National Ambulatory Care Standards PDF

**National Ambulatory Care Standards** The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is the official agency authorized to grant healthcare accreditation to all governmental and private healthcare facilities operating today in the Kingdom of Saudi Arabia. Having originally emerged from the Saudi Health Council as a non-profit organization, CBAHI is primarily responsible for setting quality and safety standards to ensure a better and safer healthcare system. Its first official inauguration was after the Ministerial Decree number 144187/11 in October 2005, which called for the formation of the Central Board for Accreditation of Healthcare Institutions, tasked with the initiation of a national voluntary healthcare accreditation program. In 1434/2013, the Council of Ministers mandated accreditation by CBAHI and gave the board its current name. The mission of the Saudi Central Board is to support all healthcare facilities, through accreditation to continuously comply with quality and patient safety standards. The vision of the Saudi Central Board is to be the leading healthcare accreditation agency in the region. In addition to the Ambulatory Healthcare Accreditation program, CBAHI currently has three other accreditation programs (Primary Healthcare, Hospital Healthcare and Clinical Laboratories and Blood Banks). Other accreditation programs are under process. CBAHI's goal is to achieve two conjoined initiatives, in congruence with (the 2030) vision. The first initiative is to expand the range of efficient and effective accreditation programs to cover healthcare services. The second initiative is to work with several partners to support the health system in Saudi Arabia and the region by increasing the depth of quality improvement and patient safety, as well as by disseminating knowledge through training and education. Driven by its core values, a dedicated team of surveyors and staff, CBAHI is determined to be a major driving force and a recognized standard for the provision of safe and high-quality healthcare. CBAHI is proud to be one of the few healthcare accreditation agencies globally, accredited by the International Society for Quality in Healthcare (ISQua), for hospital standards, surveyor training programs and for organization. Healthcare accreditation is an assessment process that involves a rigorous, transparent and comprehensive evaluation by an external independent accreditation body. The Healthcare Facility (HCF) undergoes an appraisal of its systems, processes and performance by peer reviewers or surveyors, to ensure that all tasks are conducted in a manner that meets applicable predetermined and published national standards. Before the external evaluation, i.e., the survey visit, the HCF is expected to conduct a comprehensive self-assessment to determine its level of preparedness, and how close it is to achieving full compliance with the standards. Therefore, accreditation represents the healthcare accreditation body's public recognition of the achievement of accreditation standards by an HCF. Standards set out a common framework to support HCFs in providing effective, timely and quality services. They are designed to deliver improved levels of care and treatment to the citizens and residents of Saudi Arabia. Evidence from scientific research shows that engagement in a robust healthcare accreditation program improves the structure, process and outcome of care that healthcare facilities provide. Accreditation is not merely a certificate to obtain and hang on the wall. If utilized properly, accreditation can provide the following benefits: - Accreditation provides a framework for organizational structure and management. Accreditation standards focus on the governance and leadership structures and functions within a HCF and the appropriate management of its business and day-today activities. - Accreditation helps improve patient safety and minimizes the risk of near misses, adverse outcomes and medical errors. Ensuring patient safety through risk management and risk reduction is at the center of all accreditation standards and is the ultimate goal of the self-assessment and survey activities. - Accreditation enhances community confidence in the quality and safety of care provided. When a HCF achieves accreditation, the message is clear -- its leaders are committed to providing a nationally accepted standard of care in health services delivery. - Surveyed HCFs have found that seeing their operation through the eyes of experienced surveyors gave them a useful, more objective assessment of their internal administrative and clinical processes, as well as effective proposals for improving their processes and services delivered to the community. - Accreditation in the long term, increases efficiency and enhances lean practices, which in turn leads to decreasing waste and achieving optimal results with less consumption of resources. - Accreditation helps improve a healthcare facility's competitiveness. - Boosting public confidence in an accredited facility will encourage more patients to seek care and treatments in that facility. This will positively impact its competitiveness in the healthcare sector and increase its market share. - Achieving accreditation will fulfill the regulations required by the Ministry of Health, which is now considering linking the national accreditation by CBAHI to the licensing of healthcare facilities. - Registration with CBAHI and enrollment in its national accreditation program are accepted by the Ministry of Health (at this stage) as satisfactory evidence for the purpose of license renewal. Eventually all HCFs operating in Saudi Arabia must achieve CBAHI accreditation. - Accreditation has a link to reimbursement from insurers and other third parties. There is a growing tendency, nationally and internationally, to link accreditation with eligibility for insurance reimbursement. - Accreditation provides a robust tool for continuous quality improvement efforts in the HCFs and helps facility leadership to ensure the sustainability of quality improvement projects and initiatives. - Accreditation offers great learning and educational opportunity. This is achieved through staff education on best practices and by emphasizing the importance of patient education and patient rights. The scope of the CBAHI survey includes all standard related functions of the surveyed HCF. Each assessment survey is tailored to the type, size and range of services the facility offers. Applicable standards from this manual are determined by CBAHI, based on the scope of the services provided by the HCF undergoing a survey. Additionally, the onsite survey team will consider the specific applicability of individual standards. A standard is a statement of excellence or an explicit predetermined expectation that defines the key functions, activities, processes and structures required for HCFs to ensure the provision of safe, quality care and services. Standards are developed by peer experts in their specific field and it is against these standards to which conformity of the healthcare facility is evaluated. Simply stated, a standard describes a HCF's acceptable performance level. Within this context, there should be no confusion between accreditation standards and licensure standards. When applied to licensure of an individual practitioner or organization, the standard is usually set at a minimal level designed to protect public health and safety. Accreditation standards, on the other hand, are designed as optimal and achievable. When met, they will establish a high-quality level in a system. Broadly speaking, CBAHI standards, as well as those of all other relevant accrediting agencies, focus on three major aspects depending on which area they are addressing. **Structure;** standards address the system's inputs, such as manpower, design of the HCF building, the availability of personal protective equipment for health workers, such as gloves and masks and the availability of equipment and supplies, such as microscopes and laboratory reagents. **Process;** standards address the clinical and administrative activities or interventions carried out within the HCF in the care of patients or the management of the facility or its staff. Examples include patient assessment, patient education and medication administration. **Outcome;** standards involve the assessment of an intervention's benefits and whether the activity's expected purpose was achieved. They provide information regarding predicted outcomes which are being realized. Examples include patient satisfaction, health-care-associated infections, medication errors, sentinel events and adverse events such as falls and injuries. CBAHI standards set expectations for HCF performance which are reasonable, attainable, measurable and therefore, conducive to a survey. Standards were built to serve as the basis of an objective evaluation process that can help HCFs measure, assess and improve performance. CBAHI is striving to be a nationally recognized symbol of excellence, respected throughout the industry and by other relevant authorities, as an assurance that accredited HCFs meet rigorous standards of quality and operational integrity that emphasize consumer protection and patient engagement. Therefore, the process of standards development at CBAHI follows a long and robust methodology to ensure our standards are correct, evidence-based, relevant and clear. As with previous accreditation books, this book contains standards of quality and patient safety that are descriptive in nature and department-oriented. Specialized task forces develop the first draft of CBAHI standards, including focus groups and standards development committees that utilize input from a variety of sources, including: - The standards set by professional scientific societies, both locally and internationally. - Scientific literature review and research studies. - Relevant laws, rules, and regulations. - National (or international) emerging issues related to healthcare quality and patient safety. - Input from healthcare professionals, providers, and patients. - Panels of experts and consensus on best practices, given the current state of knowledge and technology. The process of standard development can last up to18 months before an initial draft is produced. The draft standards are then distributed nationally for review and made available for comment on the standards Field Review page of the CBAHI website. Based on the feedback received during the field review, the draft standards may be revised and again reviewed by the relevant experts and technical committees. The draft standards are finally approved by the Steering Standards Development Committee and provided to the CBAHI Board for comments and remarks before submission to the Saudi Health Council for approval. Thereafter, standards are provided in both paper and electronic formats and distributed to HCFs. An e-version is also made available on the CBAHI website. To comply with the guidelines of the International Society for Quality in Healthcare (ISQua), a period of six months is allowed for publishing of the standards before they are effective. Once the standards are in effect, ongoing feedback is sought for continuous improvement. The survey process is then tailored to address the new standards, and surveyors are taught how to assess compliance with the standards. CBAHI surveyors typically employ a variety of evaluation techniques and strategies to objectively decide whether the facility meets standards related to key systems and functions, such as governance and leadership, patient care processes, medication management, infection control, management