Ambulatory Health Care Standards Saudi

Central Board for Accreditation of

Chapters Summary
Chapter No. Of No. Of Sub
Standards Standards
1 LD Leadership of the Organization 36 152

2 PC Provision of Care 15 58

3 LB Laboratory Services 12 82

4 RD Radiology Services 3 13

5 DN Dental Services 5 21

6 MM Medication Management 14 49

7 MOI Management of Information 7 28

8 IPC Infection Prevention and Control 14 49

9 FMS Facility Management and Safety 9 52

10 DPU Day Procedure Unit 12 66

11 DA Dermatology & Aesthetics 6 23

Total 133 593

Chapter I
Leadership of the Organization (LD)

LD.1
The governing body defines its structure and operational responsibilities in a written document.
The governing body (owner(s), board of directors) should highlight its structure, role, and responsibilities in a written document. Roles and
responsibilities include approval of 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.
LD.1.1
The governing body approves and periodically reviews, the center's mission, vision and values and
makes it public.
LD.1.2
The governing body approves the center’s scope of services, the center’s plans, programs and all policies
and procedures.
LD.1.3
The governing body approves the center’s operating and capital budgets, as well as other resources
required to manage the center efficiently.
LD.1.4
When the center is part of network, the governing body plans for services and functional relationships
among the network components.
LD.1.5
The governing body defines any approval authority delegation.
LD.1.6
The governing body appoints a qualified director responsible for managing the center.

LD.2
The governing body approves and evaluates the center’s quality and patient safety program and risk
management program.
The governing body should ensure patient, staff and visitor safety by approving the quality and patient safety and risk management
programs and periodically evaluating their effectiveness. At least every three months the governance should receive reports on selected
indicators, all safety concerns that staff reported, all medical complications, and all financial and other administrative risk issues.
Governance, together with leadership, should 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.2.1
The governing body annually approves the quality and patient safety program, including risk
management.
LD.2.2
The governing body receives and evaluates the quality and patient safety reports, including the
corrective actions and outcomes from the center, including risk management, at least quarterly.
LD.2.3
Recommended corrective actions by the governance are documented and received by the center director
for implementation.

LD.3
The center has a current organizational chart.
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, signed by the center’s director and communicated to staff and
displayed clearly in the center.
LD.3.1
An approved and updated organizational chart identifies the relationship between the center’s
governance, leadership, and other directors with names and titles.
LD.3.2
The organizational chart is communicated to all staff.
LD.3.3
The staff are aware of the organizational chart and its intent and can demonstrate their relationship to
it.

LD.4
The center is managed effectively by a qualified director.
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 qualifications and experience. The director is responsible for the center’s compliance with all
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 availability 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 visitors.
LD.4.1
The center director has a written job description and his/her qualifications match the requirements in
the job description.
LD.4.2
The center director, with other leaders, develops the mission, vision and values statements.
LD.4.3
The center director ensures the center’s compliance with all relevant laws and regulations.
LD.4.4
The center director recommends to the governing body required new policies for approval and ensures
compliance with approved policies.
LD.4.5
The center director ensures the availability of adequate and proper resources for the planned services in
accordance with the approved operating budget.
LD.4.6
The center director ensures a safe and functional facility environment for patients, visitors, and staff.

LD.5
The leaders together with governance develop the center’s scope of services based on community needs.
The center shall function according to a predefined scope of services document developed collaboratively between governance and the
center’s leaders (the center’s director, medical director, nursing director, human resources director, finance director, and administration
director, as applicable). The scope of services includes the range of clinical services in each provided specialty based on the center’s
location and the community needs (i.e., preventive, health promotion, curative, and rehabilitative). The scope of services includes the
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.
LD.5.1
The scope of services includes the range of coverage in relation to preventive medicine, health
promotion, curative and rehabilitative medicine.
LD.5.2
The scope of services includes the specialty services that the center provides, the number of clinics for
each specialty, the level of professional coverage.
LD.5.3
The scope of services includes the age group that can be served and the working hours.
LD.5.4
Services are displayed in the center, and patients and, when needed, families can obtain additional
related information from the reception staff.

LD.6
The leaders work collaboratively to develop the center’s strategic plan.
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.6.1
The strategic plan is guided by the mission, vision and inputs from patients/service users, their families,
staff and where possible the wider community.
LD.6.2
The strategic plan is based on a comprehensive evaluation of the internal and external environmental
factors.
LD.6.3
The strategic plan addresses all clinical and non-clinical services and programs.
LD.6.4
The strategic plan spans a period of three to five years and is reviewed on a regular basis.
LD.6.5
The strategic plan includes the broad goals and objectives required to fulfill the center’s mission.

LD.7
The leaders transform the approved strategic plan into an operational plan.
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.
LD.7.1
Goals and objectives are translated into operational plans with defined projects, clearly delineated
responsibilities, required resources and time frames.
LD.7.2
Governance approves the resources required for executing the operational plans.
LD.7.3
Operational plans are implemented and closely monitored for progress by structure and process
indicators.
LD.7.4
The plans are communicated to department directors and other staff.
LD.7.5
Department directors develop annual departmental plans in alignment with the center’s strategic plan.

LD.8
The leaders work collaboratively to develop the operational budget.
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.
LD.8.1
The leaders plan and budget for the upgrade or replacement of buildings, equipment, and other
resources.
LD.8.2
The budget process allocates resources to all patient care units based on the scope of care and
complexity of patient must ensure a safe and effective facility.
LD.9
The leaders work collaboratively to fulfill the mission and provide quality care.
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.9.1
The leaders communicate the mission, vision and values to all staff and customers.
LD.9.2
The leaders ensure the use of evidence-based and best practice information to develop and improve the
center’s services.
LD.9.3
The leaders work collaboratively to develop and carry out plans, policies, and procedures.
LD.9.4
The leaders meet regularly to review the key performance indicators of services, survey, audits and
feedback and use the collected data to improve the center’s operations.

LD.10
The leaders develop a staffing plan for the center.
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 center 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 regulations, and the smooth operation of other administrative areas.
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.

LD.11
The leaders develop a policy and procedure for staff recruitment.
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.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.

LD.12
All categories of staff have clearly written job descriptions.
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.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.

LD.13
The leaders develop an effective process for credentialing and re-credentialing all healthcare providers.
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.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.

LD.14
All medical staff members have current delineated clinical privileges.
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.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.

LD.15
All new employees attend a mandatory orientation program.
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.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.

LD.16
The leaders develop and implement a policy that ensures nurses and other allied healthcare staff are
competent in specific procedures.
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.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.

LD.17
The leaders ensure staff are trained and test competent in the safe operation of equipment including
medical devices.
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.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.

LD.18
The leaders support continuing education and training for all categories of staff.
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.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.
LD.19
Staff are trained and kept up to date with cardiopulmonary resuscitation.
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.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.

LD.20
The leaders develop an effective process to evaluate staff performance at least annually.
To ensure satisfactory staff performance according to job descriptions and privileges, a standardized objective process for gathering and
assessing the staff’s performance, scope of practice, professional development, and attitude must be developed for each staff category. The
evaluation is carried out at the end of the initial probationary period and at least yearly thereafter. Staff should acknowledge their
performance and comment on any required actions for improving their performance as set forth by their supervisors. The performance
evaluation should always include goals to achieve for the next year (part of the evaluation for the next year). Both the employee and his/her
supervisor sign the performance evaluation, which is kept in the employee's personnel file.
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.
LD.20.2
The evaluation is done at the end of the initial probationary period and annually thereafter.
LD.20.3
Staff are involved in the evaluation of their performance by commenting on the required corrective
action.
LD.20.4
Evaluations include personal goals to achieve for the next year that the employee will carry out.
LD.20.5
Both the employee and his/her supervisor sign the performance evaluation, which is kept in the
employee's personnel file.
LD.21
The leaders implement a comprehensive program to protect the health and safety of staff.
The health and safety of staff are vital for the provision of best care. A staff health and safety program should be available in all healthcare
organizations. The program should cover working areas to reduce occupational risks. There should be a vaccination program to protect
staff liable to infection from common viral illness (e.g., varicella zoster and hepatitis B). Staff working in offices should receive random
checks of their posture behavior and their furniture to ensure its safety for their extended office hours. Manual workers should receive
information about the safe handling of goods and about avoiding strains and sprains and should be monitored for the implementation of this
information. The program should have a policy for the prevention of needlestick injuries and other occupational hazards, such as radiation
and chemical exposures. The program should also focus on the use of personal protective clothing and equipment when dealing with
infectious diseases patients. The program should focus on security issues to manage violence and aggression against staff. The program
should be well coordinated with the quality and patient safety and risk management programs. Reports about staff health and safety should
reach the governance as per requirements for the quality and patient safety program. Staff files containing information about staff
members’ vaccinations and illnesses should be available and kept safe and secure.
LD.21.1
The program covers all employees and is consistent with laws and regulations.
LD.21.2
The program is based on the protection of staff from occupational health and safety hazards and
violence in the workplace.
LD.21.3
The program is coordinated with the center’s quality, safety, risk management, and infection control
programs, including health screening, immunization, and post exposure management.
LD.21.4
Staff have confidential and secure medical records that reflect their health status.

LD.22
The leaders support and protect the patient and family rights.
Patient and family rights and responsibilities are paramount for ethical and safe patient care. The leaders should develop all policies and
procedures pertaining to patients and family rights, including the bill of rights. Such policies and procedures should be available to patients
and their families in written documents that are close at hand or clearly displayed in the center. The leaders ensure that staff are fully
aware of – and trained on executing – the rights and responsibilities. The leaders should exert all efforts to ensure that patients are treated
with dignity and that their privacy is always respected. Leaders should also ensure the safety and security of patients' personal belongings.
Patient and family rights respect their preferences and choices to the extent possible within rules and regulations.
LD.22.1
The leaders develop and maintain a patient rights and responsibilities statement and develop processes
that support their implementation.
LD.22.2
The leaders ensure that patient rights and responsibilities are available to patients and families and
ensure patients are informed about their rights and responsibilities in a manner they can understand.
LD.22.3
The leaders ensure that patients’ dignity, privacy and confidentiality are respected.
LD.22.4
The leaders ensure that staff are provided training and education on patient and family rights and
responsibilities.
LD.23
The leaders ensure that patients/families have the right to be involved in their own care and treatment.
Patients and their families should be granted the right to be informed of their illness, the proposed treatment, the cost incurred, and the
prognosis of their treatment in a manner and language they understand. Patients should agree to their care plans and should have the right
to manage their pain effectively. Patients are granted the right to ask for a second opinion if necessary, without fearing that their care may
be compromised. Patients have the right to request a detailed medical report to be presented to other centers and sick leave notification for
regulatory purposes.
LD.23.1
Patients/families have the right to be informed of their illness, the proposed treatment and its prognosis.
LD.23.2
Patients/families have the right to be involved in the decision making of their care plans.
LD.23.3
Patients/families have the right to professional assessment and management of pain.
LD.23.4
Patients/families have the right to refuse or discontinue treatment or ask for a second opinion.
LD.23.5
Patients/families have the right to request a detailed medical report and sick leave notification.

LD.24
The leaders develop and implement a policy and procedure to describe the patients’ right to voice their
complaints and concerns.
Patients' satisfaction is a measure of their appreciation of the services that the center provides. Patients' complaints identify areas that
require the immediate attention of leaders. The leaders support the patients in their right to complain in a manner they prefer. The
complaint system is the responsibility of the patients’ relations officer or similar staff, who should have a policy and procedure to follow.
Every effort must be made to finalize patients’ complaints in a time frame defined in the policy. All complaints are analyzed and trended,
and information presented to leaders for corrective actions is to be developed and implemented. Patients' satisfaction surveys should be
conducted at least quarterly. Information and action plans from complaints and surveys should be included in the quality and safety
program and reported to governance.
LD.24.1
Patients’ complaints are resolved in a time frame described in the policy.
LD.24.2
The center assigns a staff member responsible for managing complaints.
LD.24.3
Patient satisfaction surveys are conducted at least quarterly.
LD.24.4
Data collected from surveys and complaints are analysed and trended, and the information collected is
used for improvement and integrated into the quality and safety program.
LD.25
The leaders ensure that patients/families have the right to accurate billing for provided services.
The center’s price list should be accessible to patients and families and a receipt should be given for services rendered, including insurance
patients. It is the right of the patient and family to receive an initial estimated cost for their treatment if requested. The request for an
itemized bill should be honored if requested by patients and families unless the service given is under the price list of a “package deal”.
LD.25.1
The leaders ensure the availability of the price list for services provided to patients and their sponsors.
LD.25.2
The patients and families have the right to receive an initial estimated cost of required services.
LD.25.3
The patients and families have the right to obtain an invoice for services rendered.

LD.26
The leaders develop ethical standards to guide patients’ care and employees’ code of conduct.
The leaders are responsible for developing the framework that governs how patient care is conducted in an ethical manner across the
center's activities. The values and professional code of conduct describe the center’s expectations of staff regarding their behavior and
communication with each other and with their patients. This includes the ethical portraying of services; reasonable and accurate billing;
the assuring that staff are engaging in ethical behavior with patients, visitors, and staff; and the assuring that staff are wearing appropriate
attire. Patient-related dilemmas related to ethics may include decisions to not treat, to withdraw treatment, or to discontinue treatment.
LD.26.1
Marketing for staff and services, if performed, is carried out ethically as per laws and regulations.
LD.26.2
The leaders develop a set of values and a professional code of conduct for all employees.
LD.26.3
The leaders ensure that patients and their families are fully informed and protected when they are
involved in clinical research projects.
LD.26.4
The leaders develop a process to receive and resolve ethical dilemmas, patient and non-patient related in
a reasonable timeframe as determined by the center.
LD.27
The center provides assistance to patients with special needs.
Requirements critical for dealing with special needs patients should be considered in the planning of all HCFs and services. Special needs
patients should be looked after by providing them with dedicated parking slots, wide entrances, accessible elevators, ramps for elevated
areas, handrails in corridors and stairs, and accessible toilets.
LD.27.1
Dedicated street parking and drop-off points are available.
LD.27.2
Handrails for staircases are constructed.
LD.27.3
Ramps for elevated areas are available.
LD.27.4
The center’s entrance allows wheelchair access and elevators have wheelchair access doors.
LD.27.5
Wheelchair-accessible toilets are available.

