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CBAHI ESRStandards

This document outlines standards for credentialing staff members licensed to provide patient care at hospitals. It includes 20 overall standards and 145 sub-standards. The standards require hospitals to have written policies and procedures to verify and evaluate the credentials and licenses of all medical, nursing, and allied healthcare professionals. Credentials must be verified from original sources, and staff's clinical responsibilities must be based on their verified qualifications. Hospitals must also ensure all licensed providers are registered with the Saudi Commission for Health Specialties and maintain valid licenses.
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© © All Rights Reserved
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0% found this document useful (0 votes)
728 views45 pages

CBAHI ESRStandards

This document outlines standards for credentialing staff members licensed to provide patient care at hospitals. It includes 20 overall standards and 145 sub-standards. The standards require hospitals to have written policies and procedures to verify and evaluate the credentials and licenses of all medical, nursing, and allied healthcare professionals. Credentials must be verified from original sources, and staff's clinical responsibilities must be based on their verified qualifications. Hospitals must also ensure all licensed providers are registered with the Saudi Commission for Health Specialties and maintain valid licenses.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 45

ESR Standards

Total Standards: 20 | Total Sub-Standards: 145 | Total ESR Standards: 20

The hospital has a process for proper credentialing


HR.5
of staff members licensed to provide patient care.
HR.5.1 The hospital has a written policy describing the process Document  Review credentialing policy that should
used for the verification of credentials. Review 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.
 The policy of credentialing verification
should include the elements mentioned in
standard HR.5 (such as HR.5.2, 5.3, 5.8,
5.9)
 The policy should specify the procedure
for verification of credentials and should
be signed by the process owner (e.g. HR).

HR.5.2 The hospital gathers, verifies, and evaluates the Personnel File This substandard consist of three (3) elements;
credentials (license, education, training, certification and Review gathering, verification and evaluation.
experience) of those medical staff, nursing staff, and other
health professionals licensed to provide patient care.  Gathering; having copy of all credentials
in personal file.
 Verification; having primary source
verification for credentials (license,
education, training and experience).
Primary source verification can either be

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Total Standards: 20 | Total Sub-Standards: 145 | Total ESR Standards: 20

from a third party such as dataflow or


done directly by the hospital.
 Evaluation; having documented evidence
in personnel file or meeting 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).

HR.5.3 Credentials are verified from the original source. Personnel File  Qualification needs to be verified from
Review the original source,
 If staff experience (in current position)
exceeding the required years of
experience as per job description (JD),
experience verification is not required,
 Training should be based on JD.
 Verification is not required for life
support certificates such as BLS, ACLS,
PALS.

HR.5.4 Job responsibilities and clinical work assignments/ Personnel File  All personal files of healthcare
privileges are based on the evaluation of the verified Review professionals should include copy of
credentials. current job description. Additionally,
privileges should be included for medical
staff.
 If the hospital does not conduct primary
source verification or staff is assigned out
of his/her profession (e.g., nurse working

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as anesthesia technician), then the score


will be affected.

HR.5.5 The hospital ensures the registration of all healthcare Personnel File Files of medical, nursing, pharmacy, laboratory,
professionals with the Saudi Commission for Health Review social work, and other healthcare providers
Specialties. contain valid and current license from the Saudi
Commission for Health Specialties (i.e., SCFHS
card is valid).
HR.5.6 Staff licensed to provide patient care must always have Personnel File This substandard requires hospital to have a valid
and maintain a valid license to practice only within their Review copy of Ministry of Health (MOH) license in the
profession. personnel file. Thus, this will be scored in private
hospitals accordingly and scored as NA in
governmental hospitals.
HR.5.7 The hospital maintains an updated record of the current Personnel File Files of medical, nursing and allied healthcare
professional license, certificate, or registration, when Review staff providing patient care shall contain
required by laws, regulations, or by the hospital for every credentialing documents (valid license from
medical staff, nursing staff and other healthcare SCFHS; education, training, certification and
professionals. experience).
HR.5.8 When verification of credentials is conducted through a Personnel File  Confirmatory documents supporting the
third party, the hospital must request for a confirmatory Review process of verification of credentials by
documentation. the third party if applicable.
 This can be scored NA if a hospital
doesn’t conduct any verification through
third party and all verification for license,
experience, training and education
conducted internally.

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 Payment receipt from third party is not


considered as confirmatory
documentation.

HR.5.9 Verification process applies to all clinical staff categories Personnel File  Review samples of part-time, visitor, and
(full time, part time, visitor, and locum). Review locum clinical staff (e.g., in OR, OPD)
files to ensure they contain credentialing
documents (valid and current license
from SCFHS; education, training,
certification and experience verified from
original source).
 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).

Policies and procedures guide the handling, use,


PC.25
and administration of blood and blood products.
PC.25.1 There are policies and procedures that are developed Document Policy on blood handling/administration should
collaboratively by the blood utilization committee, Review be reviewed and signed/approved by the Blood
guiding the handling, use, and administration of blood Utilization Committee and include clear process
and blood products. for handling, use and administration of blood and
blood products.
Staff Interview clinical staff (e.g., physicians and
Interview nurses) in different areas to confirm their
competency and awareness of blood
administration policies and procedures.

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PC.25.2 Only physicians order blood and in accordance with a Closed  Check the record of a patient who
policy clarifying when blood and blood products may be Medical received blood to make sure that the
ordered. Record blood order is only made by physician
Review and in accordance with hospital policy.
 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.

