolkit/course/iindex.htm 54 IFC Self-Assessment Guide for Health Care Organizations Patient Safety (PS) Standard PS.1 [Patient identification] The organization has established procedures for accurately identifying patients. Intent of PS.1 Wrong-patient errors occur in virtually all aspects of diagnosis and treatment. Patients may be sedated, disoriented, or not fully alert; may change beds, rooms, or locations within the hospital; may have sensory disabilities; or may be subject to other situations that may lead to errors in correct identification. The intent of this goal is twofold: first, to reliably identify the individual as the person for whom the service or treatment is intended; second, to match the service or treatment to that individual. Policies and/or procedures are collaboratively developed to improve identification processes. In particular, these include the processes used to identify a patient: prior to surgery; when giving medications; blood, or blood products; taking blood and other specimens for clinical testing; or providing any other treatments or procedures. The policies and/or procedures require at least two ways to identify a patient, such as the patient’s name, identification number, birth date, or other ways. The patient’s room number or location cannot be used for identification. The policies and/or procedures clarify the use of two different identifiers in different locations within the organization, such as outpatient services, the emergency department, or operating theater. Procedures for identifying comatose patients who are not in possession of identification documents are also included. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) A collaborative process Physicians, nurses and other health is used to develop policies care workers work together to ........................................................ and/or procedures that write and implement policies and address the accuracy of procedures to accurately identify ........................................................ patient identification. patients. Review minutes of meetings and talk with staff ........................................................ members regarding their involvement. ........................................................ 2) The policies and/or Review the policy and procedure. procedures require the use ........................................................ of two patient identifiers, not including the use of ........................................................ the patient’s room number or location. (Identifiers for ........................................................ neonates may be different from those defined for adult patients). ........................................................ 3) Patients are identified Ask unit staff members how they before administering identify patients prior to ........................................................ medications, blood, or administering medications and blood products; blood. Determine if their response ........................................................ is consistent with the policy and procedure. Observe practice. ........................................................ 4) Patients are identified As above before taking blood and ........................................................ other specimens for clinical testing. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 55 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 5) Patients are identified As above. before providing ........................................................ treatments and performing procedures. ........................................................ 56 IFC Self-Assessment Guide for Health Care Organizations Standard PS.2 [Effective communication] The organization develops an approach to improve the effectiveness of communication among caregivers. Intent of PS.2 Effective communication, which is timely, accurate, complete, clear, and understood by the recipient, reduces errors, and results in improved patient safety. Communication can be electronic, written, or verbal. The most error-prone communications are patient care orders given verbally, including those given over the telephone. (For example, an error-prone communication is the verbal report back of critical test results, such as a clinical laboratory telephoning a patient care unit to report the results of a STAT test). The organization collaboratively develops a policy and/or procedure for verbal and telephone orders that includes: • the writing down, or entering into a computer, of the complete order (or test result by the receiver of the information), • the receiver reading back the order (or test result), and • the confirmation that what has been written down and read back is accurate. (This practice is sometimes referred to as “Listen, Write and Read”). The policy and/or procedure identify permissible alternatives when the read-back process may not be possible, such as in the operating theater and in emergency situations. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) A collaborative process Physicians, nurses and other health is used to develop policies care workers work together to ........................................................ and/or procedures that write and implement policies and improve the accuracy of procedures regarding verbal and ........................................................ verbal and telephone telephone communications. Review communications. minutes of meetings and talk with ........................................................ staff members regarding their involvement. ........................................................ 2) Verbal and telephone Review the policy and procedure. orders or test results are Review medical records to ........................................................ written down by the determine whether the relevant receiver of the order or documentation is complete. ........................................................ test result. 3) Verbal/telephone Ask staff members about their orders or test results are practice when receiving a ........................................................ read back by the receiver telephone order or test result. of the order or test result. ........................................................ 4) The order or test result Ask physicians, lab and radiology is confirmed by the staff regarding their process of ........................................................ individual who gave the confirming orders and tests that order or test result. they relay by phone. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 57 Standard PS.3 [High alert medications] The organization develops an approach to improve the safety of high-alert medications. Intent of PS.3 When medications are part of a patient treatment plan, appropriate management is critical to ensuring patient safety. A frequently cited medication safety issue is the unintentional administration of concentrated electrolytes (e.g. potassium chloride [2mEq/ml or more concentrated], potassium phosphate, sodium chloride [0.9% or more concentrated], and magnesium sulfate [50% or more concentrated]). This error can occur when a staff member has not been properly oriented to the patient care unit, when contract nurses are used and not properly oriented, or during emergencies. The most effective means to reduce or eliminate this occurrence is to remove the concentrated electrolytes from the patient care unit to the pharmacy. The organization collaboratively develops a policy and/or procedure that prevents the location of concentrated electrolytes in patient care areas where misadministration can occur. The policy and/or procedure specifies any areas where concentrated electrolytes are clinically necessary (such as the emergency department or operating theater); how they are clearly labeled; and how they are stored in those areas in a manner that restricts access to prevent inadvertent administration. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) A collaborative process Physicians, nurses and other health is used to develop policies care workers work together to ........................................................ and/or procedures that write and implement policies and address the location, procedures to deal with ........................................................ labeling, and storage of concentrated electrolytes. Review concentrated electrolytes. minutes of meetings and talk with ........................................................ staff members regarding their involvement. ........................................................ 2) Concentrated Make observations during safety electrolytes are not present rounds to ensure that concentrated ........................................................ in patient care units unless electrolytes are not kept on the clinically necessary. Actions units, except where policy permits. ........................................................ are taken to prevent In these permitted areas (e.g. inadvertent administration emergency department, ICU) check ........................................................ in those areas where that they are properly stored and permitted by policy. labeled. ........................................................ 58 IFC Self-Assessment Guide for Health Care Organizations Standard PS.4 [Correct site, procedure, and patient for surgery] The organization develops an approach to ensuring correct-site, correct-procedure, and correct-patient surgery. Intent of PS.4 Wrong-site, wrong-procedure, wrong-patient surgery is a disturbingly common occurrence in health care organizations. These errors are the result of ineffective or inadequate communication between members of the surgical team, lack of patient involvement in site marking, and lack of procedures for verifying the operative site. Frequent contributing factors include inadequate patient assessment, a culture that does not support open communication among surgical team members, problems related to illegible handwriting, and the use of abbreviations. Organizations need to collaboratively develop a policy and/or procedure that is effective in eliminating these problems. Evidence-based practices include those described in the WHO Safe Surgery Checklist51 and the Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery™52. The essential processes found in these protocols are: • marking the surgical site; • a preoperative verification process; and • a time-out that is held immediately before the start of a procedure. Marking the surgical site involves the patient and is done with an unambiguous mark. The mark: • should be consistent throughout the organization; • should be made by the person performing the procedure (i.e. the surgeon); • should take place with the patient awake and aware, if possible; and • must be visible after the patient is prepped and draped. The surgical site is marked in all cases involving laterality, multiple structures (fingers, toes, lesions), or multiple levels (spine). The purpose of the preoperative verification process is to: • verify the correct site, procedure, and patient; • ensure that all relevant documents, images, and studies are available, properly labeled, and displayed; and • verify that any required special equipment and/or implants are present. The time-out permits any unanswered questions or confusion to be resolved. The time-out is conducted in the location the procedure will be done, just before starting the procedure, and involves the entire operative team. The organization determines how the process is to be briefly documented, such as in a checklist. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) A collaborative A multi-disciplinary team consisting approach is used to of surgeons, anesthesiologists, ........................................................ develop policies and/or surgical nurses and technicians, and procedures to ensure the surgical ward staff work together ........................................................ correct site, correct to develop an effective process to procedure, and correct ensure the correct site, procedure ........................................................ patient, including and patient. procedures done in settings other than the ........................................................ operating theater. ........................................................ 51 Available at www.who.int/patientsafety/safesurgery 52 Available at: www.jointcommission.org/PatientSafety/UniversalProtocol IFC Self-Assessment Guide for Health Care Organizations 59 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 2) The organization uses Ask surgery staff members a clearly understood mark regarding the process that they use ........................................................ for surgical site for marking the site. Make identification and involves observations during safety rounds. ........................................................ the patient in the marking process. ........................................................ 3) The organization uses Review completeness of the a process to verify that all checklist used by surgical staff to ........................................................ documents and equipment ensure all documents, equipment needed are on hand, etc are in order. Ask surgical staff ........................................................ correct, and functional. members regarding the process that they use to ensure all elements ........................................................ are confirmed. 4) The organization uses As above a checklist and time-out ........................................................ procedure just before starting a surgical ........................................................ procedure. 60 IFC Self-Assessment Guide for Health Care Organizations Standard PS.5 [Health care associated infections] The organization develops an approach to reduce the risk of health care associated infections. Intent of PS.5 Infection prevention and control are challenging in most health care settings, and rising rates of health care associated infections are a major concern for patients and health care professionals. Infections common to all health care settings include catheter-associated urinary tract infections, blood stream infections and pneumonia (often associated with mechanical ventilation). Central to the elimination of these and other infections is proper hand hygiene. Internationally acceptable hand hygiene guidelines are available from the World Health Organization (WHO) and the United States Centers for Disease Control and Prevention (US CDC) – see resources referenced in earlier footnotes 44 to 48. The organization has a collaborative process to develop policies and/or procedures that adapt or adopt currently published and generally accepted hand hygiene guidelines, and for the implementation of those guidelines within the organization. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization has Review the policy and procedures adopted or adapted adopted. References used (e.g. ........................................................ currently published and WHO, US CDC, JCI) should be cited generally accepted hand on the procedure and dated. ........................................................ hygiene guidelines. 2) The organization Make routine observations of hand implements an effective hygiene practices. Clinical units ........................................................ hand hygiene program. should collect data for all levels of staff and report findings to the ........................................................ Infection Control/Prevention Committee. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 61 Standard PS.6 [Falls prevention] The organization develops an approach to reduce the risk of patient harm resulting from falls. Intent of PS.6 Falls account for a significant portion of injuries in hospitalized patients. The organization should evaluate patients’ risk of falls and take action to reduce this risk and to reduce the risk of injury should a fall occur. The evaluation could include fall history, medications and alcohol consumption review, gait and balance screening, and walking aids used by the patient. The organization establishes and implements a fall-risk reduction/prevention program. This is based on appropriate policies and/or procedures, and on physical modifications to the facilities (e.g. fitting of hand-rails, non-slip floor covering etc). Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) A collaborative process Physicians, nurses and other health is used to develop policies care workers work together to ........................................................ and/or procedures aimed write and implement policies and at reducing the risk of procedures to reduce the risk of ........................................................ patient harm resulting falls. Review minutes of meetings from falls in the and talk with staff members ........................................................ organization. regarding their involvement. 2) The organization Review policies and procedures, implements a process for e.g. fall risk assessment and ........................................................ the initial assessment of protocol. Ask staff members patients for risk of falls. regarding how they assess patients ........................................................ This includes reassessment for risk of falls. Review medical of patients when indicated records to determine if a fall ........................................................ by a change in condition, assessment has been completed, medications, etc. and re-assessments done as indicated. ........................................................ 3) Measures are Observe the use of fall-prevention implemented to reduce fall measures during safety rounds. Ask ........................................................ risk for those assessed to staff regarding their knowledge of be at risk. the fall risk protocol. ........................................................ Observe physical measures taken, e.g. handrails, non-slip floor ........................................................ surfaces etc. ........................................................ 62 IFC Self-Assessment Guide for Health Care Organizations Facility Safety and Emergency Management (FSE) Standard FSE.1 [Safety and security] The organization plans and implements a program to provide a safe and secure physical environment. Intent of FSE.1 The organization provides a safe and secure facility. Prevention and planning are essential to creating a safe and supportive patient care facility. To plan effectively, the organization must be aware of all of the risks present in the facility. This includes safety as well as security risks. The objectives are to: 1. prevent accidents and injuries; 2. maintain a safe and secure environment for patients, families, staff and visitors; and 3. reduce and control potential hazards and risks. (These are particularly important during periods of construction or renovation). In addition, to ensure security, all staff, visitors, vendors and others in the organization are identified and issued temporary or permanent badges or other identification. Areas intended to be secure (such as the newborn nursery) are secure and monitored. Periodic inspections of the facility check for potential hazards, e.g. sharp and broken furniture that could injure, locations where there is no escape from fire, or secure areas where there is inadequate monitoring/control. These periodic inspections are documented and help the organization to plan and carry out improvements and to plan for longer-term facility upgrading or replacement. By understanding the risks present in the organization’s physical facility, the management can develop a proactive plan to reduce these risks for patients, families, staff, and visitors. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization As a minimum, all staff are wearing ensures that all staff, ID badges. A process is in place to ........................................................ visitors and vendors are screen visitors and vendors. identified and all security ........................................................ risk areas are monitored Check designated secure areas (e.g. and kept secure. nursery) for additional adequate security measures. ........................................................ 2) The organization has a An in-depth inspection of the documented, current and facility has been undertaken within ........................................................ accurate inspection report the past year. The inspection was of its physical facilities. carried out by a reputable ........................................................ individual/group, e.g. engineer. 3) The organization A plan has been developed and implements a plan to actions implemented to address the ........................................................ reduce evident risks based findings of the facility inspection. on the inspection. ........................................................ 