LD.28
The center has an implemented policy for controlling the development and maintenance of key
documents.
For the proper execution of key function documents, policies, procedures, and processes, they must be identical in their format for writing,
and have tags that identify the originating department, date of issue, date of revision, date of implementation, and date of expiry. Only
authorized individuals can change policies. Key function documents, policies, procedures, and processes carry the name(s) of the author(s)
and approving authority. A system must be in place to ensure that only approved and non-expired policies are circulating and available to
staff. All staff should be familiar with the available key function documents, policies, procedures, and processes relevant to their practice.
LD.28.1
The center has a unique identification for each key document, with title, number, date of issue, and date
of revision.
LD.28.2
Key documents are developed, approved, revised, and terminated by an authorized individual.
LD.28.3
Key documents are dated and current.
LD.28.4
Key documents are revised according to a defined revision due date.
LD.28.5
Key documents are communicated to relevant staff and are always accessible.
LD.28.6
A process is in place to ensure that key documents are always implemented.
LD.28.7
A process is in place to ensure that only the last updated versions of key documents are available for use
in the center.
LD.29
The center develops a comprehensive quality improvement and patient safety program.
The center should ensure the quality of its services and its continuous improvement by developing a quality management and patient safety
program. Key performance indicators are utilized to measure the performance of the services provided. Staff are notified of the performance
findings, and the information provided is utilized to further improve the clinical and managerial areas (structure, process, and outcome).
Improvements in quality utilize an evidence-based approach such as FOCUS-PDCA.
LD.29.1
The leaders develop the program collaboratively.
LD.29.2
The program utilizes key performance indicators, and patient and staff surveys to measure performance
and improve clinical and managerial areas.
LD.29.3
The information generated is readily accessible on a timely basis to those responsible for and/or involved
in the delivery of the services, and is utilized for making improvements and supporting the leaders’
decision making.
LD.29.4
The program utilizes an evidence-based quality improvement method such as “FOCUS – PDCA”.
LD.29.5
The center implements at least one improvement project per year.

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.
The collection of key performance indicators should follow an evidence-based approach as outlined in LD.30.1 through LD.30.7. The
indicators should cover a variety of issues based on structure, process, and outcome. The indicators should regularly be presented to staff to
enhance their performance and also be utilized in their evaluation. Benchmarking of one’s own performance should be carried out
internally (comparing historical data) and externally, either locally or internationally, to define the center’s position in terms of
performance. A quarterly report should be presented to the governance with improvement action plans if required.
LD.30.1
The selection process is based on the center’s important processes and priorities.
LD.30.2
Each indicator has an operational definition, data collection method, frequency for collection, analysis
by qualified staff, mathematical expression such as a ratio, with a defined numerator and denominator
or a percentage and a desirable target.
LD.30.3
Structure indicators may include, but not be limited to the following: availability of essential supplies
and equipment, availability of medical records, availability of emergency medications, surgical volume,
and staff ratios.
LD.30.4
Process indicators may include, but not be limited to the following: waiting time, documentation in
medical records, site marking, and time out processes.
LD.30.5
Outcome indicators may include, but not be limited to the following: Patient and staff satisfaction,
patient’s complaints, health-care-associated infections, medication errors, sentinel events and various
adverse events.
LD.30.6
The performance monitoring results are discussed with staff, utilized in their evaluation, and reported
quarterly to the governance together with action plans taken for improvement.
LD.30.7
The indicators are compared internally by historical trends and externally by benchmarking to other
similar centers when available.

LD.31
The leaders develop and implement a comprehensive risk management program.
Healthcare organizations are risky places to visit and work in. The center should develop and implement a risk management program that
covers all aspects of its activities: clinical, managerial, and financial. The program should be based on both reporting incidents and
analyzing them to prevent recurrences as well as a proactive approach such as failure mode and effects analysis (FMEA) or any similar
proactive risk management approach. The proactive approach should target improving practices that are high risk, problem prone, or high
volume, that have a substantial financial impact, such as insurance rejections or that can markedly improve patients or staff satisfaction.
Risks should be graded according to an evidence-based unified score system, and the center should maintain a list registering all its risky
practices and procedures. Information collected from the risk management program should be used to improve the system, and staff should
be informed of the findings and improvement projects at least quarterly.
LD.31.1
The program addresses clinical, managerial and financial risk.

LD.31.2
The reporting of incidents and variances, patients’ morbidities, and clinical and financial claims
constitute the program’s essential reactive arm.
LD.31.3
The center develops and implements at least one proactive risk management approach per year.
LD.31.4
The center develops and periodically updates a risk register for all potential clinical, managerial, and
financial processes in the center.
LD.31.5
The center utilizes an evidence-based process for grading risks based on severity, frequency, and/or
likelihood of occurrence.
LD.31.6
Information from the risk management program, including incidents, analysis, and improvement
projects, is communicated to staff and the governing body at least quarterly.
LD.32
The leaders develop and implement an incident reporting policy.
The center should develop an incident reporting policy with a unified reporting mechanism for all occurrences, variances, or accidents.
Reporting should include near misses as well (accidents that were prevented or discovered before reaching the patient). To encourage staff
to report, it is preferable that the reporting be anonymous. Reporting any adverse event to the MOH or other relevant authorities when
required by rules and regulations is a must. All incidents are categorized by type and severity. The center uses a risk scoring matrix to
identify the severity of the incidence. The center prepares a report on all incidences (including near misses) by its type and severity and
leaders develop an action plan to prevent its recurrence. The report is distributed to staff and to the governing body at least quarterly.
Sentinel events are situations that lead to the death or serious incapacitation of a patient, and may include the following: a. Unexpected
death b. Unexpected loss of a limb or function c. Retained instruments or sponge d. Serious medication error leading to death or major
morbidity e. Infant or child abduction f. Wrong site, wrong patient, or wrong procedure or surgery Sentinel events are reported to CBAHI
within 5 working days and a credible root cause analysis is also reported to CBAHI within 30 working days. Sever near misses, that could
lead to sentinel events if reaches the patient, are a great opportunity to investigate and find a root cause that is mitigated to prevent its
recurrence.
LD.32.1
The policy outlines the types of incidents to be reported internally and to relevant regulatory authorities
and the time frame and mechanism for reporting.
LD.32.2
The center utilizes a risk scoring matrix to categorize the severity of incidences.
LD.32.3
Incidences, including near misses, involving patients are documented in the medical record and patient
and family are informed by the physician of any investigation results.
LD.32.4
The center compiles a report on incidences according to type and severity, and an action plan to prevent
its recurrence is distributed to staff and governance at least quarterly.
LD.32.5
Sentinel events and severe near miss incidents are reported and investigated and findings utilized to
prevent recurrence.

LD.33
The leaders oversee any contracts for clinical or operational services.
To ensure the best cost-effective outcomes from contracted services, the process owners should closely monitor the implementation of
contracts related to outsourced services, such as housekeeping or laboratory services. To ensure that the monitoring process is translated
into agreed-upon process and outcome indicators, the process owners should approve contracts before leaders give their final approval.
Contract renewal should be based on the findings of the indicators’ monitoring.
LD.33.1
Contracted entities are selected based on evidence-based criteria that the relevant department develops.
LD.33.2
The center director ensures relevant leaders’ recommendations and approval on contracts.
LD.33.3
The leaders ensure that the contracted entity and services provided meet applicable laws and
regulations.
LD.33.4
The leaders ensure that the services provided are integrated into the overall quality and patient safety
program.
LD.33.5
The leaders regularly monitor and document the compliance of contracted services with the appropriate
standards and take documented corrective actions for improvement when standards are not met.
LD.34
The leaders ensure the integrity and security of telemedicine, teleradiology and interpretation of other
diagnostic remote contracted services.
The provision of telemedicine and teleradiology among other remote diagnostic services such as ECG interpretation has been recently
introduced in the kingdom and has its own regulation. The services provider should be approved and registered with the ministry of health.
The center should ensure the competency of the physicians providing the services by subjecting them to the center’s credentialing and
privileging process like other practicing physicians in the center. The confidentiality and security of patient information should be secured
by allowing access to the relevant required information from the patient’s file only.
LD.34.1
Telemedicine, teleradiology and interpretation of other diagnostic remote contracted services are
registered with Ministry of Health.
LD.34.2
The leaders ensure the credentialing and privileging of the physicians involved before starting the
service.
LD.34.3
The leaders ensure the security and confidentiality of patient information that may be exposed as a
result of the telecommunication process.

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.
Non-approved medical equipment and supplies may not provide accurate investigation results, accurate monitoring parameters, or safe
patient care. Therefore, leaders should develop a procurement policy to ensure the purchase of nationally approved medical equipment,
medications, and essential supplies. SFDA provides such information and performs visits to institutions to ensure that only approved
equipment, medications, and supplies are in use. Newly introduced consumables require formal testing and approval by the end user before
purchase.
LD.35.1
Leaders ensure that all medical devices and supplies contractors and suppliers have a Medical Device
Establishment License (MDEL).
LD.35.2
Leaders ensure that all newly purchased medical devices have a Medical Device Marketing
Authorization (MDMA) certificate.
LD.35.3
Leaders approve newly introduced consumables based on a formal testing and feedback process from
end users.
LD.36
The leaders ensure an aesthetic appeal for the center.
Confidence of patients’ in the center starts from the first impression. Patients’ experience is also enhanced by feeling comfortable being
treated in a clean and relaxing environment. The center should always maintain cleanliness at all times with room temperatures ranging
between 20 and 24.4 Celsius as per Occupational Safety and Health Administration “OSHA” standards. Nonirritant air freshener is used to
control odor of the different areas. Maintenance team should always ensure the integrity of wall paint, floor tiles and furniture.
LD.36.1
The center is clean and tidy at all times.
LD.36.2
The center is free of broken furniture, scratched and distorted walls.
LD.36.3
The ambient temperature is maintained between 20 - 24.4 Celsius.
LD.36.4
Nonirritant air freshener is used to control unwanted odor in the center.

Chapter II

Provision of Care (PC)

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.
A uniform process for registering patients ensures a strong link between the patient and the unique medical record number generated. The
use of a patient’s full name and medical record number in identifying patients avoids miscorrelation with investigation results or the
performing of a procedure on the wrong patient. Appointments reduce congestion and ensure the availability of services. Appointment staff
should be made fully aware of the services provided and trained to direct patients to the appropriate services. If the appointment staff are
not fully aware of the services, at a minimum, a nurse should be available at the appointment desk to book patients into the appropriate
clinics. Patients should be registered. Patients presenting with emergencies beyond the center’s capacity should be stabilized before
transfer to a higher center. The center provides patients, families, and the wider community with information about accessing its services,
using an appropriate format and language (e.g., displayed posters, brochures, handouts, and websites).
PC.1.1
A standardized process is in place for registering patients for services based on their full name and ID
number or passport number for visitors.
PC.1.2
Registration creates a medical record number that is unique to every patient.
PC.1.3
Appointment staff are aware of the services that the center offers and to direct patients to the
appropriate services.
PC.1.4
An appointment system is in place to book patients in advance.
PC.1.5
Patients who present with emergencies beyond the capacity of the center are stabilized before transfer to
a higher center.

PC.2
The center has a process to ensure the correct identification of patients.
Ensuring that the right patient receives the right care is an essential aspect of safe care. Patient identification errors can occur in all types
of clinical activities, whether diagnostic or therapeutic. The intent is to precisely identify the individual as the person for whom the service
or treatment is intended and, additionally, to match the service or treatment to that individual. Acceptable identifiers may be the patient’s
name (at least three names) and medical record number, the date of birth, etc. At least two identifiers are used, and the patient’s name
should be one of them. Patients are identified at the point when they enter the healthcare facility. Patient identification is reconfirmed
during the: • Collecting of blood samples and other specimens for clinical testing. • Administration of medications. • Performing of a
surgery or procedure. • Performing of an X-ray or imaging procedure.
PC.2.1
Patients are identified by at least two identifiers, full name as in identification document and unique
medical record number.
PC.2.2
Patients are identified prior to any blood withdrawal, investigation, administration of medications and
surgery or procedure.
PC.2.3
Patients are actively involved in the process of patient identification.

PC.3
Patients are clinically assessed through an established assessment policy and procedure.
Patient’s assessments are of paramount importance to reach the right diagnosis and establish the appropriate plan of care. The center
should have an assessment policy and procedure that the various entities have developed collaboratively. This policy should clearly identify
the scope and content of the history and physical examination of the different specialties. During their first clinic visit, all patients should
undergo a comprehensive history and physical examination, regardless of the nature of the disease. Patients should be screened for
nutritional needs, functional needs, the presence or absence of pain, the risk of fall, and any social needs. Those patients who screen
positive should be fully assessed and managed according to the findings.
PC.3.1
The policy and procedure are developed collaboratively, highlighting the scope and content of
assessment by different specialties and in different locations.
PC.3.2
The policy and procedure ensure the availability of a comprehensive patient assessment in the first
center’s visit.
PC.3.3
The policy and procedure highlight required screening for nutritional needs, functional needs, the
presence or absence of pain, the risk of fall, and social needs.
PC.3.4
The policy and procedure explain the specific assessments when the initial screening labels the patient
“at risk” for the screening elements in PC.3.3.

PC.4
Physicians are provided with the results of requested investigations according to a time frame.
For an effective treatment planning, physicians should receive the results of ordered investigations in a time frame acceptable for the type
of investigation carried out. The document should be available for the turnaround time of routine and urgent investigations, whether carried
out inside or outside the center.
PC.4.1
The time frame for routine and stat or urgent investigations is developed collaboratively with the
laboratory, radiology and other services.
PC.4.2
The Turnaround Time document is available for routine and stat or urgent radiology, laboratory and
other services tests.

PC.5
The center develops and implements a process for reporting critical test results whether on-site or
outsourced.
Critical test results are reported following a process developed cooperatively. The process clearly defines the notified parties, means of
communication, read-back sequence, and elements required for documenting the event (date, time, patient identification, critical test result,
read-back documentation, and identification of both the notifying and notified persons).
PC.5.1
The process defines staff who receive the result.
PC.5.2
The process involves writing down the result by the receiver and reading back the findings to the result
provider.
PC.5.3
The read-back process and the physician’s intervention are documented in the patient’s medical record.
PC.5.4
The center develops a process for contacting patients who left the center when critical test results were
reported.
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.
A documented care plan is vital to managing a patient’s condition. The care plan is developed according to the assessment information that
the healthcare team obtains. The plan should be tailored to the patient and family’s spiritual and cultural needs as well. The care plan
should be in measurable goals, for example, maintain blood pressure between 120 over 80, maintain a pain score below 4, and maintain
fasting blood sugar between 90 to 110 mg%. The attending physician should review this care plan during every visit and change it
according to the patient’s response, if necessary.
PC.6.1
The attending physician develops and documents the care plan by utilizing the assessment information
obtained by the nurse and other disciplines participating in the care and the investigation results, as
applicable.
PC.6.2
The care plan is designed to achieve desired outcomes specified as measurable goals.
PC.6.3
The care plan, is reviewed during every visit based on the outcome measures and other significant
changes in the patient’s condition.

