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Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬

‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

Introduction:
No. Question Answer

What does the abbreviation ESR stand Essential Safety Requirements.


1. for? The hospital will not be accredited if these standards are not fully met

Total standard: 20
Total Sub-standard: 113
How many ESR standards are there in the
2. CBAHI hospital standards 3rd Edition?
They are deemed to be basic conditions that must be fully observed to
ensure patient safety and protection against healthcare related errors.

 Proximity of risk
What are the criteria for selection of a  Probability of harm
3. standard as an ESR?Proximity of risk  Severity of harm, and
 Number of patients at risk

Categories of ESR:
HR= Human Resources
MS= Medical Staff
PC= Provision of Care
QM= Quality Management and Patient Safety
4. How are they distributed in the chapters? AN= Anesthesia
IPC= Infection Prevention and Control
MM= Medication Management
LB= Laboratory and Blood Bank
FMS= Facility Management and Safety
No of
Code Chapter
Standards
HR HR.5 1
MS MS.7 1
PC PC.25, 26 2
QM QM.17,18 2
AN AN.2, 15 2
IPC IPC.4, 15 2
MM MM.5, 6, 41 3
LB LB.51 1
FMS FMS.9,21,22,23,24,32 6
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

HR.5 The hospital has a process for proper credentialing of staff members licensed
to provide patient care.
No. Question Answer
 License
 Education
1. What are “credentials”?  Training
 Certification
 Experience
The process to gather, verify and evaluate the credentials
(license, education, training, competence and experience) of all
medical staff for appointment, assignment of work and granting
2. What is “credentialing”
of privileges.

(IPP: AD-HR-001 / NR-181)


Yes.
 MS-022- Credentialing and Privileging of Medical Staff ,
Do we have a policy on delineating
3.  MS-043- Credentialing of Technicians and non-Medical
clinical privileges?
Specialist Technicians
 NR-001- Nursing Staff Credentialing,

Credentials verification can be conducted through letter, secure


website, email, documented phone call (internally or through third
4. How are credentials verified?
party) From the original source that issued the credential.
This process is called Primary Source Verification

What is the accepted primary source Third party verification by “Data Flow”. A confirmation letter
5. verification for SCFHS? should be filed in the personnel file of the employee.

By directly contacting the original source thorough letters,


How does the hospital conduct primary telephone or website. If no response received after three (3) trials
6. source verification? (phone calls or emails)–at one month interval-documented in
personnel file

Is the process of checking the validity and completeness of a


7. What is primary source verification?
credential from the source that issued the credential.
Do Saudi employees need Primary Source
8. Verification? Yes. From their universities
Credentialing and primary source verification are applicable to
To which category of staff are Credentialing
9. and primary source verification applicable?
all clinical staff categories- (full-time, part-time, visitor and
locum)
How are clinical work, job responsibilities and
10. privileges assigned? Based on evaluation of credentials
What is the most important and mandatory
11. requirement to independently start work in Registration with SCFHS
hospital?
HR.5 is checked by the SCFHS registration in personnel file, and
12. What is the difference between HR.5 and HR.6 HR.6 is checked by matching the registration license with the
current position
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

MS.7 Medical staff members have current delineated clinical privileges.


No. Question Answer
Medical staff is allowed to practice only within the privileges
granted by the Credentialing and Privileging Committee to
provide safe patient care. This process makes sure that the patients
1. Why delineating clinical privileges is an ESR?
are protected from inappropriate care Physicians are also legally
protected if they limit their practice to the assigned privileges.

The process of reviewing an individual's credentials through


credentials committee channels to determine the authority and
responsibility to be granted to a practitioner for making
What is Privileging?
2. independent decisions to diagnose, initiate, alter, or terminate a
regimen of medical or dental care. Privileging determines the
physician's scope of practice in the hospital determined by his/her
competencies.
What is Medical staff delineated List of medical staff name, specialty, approved privileges and
3. Clinical privileges? renewal date as per credentialing and privileging committee.
Temporary, Permanent, Emergency
 Temporary privileges: Privileges assigned to a medical
staff member pending registration with the Saudi
Commission for Health Specialties or to a licensed visiting
physician for a period not exceeding 90 day are not
renewable.
 Permanent privileges: Clinical privileges assigned after
completion of primary source verification and obtaining the
4. What are the types of clinical privileges? license from Saudi Commission for Health Specialties
renewed every 2 years.
 Emergency privileges: Clinical privileges granted to a
medical staff member or a licensed non-member medical
staff during a disaster / medical emergencies and withdrawn
at the end of emergency are not renewable.

(IPP Number: MS-022) “Credentialing and Privileging for


Medical Staff”
 Request to Chief of Department
 Reviewed by Chief of department and Medical Director
5. What are the steps in granting clinical privileges? (accepted/denied) based on verification of credentials
 Recommended by the credentialing and privileging
committee and approved by Hospital Director.
All physicians re-apply and get renewal of their privileges every 2
years
 With valid medical license and a completed medical staff
evaluation form.
6. How the clinical privileges renew?
 The renewal is recommended and signed by the Assistant
Hospital Director for Medical Affairs and approved by
Credentialing and Privileging Committee & Hospital
Director.
In personnel (credential) file. It is accessible in all the workstation
Where can you access your clinical
7. privileges?
computers in patient care units in Intranet system for quick
verification of privileges.

List of medical staff name, specialty, approved privileges and


8. renewal date as per credentialing and privileging committee.

By submitting new request to the Chief of Department with the


How can you request for additional or new
9. privilege?
relevant credential. This request will be forwarded to the
Credentialing and Privileging committee for final decision.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

Yes. You can appeal to the Hospital Director


 An appeal against privileging decision is made in writing to
Can you appeal against the privileging the Chairperson of Credentialing & Privileging Committee
10. decision/s? and will be handled according to the Disciplinary procedures
for Medical Staff, Corrective Actions and Appeals process
included in the medical staff bylaws.

PC.25 Policies and procedures guide the handling, use, and administration of blood and
blood products.

No. Questions Answer


 Transfusion of blood and blood products can be harmful to the patient
if proper precautions are not taken before and during transfusion.
Why is “handling, use and administration of
1  Transmission of infectious diseases can occur Hemolytic transfusion
blood and products” an ESR?
reaction due to ABO incompatibility is a Sentinel Event

Yes.

Do we have a policy on handling, use and IPP Number: LB-BBD-001 “Guideline to Use Handling and
2 administration of blood products? Administration of Blood and Blood Products”
- Developed and approved by Blood Utilization Committee

Only Physician
 Blood and blood components transfusion shall be given upon the
written order of a physician. It should have written on the
prescription chart the of blood product, the volume required, date
3 Who can order blood/products transfusion?
and duration of infusion. This must be signed by them. In addition,
as a medico-legal requirement, the notes must clearly state the
reason for transfusion.

Yes.

Types of Consent related Blood Transfusion in KKH:


1. LB-BBD-005 Form 34
“Blood Transfusion Consent”
2. MS-047 Form 28
Do you need consent for blood/products “Authorization and Informed Consent for Surgical Procedures, other
4
transfusion? What TYPE OF CONSENT Invasive Procedures, Anesthesia & Blood Transfusion During
procedures”
3. LB-BBD-029 (6) Form 173
“Permit of Blood/Blood Component Transfusion Without NAT Test”
4. LB-BBD-005 (6) Form 35
“Refusal to Permit Blood/Blood Component Transfusion”
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

The physician ordering it.


 Physician obtain informed consent for blood products transfusion,
must be filled properly (patient/family sign, physician sign and
wetness sign (nurse) unless in emergency case (unknown patient or
new natal babies only attending physician sign the consent with
Who should obtain informed consent for explain the reasons (case diagnosis).
5  Unless the situation is a lifesaving emergency, doctors will have
blood/products transfusion?
gained parental consent for the transfusion. Ensure that the consent
form is signed and filled in the notes.

(IPP Number: LB-BBD-005) “INFORMED CONSENT OF BLOOD


TRANSFUSION”
 Description of the transfusion process
 Identification of the risks/benefits of transfusion
What are the CONTENTS of the  Identification of alternatives
6 Informed Consent for blood/blood
 Consequences of refusing transfusion
product transfusion?
 Opportunity to ask questions
 Giving the right to accept or refuse transfusion
Consent for transfusion must be obtained for each admission.
 It will be valid for the course of the current admission needs to be
documented once.
The VALIDITY Informed Consent for  Exceptional cases requiring regular or frequent transfusions
7 blood/blood product transfusion consent will remain valid for l2 months unless there is a significant
change in the risk profile of transfusion.
 In dire emergencies, patient/family signs consent for "Transfusion
without NAT testing.
Independent Double check by two (2) staff members (nurses) for
patient identity; aseptic technique.
 Two (2) nurses verify the patient's identity prior to blood
drowning for crosshatch.
 The blood collector must sign the cross match requisition.
How is blood withdrawn for cross-matching?
 The specimen tube is labeled at the BEDSIDE (not pre-labeled);
8 SAFE COLLECTION OF BLOOD SAMPLES
 Only one patient should be bled at a time to minimize the risk of
for pre-transfusion compatibility testing.
error.
 The sample must be labeled immediately after the blood has
been added, before leaving the patient.
 The collector must verify patient identification by signing both
the request form and the sample label to this effect.
Refusal consent - (LB-BBD-005 (6) Form 35 “Refusal to Permit
What should be done if the patient REFUSES
9 Blood/Blood Component Transfusion” ) for transfusion to be signed by
transfusion?
patient with witness either patient affair/nurse.

What PRECAUTION is taken Visual inspection of the blood/component Independent Double check
10 before administration? by two (2) staff members (nurses) for patient identity.

Independent Double check by Two (2) staff members verify the


For SAFE HANDLING of blood patient's identity:
11 /blood components what must be  prior to blood drawing for cross match
done?  prior to the administration of blood match
 prior to the administration of blood
Transfusion should commence within 30 minutes of a pack of red cells
being removed from the blood bank.
Vital signs must be taken & recorded:
How often the VITAL SIGNS must be  Before starting the transfusion
12 monitored and recorded for blood
 Every 15 minutes in the first hour,
transfusion?
 Every 30 minutes until the end,
 After finishing the transfusion.
 Post transfusion hourly for 2 hours.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

 Transfusion reaction - an undesirable event occurring in patient


during or after transfusion of blood Product.
What you must do if TRANSFUSION
13 REACTION is suspected? 1. The attending nurse or doctor stop the infusion immediately;
2. Keep the line open with a slow infusion of saline.
3. Notify the treating physician immediately.
4. Re-check the identification of the patient and blood infused.
5. Monitor and document the vital signs
6. Notify the Blood Bank (extension 1833 immediately)
 Order a Transfusion Reaction investigation STAT
procedure: Extract 5 ml blood specimen in EDTA tube send to
blood bank (with blood unit & attached transfusion set)
 Obtain first Urine Analysis test (for free Hemoglobin, if
hemolytic reaction is suspected.)
 Monitor fluid/electrolyte balance (for renal function,
electrolytes, liver function test, LDH, S. haptoglobin)
 Send blood culture to microbiology lab (especially if
there is more than one degree rise in the patient's
temperature)
7. Remove the needle from the set and close the tubes by clamps
properly.
8. Completely fill a Transfusion Reaction Form
9. An OVR is initiated by the nursing staff. A report is given to the
blood utilization committee to ensure the implementation of
corrective actions

(IPP Number: LB-BBD-043)”Adverse or Suspected Transfusion


Reaction”
 Fever (increase of equal to or greater than l oC or 2 oF), with or
without chills
 Chills (rigors), with or without fever
 Skin symptoms - hives (urticaria) or itching
What are the most common signs &  Chest pain and/or dyspnea
symptoms of an ADVERSE
 Acute hypotension or acute hypertension
14 REACTION due to transfusion of
 Nausea, vomiting
blood or blood products?
 Flushing
 Bleeding
 Hematuria
 Hemoglobinuria
 Anaphylaxis
 Treating or attending physician is responsible for blood transfusion to
the patient during transfusion (stay for 1st 15 minutes of transfusion
with patient) and follow up the patient for any transfusion reaction-
What is the physician responsibility immediate and delayed.
15
during blood transfusion?  The ROD should attend the patient when called by the ward
nurse for any reaction. He should stabilize the patient and inform the
specialist on call. The transfusion reaction form should be completed
by the specialist.
“Nucleic acid testing (NAT)” is a molecular technique for screening
16 What is transfusion without “NAT” blood donations to reduce the risk of transfusion transmitted
testing? infections (TTIs) in the recipients, thus providing an additional layer of
blood safety. Not done in dire emergencies when saving life outweighs
the benefit of testing.
These tests include:
 Nucleic acid testing (NAT),
 HBsAg
 Anti-HBc
 Anti-HCV
 HIV I/II
 HIV P24 Antigen,
 Anti-HTLV I/II,
 Syphilis
 Malaria
 or any other MOH approved tests.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

In dire emergencies, patient/family signs consent for “Permit Of


Blood/Blood Component Transfusion Without Nat Test”
LB-BBD-029 Form 173

(IPP Number: LB-BBD-029) “Release of Incompletely Tested Blood”

PC.26 Patients at risk for developing venous thromboembolism are identified and managed.