4) The organization plans The organization’s budget includes and budgets for upgrading provision for necessary physical ........................................................ or replacing physical upgrading. infrastructure needed for ........................................................ the continued operation of a safe and effective facility ........................................................ and to meet legal and regulatory requirements. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 63 Standard FSE.2 [Hazardous materials plan] The organization has a plan for the inventory, handling, storage, and use of hazardous materials and the control and disposal of hazardous materials and waste. Intent of FSE.2 The organization identifies and safely controls hazardous materials and waste according to a Hazardous Materials Management Plan (or similar). Such materials and waste include chemicals, chemotherapeutic agents, radioactive substances, hazardous gases and vapors, and other regulated medical and infectious waste. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization The list of hazardous materials and identifies hazardous waste is current and ........................................................ materials and waste and comprehensive, and includes all has a current list of all such departments. ........................................................ materials within its facilities. ........................................................ 2) A Hazardous Materials A Hazardous Materials Management Plan provides Management Plan (or similar) ........................................................ for: describes the processes for all of the required elements. ........................................................ a. the inventory of hazardous materials and waste, ........................................................ b. the proper labeling of hazardous materials ........................................................ and waste, c. safe handling, storage, ........................................................ and use of hazardous materials, ........................................................ d. procedures for coping with spills, exposures ........................................................ and other incidents, ........................................................ e. procedures for reporting and investigating of spills, ........................................................ exposures, and other incidents, ........................................................ f. procedures for proper disposal of hazardous ........................................................ waste, g. proper use of ........................................................ protective equipment, and ........................................................ h. documentation, including any permits, ........................................................ licenses, or other regulatory ........................................................ requirements. ........................................................ 64 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 3) Hazardous materials Interviews with staff indicate that and waste are managed they understand the Hazardous ........................................................ according to the Hazardous Materials Management Plan. Waste Management Plan. Posters and signs remind staff of ........................................................ key procedures. During safety rounds, handling and disposal of ........................................................ hazardous materials and waste is observed to be carried out according to policy. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 65 Standard FSE.3 [Emergency management plan] The organization develops and maintains an Emergency Management Plan (or similar) and program to respond to likely community emergencies, epidemics, and natural or other disasters. Intent of FSE.3 Emergencies, epidemics, and disasters may directly affect the organization. These might range, for example, from earthquake damage to patient care areas, to a flu outbreak that prevents staff from coming to work. To respond effectively, the organization develops an Emergency Management Plan and a program to manage such emergencies. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization has A document lists all the major identified the major internal and external disasters and ........................................................ internal and external epidemics that could pose a risk to disasters and major the organization. ........................................................ epidemic events which pose significant risks of ........................................................ occurring. 2) The organization plans A disaster plan addresses actions to its response to likely take for all the identified risks ........................................................ disasters. The plan sets out processes for ........................................................ a. determining the type, likelihood and ........................................................ consequences of hazards, threats, and ........................................................ events, b. determining the ........................................................ organization’s role in such events, ........................................................ c. communicating strategies for events, ........................................................ d. the managing of resources during ........................................................ events, including alternative sources, ........................................................ e. the managing of clinical activities during ........................................................ an event, including alternative care sites, ........................................................ and f. the identification and ........................................................ assignment of staff roles and ........................................................ responsibilities during an event. ........................................................ 66 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 3) The Emergency Staff training in the Emergency Management Plan is tested Management Plan is documented. ........................................................ annually. Staff members The annual test of the Plan is participate in at least one documented with an analysis of the ........................................................ emergency-preparedness findings and a corrective action test per year. plan. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 67 Standard FSE.4 [Fire/smoke safety plans] The organization plans and implements a program to ensure that all occupants are safe from fire, smoke, or other potential emergencies in the facility. Intent of FSE.4 Fire is an ever-present risk in a health care facility. Thus, every organization needs to plan how it will keep its occupants safe in case of fire or smoke. The organization adopts preventive measures including: • safe storage and handling of potentially flammable materials (e.g. flammable medical gasses such as oxygen); • use of early warning/early detection systems such as fire patrols, smoke detectors and fire alarms; • provision of suppression mechanisms such as water hoses, chemical suppressants, and sprinkler systems; • managing hazards related to any construction in or adjacent to the patient-occupied buildings; and • ensuring safe and unobstructed means of exit for patients, staff and visitors in the event of a fire. Such plans and safeguards are required no matter what the age, size, or construction of the facility. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) The organization has a A Fire Safety Plan contains all the program to ensure that all required elements. ........................................................ occupants of the facility are safe from fire and There is evidence that the Plan is ........................................................ smoke (or other non-fire continually updated, e.g. based on emergencies). A Fire Safety regulatory changes, facilities development and corrective actions ........................................................ Plan specifies identified during regular testing of a. the frequency of ........................................................ the Plan. inspecting, testing, and maintaining fire ........................................................ protection and safety systems, ........................................................ b. the procedures for safely evacuating the facility in the event of ........................................................ a fire or smoke, ........................................................ c. the process for testing (exercising all or a portion of the plan), at ........................................................ least twice per year, ........................................................ d. the necessary training of staff to effectively protect and remove ........................................................ patients when an emergency occurs, and ........................................................ e. the participation of staff members in at ........................................................ least one fire safety test per year. ........................................................ 68 IFC Self-Assessment Guide for Health Care Organizations Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 2) The program includes Minutes of the construction project the assessment of fire risks team meetings and action plans ........................................................ during construction within describe how risks will be or adjacent to the facility. minimized during construction. ........................................................ 3) Fire detection and A maintenance record indicates the abatement systems are inspection dates, test results and ........................................................ inspected, tested, and maintenance of fire systems. maintained at a frequency ........................................................ determined by the organization. ........................................................ 4) Staff are trained to Staff training attendance records participate in the Fire show the number of staff who ........................................................ Safety Plan. participated. The percentage of staff attending is tracked. ........................................................ 