PC.7
Consultations are available to meet the healthcare provider's request and patient’s needs in a timely
manner.
Patients may need consultations to other specialties, and such consultations should be available if the service sought is available. The
consultation should clearly state the reason and its nature (urgent or routine). The consultation should be formulated in a manner that will
help the consulted physician provide the appropriate answers to the issues that the referring physician raised. All urgent consultations are
immediately referred to the emergency room if one is available in the center.
PC.7.1
The consultation clearly states the reason for and urgency of the request.
PC.7.2
Consultation requests provide appropriate answers to the issues that the referring physician raised.
PC.7.3
Arrangements are made to ensure that consultations are immediately available for emergency cases.
Urgent consultations are referred to the emergency room.
PC.8
Staff members assist patients and, when appropriate, their families in fully participating in making
informed decisions about their care, treatment and procedures.
To help patients and families make the right decision in accepting a treatment or procedure, the treating staff should strictly follow the
elements in PC.8.1 through PC.8.4.
PC.8.1
Staff members provide patients/families with honest and accurate information in a manner they can
understand, about their illness, options for treatment, proposed treatment, potential benefits, potential
complications, and the likelihood of success of treatment, respecting their choices.
PC.8.2
Patients are supported in discussing their plan of care with the physician and having all their questions
answered.
PC.8.3
Patients are provided with all the information regarding the identity and the professional status of
his/her treating physician and how to contact him/her.
PC.8.4
When a surgery or procedure is performed, the patient/family receive from the surgeon information
related to the surgery and from the anesthesiologist information related to anesthesia or sedation.

PC.9
Patients and, when applicable, their families are educated about their healthcare needs.
Patient and family education is a cornerstone of the success of any treatment plan. A patient and his/her family must be educated on the
elements mentioned in PC.9.1 and PC.9.2. Staff should make every effort to ensure the patient/family clearly understand the education
provided. e.g., the patient/family member demonstrates learning or verbalizes understanding. This education is documented in the patient’s
medical record.
PC.9.1
Patients’ and families’ education is based on their healthcare needs, which include, but are not
necessarily limited to: the nature of their disease; necessary treatments; infection control practices; safe
use of medications, diet, and nutrition; medical equipment use; and preoperative and postoperative care.
PC.9.2
Each patient and his/her family receive education to help them give informed consent, participate in the
care process, and understand any financial implications of care choices.
PC.9.3
The clinical staff educate patients and families in easily understandable language, and the provided
education is evaluated for effectiveness.
PC.10
Informed consent is obtained from the patient or guardian.
Patients have the right to be fully aware of the benefits, risks, complications, and consequences of refusing treatments or investigations of
an invasive nature, such as surgery, sedation, anesthesia, contrast injections for radiology, chemotherapy, or blood administration. This
consenting process should also take place before the taking of any photographs for the patient or body parts and before the patient’s
involvement in any research project that may expose the patient’s identity or jeopardize the patients' safety.
PC.10.1
Informed consent is obtained before surgery, invasive procedures, anesthesia and sedation, the
administration of blood and blood products, and other high-risk treatments.
PC.10.2
Informed consent is obtained prior to taking photographs of body parts, even if this is deemed critical
for care.
PC.10.3
Informed consent is obtained before involving the patient in a research project.
PC.10.4
The center develops and regularly updates a list of procedures and conditions requiring informed
consent.

PC.11
Patients planned for a surgery/procedure give their informed consent to the surgery/procedure and the
anesthesia/sedation.
Patients and families have the right to fully understand the nature of the intended surgery or procedure, including the expected benefits and
risks, alternative methods for treatment or investigation, the likelihood of success, and the risks of refusing the surgery or procedure. The
information must be given by the physician performing the surgery or procedure, and be relayed in a manner understandable to the patient.
It may include drawings or animations. The anesthesiologist is responsible for providing information related to sedation or anesthesia. The
giving physician must sign the information. The patient (or substitute decision maker) must acknowledge receipt of the information by
signing against the information given. The consenting process must be witnessed by another healthcare provider (for example, the nurse),
who shall also sign against the information as a witness. The center must have a policy outlining the consenting process as in PC.11.1
through PC.11.4.
PC.11.1
The leaders develop and monitor the implementation of a policy for obtaining informed consent for a
surgery or procedure, or for anesthesia or sedation.
PC.11.2
The physician/dentist performing the procedure conducts the informed consent process, which includes
an explanation of the nature of the procedure, the benefits of the procedure, the risks of the procedure,
alternative modalities, and the risks of not undergoing the procedure.
PC.11.3
A qualified physician/dentist conducts the informed consent process for surgery/procedure.
PC.11.4
A qualified anesthesiologist conducts the informed consent process for anesthesia/moderate and deep
sedation.
PC.12
The center has an effective process to safely provide care to patients who require Cardio Pulmonary
Resuscitation (CPR).
To effectively resuscitate patients in cardiopulmonary arrest, policy and procedure must be developed. The policy should emphasize the
unification of all crash carts so that staff familiarize themselves with crash carts in different locations. The crash cart should have a
conversion table for pediatric emergency medications and pediatric paddles for the defibrillator. The policy highlights the frequency of
checking the crash cart by the responsible nursing staff to ensure its readiness at all times. The policy also highlights the team members
responsible for the resuscitation, and the role of each member.
PC.12.1
The center develops and implements a policy and procedure outlining the process.
PC.12.2
Standardized crash cart(s) are available in the patient care areas and are age specific.
PC.12.3
The crash cart is checked every shift by a qualified staff.
PC.12.4
The role of staff involved in the CPR process is clearly defined in the policy and monitored for
implementation.

PC.13
Policies and procedures guide the transfer of patients in need of urgent admission to hospitals.
The safety of patients requiring transfer to a higher healthcare setting is important and is based on patients’ acuity and the center's clinical
capability. The patient should be monitored closely during the transfer process, and the monitoring findings recorded on a transfer
monitoring sheet. The receiving hospital receives a report on the patient's condition. On the monitoring sheet, the receiving hospital
acknowledges having received the patient. The sheet should be kept in the patient's medical record back in the referring center.
PC.13.1
Transfers are based on the patient's need for continuing care and the center's capabilities.
PC.13.2
The receiving hospital clearly accepts responsibility for the patient's care.
PC.13.3
The receiving hospital receives the necessary information to provide care to the patient.
PC.13.4
The patient is monitored during the transfer process and the monitoring data is kept in the patient’s
medical record. The time of transfer is documented.
PC.13.5
The receiving hospital acknowledges receiving the patient, the time of arrival, and the patient’s
condition, and the document is kept in the patient’s medical record.
PC.14
Ambulance services are available and meet the patient’s needs.
A fully equipped ambulance should be available at all times to transport patients requiring a higher level of care in a hospital setting. The
ambulance should be equipped with life support measures for all age groups for whom the center cares. The ambulance should be
periodically maintained with documented logs. The ambulance’s patient care compartment should be disinfected after the transfer of
patients, and should be included in the center's infection control program.
PC.14.1
The center owns or contracts with a fully equipped ambulance capable of transferring sick patients of all
age groups to higher centers when needed.
PC.14.2
The required equipment is checked for proper functionality daily and after each dispatch by the
emergency services nurse or technician. Findings are documented.
PC.14.3
Ambulance medications are checked for availability and expiry daily and after each dispatch by the
emergency services nurse or technician. Findings are documented.
PC.14.4
During the transportation, the accompanying staff have the appropriate life support certification.
PC.14.5
The ambulance is tested daily for proper operation and periodically maintained. Findings are
documented.
PC.14.6
The ambulance is included in the center’s infection prevention and control program.

PC.15
The center has an emergency services to deal with minor emergencies.
The center should be able to manage minor emergencies in a dedicated emergency area that is easily accessible by the public. The staff
managing the emergency area should be qualified and trained in emergency care and in immediately identifying critical cases that require
immediate stabilization prior to transfer to a hospital. At a minimum, on each shift, a physician and a nurse are ACLS certified to manage
complicated cases and help with cardio-pulmonary resuscitation. To expedite the transfer of emergency cases requiring a hospital, the
center should have formal agreements with several hospitals, and the staff should have the required contact information for the referral
centers.
PC.15.1
Qualified staff manage the emergency services with a minimum of two (2) years of experience.
PC.15.2
At a minimum, a physician and a nurse are ACLS certified per shift.
PC.15.3
The emergency service have the necessary equipment for the stabilization and resuscitation of major
emergencies.
PC.15.4
The center has a formal agreement with hospitals to transfer major emergencies after stabilization.

Chapter III

Laboratory Department (LB)

LB.1
Laboratory services are available or outsourced to meet the needs of the patient population served.
Developing and maintaining a current scope of services that meets the needs of the patient population, clients, and customers is a sign of
commitment to quality and professional practice. The laboratory scope of services should be clearly defined, and easily accessible to all lab
staff, as well as internal and external customers. Equally important is the availability of a comprehensive specimen collection manual to
guide the clinical staff in the process of lab test requisition, specimen collection, labeling, and handling.
LB.1.1
The laboratory develops a services and specimens’ manual that is distributed to all patient care areas.
LB.1.2
The manual includes the available tests either in-house or send-out and their Turn Around Times
(TATs).
LB.1.3
The manual includes the prescribed process for requesting the introduction of a new test.
LB.1.4
The manual includes patient preparation for specimen collection.
LB.1.5
The manual includes positive patient identification.
LB.1.6
The manual includes quality and quantity of sample.
LB.1.7
The manual includes phlebotomy, sample collection and labeling procedures.
LB.1.8
The manual includes requisition and required clinical data.
LB.1.9
The manual includes specimen packing, handling and transportation.

LB.1.10
The manual includes specimen rejection reasons.
LB.2
The laboratory has the right space and facilities relevant to the services provided.
Deficiencies in space and/or facilities are regarded as minor unless they are so severe that they interfere with the quality of work or quality
control activities and safety. In this case, they become a major issue.
LB.2.1
The laboratory’s design and location meet applicable local and international regulations.
LB.2.2
The laboratory has adequate patient waiting areas and lavatories.
LB.2.3
Adequate spaces are available for each laboratory activity/section.
LB.2.4
The laboratory has adequate storage space for reagents, supplies, consumables, samples, waste holding,
and records.
LB.2.5
The laboratory has adequate space for administrative and clerical staff.
LB.2.6
The laboratory has adequate water taps and sinks for handwashing and for washing contaminated
equipment.
LB.2.7
The laboratory is equipped with adequate electrical outlets and emergency power.
LB.2.8
The laboratory has adequate lighting, ventilation and adequate temperature and humidity controls.
LB.2.9
The laboratory corridors are not obstructed and maintain access control and adequate emergency exits.
LB.2.10
Safety signs are adequately displayed and distributed in the laboratory.
LB.2.11
The laboratory workplace is free of hazards, clutter and distractions, with clean and well-maintained
floors, walls, ceilings, bench tops, and sinks.

LB.2.12
Means of communication and telephones are conveniently located in the laboratory.
LB.3
The laboratory develops and implements a comprehensive safety program.
The laboratory director is the person who is ultimately responsible for laboratory safety. He/she will be responsible for providing laboratory
personnel with a comprehensive safety manual and assigning a safety officer to provide guidance and monitoring. The safety manual outlined
above addresses common laboratory risks and hazards. To meet specific risk factors, specialized laboratories might need to develop
additional safety requirements. Regardless of how much experience they may have, laboratory personnel must be properly trained on all
applicable safety procedures and assessed for competence, both upon their hire and periodically thereafter. The director of the laboratory or
a designee is responsible for conducting regular safety inspections/audits to ensure the proper state of readiness and function of safety
apparatuses, alarms, and evacuation procedures. Appropriately trained personnel should conduct inspections/audits.
LB.3.1
The laboratory safety program complies with the national and international laboratory safety standard
and is readily available to all laboratory personnel.
LB.3.2
The safety program includes a chemical hygiene plan, control of compressed and flammable gases, and
the monitoring of fumes and vapors, as well as their respective Safety Data Sheets.
LB.3.3
The safety program includes biological safety procedures, the use of standard precautions, and the use of
eyewash stations and emergency showers.

LB.3.4
The safety program includes electrical safety as well as fire prevention and control plans.
LB.3.5
The safety program mandates an annual safety training and competency assessment.
LB.3.6
The laboratory has a process for the monitoring of the safety program through regular safety inspections
and analysis of the findings. The process is used to improve the laboratory’s safety, and its findings are
integrated with the center’s quality improvement and patient safety program.

LB.4
The laboratory develops and implements a comprehensive infection control program.
Labs, because of their equipment and function, constitute a key area. All efforts should be made to prevent infection. Therefore, the elements
in LB.4.1 to LB.4.6 should be strictly followed. Regardless of how much experience they have, laboratory personnel must be properly trained
on all applicable infection control procedures and assessed for competence, both upon their hire and periodically thereafter. The director of
the laboratory or a designee is responsible for conducting regular infection control inspections/audits to ensure the proper state of infection
prevention and control practices. Appropriately trained personnel should conduct inspections/audits.
LB.4.1
The laboratory infection control program complies with the national and international laboratory
infection control standards and is readily available to all laboratory personnel.
LB.4.2
The infection control program includes the provision and use of Personal Protective Equipment.
LB.4.3
The infection control program includes biological safety procedures, the use of standards precautions,
and the use of fume hoods and biological safety cabinets.
LB.4.4
The infection control program includes an infectious diseases and viral exposure plan.
LB.4.5
The infection control program mandates an annual training and competency assessment.
LB.4.6
The laboratory maintains a process for monitoring the infection control program through regular
infection control inspections and analysis of the findings, which are utilized to improve the laboratory
infection control and integrated with the center’s 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.
Laboratories may outsource advanced testing for better quality and/or cost-effectiveness. Reference laboratory services are some of the
critical services that should be adequately controlled. Proper control of reference laboratory services includes: • Selection: Selection of
reference laboratories must be based primarily on the quality of such laboratories’ performance. Referral specimens should be sent to an
accredited laboratory. The laboratory director should ensure that the reference laboratories provide turnaround times that meet clinical
needs. • Scope of service: An inclusive list of outsourced services/tests must be kept current. • Specimen requirements: The referring
laboratory should follow all requisition, collection, and handling instructions that the reference laboratory specifies. • Result reporting:
Testing records and patient reports must state the name of the reference lab performing the test and the identification of the person
authorizing the release of the results. • Agreement/service contract: a signed document specifying the expectations of the two parties involved
should be readily available for quick reference. Essential elements of such a document may include: o Scope of service o Agreement
conditions (including accreditation status) o Sample requirements o Turn Around Time o Result reporting o Release of information to the
third party o Solving disputes o Validity of the agreement and review schedule
LB.5.1
The process requires selection criteria, including accreditation status.
LB.5.2
The process outlines an inclusive list of send-out tests.
LB.5.3
The process describes specimen collection, labeling, handling, transportation, and results reporting.
LB.5.4
A service contract specifies agreements’ conditions with the reference laboratory.
LB.6
The laboratory has a clearly defined and implemented process for laboratory instrument and equipment
management.
The process of critical equipment selection should consider the criteria that the laboratory established. In the selection of new equipment, it
is important to consider not only the performance of equipment as it will be used in the facility but also any supplier issues regarding
ongoing service and support. Also, a mechanism should be in place to uniquely identify and track all critical equipment. The unique identifier
may be the manufacturer’s serial number or a unique identification applied by the laboratory or organization-wide identification system.
Upon receipt of critical equipment, the laboratory should develop a written plan for installation and operational and performance
qualifications; • Install according to the manufacturer’s specifications. • Verify the equipment’s functionality by ensuring that the criteria the
manufacturer established for the equipment’s intended use are met. • Assure that the equipment performs as expected in the facility’s
processes. After installation, activities designed to ensure that equipment functions as intended should be scheduled and performed
according to the manufacturer’s recommendations and regulatory requirements. Such activities include calibration, maintenance,
monitoring, functional and safety checks, and preventive maintenance. Recalibration and requalification may be necessary if repairs are
made that affect the equipment’s critical operating functions. Recalibration and requalification should also be considered when existing
equipment is relocated. Evaluation and trending of equipment calibration, maintenance, and repair data will help the facility identify
equipment that may need replacement. When equipment is found to be operating outside acceptable parameters, the potential effects on the
quality of products or test results must be evaluated and documented. Good laboratory practices call for a defined process for dealing with
reported results and delivered services when the system is later found to be compromised.
LB.6.1
The process defines the selection, receipt, installation, and identification of equipment.
LB.6.2
The process outlines the validation of laboratory equipment for its intended use.
LB.6.3
Manufacturer instructions related to monitoring, maintenance, calibration, and standardization are
referenced.
LB.6.4
The process includes the required investigation and follow-up of equipment malfunction or failure.