No. Questions Answer


Pulmonary Embolism is a major cause of death among hospitalized
patients. Death due to hospital acquired pulmonary embolism has been
Why assessing patients for the risk of VTE is
1 designated as a Sentinel Event. PE due to VTE in hospitalized patients
an ESR?
may result as a consequence of inadequate assessment and lack or
delay in prophylaxis of VTE.
All adult patients (18 years and older) admitted to hospital as inpatients
or formally admitted to a bed for day case procedures are screened and
assessed for the risk of VTE and bleeding on admission to hospital on
admission and appropriate prophylaxis given and reassessed at regular
2 intervals.
 Venous thromboembolism (VTE): the blocking of a blood
vessel by a blood clot. It includes both DVT and PE.
 Deep vein thrombosis (DVT): a thrombus or blood clot
partially blocking the deep veins (usually in the lower limb or
pelvis).
 Pulmonary embolism (PE): a blood clot blocking the
pulmonary arteries
Methods of prevention and signs and symptoms of DVT and PE on
admission part of the discharge process and documented in discharge
plan. The policy will enable healthcare practitioners to identify patients
at risk of developing VTE and select the appropriate therapy, thus
reducing the incidence of VTE and the associated mortality and
morbidity.
How can we comply with this standard?
Groups that will be covered:
 Surgical patients (including day surgery)
 Medical inpatients
 Trauma inpatients
 Cancer inpatients
 Patients undergoing long term rehabilitation in hospital
Groups that will be not be covered:
 Patients under the age of l8 year
 Patients attending the hospital as outpatients
 Patients presenting to emergency departments without
admission
 Elderly or immobile people care cared at home, or in a
residential care or rest home, unless admitted to hospital

(IPP Number: MS-056) “Reducing the Risk of Venous


Thromboembolism (VTE) in Adult Patients admitted to Hospital”
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

The specialist admitting the patient should assess the patient for the
risk for VTE and initiate the prophylaxis according to the score.
What is the physician responsibility in
3 This should be reviewed by the senior clinician (Consultant or
initial assessment of VTE Risk?
registrar) within 24 hours. The form should be signed and stamped by
both with date and time.

Two (2) types of VTE Prophylaxis:

1. Pharmacological
a) low molecular weight heparin (LMWH) : class of
anticoagulation medication:
 Heparin
 Enoxaparin
What are the VTE prophylaxis or
4 thrombo-prophylaxis ? 2. Mechanical
a) Devices are used to help prevent blood clots in the deep veins
of the legs. The devices use cuffs around the legs that fill with
air and squeeze your legs. This increases blood flow through
the veins of your legs and helps prevent blood clots and
reducing reducing the risk of DVT.
 Intermittent pneumatic compression devices (IPC Device)
 Sequential Compression Device (SCD)

To be done by senior clinician (registrar or consultant).


 All patients need to be reassessed weekly using same form for
patients at risk for VTE.
 Reassess and use new form if there is change in the condition or
5 How are patients reassessed for VTE Risk?
score
 If patient was not at VTE risk or at Risk with contraindications to
pharmacological prophylaxis; reassess regularly every 72 hours
on the same form.

6 How is reassessment documented? In the (MS-056 form 33 form) in the specified area

What should be done if the score or treatment


7 Use a new form. Do not make corrections in the forms
changes?

Yes, we have revised our policy according to MOH Guidelines and


have fully implemented the policy (IPP Number: MS-056)
8 Do we have a policy for VTE Prophylaxis? “Reducing the Risk of Venous Thromboembolism (VTE) in Adult
Patients admitted to Hospital”

Registered nursing staff are responsible for:


 Ensuring that all patients in their care have been assessed and
documented properly by physician for their risk of VTE and
bleeding and that this risk assessment is up to date.
 Ensuring that this is carried out or administering both mechanical
and pharmacological VTE prophylaxis as prescribed.
9
What is the responsibility of Registered Nursing  Ensuring that all patients receive verbal and written information
Staff? on their risks of VTE, methods of prevention and signs and
symptoms of DVT and PE on admission and as part of the
discharge plan
 Teaching patients to self-administered VTE prophylaxis where
appropriate.
 Ensuring that they are up to date with VTE training.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

 The VTE Committee /task force will provide quarterly reports to


the Patient Safety, board committee and regional VTE committee
to ensure that International VTE Guidance is fully implemented, up
to date and consistent with international and MOH guidance.
10 How do we monitor compliance?
 Continuous monitoring is done by the Nursing and Quality
Departments VTE Committee chaired by Medical Director meets
monthly, reviews the data, and reports it to MOH in the required
format. Monitoring is also done by the Clinical Audit Program and
monthly data is sent to the Clinical Audit Center.

QM.17 The hospital has a process to ensure correct identification of patients.

No. Questions Answer


By using two (2) identifiers:
1. Full (complete) names
1 How do you identify your patients?
2. Medical Record Number (MRN)

 For Saudi patients complete 4 names (three names and the


patient's family name)and for non-Saudi patients complete 3
names as written in the iqarna or other available official
document (driver's license, passport, and identification card)
and MRN.
 DO NOT include:
• Patients’ room number or bed number (location)
*in identifying patients as these are likely to change

Do you have a policy on correct patient Yes.


2 identification? IPP Number: AD-QM-006 “Identifying Patients Correctly”
From Quality Management and Patient Safety

What is the importance of identifying


3 It is the only way to match the correct patient to correct care
patients correctly?
Sources of the patient identifiers may include:
 Patient
4 What arte the sources of patient identifiers?  Relative / Guardian (parent, spouse, adult sibling, etc.,)
 Transferring facility if the patient is unable or surrogate
is unavailable to provide information
Any circumstance involving patient interventions e.g.,
 Before providing treatments
(administration of medications, blood or blood products;
serving a restricted diet tray, or providing radiation therapy)
 Before performing procedures
What are the clinical situations in which you
5 (insertion of an intravenous line or hemodialysis)
have to identify patients?
 Before any diagnostic procedures
(taking blood and other specimens for clinical testing or
performing a cardiac catheterization or diagnostic radiology
procedure and as part of “time out)
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

Use of ID wrist bands with standardized informations:


 Full name,
What is the standardized procedure in KKH  MRN,
6
for patient identification?  Gender,
 Age
 Bar codes in laboratory

 In the wards the nurses explain to the patients why the wrist
band is being applied, the importance of correct identification
and they ask the patients their names and age before applying
Do you involve patients in identification the wrist band. Ask the patients to identify them before
7 process? receiving any medication or any procedure.

 In OPD the physician and the nurse ask the patients’ full name
and confirm it from the appointment paper and in OASIS.

Medical Record Number is generated for all patients.


If staffs are unable to identify the patient, the patient name is
How do you identify comatose or confused placed in a "Majhoul / Unknown" status until the true identity is
8 patients when there is no watcher? established (Temporary Identification Band) till the patients are
identified correctly by name also; then change to correct name
and MRN in ID band.

QM.18 The hospital has a process to prevent wrong patient, wrong site, and wrong
surgery/procedure

No. Questions Answer


Why “prevent wrong patient, wrong site, Because the outcome of non-compliance will be a “never event” or
1
wrong surgery/procedure” is an ESR? “sentinel event”

2 What is a “never event”? A medical error that should never occur. E.g., amputation of wrong limb

An unexpected occurrence leading to death or permanent physical or


psychological loss of function unrelated to the underlying illness of the
3 What is a sentinel event?
patient.
Examples:
 Unexpected death
 Unexpected loss of limb or function
 Wrong patient, wrong procedure or wrong site
 Retained instrument or sponge
 Serious medication error leading to death or major morbidity
 Suicide of a patient in an inpatient unit
 Maternal death
 Hemolytic blood transfusion reaction
 Air Embolism
 Death of a full term infant
 Transmission of a chronic, fatal diseases or illness as a result of
infusing blood or blood products or transplanting contaminated
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

organs or tissue
 Deviation from standard of care (e.g. Policy, procedure,
protocol, delay in management) that lead to death or serious
harm.
 Child/ Infant abduction
 Infant discharged to a wrong family
 Rape
 Workplace violence such as assault; or homicide (willful
killing) of a patient, any employee, visitor or sub-contractors
while on hospital property.
 Fire: Major destruction or loss of function to the surrounding
environment (natural or facility), events that result in death
 Suicide of staff, visitors, watchers anywhere on property
 Critical equipment breakdown or failure when in use
 Unintended collapse of any building or structure under
construction or alteration
 Collapse or overturning of any load bearing part of any lift or
lifting equipment when in use

(IPP Number: AD-QM- 003)”Sentinel Event and Root Cause Analysis”


MOH SAUDI Patient Safety Taxonomy – 2018

What are the 5 processes in our hospital to implement this goal?


1. Surgical site/invasive procedure marking
2. Pre-operative / procedure verification
3. Sign-in
4. Time-out
5. Sign-out

1. Surgical site/invasive procedure marking : The surgical/procedural


site is marked before conducting the surgery/invasive procedure. The
site is marked especially in bilateral organs and multiple structures,
(e.g. fingers and toes and spine).
What are the processes to prevent wrong
2. Pre-operative / procedure verification: A ore-surgical/procedure
4 patient, wrong site, wrong
verification of the patient information is carried out including the
surgery/procedure?
patient's identity, consent, full details of the procedure, laboratory
tests and images, and any implant or prosthesis
3. Sign-in: Pre-operative / procedure verification process conducted in
operating room before induction of anesthesia.
4. Time Out: The final verification process of the patient, procedure,
site and implants (if applicable), before performing any
surgical/invasive procedure in operating/invasive procedure room
and is conducted before incision. Any unanswered questions or
confusion about patient, procedure or site are resolved by the entire
surgical or procedural team during a time out.
5. Sign Out: Procedure during or immediately before patient leaves the
operating /procedure room to ensure safe completion of the
procedure.
Do we have a policy on preventing wrong Yes,
5 patient, wrong site, and wrong AD-QM-004 “Ensure correct site, correct procedure, correct patient
surgery/procedure? surgery and surgical /invasive procedure safety”
The ward nurse for completing the verification checklist and then
Who is responsible for the for the pre- endorsing to the OR Receiving nurse. The OR receiving team
6 procedure verification in OR re-confirms the verification. The same procedure is followed for
procedures outside of OR.
In the form in OASIS by the ward nurse
Where do you document pre-procedure
7 Again in the OR receiving area both ward nurse and OR nurse together
verification?
check and document in OASIS

What are the important items verified  Patient identity,


8
pre-procedure?  consent,
 full details of the procedure,
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

 site marking
 laboratory tests and images,
 any implant or prosthesis

Correct patient - The patient correctly identified as the person who has
agreed and consented to the said procedure with informed consent.
Correct site - The unambiguously intended site of an incision or
insertion, which has been previously agreed by the patient with
informed consent.
Pre-operative /procedure verification - Done by the nurse in charge
of the patient using a checklist to make sure that all requirements for
surgery / procedure carried out .
Correct procedure - The procedure is the planned intervention based
on current professional knowledge, which has been previously agreed
by the patient with informed consent.

When and where is the site marking Before conducting the surgery/procedure. In our hospital, in the ward, or
9
carried out? day surgery unit/ location of the procedure

10 Who marks the surgical site? The surgeon/physician who will conduct the Procedure

Is the patient involved in site marking and Yes.


11 Before marking by explaining the importance of site marking to the patient
how?
Especially bilateral organs and multiple structures and levels (fingers, toes,
12 Which sites are marked? spine).
The mark is made using an indelible, hypoallergenic, latex-free, skin
marker (Permanent waterproof Board Marker).
13 What notation is used? We use “SS” uniformly for all sites and all surgeries in KKH

What are the other requirements for the Should be done with indelible ink The mark should be visible after the
14 site marking patient is prepped and draped.

The physician who will do the surgery/procedure will document in


15 Who documents site marking and where? progress notes in OASIS The ward nurse will document in the pre-op
checklist in OASIS

There is handover between the unit nurse and operating room reception and
16 What is the handover process in OR between OR reception and OR nurse using SBAR

Pre-operative / procedure verification process conducted in operating room


17 What is “sign in” and when is it done?
before induction of anesthesia

18 What is the procedure for “sign in”? The operating room nurse, (the person coordinating the checklist) and the
anesthetist will review with the patient that his or her identity has been
confirmed, that the procedure and site are correct and that informed
consent for surgery has been taken and that the documents and related
information, equipment are available prior to the start of the procedure,
correctly identified, labeled and matched the patient identifiers.

19 Who documents “sign in” and where? OR Nurse in the OASIS

The final check- just before initiating the procedure during which the team
20 What is “time-out”? discusses all issues related to the surgery
The location of the surgery/procedure (OR and
21 What is the location of time-out? outside OR e.g., Endoscopy)

22 When to do time-out done exactly? After induction of anesthesia, just before initiating the surgery (incision)
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

23 Who initiates the time-out? In our hospital, the Circulating nurse in OR An assigned nurse outside OR

All members of the team- the individual performing the procedure,


24 Who are involved in time-out? anesthesia providers and the nurses involved

Active communication in within the team- Team members agree on the


What communication happens during
25 correct patient identity, correct procedure to be performed, correct site,
timeout?
and when applicable, availability of the correct implant or equipment

The circulating nurse in OR; assigned staff nurse if done outside OR-In
26 Who documents time-out and where? the electronic form in OASIS
Process during or immediately before patient leaves the operating
27 What is “sign out”? /procedure room to ensure safe completion of the surgery/procedure

28 Who are involved in sign out? OR Nurses, surgeon and anesthesiologist and all the surgical team

AN.2 Anesthesia staff members have the appropriate qualifications.