 Document Review the hospital policies and procedures on


Review handling, use, and administration of blood and
blood products to confirm the clear identification
of medical staff authorized to order blood
transfusion.
PC.25.3 The physician obtain informed consent for transfusion of Closed Check the record of a patient who received blood
blood and blood products. Elements of patient consent Medical to make sure that the patient appropriately
include: Record consented for the transfusion after being educated
PC.25.3.1 Description of the transfusion process. Review by a physician.
PC.25.3.2 Identification of the risks and benefits
of the transfusion.
PC.25.3.3 Identification of alternatives including
the 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.
Document Review the hospital policies and procedures on
Review handling, use, and administration of blood and

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blood products. The policy mandate documenting


informed consent and identify the elements of
proper consent.
PC.25.4 Two staff members verify the patient’s identity prior to Closed Check the medical record of a patient who
blood drawing for cross match and prior to the Medical received blood to make sure the patient identity
administration of blood. Record has been verified by two staff members prior to
Review blood drawing and transfusion.
Document  Review the hospital policies and
Review procedures on handling, use, and
administration of blood and blood
products. The implemented system
mandate two staff members verify the
patient’s identity prior to specimen
collection and prior to blood transfusion.
 If the hospital mandates taking two (2)
samples to verify cross match and that
clearly written in the policy, it is
accepted.

PC.25.5 In dire emergencies, patient/family signs consent for Document Review policy to confirm consent mandate for
"transfusion without NAT testing". Review "transfusion without NAT testing" in
emergencies,

(a) hospital has donation area and conduct NAT


testing internally, policy should mandate consent
for transfusion without NAT.

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(b) hospital has donation area & NAT testing is


outsourced, policy should mandate consent for
transfusion without NAT.

(c) hospital does not have donation area and


receiving tested blood from outsource facility
(based on written agreement), PC.25.5 will be
NA.
PC.25.6 Blood is transfused according to accepted transfusion Closed Check medical record of patients who received
practices from recognized professional organizations. Medical blood to make sure that Blood is transfused
Record according to hospital policy and using accepted
Review transfusion practices from recognized
professional organizations (e.g., blood transfusion
process, blood monitoring, and duration of
transfusion in congruent with the best practices)
Document Review hospital policies that developed
Review collaboratively by the blood utilization committee
to confirm that blood transfusion guidelines
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.
PC.25.7 Policies and procedures guide the administration of blood Observation Observe the accessibility and availability of blood
transfusions. transfusion policy in the visited areas (such as
ICU, ER or Surgical Ward).

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PC.25.8 Patients receiving blood are closely monitored. Closed Check the medical record of a patient who
Medical received blood to make sure that the patient was
Record closely monitored during transfusion.
Review
Document Review hospital policies and procedures to
Review confirm that the policy mandate close monitoring
of the patient during the transfusion and the
policy specify monitoring intervals and
procedure.
PC.25.9 Transfusion reactions are reported and analyzed for Closed  Check the medical record of a patient
preventive and corrective actions. Medical who experienced adverse transfusion
Record event to confirm proper reporting,
Review investigation and actions.
 This substandard can be scored as NA, if
the rate of transfusion is confirmed to be
too low.

 Document  Review the hospital policies and


Review procedures on recognizing, handling and
reporting of adverse transfusion events.
 It’s acceptable to have transfusion
reaction policy as part of the blood
administration policy.

Patients at risk for developing venous


PC.26
thromboembolism are identified and managed.
PC.26.1 Patients are screened for the risk of developing venous Open Medical • Review medical record to check if patients are
thromboembolism. Record screened for the risk of developing venous
Review thromboembolism. Form used for VTE screening

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should include all identified risk factors according


to patients’ categories (medical/surgical,
antenatal, and postnatal) and the calculation of
these risks result in adequate treatment.

• 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.
PC.26.2 Patients at risk receive prophylaxis according to current Open Medical  Review medical record to check if
evidence-based practice. Record patients at risk of developing venous
Review thromboembolism receive prophylaxis
according to current evidence-based
practice. Ensure that prophylaxis given
according to risk factors identified in
PC.26.1.
 Observe the availability of mechanical
prophylaxis.

The hospital has a system for the safety of high-


MM.5
alert medications.
MM.5.1 There is a written multidisciplinary plan for managing Document Review the multidisciplinary plan/policy for
high-alert medications and hazardous pharmaceutical Review managing high-alert medications and hazardous
chemicals. It includes identification, location, labeling, pharmaceutical chemicals. Policy should be
storage, dispensing, and administration of high-alert signed by the process owners (Pharmacy Director,
medications. Nursing Director, Medical Director). It should
include high-alert medications and hazardous
pharmaceutical chemicals, and specify the process
of identification, location, labeling, storage,

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dispensing and administration of these


medications.
MM.5.2 The hospital identifies an annually updated list of high- Document - Review the updated list (annually) of high-alert
alert medications and hazardous pharmaceutical Review medications and hazardous pharmaceutical
chemicals based on its own data and national and chemicals.
international recognized organizations (e.g., Institute of
Safe Medication Practice, World Health Organization). - MM.5.2.1 to MM.5.2.9 are examples that need
The list contains, but is not limited to, the following: to be part of the list along with other intra-
MM.5.2.1 Controlled and narcotics medications. hospital frequently used high alert medications.
MM.5.2.2 Neuromuscular blockers.
MM.5.2.3 Chemotherapeutic agents.  The list needs to be approved by
MM.5.2.4 Concentrated electrolytes (e.g., Pharmacy and Therapeutics Committee;
hypertonic sodium chloride, concentrated otherwise it would partially meet the
potassium salts). standard.
MM.5.2.5 Antithrombotic medications (e.g.,  List must be from within the hospital’s
heparin, warfarin). formulary
MM.5.2.6 Insulins.  Covers to a minimum the list mentioned
MM.5.2.7 Anesthetic medications (e.g., propofol, in the standard, as applicable
ketamine).  List should include the specific drug
MM.5.2.8 Investigational (research) drugs, as names, not just categories.
applicable.
MM.5.2.9 Other medications as identified by the
hospital.
MM.5.3 The hospital plan for managing high-alert medications Observation Observe for evidence of implementation of high
and hazardous pharmaceutical chemicals is implemented. alert plan (from MM.5.3.1 to MM.5.3.5).
This includes, but is not limited to, the following: MM.5.3.2 does not mean having all high alert
MM.5.3.1 Improving access to information about medications in a locked cabinet, but we need to
high-alert medications. ensure limiting access to these high alert
MM.5.3.2 Limiting access to high-alert medications.
medications.