LB.7
The laboratory develops and implements a policy for the documentation of specimen receipt and
inspection.
Because patient/specimen misidentification may cause morbidities or mortalities, the best hope for prevention lies in preventing or detecting
errors in every phase of the laboratory processes. When a sample is received in the laboratory, documented checks must be made to confirm
that the information on the sample label and the information on the request are identical. If any doubt exists about the identity of the patient
or about the labeling of the sample, a new sample must be obtained. Requests for tests or services may be submitted in electronic or written
format. Requests must contain sufficient information for accurate patient identification. Other information necessary to process a lab request
includes gender, age, diagnosis, and the name of the authorized prescriber ordering the test. Verbal requests are acceptable in urgent
situations but should be documented in accordance with facility policies
LB.7.1
The policy includes the required checks for proper packaging.
LB.7.2
The policy includes the required checks for quality and quantity of the specimen.

LB.7.3
The policy includes the required checks for the adequacy of specimen labeling.
LB.7.4
The policy includes the required checks for request completion.
LB.7.5
The policy includes the required checks for label/request discrepancies.
LB.8
The laboratory develops a policy and procedure for the quality control of test methods.
Quality control (QC) testing is performed to ensure the proper functioning of materials, equipment, and methods during operations. QC
performance expectations and acceptable ranges should be defined and readily available to staff so that they will recognize unacceptable
results and trends to respond appropriately. The facility determines the frequency of QC testing in accordance with the applicable regulatory
requirements, accreditation standards, and manufacturer instructions. QC results should be documented concurrently with performance.
Unacceptable QC results must be investigated, and corrective action must be taken, if indicated, before continuing the operational process. If
products or services were provided since the last acceptable QC results were obtained, it may be necessary to evaluate the conformance of
these products or services. The review of quality control data must be documented and include follow-up for outliers, trends, or omissions not
previously addressed.
LB.8.1
Quality control follows the manufacturer’s instructions.
LB.8.2
The policy and procedure clearly identify the performance and review responsibility. Control specimens
are handled and tested in the same manner and by the same laboratory personnel who are testing patient
samples.
LB.8.3
The policy and procedure highlight the number and frequency of running controls.
LB.8.4
The policy and procedure mandate the acquisition of the correct reference range when the
reagents/methodology change.
LB.8.5
The policy and procedure mandate the establishment of tolerance limits for results.
LB.8.6
The policy and procedure highlight the corrective action(s) to be taken in the event of unacceptable
results.

LB.9
The laboratory develops a policy and procedure for Proficiency Testing (PT) sufficient for the extent,
complexity and scope of services.
Assessments are systematic examinations to determine whether actual activities comply with planned activities, are implemented effectively,
and achieve objectives. Assessments can be internal or external and can include quality assessments, peer reviews, self-assessments, and
proficiency testing. The laboratory must establish and maintain a process for proficiency testing (External Quality Assessment). The
laboratory director must review the results of assessments to determine the appropriateness and effectiveness of corrective/ preventive
actions (if taken).
LB.9.1
The policy and procedure ensure all analytes are covered with PT.
LB.9.2
The policy and procedure highlight alternative PT performed when appropriate.
LB.9.3
The policy and procedure have clear instructions for the receipt, processing, and reporting of PT results.
LB.9.4
PT samples are tested by the same personnel handling the patient samples.
LB.9.5
PT samples are tested using the same method used for testing the patient samples.
LB.9.6
PT samples are not referred to another external laboratory for testing.
LB.9.7
PT results are not shared with another external laboratory.
LB.9.8
PT results are evaluated and compared to the acceptable performance.
LB.9.9
Unacceptable performance is investigated, and appropriate corrective actions are taken.
LB.9.10
Laboratory management review and approve PT records.
LB.9.11
Corrective actions are implemented and monitored.

LB.10
The laboratory defines the format and contents of laboratory reports.
As applicable, all the above elements of a laboratory report must be available in the laboratory information system or in paper records.
LB.10.1
The report identifies the testing laboratory.
LB.10.2
The report includes full patient identification.
LB.10.3
The ordering physician is identified.
LB.10.4
The date and time of specimen collection and the source of the specimen are clearly written.
LB.10.5
The reporting date and time are identified.
LB.10.6
The test result(s) and reference intervals/range are highlighted.
LB.10.7
The condition of the specimen that may limit the test’s adequacy is written down.
LB.10.8
Identification of the authorized person releasing the report is highlighted.
LB.11
The laboratory has a process for correcting or amending reported results.
If a formal reference interval study is not possible or practical, the laboratory should carefully evaluate the use of published data for its own
reference ranges, and retain documentation of this evaluation. The reference interval can be verified by testing samples from 20 healthy
representative individuals; if no more than two results fall outside the proposed reference interval, that interval can be considered verified
for the population studied. For many analytes (e.g., therapeutic medications and CSF total protein), literature references or a manufacturer's
package insert information may be appropriate. Criteria for evaluating reference intervals include the introduction of a new analyte, a
change in analytic methodology, or a change in patient population. If it is determined that the range is no longer appropriate for the patient
population, corrective action must be taken.
LB.11.1
The process highlights the definitions of report corrections and amendments.
LB.11.2
The process describes the format of the corrected report.
LB.11.3
The process requires the inclusion of the previous result in the corrected report.
LB.11.4
The process requires the notification of the ordering physician.

LB.12
The laboratory develops and implements a comprehensive process for Point-of-Care-Testing (POCT).
Point-of-Care Testing (POCT) is defined as tests that are designed to be used at or near the site where the patient is located, that do not
require permanent dedicated space, and that are performed outside the physical facilities of the clinical laboratories. Other standards for
quality management, results reporting, and safety are applied. The POCT program should be centrally coordinated in the laboratory, with
designated qualified personnel who review testing and quality control procedures, and conduct/oversee the training and competency
assessment of testing personnel. The surveyor will review all centrally maintained records and visit at least three testing sites to evaluate
compliance.
LB.12.1
POCT is defined in writing.
LB.12.2
The responsibility of managing the POCT is assigned to the laboratory.
LB.12.3
Guidelines are available describing the process of acquiring POCT devices/methods.
LB.12.4
The process defines the training and competency testing requirements.
LB.12.5
A list and location of all POCT devices is available around the center.
LB.12.6
The process defines the maintenance and quality control of POCT devices/methods.
 Chapter V

Radiology Department (RD)

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.
Basic radiological investigations should be available in the center, or the center should contract with a licensed radiology unit to ensure
timely performance of the investigations and receipt of the written radiology report. The center’s radiology unit should be supervised by, at
a minimum, a radiology specialist who reads, reviews, and authorizes reports, and a licensed technician(s) is responsible for performing the
procedure. In the case of contracted radiological services, the center should ensure the safety of its patients and the quality of its
procedures by periodically reviewing the radiation safety report and the maintenance reports of the radiology machine(s).
RD.1.1
When radiology services are provided through a contract, the center is responsible for providing
oversight of the contracts.
RD.1.2
A licensed radiology technician carries out radiology services.
RD.1.3
Radiology services are supervised by, at a minimum, a radiology specialist who reads, reviews, and
authorizes all radiology reports.

RD.2
The center has a radiation safety program.
Patients, staff, and the environment should be protected from radiation by a well-constructed radiation safety program. The program
includes all areas utilizing ionizing radiation, such as the dental panorama and mobile x-rays. Radiology rooms should be tested initially to
ensure the absence of a radiation leak. Equipment should be tested periodically to ensure the absence of a leak. The same testing should be
done for the dental panorama (if present). Warning signs should be clearly posted. Women in childbearing periods should undergo a
pregnancy test if they have missed a period. Staff exposure to radiation should be monitored using thermoluminescence dosimeters that are
examined periodically, and staff should receive replacement cards during the test time. Radiation protection aprons should also be tested
periodically for their integrity.
RD.2.1
The program covers all areas that use ionizing radiation.
RD.2.2
All rooms where ionizing radiation is administered are tested and certified radiation leak proof by the
appropriate certifying local authority.
RD.2.3
Safety warnings are posted on the doors in clear and appropriate locations.
RD.2.4
Prior to X-ray tests, women in the childbearing period with missed menstruation are checked for the
possibility of pregnancy.
RD.2.5
Personnel are monitored for radiation exposure by thermoluminescence dosimeters (TLD) that are
regularly checked.
RD.2.6
All types of radiation protection aprons are periodically inspected and tested for integrity and
effectiveness with documentation.

RD.3
There is implemented process to keep the radiology equipment in safe, functional condition.
To ensure the quality of films, avoid radiation leaks, and prevent overexposure, the radiology equipment should follow a radiology
maintenance program or system that must include, at a minimum, the elements in RD.3.1 to RD.3.4.
RD.3.1
An operation and service manual is available for all equipment.
RD.3.2
Qualified personnel maintain the equipment.
RD.3.3
Maintenance and repair records are properly maintained, including corrective actions.
RD.3.4
Equipment is periodically inspected and calibrated for proper functioning.

Chapter VI

Dental Department (DN)

DN.1
Dental staff have appropriate qualifications.
To avoid unwanted complications, dentists should work within their assigned privileges, assisted by qualified dental assistants. To provide
the best assistance to dentists, a minimum of one dental assistant is required per chair.
DN.1.1
The head of the dental services is a dentist qualified by education, training and experience.
DN.1.2
Dentists perform dental treatments and procedures within their approved privileges.
DN.1.3
During dental procedure the dentist is assisted by dental assistant.

DN.2
A comprehensive assessment is performed and documented for each patient.
Not knowing that a patient has a valvular lesion or is on anticoagulation medicines or suffer from chronic illnesses (e.g., congenital heart
disease), infectious diseases, hematological diseases (e.g., hemophilia), can lead to serious morbidities if such patients undergo dental
procedures before following the appropriate precautions. Therefore, a comprehensive assessment must be documented beforehand.
DN.2.1
Chief complaint, chronic illnesses, medication history and allergies are assessed and documented for each
patient before dental procedures.

DN.3
The dentist documents the treatment plan in the patient’s medical record.
Based on assessment and dental examination findings, and to be both efficient and effective, a treatment plan should be agreed upon by the
patient and documented before the initiation of any dental procedure. The plan includes elements in DN.3.1 to DN.3.6.

DN.3.1
The dentist documents the required radiological procedures.
DN.3.2
The dentist documents the type of antibiotic prophylaxis when needed.
DN.3.3
The dentist documents the procedure(s) to be performed and highlights the teeth involved.
DN.3.4
The dentist documents the type and dose of local anesthesia or moderate sedation if needed.
DN.3.5
The dentist documents the material used for filling.
DN.3.6
The need for informed consent is highlighted.

DN.4
Infection control guidelines are available and implemented by dental staff.
Dental practice is a recognized source of infection for patients and staff. All efforts should be made to prevent cross infection. The elements
in DN.4.1 to DN.4.5 should be implemented and monitored.
DN.4.1
A new pair of gloves and a new mask are used by the dentist and assistant for every case.
 DN.4.2
Protective eyewear is used by the dentists and assistant for every case.
DN.4.3
Patients receive eye protection by the assistant.
DN.4.4
Working area surfaces are cleaned by the assistant between patients.
DN.4.5
Evidence-based disinfection and sterilization practices are maintained and updated by the assistant.

DN.5
Safety rules are applied in the dental laboratory.
Dental labs, by nature of their equipment, pose serious safety risks. Therefore, staff safety is crucial in dental labs. The safety rules in DN.5.1
to DN.5.6 must be strictly followed.
DN.5.1
Fire detection and abatement equipment is available.
DN.5.2
Butane and other flammable gases are stored safely outside the laboratory.
DN.5.3
A hooded exhaust is available in the casting area.
DN.5.4
Oxygen cylinders are safely stored.
DN.5.5
Fumes and dust are safely evacuated.
DN.5.6
An eyewash station is available and in good functioning condition.

Chapter VII

Medication Management (MM)

MM.1
Medication use processes are available to meet patient needs and in accordance with applicable laws and
regulations.
Medications are an important resource and a cornerstone of patient care. As such, they must be managed by qualified licensed staff as per the
Saudi commission and MOH regulations. All healthcare providers involved in purchasing, storing, prescribing, dispensing, and administering
medications are involved in overseeing medication management in the center. The appropriate medication room space, in ED and DPU, and its
hours of operation should allow for the optimal and satisfactory delivery of medications to patients. To facilitate communication and safe
prescribing practices, the center maintains an updated list of current prescribers in the center, including their signatures and prescribing
privileges.
MM.1.1
The medication use processes are managed by qualified staff who have a valid registration with the Saudi
Commission for Health Specialties.
MM.1.2
The center establishes an interdisciplinary mechanism for overseeing and monitoring medication
management processes.
MM.1.3
An updated list exists of the signatures of medical staff who are authorized to prescribe medications, along
with their prescribing privileges.