No. Questions Answer

How can you confirm the qualification of the From the personnel file- ACLS is mandatory
1 anesthetist?

Anesthesia Consultant

Who administers and supervises anesthesia Examples of such operations in KKH


2 for major specialized operations and  Pediatric operations
high-risk patients?  Cardio-pulmonary operations
 Neurosurgery operations
 Any patient with ASA 4&5
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

AN.15 Qualified staff perform moderate and deep sedation/analgesia.

No. Questions Answer


Do we have a policy on moderate and deep Yes.
1
sedation analgesia? IPP Number: MS-AN-010- “Moderate and Deep Sedation Policy”
The physician
 Should have competency based privileges granted to perform
moderate and deep sedation analgesia
 Clinical staff participating in caring for patients receiving moderate
and deep sedation analgesia
What are the requirements for the staff to
 Should have recent valid ACLS/PALS or more advance
2 perform moderate and deep sedation
certificate
analgesia?
 Must have successfully completed training course certificate &
renewed every 2 years
 Must satisfactorily demonstrate Basic airway management skill
 Show a working knowledge of the drug's time to onset and
duration of clinical effect for those agents
How is the patient prepared for moderate Informed consent after patient/family education IV access is inserted
3 and deep sedation analgesia? maintained till patient is fully recovered
4 Who conducts the pre-sedation assessment? Qualified physician
Areas in which conscious sedation is performed should have the
following necessary equipment to provide safe care:
 Wall suction or suction equipment
What are the requirements for areas  Pulse oximetry
5 where moderate and deep sedation  Oxygen source
analgesia is performed?  Automated blood pressure monitoring,ECG monitor
 A crash cart with defibrillator, medications, IV access, and
intubation equipment that is appropriate to age of the patient.
 Recovery beds
 Emergency Departrnent
 Radiology department (Angiogram, MRI, CT Scan).
What are the Moderate & Deep  Cardiac Catheterization Unit
6
Sedation Areas?  Endoscopy
 ICU
 OR
Aldretes Discharging Scoring Assessment (IPP Number: MS-AN-011)
“ Criteria For Recovery And Discharge From Sedation”

What is the discharge criteria for


7
conscious sedation?
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

PC.4 There is a designated multidisciplinary committee that provides oversight of the infection
prevention and control program.

IPC.15 Facility design and available supplies support isolation practices.

No. Questions Answer


Do you have an Infection Prevention and Yes.
1
Control (IPC) committee? Chaired by the Medical Director
1. Surveillance of HAIs
2. Establishing a defined process for investigating outbreaks
3. Proper monitoring of antimicrobial use- preparation of
What are the areas of focus for Infection antibiogram
2 4. Staff education
Prevention and Control (IPC)?
5. Safe medical waste disposal
6. Review and supervision of reconstruction project
7. Allocation of adequate resources for IPC program
 Anteroom
 Air is exhausted to outside and is nor re- circulated
What are the requirements for the  HEPA filters
3 negative pressure isolation room?  12 Air exchanges/hour
 Isolation signs
 Standard and isolation precautions- N95 masks
26
Location Number
ER 1
ICU 4
How many negative pressure rooms do we
4 have in our hospital? M1 5
M2 4
M4 5
S2 5
AKU 2
 Hand hygiene
How can you reduce the risk of Healthcare  Standard precautions- PPE
5 Associated Infections (HAI)?  Expanded precautions-Isolation, N-95 masks (single use only)
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

Types of Hand Hygiene


1. Routine Handwash ----- 40-60 seconds
6 What are the types of hand hygiene? 2. Alcohol-Based Handrub ---- 20-30 seconds
3. Anti-septic Handwash----- 1-2 minutes
4. Surgical Handwash ------ 3-5 minutes
Types & lndications of Hand Hygiene:
7
Types & lndications of Hand Hygiene?
1. Routine Hand washing - Wash hands with soap and water
when visibly dirty or visibly soiled with blood or other body
fluids, or after using the toilet.

2. Antiseptic hand wash - removal or destruction of transient


microorganisms washing hands with water and soap or other
detergents containing an antiseptic.

3. Alcohol-based hand rub - as the preferred means for routine


hand antisepsis in all other clinical situations it applies, if hands
are not visibly soiled

4. Surgical hand hygiene/antisepsis - Surgical hand antisepsis


should be performed using either a suitable antimicrobial soap
or suitable alcohol-based hand rub, preferably with a product
ensuring sustained activity, before donning sterile gloves, the
duration of entire procedure is 3 - 5 minutes duration.

(IPP Number: IC-007) Hand Hygiene Guidelines


5 Moments of Hand Hygiene:
What are the 5 Moments of Hand Hygiene?
8 Moment #1. Before touching the patient
Moment #2. Before clean Aseptic procedure
Moment #3. After blood body fluid exposure risk
Moment #4. After touching the patient
Moment #5. After touching patient surroundings

2 Types of Isolation Precaution:


1. Standard Precautions: is the primary strategy for preventing
transmission of microorganisms to patients, They are applied to
all patients.
2. Expanded Precautions: (Transmission Based Precaution) are
designed for patients with documented or suspected infection
with communicable or epidemiologically important pathogens for
which additional precautions beyond standard precaution are
needed to interrupt transmission.

Types of Expanded Precautions:


9 Types of Isolation Precaution?
 Airbome precautions
– Prevent transmission by air current
– (BLUE sign on the door) - N95 Mask
 Droplet precautions
– Prevent transmission by small and large droplets
– (GREEN sign on the door) - Surgical Mask
 Contact precautions
– Prevent transmission by direct or indirect contact
– (RED sign on the door ) - Gloves and Gown
 Combination of airborne and contact precautions

(IPP Number: IC-009) “Isolation Precautions”


Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

-2.5 to -20 pascal (To be monitored daily if there is patient, and


What is the Reading of negative Pressure weekly if there is none) With Nurse’s Signature IPP: IC-009 (5)
10 Room?
(IPP Number: IC-009) “Isolation Precautions”
Minimum of 12 air exchange per hour (To be monitored every 3
11 What is the Negative Pressure Air Exchange?
months) with Engineer’s Signature IPP: IC-009 (5)
12 What are the sequence of donning and doffing DONNING OF PPE:
of Personal protective equipment (PPE)? 1. Hand Hygiene
2. Gown
3. Mask(N95/surgical mask)
4. Eye Protection/Googles
5. Face shield
6. Gloves

DOFFING OF PPE:
1. Gloves
2. Hand Hygiene
3. Face shield
4. Gown
5. Hand Hygiene
6. Mask(Outside of the isolation Room)
7. Hand Hygiene

(IPP Number: IC-008) “ Personal protective equipment (PPE)


1. Hand Hygiene by hospital wide/departmental/professions
What are the Key performance Indicators
13 2. MDRO project (ICU, surgical ward and oncology)
(KPI) for infection control?
3. Reduction of CLABSI in ICU.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

MM.5 The hospital has a system for the safety of high‐alert medications.

No. Questions Answer


High-alert medications are drugs that bear a heightened risk of
1 What are high-alert medications? causing significant patient harm when used in error
Concentrated electrolytes, Insulin, Heparin
2 Can you give some examples?
-see list in PH-03 Appendix 1
Yes.
Do you have a POLICY on high-alert
3 Code Number: PH-03 “High Alert Medications and Hazardous
medications?
Pharmaceutical Chemicals Management Plan”

Where can you access the LIST of High Attached to the plan Code Number: PH-03 in Intranet System. The
4 alert Medications Hard copy is available in the nursing stations or preparation room.

How can you identify a high-alert By the RED label affixed to them. You can see flashing “high alert”
5 medication? sign in Omnicell

How can you identify a high-alert You can see “high alert” along with name of the medication when you
6
medication in OASIS? select medication.

Can you order High alert Medications by NO.


6
Telephone or verbal order?  Telephone orders will not be accepted for any narcotic
medication.
 Telephone orders will not be accepted for Total Parenteral
Nutrition (TPN), Adrenergic agonists, Inotropic medications
and Neuromuscular Blockers. (PH-050 Appendix 1)
 Verbal or Telephone Orders will not be given for initiating,
or modifying any Chemotherapeutic drug.

7 How are High alert Medications administered? After independent double check (by (2) two nurses)

Which concentrated Electrolytes are available in


8 the hospital? Sodium chloride 3%,potassium chloride (KCL)15%

Are the concentrated Electrolytes present in the


9 patient care areas as floor stock? NO, the pharmacy supplies only the diluted ones when required
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

MM.6 The hospital has a system for the safety of look‐alike and sound‐alike
(LASA) medications.

No. Questions Answer


1 What are LASA Medications? Look-Alike Sound-Alike Medications

 Look alike Medication: Medications in which the packaging is


visually similar to another product or medication.

 Sound Alike Medications: Medications for which the generic or


trade name of the product or medication sounds similar in the spoken
or written words
How are they otherwise known as? Confused drug names
2

Do you have a policy on Look-Alike Yes.


3 Sound-Alike Medications PH-048: Look-Alike Sound-Alike drugs
By the YELLOW label affixed to them.
Attached to the plan PH-048 in Intranet. Hard copy available in the
4 How can you identify LASA Medications nursing stations or preparation room

See list in PH-048 Appendix I “Look-Alike Sound alike Drug”

How can you identify a LASA medication in You can see “LASA” along with name of the medication when you
5
OASIS? select medication
What additional precaution is required for LASA
6 Indication has to be written clearly in the clinical notes box
ordering in OASIS?
To ensure the safety of LASA is by following the TALLman Method
of labeling (e.g., hydrOXYzine, hydrALAzine), and
How to ensure the safe administration of LASA
7 By Independent Double Checking by the two (2) nurses will be
medications?
employed to confirm the right medication before administration of
LASA medications.
Where can you access the list of LASA Attached to the policy PH-048: Look-Alike Sound- Alike drugs.
8 Hard copy available in the nursing stations
Medications

9 Can you order LASA Medications by telephone? NO.

10 How are LASA Medications administered? After independent double check (by (2) two nurses)

Two persons check separately and compare the results, each


How do you perform independent double
11 component of prescribing, dispensing, and verifying the high-alert
check?
medication before administering it to the patient.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

MM.41 The hospital has a process for monitoring, identifying, and reporting significant
medication errors, including near misses, hazardous conditions, and at‐risk behaviors that
have the potential to cause patient harm

No. Questions Answer


A medication error is any preventable event that may cause or
lead to inappropriate medication use or patient harm while the
1 What is a medication error? medication is in the control of the health care professional, patient,
or consumer.
Any medication error that, if not prevented, may cause significant
2 What is significant error? harm to the patient (i.e. permanent harm or death).
How do you report a medication error? Through the electronic medication error reporting system
 Reporting Medication Error is thru the link to electronic
3 reporting system http://10.5.33.33/medierror/
 Paper-based Medication Error/Near Miss Report Form (PH-
012 Form 11)
Do you have a policy on medication error Yes. IPP Number: PH-012 “Medication use process errors - detection,
4 reporting? correction, reporting and prevention”
What are included medication error reporting Medication errors, near misses, hazardous conditions, and at-risk behaviors
5
systems?
Is an event or situation that could have resulted in an accident, injury
6 What is near miss? or illness, but did not, either by chance or through timely intervention.
Observe the seven (7) rights of MEDICATION ADMINISTRATION:
1. Right Medication
2. Right Patient
3. Right Dosage
What are the 7 Rights of Medication 4. Right Route
7 5. Right Time
Administration?
6. Right Frequency
7. Right Documentation

-See policy IPP Number:NR-129 (4) “Medication Administration”


– Selection/Procurement
– Ordering/Prescribing/Transcribing
– Preparing/Dispensing
– Administration
– Monitoring
– Compliance
What are the process involved with description of – Impact of the error
the error? – Outcome of the Error if it reached the patient
8
– Immediate Actions Taken
– Physician Follow-up: (If error reached the patient)
– Action taken by The Responding Department to
prevent recurrence of such an error.
-See policy IPP Number: PH-012 (8) Form 11
“Medication Use Process Errors - Detection, CorrectioN, Reporting
And Prevention”
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

9 Where do you document a medication error? In the patient medical record

How do you receive a feedback on your medication


10 Yes, Through SMS/MOH Email
error report?
Do you have to write an OVR also for medication
11 error? No
Did you receive any education on Medication Error
12 Yes. From the pharmacists
reporting? From whom?

What action is required from the quality point of Root Cause Analysis should be conducted and the action plan be
13 view in case of a significant or potentially implemented and monitored.
significant medication error? A sentinel event due to medication error will be reported to relevant
authorities

LB.51 The blood bank develops a process to prevent disease transmission by blood/platelet
transfusion.

No. Questions Answer


The policy LB-BBD-024
Screening Of Blood Donors For transfusion- transmissible
How does the blood bank prevent disease by
1 Infections (TTI) clearly describes all the precautions taken to
blood/platelet transfusion?
prevent disease by blood/platelet transfusion

Testing of donor sample for infectious diseases Limiting and


2 What are the important contents of this policy? detection of bacterial contamination of platelets using sensitive
methods.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.9 The hospital ensures that all its occupants are safe from radiation hazards.