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MM.5.3.3 Using auxiliary labels or computerized


alerts if available.
MM.5.3.4 Standardizing the ordering,
transcribing, preparation, dispensing,
administration, and monitoring of high-alert
medications.
MM.5.3.5 Employing independent double
checks.
Staff Staff interview to verify awareness of strategies to
Interview prevent errors associated with using of high-alert
medications and hazardous pharmaceutical
chemicals. Independent double check should be
carried out in both dispensing and administration.
In addition, improving access to drug information
on high alert medications include having access to
dosing, storage, precautions, adverse reactions,
etc.
MM.5.4 The hospital develops and implements standard Document Review the hospital approved standard
concentrations for all medications administered by Evidence concentration for all high alert medications
intravenous infusion. administered by intravenous infusion. (Note: this
substandard cannot be scored NA in any hospital
setting).
Staff Interview staff (nurses, physicians, and
Interview pharmacists) for evidence of implementation of
standard concentrations of all high alert
medications administered by intravenous
infusion.
The hospital has a system for the safety of look-
MM.6
alike and sound-alike (LASA) medications.

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MM.6.1 There is a multidisciplinary policy and procedure on Document Review the multidisciplinary plan/policy on
handling look- alike/sound-alike (LASA) medications. Review handling LASA. Policy should be signed by
process owners (Pharmacy Director, Nursing
Director, Medical Director), and outlines the
process of identification, location, labeling,
storage, dispensing and administration of LASA
medications. In addition, it should include error
prevention strategies at each phase
MM.6.2 The hospital reviews and revises annually its list of Document Review the updated list (annually) of confusing
confusing drug names, which include LASA medication Review drug names including look alike and sound alike
name pairs that the hospital stores, dispenses, and medications. Hospitals need to have annually
administers. updated list for LASA medications. The list must
be:

 Approved by Pharmacy and Therapeutics


Committee
 Have both look alike and sound alike
medications in separate tables or lists.
 From within the hospital’s formulary
 Updated Annually

MM.6.3 The hospital takes actions to prevent errors involving Document Ensure having evidence (material and attendance
LASA medications including the following, as applicable: Evidence record) that adequate number of relevant staff
MM.6.3.1 Providing education on LASA members were educated on LASA medications.
medications to healthcare professionals at
orientation and as part of continuing education.
MM.6.3.2 Using both the brand and generic
names for prescribing LASA medications.
MM.6.3.3 Writing the diagnosis/ indication of
the LASA medication on the prescription.

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MM.6.3.4 Changing the appearance of look-alike


product package.
MM.6.3.5 Reading carefully the label each time a
medication is accessed, and/or prior to
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.
Observation Observe for evidence of error prevention due to
LASA medications (from MM.6.3.2 to MM.6.3.8)
Staff Interview staff for evidence of implementation of
Interview error prevention strategies due to LASA
medications (from MM.6.3.1 to MM.6.3.8)
The hospital has a process to ensure correct
QM.17
identification of patients.
QM.17.1 At least two patient identifiers (e.g., patient full name and Staff  Interview staff to ensure that they are
medical record number) are required whenever taking Interview aware of the policy and using at least 2
blood samples, administering medications or blood patient identifiers before procedures,
products, or performing procedures. blood sampling, medications
administration… etc.
 Although the activity required for
QM.17.1 is staff interview, identification

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policy/protocol needs to be reviewed to


ensure consistency of practice.

QM.17.2 The hospital has a standardized approach to patient Observation  Visit and observe different location to
identification (e.g., use of ID bands with standardized ensure consistency and standardization of
information). patient identification process.
 Suggested areas for observation:
(Observe if patients in ER having ID and
its content is visible, readable and clear,
observe staff administering medications
without verification against medication
records, observe newborn identification,
observe to make sure NOT using room
number as identifier in medication
drawers)

QM.17.3 Patients are actively involved in the process of patient Staff  Interview staff and patients to assess
identification. Interview implementation.
 Most common areas to assess: outpatient
pharmacy, phlebotomy area, patient pre-
procedure.
 This substandard is not applicable (NA)
in mental health hospitals.

The hospital has a process to prevent wrong


QM.18
patient, wrong site, and wrong surgery/procedure.
QM.18.1 There is a process implemented to prevent wrong patient, Staff  Interview staff to verify adherence to
wrong site, and wrong surgery/procedure during all Interview surgical safety protocol.

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invasive interventions performed in operating rooms or  Although QM.18.1 activity is staff


other locations. interview, policy on 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 The process consists of three phases: verification, site Closed  This substandard consists of 3 elements;
marking, and time out. Medical verification, site marking, & time- out.
Record Review medical records to ensure a
Review 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 Closed Review medical records of patients went for
carried out including the patient’s identity, consent, full Medical invasive procedure to make sure that the pre-
details of the procedure, laboratory tests and images, and Record procedure verification is documented in the chart.
any implant or prosthesis. Review
QM.18.4 The surgical/procedural site is marked before conducting Closed  Review medical records of patients went
the surgery/procedure. Medical for intraoperative surgical procedures to
make sure that the pre-procedure