MM.2
The center has an updated and well-structured formulary.
The formulary process is the cornerstone of proper medication management and rational use. It consists of preparing, using, and updating a
formulary list of essential medications. The formulary manual provides adequate information about all essential medications that should be
available in the center at all times. Formulary medications are selected based on the standard treatment guidelines or protocols that the center
has developed or adapted for use. Periodic review is necessary because of changing costs and indications, new information about safety, and the
emergence of new medicines. The formulary supports clinical staff in choosing the most appropriate therapies and selecting the most cost-
effective, good-quality medication according to the standard treatment guidelines. This ensures the provision of better-quality care and more
efficient, equitable use of resources.
MM.2.1
The formulary contains all the essential medications and is updated annually.
MM.2.2
The formulary is adopted from a relevant source that is available for Saudi Arabia and approved by the
Saudi Food and Drug Authority.
MM.2.3
The medication formulary is available to the healthcare team.

MM.3
The center has a process for the appropriate storage of medications.
Medications can lose its potency if not stored in the appropriate environment as recommended by the manufacturer. Loss of potency during
storage may influence pharmaceutical efficacy and safety. Proper environmental control (i.e., proper temperature, light, and humidity;
sanitation, ventilation, and segregation conditions) must be maintained wherever drugs and supplies are stored anywhere in the center. Vaccines
are more susceptible to temperature fluctuations, therefore it is best to be stored separately from other refrigerated medications that are in a
more demand for opening and closing the refrigerator. All medication refrigerators must be connected to an electrical outlet that has an
alternate power supply that starts immediately if there is an interruption to the main power supply. The center must develop a process on what to
do with medications that are stored in an area that had out of range temperature.
MM.3.1
The center has an appropriate storage area for non-refrigerated medications and refrigerators for storing
vaccines and commonly refrigerated medications.
MM.3.2
Medications are stored as per manufacture guidelines.
MM.3.3
All medication and vaccine refrigerators are connected to alternate power source and a temperature log is
maintained at all times.
MM.3.4
The center develops and implements a process for the handling of medications and vaccines when
temperature monitoring indicates out of range.

MM.4
The center has a process for ensuring the stability of medication available in multi-dose containers.
Multiple-dose vials (MDVs) are widely used in all healthcare settings. By definition, an MDV contains antibacterial preservatives and,
according to manufacturer’s recommendations, may be used more than once. It is important to recognize that although common preservatives
used in MDVs are effective against most bacteria, they are not antiviral agents. They do not protect against contamination when healthcare
personnel fail to follow safe injection practices. In addition, contaminating pathogens are able to survive in MDVs for approximately two hours
before the preservative takes full effect. Endotoxins can survive even after the preservative inactivates the organism. The contamination rate of
MDVs in published studies has been as low as 0% and as high as 27%. Whenever possible, multi-dose vials should be dedicated to a single
patient. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area.
If a multi-dose has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 30 days unless the
manufacturer specifies a different (shorter or longer) date for that opened vial. If a multi-dose vial has not been opened or accessed (e.g.,
needle-punctured), it should be discarded according to the manufacturer’s expiration date. The manufacturer’s expiration date refers to the date
after which an unopened multi-dose vial should not be used. The beyond-use date refers to the date after which an opened multi-dose vial should
not be used. The beyond-use date should never exceed the manufacturer’s original expiration date.
MM.4.1
The center develops and maintains a set of guidelines for ensuring the stability of sterile multi-dose vials,
vaccines, and other multi-dose medications.
MM.4.2
The center ensures all open multi-dose containers are labeled with the opening date and time, the expiry
date and staff initials.

MM.5
The center has a process for identifying and handling expired medications.
Expired medications may lose all their potency over time and become ineffective for treatment. The center should maintain a written policy for
managing near-expiry and expired medications following the requirements in MM.5.1 through MM.5.4
MM.5.1
The center has a written and implemented process for detecting and returning the nearly expired
medications before the expiration date.
MM.5.2
Expired medications are not found in any patient care areas.
MM.5.3
The center maintains documents of return of expired medications to the supplier or manufacturer, or
evidence of its proper destruction.
MM.5.4
All expired and/or nearly expired medications are properly labeled and stored separately from other
medications.
MM.6
The center develops a policy and procedure for the safe prescribing of medications.
Inappropriate prescriptions account for 30% of medication errors; some of these errors can be serious. Medication prescription in the center
should follow the elements mentioned in MM.6.1 through MM.6.6.
MM.6.1
All prescriptions are identified by accurate patient demographics including name, age and medical record
number.
MM.6.2
Allergy status is clearly identified on the prescription.
MM.6.3
For all pediatric prescriptions, weight is identified.
MM.6.4
Abbreviations are not used in prescriptions.
MM.6.5
Prescribed medication is documented in the medical record.
MM.6.6
The prescribing of narcotics and controlled medications follows Ministry of Health laws and regulations.

MM.7
The center develops and implements guidelines for the correct prescribing of antibiotics.
Antibiotics misuse is a global concern. Misuse of antibiotics has a negative impact on the safety of patients and the community, increasing
antibiotic-resistant micro-organisms and the overall cost of healthcare. The development and implementation of antibiotic guidelines are
scientifically proven to prevent, control, and treat infections. Each center should develop and update its own evidence-based guidelines, taking
into consideration its own anti-bigram and pathogens identified by the surveillance system. Guidelines should include surgical prophylaxis and
the empiric and therapeutic use of antibiotics. Appropriate antibiotic use can be challenging nowadays. To prevent the development of
resistance, centers are expected to define the prescribing privileges of antibiotics.
MM.7.1
A multidisciplinary team from the center adopts and updates the antibiotics guidelines.
MM.7.2
The guidelines for antibiotics prophylaxis are properly implemented before surgery and/or dental
procedures and monitored.
MM.7.3
The guidelines for empiric and therapeutic use of antibiotics are properly implemented and monitored.
MM.8
The center develops a process to manage narcotics, psychotropic medications, and other controlled
medications according to laws and regulations.
Narcotics and controlled medicines are those agents, either naturally or compounded, that have been included in schedule #1 and schedule #2 in
the SFDA regulations manual. The center must implement the related rules and regulations of the SFDA and MOH as stated. Medications are
stored and secured behind locked steel doors or inside steel cabinets with double locks and/or double doors all over the center. Limited
quantities of essential controlled and narcotics medications may be allowed in patient care units according to clinical needs. The documentation
process should be maintained for all related steps, such as requisition, procurement, ordering, dispensing, distribution, endorsement,
registration, and discarding of the unused portion and empty containers.
MM.8.1
The center has a process for receiving, storing and dispensing narcotics, psychotropic medications, and
other controlled medications.
MM.8.2
The center maintains an inventory of narcotics, psychotropic medications, and other controlled
medications.
MM.8.3
The center has a process for prescribing narcotics, psychotropic medications, and other controlled
medications.

MM.9
The center safely manages high-alert and look-alike, sound-alike (LASA) medications.
Throughout the medication use process, medication errors related to look-alike and/or sound-alike medications and/or packages are common in
the healthcare setting. Look-alike, sound-alike medications account for an estimated 25% to 30% of medication errors. With tens of thousands of
medications currently on the market, the potential for serious error due to confusing medication names is significant. Contributing to this
confusion are incomplete knowledge of medication names; newly available products; similar packaging or labeling; similar clinical use;
illegible prescriptions; and misunderstandings during the issuing of verbal orders. Examples of high-alert medications include concentrated
electrolytes, controlled medications and narcotics, antithrombotic medications (e.g., heparin, warfarin), and insulin. The full list is published by
the Institute of Safe Medication Practice and the World Health Organization. The process for managing such medications may include
separating the look-alike/sound-alike medications and limiting access to high-alert medications.
MM.9.1
The center identifies, in writing, its high-alert and LASA medications.
MM.9.2
The center has a process for managing high-alert and LASA medications.
MM.10
The center evaluates the appropriateness of prescriptions before dispensing.
The following could harm patients or render treatment ineffective: dispensing unclear prescriptions; dispensing prescriptions without ensuring
the relevant diagnosis; dispensing prescriptions without determining allergies or the presence of interactions, and dispensing the wrong dose.
The center should adopt a safety culture allowing the pharmacist to contact physicians for clarification of prescriptions or receipt of additional
information pertinent to the prescription, and to notify the physician if the medication is not available so an alternative may be prescribed.
Drug-drug and drug-food interactions should be clearly documented in the medical records. Pharmacist should dispense medications only for
their approved indications.
MM.10.1
The appropriateness review includes allergies, indications, dosage, frequency, route of administrations
therapeutic duplication and possible interactions.
MM.10.2
The center maintains an updated medication profile for each patient treated in the emergency room or day
procedure unit.
MM.10.3
The review process is done by a pharmacist or a physician.
MM.10.4
The reviewer discusses any concerns in the process with the prescriber before medication dispensing.

MM.11
Medication preparation areas comply with infection control measures and safe practices.
Prepared medications can be a cause of patient morbidity if they were prepared aseptically or given to the wrong patient. Therefore, medication
preparation should follow the elements mentioned in MM.11.1 through MM.11.4
MM.11.1
Medication preparation areas are clean and tidy, with clean preparation surfaces.
MM.11.2
The preparation area is equipped with a wash sink, antiseptic soap, and a sharps container of appropriate
size.
MM.11.3
Parenteral medications are prepared aseptically.
MM.11.4
Medications that are prepared and not immediately utilized are labeled with the medication name, dose,
route of administration, and patient’s identifiers.
MM.12
The center develops and implements a policy and procedure on medication error reporting.
Reporting medication errors prevents recurrence and enables the immediate management of the incident to reduce patient harm. The center
should maintain a policy for the reporting of medication errors, including classification, definition, reporting format, time frame for reporting,
and immediate intervention for patients to reduce harm. All significant medication errors should undergo a root cause analysis. Data gathered
from the reporting and the root cause analysis is used to modify the medication management process to prevent recurrence of errors.
MM.12.1
The pharmacy maintains a written policy and procedure for medication error reporting.
MM.12.2
The policy defines significant medication error, the time frame for reporting, and the reporting format.
MM.12.3
Medication error reporting is active and ongoing.
MM.12.4
The center performs an intensive root-cause analysis for all significant medication errors.

MM.13
The center monitors allergies to medications.
Allergies can be a source of morbidity among patients if they are not highlighted to caregivers, including pharmacy staff. All prescriptions
should clearly highlight the patient’s allergy status. As part of the prescription review process, relevant staff should discuss allergy status with
the prescriber to stop or change prescribed medication.
MM.13.1
The center has a process in place to ensure the reporting of medication allergies.
MM.13.2
The newly discovered allergies are documented in patient medication profile.

MM.14
The center develops and implements a policy and procedure for the reporting of adverse drug reactions
(ADR’s).
Adverse drug reaction (ADR) is a response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for
the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. An unexpected adverse reaction refers to a
reaction whose nature or severity is not consistent with domestic labeling or market authorization or expected based on the drug’s
characteristics. A serious adverse reaction is any medical occurrence that, at any dose normally used in humans, results in death, requires
inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, or is life-threatening. The
monitoring of medication effects includes observing and documenting any adverse effects. The healthcare institution establishes a mechanism for
reporting adverse events and the time frame for reporting. Healthcare organizations are responsible for ensuring that patients are treated as
safely as possible. Prevention of ADRs is possible and, indeed, necessary. Studies have shown that over 50% of adverse drug reactions may be
preventable. Most ADRs are related to the prescribing of an incorrect dose or the administration of a drug to a patient with a known allergy.
Many ADRs could be avoided if the relevant healthcare worker had asked specific questions before prescribing and/or dispensing a drug. ADRs
are to be reported to the SFDA.
MM.14.1
The policy and procedure defines significant ADRs and the time frame for reporting.
MM.14.2
An intensive analysis is performed for all significant ADRs.
MM.14.3
Treating physicians are notified of the analysis results.
MM.14.4
The medical record is flagged for significant ADRs and the patient receives the appropriate medical care for
the reaction.
MM.14.5
Significant ADRs are reported to the relevant authorities as per laws and regulations.

Chapter VIII

Management of Information (MOI)

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.
Communication failures are responsible for a third of the causes of morbidities and mortalities in healthcare. Identifying and organizing the
flow of information inside the organization and with external customers helps streamline communication and eliminate communication
errors. All stakeholders should collaboratively develop a management of information plan that includes the following: • Managing the
patients’ information (medical records and whether it is in paper format, electronic or combined) • Managing the internal communication
between staff and the leaders such as memoranda, management notifications and staff complaints. • Managing externally required
information by MOH and other regulatory bodies. • The plan identifies how information is secured. • The plan identifies the level of security
for each type of document and how staff can access only the information authorized to see. • The plan identifies how the information is
backed up and restored if needed. • The plan identifies the retention time of the different documents and information relevant to the rules and
regulations of MOH and other regulatory bodies.
MOI.1.1
The plan highlights how patient demographic and medical information is shared among medical and
administrative staff.
MOI.1.2
The plan identifies how the types of information are communicated by leaders to staff and vice versa.
MOI.1.3
The plan includes the Ministry of Health required information and the frequency of reporting.
MOI.1.4
The plan highlights the patient’s personal and medical information required to refer the patient to a
higher center.
MOI.1.5
The plan identifies the staff security levels for accessing the information.
MOI.1.6
The plan identifies how the various information is secured and safely stored.
MOI.1.7
The plan highlights the different documents retention time consistent with Ministry of Health rules and
regulations.
MOI.2
The leaders develop standardized diagnosis codes, procedure codes and symbols, and minimize
abbreviations.
Abbreviations can be problematic and at times even dangerous, particularly in the context of the prescribing of medications. In addition,
when one abbreviation is used for multiple medical terms, confusion regarding the author’s intent may result in medical errors.
Standardized diagnoses and procedure codes help centers track pathology and common procedures, and complies with insurance companies'
requirements. Abbreviations and symbols could be interpreted differently, thus inadvertently changing the intended care plans. Therefore, a
limited list should be circulated to all staff in all areas, and its correct use monitored.
MOI.2.1
The staff use diagnosis and procedure codes consistent with Ministry of Health and other regulatory
bodies’ requirements.
MOI.2.2
A list of approved abbreviations and symbols is distributed in all patient care areas for reference.

MOI.3
All patients seen in the center have unique medical records.
To ensure continuity of care, each patient cared for in the center should have his/her own medical record that has a unique medical record
number. The medical record shall contain, at a minimum history and physical examination, plan of care, investigations, consultations,
observations, allergies, consents, procedure reports, and medications, all the elements in MOI.3.3 through MOI.3.6.
MOI.3.1
Each patient has a unique medical record number.
MOI.3.2
Each patient has only one medical record or historical volumes of the same.
MOI.3.3
The medical record’s contents are arranged according to a standardized process.
MOI.3.4
Medical record contains the required patient demographics, including national identification, contact
information, emergency contacts and insurance category.
MOI.3.5
Medical record contains updated medical information sufficient to safely manage the patient and
promote continuity of medical care.
MOI.3.6
Patient allergies, prior adverse reactions, and chronic infections are confidentially documented and
consistently displayed in a specified area of the patient’s record.