5) A fire and smoke A report of the evacuation drill safety evacuation plan is includes an analysis of the exercise ........................................................ tested at least twice a year. and the corrective actions taken. 6) Staff participate in at Attendance records of staff least one fire and smoke participation are kept. ........................................................ safety test per year. 7) The organization A smoking policy is written. No- develops and implements a smoking signs are clearly displayed. ........................................................ policy and plan to limit Observation of smoking behavior smoking. These: within the organization shows that ........................................................ the policy is followed. a. apply to all patients, families, staff and ........................................................ visitors; and b. eliminate smoking in ........................................................ the organization’s facilities or minimally ........................................................ limits smoking to designated non– ........................................................ patient care areas that are ventilated to the outside. ........................................................ IFC Self-Assessment Guide for Health Care Organizations 69 Standard FSE.5 [Medical equipment maintenance] The organization plans and implements a program for inspecting, testing, and maintaining medical equipment and documenting the results. Intent of FSE.5 In order to ensure that medical equipment is available for use and functioning properly, the organization • maintains an inventory of medical equipment; • regularly inspects medical equipment; • tests medical equipment as appropriate to its use and requirements; and • undertakes preventive maintenance. Qualified individuals provide these services. Equipment is inspected and tested when new and then on an ongoing basis, as appropriate to the equipment’s age and use, or based on manufacturers’ instructions. Inspections, test results, and any maintenance undertaken are documented. This helps ensure continuity of the maintenance process and supports capital planning for equipment replacements, upgrades, and other changes. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) There is a program to An inventory with each item of register, test and maintain equipment individually numbered/ ........................................................ all medical equipment. identified is available. The inventory is updated when new ........................................................ equipment is added or when equipment is disposed of. New ........................................................ equipment is tested and logged into the inventory system. An inspection process is recorded. A ........................................................ label/tag with the inspection date is on each piece of equipment. ........................................................ Equipment is maintained according to manufacturers’ ........................................................ recommendations. 2) Qualified individuals A trained biomedical engineer manage the medical maintains the equipment. ........................................................ equipment program. 3) Data are collected and A report or register includes analyzed for the medical information regarding the state of ........................................................ equipment management the equipment, with program. recommendations. ........................................................ 70 IFC Self-Assessment Guide for Health Care Organizations Standard FSE.6 [Utilities management] Potable water, electrical power, and medical gases are available 24 hours a day, seven days a week, through regular or alternate sources, to meet essential patient care needs. Intent of FSE.6 Patient care, both routine and urgent, is provided on a 24-hour basis, every day of the week in most health care organizations. Thus, an uninterrupted source of clean water and electrical power is essential to meet patient care needs. The organization continually endeavors to ensure uninterrupted supply of potable water and of electrical power. Regular and alternate sources may be used to achieve this. Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 1) Water quality is A log is kept of checks of water monitored regularly. quality. Actions are taken if a ........................................................ problem is identified. 2) Potable water, If availability is a problem, a log is electrical power and kept regarding how often ........................................................ medical gases are available problems occur. 24 hours a day, seven days ........................................................ a week. 3) The organization has If availability of water or power is a identified the areas and problem, the organization has ........................................................ services at greatest risk documentation that describes the when power fails or water areas and services that are at ........................................................ is contaminated or greatest risk, e.g. patients on interrupted. ventilators or dialysis. ........................................................ 4) The organization plans Based on the risks identified, the alternate sources of power organization has a plan outlining ........................................................ and water in emergencies. what to do when these situations arise. ........................................................ An alternative power supply is maintained and tested on a regular ........................................................ basis. A maintenance log is kept. ........................................................ 5) Key systems such as Diagrams of the utility, medical gas utility, medical gas, and and ventilation systems are ........................................................ ventilation are identified, available. Emergency services such inspected, tested and as Civil Defense have copies of ........................................................ maintained by the these diagrams in case of a fire or organization. other emergency. A maintenance ........................................................ record is kept for all systems. IFC Self-Assessment Guide for Health Care Organizations 71 Measurable Element Look for Score Observations How is this element What is required? 0 5 10 Why did you give this score? assessed? 6) Data are collected and Key indicators for effective analyzed for the for the functioning of the utility systems ........................................................ purposes of planning and are kept. Reports or minutes show improvement, e.g. under a that the monitoring data are ........................................................ medical utility reviewed and used for improving management program. the utility systems ........................................................ IFC information resources - Environmental, fire and life safety More detailed resources are available online at: IFC Environmental, Health and Safety Guidelines for Health Care Organizations www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_HealthCareFacilities/$FILE/Final+- +Health+Care+Facilities.pdf IFC Performance Standards on Social and Environmental Sustainability www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/pol_PerformanceStandards2006_full/$FILE/IFC+Performance+Standards.pdf IFC Environmental, Health and Safety General Guidelines (section on Life and Fire Safety in section 3.3, p79-81) www.ifc.org/ifcext/sustainability.nsf/AttachmentsByTitle/gui_EHSGuidelines2007_GeneralEHS/$FILE/Final+-+General+EHS+Guidelines.pdf 72 IFC Self-Assessment Guide for Health Care Organizations IFC Self-Assessment Guide for Health Care Organizations 73 74 IFC Self-Assessment Guide for Health Care Organizations After the self-assessment Next Steps IFC Self-Assessment Guide for Health Care Organizations 75 After the Self-Assessment Next Steps STEP 4: Score Performance and Identify Gaps After completing the assessment, the team should calculate the scores and review the findings. The aim of this exercise is to identify the gaps toward meeting the standards in order to make improvements and take corrective actions. The process for doing this is described below. The responses for each standard are summed to determine the level of achievement, as follows: 1. Enter the scores for each question/element in the Self-Assessment Template on the following pages. The Scoring Key is: 0 = the organization does not meet the criterion 5 = yes, some elements are in place, but the criterion is not fully satisfied 10 = yes, the criterion is fully satisfied 2. Add the 0, 5 and 10 scores for all of the measurable elements. 3. Determine overall achievement by adding together the scores for all the standards and dividing by 1,600* (the total score possible). * Note - The Highest Possible Score will be less if there are standards that are not applicable (e.g. IVF, organ transplantation). Subtract 10 from the Highest Possible Score for each element that is not applicable. The reason that the following score-tables have a “Baseline Score” column along with additional Score columns is to allow progress to be tracked over time, i.e. as future assessments are undertaken. 