and safety of the facility environment and quality assurance. For example, the survey team may review written documents (e.g., strategic and operational plans and budgets, and clinical policies and procedures). In addition to reviewing documents, surveyors will interview facility leaders, physicians, nurses, employees and patients to determine the facility's performance and compliance with standards. For example, the surveyor might interview a staff member to check on the process he or she would complete to report a medical error, that caused harm to one of the patients receiving care in that facility. Similarly, a surveyor might interview a patient about his or her level of satisfaction with the care the HCF provides. HCF leaders, including members of the governing body, may be interviewed regarding facility processes and how they are designed to meet standards related to planning, budgeting, quality assurance activities and human resources management. Surveyors tour the facility's buildings and patient care areas to evaluate standards related to overall cleanliness, building safety, fire safety, waste management, equipment and supply management, infection control and emergency preparedness. Other diagnostic and support services such as the laboratory, radiology, pharmacy, central sterile services and day procedure unit are also assessed for safety, effectiveness, quality control and equipment management. In summary, during an on-site survey, surveyors use a variety of evaluation approaches to determine the facility's compliance or performance regarding applicable structure, process and outcome standards. These methods might include any combination of the following: In summary, during an on-site survey, surveyors use a variety of evaluation approaches to determine the facility's compliance or performance regarding applicable structure, process and outcome standards. These methods might include any combination of the following: - Interviews with facility leadership, clinical and support staff, patients and family. - Observation of patient care and services. - Facility tour and observation of patient care areas, building facilities, equipment management and diagnostic testing services. - Review of written documents such as policies and procedures, orientation and training plans, budgets and quality improvement plans. - Review of personnel files. - Review of patients' medical records. - Evaluation of the facility's achievement of specific outcome measures (e.g., acquired infection rates, patient satisfaction) through review and discussion of monitoring and improvement activities. The CBAHI team surveys a HCF depending on the volume and complexity of the services that the facility provides, the number of locations or care settings included in the survey and the type of survey such as focused or full. The scope of the survey visit includes all standards-related functions in the HCF. This implies that any service/function/area not covered by CBAHI standards will not be assessed during the survey visit. CBAHI determines applicable standards from this book based on the scope of services and the onsite survey team's decision regarding the applicability of individual standards. The National Standards for Ambulatory Care Centers are assembled into eleven chapters consisting of key services and functions that ambulatory healthcare centers provide in Saudi Arabia. The standards within these chapters are arranged according to the workflow within the services. The chapters are: - Leadership of the Organization (LD) - Provision of Care (PC) - Laboratory Services (LB) - Radiology Services (RD) - Dental Services (DN) - Medication Management (MM) - Management of Information (MOI) - Infection Prevention and Control (IPC) - Facility Management and Safety (FMS) - Day Procedure Unit (DPU) - Dermatology & Aesthetics Medicine (DA) Each chapter includes a brief introduction that explains the chapter's relevance and contribution to safety and quality patient care. Each standard consists of a stem represented by a concise statement. This is followed by one or more sub standards to further illustrate the standard's requirements. Each substandard is constructed in a way to serve by itself as the evidence of compliance that is going to be measured and scored during the on-site survey. Each standard is accompanied by an explanation to help the ambulatory HCFs understand the intent behind it. No matter how robust the methodologies used in building the standards, room for improvement will always exist. Therefore, all comments and remarks on standards can be made and viewed on the CBAHI website, which includes an electronic form that allows HCFs, experts and other interested parties to comment on current standards. The form allows for continual stakeholder feedback on the standards. This is one of several CBAHI initiatives for improving the efficiency and effectiveness of internal processes, including standards development to better meet the needs and expectations of our partners. The goal of the survey process is to ensure that the CBAHI standards are integrated into the HCF's daily practices. In addition to conferences, interviews and a review of documents, the major part of the survey visit will involve an evaluation of standards implementation and the performance of different processes within the HCF. Preventable adverse events commonly occur in HCFs all over the world. Thus, CBAHI realizes that compliance with the standards does not guarantee a safe patient environment. The ambulatory healthcare facilities undergoing CBAHI accreditation must fully comply with these standards. The central principle behind CBAHI standards selection is to ensure that the center has wellqualified and competent staff working in a well-organized setting to deliver effective and reliable services. If you cannot imagine the importance of the presence, of the following standards, try to imagine the adverse effect and impact of their absence. However, accreditation itself is not the end. Rather, it should be viewed as the first step in an endless journey towards quality improvement and excellence. There are (133) Standards distributed throughout the chapters. \* **(C)** denotes core standard, i.e. full compliance is mandatory for all. **List of Standards** ----------------------- ------------------------------------------------------------------------------------------------------------------------ **Standard** LD.1 The governing body defines its structure and operational responsibilities in a written document. LD.2 The governing body approves and evaluates the center's quality and patient safety program and risk management program. LD.3 The center has a current organizational chart. LD.4 The center is managed effectively by a qualified director. LD.5 The leaders together with governance develop the center's scope of services based on community needs. LD.6 The leaders work collaboratively to develop the center's strategic plan. LD.7 The leaders transform the approved strategic plan into an operational plan. LD.8 The leaders work collaboratively to develop the operational budget. LD.9 The leaders work collaboratively to fulfill the mission and provide quality care. LD.10 The leaders develop a staffing plan for the center. LD.11 The leaders develop a policy and procedure for staff recruitment. LD.12 All categories of staff have clearly written job descriptions. LD.13 **(C)** The leaders develop an effective process for credentialing and re-credentialing all healthcare providers. LD.14 **(C)** All medical staff members have current delineated clinical privileges. LD.15 All new employees attend a mandatory orientation program. **List of Standards** ----------------------- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- **Standard** LD.16 The leaders develop and implement a policy that ensures nurses and other allied healthcare staff are competent in specific procedures. LD.17 The leaders ensure staff are trained and test competent in the safe operation of equipment including medical devices. LD.18 The leaders support continuing education and training for all categories of staff. LD.19 Staff are trained and kept up to date with cardiopulmonary resuscitation. LD.20 The leaders develop an effective process to evaluate staff performance at least annually. LD.21 The leaders implement a comprehensive program to protect the health and safety of staff. LD.22 The leaders support and protect the patient and family rights. LD.23 The leaders ensure that patients/families have the right to be involved in their own care and treatment. LD.24 The leaders develop and implement a policy and procedure to describe the patients' right to voice their complaints and concerns. LD.25 The leaders ensure that patients/families have the right to accurate billing for provided services. LD.26 The leaders develop ethical standards to guide patients' care and employees' code of conduct. LD.27 The center provides assistance to patients with special needs. LD.28 The center has an implemented policy for controlling the development and maintenance of key documents. LD.29 The center develops a comprehensive quality improvement and patient safety program. LD.30 The leaders prioritize and select a set of indicators that focus on the structure, process, and outcome of the services provided within the center. LD.31 The leaders develop and implement a comprehensive risk management program. LD.32 The leaders develop and implement an incident reporting policy. LD.33 The leaders oversee any contracts for clinical or operational services. LD.34 The leaders ensure the integrity and security of telemedicine, teleradiology and interpretation of other diagnostic remote contracted services. LD.35 The leaders implement policies and procedures to guide the efficient procurement of equipment either purchased or donated, medications and essential medical consumables in accordance with national laws and regulations. LD.36 The leaders ensure an aesthetic appeal for the center. PC.1 Patients have access to services based on their health needs and available services and are registered with the center for providing such services. PC.2 **(C)** The center has a process to ensure the correct identification of patients. **List of Standards** ----------------------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------- **Standard** PC.3 Patients are clinically assessed through an established assessment policy and procedure. PC.4 Physicians are provided with the results of requested investigations according to a time frame. PC.5 The center develops and implements a process for reporting critical test results whether on-site or outsourced. PC.6 A care plan is developed by the attending physician to meet the patient's needs considering patient and family's cultural and spiritual matters. PC.7 Consultations are available to meet the healthcare provider\'s request and patient's needs in a timely manner. PC.8 Staff members assist patients and, when appropriate, their families in fully participating in making informed decisions about their care, treatment and procedures. PC.9 Patients and, when applicable, their families are educated about their healthcare needs. PC.10 Informed consent is obtained from the patient or guardian. PC.11 Patients planned for a surgery/procedure give their informed consent to the surgery/procedure and the anesthesia/sedation. PC.12 The center has an effective process to safely provide care to patients who require Cardio Pulmonary Resuscitation (CPR). PC.13 Policies and procedures guide the transfer of patients in need of urgent admission to hospitals. PC.14 Ambulance services are available and meet the patient's needs. PC.15 The center has an