MOI.4
The leaders develop a policy on the rules and regulations for writing in patients’ medical records.
Uniformity of writing in medical records ensures proper documentation and avoids misinterpretation of written information. Therefore, a
policy should be developed and implemented based on the elements in MOI.4.1 through MOI.4.4
MOI.4.1
The policy identifies the category of staff allowed to write in the medical record.
MOI.4.2
All entries are legible, dated, timed, and signed by the author.
MOI.4.3
Entries written in error are not deleted or erased. Instead, a line is passed through the error text and
dated, timed, and signed by the author.
MOI.4.4
Only standardized and approved abbreviations and symbols are used in medical records.

MOI.5
The leaders develop a process for completing and storing the patient medical record.
At the end of a patient's visit, the medical record should be returned to the medical records store. This keeps the medical records safe, secure,
and in good order. Upon its receipt in the store, the medical record should be checked for completeness according to a written process that
includes complete demographics, medical information, and authentication. Every effort should be made to complete the incomplete records
within a time frame that the organization has identified. On a monthly basis, the center should check a percentage of its records for
completion, and the collected information should be conveyed to staff and used to improve staff compliance with completion.
MOI.5.1
The center has a dedicated and secure storage area for medical records.
MOI.5.2
Regular checks are made on returned medical records to ensure their completion.
MOI.5.3
Non-completed medical records are clearly separated from completed ones in the storage area and are
completed within a timeframe that the organization defines.
MOI.5.4
The center maintains a record of the percentage of incomplete records over time and uses this
information to improve staff compliance with record completion.
MOI.6
The center has an implemented policy and procedure for the use of information technology.
Despite advances in infrastructure robustness, many HCFs still face database, hardware, and software downtime, lasting short periods or
shutting down work for days. To maintain the completeness and comprehensiveness of data, an adequate data capturing process during
downtimes is critical. Gaps in patient data may result in gaps in patient care. A complete manual system must be prepared for use during the
downtime period and include both managerial and clinical activities to prevent the interruption of care processes. End users involved in
providing center services should be trained on the planned manual system and know how to shift once the electronic system is down. The
downtime system must be assessed for effectiveness regularly and after actual downtime incidents. Documented reports of this assessment
should be available, and actions taken in response to any deficiencies. Even though organizations may treat their storage media with care,
these media can be damaged accidentally or on purpose, and medical records can be unconsciously changed or erased. The creation of
backup copies limits the amount of information lost. Backup media should be safely stored. As part of information and data integrity,
organizations are expected to have a clear mechanism for backing up data to ensure ease of retrieval. The backup process is regularly
implemented to avoid any data loss or gaps in information which may affect gaps in the care and service provided, as well as to avoid
misinformed decision-making by leaders.
MOI.6.1
The policy and procedure highlight how the generated information is stored and regularly backed up.
MOI.6.2
The policy and procedure describe the manual procedures required to execute the various activities in
the event of system failure, maintenance or repair.
MOI.6.3
Staff can demonstrate the manual procedure for the downtime regulation.

MOI.7
The center has an effective clinical documentation improvement (CDI) program.
Clinical Documentation Improvement (CDI) is fundamental in any healthcare organization. CDI ensures the accurate reporting of the
diagnoses and procedures to the health authorities as per local regulations. Moreover, health Insurance payments and reimbursement are
directly linked to the proper documentation of the clinical episode, so that over and under-payments are avoided. Documentation also helps
in the proper utilization of resources, including time, medications, supplies, investigations, and usage of the operating theatre. CDI ensures
timely completion of the medical records which would support safer care for patients as well as all research activities related to the
prevalence of medical errors, utilization of resources, areas for improvement and so forth. A proper documentation translates into proper
coding which makes it possible for healthcare leaders plan for better delivery of healthcare services. The center leadership is responsible for
ensuring that clinical staff are well trained on all aspects of clinical documentation as per CBAHI guidelines in this regard. Auditing of the
quality of clinical documentation in the medical records will be part of the survey activities.
MOI.7.1
There is a policy and procedure for clinical documentation improvement in the center.
MOI.7.2
The center has at a minimum a physician and a nurse who are properly trained on clinical
documentation improvement.
 Chapter IX

Infection Prevention and Control (IPC)

IPC.1
The center implements a coordinated program to reduce the risk of healthcare-associated infections.
The center should establish an evidence-based infection control program according to its scope of services. The program must cover all
related IC prevention and control activities that could ensure maximum safety for patients, visitors, staff, volunteers, contractors, etc.
Infection prevention and control activities should be overseen by a person qualified in infection prevention and control practices through
education, training, experience, or certification. This qualified staff member should directly report to higher administrative authority to
ensure the presence of an independent administrative unit that oversees IC issues in the whole center. The person fulfills program oversight
responsibilities as per standard requirements that should be described in the job description.
IPC.1.1
A qualified individual, acting on a full-time or part-time basis, is responsible for the infection control
program.
IPC.1.2
The program involves patients, visitors, staff, and volunteers.
IPC.1.3
The program involves all patient care areas and support services.
IPC.1.4
The infection control program is based on current scientific knowledge, accepted practice guidelines,
and applicable laws and regulations.
IPC.1.5
The infection control program’s components are contained in a manual that is available to all staff
members.

IPC.2
Infection prevention and control activities are integrated and coordinated by an interdisciplinary team.
Infection control personnel, in collaboration with quality personnel and the medical director (or representative), must regularly review,
approve, monitor, and evaluate all infection control program components and activities to maintain optimum IC activities, outcomes, and
safety.
IPC.2.1
The interdisciplinary team reviews and approves the infection control policies and procedures and the
improvements plans.
IPC.2.2
The interdisciplinary team evaluates and revises, on a continuous basis, the procedures and mechanisms
that the center develops to serve established standards and goals.
IPC.2.3
The interdisciplinary team brings to the center’s attention new infection control issues arising in
different departments and suggestions for solutions.
IPC.2.4
The interdisciplinary team evaluates the infection control program annually and suggests any necessary
additions or changes.

IPC.3
The leaders develop and ensure the implementation of infection control policies and procedures
targeting the most important infection risk processes.
To ensure a safe workplace for all the center’s attendees, all activities at the center should be regulated and controlled by scientifically
based infection control policies and procedures.
IPC.3.1
Disinfection and sterilization.
IPC.3.2
Handling of sharps.
IPC.3.3
Infectious materials and waste disposal.
IPC.3.4
Prevention and management of patients’ and workers’ exposure to healthcare-associated infections.
IPC.3.5
Laundry and linen management processes.
IPC.3.6
Renovation projects guidelines.
IPC.3.7
Practices for support services departments.

IPC.4
Communicable diseases are tabulated and reported as required by laws and regulations.
To ensure that the center complies with MOH health requirements with regards to the reporting of notifiable communicable diseases, the
center should maintain evidence of reporting communicable diseases to MOH as per the center policy. The center should also maintain
evidence of staff awareness of the center reporting system.
IPC.4.1
The center tabulates and reports communicable diseases to the Ministry of Health.
IPC.5
The leaders develop and implement a policy and procedure for healthcare associated infection
prevention.
To optimize urinary catheter and peripheral line insertion and other procedures in patient care areas, the center should maintain a policy
for device-related infection prevention and the care bundle (when applicable). The staff must be fully educated about the elements of the
adopted care bundle (when applicable). The center should regularly collect and analyze the data and assess the bundle compliance rate for
performance improvement.
IPC.5.1
Evidence based bundles are used for the insertions of devices.
IPC.5.2
Staff regularly collect and analyze data on device related and surgical site infections.

IPC.6
The leaders design and ensure the implementation of an effective hand hygiene program.
Hand hygiene (HH) is the most effective method of preventing infectious disease transmission. The center should develop HH policies and
procedures. The center supports HH by providing sinks and appropriate hand washing soap and sanitizers in appropriate locations in the
facility. The center should maintain a monitoring process to continuously evaluate HH compliance among staff. In addition, data about HH
compliance and monitoring should be analyzed and integrated into improvement projects.
IPC.6.1
Written policies and procedures for implementing and monitoring appropriate hand hygiene are
available.
IPC.6.2
The center provides hand washing facilities sufficient to meet its needs.

IPC.7
Centers providing sterilization services strictly follow rigorous sterilization rules.
Infection risk is minimized through proper cleaning, disinfection, and sterilization of surgical supplies and other invasive or noninvasive
patient care equipment. To ensure the proper method of collection, decontamination, cleaning, and sterilization, these services must be
centralized and maintained. CSSD staff must set clearly written policies and procedures that guide collection and transportation,
decontamination and disinfection, cleaning and sterilization, the storage of sterile items, and a mechanism for the recall of sterile items in
the event that the sterilization process fails. The policy must be scientifically sound, and reviewed and approved by the infection prevention
and control, quality, and administration. When this service is outsourced, the center should ensure that the contractor complies with all
required safety standards. Re-sterilization of single-use items should be carried out according to an evidence-based policy that ensures safe
sterilization without affecting the integrity of the item’s use and that specifies the number of re-sterilization cycles and the point at which the
item cannot be further re-sterilized.
IPC.7.1
Qualified staff conduct the sterilization processes.

IPC.7.2
Adequate space is available for sterilization services that support sterilization processes, and no
instrument or equipment sterilization takes place outside this area.
IPC.7.3
A policy and procedure on the safe reprocessing of single-use items have been implemented.
IPC.7.4
Personal protective equipment is available and used during decontamination: heavy-duty gloves,
waterproof aprons, facemasks, goggles, and face shields.
IPC.7.5
Sterilizers are in good working order, and instructions for their use are available.
IPC.7.6
Proper sterilization parameters are recorded.
IPC.7.7
Sterilization records are retained for one year.
IPC.7.8
Chemical indicators are used in every package. Biological indicators are used at least weekly. Records of
results are kept for one year.

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.
This is to ensure proper implementation of the appropriate type of isolation precautions (contact, droplet, and airborne isolation
precautions). Center preparedness for isolation precautions includes: the availability of a negative pressure airborne isolation room (or an
isolation room with a portable HEPA filter) and of required supplies, particularly a respirator (high-filtration mask, e.g., N95) in patient
care areas.
IPC.8.1
Written and implemented policies and procedures address standard and isolation precautions for cases
of suspected or proven communicable diseases.
IPC.8.2
Patients with suspected communicable diseases are dealt with in an isolation room equipped with a sink
and personal protective equipment.
IPC.8.3
The isolation room is a negative pressure ventilation that is exhausted to the outside unless it is filtered
through a High-Efficiency Particulate Air (HEPA) filter, or, at a minimum, is equipped with a portable
HEPA filter that is regularly maintained according to the manufacturer’s recommendation.
IPC.8.4
Staff are trained to triage suspected communicable disease cases and isolate them before transfer to the
appropriate healthcare setting.
IPC.8.5
During direct care of patients on airborne precautions, staff use high-filtration respirator masks (N-95,
N-99).
IPC.9
Personal protective equipment is readily accessible and available and is used correctly by staff in all
patient care areas.
Personal protective equipment (PPE) is a fundamental tool for proper infection prevention and control practices. The center identifies those
situations in which masks, eye protection, gowns, or gloves are required in written policy, and provides a sufficient supply of PPEs as well
as training in their proper use.
IPC.9.1
Written policies and procedures are available for the appropriate use of gloves, gowns, facemasks, and
protective eyewear.
IPC.9.2
Gloves are worn when the potential exists for contact with blood/body fluids.
IPC.9.3
Gowns, masks, eyewear, or face shields and other protective equipment are worn during all procedures
which are likely to generate splashes, soiling, or droplets of blood or other body fluids.

IPC.10
The leaders define in a policy the cleaning, decontamination and disinfection processes in all patient care
areas.
Disinfectants are frequently used to eliminate infectious organisms. The choice of disinfectant to be used depends on many factors. Some
disinfectants have a wide spectrum (kill many different types of microorganisms), while others kill a narrower range of disease-causing
organisms but are preferred for other properties (they may be non-corrosive, non-toxic, or inexpensive). To ensure the proper use of
disinfection, the selections and indications for use must be based on scientific references and national laws and regulations, reviewed and
supervised by infection control personnel.
IPC.10.1
The policy has a list of appropriate detergents and disinfectants as defined and approved by the
infection control personnel.
IPC.10.2
Detergents and disinfectants are available in all patient care areas.
IPC.10.3
Patient care areas are clean, and equipment is properly disinfected.

IPC.11
The leaders define in a policy the safe procedures for waste collection, storage and disposal.
To protect the public and the environment from infectious organisms and to provide a safe, healthy environment for the patient, healthcare
worker, and visitors, the center should implement a Medical Waste Management Program that regulates the segregation, handling, storage,
and disposal of medical waste and provide oversight for its implementation as per center policy. The program should be implemented under
national laws and regulations. The center should ensure the availability of required supplies (yellow bags, red bags, medical waste
containers, etc). Medical waste workers should be vaccinated and trained on the safe handling of medical waste as reflected in their
employee health records.
IPC.11.1
The policy differentiates between regular waste and infectious waste.
IPC.11.2
The infectious waste is treated and disposed of in accordance to laws and regulations.

IPC.12
The leaders develop and ensure the implementation of a program for the prevention and management of
sharp injuries.
To prevent sharps injuries with exposure to blood-borne infections, the center should have a defined system to prevent sharps injuries and
ensure the proper handling of sharps. The handling, use, and disposal of sharps within the center should be practiced according to a written
policy and procedure. Center staff should have the knowledge and skills necessary to handle sharps (i.e., needles are not bent or broken, the
scoop method is used for necessary recapping, etc.).
IPC.12.1
Needles are not bent, broken, or recapped except in special and approved circumstances. If recapping is
necessary, the "scoop method" is used.
IPC.12.2
Needle sticks or sharps injuries are reported in a timely manner and investigated. Data are trended over
time and used to develop improvement interventions.

IPC.13
Sharps are discarded in appropriate containers.
The center should provide the necessary resources to implement a comprehensive program for preventing sharps injuries. The center should
ensure that the type of sharps box used is puncture-resistant and leak-proof and that it presents no risks to staff or patients. A sufficient
number of appropriate sharp containers should be made available. Sharps boxes are properly located and used, and sharps box disposal is
handled in accordance with national laws and regulations.
IPC.13.1
At least one puncture-proof and leak-proof sharps container is available in a convenient place in every
patient care area
IPC.13.2
Sharp containers are not overfilled and are disposed of as medical waste when their contents are three-
quarters of their sizes. They are not opened to facilitate the transfer of sharps into other containers.
IPC.14
Housekeeping has policies and procedures describing its functions.
Environmental cleaning is a fundamental principle of infection prevention and control in the center. The policy ensures appropriate
decontamination of surfaces that could play an important role in the transmission of dangerous pathogens including Clostridium difficile,
and antibiotic-resistant organisms such as methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE),
etc. The center must implement clearly written housekeeping policies and procedures that are reviewed by infection control staff. The center
must also maintain detailed cleaning schedules listing the center environmental surfaces, prepared and implemented by housekeeping staff
and monitored by Infection Control staff.
IPC.14.1
All units have a cleaning/disinfection schedule that lists all environmental surfaces and items to be
cleaned.
IPC.14.2
The infection control staff periodically review the cleaning procedures, schedules, and agents.
IPC.14.3
A process is in place to safely handle blood/ body fluids spills and waste.