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QM.18.4.1 The site is marked especially in Record verification, site marking, and time out
bilateral organs and multiple structures (e.g. Review are documented in the chart.
fingers, toes, and spine).  In mental health hospitals, site marking
QM.18.4.2 The site is marked by the individual for ECT is Not Applicable.
who will perform the procedure.
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 A final check (time-out) is conducted before the Observation  Hospitals need to have a clear
procedure is initiated. documented evidence in medical records
QM.18.5.1 The time-out is conducted in the for conducting time-out (prior to skin
location where the procedure will be done, just incision).
before starting.  Observation activity can be replaced by
QM.18.5.2 The time-out is initiated by a staff interview (e.g., in recovery room or
designated member of the team and involves the surgical wards) if there are no cases of
members of the team, including the individual invasive procedures to observe during the
performing the procedure, the anesthesia visit to ensure staff awareness of time-out
providers, and the nurse(s) involved. process.
QM.18.5.3 The entire procedure team uses active
communication during the time out.
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.
 Staff Assess awareness of concerned staff regarding the
Interview time out process

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QM.18.6 The hospital documents its processes for preventing Open Medical Review medical records of patients went for
wrong patient, wrong site, and wrong surgery/procedure. Record invasive procedure/surgical operation to make
Review sure that the pre-procedure verification, site
marking, and time out are documented in the
chart.
Facility design and available supplies support
IPC.15
isolation practices.
IPC.15.1 There is at least one negative pressure airborne isolation Observation  Hospitals are expected to have at least
room in the emergency room and one in patient care areas one negative pressure room in ER and
(one negative pressure room for every 25-30 beds in one for every 25-30 beds in general
general hospitals). hospitals (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.
 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 Document Review completeness of engineering control
provides pressure patterns that prevent airborne pathogens Evidence records for air changes per hour, HEPA filter,
from being distributed to other areas of the hospital. negativity, humidity, and temperature; (review
IPC.15.3.1 Rooms designed for airborne isolation standard's intent to understand engineering
patients are under negative pressure. records requirements)

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IPC.15.3.2 Air is exhausted to the outside and is


not re-circulated unless it is filtered through
High-Efficiency Particulate Air (HEPA) Filter.
IPC.15.3.3 The negative pressure for the
isolation 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
Staff Interview infection control staff and hospital staff
Interview to verify their awareness of negative pressure
isolation rooms’ engineering control records.
IPC.15.5 Toilet, shower, or tub and hand washing facilities are Observation Observe the availability of hand washing
provided for each isolation room. facilities, toilets, and shower in negative pressure
isolation rooms (note: shower and toilet in ICU
isolation room is not mandatory).
IPC.15.6 Transmission-based precaution cards (isolation signs) are Document Review isolation precautions policy that should
consistent with the patient diagnosis and are posted in Review include the specification of isolation precaution
Arabic and English and indicate the type of precautions cards.
required.
IPC.15.6.1 Transmission-based precaution cards
(isolation signs) are color coded for isolation of
different categories (e.g., contact: green, airborne:
blue, droplet: pink or red).
IPC.15.6.2 Transmission-based precaution cards
(isolation signs) should contain short statements
and supported with the required figures.

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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).
Observation Observe the availability of transmission-based
precaution card that should be consistent with
diagnosis, posted in both Arabic and English,
color coded, contain short statements, contain
figures, and include transportation instructions.
IPC.15.7 Respirator (high filtration) masks (N-95, N-99) are used Observation Observe the availability and appropriate use of
by staff during direct care of patients on airborne N95 by staff when dealing with patient with
precautions and are available on all units likely to admit airborne diseases and ensure;
patients on airborne precautions.
1) the availability of different sizes of N95 masks,

2) having fitting test and staff are aware about


their results,

3) observe donning and removing of N95.


Staff Assess staff knowledge about the policy of re-
Interview suing high filtration masks.
IPC.15.8 Respirator (high filtration) masks (N95, N-99) can be Document Review hospital’s policy on single use or re-use
reused by the same patient care giver as per the period Review of N95 masks: - If policy stated single use of
specified by the manufacturer. N95, document review (DR) and 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

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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.
Staff Assess the staff knowledge about the
Interview manufacturer recommendation for reusing high
filtration masks.
FMS.21 The hospital has an effective fire alarm system.
FMS.21.1 There is a fire alarm system that is functioning and Document  Review the fire alarm inspection schedule
regularly inspected as per civil defense guidelines. Evidence and reports. (The inspection can be done
by the hospital technical staff). The
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.

 Observation  Observe fire alarm control panels and


make sure that they work properly with
no alarms or errors. Observe random
smoke detectors, make sure they are
operational, have number tags, and not
obstructed.

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 This sub-standard is linked to FMS.21.3


and its score can’t be higher than
FMS.21.3.

FMS.21.2 The fire alarm system testing results are documented. Document  Review the fire alarm testing schedule
Evidence and reports. (The weekly or monthly
testing can be done by hospital 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 The fire alarm system has preventive maintenance. Document  Review the fire alarm maintenance
Evidence schedule and preventive 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.

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 Review corrective action plans for


identified findings.

FMS.21.4 The elevators are connected to the fire alarm system. Document Check fire alarm system distribution drawings to
Review ensure that elevators are connected to the fire
alarm system or certificates from a certified
contractor.
Observation 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.
The hospital has a fire suppression system
FMS.22
available in the required area(s).
FMS.22.1 The hospital has a functional sprinkler system. Document  Review sprinkler system inspection
Evidence schedule and reports. Review performed
corrective actions.
 Review sprinkler system preventive
maintenance schedule and reports.
Review performed corrective actions.
 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 / components to be maintained,

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maintenance points and criteria for each


device, maintenance date, technician’s
name and signature, and comments that
are resolved.
 This activity is linked to observation and
cannot be scored higher.

 Observation Visit Fire Pump area, make sure that the jockey,
electrical and 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 preaction
valve.

FMS.22.2 The hospital has clean agent suppression system. Document  Review clean agent system inspection
Evidence schedule and inspection reports. All
corrective actions are performed.
 Review clean agent system preventive
maintenance schedule and reports. All
corrective actions are performed.
 Monthly inspection and PPM for the
clean agent system can be done by the
hospital maintenance department. While,

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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.
 This activity is linked to observation and
cannot be scored higher.