76 IFC Self-Assessment Guide for Health Care Organizations   Baseline Score Score Score Clinical Governance and Leadership  CGL.1 Governance documents, e.g. bylaws, policies/       procedures 1 Structure described       2 Strategic and operational plans       3 Budget       4 License to operate       CGL.2 Senior manager responsible for operations       1 Manages day-to-day operations       2 Assures compliance with policies       3 Assures compliance with laws and regulations       4 Responds to reports of inspecting and       regulatory agencies 5 Plans services with community and other       providers CGL.3 Oversight of contracts       1 Quality oversight of contracts       2 Contract services meet patient needs       CGL.4 Departmental scope of services and policies and       procedures 1 Scope of service; policy and procedures       2 Coordination and integration of services       3 Criteria for professional staff qualifications       4 Process for clinical privileging       CGL.5 Department directors recommend space,       equipment, etc 1 Department directors recommend space,       equipment, etc 2 Processes to respond to resource shortages       CGL.6 Programs for recruitment, retention and staff       development 1 Program for recruitment and retention       2 Staff orientation program        3 Staff personal development and continuing       education plan 4 Employee health and safety program       Total Highest Possible = 210   Percent achievement % % % IFC Self-Assessment Guide for Health Care Organizations 77   Baseline Score Score Score Ethics and Patient Rights EPR.1 Credential verification of professional staff       1 Licensure, education and training verified       2 Separate records for professional staff       3 Records reviewed at least every 3 years       EPR.2 Processes to support patient and family rights       1 Policies and procedures that support patient       rights 2 Vulnerable groups are protected against abuse       3 Health information is confidential       4 Patients/families informed of their rights       5 Patients can voice complaints       EPR.3 Informed consent       1 Informed consent policy/procedure       2 Staff trained to obtain informed consent       3 Informed consent given for high-risk procedures/ treatments 4 Process when others can grant informed consent EPR.4 Framework for ethical management       1 Ethical and legal norms established       2 Disclosure of organizational ownership       3 Honest portrayal of service offered       4 Accurate billing of services       5 Discloses and resolves financial conflicts of interest 6 Staff are supported in dealing with ethical issues 7 Safe reporting of ethical and legal concerns EPR.5 Organ and tissue donation and transplantation       1 Patient/family supported in making decisions to       donate 2 Organ and tissue donation policies and       procedures 3 Staff are trained in policies and procedures 4 Valid informed consent from live donors 5 Organization cooperates with community organizations 78 IFC Self-Assessment Guide for Health Care Organizations EPR.6 Reproductive health policies and procedures       (IVF) 1 IVF services are integrated into MCH services       2 Policies and procedures for services support       women's rights 3 Staff are trained in examination, diagnosis,       referral and transfer 4 Procedures and equipment are standardized       5 Patients are provided with full information 6 Donors are provided with full information 7 IVF registry maintained 8 Register linked with national health registries EPR.7 Termination of pregnancy services 1 Services are integrated into MCH services 2 Policies and procedures for services support women's rights 3 Staff trained in screening, exam, diagnosis, referral and transfer 4 Procedures and equipment are standardized 5 Patients provided with full information EPR.8 Clinical research trials 1 Benefits and ethical issues fully considered prior to proceeding. 2 Research committee oversight 3 Appropriate pts identified and informed how to gain access 4 Research policies and procedures 5 Informed consent obtained 6 Patients informed about refusal to participate Total Highest Possible = 430   Percent achievement % % % IFC Self-Assessment Guide for Health Care Organizations 79   Baseline Score Score Score Quality Measurement and Improvement QMI.1 Clinical practice guidelines and pathways       1 Clinicians use clinical practice guidelines and       pathways 2 Process for implementing guidelines and       pathways 3 One guideline or pathway developed each year       QMI.2 Leadership involvement and support       1 Systematic approach to quality improvement       2 Multidisciplinary Quality Committee       3 Leaders set priorities for improvement activities       4 Leaders receive and act on quality reports       5 Quality improvement training program       6 Clinical indicators 7 Management indicators 8 Data aggregated, analyzed, and transformed into information 9 Improvements achieved and sustained QMI.3 Infection prevention and control       1 Coordinated infection control program       2 Adequate resources allocated       3 Systematic and proactive surveillance 4 Processes implemented to prevent or reduce infections 5 Equipment cleaning and sterilization 6 Laundry and linen management 7 Disposal of infectious waste 8 Sharps and needle disposal 9 Kitchen sanitation and food preparation 10 Risks and impact of construction is managed 11 Isolation procedures 12 Universal procedures 13 Staff oriented to infection control policies and procedures 14 Patients and families educated about reducing transmission 15 Reduce risk of hospital-associated infections in       staff 80 IFC Self-Assessment Guide for Health Care Organizations QMI.4 Medications use       1 Medication policies and procedures       2 Pharmacy services and medication use comply       with laws 3 Licensed, trained pharmacy supervisor       4 List of medications 5 Process to inform prescribers of unavailability of meds 6 Medications protected from loss or theft 7 Medications properly stored 8 Controlled substances accounted for 9 Emergency medications available 10 Medications prescribed by licensed individuals 11 Medications reviewed and verified for appropriateness 12 Meds prepared and dispensed in clean, safe areas 13 Staff trained in aseptic technique 14 Uniform medication dispensing and distribution system 15 Medications appropriately labeled after preparation 16 Medication effects are monitored 17 Adverse effects are reported 18 Medication errors and near misses are reported 19 Medical error reporting is used to improve processes 20 Antibiotic policy QMI.5 Sentinel events       1 Definition of sentinel event       2 High risk areas are identified       3 Patient and safety risks formally assessed annually Total Highest Possible = 500   Percent achievement % % % IFC Self-Assessment Guide for Health Care Organizations 81   Baseline Score Score Score Patient Safety PS.1 Patient identification       1 Collaborative process for development of       policies/procedures 2 Use of two patient identifiers       3 Patient identified before giving medications, blood, etc. 4 Patient identified before taking blood or specimens 5 Patient identified before giving treatments or       procedures PS.2 Safe communication       1 Collaborative process for development of       policies/procedures 2 Complete verbal or telephone order written       down 3 Read back of verbal or telephone order       4 Order or test result is confirmed       PS.3 High alert medications       1 Collaborative process for development of       policies/procedures 2 High alert medications not present on units       PS.4 Correct site, procedure, patient for surgery       1 Collaborative process for development of policies/procedures 2 Clearly understood mark for surgical identification 3 Verification of documents, equipment on-hand, correct, functional 4 Checklist and time out procedure PS.5 Health associated infections       1 Hand hygiene guidelines 2 Effective hand hygiene program PS.6 Risk of falls       1 Collaborative process for development of       policies/procedures 2 Fall risk assessments       3 Measures to reduce risk of falls       Total Highest Possible = 200   Percent achievement % % % 82 IFC Self-Assessment Guide for Health Care Organizations   Baseline Score Score Score Facility Safety and Emergency Management FSE.1 Program to provide safe and secure       environment 1 Staff, visitor and vendor identification       2 Inspection of physical facility       3 Plan to reduce risks identified during inspection 4 Plans for upgrading and replacing systems FSE.2 Hazardous materials       1 List of hazardous wastes       2 Plan covers listed processes       3 Hazardous materials managed according to plan       FSE.3 Emergency management plan       1 Identification of potential major internal and       external disasters 2 Plan to respond to identified disasters 3 Plan tested annually       FSE.4 Fire/smoke plans       1 Fire safety plan 2 Fire assessment during construction 3 Inspection of fire detection and abatement systems 4 Staff trained to participate in fire plan 5 Fire evacuation plan tested twice a year 6 Staff participate in one fire test per year 7 Smoking policies FSE.5 Medical Equipment Maintenance       1 Program to test, maintain and keep inventory of equipment 2 Qualified staff to manage medical equipment 3 Data for medical equipment management program IFC Self-Assessment Guide for Health Care Organizations 83 FSE.6 Utilities Management       1 Potable water, electrical power and medical gas       24/7 2 Data for medical utility management       3 Areas of risk identified       4 Plans for alternate sources of power and water 5 Utility systems identified, inspected and maintained 6 Water quality monitored Total Highest Possible = 260   Percent achievement % % % Overall Achievement of Standards – SCORE (Highest possible = 1,600) Overall Achievement of Standards – Percent % % % The team will be able to determine the percentage of the standards met for each category, as well as the overall percentage of standards met. This percentage will give the team a guide to where the main gaps are and where the organization needs to focus its attention. The team should graph the overall score and use this percentage as a measure of on-going progress. 