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Chapter X
Facility Management and Safety

FMS.1

The leaders establish and support a facility management and safety program.

The center develops individual programs or one master program that includes the following: a) Safety and Security Safety—The
degree to which the center’s buildings, grounds, and equipment do not pose a hazard or risk to patients, staff, and visitors
Security—Protection from loss, destruction, tampering, or unauthorized access or use b) Hazardous materials—Handling, storage
and use are controlled, and hazardous waste is safely disposed of. c) Emergencies—Response to disasters and emergencies is
planned and effective. d) Fire safety—Property and occupants are protected from fire and smoke. e) Medical technology—
Technology is selected, maintained, and used in a manner that reduces risks. f) Utility systems—Electrical, water, and other utility
systems are maintained to minimize the risks of operating failures. A backup system is available in case of failure. Such programs
are written and up to date in that they reflect actual conditions within the center’s environment. A process exists for their review
and updating. When the center has other entities within the facilities to be surveyed (e.g., coffee shop or gift shop), the center has
an obligation to ensure that these independent entities comply with the facility management and safety program. To ensure
these plans are properly disseminated to the center’s newly hired staff, an orientation program should be established, covering all
aspects of the program to ensure patient, staff and visitor safety.

FMS.1.1

A qualified individual is responsible for the facility management and safety program as a full-time or part-
time employee.
FMS.1.2

The leaders establish an interdisciplinary team for overseeing and monitoring the facility management and
safety program.

FMS.1.3

The safety management program includes plans for emergency management, utility systems, hazardous
materials, fire safety, medical equipment, building safety and security.

FMS.1.4

The safety management program includes the regular inspection, testing, and maintenance of all the
program’s operating components.

FMS.1.5

Data related to safety concerns are reviewed and analyzed with proper action to prevent reoccurrences.

FMS.1.6

The leaders maintain adequate and complete documentation for the facility management and safety
program.

FMS.1.7

All staff including new hires, locum and trainees receive education on the program. This education is
repeated annually as relevant to their practice.

FMS.2

Interdisciplinary rounds are scheduled and conducted to ensure safety.

Safety rounds by the safety team and other disciplines should take place regularly in the center. The rounds are designed to
discover any inconsistencies and to identify existing safety or security hazards related to settings and environment. The results of
rounds are formally documented. Corrective actions are taken to ensure that safety requirements are met. The center should be
able to establish a systematic approach for the necessary safety expenditures (allocated budget).

FMS.2.1

The interdisciplinary team conducts a facility inspection round at least four times per year.
FMS.2.2

The resulting information is documented and used for corrective actions, planning, and budgeting for long-
term facility upgrading and replacement.

FMS.3

The center’s environment is safe for patients, visitors and staff.

To ensure occupants’ safety and manage the risks within the healthcare environment, all centers, regardless of size and resources,
must comply with national standards, environmental protection standards, laws and regulations, and the recommendations of
professional agencies. The leadership is responsible for: The building and its surroundings should be free of hazards such as;
potentially loose objects, exposed outlets or wiring, slippery floors, sharp ends and holes in the ground. • Knowing which national
and local laws, regulations, and other requirements apply to the center’s facilities; • Planning and budgeting for the necessary
upgrading or replacement as identified by monitoring data or to meet applicable requirements and providing evidence of
progress toward implementing the improvements. The center must develop and implement a plan for periodic preventive and
corrective maintenance for the center’s setting, including electrical and mechanical systems. Maintenance records are kept for all
mechanical and electrical equipment, such as air conditioning, power and equipment to help in decisions regarding replacement
or upgrades. When the center has been cited for not meeting requirements, center leadership takes responsibility for planning for
and meeting the requirements in the prescribed time frame.

FMS.3.1

The leaders ensure that the building and its services comply with national standards, environmental
protection standards, laws and regulations and the recommendations of professional centers.

FMS.3.2

The building and its surroundings are hazard free.

FMS.3.3

Periodic preventive maintenance (PPM) and corrective maintenance are performed and recorded for all
electrical and mechanical systems.

FMS.3.4

Maintenance records are kept for all electrical and mechanical systems, including periodic preventive
maintenance.
FMS.3.5

The center has adequate parking space, waiting areas and toilets.

FMS.4

The leaders develop and monitor the implementation of a fire prevention program.

The fire safety of the center and its occupants must be ensured through a number of facility control measures, in addition to staff
training on fire drills including the use of acronyms such as RACE/PASS and evacuation techniques. These measures must include
the procurement of fire-rated materials such as furniture and curtains (proven through the materials’ specifications) and the
establishment of fire and smoke compartments, especially for high-risk areas like the laboratory. Fire rating should also include
windows, glass, and doors along the compartment. Also, a staff training schedule on fire extinguisher use should be provided and
consider different types of fire extinguishing systems. The fire alarm system is to be maintained and tested, and all maintenance
records are to be kept and updated. The NFPA rates cigarette smoking as one of the three main causes of fire in healthcare
facilities. Cigarette smoking also poses a health risk for others in the form of passive smoking. "No smoking” signs are posted and
a no smoking policy is enforced.

FMS.4.1

At least annually, staff are trained on fire drills and evacuation plans.

FMS.4.2

Records of fire and evacuation training are kept in personal staff files.

FMS.4.3

Egress routes, corridors, and fire escapes are marked and free from obstacles.

FMS.4.4

Fire systems, including the fire alarm and fire equipment, are in place and functioning.

FMS.4.5

Fire extinguishers are tested and distributed in the center according to the type of extinguisher required.

FMS.4.6

The fire alarm system is maintained and tested and all maintenance records are maintained.
FMS.4.7

A no smoking policy is approved and enforced.

FMS.4.8

“No smoking signs” are posted at all entrances and waiting areas.

FMS.5

The center is secured and protects its users.

The center’s security program must ensure that everyone in the center is protected from harm, loss, or damage to property. Staff,
vendors and others that the center identifies, such as contractors, wear badges (temporary or permanent) or other forms of
identification. Restricted areas such as operating rooms, labs, and intensive care units , medical records and IT server rooms must
be secure and monitored by security personnel and/or security access control systems. Children, elderly people and other
vulnerable patients unable to protect themselves or signal for help must be protected from harm. In addition, remote or isolated
areas of the facility and grounds may require the use of security cameras or the presence of security staff. Security program
policies and procedures must be disseminated to center staff to clarify their roles and responsibilities in different situations. To
ensure security coverage of facilities, a security risk-assessment must be conducted to determine the number of security personnel
necessary to cover the center’s main gates, entrances, and security-sensitive areas, and to conduct security actives such as
security rounds. Patients, employees, and others must be able to sense the security presence in the center. This presence must be
available throughout the center’s operational time. Security personnel must be oriented to and familiar with their job
descriptions, roles, and responsibilities during various security scenarios and emergency cases. Female security personnel must be
available as required, and security personnel must be able to communicate properly with the center’s employees and patients,
without language barriers.

FMS.5.1

Trained security personnel are available in the center according to its size and design complexity.

FMS.5.2

The center’s equipment and data are secured.

FMS.5.3

The patient’s privacy is respected.

FMS.5.4

Security personnel or security systems restrict access to sensitive and high risk areas.
FMS.5.5

Patient and staff files are accessible only to authorized persons.

FMS.5.6

All staff wear properly displayed identification badges.

FMS.6

The leaders develop a plan for the inspection, testing and maintenance of medical equipment.

The medical equipment management program must be supported by policies and procedures that mitigate the risks associated
with the introduction of new medical equipment, the tagging of medical equipment, the removal of equipment from service,
agent/sub-contractors’ repairs, and the use of extension cords and cellular phones. To ensure that medical equipment is safe to
use through proper installation, regular inspection, maintenance, and testing, a medical equipment management program must
be implemented. Such a program must include: 1. An inventory of medical equipment that covers, at a minimum, the equipment
name, its manufacturer, its model, its serial number, its location, its organization number, and its maintenance history. 2.
Installation requirements including modification of HVAC requirements and safety precautions (for some types of laser equipment
in ophthalmology and dermatology clinics). 3. The availability of a system for medical equipment alerts and recall monitoring
through SFDA and manufacturer notifications and reporting medical equipment failures in a serious injury or illness to SFDA. 4.
The availability of a necessary service and operation manual, whether a hardcopy or softcopy, for reference when needed. 5. The
availability of calibrated necessary test and calibration equipment. Because medical equipment failures are expected, the center
must develop a risk-assessment-based backup plan for failed medical equipment through the provision of standby medical
equipment or by shifting to an equal medical intervention alternative.

FMS.6.1

An updated inventory list is available of all medical equipment.

FMS.6.2

Medical equipment with special installation requirements, HVAC, or room modifications is installed following
the manufacturer’s recommendations and safety requirements.

FMS.6.3

The periodic preventive maintenance (PPM) program is implemented for all medical equipment, according to
the supplied and available manufacturer’s service manual, and records are maintained.

FMS.6.4

The medical equipment is tagged with a PPM label.

All defective medical equipment is labeled accordingly.

FMS.6.6

Medical equipment is discontinued according to a clear policy including lifespan, beyond economic repair,
and vendor or governmental recalls. Equipment is disposed of as per governmental rules and regulations.

FMS.7

The leaders develop an emergency plan, and staff are trained on it.

To ensure the life safety of all occupants within the center and provide the utmost protection for the facility and its equipment,
staff must participate positively in protecting the environment and responding to emergencies. The center has a documented,
evaluated, and updated (as needed) emergency plan. The center must assess the types of emergencies it is more likely to
encounter and determine the types of action needed to ensure that patients and staff remain safe. A clear plan must outline
leader and staff duties and responsibilities in such emergencies. Staff are well trained in emergency drills and know where to
refer patients during emergencies if needed. Ongoing training is required to help ensure that staff are aware of those duties and
responsibilities. To test staff readiness, all department staff must participate in a mix of announced and unannounced drills, which
must be documented. Contingency plans are available for water and power sources during an emergency to ensure the
availability of alternate sources if needed.

FMS.7.1

The center’s emergency plan details how to respond to different emergencies and how to minimize risks in
the center.

FMS.7.2

The emergency plan defines the staff roles.

FMS.7.3

Staff are trained on the emergency drills annually. Staff are certified in completing the emergency drills.

FMS.7.4

The emergency plan includes contact persons and authorities.

FMS.7.5

The emergency plan identifies the nearest healthcare facilities and staff know where to refer patients during
emergencies if needed.
FMS.7.6

The center has alternative power and water sources as part of its emergency preparedness.

FMS.7.7

The emergency plan is documented, evaluated annually, and updated as needed.

FMS.8

The leaders develop a hazardous materials (HAZMAT) and waste disposal plan.

The center must protect its occupants from the effects of hazardous materials and waste. Centers produce a considerable amount
of potentially infectious waste every day. Thus, the proper handling, segregation of and disposal of waste contribute to the
reduction of infection risk in the center. A hazardous materials plan is in place that includes identifying and safely controlling
hazardous materials and waste throughout the facility. A hazardous material is any solid, liquid, or gas that can harm people,
other living organisms, property or the environment. Hazardous materials may be radioactive, flammable, explosive, toxic,
corrosive, oxidizers, asphyxiants, pathogens, or allergens, or may have other characteristics that render them hazardous in
specific circumstances. The hazardous materials program includes processes for: • Inventory of hazardous materials. • Handling,
storage, and use of hazardous materials. • Proper protective equipment and procedures to use and follow during use, spill, or
exposure. • Proper labeling of hazardous materials and waste. • Reporting and investigation of spills, exposures and other
incidents. • Documentation, including any permits, licenses or other regulatory requirements. • Education and training on the
signs and symptoms of exposure to hazardous materials and the appropriate treatment according to Safety Data Sheets (SDSs).
Information regarding procedures for handling or working with hazardous materials in a safe manner must be immediately
available at all times, and include the physical data of the material (such as its boiling point, flash point, etc.), its toxicity, its
health effects, identification of proper storage and disposal after its use, the type of protective equipment required during its use,
and spill-handling procedures, including the required first aid for any type of exposure. Waste (medical and non-medical) must be
disposed of according to local rules and regulations.

FMS.8.1

The leaders keep an updated register of all hazardous materials in the center, along with their “Safety Data
Sheets”.

FMS.8.2

Staff are trained in dealing with available hazardous materials and waste disposal.

FMS.8.3

Hazardous materials and waste are controlled. The center exerts a continuous effort to reduce hazardous
materials.
FMS.8.4

Hazardous materials are stored, handled, transported, used, and disposed of as per the “Safety Data Sheets”.

FMS.8.5

Waste disposal is done in an effective manner within the facility or through an authorized contractor.

FMS.8.6

Fire-rated cabinets are used for flammable hazardous materials.

FMS.9

The leaders develop a policy and procedure for the safe use of various types of compressed gasses.

Compressed gas systems are a standard feature of most healthcare facilities, and they require special monitoring and
maintenance to ensure their proper operation. Unlike other medical equipment and systems, the use of gas under pressure can
lead to a unique set of potential failures that may not be readily apparent. This makes medical gas preventative maintenance
critical to a problem-free working environment. Medical gas source equipment will vary depending on the type of gas and the size
of the institution. For smaller needs, cylinder-only solutions are often adequate. Compressors are also used to provide medical air,
and vacuum pumps are needed for suction. Failing to properly monitor these complex pressurized systems can be costly, in terms
of both increased use of consumables and damage to permanent equipment. Due to the nature of gas cylinders, special storage
and handling precautions are necessary. The hazards associated with compressed gases include oxygen displacement, explosion,
toxicity, and the physical hazards of a ruptured cylinder. HCFs must develop and implement a policy for handling, storing,
transporting, and disposing of various types of compressed gasses. Centers equipped with piped gas systems should follow the
regulatory body’s testing and safety requirements.

FMS.9.1

The document highlights the use of cylinder transporters.

FMS.9.2

The document emphasizes the cylinder storage in well-ventilated areas.

FMS.9.3

The document describes how to secure the cylinders by positioning upright against the wall and securing it
by a chain or inside special containers.
 FMS.9.4

The document ensures the timely replacement of empty cylinders and the availability of a backup system.

FMS.9.5

Centers equipped with piped gas systems follow the regulatory body’s testing and safety requirements.