 Observation  Make sure that hospital has clean agent


suppression system installed at the
medical records department, servers’
room (data center), electrical rooms, and
generators’ rooms.
 Check clean agent suppression system
inspection tag to verify that inspection
performed.

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

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opening with fire stop materials do not require


clean agent systems, only CO2 fire extinguishers
located by the room door.
FMS.22.3 The hospital has wet chemical system. Document  Monthly inspection and PPM for the wet
Evidence 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.

 Observation  Inspect hospital wet chemical system in


the kitchen during hospital 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.

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FMS.22.4 The hospital has stand pipes and hose system. Document  Monthly inspection and PPM for the
Evidence 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.
 Review corrective action plans for
identified findings.
 This activity is linked to observation
activity and cannot be scored higher.

 Observation  Inspect hospital's stand pipes and hose


system during building 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.

There are fire exits that are properly located in the


FMS.23
hospital.

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FMS.23.1 Fire exits are available and are properly located in the Observation  Observe fire exits are available, properly
hospital. located in the hospital. (It is not
mandatory to have 2 exits for each
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 Fire exits are not locked. Observation  Test three to five fire exits and make sure
that they are not 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) and ensure smooth
evacuation.
 The score of this sub-standard can’t be
higher than FMS.23.1.

FMS.23.3 Fire exits are not obstructed. Observation  Observe fire exits and make sure that
there are no obstructions from both ends
(furniture, project debris, boxes...etc.)

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 The score of this sub-standard can’t be


higher than FMS.23.1.

FMS.23.4 Fire exits have panic hard ware. Observation  Check escape exits to ensure they have
necessary panic 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 Fire exits are clearly marked with illuminated exit sign. Observation  Observe fire exits are clearly marked with
illuminated exit signs.
 The score of this sub-standard can’t be
higher than FMS.23.1.

The hospital and its occupants are safe from fire


FMS.24
and smoke.
FMS.24.1 The hospital implements a strict “No Smoking” policy. Document Review the “No Smoking” policy to ensure that it
Review includes all types of smoking (e-cigarettes, pipe,
water pipe incense...etc.) and disciplinary actions
against violators.
Observation 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 There are no obstructions to exits, fire extinguishers, fire Observation Observe that there are no obstructions to fire
alarm boxes, emergency blankets, safety showers, and eye extinguishers, fire alarm boxes, and fire blankets.
wash stations.

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FMS.24.3 Emergency lighting is adequate for safe evacuation of the Observation  Observe that emergency lighting is
hospital. adequate for safe evacuation of the
hospital. (Light batteries are mandated
only in OR and generator rooms).
 Perform functional test for emergency
lighting to ensure that it is
charging/working properly.

FMS.24.4 Storage areas are properly and safely organized: Observation  Observe storage areas are properly and
FMS.24.4.1 Shelves and racks are sturdy and in safely organized (note: pay special
good condition. attention to the central supplies store).
FMS.24.4.2 No items stored directly on the floor  In Central supply store; Test emergency
(a minimum of ten centimeters is left to manage doors, observe exit signage, inspect fire
spills). extinguishers, access control and safe
FMS.24.4.3 Items should be stacked on a flat storage protocol.
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 Fire rated doors are available according to the hospital Observation  Observe Fire rated doors are available
zones with no separation between walls and ceiling to according to the hospital zones with no
prevent smoke spread between rooms and areas. separation between walls and ceiling to
prevent smoke spread between rooms and
areas.
 Make sure to remove ceiling tiles on 3
different locations to ensure that the fire
wall is intact.

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 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.

Medical staff members have current delineated


MS.7
clinical privileges.
MS.7.1 Medical staff members are allowed to practice only Document  In visited units such as ICU, OR, ER and
within the privileges granted by the credentialing and Evidence Radiology, it is required to verify the
privileging committee. availability and accessibility of valid
copy of privileges for the physicians
working in these areas (hard copy or
controlled electronic copy).
 Note: Although the validity of privileges
will be assessed by MS.7.2, such finding
needs to be verified as part of MS.7.1 too
since both sub-standards are linked.

MS.7.2 Clinical privileges are reviewed and updated every two Personnel File Review Sample of physician’s personnel files to
years and as needed. Review make sure that clinical privileging is reviewed
and updated every two years and as needed.
Updated privileges imply both
upgrading/downgrading.
MS.7.3 The hospital identifies the circumstances under which Document Privileging policy should include;
temporary or emergency privileges are granted. Review
1) definition of temporary and emergency
privileges

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2) the circumstances and process of granting


temporary and emergency privileges.
Personnel File  Review physician personnel file to check
Review the implementation of the hospital policy
on granting temporary or emergency
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 Temporary or emergency privileges are not granted for Document Review the hospital policy on granting temporary
more than 90 days and are not renewable. Review or emergency privileging. Both elements (not
granted more than 90 days and not renewable)
should be written in the policy.
MS.7.5 When a new privilege is requested by a medical staff Personnel File  Review sample of physicians’ files to
member, the relevant credentials are verified and Review assess the implementation of privileging
evaluated prior to approval. process in case of requesting new
privileges.
 Review the last 3 meeting minutes for the
privileging committee to check if there
were medical staff requesting new
privileges.