84 IFC Self-Assessment Guide for Health Care Organizations STEP 5: Develop an Action Plan STEP 6: Communicate the Findings/ The team should develop an Action Plan to close the gaps to meet the Actions standards. Each measurable element that is scored as “partially met” The assessment findings and action plans should be shared with all or “not met” requires an action. key parties. A Communication Plan should include: 1. Who needs the information? Quality Gap Analysis List all the individuals or groups that need the information, e.g. staff, board of directors, committees. All Standards Met Desired State 2. What information is needed? Each group has a different need for the information. For instance, the infection control committee will be interested in the findings related to specific standards, whereas the board of directors is more Gap between current and desired state likely to be interested in a summary of the findings. based on self assessment Current 3. How will the information be delivered? State The method that best suits the target group should be used. Current Standards Met A formal report might be sent to the board of directors and a presentation might be made to the medical staff. It is likely that some of the actions that need to be taken will be 4. Who will convey the information? straightforward. For example, if a process for checking water quality The person selected for delivering the information must be an is needed, then the action is clear – a procedure needs to be written appropriate authoritative figure. identifying who checks the water, when, and how. In some cases, the way forward is likely to be less clear and the team may need to 5. When will the information be given? collect more information in order to understand the situation. For Specific dates need to be assigned so that the plan can be monitored. example, one hospital that investigated the reason for a higher rate of incomplete medication orders discovered that this occurred when Example: Communication Plan new medical interns joined. This finding was clearly important in determining a solution to the problem. Who needs the information? All clinical staff Some issues arising may be difficult to resolve and require specialist assistance. In other instances there may well be internal resistance to change (e.g. relating to new working practices) and will require What information is needed? sustained, explicit management support. Colored graphs and charts Informed consent policy and procedure showing progress on key indicators (e.g. infection rates, patient satisfaction) over time, displayed in departmental areas are also an How will the information be delivered? effective way of promoting quality improvement efforts. Formal presentation Action plans should be as specific as possible, e.g. regarding responsibilities and timetables. Who will convey the information? Example: Action Plan Winona Amory, Senior Nurse What needs Who is going When will it to be done? to do it? be done? When will the information be given? 1. Develop a policy Winona Amory, May 15 June 30 and procedure Senior Nurse, regarding obtaining Surgical Ward informed consent. IFC Self-Assessment Guide for Health Care Organizations 85 STEP 7: Sustain the Gain Even when all of the standards have been met, organizations should conduct an assessment at least annually in order to sustain the Some organizations using this Guide may be conducting a self- improvement process. assessment for the first time. In order to sustain improvement efforts, the initial baseline assessment should be conducted and then, further assessments performed at intervals to establish progress. Organizations Your views may choose to begin by focusing their attention on a small number of IFC seeks to support health care organizations in developing standards in specified priority areas and meet these before going on to countries to raise their standards to international levels. tackle additional ones. The action plans should be used to move the process forward. The full assessment might be done on a semi-annual What did you think of this Guide? And how was your experience or annual basis. The assessment should not be considered a “once off” of using it? We welcome your views, including ways you think activity – see the Quality Improvement Cycle below. we can make it even more useful and relevant. 吀栀攀 儀甀愀氀椀琀礀 䤀洀瀀爀漀瘀攀洀攀渀琀 䌀礀挀氀攀 Please send your views by email to: healthstandards@ifc.org 䴀攀愀猀甀爀攀  䤀洀瀀氀攀洀攀渀琀  䌀甀爀爀攀渀琀  琀栀攀 䌀栀愀渀最攀猀 倀攀爀昀漀爀洀愀渀挀攀 倀氀愀渀 琀栀攀  䄀渀愀氀礀稀攀 琀栀攀  䌀栀愀渀最攀猀 刀攀猀甀氀琀猀 86 IFC Self-Assessment Guide for Health Care Organizations IFC Self-Assessment Guide for Health Care Organizations 87 88 IFC Self-Assessment Guide for Health Care Organizations Appendices IFC Self-Assessment Guide for Health Care Organizations 89 Appendix I: IFC Code of Conduct for Health Care Organizations PURPOSE 4. Non-discrimination To establish a culture of openness, trust and integrity in business Discrimination or harassment on the basis of race, color, religion, practices. This document will serve to guide behavior to ensure gender, nationality, age or disability is not tolerated. ethical conduct based on the values of the International Finance Corporation (IFC). 5. Confidentiality The organization shall maintain the confidentiality of clients and that POLICY of their service users and other confidential information in accordance Organizations receiving funds from the IFC are expected to maintain with applicable legal and ethical standards. high standards of professional and business integrity, to comply with all applicable laws, rules and regulations, deter wrongdoing and to 6. Records avoid situations and behaviors that could reasonably be foreseen to All organizational records, documents and reports must be accurate, reflect negatively on the integrity or reputation of IFC. complete, and un-tampered. Prior to financing agreements, officers of the organization are to 7. Avoidance of conflicts of interest receive this document and are required to execute a Code of Conduct Executives, managers, employees, and Board members owe a duty of Statement. This statement will indicate that the document has been loyalty to the organization. Persons holding such positions may not read and understood, that the organization will conduct business to use their positions to profit personally or to assist others in profiting the expectations outlined, that prohibited conduct will be avoided, in any way at the expense of the organization. and any relevant conflicts will be disclosed. 8. Business relationships The intent of these guidelines is not to attempt to foresee or define Business transactions with vendors, contractors and other third each situation that does or might involve a breach in ethics. The parties shall be transacted appropriately, without offers, solicitation intent is rather to focus on situations that are viewed as likely to pose or acceptance of gifts and favors or other improper inducements actual or potential concerns or to reflect negatively on the integrity in exchange for influence or assistance in a transaction. Business or reputation of IFC. The intent is also to focus on IFC’s expectation activities must be conducted on the basis of fair competitive practices. that, in questionable or unforeseen situations, timely disclosure will All purchases of services and supplies must be from qualified and facilitate satisfactory resolution before any such situation becomes reliable sources and be based upon objective factors, consistent with problematic. the organization’s policies and procedures. During and, as applicable, subsequent to the agreement with IFC, 9. Occupational safety the following issues shall be disclosed and avoided or managed as The organization abides by all laws and regulations regarding appropriate: occupational safety. This requires an active participation in maintaining a safe working environment and includes observance 1. Compliance with Laws and Regulations of established safety procedures and making recommendations for The organization will ensure all activity by or on behalf of the changes where they are needed. organization is in compliance with applicable laws and regulations. 10. Clinical research 2. Adherence to Ethical Standards The organization has a committee or other mechanism to oversee Organizations will accurately and honestly represent their services all research within the organization. Any person enrolled in clinical and will not engage in any activity intended to defraud any individual research is fully informed of the risks and benefits and their right to or organization of money, property or honest services. refuse to participate or drop out of the activity without risk of reprisal. 3. Client focus The organization has the responsibility to ensure that there are no compromises in delivering the highest standard of services and that every aspect of their operations promotes and reflects these standards. No one is to take unfair advantage of anyone through manipulation, concealment, abuse of privileged information or misrepresentation of material facts. 90 IFC Self-Assessment Guide for Health Care Organizations 11. Organ donation and transplant The organization complies with the WHO Guiding Principles on Human Organ Transplantation. Organ retrieval from living persons is not undertaken where there are reasonable grounds to suspect that the donation is coerced or that a financial consideration is expected by the donor. The organization permits the allocation of organs on the basis of morally relevant criteria only. Transplantation is prohibited when the chance of success is insufficient to justify the risks. The buying and selling of organs are not performed or condoned by the organization. The harvesting of organs without prior consent from dead patients (or their legal representative) is not performed or condoned by the organization. 12. Gender selection Sex selection, by selectively terminating a pregnancy for non-medical reasons, is not performed or condoned. This encompasses a number of related practices, including pregnancy ultrasound scanning, where there are reasonable grounds to suspect a risk of termination of pregnancy dependent upon the determined sex of the embryo or fetus. 13. Assisted reproductive technologies Interventions of human procreative processes [e.g. invitro fertilization (IVF), gamete intrafallopian transfer (GIFT), artificial insemination by donor (AID)] are carried out with due consideration to donor confidentiality, parental age limits, same sex couples, ownership of donated sperm/eggs, multiple embryo transfer and genetic testing. All such procedures are carried out within the laws and regulations of the country. Exploitation of clients seeking reproductive assistance (e.g. non- required testing procedures or procedures unlikely to yield results), or of egg donors is prohibited. Harvesting of stem cells must only be done with the express permission of the donor under the laws and regulations of the country. 14. Female genital mutilation Female circumcision is not performed or condoned by the organization. IFC Self-Assessment Guide for Health Care Organizations 91 Appendix II: Outline Terms of Reference for Key Committees in Health Care Organizations Quality and Patient Safety Committee Safety Committee 1. Ensure that policies and systematic processes are in place and 1. Ensure hospital environment is safe and healthy for hospital working to assess and improve the quality of care and services personnel, patients and visitors by: provided to patients in the facility. a) conducting risk assessment, risk communication and risk 2. Assess safety risks and take actions to reduce potential injury. management, 3. Review reports on the evaluation of clinical and non-clinical b) conducting safety audits, quality indicators and of quality management programs and c) implementing safety programs, services of the organization. d) providing technical advice to improve the facility 4. Ensure that actions are taken to correct identified problems and environment, improve the quality of care. e) developing plans for the management of hazardous waste 5. Ensure that processes are in place to facilitate implementation materials and waste, and of quality standards. f ) developing plans for fire safety and general safety and 6. Recommend or provide education programs concerning security. quality. 