No. Questions Answer


How does the hospital ensure that hospital staff, By implementing the radiation safety program, complying with
1 patients and visitors are safe from un-necessary national regulations and providing the necessary radiation
radiation hazards (ionizing/non-ionizing)? protection equipment

All radio-active materials clearly labeled and safely and securely


2 How do you store radioactive materials?
stored

3 What are the requirements for ensuring


radiation safety? 1. All radio-active materials clearly labeled and safely and
securely stored
2. Relevant Valid license/s from the King Abdulaziz City for
Science and Technology
3. Staff handling nuclear materials are qualified and certified
by King Abdulaziz City for Science and Technology
4. Valid shielding certificate of the x-ray rooms including
regular tests to ensure permissible radiation levels
5. Lead aprons and gonad/ thyroid shields are available to
cover patients and staff and annually tested according to
hospital inventory
6. Personal radiation dosimeters (TLD) are available, tested
every 3 months and actions taken when the test results
exceed permissible levels

FMS.21 The hospital has an effective fire alarm system.

No. Questions Answer


1 How does the hospital ensure effectiveness of Regular inspection as per Civil Defense Guidelines To ensure
the fire alarm system? functionality of hospital’s fire detection and alarm system a record
of all inspections, testing, and maintenance (PPM) shall be
provided that includes the following information regarding tests
and all the applicable information requested:
It includes the following:
 Date
 Test frequency
 Name and address of property
 Name and signature of the individual performing inspection,
maintenance, tests, or combination thereof, and affiliation
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

 Designation of the detector(s) tested


 Functional test of detectors
 Functional test of required sequence of operations
 Check of all smoke detectors
 Loop resistance for all fixed-temperature, line-type heat
detectors
 Other tests as required by equipment manufacturers and
authorities.
 Disposition of problems identified during test (e.g., owner
notified, problem corrected/successfully retested, device
abandoned in place)

Testing Frequency: Testing shall be performed in accordance


with an approved schedule Elevators are connected to the fire
alarm system.

FMS.22 The hospital has a fire suppression system available in the required area(s).

No. Questions Answer


1. Functional sprinkler system
What are the components of the fire 2. Clean agent suppression system
1 suppression system? 3. Wet chemical system
4. Stand pipes and hose system
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.23 There are fire exits that are properly located in the hospital.

No. Questions Answer


1. Fire exits are available and properly located
2. Not locked
3. Not obstructed
1 What are the requirements for a proper fire exit? 4. Have panic hardware
5. Are fire resistant
6. Clearly marked with illuminated exit sign

1. “NO SMOKING” policy: FMS-SF-001


2. NO obstruction to exits, fire extinguishers, fire alarm
boxes, emergency blankets, safety showers, and eye
wash stations
How does the hospital ensure that its occupants 3. Adequate emergency lighting for safe
2 are safe from fire and smoke evacuation
4. Properly and safely organized storage areas
5. Fire rated doors
6. No separation between walls and ceiling
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.24 The hospital and its occupants are safe from fire and smoke

No. Questions Answer


1 Do you know what to do in case of a fire? Yes. RACE and PASS

R.A.C.E: An acronym that hospital personnel use to remember


their duties in case of fire.
R – Rescue the staff or patient in danger
A – Activate the Alarm
C – Confine / Contain the smoke / fire.
E - Extinguish / Evacuate

P.A.S.S: An acronym that hospital personnel use to remember their


duties for discharging a fire extinguisher.
P – pull the safety needle pin
A - aim the nozzle to the base of the fire
S - Squeeze the handle
S - Swipe from side to side

Dis you attend any lectures/ workshop on


2
fire disaster?
Did you take part in a fire drill? Your role?
3

Do you know the location of the fire exit


4
nearest to you place of work?
Do you know the assembly point nearest
5
to you place of work?
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.32 The hospital ensures proper maintenance of the medical gas system.

No. Questions Answer

How does the hospital ensure proper According to the Policy and Procedure for effective use of
1 maintenance of the medical gas system? medical gas system-FMS-GM-003- available in Intranet

Who is responsible for closure of the shut-off the Trained unit headnurse or the shift charge/registered nurses
2 gas valves in the units? working in the unit and authorized to perform this.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

HR.5 The hospital has a process for proper credentialing of staff members licensed to
provide patient care.
Physicians, dentists, and others who are licensed to provide patient care independently represent those primarily responsible for
patient care and care outcomes. Applicable laws, regulations, and the organization identify those permitted to work independently.
The organization is responsible for ensuring that these individuals are qualified to provide patient care independently as per
applicable laws and regulations. Organizations are also responsible for specifying the types of care they are permitted to pr ovide at
their facilities. The organization needs to ensure that it has qualified staff that appropriately matches its mission, resources, and
patient needs.
Standard-Substandard Statement Description & instructions
 Review credentialing policy that should include a process for
credential verification for all healthcare professionals providing patient
care. This includes: Saudis and Non-Saudis, Medical, Nursing and
Allied Healthcare staff.
HR.5.1
 The policy of credentialing verification should include the elements
The hospital has a written policy describing the process
mentioned in standard HR.5 (such as HR.5.2, 5.3, 5.8, 5.9)
used for the verification of credentials.
 The policy should specify the procedure for verification of credentials
and should be signed by the process owner (e.g. HR) the policy and
should specify if this Third Party covers all credentials (education,
license, training, experience).
This substandard consist of three (3) elements; gathering, verification and
evaluation.
 Gathering: having copy of all credentials in personal file.
HR.5.2  Verification: having primary source verification for credentials
The hospital gathers, verifies, and evaluates the (license, education, training and experience). Primary source
credentials (license, education, training, certification verification can either be from a third party such as dataflow or done
and experience) of those medical staff, nursing staff, directly by the hospital.
and other health professionals licensed to provide  Evaluation: having documented evidence in personnel file or meeting
patient care. minutes that credentials were evaluated (signed by credentialing
committee for medical staff, and a relevant entity for nursing and
allied health staff. An entity could be a committee, a group or an area
manager).
 Qualification needs to be verified from the original source
 If staff experience (in current position) exceeding the required years of
HR.5.3 experience as per job description (JD), experience verification is not
Credentials are verified from the original source. required. Training should be based on JD
 Verification is not required for life support certificates such as BLS,
ACLS, PALS, ATLS etc.
 All personal files of healthcare professionals should include copy of
HR.5.4 current job description. Additionally, privileges should be included for
Job responsibilities and clinical work assignments/ medical staff.
privileges are based on the evaluation of the verified  If the hospital does not conduct primary source verification or staff is
credentials. assigned out of his/her profession (e.g., nurse working as anesthesia
technician), then the score will be affected.
HR.5.5 Files of medical, nursing, pharmacy, laboratory, social work, and other
The hospital ensures the registration of all healthcare healthcare providers contain valid and current license from the Saudi
professionals with the Saudi Commission for Health Commission for Health Specialties (i.e., SCFHS card is valid).
Specialties.
HR.5.6 This substandard requires hospital to have a valid copy of Ministry of
Staff licensed to provide patient care must always have Health (MOH) license in the personnel file.
and maintain a valid license to practice only within
their profession.
HR.5.7 Files of medical, nursing and allied healthcare staff providing patient care
The hospital maintains an updated record of the current shall contain credentialing documents (valid license from SCFHS;
professional license, certificate, or registration, when education, training, certification and experience).
required by laws, regulations, or by the hospital for
every medical staff, nursing staff and other healthcare
professionals.
HR.5.8  Confirmatory documents supporting the process of verification of
When verification of credentials is conducted through a credentials by the third party if applicable.
third party, the hospital must request for a confirmatory  This can be scored NA if a hospital doesn’t conduct any verification
documentation.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

through third party and all verification for license, experience, training
and education conducted internally.
 Payment receipt from third party is not considered as confirmatory
documentation.
Review samples of part-time, visitor, and locum clinical staff (e.g., in OR,
OPD) files to ensure they contain credentialing documents (valid and
HR.5.9
current license from SCFHS; education, training, certification and
Verification process applies to all clinical staff
experience verified from original source).
categories (full time, part time, visitor, and locum).
Note: use HR.5.3 to score Full time and HR.5.9 to score part time,
visitor and locum (The scores are independent of each other)

MS.7 Medical staff members have current delineated clinical privileges.


Mandatory that medical staff members are only allowed to practice within the privileges granted by the credentialing and privileging
committee after verifying their relevant credentials. Medical staff clinical privileges are reviewed and updated every two years and as
needed. The circumstances under which temporary or emergency privileges (not more than 90 days) are granted must be clearly
defined. When a new privilege is requested by a medical staff member, the relevant credentials are verified and evaluated prior to
approval.
Standard-Substandard Statement Description & instructions
In visited units such as ICU, OR, ER and Radiology, it is required
to verify the availability and accessibility of valid copy of
MS.7.1 privileges for the physicians working in these areas (hard copy or
Medical staff members are allowed to practice only within the controlled electronic copy).
privileges granted by the credentialing and privileging Note: Although the validity of privileges will be assessed
committee by MS.7.2, such finding needs to be verified as part of
MS.7.1 too since both sub-standards are linked.

Review Sample of physician’s personnel files to make sure that


MS.7.2
clinical privileging is reviewed and updated every two years and as
Clinical privileges are reviewed and updated every two years
needed. Updated privileges imply both upgrading/downgrading.
and as needed
 Privileging policy should include;
1) Definition of temporary and emergency privileges
2) The circumstances and process of granting temporary and
emergency privileges.
MS.7.3  Review physician personnel file to check the implementation
The hospital identifies the circumstances under which of the hospital policy on granting temporary or emergency
temporary or emergency privileges are granted privileges.
 Although emergency privilege can be scored NA if it is not
used, temporary privilege cannot be scored NA as it’s the
initial step in granting privileges for newly hired staff.

MS.7.4
Review the hospital policy on granting temporary or emergency
Temporary or emergency privileges are not granted for more
privileging. Both elements (not granted more than 90 days and not
than 90 days and are not renewable
renewable) should be written in the policy.
 Review sample of physicians’ files to assess the
implementation of privileging process in case of requesting
MS.7.5
new privileges.
When a new privilege is requested by a medical staff member,
 Review the last 3 meeting minutes for the privileging
the relevant credentials are verified and evaluated prior to
committee to check if there were medical staff requesting new
approval.
privileges
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

PC.25 Policies and procedures guide the handling, use, and administration of blood and
blood products
The use of blood in the organization is supervised and closely monitored by the blood utilization committee. Blood must be handled
and used in accordance with standards of practice and in a consistent manner to ensure the safety of the recipient. Policies and
procedures are developed and approved by the blood utilization committee covering the administration of blood (including patients’
identification, accepted practices, monitoring during and after the transfusion and reporting of transfusion errors) and when to
administer blood without consent. Only physicians can order blood for transfusion. Patients are informed for the reason for
transfusion and sign an informed consent for blood transfusion that must include the elements in the substandard PC.25.3.1 through
PC.25.3.5. All transfusion reactions are immediately reported to the blood bank and investigated by the appropriate blood bank staff
to avoid its recurrence. A report is given to the blood utilization committee for review. This standard is Not Applicable in mental
health, rehabilitation, and convalescent hospitals if it is clearly written that blood transfusion is out of their scope of service. Such
hospitals need to have a clear written policy specify the process of transferring patients who require blood transfusion after
stabilizing to another facility.
Standard-Substandard Statement Description & instructions
 Policy on blood handling/administration should be reviewed and
PC.25.1 signed/approved by the Blood Utilization Committee and include
There are policies and procedures that are developed clear process for handling, use and administration of blood and blood
collaboratively by the blood utilization committee, products.
guiding the handling, use, and administration of blood  Interview clinical staff (e.g., physicians and nurses) in different areas
and blood products to confirm their competency and awareness of blood administration
policies and procedures.
 Review the hospital policies and procedures on handling, use, and
administration of blood and blood products to confirm the clear
identification of medical staff authorized to order blood transfusion.
PC.25.2
 Check the record of a patient who received blood to make sure that
Only physicians order blood and in accordance with a
the blood order is only made by physician and in accordance with
policy clarifying when blood and blood products may be
hospital policy.
ordered
 Electronic or handwritten orders are accepted.
 Open and closed medical record may be reviewed, if open medical
record is breached, this should be reflected in the score
PC.25.3
The physician obtains informed consent for transfusion of
blood and blood products. Elements of patient consent
include:
PC.25.3.1
 Review the hospital policies and procedures on handling, use, and
Description of the transfusion process.
administration of blood and blood products. The policy mandate
PC.25.3.2
documenting informed consent and identify the elements of proper
Identification of the risks and benefits of the
consent.
transfusion.
 Check the record of a patient who received blood to make sure that
PC.25.3.3
Identification of alternatives including the the patient appropriately consented for the transfusion after being
educated by a physician.
consequences of refusing the treatment.
PC.25.3.4 Giving the opportunity to ask
questions.
PC.25.3.5 Giving the right to accept or refuse
the transfusion.
 Review the hospital policies and procedures on handling, use, and
administration of blood and blood products. The implemented system
PC.25.4 mandate two (2) staff members verify the patient’s identity prior to
Two staff members verify the patient’s identity prior to specimen collection and prior to blood transfusion.
blood drawing for cross and prior to the administration of  Check the medical record of a patient who received blood to make
blood. sure the patient identity has been verified by two staff members prior
to blood drawing and transfusion.