Anesthesia staff members have the appropriate


AN.2
qualifications.
AN.2.1 Qualified anesthesiologists provide anesthesia services. Personnel File Review random sample of anesthetist’s personnel
Review files for qualification and Privileges. Qualified

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anesthesiologist could be specialist, senior


specialist or consultant.
AN.2.2 Qualified anesthesiologist is present inside the operating Closed  Review medical records to verify having
room throughout the operation. Medical a documented evidence that
Record anesthesiologist is present in OR
Review throughout the operation.
 Discharge recovery sheet, intraoperative
anesthesia 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 Anesthesia consultant administers and supervises Closed Review medical record of patient who had major
anesthesia for major/specialized operations or high risk Medical or high-risk surgery (Pediatric operations, cardio-
patients, including: Record pulmonary operations, neurosurgery operations,
AN.2.3.1 Pediatric operations. Review and transplant operations) to make sure that
AN.2.3.2 Cardio-pulmonary operations. anesthesia consultant administers and supervises
AN.2.3.3 Neurosurgery operations. anesthesia.
AN.2.3.4 Transplant operations.
AN.2.4 Anesthesia staff are certified in advanced life support as Personnel File Review sample of anesthesia medical staff
appropriate to the patient’s age. Review personal files to verify having an evidence of
advanced life support training as appropriate to
the patient’s age (e.g., if anesthesiologist
participating in pediatric operations, PALS
certificate should be checked).
Qualified staff perform moderate and deep
AN.15
sedation/analgesia.

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AN.15.1 Physicians who perform moderate and deep Personnel File  All physicians (non-anesthesiologist) who
sedation/analgesia have competency-based privileges Review perform moderate/deep sedation must
granted to perform moderate and deep sedation/analgesia. have competency-based privileges in their
personal files if they participate in
conducting moderate and deep sedation .
 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 who participate in caring for patients Personnel File Clinical staff such as nurses, anesthesia
receiving moderate or deep sedation are certified in Review technicians, radiology technicians, labor and
advanced life support as appropriate to the age of the delivery staff who participate in caring of patients
patients served. received moderate sedation are required to have
evidence of advanced life support training (and
PALS if they serve pediatric group) in their
personal files.
AN.15.3 Clinical staff who participate in conducting sedation must Personnel File  Clinical staff such as nurses, radiology
successfully complete a proper education/training on Review technicians, labor and delivery staff who
moderate and deep sedation. participate and conduct sedation must
complete adequate training in moderate
and deep sedation that 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.

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The hospital ensures proper maintenance of the


FMS.32
medical gas system.
FMS.32.1 The medical gas system is regularly tested for: Document Review preventive maintenance schedule and
FMS.32.1.1 Pressure. Evidence reports for piped medical gas system (manifolds,
FMS.32.1.2 Leaks. air compressor, liquid oxygen and suction
FMS.32.1.3 Functionality of valves, alarms, system).
pressure gauge, and switches.
FMS.32.2 There is a policy and procedure that ensures effective use Document Review medical gases policy and procedure to
of medical gas system. Areas covered include, but are not Review ensure covering the following:
limited to, the following:
FMS.32.2.1 The procedures to follow for taking  Procedure of taking part of the system
any part of the system offline. offline,
FMS.32.2.2 Commissioning and testing new  Procedure of modifying, altering,
branching or modifications. commissioning, testing any part of PMG,
FMS.32.2.3 The procedure for ordering and  Procedure of ordering/refilling liquid
filling liquid oxygen. oxygen,
FMS.32.2.4 Documenting all  Documenting repairs/ alterations/ tests/
repairs/alterations/tests/filling logs/consumption. filling logs/ consumption.

FMS.32.3 Compressed medical air is regularly tested for humidity Document Review compressed medical air testing reports to
and purity. Evidence include humidity and purity (particles, water =<
0.05mg/L / dewpoint of -46oC, CO =< 5ppm,
CO2 =< 500ppm, SO2 =< 1ppm) measurements.
FMS.32.4 The central medical gas station is in a safe and secure Observation  Observe that medical gases manifold
place. room and compressors rooms are safe and
secure (locked, signage, clean, no oil, no
exposed wiring…etc.).
 In hospitals that use only local anesthesia,
mental health, rehabilitation and

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convalescent hospitals this substandard is


applicable to ensure storing medical gas
cylinders in safe and secure place.

FMS.32.5 The outlets of medical gases in patient care areas are Observation Observe that all PMG outlets are functioning and
clearly marked with the type of gas and have different unified in label and connection type for each gas.
connections according to the gas type.
FMS.32.6 All medical gas pipes are clearly marked and labeled for Observation Medical gas pipes are clearly identified for type
the contents and direction of gas flow. and direction as per SBC (Saudi Building Code).
FMS.32.8 The hospital keeps standby oxygen and medical air Observation  Compare average consumption rate with
cylinders enough for forty eight hours of average the number of standby cylinders to ensure
consumption. sufficiency for 48 hours. (to change LOX
to gas: 1 liquid O2 liter = ~ 855 liters of
gas @ 20 Celsius & 1 K size gas cylinder
= ~ 6800 liters @ 2000 psi)
 Make sure there are no active alarms for
low pressure during your visit the medical
gas manifold.

 Staff Utility manager(s)/engineer(s) are aware of the


Interview average daily consumption rate of oxygen and
medical air.
FMS.32.9 The gas cylinders are regularly tested for gas type, Observation Observe that the gas cylinders are regularly tested
amount, and any leaks. for gas type, amount and any leaks.
FMS.32.10 Emergency shut off valves are available in all units and Observation Observe availability of labels indicating room
are clearly marked with areas/rooms affected. numbers served by the gas valve box at wards.
Staff Interview clinical staff to ensure their awareness
Interview of PMG shutoff valves location and affected