2. Ensure facility is well prepared in time of emergency by: Infection Prevention and Control Committee a) developing emergency/disaster plans, and 1. Develop standards, guidelines and/or best practices for infection prevention and control. b) supporting the implementation of the plans. 2. Provide infection prevention and control training and Medical Records Committee53 education, for both infection control professionals (ICPs) and 1. Ensure that accurate and complete medical records are kept and non-ICP front-line health care workers. readily available for every patient treated in the hospital. 3. Develop evaluation strategies for infection prevention and 2. Help to ensure that medical staff complete all the medical control programs, practices and procedures through the records of patients under their care by recording a discharge development of measures and indicators. diagnosis and writing a discharge summary. 4. Supervise surveillance of infection risks, e.g. surgical site, 3. Determine the standards and policies for the medical record urinary tract, and blood stream infections. services of the health care facility. Pharmacy and Therapeutics Committee 4. Recommend action when problems arise in relation to medical 1. Make recommendations on and formulate Hospital Policy records and the medical record service. regarding the safe, effective and cost-effective prescribing and 5. Control new and existing medical record forms used in the use of medicines for the treatment of patients. health care facility. 2. Review medication usage in the hospital and make recommendations or publish guidance as appropriate. 3. Monitor and review prescribing practices within the hospital and provide appropriate guidance or feedback as necessary. 4. Establish and maintain a Hospital Formulary or Preferred Prescribing Guide. 53 WHO (2002) Medical Records Manual: A Guide for Developing Countries. Available at www.ifhro.org/9290610050.pdf 92 IFC Self-Assessment Guide for Health Care Organizations Clinical Privileging Committee The Committee is charged with advising on credentialing and defining the Clinical Privileges of Medical Practitioners and Allied Health Professionals by: 1. Providing advice, guidance and/or endorsement to other clinical and advisory committees with regard to policies and procedures, clinical reviews, and safety, quality, audit and education processes. 2. Advising the Director of Medical Services on the range of clinical services, procedures and other interventions that can be provided safely in the Relevant Hospital setting. 3. Advising the Director of Medical Services on the minimum credentials necessary for a Medical Practitioner or Allied Health Professional to fulfill competently the duties of a specific position or Clinical Privileges, within the Relevant Hospital. 4. Advising the Hospital Director on the information that should be requested and provided by applicants for appointment to specific Medical Practitioner and Allied Health Professional positions or for specific clinical privileges. 5. Accepting requests to undertake the processes of credentialing and defining the clinical privileges in line with the range of clinical services, procedures and other interventions: a) relevant to all Medical Practitioners applying for initial appointment, b) from an Authorized Person, in respect of a review of the Medical Practitioner or Allied Health Professional and/or their clinical Privileges, and c) from any Medical Practitioner or Allied Health Professional who requests a review of their clinical privileges. 6. Ensuring the credentials of each Medical Practitioner or Allied Health Professional are reviewed and verified in accordance with the organization’s by-laws and policies. 7. Advising the Hospital Director of the committee’s recommendations in relation to the clinical privileges of each Medical Practitioner and Allied Health Professional. IFC Self-Assessment Guide for Health Care Organizations 93 Appendix III: Glossary accreditation confidentiality 1. The process in which an independent external “accrediting” 1. The restricted access to data and information to individuals organization (usually non-governmental) assesses a health care who have a need, a reason, and permission for such access. organization to determine if it meets a formal set of standards designed to improve the quality of care. 2. An individual’s right to personal and informational privacy, including for his or her health care records. 2. The positive formal decision by an accrediting organization that a health care organization meets an applicable set of continuum of care standards. Matching the individual’s ongoing needs with the appropriate level and type of care, treatment, and service within an organization or adverse event across multiple organizations. An unanticipated, undesirable, or potentially dangerous occurrence in a health care organization. Also see sentinel event. continuity of care The degree to which the care of individuals is coordinated among client practitioners, among organizations, and over time. A recipient of health care regardless of the state of health. Clients may, for example, include people receiving screening or contracted services preventative services. Patients’ families may also be considered as Services provided through a written agreement with another clients. Clients are sometimes classified as being “internal” and organization, agency, or individual. The agreement specifies the “external”; “internal” clients/customers are people who work services or personnel to be provided on behalf of the applicant inside the organization (e.g. physicians, staff, management) and organization and the fees to provide these services or personnel. “external” are those that use the services of the organization (e.g. patients, families, insurers, vendors). credentialing The process of obtaining, verifying, and assessing the qualifications clinical governance of a health care practitioner to provide patient care services in or The means by which organizations ensure the provision of for a health care organization. The process of periodically checking quality clinical care by making individuals accountable for setting staff qualifications is called recredentialing. maintaining and monitoring performance standards.54 credentials clinical pathway Evidence of competence, current and relevant licensure, education, An agreed-upon treatment regime that includes all elements of training, and experience. Other criteria may be added by a health care. (There are several terms used for clinical pathway - such as care organization. Also see competence; credentialing. “care pathway” or “care map”). data clinical practice guidelines Facts, clinical observations, or measurements collected during an Statements that help practitioners and patients choose appropriate assessment activity. Data before they are analyzed are called “raw health care for specific clinical conditions (for example, data.” recommendations on the case management of diarrhea in children under the age of five years). The practitioner is guided through all disaster steps of consultation (questions to ask, physical signs to look for, See emergency lab exams to prescribe, assessment of the situation, and treatment to prescribe). discharge The point at which an individual’s active involvement with an clinician organization or program is terminated and the organization or A health professional, such as a physician, psychiatrist, psychologist, program no longer maintains active responsibility for the care of or nurse, involved in clinical practice (as distinguished from one the individual. specializing in research). competence A determination of an individual’s skills, knowledge, and capability to meet defined expectations, as frequently described in a job description. 54 Pietroni, Advancing Clinical Governance (1998). Available at: www.clinicalgovernance.scot.nhs.uk/documents/Clinical_Governance_Definitions.pdf 94 IFC Self-Assessment Guide for Health Care Organizations emergency IDA 1. An unanticipated or sudden occasion, as in emergency surgery The International Development Association is the part of the needed to prevent death or serious disability. World Bank that helps the world’s poorest countries. Established in 1960, IDA aims to reduce poverty by providing interest-free 2. A natural or man-made event that significantly disrupts the credits and grants for programs that boost economic growth, environment of care (for example, damage to the organization’s reduce inequalities and improve people’s living conditions. building(s) and grounds due to severe winds, storms, or earthquakes); that significantly disrupts care and treatment (for indicator example, loss of utilities such as power, water, or telephones A measure used to determine, over time, an organization’s due to floods, civil disturbances, accidents, or emergencies in performance of functions, processes, and outcomes. the organization or its community); or that results in sudden, significantly changed or increased demands for the organization’s infectious waste services (for example, bioterrorist attack, building collapse, or See hazardous materials and waste plane crash in the organization’s community). Some severe emergencies are called “disasters”. informed consent Agreement or permission accompanied by full information on the ethical nature, risks, and alternatives of a medical procedure or treatment Conforming to accepted standards of moral, social or professional before the physician or other health care professional begins the behavior. procedure or treatment. After receiving this information, the patient then either consents to or refuses such a procedure or governance treatment. The individual(s), group, or agency that has ultimate authority and responsibility for establishing policy, maintaining quality of care, in-service education and providing for organization management and planning. Other Organized education, usually provided in the workplace, designed names for this group include “board,” “board of trustees,” “board to enhance the skills of staff members or teach