emergency services to deal with minor emergencies. LB.1 Laboratory services are available or outsourced to meet the needs of the patient population served. LB.2 The laboratory has the right space and facilities relevant to the services provided. LB.3 The laboratory develops and implements a comprehensive safety program. LB.4 The laboratory develops and implements a comprehensive infection control program. LB.5 The laboratory has a clearly defined and implemented process describing its role in selecting and evaluating providers of reference laboratory services. LB.6 The laboratory has a clearly defined and implemented process for laboratory instrument and equipment management. LB.7 The laboratory develops and implements a policy for the documentation of specimen receipt and inspection. LB.8 The laboratory develops a policy and procedure for the quality control of test methods. **List of Standards** ----------------------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- **Standard** LB.9 The laboratory develops a policy and procedure for Proficiency Testing (PT) sufficient for the extent, complexity and scope of services. LB.10 The laboratory defines the format and contents of laboratory reports. LB.11 The laboratory has a process for correcting or amending reported results. LB.12 The laboratory develops and implements a comprehensive process for Point-ofCare-Testing (POCT). RD.1 Radiology services are available or planned with other institutions to meet patient needs and in accordance with applicable national standards, laws and regulations. RD.2 **(C)** The center has a radiation safety program. RD.3 There is implemented process to keep the radiology equipment in safe, functional condition. DN.1 Dental staff have appropriate qualifications. DN.2 A comprehensive assessment is performed and documented for each patient. DN.3 The dentist documents the treatment plan in the patient's medical record. DN.4 Infection control guidelines are available and implemented by dental staff. DN.5 Safety rules are applied in the dental laboratory. MM.1 Medication use processes are available to meet patient needs and in accordance with applicable laws and regulations. MM.2 The center has an updated and well-structured formulary. MM.3 The center has a process for the appropriate storage of medications. MM.4 The center has a process for ensuring the stability of medication available in multidose containers. MM.5 The center has a process for identifying and handling expired medications. MM.6 The center develops a policy and procedure for the safe prescribing of medications. MM.7 The center develops and implements guidelines for the correct prescribing of antibiotics. MM.8 The center develops a process to manage narcotics, psychotropic medications, and other controlled medications according to laws and regulations. MM.9 The center safely manages high-alert and look-alike, sound-alike, LASA medications. MM.10 The center evaluates the appropriateness of prescriptions before dispensing. MM.11 Medication preparation areas comply with infection control measures and safe practices. MM.12 The center develops and implements a policy and procedure on medication error reporting. MM.13 The center monitors allergies to medications. **List of Standards** ----------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- **Standard** MM.14 The center develops and implements a policy and procedure for the reporting of adverse drug reactions ADR's. MOI.1 The leaders define in a plan the information that is shared among the staff and with other governmental and non-governmental entities and its format. MOI.2 The leaders develop standardized diagnosis codes, procedure codes and symbols, and minimize abbreviations. MOI.3 All patients seen in the center have unique medical records. MOI.4 The leaders develop a policy on the rules and regulations for writing in patients' medical records. MOI.5 The leaders develop a process for completing and storing the patient medical record. MOI.6 The center has an implemented policy and procedure for the use of information technology. MOI.7 **(C)** The center has an effective clinical documentation improvement (CDI) program. IPC.1 The center implements a coordinated program to reduce the risk of healthcareassociated infections. IPC.2 Infection prevention and control activities are integrated and coordinated by an interdisciplinary team. IPC.3 The leaders develop and ensure the implementation of infection control policies and procedures targeting the most important infection risk processes. IPC.4 Communicable diseases are tabulated and reported as required by laws and regulations. IPC.5 The leaders develop and implement a policy and procedure for healthcare associated infection prevention. IPC.6 The leaders design and ensure the implementation of an effective hand hygiene program. IPC.7 **(C)** Centers providing sterilization services strictly follow rigorous sterilization rules. IPC.8 Patients with communicable diseases and those who are colonized or infected with epidemiologically important organisms are separated from other patients, staff and visitors. IPC.9 Personal protective equipment is readily accessible and available and is used correctly by staff in all patient care areas. IPC.10 The leaders define in a policy the cleaning, decontamination and disinfection processes in all patient care areas. IPC.11 **(C)** The leaders define in a policy the safe procedures for waste collection, storage and disposal. IPC.12 The leaders develop and ensure the implementation of a program for the prevention and management of sharp injuries. IPC.13 Sharps are discarded in appropriate containers. -------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- IPC.14 Housekeeping has policies and procedures describing its functions. FMS.1 The leaders establish and support a facility management and safety program. FMS.2 Interdisciplinary rounds are scheduled and conducted to ensure safety. FMS.3 The center's environment is safe for patients, visitors and staff. FMS.4 The leaders develop and monitor the implementation of a fire prevention program. FMS.5 The center is secured and protects its users. FMS.6 The leaders develop a plan for the inspection, testing and maintenance of medical equipment. FMS.7 The leaders develop an emergency plan, and staff are trained on it. FMS.8 The leaders develop a hazardous materials (HAZMAT) and waste disposal plan. FMS.9 The leaders develop a policy and procedure for the safe use of various types of compressed gasses. DPU.1 All day surgeries and procedures are performed in the day procedure unit. DPU.2 Leaders develop and implement a policy and procedure to guide the care of patients in the day procedure unit. DPU.3 The patient is accepted into the unit by the nursing staff after a rigorous verification procedure. DPU.4 The procedure/surgery room is a functional operating room. DPU.5 The day procedure unit is fully equipped for managing difficult intubations. DPU.6 Patients booked for a surgery/procedure shall have a pre-sedation/anesthesia assessment performed by the anesthesiologist prior to the surgery. DPU.7 The center ensures the correct implementation of the policy on preventing wrong patient, wrong site and wrong procedure. DPU.8 The patient's condition is continuously monitored during sedation or anesthesia, including local anesthesia and the information is documented in the patient medical record before the patient leaves the operating room. DPU.9 The unit has a recovery room. DPU.10 Each patient's post-sedation/anesthesia physiological status is continuously monitored and documented in the patient's medical record. DPU.11 An operative report is documented immediately after the surgery/procedure, before the patient leaves the recovery room and is signed by the surgeon. DPU.12 The patient is discharged home by an attending physician after the procedure. DA.1 Dermatology and aesthetics services are managed by an experienced physician. DA.2 Physicians' privileges outline the exact procedures to be done by each physician. DA.3 The unit performs periodic education and competency testing for clinical staff assisting in procedures. DA.4 The managing physician ensures the compliance of procedural rooms with all required safety rules. DA.5 The unit maintains a dated and timed list of the procedures performed. DA.6 Implemented evidence based clinical practice guidelines are developed by the unit physicians and approved by the service manager for all procedures performed in the unit. -------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- The effective date is 1^st^ January 2020. This applies to ambulatory healthcare centers seeking accreditation by CBAHI. All HCFs licensed to practice in the Kingdom of Saudi Arabia are eligible for CBAHI accreditation. However, eligibility for a survey visit is contingent upon the following requirements: - The HCF meets all licensing requirements to operate (and therefore, has a valid license, when applicable) as indicated by the statutes and regulations of the Ministry of Health. - The HCF meets any additional licensing requirements as indicated by other relevant authorities (e.g., Civil Defense, Saudi Commission for Health Specialties, Saudi Food and Drug Authority). - The HCF meets the legal definition as per the regulations of the Ministry of Health and the international guidelines in this regard: - - - - - The HCF provides healthcare services addressed by CBAHI's National Standards. - The HCF has been in operation for at least twelve (12) months before the on-site survey. - The HCF completes and returns an application form. Registration with CBAHI for accreditation is required for all eligible HCFs. This is the first step towards accreditation. HCFs are required to register by completing the [Healthcare Facility Registration Form] located on CBAHI's portal. Registration is a quick yet essential step, that provides the Healthcare Accreditation Department at CBAHI with necessary information about the registering facility. Upon successful registration, a system-generated auto-reply with a code number will be provided to the registering facility. The code number will be used for all future communications with CBAHI. To obtain CBAHI accreditation, a healthcare facility must complete several activities. Upon successful registration, the following resources will be provided to HCFs seeking CBAHI accreditation: - National Standards - Healthcare Accreditation Guide The Accreditation Guide provides all required information to help the HCF prepare for the survey visits. It contains an abstract of each survey activity, including logistical needs, session objectives and suggested participants. Each year, CBAHI decides based on "first-come, first-served" scheduling and in accordance with its yearly operational plan, which HCFs will be enrolled in its accreditation program for that particular year. CBAHI will notify by a letter of enrollment those HCFs included in its yearly accreditation program. CBAHI provides ongoing [HCF Orientation Programs] in different locations throughout the year. HCFs must to attend at least one of the [HCF Orientation Programs] that CBAHI offers. Although any HCF can attend, preference is giving to facilities selected for the current year accreditation program. During these orientation sessions, the standards, accreditation policies and survey process are explained in detail. This is a good opportunity for HCF representatives to ask about the intent of a standard and how it will be implemented. Dates and venues of the orientation programs will be communicated to the HCFs in a timely manner. All HCFs enrolled in accreditation are encouraged to conduct a comprehensive self-assessment using the [Self-Assessment Tool] (SAT) that CBAHI provides. This tool is intended to help the facility assess how close it is to satisfactory compliance with the standards and requirements. It also provides an idea of how much preparation and time the HCF needs before it can be ready for a survey visit. Usually, SAT is for the HCF's internal use, but CBAHI might require it before conducting a survey to help determine the facility's preparedness. Several other accreditation organizations use self-assessment. If objectively and adequately conducted, self-assessment obtains better insight into the baseline situation of each facility and provides a common communication tool between the facility seeking accreditation and the accrediting body. When both parties reach a compromise about the level of preparedness for a survey visit based on the self-assessment findings, a survey can be scheduled for a tentative date suitable for both. Some HCFs (especially those with no experience in accreditation) may choose a [Mock Survey] Visit. This visit is offered by CBAHI (subject to the availability of resources) mainly as an educational tool to clarify accreditation policies, standards and their explanation. In addition to the survey process, the applicability of the different chapters of the standards manual, as well as to further assess the position of the facility by verifying the self-assessment's findings. The Mock Survey is recommended, but not mandatory. Some HCFs may choose for an upfront [Real Survey]. Once a HCF has applied for a real survey visit and completed the pre-survey requirements as mentioned below, the date of the visit will be determined depending on the scheduling availability as decided by the Healthcare Accreditation Department at CBAHI. The date of the survey will be shared with the facility. [Generally, a minimum of seven days] will be allowed for HCF notification before the survey is conducted. When a short-notice survey is to be conducted, the facility leadership is expected to receive the survey team and facilitate its work. Failure to do so will subject the HCF to denial of accreditation, as explained later. In all cases, the following requirements must be completed before CBAHI conducts a survey visit: - The HCF must submit a completed Survey Application Form, located on CBAHI's portal. - The Service Agreement must be acknowledged and duly signed by the facility, and a copy returned to CBAHI a minimum of 45 days before the actual survey date. - The HCF must provide evidence of payment of the required accreditation fees. It should be noted that the maximum number of mock surveys in which a HCF can participate is subject to several variables (e.g., the available resources at CBAHI, the level of commitment demonstrated by the HCF towards achieving compliance with the standards, the findings of the self-assessment and so forth). A mock survey is a valuable opportunity for education and learning from experienced peer surveyors who, through their work in healthcare organizations, are exposed to a wide variety of best practices. There is no limit to the number of real surveys a facility can have before achieving accreditation, but six months is the minimum time interval between two consecutive real surveys. However, this should not be misinterpreted as an "openended" exercise. The time interval between registration and the achievement of accreditation is 6 to 18 months, on average. Therefore, the facilities that will eventually prove incapable of achieving accreditation as reasonably persuaded by CBAHI will be excluded, either temporarily or permanently from the national accreditation program and referred to the relevant authorities for further action. To earn and maintain accreditation, a HCF must undergo an on-site survey conducted by the CBAHI survey team. CBAHI handles all scheduling arrangements for surveys in coordination with the healthcare facility. The date of the survey visit will be determined based on the capacity of CBAHI's yearly operational plan and the satisfactory level of preparedness as evidenced by the findings of the self-assessment. HCFs enrolled in the accreditation program will be notified by CBAHI to complete and submit the Survey Application Form (SAF) available on CBAHI's portal, and to indicate the type of survey requested (e.g., mock or real survey). A survey notification letter will be sent to the facility indicating the date of the survey and other relevant information. The size and specialties of facility survey team members are usually fixed, but this might change according to the size of the HCF and its scope of services. As mentioned before, compliance assessment is accomplished through various survey activities and methods, such as a review of documents, a review of medical records and personnel files, staff or patient interviews and the findings observed during the facility tour and unit visits. Whatever the methodology used, the CBAHI survey is structured to be an intelligent search for areas of noncompliance with the standards rather than as a checklist exercise. Generally, the survey team is composed of two healthcare professionals. The survey is conducted under the leadership that has been designated by CBAHI. The team leader is responsible for assuring that all survey activities are completed within the specified timeframes and according to CBAHI's policies and survey protocols. The HCF under survey is required to facilitate the work of the survey team members and to allow the survey team leader to practice his/her role and responsibilities, which include: - Preparing and communicating the survey plan to the HCF; - Chairing the opening and closing meetings; - Communicating with facility leadership regarding survey progress and initial findings; - Evaluating team progress and adjusting survey plans as needed; - Coordinating and preparing the survey report and submitting it to CBAHI. Further details about the survey team and the dynamics of the survey visit can be found in the Accreditation Guide provided to all HCFs upon successful registration. HCFs scheduled for surveys are strongly encouraged to adhere to the survey date proposed by CBAHI. However, rescheduling may be considered for review at CBAHI's discretion on a case-bycase basis, only upon: - A rationale for rescheduling that is acceptable to CBAHI (e.g., events that will hinder the flow of the survey process such as changes in the ownership of the facility, natural or other disasters, or relocation of the facility to another building). - At least thirty (30) days' notice with an official letter from the HCF chief executive officer indicating the reason(s) for the rescheduling request. Occasionally, requests for rescheduling of the survey visit that meet the above conditions are accepted with no penalties. Another more realistic date is selected and agreed upon with the facility, provided this does not happen more than once during one accreditation cycle. However, requests for rescheduling that do not meet the above conditions are subject to rejection (and the survey will be conducted) or a "penalty charge" equal to (25%) of the required survey fee. In general to become accredited, the HCF must meet all applicable standards at an acceptable level. CBAHI utilizes a multilevel process for making accreditation and reaccreditation decisions. This is to ensure fairness, consistency, objectivity, and accuracy. Therefore, CBAHI benefits from any relevant report and/or significant findings or issues of concern related to the surveyed facility that were brought to attention by relevant health authorities or past accreditation surveys. Accreditation decisions are released and communicated to the HCF within thirty (30) days after the conclusion of the survey visit. The accreditation decision-making process is based on: - The findings of the survey team members as recorded in the survey report. - Discussions regarding the survey findings between the surveyor and the specialty team leader (STL). - Review of the draft report by the participating HCF for feedback or correction of any issues of fact before the accreditation decision is made. - Review/discussion during the meeting of the Accreditation Decision Committee (ADC). This committee may request additional evidence before making a final recommendation for an accreditation decision. All accreditation decisions are then ratified by the CBAHI Director General. It is important to note that the decision to grant accreditation is based primarily on the findings of the on-site survey as recorded by the surveyors in the survey report. However, the overall numerical score the HCF obtains is one important factor, among others, upon which the ADC members rely when making their recommendation. Other factors are: - Criticality of the non-compliant standard(s), for example the degree of severity and immediacy of risk to patients, visitors or staff safety. - Any concerns regarding the non-compliant standard(s), for example the degree of severity and immediacy of risk to patients, visitors or staff and the facility. Criticality has several levels. The most serious is when the surveyor notices an immediate threat to safety or quality of care. Examples include: - Expired material is being used. - A bare electrical wire is hanging down without any protection. - A patient is not properly identified. When a CBAHI surveyor notices an immediate threat, whether or not it is directly linked to the standards, the survey team leader will notify the HCF director and include the findings in the survey report. Each standard is composed of a stem statement and sub-standard(s). The substandard is the evidence of compliance to be scored by the surveyor during the on-site survey. Each substandard has an equal weight and is scored on a three-point scale as follows: 1. = Insufficient Compliance (less than 50% compliance with the standard). 2. = Partial Compliance (from 50% to less than 85% compliance with the standard). 3. = Satisfactory Compliance (85% and more compliance with the standard). N/A = Not Applicable The score of each standard is calculated using the sum of the scores of the sub standards divided by the maximum score of all the sub-standards. Partial compliance is not acceptable for core standards. The overall score of the HCF is calculated using the sum of the scores of all the applicable substandards divided by the maximum score. When one or more chapters of this manual are not applicable to a particular HCF, they are indicated by "N/A." Non-applicable chapters are not scored and are not included in either the numerator or denominator of the overall score. The ADC shall recommend one of the following accreditation decisions: [Accredited] ------------------------ Accreditation will be awarded when the surveyed HCF demonstrates an overall acceptable compliance with all applicable standards at the time of the initial (or re-accreditation) on-site survey, and when there are no issues of concern related to the safety of patients, staff, visitors or the facility itself. Accreditation will also be recommended when the HCF has successfully addressed all post-survey requirements and does not meet any rules for denial. Scoring Guidelines: - Overall score 75% or above. - All Core standards are fully met. - All applicable standards score 50% and above. [Denial of Accreditation] ------------------------------------- Denial of accreditation results when an HCF shows significant noncompliance with the accreditation standards at the time of the on-site survey. It also results if one or more of the other reasons leading to the denial of accreditation have not been resolved. When the HCF is denied accreditation, it is prohibited from participating in the