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rooms. In addition to their ability to demonstrate


how to shut-off valves safely.
FMS.32.11 The hospital dedicates the responsibility of the closure of Staff Interview staff responsible for valve shut off and
shut off valves to well-trained individual(s) available in Interview make sure that he/she is aware of the risk
the unit concerned. associated with valve shut off, breaking valve box
cover, and what rooms are affected by closing the
valve.
FMS.32.12 The hospital has adequate medical gases outlets in the Observation Observe that the PMG outlets are adequate in-
patient care areas as appropriate and these outlets are to patient care areas and are to be error proof.
be error proof medical gas outlets- preferred to be in
accordance with DIN standards related to gases piping,
outlets and valves.
The hospital has a process for monitoring,
identifying, and reporting significant medication
MM.41 errors, including near misses, hazardous
conditions, and at-risk behaviors that have the
potential to cause patient harm.
MM.41.1 There is a multidisciplinary policy and procedure on Document Review the multidisciplinary policy on handling
handling medication errors, near misses, and hazardous Review medication errors. Policy should be signed by
situations (e.g., confusion over look-alike/sound-alike process owners (Pharmacy Director, Nursing
drugs or similar packaging). Director, Medical Director). It should highlight
the following:

 Reference to the reporting form


 Notification of provider about the error
 Feedback to reporters
 Timeframe for reporting and notification
of provider

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 Documenting medical errors and who


should document and where

MM.41.2 The policy has a clear and acceptable definition of Document Review the multidisciplinary policy on handling
significant medication error, near misses, and hazardous Review medication errors. Policy should include clear and
situations. acceptable definition of significant medication
error, near misses, and hazardous situations.
MM.41.3 The treating physician is notified of the medication error Staff Interview physicians (treating/attending/most
at the appropriate time. Interview responsible) on how they get to know/informed
about a medication error and when.
MM.41.4 Medication error reporting is completed within the Staff Interview healthcare providers on when they
specified time frame after discovery of the error. Interview report medication errors. Match the timeframe in
the policy with staff awareness
MM.41.5 The hospital has a standard format for reporting Document Ensure that pharmacist, physicians, and nurses in
medication errors. Evidence different areas (clinical areas and pharmacy) are
using the same standardized format for reporting
medication errors.
MM.41.6 Staff are educated on the process and importance of Staff Interview healthcare providers on the process and
medication error reporting. Interview importance of medication error reporting. If a
documented evidence shown (list of trained staff),
we need to ensure that education involves the
highest possible number of staff and not limited to
specific area.
MM.41.7 There is active reporting of medication errors, near Document  Review medication errors, near misses,
misses, and hazardous situations. Evidence and hazardous situations reports
 Active reporting means reporting
different types of errors by different
stakeholders (medical, nursing,
pharmacist) and number of reported

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events should be relevant to the size and


scope of service.

MM.41.8 The hospital conducts intensive root-cause analysis for all Document  Review root-cause analysis of all
significant or potentially significant medication errors. Evidence significant or potentially significant
medication errors.
 This substandard is linked with MM.41.7,
if the hospital doesn’t have an active
reporting system.

MM.41.9 Medication errors are documented in the patient’s Open Medical Review medical records for selected cases of
medical record. Record reported medication errors (reached the
Review patient). Inserting a copy of the report in the
medical record is NOT ACCEPTABLE
MM.41.10 The hospital utilizes reported data to improve the Pharmacy and Interview members of pharmacy and therapeutics
medication use process, prevent medication errors, and Therapeutics committee and review the Committee’s meeting
improve patient safety. Committee minutes to ensure that hospital is analyzing the
reported event to take corrective and preventive
actions to improve the patient safety. A sub-
committee reporting to P&T or any other
equivalent committee is acceptable to be
responsible for the analysis.
MM.41.11 Healthcare professionals are provided with feedback on Staff Interview healthcare provider who previously
reported medication errors, near misses, and hazardous Interview reported medication error to verify if and how
situations. they received a feedback regarding the analysis of
the reported event and the action taken to prevent
reoccurrence of the event or not. If the reporter is
known, then he or she should get feedback based
on the hospital’s process in providing feedback. If

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the reporter is anonymous then the


unit/section/department should get feedback.
MM.41.12 The hospital reports sentinel events related to serious Document Review documents supporting the fact that the
medication errors to the relevant authorities. Evidence hospital reports sentinel events related to serious
medication errors to the relevant authorities.
Pharmacy and Interview members of pharmacy and therapeutics
Therapeutics committee on reporting sentinel events related to
Committee 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
There is a designated multidisciplinary committee
IPC.4 that provides oversight of the infection prevention
and control program.
IPC.4.1 The infection prevention and control committee is chaired Infection Review Infection Prevention and Control
by the hospital director or the medical director. Prevention Committee term of reference (TOR) and meeting
and Control minutes to verify that the committee is chaired by
Committee 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 The membership of the infection prevention and control Infection  Review Infection Prevention and Control
committee includes representatives from the medical Prevention Committee term of reference (TOR) and
staff, nursing staff, microbiology, operating room, central and Control meeting minutes to verify
sterilization service, pharmaceutical care, dietary services, Committee multidisciplinary involvement.
housekeeping, infection prevention and control staff, and  Medical staff involvement should include
other departments as needed. a representative from critical care areas

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(adults and pediatrics) depending on the


scope of service.
 Issues discussed in IPC committee
meetings are assigned to concerned
representatives and should be traceable
and timely closed.

IPC.4.3 The infection prevention and control committee meets on Infection Review Infection Prevention and Control
a regular basis (at least quarterly). Prevention Committee term of reference (TOR) and meeting
and Control minutes to verify that the committee is meeting on
Committee regular basis. Also, make sure they have been
discussing critical issues related to infection
control as applicable (e.g. outbreaks).
IPC.4.4 Functions of the infection prevention and control Infection Review Infection Prevention and Control
committee include, but are not limited to, the following: Prevention Committee term of reference (TOR) and meeting
IPC.4.4.1 Review of the hospital infection and Control minutes to ensure incorporating IPC.4.4.1-
prevention and control policies and procedures. Committee IPC.4.4.6.
IPC.4.4.2 Review of the reports of healthcare-
associated infections surveillance submitted
regularly by the infection prevention and control
team and suggestion of appropriate actions.
IPC.4.4.3 Revision of the yearly plan submitted
by infection prevention and control team and
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

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issues arising in different departments of the


hospital & suggests solutions.
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.
The hospital ensures that all its occupants are safe
FMS.9
from radiation hazards.
FMS.9.1 The hospital has a radiation safety policy and procedure Document Review the radiation safety policy and procedure
and it is implemented. Review to ensure having the following;

 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
 Radiation emergencies (spills).