Review policy to confirm consent mandate for "transfusion without


NAT testing" in emergencies,
a) Hospital has donation area and conduct NAT testing internally,
PC.25.5 policy should mandate consent for transfusion without NAT.
In dire emergencies, patient/family signs consent for b) Hospital has donation area & NAT testing is outsourced, policy
"transfusion without NAT testing” should mandate consent for transfusion without NAT.
c) Hospital does not have donation area and receiving tested blood
from outsources facility (based on written agreement), PC.25.5 will
be NA.
PC.25.6  Review hospital policies that developed collaboratively by the blood
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

Blood is transfused according to accepted transfusion utilization committee to confirm that blood transfusion guidelines
practices from recognized professional organizations. adopted from recognized professional organizations and best practice
(e.g., blood transfusion process, blood monitoring, and duration of
transfusion in congruent with the best practices). Accepted references
used in developing transfusion policy should be based on recognized
professional organization.
 Check medical record of patients who received blood to make sure
that Blood is transfused according to hospital policy and using
accepted transfusion practices from recognized professional
organizations (e.g., blood transfusion process, blood monitoring, and
duration of transfusion in congruent with the best practices)
PC.25.7
Observe the accessibility and availability of blood transfusion policy
Policies and procedures guide the administration of blood
in the visited areas (such as ICU, ER or Surgical Ward).
transfusions.
 Review hospital policies and procedures to confirm that the policy
mandate close monitoring of the patient during the transfusion and
PC.25.8
the policy specify monitoring intervals and procedure.
Patients receiving blood are closely monitored.
 Check the medical record of a patient who received blood to make
sure that the patient was closely monitored during transfusion.
 Review the hospital policies and procedures on recognizing, handling
and reporting of adverse transfusion events.
 It’s acceptable to have transfusion reaction policy as part of the blood
PC.25.9 administration policy.
Transfusion reactions are reported and analyzed for  Check the medical record of a patient who experienced adverse
preventive and corrective actions. transfusion event to confirm proper reporting, investigation and
actions.
 This substandard can be scored as NA, if the rate of transfusion is
confirmed to be too low.

PC.26 Patients at risk for developing venous thromboembolism are identified and managed.
The hospital must develop a risk assessment tool to identify patients for risk of venous thromboembolism and to start appropriate
prophylaxis either mechanical, pharmacological or both according to risk severity and to reassess whenever patient’s condition
changed. The hospital must adopt an international guideline and policy of venous thromboembolism prophylaxis.
Standard-Substandard Statement Description & instructions
 Review medical record to check if patients are screened for the risk
of developing venous thromboembolism. Form used for VTE
screening should include all identified risk factors according to
PC.26.1 patients’ categories (medical/surgical, antenatal, and postnatal) and
Patients are screened for the risk of developing venous the calculation of these risks result in adequate treatment.
thromboembolism.
 Although the activity required for PC.26.1 and PC.26.2 is medical
record review, VTE prophylaxis policy needs to be reviewed to
ensure consistency of practice.

Review medical record to check if patients at risk of developing venous


PC.26.2 thromboembolism receive prophylaxis according to current evidence-
Patients at risk receive prophylaxis according to current based practice. Ensure that prophylaxis given according to risk factors
evidence‐ based practice. identified in PC.26.1. Observe the availability of mechanical
prophylaxis.

QM.17 The hospital has a process to ensure correct identification of patients.


To assure correct patient identification and eliminate errors that can have fatal consequences, there should be a standard process for
patient identification throughout the healthcare institution. The identification process should include at least two identifiers (e.g.,
patient full name and medical record number). The identification process is required in any circumstance involving patient
interventions e.g., performing procedures (such as inserting a catheter or performing lumbar puncture), before providing treatment
(such as administering medication, or blood and blood products) and before any diagnostic procedures (such as taking blood samples
or radiological investigations). When possible, patients are required to be involved in the identification process.
Standard-Substandard Statement Description & instructions
QM.17.1  Interview staff to ensure that they are aware of the policy and
At least two patient identifiers (e.g., patient full name and using at least 2 patient identifiers before procedures, blood
medical record number) are required whenever taking blood sampling, medications administration… etc.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

samples, administering medications or blood products, or  Although the activity required for QM.17.1 is staff interview,
performing procedures. identification policy/protocol needs to be reviewed to ensure
consistency of practice.
 Visit and observe different location to ensure consistency and
standardization of patient identification process.
 Suggested areas for observation: (Observe if patients in ER
QM.17.2
having ID and its content is visible, readable and clear,
The hospital has a standardized approach to patient
observe staff administering medications without verification
identification
against medication records, observe newborn identification,
observe to make sure NOT using room number as identifier in
medication drawers)
QM.17.3  Interview staff and patients to assess implementation.
Patients are actively involved in the process of patient  Most common areas to assess: outpatient pharmacy,
identification phlebotomy area, patient pre-procedure.

QM.18 The hospital has a process to prevent wrong patient, wrong site, and wrong
surgery/procedure
Preventing medical errors is an essential component of patient safety and surgery is an area of health care in which preventable
medical errors and near misses can occur. Clinicians must be aware of the surgery-associated injuries, deaths, and near misses and
the process to prevent them. An important aspect in this regard is the process to prevent wrong-site surgery, which encompasses
surgery performed on the wrong side or site of the body, a wrong surgical procedure performed, and surgery performed on the wrong
patient. This process also includes any invasive procedure performed in settings other than the operating room. Hence, all health care
facilities should develop and implement policy and procedure to include the three phases of this process (verification, site marking,
and time out.) and to ensure its timely documentation in the patient medical record.
Standard-Substandard Statement Description & instructions
QM.18.1  Interview staff to verify adherence to surgical safety
There is a process implemented to prevent wrong patient, wrong site, protocol.
and wrong surgery/procedure during all invasive interventions  Although QM.18.1 activity is staff interview, policy on
performed in operating rooms or other locations preventing wrong patient, wrong site, and wrong surgery
needs to be reviewed to ensure practice consistency.
Process should include invasive procedures
(intraoperative and outside OR e.g., endoscopy,
radiology, etc.).
 QM.18 is NA in Mental Health Hospitals, unless they are
conducting ECT procedure
QM.18.2 This substandard consists of 3 elements; verification, site
The process consists of three phases: verification, site marking, and marking, & time- out. Review medical records to ensure a
time out. proper timely documentation of verification, site marking,
& time- out (e.g., in recovery room).
Verification and time-out need to be reviewed in surgical
operations and invasive procedures too, to ensure
compliance.
QM.18.3
A pre‐procedure verification of the patient information is carried out Review medical records of patients went for invasive
including the patient’s identity, consent, full details of the procedure, procedure to make sure that the pre-procedure verification
laboratory tests and images, and any implant or prosthesis is documented in the chart.
QM.18.4
The surgical/procedural site is marked before conducting the surgery /
procedure.
QM.18.4.1 The site is marked especially in bilateral organs
and multiple structures ( e.g. fingers , toes and spine)
QM.18.4.2 The site is marked by the health hospitals, site Review medical records of patients went for
marking for ECT is Not Applicable. Individual who will intraoperative surgical procedures to make sure that the
perform the procedure. pre-procedure verification, site chart.
QM.18.4.3 The patient is involved in the marking process.
QM.18.4.4 The marking method is consistent throughout
the hospital.
QM.18.4.5 The mark is visible after the patient is prepped
and draped.
QM.18.5
 Hospitals need to have clear documented evidence in
A final check (time‐out) is conducted before the procedure is initiated.
medical records for conducting time-out (prior to skin
QM.18.5.1 The time‐out is conducted in the location where
incision).
the procedure will be done, just before starting.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

QM.18.5.2 The time‐out is initiated by a designated  Observation activity can be replaced by staff interview
member of the team and involves the members of the team, (e.g., in recovery room or surgical wards) if there are
including the individual performing the procedure, the no cases of invasive procedures to observe during the
anesthesia providers, and the nurse(s) involved visit to ensure staff awareness of time-out process.
QM.18.5.3 The entire procedure team uses active  Assess awareness of concerned staff regarding the
communication during the time out. time out process
QM.18.5.4 During the time‐out, the team members agree on
the correct patient identity, the correct procedure to be
performed, the correct site, and when applicable, the
availability of the correct implant or equipment.
Review medical records of patients went for invasive
QM.18.6
procedure/surgical operation to make sure that the pre-
The hospital documents its processes for preventing wrong patient,
procedure verification, site marking, and time out are
wrong site, and wrong surgery/procedure
documented in the chart.

AN.2 Anesthesia staff members have the appropriate qualifications.


Anesthesia staff is qualified by documented training and experience, consistent with applicable laws and regulations. Anesthesia
consultant administers and supervises anesthesia for major/specialized operations or high-risk patients, including; Pediatric
operations, cardio-pulmonary operations, neurosurgery operations, and transplant operations.
Standard-Substandard Statement Description & instructions
Review random sample of anesthetist’s personnel files for
AN.2.1
qualification and Privileges. Qualified anesthesiologist could be
Qualified anesthesiologists provide anesthesia services.
specialist, senior specialist or consultant.
Review medical records to verify having documented evidence
that anesthesiologist is present in OR throughout the operation.
AN.2.2
Qualified anesthesiologist is present inside the operating room Discharge recovery sheet, intraoperative anesthesia operation
throughout the operation sheet, coupled with adequate match between number of available
anesthesiologist (using anesthesia Rota) can be used to verify the
availability of anesthesiologist in OR throughout operation time
AN.2.3 Review medical record of patient who had major or high-risk
Anesthesia consultant administers and supervises anesthesia surgery (Pediatric operations, cardio-pulmonary operations,
for major/specialized operations or high risk patients, Review medical record of patient who had major or high-risk
including: surgery (Pediatric operations, cardio-pulmonary operations,
AN.2.3.1 Pediatric operations. neurosurgery operations, and transplant operations) to make sure
AN.2.3.2 Cardio‐pulmonary that anesthesia consultant administers and supervises anesthesia
AN.2.3.3 Neurosurgery operations. operations) to make sure that anesthesia consultant administers and
AN.2.3.4 Transplant operations supervises anesthesia
Review sample of anesthesia medical staff personal files to verify
AN.2.4 having an evidence of advanced life support training as
Anesthesia staff are certified in advanced life support as appropriate to the patient’s age (e.g., if anesthesiologist
appropriate to the patient’s age participating in pediatric operations, PALS certificate should be
checked).

AN.15 Qualified staff perform moderate and deep sedation/analgesia.


The physician or dentist responsible for the patient receiving moderate and deep sedation must be qualified and have competency
based privileges if they participate in conducting moderate and deep sedation They must be certified in advanced life support as
appropriate to the patient age and successfully complete education/training on moderate and deep sedation.
Standard-Substandard Statement Description & instructions
AN.15.1  All physicians (non-anesthesiologist) who perform moderate/deep
Physicians who perform moderate and deep sedation must have evidence of training or specific privileges on
sedation/analgesia have competency‐based privileges moderate sedation in their personal files. ICU Intensivist and ER
granted to perform moderate and deep sedation/analgesia. Physicians classified by SCFHS do not require such training.
 If moderate/deep sedation given by anesthesia staff inside and
outside operating room, this will satisfy the requirement of this
sub-standard.
AN.15.2 Clinical staff such as nurses, anesthesia technicians, radiology
Clinical staff who participate in caring for patients receiving technicians, labor and delivery staff who participate in caring of
moderate or deep sedation are certified in advanced life patients received moderate sedation are required to have evidence
support as appropriate to the age of the patients served. of advanced life support training (and PALS if they serve pediatric
group) in their personal files
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

AN.15.3  Clinical staff such as nurses, radiology technicians, labor and


Clinical staff who participate in conducting sedation must delivery staff who participate and conduct sedation must
successfully complete a proper education/training on complete adequate training in moderate and deep sedation that
moderate and deep sedation. conducted by a qualified anesthesiologist and kept in their
personal files.
 Anesthesia physicians and technicians do not require training on
moderate/deep sedation as it is already part of their study.