accreditation program for a period of six months unless the Director General of CBAHI, for good reason, waives all or a portion of the waiting period. - Overall score less than 75%, or one of the core standards is not in full compliance, or an applicable standard scores less than 50%. - Presence of an immediate threat to the safety of patients, visitors or staff that is observed by CBAHI surveyors during the on-site survey. - Significant noncompliance with the accreditation standards at the time of the on-site survey. - Failure to submit the post-survey requirements in a timely manner. - The HCF was subjected to a focused survey but still could not meet the requirements for accreditation. - Reasonable evidence exists of fraud, plagiarism or falsified information related to the accreditation process. Falsification is defined as the fabrication of any information (given by verbal communication or paper/electronic document) provided to CBAHI by an applicant or accredited HCF through redrafting, additions or deletions of a document's content without proper attribution. CBAHI perceives plagiarism as the deliberate use of other HCF original (not common knowledge) material without acknowledging its source. - Refusal by the HCF to conduct a survey. A surveyed HCF can appeal the following accreditation outcomes: - Denial of Accreditation (provided this is not due to a failure to submit the post-survey requirements in a timely manner after granting accreditation or a failure to meet requirements after a follow-up focused survey). - Suspension/Revocation of Accreditation. All appeals shall be made within a maximum of fifteen (15) calendar days from receipt of the official survey report, through a cover letter sent from the center director to the CBAHI Director General via registered mail/fast courier. This should include documentation to support the argument for the appeal and a completed [Appeal Request Form] (ARF), located on CBAHI's portal. Letters sent via electronic mail or facsimile will not be considered. [Grounds for Appeal] -------------------------------- The HCF is entitled to an appeal if the appeal is based on one or more of the following grounds: - Relevant and significant information which was available to the survey team was not considered in the making of the accreditation decision. - The report of the surveyors(s) was inconsistent with the information presented to the survey team. - The existence of perceived bias among the surveyor(s). - Information provided by the survey team was not duly considered in the survey report. - The outcome of the appeal, if in favor of the appealer, will result in a change in the accreditation status. CBAHI will not consider appeals that will not result in a change of accreditation status. Upon the initial acceptance of the appeal request (only when clear and convincing evidence indicates that the facility sustained one of the grounds for appeal), the prior status of the HCF, if any, shall be restored pending disposition of the appeal. The appeal request shall set forth the specific grounds for the request and shall include a statement of the reasons for each ground, along with any other relevant statements or documents the HCF wishes to include. A HCF applying for an appeal must identify the specific alleged procedural failures or the specific manner in which the decision was arbitrary or unreasonable and not based on, or consistent with, CBAHI standards and policies. After a study of all relevant reports and evidence, one of the following decisions shall be made and communicated to the appealer in a timely manner: - The adverse decision is upheld. - The healthcare facility's appeal is upheld, and the denial of accreditation is modified or reversed. In this circumstance, a full or focused re-survey may be decided upon. CBAHI has redesigned its accreditation to represent a continuous process versus a once-everythree-years evaluation. Accredited HCFs must maintain their accreditation status by showing their continued compliance with the standards and requirements of CBAHI throughout the accreditation cycle and in accordance with the specified time frames. This translates into **standing** and **ad hoc** requirements. **[Standing Requirements for Accreditation Maintenance]** [1- Corrective Action Plan (CAP)] --------------------------------------------- [2- Midterm Self-Assessment] ---------------------------------------- [2- Notification of significant changes ] ----------------------------------------------------- Accredited HCFs must notify CBAHI in writing about any significant structural/functional/regulatory changes that took place after the accreditation survey, no more than thirty (30) days after the initiation/occurrence of such changes. These changes include, but are not limited to the following: - A national regulatory body has mandated closure for all or part of the HCF. - HCF accreditation by other international accrediting organizations has been suspended or revoked. - A new service is initiated for which CBAHI has standards, and that was not included in the last survey. - Any of the services are being offered in a new location or branch. - Major construction/destruction/renovation work (building, floor or unit) has been undertaken. - A significant (30% or above) increase (or decrease) in the volume of services has been experienced. - The HCF has merged with or acquired an unaccredited facility. - A significant change has occurred in the governance or ownership. CBAHI will evaluate the impact of these changes, and a decision for conducting a focused survey may be warranted accordingly. A delay in notifying CBAHI of such significant changes in an accredited facility by more than sixty (60) days from the due date, without a justification acceptable to CBAHI, may result in temporary suspension of accreditation, followed by revocation of accreditation if the total delay exceeds ninety (90) days. A sentinel event is defined as any event leading to serious patient harm or death and that is caused by healthcare rather than the patient's underlying illness. By investigating sentinel events, we can identify deficiencies in healthcare systems and processes and put actions in place to prevent recurrence. CBAHI has adopted the following as must-report events: - Unexpected death - Wrong patient, wrong procedure or wrong site - Retained instrument or sponge - Medication error leading to death or major morbidity - Infant or child abduction - Unexpected loss of a limb or function The policy of CBAHI on sentinel events calls for the following: - Open disclosure/open communication: Patients and their families are entitled at all times to truthful and transparent communication and explanation of any sentinel events happening to them. - When a reportable sentinel event occurs in an HCF accredited by CBAHI, it must be reported to CBAHI as indicated in the relevant policy. Healthcare facilities that are not accredited by CBAHI are encouraged, but not required to report. Outside reporting, CBAHI may become aware of the occurrence of a sentinel event through a communication from one of CBAHI's surveyors, from the media, from a patient or relative, from the healthcare facility's employees or through other means of communication. - CBAHI is interested in knowing about reportable sentinel events when they occur in accredited facilities for learning and disseminating lessons learned to the medical community, thereby avoiding the recurrence of such events in the future. Medical errors and adverse events are opportunities for education and quality improvements. - Reporting must be safe. Patients, families, and staff are encouraged and should be empowered by the HCF leadership to report any sentinel event without fear of retribution. CBAHI has zero tolerance for accredited HCFs taking disciplinary actions against a staff member who reports a sentinel event. If the disciplinary action proves to be related to reporting, this might negatively impact the HCF's accreditation status. - The HCF must report to CBAHI all sentinel events by filling out and submitting the Sentinel Event Reporting Form (SERF), which is available at the CBAHI portal, within five (5) working days of the internal notification of the sentinel event (the date when the relevant authority in the HCF was notified of the incident). This should be followed by a Root Cause Analysis (RCA) and Risk Reduction Action Plan within thirty (30) working days from the date of notification of the sentinel event. Root Cause Analysis is a formal process of investigation designed to identify the root causes of adverse events. - CBAHI will study the sentinel event report for further action as appropriate. This includes the submission of a progress report to show the progress made in implementing the risk reduction plan and eliminating the chance of recurrence. It might also include a validating focused survey scheduled or unannounced at CBAHI's discretion. - The outcome of a reported sentinel event is dependent on the level of commitment the HCF demonstrates towards studying the root cause(s) of the incident and [redesigning its processes and systems] to prevent recurrence. When CBAHI is persuaded of this constructive approach of the concerned HCF in dealing with sentinel events, accreditation is usually maintained. When this is not the case, CBAHI will pursue this further to decide on the HCF's eligibility to maintain its accreditation until the required corrections are made. In other situations, in which the accreditation certificate is less than six (6) months, and CBAHI is not persuaded that the corrections have been made, an early full re-accreditation survey may be warranted. CBAHI expects nothing but truth, honesty and sincere intentions in all dealings and propositions from HCFs engaged in its accreditation program. This "good faith" engagement applies continuously throughout the accreditation cycle, and the HCF must ensure that it is not violated. In addition, accredited HCFs must maintain the same momentum both before and after accreditation. Some might argue that it is a natural tendency to ease back after a survey visit, but compliance with the standards must not drop simply because the survey is completed, and accreditation has been awarded. If CBAHI becomes aware, by any means of an accredited HCF that is not in compliance with the standards, CBAHI will verify the situation and take appropriate action. CBAHI may receive information regarding possible violations from accredited HCFs through several channels, most importantly reports of related government agencies, written or verbal complaints and the media. Types of violations include, but are not limited to, the following: - CBAHI becomes aware of the presence of an immediate threat to the safety of patients or staff in an accredited HCF. - The HCF is not committed to the specified timeframes for accreditation, for example maintenance of timely submission of a corrective action plan after accreditation or timely submission of a midterm self-assessment. - The HCF failed to report a sentinel event as per the relevant policy without an acceptable justification. - The HCF is committing an act of misuse (see the policy on accreditation certificate and seal), deception or any deliberate misrepresentation of the truth (see the policy on truthfulness and the ethics clause). - The HCF is discouraging communication or taking disciplinary action/reprisal against patients or staff members trying to communicate directly with CBAHI about concerns regarding safety or quality of care. - The HCF intentionally lacks commitment to continuous compliance with CBAHI standards. This might represent an overweening behavior and is a strong violation of the