In case the hospital has radio-active materials,


then the policy should also include safe
handling/storing of radio-active materials and
radioactive waste disposal.
FMS.9.2 All radio-active materials are clearly labeled and safely Observation Observe all radio-active materials are clearly
and securely stored. labeled and safely and securely stored.
FMS.9.3 The hospital has the relevant valid license(s) from King Document Review the validity of the hospital’s license from
Abdulaziz City for Science and Technology. Review the National Authorities (i.e. K.A. CARE,

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ESR Standards

Total Standards: 20 | Total Sub-Standards: 145 | Total ESR Standards: 20

KACST, ….) for dealing with radio-active


materials.
FMS.9.4 Staff handling nuclear materials are qualified and Personnel File Review RSO’s personal file to see certificate
certified by King Abdul-Aziz City for Science and Review from the national authorities (i.e. K.A. CARE,
Technology. KACST …).
Staff Interview staff handling radio-active materials
Interview and evaluate the implementation of the radiation
safety policy. If the hospital has radio-active
materials, there must be a certified Radiation
Safety Officer (RSO).
FMS.9.5 There is a valid shielding certificate of the x-ray room(s) Document Review the validity of shielding
including regular test to ensure permissible radiation Evidence certificate/radiation survey (leak test) of the X-ray
levels. (mammography, CT, fluoroscopy, conventional
x-ray and dental panorama x-ray) room(s) and
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.
Staff Interview relevant staff (e.g. medical physicist,
Interview RSO in charge) on how he/she regularly tests
concerned areas for permissible radiation levels.
FMS.9.6 Lead aprons and gonad/thyroid shields are available to Document Make sure that all lead aprons, gonad, and thyroid
cover patients and staff needs and are annually tested Evidence shields are tested annually according to a
according to a hospital-wide inventory. hospital-wide inventory; not only those available
at the radiology department (e.g., OR, ER and
Cath Lab)
Observation Make sure that lead aprons, gonad and thyroid
shields are available to cover patients and staff

Page: 42 of 45
ESR Standards

Total Standards: 20 | Total Sub-Standards: 145 | Total ESR Standards: 20

needs and are regularly tested according to a


hospital-wide inventory. Also, make sure that
identified defective aprons and shields are not
returned to service.
FMS.9.7 Personal radiation dosimeters (TLD cards) are available, Document Personal radiation dosimeters (TLD cards) are
tested every 3 months, and actions taken when test results Evidence tested quarterly and the results are reviewed by
exceed permissible levels. radiation physicist or radiation safety officer to
ensure staff safety and cumulative results are
interpreted.
Observation Make sure that personal radiation dosimeters
(TLD cards) are available to cover staff needs and
staff are provided with replacement TLDs during
the testing period. Also make sure that all staff
working in radiation areas are wearing TLD cards
during procedures.
The blood bank develops a process to prevent
LB.51
disease transmission by blood/platelet transfusion.
LB.51.1 There are policies and procedures mandating that a Document  Review randomly-selected records to
sample of blood obtained from the donor during blood/ Evidence confirm the laboratory compliance with
blood component collection is subjected to the following TTDT policy.
infectious diseases testing:  If a hospital does not have donation
LB.51.1.1 HBsAg. service, written agreement is needed
LB.51.1.2 Anti-HBc. (review standard's intent to understand
LB.51.1.3 Anti-HCV. agreement requirements)
LB.51.1.4 Anti-HIV-1/2.
LB.51.1.5 Anti-HTLV-I/II.
LB.51.1.6 HIV-1 RNA.
LB.51.1.7 HCV RNA.
LB.51.1.8 HBV DNA.

Page: 43 of 45
ESR Standards

Total Standards: 20 | Total Sub-Standards: 145 | Total ESR Standards: 20

LB.51.1.9 Serological test for syphilis.


LB.51.1.10 Other additional or supplemental tests
as mandated by relevant health authorities.
 Document  Review the laboratory policies and
Review procedures on Transfusion Transmitted
Disease Testing (TTDT) of donor
specimen to confirm its comprehensive
cover of the requirement.
 If a hospital does not have donation
service, written agreement is needed
(review standard's intent to understand
agreement requirements)

 Observation  Observe TTDT process to confirm


compliance.
 If a hospital does not have donation
service, written agreement is needed
(review standard's intent to understand
agreement requirements)

 Staff  Interview personnel to assess their


Interview competence with TTDT procedures.
 If a hospital does not have donation
service, written agreement is needed
(review standard's intent to understand
agreement requirements)

LB.51.2 The blood bank has a process to limit and detect bacterial Document  Review randomly-selected records of
contamination in platelet components. The process: Evidence platelets units to confirm the laboratory

Page: 44 of 45
ESR Standards

Total Standards: 20 | Total Sub-Standards: 145 | Total ESR Standards: 20

LB.51.2.1 Describes the blood bank approach to compliance with bacterial detection
limit bacterial contamination and the policy.
investigations of positive cases.  Review the validation documents of the
LB.51.2.2 Ensures the employed detection employed bacterial detection method to
method is sensitive enough to detect significant confirm that the employed method is
bacterial contamination. sensitivity in detecting significant
bacterial contamination.

 Document Review the laboratory policies and procedures on


Review limiting and detecting bacterial contamination in
bacterial contamination.
Observation 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.
Staff Interview personnel to assess their competence
Interview with bacterial contamination prevention and
detection procedures.

Page: 45 of 45

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