IPC.4 There is a designated multidisciplinary committee that provides oversight of the


infection prevention and control program.
The activities of the Infection Prevention and Control unit should be supervised and overseen by a multidisciplinary body that is
chaired by hospital director or the medical director. This would empower Infection Prevention and Control Committee decisions and
recommendations Infection prevention and control activities should reach to every part of a health care hospital and involve
individuals from multiple departments and services via multidisciplinary committee. Coordination involves communicating with all
parts of the hospital to ensure that the program is continuous and proactive; physicians and nurses are represented and engaged in the
activities with the infection prevention and control professionals. Others may be included as determined by the hospitals size and
complexity of services (for example, clinical epidemiologist, central sterilization manager, microbiologist, pharmacist, housekeeping
services, environmental or facilities services, operating theatre supervisor). Responsibilities include, for example, setting criteria to
define healthcare associated infections, establishing data collection (surveillance) methods, designing strategies to address infection
prevention and control risks, and reporting processes. Infection Control committee formation order and Term of References should
reflect its membership and functions.
Standard-Substandard Statement Description & instructions
IPC.4.1 Review Infection Prevention and Control Committee term of
The infection prevention and control committee is chaired by reference (TOR) and meeting minutes to verify that the committee
the hospital director or the medical director is chaired by hospital director or medical director (i.e., committee’s
chairman name should be reflected in TOR and meeting minutes).
If IPC Committee is reporting to the corporate IPC Committee, it is
still necessary that the Chairman be the Medical Director or
Hospital Director at the hospital level.
IPC.4.2  Review Infection Prevention and Control Committee term of
The membership of the infection prevention and control reference (TOR) and meeting minutes to verify
committee includes representatives from the medical staff, multidisciplinary involvement.
nursing staff, microbiology, operating room, central  Medical staff involvement should include a representative from
sterilization service, pharmaceutical care, dietary services, critical care areas (adults and pediatrics) depending on the scope
housekeeping, infection prevention and control staff, and of service.
other departments as needed.  Issues discussed in IPC committee meetings are assigned to
concerned representatives and should be traceable and timely
closed.
IPC.4.3 Review Infection Prevention and Control Committee term of
The infection prevention and control committee meets on a reference (TOR) and meeting minutes to verify that the committee
regular basis (at least quarterly). is meeting on regular basis. Also, make sure they have been
discussing critical issues related to infection control as applicable
(e.g. outbreaks).
IPC.4.4  Review Infection Prevention and Control Committee term
Functions of the infection prevention and control committee of reference (TOR) and meeting minutes to ensure
include, but are not limited to, the following: incorporating IPC.4.4.1-IPC.4.4.6.
IPC.4.4.1 Review of the hospital infection  Hospitals need to ensure incorporating these six (6)
prevention and control policies and procedures. functions in the terms of reference. Additionally, must be
IPC.4.4.2 Review of the reports of healthcare‐ verify that the infection prevention and control team
associated infections surveillance submitted decides the need for more airborne isolation rooms
regularly by the infection prevention and control depending on the volume of patients in need for airborne
team and suggestion of appropriate actions. isolation admitted to the hospital.
IPC.4.4.3 Revision of the yearly plan submitted by  Infection prevention and control annual plan need to be
infection prevention and control team and reviewed and signed by the committee (IPC.4.4.3).
suggestion of additions/changes if necessary.
IPC.4.4.4 Evaluates and revises on a continuous
basis the procedures & the mechanisms developed
by the infection prevention & control team to serve
established standards and goals.
IPC.4.4.5 Brings to the attention of the infection
prevention & control team new infection control
issues arising in different departments of the
hospital & suggests solutions.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

IPC.4.4.6 Each member of the committee acts as


an advocate of infection prevention & control in his
department, trying to promote its principles, and
ensures application of its rules.
IPC.15 Facility design and available supplies support isolation practices.
This is to ensure proper implementation of the appropriate type of isolation precautions. The hospital preparedness of isolation
precaution includes: the availability of negative pressure airborne isolation room which meets the measurable elements
requirements, the availability of required supplies particularly respirator (high filtration mask e.g. N95) in patient care areas, and the
availability of isolation card indicating the type of isolation precautions. In certain hospitals (e.g., mental health, rehabilitation, eye
hospitals), one negative pressure isolation room in ER and one in inpatient wards is acceptable regardless of hospital’s bed capacity.
In addition, they should have clearly written agreement with comprehensive transfer plan for referral of infectious cases. The
following should be considered in engineering control record; Log sheet for negative pressure monitoring at least daily if room is
equipped with a patient who require airborne isolation and weekly monitoring if room is vacant. HEPA filter should be changed
every 6 months unless the hospital has a cleaning system for the filter with documented evidence on the quality of differenti al
pressure. Portable HEPA filter doesn’t ensure enough air changes per hour. An acceptable air change per hour is 12 or more.
Acceptable temperature is 20-24 and humidity between 20-60.
Standard-Substandard Statement Description & instructions
IPC.15.1  Hospitals are expected to have at least one negative pressure
There is at least one negative pressure airborne isolation room in ER and one for every 25-30 beds in general hospitals (In
room in the emergency room and one in patient care areas certain hospitals (e.g., mental health, rehabilitation, eye
(one negative pressure room for every 25‐30 beds in general hospitals), one negative pressure isolation room in ER and one in
hospitals). inpatient wards is acceptable regardless of hospital’s bed
capacity. In addition, they should have clearly written agreement
with comprehensive transfer plan for referral of infectious cases.
 Having adequate number of negative pressure isolation rooms for
inpatient, with no isolation room in ER will partially meet
IPC.15.1 requirement.
IPC.15.3
The ventilation system serving airborne isolation facilities
provides pressure patterns that prevent airborne pathogens
from being distributed to other areas of the hospital.
Interview infection control staff and hospital staff to verify their
IPC.15.3.1 Rooms designed for airborne isolation
awareness of negative pressure isolation rooms’ engineering
patients are under negative pressure.
control records.
IPC.15.3.2 Air is exhausted to the outside and is Review completeness of engineering control records for air
not re‐circulated unless it is filtered through High‐ changes per hour, HEPA filter, negativity, humidity, and
Efficiency Particulate Air (HEPA) Filter. temperature; (review standard's intent to understand engineering
IPC.15.3.3 The negative pressure for the isolation records requirements)
room should be validated on daily basis when
patient is isolated (admitted in the room). Weekly
validation is done when the room has no patients. A
minimum of 12 air changes per hour should be
maintained by testing and documentation as per
manufacturer's recommendation/hospital's policy
IPC.15.5 Observe the availability of hand washing facilities, toilets, and
Toilet, shower, or tub and hand washing facilities are shower in negative pressure isolation rooms (note: shower and
provided for each isolation room toilet in ICU isolation room are not mandatory).
IPC.15.6
Transmission‐based precaution cards (isolation signs) are
consistent with the patient diagnosis and are posted in Arabic
and English and indicate the type of precautions required.
IPC.15.6.1 Transmission‐based precaution cards  Review isolation precautions policy that should include the
(isolation signs) are color coded for isolation of specification of isolation precaution cards.
different categories (e.g., contact: green, airborne:  Observe the availability of transmission-based precaution card
blue, droplet: pink or red) that should be consistent with diagnosis, posted in both Arabic
IPC.15.6.2 Transmission‐based precaution cards and English, color coded, contain short statements, contain
(isolation signs) should contain short statements figures, and include transportation instructions
and supported with the required figures.
IPC.15.6.3 Isolation instructions must highlight the
transmission‐based precaution cards (isolation
signs) needed while transporting the patients under
transmission‐based precautions to other department
(e.g., radiology).
IPC.15.7 ‐ Respirator (high filtration) masks (N‐95, N‐99)  Observe the availability and appropriate use of N95 by staff
are used by staff during direct care of patients on airborne when dealing with patient with airborne diseases and ensure; 1)
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

precautions and are available on all units likely to admit the availability of different sizes of N95 masks, 2) having fitting
patients on airborne precautions. test and staff are aware about their results, 3) observe donning
and removing of N95.
 Interview the staff to assess their knowledge about the use of
appropriate PPEs for airborne cases and fit test
IPC.15.8 ‐ Respirator (high filtration) masks (N95, N‐99) can  Review hospital’s policy on single use or re-use of N95 masks:
be reused by the same patient care giver as per the period - If policy stated single use of N95, document review (DR) and
specified by the manufacturer staff interview (SI) activities will be scored “Not Applicable”. -
If policy does not decide on single or reuse of N95, DR and SI
activities will be scored “Not Met”. - If policy stated reuse of
N95, it should specify the reuse criteria; for the same patient,
reuse duration, and way to store used masks… Then DR and SI
activities will be scored accordingly. The policy should mention
that “If any other precaution added in top of airborne isolation
(e.g. MERs-Cov, chicken pox etc.), N95 mask re use is
prohibited”.
 Assess staff knowledge about the policy of re-suing high
filtration masks.

MM.5 The hospital has a system for the safety of high‐alert medications.
High-alert medications are drugs that bear a heightened risk of causing significant patient harm when used in error. Errors may not
be more common with these than with other medications, but the consequences of errors may be devastating. Several worldwide
organizations had identified a list of High Alert medications such as WHO and ISMP. Hospitals shall have a plan for the safe use of
these medications and develop their own annually updated list of high alert medications with the related safety strategies to minimize
errors and harm from these medications and other hazardous pharmaceutical chemicals as much as possible.
Standard-Substandard Statement Description & instructions
MM.5.1 Review the multidisciplinary plan/policy for managing highalert
There is a written multidisciplinary plan for managing high‐ medications and hazardous pharmaceutical chemicals. Policy should
alert medications and hazardous pharmaceutical chemicals. be signed by the process owners (Pharmacy Director, Nursing
It includes identification, location, labeling, storage, Director, Medical Director). It should include high-alert medications
dispensing, and administration of high‐ alert medications and hazardous pharmaceutical chemicals, and specify the process of
identification, location, labeling, storage, dispensing and
administration of these medications.
MM.5.2.1 Controlled and narcotics medications.  Review the updated list (annually) of high-alert medications and
MM.5.2.2 Neuromuscular blockers hazardous pharmaceutical chemicals.
MM.5.2.3 Chemotherapeutic agents  MM.5.2.1 to MM.5.2.9 are examples that need to be part of the list
MM.5.2.4 Concentrated electrolytes (e.g., along with other intra-hospital frequently used high alert
hypertonic sodium chloride, concentrated medications.
potassium salts).  The list needs to be approved by Pharmacy and Therapeutics
MM.5.2.5 Antithrombotic medications Committee; otherwise it would partially meet the standard
(e.g.,heparin, warfarin).  List must be from within the hospital’s formulary
MM.5.2.6 Insulins.  Covers to a minimum the list mentioned in the standard, as
applicable
MM.5.2.7 Anesthetic medications (e.g., propofol, List should include the specific drug names, not just categories.
ketamine).
MM.5.2.8 Investigational (research) drugs, as
applicable
MM.5.2.9 Other medications as identified by the
hospital.
MM.5.3
The hospital plan for managing high‐alert medications and
hazardous pharmaceutical chemicals is implemented. This
includes, but is not limited to, the following:
MM.5.3.1 Improving access to information about  Observe for evidence of implementation of high alert plan (from
high‐alert medications. MM.5.3.1 to MM.5.3.5). MM.5.3.2 does not mean having all high
MM.5.3.2 Limiting access to high‐alert alert medications in a locked cabinet, but we need to ensure
medications. limiting access to these high alert medications.
MM.5.3.3 Using auxiliary labels or computerized  Staff interview to verify awareness of strategies to prevent errors
alerts if available associated with using of high-alert medications and hazardous
MM.5.3.4 Standardizing the ordering, pharmaceutical chemicals. Independent double check should be
transcribing, preparation, dispensing, carried out in both dispensing and administration. In addition,
administration, and monitoring of high‐ alert improving access to drug information on high alert medications
medications. include having access to dosing, storage, precautions, adverse
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

MM.5.3.5 Employing independent double checks reactions, etc.


MM.5.4  Interview staff (nurses, physicians, and pharmacists) for evidence
The hospital develops and implements standard of implementation of standard concentrations of all high alert
concentrations for all medications administered by medications administered by intravenous infusion.
intravenous infusion.  Review the hospital approved standard concentration for all high
alert medications administered by intravenous infusion. (Note:
this substandard cannot be scored NA in any hospital setting).

MM.6 The hospital has a system for the safety of look‐alike and sound‐alike (LASA)
medications.
Medication errors related to look-alike and/or sound-alike medication names and/or packages are common in the healthcare setting
throughout the medication use process Look-alike, Sound-alike medications account for an estimated 25- 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 drug names; newly available products; similar packaging or
labeling; similar clinical use; illegible prescriptions or misunderstanding during issuing of verbal orders. Several organizations
worldwide such as the WHO and the ISMP had identified, published and periodically updated several lists of look-alike and sound
alike medications. Hospitals shall initiate and then annually update their own list of LASA medication names. They should establish
scientific based safety strategies to prevent or minimize errors with these confusing medications.
Standard-Substandard Statement Description & instructions
MM.6.1 Review the multidisciplinary plan/policy on handling LASA. Policy
There is a multidisciplinary policy and procedure on handling should be signed by process owners (Pharmacy Director, Nursing
look‐ alike/sound‐alike (LASA) medications Director, Medical Director). It should include both look alike and
sound alike medications (in separate tables or lists), and specify the
process of identification, location, labeling, storage, dispensing and
administration of LASA medications.
MM.6.2 Review the updated list (annually) of confusing drug names
The hospital reviews and revises annually its list of confusing including look alike and sound alike medications. Hospitals need to
drug names, which include LASA medication name pairs that have annually updated list for LASA medications. The list must be:
the hospital stores, dispenses, and administers  Approved by Pharmacy and Therapeutics Committee
 From within the hospital’s formulary
 Updated Annually

MM.6.3
The hospital takes actions to prevent errors involving LASA
medications including the following, as applicable:
MM.6.3.1 Providing education on LASA
medications to healthcare professionals at orientation
and as part of continuing education.
MM.6.3.2 Using both the brand and generic names  Observe for evidence of error prevention due to LASA
for prescribing LASA medications. medications (from MM.6.3.2 to MM.6.3.8)
MM.6.3.3 Writing the diagnosis/ indication of the  Interview staff for evidence of implementation of error
LASA medication on the prescription. prevention strategies due to LASA medications (from MM.6.3.1
MM.6.3.4 Changing the appearance of look‐alike to MM.6.3.8)
product package.  Ensure having evidence (material and attendance record) that
MM.6.3.5 Reading carefully the label each time a adequate number of relevant staff members were educated on
medication is accessed, and/or prior to LASA medications.
administration.
MM.6.3.6 Minimizing the use of verbal and
telephone orders.
MM.6.3.7 Checking the purpose/indication of the
medication on the prescription prior to dispensing
and administering.
MM.6.3.8 Placing LASA medications in locations
separate from each other or in non‐alphabetical
order.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

MM.41 The hospital has a process for monitoring, identifying, and reporting significant
medication errors, including near misses, hazardous conditions, and at‐risk behaviors that
have the potential to cause patient harm