CBAHI accreditation process. - The HCF is deliberately violating any of the other accreditation policies mentioned in this manual or other supporting documents and manuals provided by CBAHI for accreditation. Once CBAHI is convinced that one or more of the aforementioned violations exists in an accredited HCF, it responds by taking one of the following actions, in any order: - Issuing a letter of "At Risk of Suspension of Accreditation" - Suspension of Accreditation - Revocation of Accreditation CBAHI determines the level of response to a certain violation based on several factors, including the severity of the violation, its frequency, previous accreditation history, the source of information regarding the violation, and the findings and conclusion of CBAHI's inquiry. When necessary, a focused or full survey might be conducted for validation purposes before a response can be given or an action taken. This kind of survey is always for one or more of the above causes (e.g., when concerns have been raised about an accredited facility's continued compliance with CBAHI standards). An accredited HCF may undergo a survey at any time, at the discretion of CBAHI, and the survey is usually unscheduled (the HCF receives 48 hours' notice before the survey) or unannounced (without advance notice) depending on the seriousness and type of violation. Surveys can include either all of HCF's services or only those areas in which a serious concern may exist. HCFs are usually charged for these surveys, regardless of the outcome, and results can affect the HCF's accreditation status. If the HCF does not allow CBAHI surveyors to conduct the survey, CBAHI may change the facility's status to Revocation of Accreditation. It should be noted that when the facility's accreditation is suspended, the facility can regain accreditation once the causative violation has been rectified. However, suspension will not be lifted before a prohibition period of twelve (12) months from the date of suspension. Revocation of accreditation is a more serious consequence that prohibits participation in the CBAHI accreditation program for a minimum of eighteen (18) months from the date of revocation. In both suspension and revocation of accreditation, CBAHI will communicate the new accreditation decision to the relevant authorities and display it on its website. The Director General of CBAHI, for a good reason, can waive all or a portion of the prohibition period. To support CBAHI's ongoing quality assurance initiatives, an accredited facility may be selected for a random survey from nine (9) to thirty (30) months after an accreditation survey. Random surveys are unannounced. A five percent sample of all accredited HCFs is randomly selected each year for this activity. These random, unannounced surveys are a means by which CBAHI evaluates the consistency and quality of its program, while also demonstrating to the public and regulators that accredited HCFs remain committed to CBAHI standards throughout the accreditation cycle. Random surveys also provide CBAHI and its surveyors with opportunities to further consult with accredited HCFs in the interval between regular surveys. No fee shall be charged to the HCF when a random survey is conducted. The HCF may be selected for a validation survey visit as part of an inter-rater reliability program for CBAHI surveyors within one (1) month after receipt of the accreditation decision report. This visit outcome has no impact on the accreditation status granted in the real accreditation survey visit. The HCF will not bear any cost. Once accreditation is granted, HCFs are encouraged to display the CBAHI logo, accreditation certificate and seal on the facility's bulletin boards, banners, website, newsletters, brochures and headed stationery. CBAHI requires all accredited healthcare facilities to follow the guidelines and conditions for the appropriate use of the CBAHI logo, accreditation certificate, and seal. Specifically, CBAHI works to ensure that no accreditation material is used in a way that may mislead the public or others or provide false information related to a healthcare facility's accreditation status. Upon receiving the certificate package, accredited HCFs are required to sign and return a disclaimer/guidelines form related to the conditions of display and publication of the CBAHI logo, accreditation certificate, and seal. These include: - The printing of the accreditation seal is accurate and legible, with no degradation or distortion. - The size of the CBAHI logo and its accreditation seal should remain in the same permitted proportion as that provided. - The CBAHI logo, certificate, and seal should be used in the same format, with no extra graphics or words. - The HCF employs the same colors used in the CBAHI logo, or black and white when the logo is used for certain printed materials such as newspaper advertisements, newsletters, brochures, flyers, and posters. - The HCF is prohibited from using the CBAHI logo or accreditation seal on business cards. - Upon expiry of the certificate validity period, or suspension/revocation of the accreditation, the HCF shall immediately take action within a maximum of thirty (30) days to refrain from using the CBAHI logo, accreditation certificate, and seal. Failure to comply with the specified timeframe might subject the HCF to the appropriate decision according to the policy on accreditation suspension and revocation. CBAHI acknowledges that HCFs undergoing its accreditation survey are expected to provide access to information related to the evaluation of their compliance with CBAHI standards. As a guiding policy, to HCFs engaged in its different accreditation programs, CBAHI commits to keeping confidential all information obtained or received during the accreditation process, including all survey data and information that surveyors come across during the survey process. For an HCF that is a participating member of the CBAHI accreditation program, some information is subject to public release. This includes: - The healthcare facility accreditation status being posted on the CBAHI website. - The areas of the HCF that were included in the accreditation survey. - The standards under which the accreditation survey was conducted. Other accreditation-related information is not subject to public release except to the HCF in question. The exception to this rule is when the CBAHI receives an official request for clarification from relevant health authorities or public health agencies. This information includes: - The mock and final accreditation survey reports. - Accreditation Committee minutes and agenda materials. - The notification letter of the survey report to the healthcare facility's director. - The accreditation certificate. - The post-survey requirements, including any CAPs. - The results of investigations related to a sentinel event, including the root cause analysis prepared in response to that event. - The results of investigations involving any falsified information the healthcare facility provided to CBAHI. - Any other information related to compliance with CBAHI standards obtained from the HCF before, during or after the accreditation survey. CBAHI is interested in collecting information from a variety of sources to improve the quality and safety of all accredited HCFs. One of these sources is complaints from patients, their families, HCF staff, government agencies, the media and the public. In particular, staff members at any given HCF accredited by CBAHI must be informed that they may make complaints directly to CBAHI without fear of retaliatory actions from their HCF. CBAHI addresses all complaints that would help identify possible noncompliance with its accreditation standards, thereby posing a possible threat to the safety of patients, staff or the public. More precisely, CBAHI can evaluate complaint information only in terms of its relevance to compliance with CBAHI's standards. Issues of a personal nature or individual disputes should be dealt with by the concerned facility or the regional health authority. CBAHI cannot follow up on complaints about HCFs which are not accredited. When CBAHI receives a complaint against an accredited HCF, CBAHI will conduct an initial screening to determine its relationship to standards and its impact on patient safety. If the complaint does not relate to compliance with CBAHI standards, a response of "non-relevance" will be forwarded to the complainant, who will be advised to forward the complaint to the HCF leadership or the regional health authority. If the complaint relates to compliance with one or more CBAHI standards, a response shall be made accordingly. The response will depend on a risk assessment matrix that determines the probability and severity of the complaint. CBAHI will check for other complaints about the same HCF. Broadly speaking, CBAHI will give one or both of the following responses: - CBAHI may write to the HCF about the complaint. When requested, the HCF must make available its records of complaints and subsequent actions taken. - CBAHI may decide to visit the healthcare facility to verify whether a problem exists in terms of meeting the standards involved in the complaint. Such visits are usually unannounced, and the outcome may change the accreditation decision. It is CBAHI policy not to disclose any information related to patients or complainants unless it is authorized to do so. In addition to information about the complaint's relevance to CBAHI standards, the complainant will receive the following information: - The course of action CBAHI took regarding the complaint. - Whether CBAHI has decided to take action regarding an HCF accreditation decision following completion of the complaint's investigation. To file a complaint against a CBAHI-accredited healthcare facility, an individual can send his/her concern via the contact form on the CBAHI website. The individual can also file the complaint directly by calling the Universal Access Number . CBAHI requires that the complainer reveal his or her identity. Therefore, CBAHI will not consider anonymous complaints. CBAHI works to ensure the integrity and fairness of all businesses conducted by employees working in the central office as well as the surveyors. In addition, all healthcare facilities engaged in the CBAHI accreditation process are required to refrain from any actual or potential act or behavior that might create a conflict of interest, including: - Proposing any fee, remuneration, gift or gratuity of any value to CBAHI employees or surveyors for performance of their duties or survey-related activities. - Employing, contracting or having any financial relationship with CBAHI employees or surveyors for the purpose of providing consulting or related services in any capacity, either directly or through another party. This includes services provided in preparation for the survey, assisting in preparation of the self-assessment, conducting mock surveys, helping with the interpretation of the standards and the like. All requests for consulting services utilizing CBAHI employees or surveyors shall be directed to CBAHI. - Not declaring to CBAHI any business (including consulting) or recruiting relationship with one or more CBAHI surveyors either directly or through another party with whom he or she is affiliated at any time during the preceding three (3) years. CBAHI strives to maintain the highest ethical and legal standards in the conduct of its business. This includes honesty, transparency, and truthfulness in all its dealings, with avoidance of all situations that might appear unethical or illegal. The same is expected from the HCFs seeking CBAHI accreditation. CBAHI employees are committed