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Chapter XI

Day Procedure Unit (DPU)

DPU.1
All day surgeries and procedures are performed in the day procedure unit.
For patients' safety, all procedures done in the center as day cases should be performed in a special day procedure unit. The unit design
should enable a patient and instrument flow that prevents the spread of infection to patients and should have special positive pressure
ventilation to prevent the influx of potentially contaminated air. Bed space for pre-procedure and post-recovery areas should follow
minimum requirements. The procedure room measurement and design should follow MOH requirements. A qualified physician should
oversee the unit. The administration of sedation or anesthesia should be done by a board-certified anesthesiologist, who shall also be
responsible for monitoring patients during the procedure and in the recovery area. One or two ICU beds should be available in the unit in
case a patient requires a longer recovery time or must be observed overnight. All cases performed in the unit should be registered in a log
book for statistical purposes and for possible tracking of cases. Dental cases requiring sedation should follow the same rules.

DPU.1.1
A qualified physician or anesthesiologist directs the unit.
DPU.1.2
A Saudi board-certified or equivalent anesthesiologist performs anesthesia and/or sedation as required
and is in charge of monitoring the patient until the patient is discharged home.
DPU.1.3
The unit has a patient receiving area, procedure room(s), and a recovery area with an ICU setup.
DPU.1.4
The unit has its own staff changing area.
DPU.1.5
The unit design follows infection control standards for the segregation of clean and potentially infectious
areas and air-conditioning requirements.
DPU.1.6
Dental procedures requiring sedation are performed under the same conditions developed for the day
procedure unit, and patients recover in either a dedicated recovery room or the same dental room where
the procedure was performed.
DPU.1.7
The center maintains a registry of all the day cases performed.

DPU.2
Leaders develop and implement a policy and procedure to guide the care of patients in the day
procedure unit.
To streamline activities in the day procedure unit and prevent morbidities, the unit must have implemented policies and procedures for the
activities mentioned in DPU.2.1 through DPU.2.9.
DPU.2.1
The policy highlights the types of operations and procedures that may be performed in the unit.
DPU.2.2
The policy describes how patients are received in the operating room.
DPU.2.3
The policy clearly explains the timeout procedure.
DPU.2.4
The policy includes the daily checking of anesthesia equipment.
DPU.2.5
The policy describes the required pre-sedation/anesthesia assessment and pre-induction assessment.
DPU.2.6
The policy describes the intra-procedural/operative monitoring of patients with or without anesthesia or
sedation.
DPU.2.7
The policy describes how patients are received and discharged from the recovery room.

DPU.2.8
The policy highlights the special considerations for surgeries involving implantable devices or lenses.
DPU.2.9
The policy includes the identification and storage of gametes in assisted reproduction units.
DPU.3
The patient is accepted into the unit by the nursing staff after a rigorous verification procedure.
To ensure the patient readiness for the procedure, staff should ensure the availability of the elements in DPU.3.1 to DPU.3.6 before
accepting the patient in the procedure room.
DPU.3.1
The patient is properly identified.
DPU.3.2
Informed consent is available.
DPU.3.3
The attending physician documents patient assessment and the operational plan.
DPU.3.4
Surgical/procedural site marking is done, if required.
DPU.3.5
Relevant laboratory and radiology results are available.
DPU.3.6
The pre-sedation/anesthesia assessment is documented.

DPU.4
The procedure/surgery room is a functional operating room.
The equipment mentioned in DPU.4.1 to DPU.4.6 constitute the minimum requirement in the procedure room to safely operate on patients.
DPU.4.1
The room has an anesthetic machine.
DPU.4.2
A scavenging system is connected to the room.
DPU.4.3
An ECG machine is available within the vicinity.
DPU.4.4
A cardiac defibrillator is available and regularly checked.
DPU.4.5
A ventilator is available and regularly checked.
DPU.4.6
Medical gases and suction are available with a backup system.

DPU.5
The day procedure unit is fully equipped for managing difficult intubations.
The equipment mentioned in DPU.5.1 to DPU.5.5 has proven to be lifesaving in cases of difficult intubation and should be present in the
day procedure unit.
DPU.5.1
Laryngeal mask.
DPU.5.2
Gum elastic bogie.
DPU.5.3
Lighted stylet.
DPU.5.4
Cricothyroidotomy kit.
DPU.5.5
Fiber optic intubations scope.

DPU.6
Patients booked for a surgery/procedure shall have a pre-sedation/anesthesia assessment performed by
the anesthesiologist prior to the surgery.
To decide on the most suitable type of sedation or anesthesia, patients must have a full pre-anesthesia/sedation assessment performed
before any procedure in the day procedure unit. A sedation or anesthesia written plan is crucial for the patient’s safety. The pre-
sedation/anesthesia assessment is valid for up to thirty days before the procedure. The assessment should highlight the anesthesia risk
score, such as the “ASA.” The immediate pre-induction anesthesia assessment focuses on the patient's immediate readiness for the
procedure and excludes findings that may require changing the anesthetic technique or postponing the procedure.
DPU.6.1
The pre-sedation/anesthesia assessment is performed no more than thirty (30) days before the surgery
date. If the pre-anesthesia assessment is performed within thirty (30) days, the pre-anesthesia
assessment is updated with documentation in the medical record.
DPU.6.2
The pre-sedation/anesthesia assessment highlights anesthetic risk score and the patient’s suitability for
the type selected.
DPU.6.3
The assessment results in a sedation/anesthetic plan that is agreeable to both the physician performing
the procedure and the patient/family.

DPU.6.4
The anesthesiologist reassesses the patient immediately before sedation/anesthesia induction to assess the
patient’s immediate suitability for the procedure.

DPU.7
The center ensures the correct implementation of the policy on preventing wrong patient, wrong site and
wrong procedure.
Unfortunately, wrong patient, wrong site, and wrong procedure are still reported worldwide. The evidence-based approach to prevent it is
mentioned in DPU.7.1 to DPU. 7.3 and must be followed and documented.
DPU.7.1
The procedure site is marked before surgery if required, as in multiple organs, laterality, or different
levels.
DPU.7.2
A preoperative verification process is used and documented in the day procedure unit before the patient
is placed in the procedure room to ensure the availability of the appropriate assessments, plans,
consents, diagnostics, equipment, instruments and implants.
DPU.7.3
The team which comprises of the surgeon, anesthesiologist and circulating nurse performs and
documents a time-out process immediately before the 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.
Patients may bleed unnoticed during surgery, develop lowered or raised blood pressure, or experience cardio-respiratory compromise.
Therefore, the patient's general status should be continuously monitored, even if the procedure is performed under local anesthesia.
Monitored findings should be recorded regularly on a specific monitoring sheet. The sheet should also include the time that anesthesia
began, the anesthetic agent used and its amount, the starting time of the surgery or procedure, the fluid used, any investigations done during
the procedure, any unusual events, and the patient's general status at the end of the procedure.
DPU.8.1
The patient’s vital signs, oxygen saturation, and ECG findings are recorded by the anesthesiologist.
DPU.8.2
The anesthetic technique is recorded by the anesthesiologist.
DPU.8.3
The anesthetic or sedation agent, IV medications and other medications, including dosage and the timing
of administration are recorded by the team.
DPU.8.4
Any unusual events are recorded.
DPU.8.5
Any investigations carried out are recorded.
DPU.8.6
The status of the patient at the end of the procedure is recorded.

DPU.9
The unit has a recovery room.
Following surgery or procedure, patients must be monitored for some time until their general condition returns to the pre-
anesthesia/sedation status and to ensure the absence of immediate complications. Therefore, patients should be observed in a special unit
equipped with the elements mentioned in DPU 9.1 through DPU. 9.5. In the absence of a specified recovery room, patients shall recover in
the procedure room until they are fit enough and able to be escorted home.
DPU.9.1
A qualified anesthesiologist covers the recovery room.
DPU.9.2
The recovery room is equipped with continuous vital signs monitoring, ECG, and pulse oximetry.
DPU.9.3
The recovery room is equipped with oxygen and suction.
DPU.9.4
The recovery room is equipped with a crash cart and defibrillator.
DPU.9.5
The recovery room is equipped with facilities for mobile ventilation in the event that transportation to a
hospital is required.

DPU.10
Each patient’s post-sedation/anesthesia physiological status is continuously monitored and documented
in the patient’s medical record.
To follow the patient’s recovery status and anticipate possible delays in recovery or potential procedure complications, the parameters in
DPU.10.2 through DPU 10.5 should be recorded at regular intervals and documented in the patient’s records. The date and time of the
patient’s receipt and discharge from recovery should be documented to assist in the overall evaluation of the patient’s recovery period.

DPU.10.1
The date and time of admission to the day procedure and discharge to recovery are recorded.
DPU.10.2
The patient’s vital signs, oxygen saturation, and level of consciousness are recorded.
DPU.10.3
The pain score is recorded.
DPU.10.4
Fluid output including urine and drains is recorded.
DPU.10.5
Tolerance to oral fluid is recorded.

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.
A complete operative or procedure report is essential for the immediate post-procedure care and for continuing the care of the patient as an
outpatient. The elements mentioned in DPU.11.1 to DPU.11.7 are the minimum required to be written down before the patient leaves the
recovery room.
DPU.11.1
The report highlights the pre- and post-operative diagnosis.
DPU.11.2
The operative report documents the name of the surgeon, anesthesiologist, and assistants.
DPU.11.3
The operative report clearly documents the operation or procedure performed.
DPU.11.4
The operative report includes a description of the surgery or procedure, findings, and complications, if
any.
DPU.11.5
The amount of blood loss is documented.
DPU.11.6
The operative report flags any drains or packs left, the type of wound closure, and the type of dressing
used, with instructions on how and when to remove.
DPU.11.7
The operative report includes specimens removed and the need for histopathological examination.

DPU.12
The patient is discharged home by an attending physician after the procedure.
It is of utmost importance to ensure the safety of the patient who is going home straight from recovery. Day procedure unit patients shall be
looked after at home by their relatives and must be fully recovered from sedation and anesthesia, with no potential for complications. Such
patients are not allowed to drive home and should be escorted. The discharging physician should give clear instructions on diet, the activity
of daily living, medications and wound care (if required). The patient should also receive clear and written instructions on how to seek
medical help in case of emergency.
DPU.12.1
The physician examines the patient to ensure the patient’s suitability and stability for home discharge.
DPU.12.2
Post-procedure instructions are written in the patient medical record and the patient/family are given a
copy and educated on it.
DPU.12.3
The patient is informed about how to obtain help. An emergency contact number is available outside
normal working hours.

CHAPTER XII

Dermatology & Aesthetics Medicine

DA.1
Dermatology and aesthetics services are managed by an experienced physician.
A reliable and safe dermatology and aesthetics services requires well experienced and knowledgeable leaders with a background of the
specialty. The center leaders must design a job description that explicitly defines the roles, responsibilities and accountabilities of the
service manager in the provision of safe, effective and customer focused services. The job description highlights the supervisory role of the
manager. The job description highlights the involvement of the manager in ensuring the safety of patients and staff.
DA.1.1
The managing physician is appointed by the center’s director.
DA.1.2
The managing physician is a board-certified dermatologist or plastic surgeon.
DA.1.3
The managing physician has a job description that matches his / her supervisory role and accountability
for the provision of safe and effective services.

DA.2
Physicians’ privileges outline the exact procedures to be done by each physician.
As outlined in the leadership chapter, the privileging of physicians is the most proactive risk reduction event in clinical practice. The center
exerts all efforts to delineate the privileges of the dermatology and aesthetics physicians based on their credentials and competency. The
center ensures that the physicians are performing enough number of procedures to maintain their skills. Neither the physician nor the center
can introduce a new procedure without ensuring the competency of the physician performing the procedure and without updating his / her
privileges. All privileges must be available at the site, or where procedures are performed in order for nurses to ensure that the physician is
privileged to do the procedure before preparing the patient for it. Nursing empowerment avoids unnecessary interactions between
physicians and nurses and ensures patients’ safety. All dermatology and aesthetic procedures are to be done by the physicians due to the
delicate nature of the procedures and the its narrow safety margin, however some procedures could be done by trained nurses under the
direct supervision of the physician.

DA.2.1
Privileges approved by the managing physician based on the physicians’ competency and experience.
DA.2.2
New procedures are performed by a physician only after updating his / her privilege.
DA.2.3
The managing physician ensures that copies of privileges are available at the procedural areas.
DA.2.4
The managing physician empowers the nurses to stop and report physicians performing outside the
scope of their privileges.
DA.2.5
The managing physician ensures that only registered trained nurses perform aesthetics procedures
"under physician's supervision".
DA.3
The unit performs periodic education and competency testing for clinical staff assisting in procedures.
The center ensures that staff assisting in the procedures are competent in doing so. The competency assessment takes place at the initial
appointment of the staff and whenever a new equipment or procedure is introduced. The assessment includes observing the patient for
possible complications and how to deal with it. The competency assessment is repeated at least yearly and whenever the procedure is done
differently. Evidence of education and competency is kept in staff’s personnel file.
DA.3.1
Education and competency assessment takes place at the initial appointment and for every newly
introduced equipment.
DA.3.2
The education includes how to manage related procedure complications.
DA.3.3
The education and competency assessment is repeated yearly, and whenever a change takes place in a
procedure.

DA.4
The managing physician ensures the compliance of procedural rooms with all required safety rules.
The unit manager takes the ultimate responsibility of ensuring the safety of patients, visitors and staff during the use of laser therapy and
other invasive equipment inside the dermatology and aesthetic unit. Procedures described in DA.4.1. to DA.4.4. must be strictly followed.
The unit manager performs weekly safety rounds on areas where laser and other invasive procedures are performed and documents findings
for both immediate correction and follow up of other requirements.
DA.4.1
Safety signs are posted outside the room.
DA.4.2
Laser procedural rooms do not have reflecting surfaces and do not store flammable material.
DA.4.3
Personal eye protective goggles are worn by patient and team performing laser procedure.
DA.4.4
Laser generated airborne contaminants are controlled by local exhaust ventilation.
DA.4.5
The center’s director and the managing physician perform weekly documented safety visits to all
procedural rooms.
DA.5
The unit maintains a dated and timed list of the procedures performed.
Collecting data on procedures helps to recognize common system mistakes for the sake of its correction. Biopsy and other pathology
specimens must be also recorded in this register to strengthen the process of histopathology processing and facilitate the follow up of the
results.
DA.5.1
The list highlights the medical equipment used and the name of the physician who performed the
procedure.
DA.5.2
The list highlights the outcomes and any complications of the procedures.
DA.5.3
The list highlights the specimens sent for pathological examination.

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.
All procedures performed in the unit must be evidence based. Practice guidelines facilitate the performance of procedures by highlighting
the indications, contra-indications, pre-procedural requirements, how to manage pain, safety precautions during the procedure, recovery
from procedure and further follow up requirements.
DA.6.1
The guidelines highlight the indications and contraindications of the procedures.
DA.6.2
The guidelines outline the pre-procedural assessment and investigations required and consent
requirements.

DA.6.3
The guidelines highlight the safety precautions to be followed.
DA.6.4
The guidelines outline the post-procedural recovery and follow up and any pathology specimen
processing required.

Best wishes

Dr.Maha Batisha