Standard-Substandard Statement Description & instructions


MM.41.1 Review the multidisciplinary policy on handling medication errors. Policy
There is a multidisciplinary policy and procedure on should be signed by process owners (Pharmacy Director, Nursing Director,
handling medication errors, near misses, and and Medical Director). It should highlight the following:
hazardous situations (e.g., confusion over look‐  Reference to the reporting form
alike/sound‐alike drugs or similar packaging).  Notification of provider about the error
 Feedback to reporters
 Timeframe for reporting and notification of provider
 Documenting medical errors and who should document and where
MM.41.2 Review the multidisciplinary policy on handling medication errors. Policy
The policy has a clear and acceptable definition of should include clear and acceptable definition of significant medication
significant medication error, near misses, and error, near misses, and hazardous situations.
hazardous situations.
MM.41.3 Interview physicians (treating/attending/most responsible) on how they get
The treating physician is notified of the medication to know/informed about a medication error and when
error at the appropriate time
MM.41.4 Interview healthcare providers on when they report medication errors.
Medication error reporting is completed within the Match the timeframe in the policy with staff awareness
specified time frame after discovery of the error
MM.41.5 Ensure that pharmacist, physicians, and nurses in different areas (clinical
The hospital has a standard format for reporting areas and pharmacy) are using the same standardized format for reporting
medication errors. medication errors.
MM.41.6 Interview healthcare providers on the process and importance of
Staff are education on the process and importance of medication error reporting. If a documented evidence shown (list of trained
medication error reporting. staff), we need to ensure that education involves the highest possible
number of staff and not limited to specific area.
MM.41.7  Review medication errors, near misses, and hazardous situations reports
There is active reporting of medication errors, near  Active reporting means reporting different types of errors by different
misses, and hazardous situations. stakeholders (medical, nursing, pharmacist) and number of reported
events should be relevant to the size and scope of service.
MM.41.8 Review root-cause analysis of all significant or potentially significant
The hospital conducts intensive root‐cause analysis medication errors.
for all significant or potentially significant medication This substandard is linked with MM.41.7, if the hospital doesn’t have an
errors. active reporting system.
MM.41.9 Review medical records for selected cases of reported medication errors
Medication errors, near misses, and hazardous (reached the patient). Inserting a copy of the report in the medical record is
situations are documented in the patient’s medical NOT ACCEPTABLE
record.
MM.41.10 Interview members of pharmacy and therapeutics committee and review
The hospital utilizes reported data to improve the the Committee’s meeting minutes to ensure that hospital is analyzing the
medication use process, prevent medication errors, reported event to take corrective and preventive actions to improve the
and improve patient safety patient safety. A subcommittee reporting to P&T or any other equivalent
committee is acceptable to be responsible for the analysis.
MM.41.11 Interview healthcare provider who previously reported medication error to
Healthcare professionals are provided with feedback verify if and how they received a feedback regarding the analysis of the
on reported medication errors, near misses, and reported event and the action taken to prevent reoccurrence of the event or
hazardous situations. not. If the reporter is known, then he or she should get feedback based on
the hospital’s process in providing feedback. If the reporter is anonymous
then the unit/section/department should get feedback.
MM.41.12  Review documents supporting the fact that the hospital reports sentinel
The hospital reports sentinel events related to serious events related to serious medication errors to the relevant authorities.
medication errors to the relevant authorities  Interview members of pharmacy and therapeutics committee on
reporting sentinel events related to serious medication errors to the
relevant authorities. (note: hospitals need to report all sentinel events to
CBAHI if they are accredited). This activity CANNOT be NA.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

LB.51 The blood bank develops a process to prevent disease transmission by blood/platelet
transfusion.
Hospitals need to have written process/policy to prevent disease transmission by blood/platelet transfusion. This process mandate that
a sample of blood obtained from the donor during blood/ blood component collection is subjected to the following infectious diseases
testing; HBsAg, Anti-HBc, Anti-HCV, Anti-HIV-1/2, Anti-HTLV-I/II, HIV-1 RNA, HCV RNA, HBV DNA, Serological test for
syphilis, and other additional or supplemental tests as mandated by relevant health authorities. If hospital does not have donation
service and used to receive blood from another facilities/ central blood banks, a written agreement should ensure conducting such
tests by providing facility and this agreement should be signed by both parties, include agreement conditions, specify the role of
involved party in looking back to monitor how they release blood and blood component, include infectious diseases testing
conducted, dated with valid date, and includes the process of resolving disputes. Moreover, if a hospital has donation service but
outsourcing the transfusion transmission disease testing (TTDT), written agreement is needed too. Bacterial contamination of blood
components (mainly platelets) is a major cause of transfusion-related fatalities. To limit blood component contamination by bacteria
from donor skin, two elements of the blood collection process are critical. Before venipuncture, the donor skin must be carefully
disinfected using a method with demonstrated efficacy. Second, diversion of the first 10 to 40 mL of donor blood away from the
collection container. Furthermore, the blood bank needs to use a method sensitive enough to detect significant bacterial cont amination
in platelet components. Insensitive methods including pH, glucose and microscopy are no longer acceptable. This standard is not
applicable if blood transfusion service is out of the hospital scope of services neither by having donation area nor by outsourced blood
bank (e.g., mental health hospitals, convalescent hospitals).
Standard-Substandard Statement Description & instructions
LB.51.1
There are policies and procedures mandating that a
sample of blood obtained from the donor during
blood/ blood component collection is subjected to
the following infectious diseases testing: HBsAg,
Anti-HBc ,Anti-HCV, Anti-HIV-1/2, Anti-HTLV-
I/II, HIV-1 RNA, HCV RNA, HBV DNA
,Serologic test for Syphilis and others
LB.51.1.1 HBsAg.  Review the laboratory policies and procedures on Transfusion Transmitted
LB.51.1.2 Anti‐HBc Disease Testing (TTDT) of donor specimen to confirm its comprehensive
LB.51.1.3 Anti‐HCV cover of the requirement. • If a hospital does not have donation service,
LB.51.1.4 Anti‐HIV‐1/2. written agreement is needed (review standard's intent to understand
LB.51.1.5 Anti‐HTLV‐I/II agreement requirements)
LB.51.1.6 HIV‐1 RNA  Observe TTDT process to confirm compliance. • If a hospital does not have
LB.51.1.7 HCV RNA. donation service, written agreement is needed (review standard's intent to
LB.51.1.8 HBV DNA understand agreement requirements)
LB.51.1.9 Serological test for syphilis  Interview personnel to assess their competence with TTDT procedures. • If
LB.51.1.10 Other additional or a hospital does not have donation service, written agreement is needed
supplemental tests as mandated by (review standard's intent to understand agreement requirements)
relevant health authorities
LB.51.2
The blood bank has a process to limit and detect
bacterial contamination in platelet components. The
process:
LB.51.2.1 Describes the blood bank  Review randomly-selected records to confirm the laboratory compliance
approach to limit bacterial contamination with TTDT policy. • If a hospital does not have donation service, written
and the investigations of positive cases. agreement is needed (review standard's intent to understand agreement
LB.51.2.2 Ensures the employed requirements)
detection method is sensitive enough to  Review the laboratory policies and procedures on limiting and detecting
detect significant bacterial contamination. bacterial contamination in bacterial contamination.
 Observe practices to confirm implementation of strategies to limit bacterial
contamination in platelet components. Make sure to observe a
demonstration for proper site preparation and the use of diversion pouch.
 Interview personnel to assess their competence with bacterial
contamination prevention and detection procedures. Review randomly-
selected records of platelets units to confirm the laboratory compliance
with bacterial detection policy.
 Review the validation documents of the employed bacterial detection
method to confirm that the employed method is sensitivity in detecting
significant bacterial contamination.
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.9 The hospital ensures that all its occupants are safe from radiation hazards.
To ensure that hospital staff, patients and visitors are safe from un-necessary radiation hazards (ionizing/non-ionizing), the hospital
should implement a radiation safety program, complying with national regulations and provide the necessary radiation protection
equipment.
Standard-Substandard Statement Description & instructions
FMS.9.1 Review the radiation safety policy and procedure to ensure having
The hospital has a radiation safety policy and procedure and it the following;
is implemented.  Testing of lead aprons, thyroid and gonad shields
 Monitoring personnel TLD badges (quarterly)
 Annual testing/calibration of radiology equipment.
 Procedure for pregnant radiology staff
 Permissible Exposure limits for staff
 Safe handling/storing of radio-active materials
 Radiation emergencies (spills)
 Radioactive waste disposal
FMS.9.2 Observe all radio-active materials are clearly labeled and safely
All radio‐active materials are clearly labeled and safely and and securely stored
securely stored.
Review the validity of the hospital’s license from the National
FMS.9.3
The hospital has the relevant valid license(s) from King Authorities (i.e. K.A. CARE, KACST, ….) for dealing with
Abdulaziz City for Science and Technology radioactive materials

 Interview staff handling radio-active materials and evaluate the


implementation of the radiation safety policy. If the hospital
FMS.9.4
has radio-active materials, there must be a certified Radiation
Staff handling nuclear materials are qualified and certified by
Safety Officer (RSO).
King Abdul‐Aziz City for Science and Technology
 Review RSO’s personal file to see certificate from the national
authorities (i.e. K.A. CARE, KACST …).
 Interview relevant staff (e.g. medical physicist, RSO in charge)
on how he/she regularly tests concerned areas for permissible
radiation levels.
 Review the validity of shielding certificate/radiation survey
FMS.9.5 (leak test) of the X-ray (mammography, CT, fluoroscopy,
There is a valid shielding certificate of the x‐ray room(s) conventional x-ray and dental panorama x-ray) room(s) and
including regular test to ensure permissible radiation levels. ensure it is carried out by a company certified by national
authorities (i.e. K.A. CARE). In addition, shielding
certificate/leak test is required with every renewal of license
for these rooms or whenever there are
constructions/renovations
 Make sure that all lead aprons and gonad and thyroid shields
are available to cover patients and staff needs and regularly
tested (annually) according to a hospital- wide inventory, not
FMS.9.6 only those available at the radiology department (e.g., OR, ER
Lead aprons and gonad/thyroid shields are available to cover and Cath Lab). Additionally, make sure that identified
patients and staff needs and are annually tested according to a defective aprons and shields are not returned back to service.
hospital‐wide inventory.  Make sure that all lead aprons, gonad, and thyroid shields are
tested annually according to a hospital-wide inventory; not
only those available at the radiology department (e.g., OR, ER
and Cath Lab)
 Make sure that personal radiation dosimeters (TLD cards) are
available to cover staff needs and staffs are provided with
replacement TLDs during the testing period. Also make sure
FMS.9.7
that all staff working in radiation areas are wearing TLD cards
Personal radiation dosimeters (TLD cards) are available, tested
during procedures.
every 3 months, and actions taken when test results exceed
permissible levels  Personal radiation dosimeters (TLD cards) are tested quarterly
and the results are reviewed by a radiation physicist or
radiation safety officer to ensure staff safety and cumulative
results are interpreted.

FMS.21 The hospital has an effective fire alarm system.


To ensure proper functionality of hospitals’ fire detection and alarm systems, it is important to conduct routine inspections, testing,
and maintenance as required.
Standard-Substandard Statement Description & instructions
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.21.1  Review the fire alarm inspection schedule and reports. (The
There is a fire alarm system that is functioning and regularly inspection can be done by the hospital technical staff). The
inspected as per civil defense guidelines checklist and records should include; list of devices of zones to
be inspected, inspection points and criteria for each zone,
inspection date, technician’s name and signature, and comments
that are resolved.
 This sub-standard is linked to FMS.21.3 and its score can’t be
higher than FMS.21.3.
 Observe fire alarm control panels and make sure that they work
properly with no alarms or errors. Observe random
smokedetectors, make sure they are operational, have number
tags, and not obstructed. This sub-standard is linked to FMS.21.3
and its score can’t be higher than FMS.21.3
FMS.21.2  Review the fire alarm testing schedule and reports. (The weekly
The fire alarm system testing results are documented. or monthly testing can be done the hospital own technical staff).
The checklists and records should include; list of devices in
zones to be tested, testing points and criteria for each device or
zone, testing date, technician’s name and signature, and
comments that are resolved.
 This sub-standard is linked to FMS.21.3 and its score can’t be
higher than FMS.21.3
FMS.21.3  Review the fire alarm maintenance schedule and preventive
The fire alarm system has preventive maintenance. maintenance work orders (Maintenance must be performed by
company certified by civil defense). The preventive maintenance
checklists and records should include; list of devices in zones to
be maintained, maintenance points and criteria for each device or
zone, and maintenance date, technician’s name and signature, and
comments that are resolved.
 Review corrective action plans for identified findings
FMS.21.4  Check fire alarm system distribution drawings to ensure that
The elevators are connected to the fire alarm system elevators are connected to the fire alarm system or certificates
from a certified contractor.
 Check availability of functional fire alarms in the elevator
mechanical room. Inspect for physical connection between fire
alarm and elevator control panel. Test one elevator to ensure it
lands on the assigned floor level