to politely declining any gifts or gratuities offered to them or to members of their families, including spouses, children, and parents, when the donor expects something in return. Such gifts or gratuities may be attempts to gain an unfair advantage or influence the manner in which the employee or surveyor performs his/her job duties. Gifts of nominal value may be accepted as tokens of appreciation or goodwill provided they are given as gestures of a professional relationship and do not involve or create the appearance of any commitment in terms of survey results or accreditation decisions. Business lunches, tea, coffee and snacks during the survey are permitted. Other social gatherings are prohibited, and HCFs are encouraged to not offer such to the survey team. Using the HCF vehicle to transport the survey team to and from the survey site is acceptable. CBAHI's confidential and proprietary business information is safeguarded and is utilized only in keeping with the best interests of CBAHI, its obligations to third parties, and the highest ethical and legal standards. Such information must not be disclosed to a third party without prior approval of a duly authorized member of CBAHI management for an acceptable reason. CBAHI maintains the confidentiality of all data and information about both CBAHI and HCFs in accordance with CBAHI's core values and relevant policies. CBAHI is also committed to resolving complaints and ethical issues raised by CBAHI employees or client HCFs to ensure justice, confidentiality, impartiality, timeliness and feedback to the complainants. Leadership of the Organization (LD) =================================== For any ambulatory care center, quality and patient safety depend on effective leadership. Ambulatory care centers may vary in size, type of ownership and complexity of services. The owner of the center may be a single private owner, a group of private owners, or a governmental entity. In all cases, the owner (private or governmental) constitutes the center's governing body or governance. The governance or governing body is responsible for providing safe and quality patient care. The center's director, whom the governing body selects, is accountable for ensuring the provision of safe and quality patient care. The center may be directed by a single owner who maintains the dual role of governance and leadership Large centers may have several divisions, such as nursing, medical, administrative, and facilities, among others. A director manages each division. In such large centers, the center's director and division directors constitute the leadership group. In small centers, leadership may be presented only by the center's director. It is crucial for all ambulatory care centers to have a clearly stated mission. The leadership of the center is responsible for developing the mission and providing adequate resources, through the governing body, to fulfill this mission. Ambulatory care centers are of a much smaller size and are much less complex than hospitals. Therefore, it is expected that the leader(s) will carry out most of the administrative work, as explained in the following standards. The leadership chapter addresses the following: - Organizational structure - Structure and function of the governing body - Roles and responsibilities of the center's leaders o Mission and vision and values, scope of services and strategic planning - Effective human resource management - Staffing plan - Job descriptions for all types of employees - Staff recruitment - Credentialing and privileging - Staff orientation and education - Staff performance evaluation - Staff health and safety programo Patient and family rights - Quality improvement and patient safety - Developing and maintaining center's policies - Developing and supporting a quality improvement and patient safety program - Developing and supporting a risk management program - Contract oversight - Supplies oversight LD.1.5. The governing body defines any approval authority delegation. Explanation ----------- The governing body (owner(s), board of directors) should highlight its structure, role, and responsibilities in a written document. Roles and responsibilities include approval o f strategic and operational plans and budget, mission and vision, scope of services, the risk management program, and policies and procedures. Roles and responsibilities of the governing body also include appointing the center's director and defining any leadership delegation authority that highlights the person responsible for managing the center in the absence of the center's director. Explanation ----------- The governing body should ensure patient, staff and visitor safety by approving the q uality and patient safety and risk management programs and periodically evaluating their effectiveness. At least every three months the governance should receive reports on selected i ndicators, all safety concerns that staff reported, all medical complications, and all financial and other administrative risk issues. Governance, together with leadership, s hould work to formulate an action plan to prevent errors and mitigate risk. Governance should observe and document the implementation and outcomes of corrective actions. LD.3.2 The organizational chart is communicated to all staff. Explanation ----------- Efficient and effective healthcare organization management requires effective staff communication and clear reporting lines. The organizational chart should be developed to present the relationship between the governance (the owner or board of directors) and the center's managing director(s), and between the managing director(s) and the front-line staff. Managerial positions in the chart should be reported by title and name. All center staff should be aware of their position in relation to the organizational chart and their line of command and required reporting. The chart should be updated regularly, s igned by the center's director and communicated to staff and displayed clearly in the center. Explanation ----------- The center must be managed daily by a director. The job description of the center's director clearly highlights his/her roles and responsibilities as well as the required job q ualifications and experience. The director is responsible for the center's compliance with a ll applicable governmental laws and regulations, including, but not limited to, patient care regulations, medication management, MOH regulations for the opening licensure, staffing licensure and certification, civil defense requirements, municipality requirements, and MOH reportable diseases. The director is responsible for responding to all governmental inspections, including clear action plans for compliance. Accreditation of the center by the CBAHI is the ultimate responsibility of the center's director. The director ensures the a vailability of the adequate number and the right mix of staff required for the day-to-day activities. He/she also ensures the continuous availability of the required supplies, medications, and resources to safely run the center. The director recommends all required policies, procedures, protocols, and clinical practice guidelines that are required for the clinical, managerial and financial integrity of the center. The director ensures the facility is designed to deliver the intended services in a safe and secure environment for patients, staff and v isitors. Explanation ----------- The center shall function according to a predefined scope of services document d eveloped collaboratively between governance and the center's leaders (the center's d irector, medical director, nursing director, human resources director, finance director, and administration director, as applicable). The scope of services includes the range of clinical s ervices in each provided specialty based on the center's location and the community n eeds (i.e., preventive, health promotion, curative, and rehabilitative). The scope of services includes t he number of clinics for each specialty, age group, and working hours. The average number of patients anticipated to be seen, as well the maximum number who can be seen, should also be highlighted. The scope of services also includes the level of professional coverage for example consultants versus specialist. Explanation ----------- Ambulatory care centers require forward planning to continue their mission and achieve their vision. The planning may include mastering current services (centers of excellence) or introducing new services. This strategic planning should be based on a comprehensive evaluation and analysis of the internal and external operational and environmental factors that may affect the center's mission and vision, such as SWOT analysis and PEST analysis. The plan should have clear goals and objectives to achieve in a time frame. LD.7.4. The plans are communicated to department directors and other staff. Explanation ----------- Strategic plan should be converted into an operational plan that contains steps to follow and staff to lead and execute. Plans and resources are all approved by governance and tabulated for further timely implementation. Staff involved in and/or affected by the plan should be informed accordingly. Explanation ----------- The leaders should develop an annual budget. This budget should take into consideration any additional cost for replacing or upgrading equipment, upgrading services, and periodic maintenance and repair. The budget should be distributed between the different patient care areas (e.g., space, equipment, supplies, staffing, and other resources) to ensure seamless and safe patient care. Explanation ----------- All staff should know the center's mission and vision, and any amendments or changes should be communicated to staff. The services should be evidence-based, and all policy and practice guidelines that he leaders develop should be based on referenced and updated practices. Regular leadership meetings shall take place to ensure that all plans are carried out effectively, and that policies and practice guidelines are followed. Plans, policies, and practice guidelines should have process indicators to ensure staff compliance, and outcome indicators to ensure their effectiveness. LD.10.1. The staffing plan ensures that services meet the needs of safe patient care. ---------- ----------------------------------------------------------------------------------------------------- LD.10.2. The staffing plan defines the number, type, and credentials of required staff, and their roles. LD.10.3. The center recruits and assigns appropriately qualified staff in accordance with the staffing plan. Explanation ----------- The center's leaders (the HR director together with the center director, medical director, nursing director, and administrative director) should formulate a staffing plan for the c enter based on the scope of services the center provides and the center's capacity and working hours. The plan should include the number, type, and qualifications of staff required in all the center's areas (medical and non-medical) to ensure safe patient care, according to MOH rules and r egulations, and the smooth operation of other administrative areas. LD.11.1. The policy and procedure highlight the receiving authority(s) of staff resumes, the shortlisting process, and the accepted method for interview. ---------- -------------------------------------------------------------------------------------------------------------------------------------------------- LD.11.2. Applicants are informed of their acceptance or refusal within a set time frame. Explanation ----------- For the center to recruit the right staff, it must have a policy and procedure for