them new skills of governors,” “board of commissioners,” and “governing body.” relevant to their jobs and disciplines. harvesting, of organs inpatient Removal of an organ for means of transplantation. Generally, persons who are admitted to and housed in a health care organization at least overnight. hazardous materials and waste Materials whose handling, use, and storage are guided or defined intent statement by local, regional, or national regulation, hazardous vapors, and A brief explanation of a standard’s rationale, meaning, and hazardous energy sources. Although JCI considers infectious waste significance, noted in this manual under the heading Intent. Intent as falling into this category of materials, not all laws and regulations statements may contain detailed expectations of the standard that define infectious or medical waste as hazardous waste. are evaluated in the on-site survey process. health care–associated infection(s) (HAI) invasive procedure Also known as nosocomial infections. Any infection(s) acquired A procedure involving puncture or incision of the skin, or insertion by an individual while receiving care or services in a health care of an instrument or foreign material into the body. organization. Common HAIs are urinary infections, surgical wound infections, pneumonia, and blood stream infections. job description Explanation of an employment position including duties, health care professional responsibilities, and conditions required to perform the job. Any person who has completed a course of study and is skilled in a field of health. This includes a physician, dentist, nurse, or allied health professional. Health care professionals are often licensed by a government agency or certified by a professional organization. IFC Self-Assessment Guide for Health Care Organizations 95 leader monitoring An individual who sets expectations, develops plans, and implements The review of information on a regular basis. The purpose of procedures to assess and improve the quality of the organization’s monitoring is to identify the changes in a situation. For example, governance, management, clinical, and support functions and the health information specialist of the district health management processes. The leaders described in these standards include at least team reports every month the cases of meningitis occurring in the leaders of the governing body; the chief executive officer and villages at risk. other senior managers; departmental leaders; the elected and the appointed leaders of the medical staff and the clinical departments multidisciplinary and other medical staff members in organizational administrative Including representatives of a range of professions, disciplines, or positions; and the nurse executive and other senior nursing leaders. service areas. licensure near miss A legal right that is granted by a government agency in compliance Any process variation that did not affect an outcome but for with a statute governing an occupation (such as physicians, nurses, which a recurrence carries a significant chance of a serious adverse psychiatry, or clinical social work, or the operation of a health care outcome. Such a “near miss” falls within the scope of the definition facility). of an adverse event. Also see adverse event. measure nosocomial infection(s) 1. To collect quantifiable data about a function, system, or process See health care–associated infection(s) (one “measures”). organizational chart 2. A quantitative tool. Also see “indicator” A graphic representation of titles and reporting relationships in an organization, sometimes referred to as an “organogram” or medical equipment “organization table.” Fixed and portable equipment used for the diagnosis, treatment, monitoring, and direct care of individuals. patient record/medical record/clinical record A written account of a variety of patient health information, such medical record as assessment findings, treatment details, progress notes, and See patient record/medical record discharge summary. This record is created by physicians and other health care professionals. medical waste See hazardous materials and waste plan A detailed method, formulated beforehand, that identifies needs, medication lists strategies to meet those needs, and sets goals and objectives. Any prescription medications; sample medications; herbal The format of the plan may include narratives, policies and remedies; vitamins; over-the- counter drugs; vaccines; diagnostic procedures, protocols, practice guidelines, clinical paths, care and contrast agents used on or administered to persons to maps, or a combination of these. diagnose, treat, or prevent disease or other abnormal conditions; radioactive medications; respiratory therapy treatments; parenteral policy nutrition; blood derivatives; and intravenous solutions (plain, with A plan or course of action adopted by the organization intended to electrolytes and/or drugs). influence or determine decisions. medication, high-risk or high-alert primary source verification Those drugs that carry a risk for errors that can lead to significant Verification of an individual health care practitioner’s reported adverse outcomes. qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of medication error credentials include direct correspondence, documented telephone Any preventable event that may cause inappropriate medication verification, or secure electronic verification from the original use or jeopardize patient safety. Also see sentinel event. qualification source or reports from credentials verification organizations that meet requirements. mission statement A written expression that sets forth the purpose, or “mission,” of an organization or one of its components. The generation of a mission statement usually precedes the formation of goals and objectives. 96 IFC Self-Assessment Guide for Health Care Organizations privileging safety The process whereby a specific scope and content of patient care The degree that the organization’s buildings, grounds, and services (that is, clinical privileges) are authorized for a health care equipment do not pose a hazard or risk to patients, staff, or visitors. practitioner by a health care organization, based on evaluation of the individual’s credentials and performance. scope of practice The range of activities performed by a practitioner in a health care procedure organization. The scope is determined by training, tradition, law or Step-by-step instructions on how to perform a technical skill. regulation, or the organization. process scope of services A series of actions (or activities) that transform the inputs The range of activities performed by governance, managerial, (resources) into outputs (services). For example, a rural health clinical, and support personnel. education program will require that staff develop an education strategy, develop educational materials, and deliver the education security sessions. Protection from loss, destruction, tampering, or unauthorized access or use. program Services designed to meet the needs of a particular patient sentinel event population An unanticipated occurrence involving death or major permanent loss of function. protocol Scientific treatment plan or study outline—including types of side effect trial participants, schedule, procedures, medications and dosages, Pharmacological effect of a drug, normally adverse, other than the etc.—for using an experimental procedure or a new treatment with one(s) for which the drug is prescribed. the intent of measuring human applications. staff qualified individual As appropriate to their roles and responsibilities, all people who An individual or staff member who can participate in one or all provide care, treatment, and services in the hospital (e.g. medical of the organization’s care activities or services. Qualification is staff and nursing staff ), including those receiving pay (e.g. determined by the following: education, training, experience, permanent, temporary, and part-time personnel, as well as contract competence, applicable licensure, law or regulation, registration, employees), volunteers, and health profession students. or certification. clinical staff quality of care Are those who provide direct patient care (physicians, nurses, The degree to which health services for individuals and populations etc.) increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Dimensions of nonclinical staff performance include the following: patient perspective issues; Are those who provide indirect patient care (admissions, food safety of the care environment; and accessibility, appropriateness, service, etc.) continuity, effectiveness, efficacy, efficiency, and timeliness of care. standard recruiting A statement that defines the performance expectations, structures, Seeking; normally new employees or other members of an or processes that must be in place for an organization to provide organization. safe and high-quality care, treatment, and service. risk management program transfer Clinical and administrative activities that organizations undertake The formal shifting of responsibility for the care of a patient from to identify, evaluate, and reduce the risk of injury to patients, staff, (1) one care unit to another, (2) one clinical service to another, (3) and visitors and the risk of loss to the organization itself. one qualified practitioner to another, or (4) one organization to another organization. root cause analysis A process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. Also see sentinel event. IFC Self-Assessment Guide for Health Care Organizations 97 utility system Organization-wide system and equipment that support the following: electrical distribution; emergency power; water; vertical and horizontal transport; heating, ventilating, and air conditioning; plumbing, boiler, and steam; piped gases; vacuum systems; or communication systems, including data-exchange systems. May also include systems for life support; surveillance, prevention, and control of infection; and environment support. variation The differences in results obtained in measuring the same event more than once. The sources of variations can be grouped into two major classes: common causes and special causes. Too much variation often leads to waste and loss, such as the occurrence of undesirable patient health outcomes and increased cost of health services. 98 IFC Self-Assessment Guide for Health Care Organizations Contact Information Health and Education Department 2121 Pennsylvania Avenue, NW Washington, DC 20433 USA ifc.org 2010