FMS.22 The hospital has a fire suppression system available in the required area(s).
In a wide range of applications where human lives and assets need to be protected against the effects of fires, reliable fire
extinguishing systems need to be properly installed and maintained. Hospitals need to endure that such systems (sprinklers, clean
agent suppression, wet chemical, stand pipes and hose systems) are properly installed (depending on room functions). The syst em’s
functions are not interrupted by surrounding practices (improper storage, adjacent construction activities), and their functions are
regularly inspected and maintained
Standard-Substandard Statement Description & instructions
FMS.22.1  Visit Fire Pump area, make sure that the jockey, electrical and
The hospital has a functional sprinkler system. diesel pumps are set to auto mode. Check the sprinkler system
test valve/drain valve. Sprinkler heads should not be obstructed
nor painted and distance between each in ordinary risk area
should not be more than 5 meters. Check if the hospital has a
fire water tank or a 2-level general tank. x-ray rooms can have
sprinkler system with precaution valve.
 Review sprinkler system inspection schedule and inspection
reports. All corrective actions are performed.
 Review sprinkler system preventive maintenance schedule and
reports. All corrective actions are performed.
 This activity is linked to observation and cannot be scored
higher.
Monthly inspection and PPM for the sprinkler system can
be done by the hospital maintenance department while the
quarterly maintenance schedule and preventive
maintenance work orders must be performed by company
certified by civil defense. Preventive maintenance
checklists and records should include; list of devices /
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

components to be maintained, maintenance points and


criteria for each device, maintenance date, technician’s
name and signature, and comments that are resolved
FMS.22.2  Make sure that hospital has clean agent suppression system
The hospital has clean agent suppression system. installed at the medical records department, the servers’ room
(data center), electrical rooms, and generators’ rooms
 Check clean agent suppression system inspection tag to verify
that inspection performed.
o Some clean agent systems (e.g. Novec, FM200, or Fire
pro) can be installed in public areas. CO2 suppression
system can be installed in none occupied areas such as
generators or electrical rooms. Small electrical rooms
(dry electrical room with no combustible material
stored within) that has fire rated doors and walls and
sealed opening with fire stop materials do not require
clean agent systems, only CO2 fire extinguishers
located by the room door.
 Review clean agent system inspection schedule and inspection
reports. All corrective actions are performed.
 Review clean agent system preventive maintenance schedule
and reports. All corrective actions are performed.
 This activity is linked to observation and cannot be scored
higher.
o Monthly inspection and PPM for the clean agent
system can be done by the hospital maintenance
department while the quarterly maintenance schedule
and preventive maintenance work orders must be
performed by company certified by civil defense.
Preventive maintenance checklists and records should
include; list of devices and components to be
maintained, maintenance points and criteria for each
device, maintenance date, technician’s name and
signature, and comments that are resolved.
FMS.22.3  Inspect hospital wet chemical system in the kitchen during
The hospital has wet chemical system. building tour to ensure that its function is not jeopardized by
adjacent installations.
 Check wet chemical system inspection tag to verify that
inspection is not due.
 Monthly inspection and PPM for the wet chemical system can be
done by the hospital maintenance department while the quarterly
maintenance schedule and preventive maintenance work orders
must be performed by company or personnel certified by civil
defense. Preventive maintenance checklists and records should
include; list of devices and components to be maintained,
maintenance points and criteria for each device, maintenance
date, technician’s name and signature, and comments that are
resolved.
 Review corrective action plans for identified findings.
 This activity is linked to observation and cannot be scored higher.
FMS.22.4  Inspect hospital's stand pipes and hose system during building
The hospital has stand pipes and hose system tour to ensure that its function is not jeopardized by adjacent
installations.
 Check the pressure in at least one hose reel to ensure that it’s
functioning automatically, and the pressure is adequate.
o Monthly inspection and PPM for the stand pipes and hose
reel system can be done by the hospital technical staff,
while the quarterly maintenance schedule and preventive
maintenance work orders must be performed by company
or personnel certified by civil defense. Preventive
maintenance checklists and records should include; list of
components to be maintained and tested, maintenance
points and criteria for each component, maintenance date,
technician’s name and signature, and comments that are
resolved.
o Review corrective action plans for identified findings.
o This activity is linked to observation activity and cannot be
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

scored higher.

FMS.23 There are fire exits that are properly located in the hospital.
To ensure safe evacuation during emergencies, hospitals must maintain the integrity of its fire exits (including exit routes, exit
doors, exit stares and landing to a safe public area) through the following: Fire exits are available, properly located, not locked, not
obstructed, have panic hard ware, fire resistant, and clearly marked with illuminated exit sign.
Standard-Substandard Statement Description & instructions
FMS.23.1  Observe fire exits are available, properly located in the
Fire exits are available and are properly located in the hospital. (It is not mandatory to have 2 exits for each
hospital. room/area, it depends on the number of occupants, travel
distance, area and type of materials stored). Please refer to
Saudi Building Code (SBC) for specific cases.
 This sub-standard will affect the score of sub-standards
FMS.23.2, FMS.23.3, FMS.23.4, and FMS.23.6. If fire exits
are not available, then these sub-standards will not meet the
requirements.
FMS.23.2  Test three to five fire exits and make sure that they are not
Fire exits are not locked locked by any means (chains, access control, keys, local
lock…). If doors are locked by access control or keys, assess
proper signage and that the hospital has taken proper action to
reduce risks (key boxes, manual exit press buttons) to ensure
smooth evacuation.
 The score of this sub-standard can’t be higher than FMS.23.1.
FMS.23.3  Observe fire exits and make sure that there are no obstructions
Fire exits are not obstructed. from both ends (furniture, project debris, cartoons...etc.)
 The score of this sub-standard can’t be higher than FMS.23.1.
FMS.23.4  Check escape exits to ensure they have necessary panic
Fire exits have panic hard ware hardware to allow opening in the direction of evacuation.
 The score of this sub-standard can’t be higher than FMS.23.1
FMS.23.6  Observe fire exits are clearly marked with illuminated exit
Fire exits are clearly marked with illuminated exit sign. signs.
 The score of this sub-standard can’t be higher than FMS.23.1.

FMS.24 The hospital and its occupants are safe from fire and smoke
To ensure that hospitals and its occupants are safe from fire hazards, number of measures need to be implemented. This includes:
•Adopting a strict No-Smoking policy.
• Ensure free access to fire extinguishers, fire alarm boxes, and emergency blankets.
• Provision of necessary emergency evacuation lighting
• Installing necessary Fire rated doors and having no fire wall penetration according to identified fire zones
Standard-Substandard Statement Description & instructions
FMS.24.1  Review the “No Smoking” policy to ensure that it includes all
The hospital implements a strict “No Smoking” policy. types of smoking (e-cigarettes, pipe, water pipe incense...etc.),
disciplinary actions against violators.
 Smoking is totally prohibited on premises of healthcare
facilities. Observe any thrown cigarette butts on hospital’s
premises (e.g. hospital’s roof, mechanical rooms,
entrances...etc.)
FMS.24.2  Observe that there are no obstructions to fire extinguishers, fire
There are no obstructions to exits, fire extinguishers, fire alarm boxes, and fire blankets.
alarm boxes, emergency blankets, safety showers, and eye
wash stations

FMS.24.3  Observe that emergency lighting is adequate for safe


Emergency lighting is adequate for safe evacuation of the evacuation of the hospital. (Light batteries are mandated only
hospital in OR and generator room).
 Perform functional test for emergency lighting to ensure that it
is charging/working properly
FMS.24.4
Storage areas are properly and safely organized:
FMS.24.4.1 Shelves and racks are sturdy and in Observe storage areas are properly and safely organized (note:
good condition. pay special attention to the central supplies store). In Central
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

FMS.24.4.2 No items stored directly on the floor (a supply store; Test emergency doors, observe exit signage,
minimum of ten centimeters is left to manage inspect fire extinguishers, access control and safe storage
spills). protocol.
FMS.24.4.3 Items should be stacked on a flat base
FMS.24.4.4 Heavier objects are close to the floor
and lighter/smaller objects are higher
FMS.24.4.5 Items are not stacked so high to block
sprinklers or come in contact with overhead lights
or pipes (a minimum distance of fifty centimeters
from ceiling level).
FMS.24.5  Observe Fire rated doors are available according to the
Fire rated doors are available according to the hospital zones hospital zones with no separation between walls and ceiling
with no separation between walls and ceiling to prevent to prevent smoke spread between rooms and areas.
smoke spread between rooms and areas.  Make sure to remove ceiling tiles on 3 different locations to
ensure that the fire wall is intact.
 In relations to hospital’s identified zones, lack of fire rated
doors or having fire wall penetrations between zones would
not fulfill the requirement of this substandard.

FMS.32 The hospital ensures proper maintenance of the medical gas system.
Medical gas systems are a standard feature of most healthcare facilities, and they require special monitoring and maintenance to
ensure they are operating properly. Unlike other medical equipment and systems, their use of gas under pressure makes them
vulnerable to a unique set of potential failures, which may not be clear. This makes medical gas preventative maintenance critical
to a problem-free working environment. The medical gas source will vary depending on the type of gas and average consumption
rate of gas. 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, both in terms of increased use of consumables and damage to permanent
equipment. Piped Medical Gas (PMG) system is mandatory for healthcare facilities with; high consumption rate, active operating
theaters, emergency departments which use ventilators or handle trauma cases. PMG system is NOT mandatory for: hospitals that
use only local anesthesia, mental health, rehabilitation and convalescent hospitals. Thus, FMS. 32.1, FMS. 32.2, FMS.32.3,
FMS.32.5, FMS.32.6, FMS.32.10, FMS.32.11 would be not applicable (NA) in such hospitals. Piped Medical Gas (PMG) system is
mandatory for healthcare facilities with; high consumption rate, active operating theaters, emergency departments which use
ventilators or handle trauma cases.
Standard-Substandard Statement Description & instructions
FMS.32.1 Review preventive maintenance schedule and records for piped
The medical gas system is regularly tested for: medical gas system (manifolds, air compressor, liquid oxygen
FMS.32.1.1 Pressure. and suction system).
FMS.32.1.2 Leaks.
FMS.32.1.3 Functionality of valves, alarms,
pressure gauge, and switches.
FMS.32.2 There is a policy and procedure that ensures Review medical gases policy and procedure to ensure covering
effective use of medical gas system. Areas covered include, the following:
but are not limited to, the following: 1) Procedure of taking part of the system offline,
FMS.32.2.1 The procedures to follow for taking 2) Procedure of modifying, altering, commissioning, testing
any part of the system offline. any part of PMG,
FMS.32.2.2 Commissioning and testing new 3) Procedure of ordering/refilling liquid oxygen,
branching or modifications. 4) Documenting repairs/ alterations/ tests/ filling
FMS.32.2.3 The procedure for ordering and filling logs/consumption
liquid oxygen
FMS.32.2.4 Documenting all
repairs/alterations/tests/filling logs/consumptin
FMS.32.3 Review compressed medical air testing reports to include humidity
Compressed medical air is regularly tested for humidity and and purity (particles, water =< 0.05mg/L / dewpoint of -46oC,
purity CO = < 5ppm, CO2 = < 500ppm, SO2 =< 1ppm) measurements.
FMS.32.4  Observe that medical gases manifold room and compressors
The central medical gas station is in a safe and secure place rooms are safe and secure (locked, signage, clean, no oil, no
exposed wiring…etc.).
 In specialized hospitals that use only local anesthesia, mental
health, rehabilitation and convalescent hospitals
 This substandard is applicable to ensure storing medical gas
cylinders in safe and secure place.
FMS.32.5 Observe that all PMG outlets are functioning and unified in
The outlets of medical gases in patient care areas are clearly label and connection type for each gas.
marked with the type of gas and have different connections
according to the gas type Medical gas pipes are clearly
Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
‫وزارة الصحة‬
Ministry of Health ‫المديرية العامة للشئون الصحية بمنطقة نجران‬
‫ملة‬
General Directorate of Health Affairs, Najran ‫مستشفى الملك خالد‬
King Khalid Hospital

identified for type and direction as per SBC (Saudi Building


Code).
FMS.32.6 Medical gas pipes are clearly identified for type and direction as
All medical gas pipes are clearly marked and labeled for the per SBC (Saudi Building Code).
contents and direction of gas flow.
FMS.32.8 Observe that all PMG outlets are functioning and unified in label
The hospital keeps standby oxygen and medical air cylinders and connection type for each gas.
enough for forty eight hours of average consumption.
FMS.32.9  Compare average consumption rate with the number of
The gas cylinders are regularly tested for gas type, amount, standby cylinders to ensure sufficiency for 48 hours.
and any leaks.  Make sure there are no active alarms for low pressure during
your visit the medical gas manifold
 Utility manager(s)/engineer(s) are aware of the average
daily consumption rate of oxygen and medical air.
FMS.32.10  Observe availability of labels indicating room numbers
Emergency shut off valves are available in all units and are served by the gas valve box at wards.
clearly marked with areas/rooms affected  Interview clinical staff to ensure their awareness of PMG
shutoff valves location and affected rooms. In addition to
their ability to demonstrate how to shut-off valves safely.
FMS.32.11 Interview staff responsible for valve shut off and make sure that
The hospital dedicates the responsibility of the closure of shut he/she is aware of the risk associated with valve shut off, breaking
off valves to well‐trained individual(s) available in the unit valve box cover, and what rooms are affected by closing the valve.
concerned
FMS.32.12 Observe that the PMG outlets are adequate in patient care areas
The hospital has adequate medical gases outlets in the patient and are to be error proof.
care areas as appropriate and these outlets are to be error
proof medical gas outlets‐ in accordance with DIN standards
related to gases piping, outlets and valves

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