staff recruitment. The policy highlights the shortlisting process whereby all applicants' CVs are reviewed to ensure that they match the description of the job for which the candidate applied. An objective process must exist for assessing the interviewee or the applicants; this process must include an approved interview form. The applicants should be informed of their acceptance or denial of appointment within the time frame specified in the policy. LD.12.1. The job description outlines the knowledge, skills, and attitude necessary to perform the job responsibilities. ---------- -------------------------------------------------------------------------------------------------------------------------------- LD.12.2. The job description clearly defines roles and responsibilities for the position. LD.12.3. Job responsibilities and clinical work assignments are based on evaluation of staff credentials. LD.12.4. The job description is discussed with and signed by the employee upon his/her hiring and is located in his/her personnel file. Explanation ----------- For smooth operational performance and accountability, each staff member must have his/ her own job description that outlines daily responsibilities, necessary qualifications, skills, and experience. This job description shall help in recruiting the right staff for vacant positions and shall constitute the basis for the staff evaluation, whether it is probationary or carried out at the end of the year. This job description must be discussed with each staff personally, and it must be signed at the time of hiring to acknowledge that the staff are fully aware of the job, its requirements, and responsibilities. ---------------- **LD.13. (C)** ---------------- LD.13.1. The credentialing process applies to all clinical staff members: medical staff, nursing staff, and other clinical staff licensed to provide patient care. ---------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ LD.13.2. The credentialing process includes gathering, verifying, and evaluating credentials including license, education, training, experience and competence. LD.13.3. To the extent possible, the credentials are verified from the original source directly or through a third party with documented evidence. LD.13.4. The center ensures the registration of healthcare professionals with the Saudi Commission for Health Specialties and licensing by the Ministry of Health in accordance with laws and regulations. LD.13.5. The credentialing process guides the appointment of healthcare staff to their appropriate job assignment and is repeated every two (2) years to ensure that staff are still capable of performing their job functions. LD.13.6. Information about staff credentials, privileges, competencies, orientation, training, education, and evaluation are kept securely in an updated personnel file. Explanation ----------- The center must make all efforts to ensure the placement of new staff in the right position initially, and every two years thereafter. This process of credentialing applies to all clinical staff licensed to provide patient care (physicians, nurses, physiotherapists, technicians). The credentialing process involves collecting all the information related to the staff (education, training, experience, competencies, and licensure), verifying it from the primary source, and evaluating it to ensure the staff fits in his/her assigned position. The center ensures that all healthcare professionals are registered with the Saudi Commission and licensed by the MOH according to rules and regulations. All staff who are credentialed and approved to work in the center should have a record of their credentials kept safely with the administration. The process is repeated every two years to ensure that staff remain authorized and capable of providing the same job functions. ---------------- **LD.14. (C)** ---------------- LD.14.1. The center has a policy and procedure for granting privileges to medical staff. ---------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------- LD.14.2. Clinical privileges are determined based on the center's documented competency and available services. LD.14.3. The medical staff's clinical privileges are recommended by the medical director and approved by the governing body, either directly or by appropriate delegation. LD.14.4. The clinical privileges are reviewed and updated every two (2) years, and earlier if needed. Explanation ----------- The privileging of physicians is the most rewarding proactive risk management approach with respect to patients' safety. It allows physicians to perform procedures and surgeries for which they have been made qualified by education, training, and certification. This prevents patients' exposure to risk of morbidities. Each physician should have a list of the invasive procedures that he/she is allowed or privileged to perform. The center must have a policy and procedure for granting individual privileges. Clinical privileges should be distributed in the areas where the physician is practicing. The privileging process should be reviewed and updated every two (2) years, and earlier if a physician receives new training on a certain procedure or is found to be potentially dangerous in performing other procedures. LD.15.1. The new employees' general orientation program includes information about the center's mission, vision, values, and organizational structure; patient and family rights; safety and security; the basics of infection control; and an introduction to the center's quality and patient safety and risk management programs. ---------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- LD.15.2. Each new employee attends a department-specific orientation program, including specific infection prevention and safety issues, that helps in executing the specific job responsibilities as outlined in the job description. LD.15.3. The new employee orientation is documented in the employee's personnel file. Explanation ----------- All new employees (full-time, part-time, visiting, and volunteers) should be oriented to the center. A general orientation should include information about the center: - Mission, vision, and values - Current organizational structure - Code of conduct and ethical framework - Patient and family rights - Safety and security - Infection control - Quality and patient safety and risk management programs The orientation also includes a specific job orientation, which teaches the staff the requirements for patients' assessment and documentation, and how to deal with patient transfers, among other essential processes in the staff's area of practice. Policies related to vacations, penalties, grievances, and separation may be compiled into a manual that is provided or accessible to staff. LD.16.1. The policy contains a list of procedures requiring competency assessment in each and every staff category. ---------- ------------------------------------------------------------------------------------------------------------ LD.16.2. All newly hired staff are initially tested for the required competencies. LD.16.3. All staff are tested annually for the required competencies. LD.16.4. All test results are available in staff personal files. Explanation ----------- To ensure patients' safety, staff must be tested both and annually on their competency in certain procedures, according to their scope of work, such as: - Taking blood samples - Inserting intravenous lines - Inserting an indwelling urinary catheter or simple urinary catheterization - Inserting nasogastric tubes - Performing electrocardiograms and cardiotocography - Infection control practices and precautions (isolation procedures, hand hygiene, the use of personal protective equipment, preventing needle stick injuries) Positioning patients for common radiological procedures Competency assessment results are documented in staff personal files for evidence and monitoring of compliance with the policy. LD.17.1. A policy is in place to ensure staff are trained on the safe operation of the current and newly introduced equipment and medical devices. ---------- ------------------------------------------------------------------------------------------------------------------------------------------- LD.17.2. The policy addresses the required training and competency testing of staff operating specialized equipment. LD.17.3. Only trained and competent staff handle specialized equipment and medical devices. Explanation ----------- To safely operate medical equipment, reducing risk to patients and staff and increasing operational efficiency, staff must receive appropriate training on this medical equipment. Periodic competency testing is required, and newly introduced equipment should not be used until staff are trained and tested competent on its use. LD.18.1. The center has a scheduled educational and training program based on the center's needs and person-centred care including quality, patient safety, risk management and infection control practices. ---------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- LD.18.2. The leaders grant financial support and/or time off for staff to attend educational and training activities relevant to the center's scope of services and in line with labor law. LD.18.3. Employees' records show documented evidence of training and education. Explanation ----------- Staff professional development is important for improving the center's services. The center should drive continuous medical and nursing education and other categories of staff. The simplest way is to provide a scheduled educational program fulfilling person-center care and the center's scope of services and needs, including quality, patient safety, risk management and infection control practices, patient/service user rights, complaint management, shared decision-making, communication skills, informed consent, and the cultural beliefs, needs and activities of different patient/service user groups. Also, the center can grant either financial support or time off so that staff can attend conferences, symposia, training courses and other educational activities. Employees' personnel files should show documentation of training and education. LD.19.1. All staff members who provide direct patient care receive training on basic life support (BCLS). ---------- ------------------------------------------------------------------------------------------------------------------------------------------------- LD.19.2. The center identifies other staff members to be trained in advanced life support as appropriate to the age groups they serve (ACLS, PALS, NRP). LD.19.3. All staff maintain the validity of their life support certification. Explanation ----------- Although the scope of services of most of the centers does not include high-risk patients, sudden cardiopulmonary arrest may occur and potentially be lethal. Therefore, all staff members providing direct patient care must have at least basic life support skills and certification. The center should also identify other staff members who will be required to receive training in advanced life support, such as those serving in emergency rooms. Age group life support skills and certification may also be warranted for advanced pediatric life support and neonatal life support. LD.20.1. The performance evaluation is based on objective criteria and is consistent with the expected competencies such as knowledge, skills and attitude required to perform the employee's job responsibilities as outlined in his/ her job description. ---------- -----------------------------------------------------------------------------------------------------------

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