Surgery SOP

Delhi State Health Mission, Department of Health & Family Welfare, GNCTD Page 1
SOP for Surgery Department, Ist Edition: August; 2016

Quality Assurance Cell
Delhi State Health Mission
Department of Health and Family Welfare
Government of NCT of Delhi
Compilation facilitated by : State QA Cell (Nodal Officer: Dr. Monika Rana , Consultant :
Ramesh Pandey , Communitization Officer : Arvind Mishra , Statistical Officer : Shahadat
Hussain ), ARC ( Maneesh and Md. Irshad Ansari).
Designed and Formatted by: Graphic Designer : Mansi Rana
This document has been prepared by the Expert Committee comprising of:
Sr.
Name Designation
No.
Director Professor, Surgery, UCMS &
1. Dr Vivek Agrawal Chairperson
Guru Teg Bahadur Hospital
Professor (Anaesthesia), UCMS & Guru

2. Dr Ashok Kumar Saxena, Member
Teg Bahadur Hospital
Specialist (Anaesthesia), MAMC & Lok

3. Dr Gunjan Member
Nayak Hospital
Specialist (Surgery), Sanjay Gandhi

4. Dr Kartik Saxena, Member
Memorial Hospital
Specialist (ENT) Acharya Bhikshu Govt.

5. Dr Rajiv Dhawan Member
Hospital
Assistant Professor (Surgery), MAMC &

6. Dr Lovenish Kumar Member
Lok Nayak Hospital
Associate Professor (Anaesthesia),

7. Dr Geetanjli Chilkoti Member
UCMS & Guru Teg Bahadur Hospital
Assistant Professor (Pediatric Surgery),

8. Dr Sujoy Neogi Member
Chacha Nehru Bal Chikitsalaya
Assistant Professor(Surgery), Dr. Baba
9. Dr Ashesh Kumar Jha Saheb Ambedkar Medical College & Member
Hospital
Spl. Orthopedics, Jag Parvesh Chandra
10. Dr Binod Kalita Member
Hospital
Specialist, Anaesthesia, Chacha Nehru

11. Dr. Sapna Bathla Member
Bal Chikitsalaya
The SOPs have been prepared by a Committee of Experts and are being circulated for customization and
adoption by all hospitals. These are by no means exhaustive or prescriptive. An effort has been made to
document all dimensions / working aspects of common processes / procedures being implemented in
provision of healthcare in different departments. This document pertains to Department of Surgery. The
individual hospital departments may customize / adapt / adopt the SOPs relevant to their settings and
resources. The customized final SOPs prepared by the respective Departments must be approved by the
Medical Director / Medical Superintendent and issued by the Head of the concerned department. HOD
shall ensure that all stakeholders are trained and familiarized with the SOPs and the existing relevant
technical guidelines / STGs / Manuals mentioned in the SOPs are made available to the stakeholders.
DETAILS OF THE DOCUMENT
-------------------------HOSPITAL
Address:
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Document Name :
Document No. :
No. of Pages :
Date Created :
Designation :
Name :
Prepared By :
Signature :
Designation :
Approved By : Name :
Signature :
Designation :
Responsibility of Updating : Name :

Signature :
INDEX
S. No. Title Pages

1 Surgery Outdoor Patient Department 8-12
2 Surgery Inpatient Department 13-20
3 Pre-Anaesthesia Check up (PAC) 21-26
4 Policy on consent 27-33
5 Operation Theatre 34-39
6 Post Anaesthesia Care Unit (PACU) 40-46
7
Post Operative Recovery Ward 47-49
8 Paediatric Anaesthesia 50-61
9 Central Sterile Services Department (CSSD) 62-178
AMENDMENT SHEET
S.No. Page Date of Details of the amendment Reasons Signature of Signature
no. amendment the of the
reviewing approval
authority authority
CONTROL OF THE DOCUMENT
The holder of the copy of this manual is responsible for maintaining it in good and safe condition
and in a readily identifiable and retrievable form.
The holder of the copy of this manual shall maintain it in current status by inserting latest
amendments as and when the amended versions are received.
The Manual is reviewed atleast once a year (or in between SOS if so required) and is updated as
relevant to the Hospital policies and procedures.
The Authority over control of this manual is as follow:
Prepared By Approved By Issued By
Quality – Nodal Officer
Name: Medical Superintendent
Designation : HOD /Dept. In charge Name: Name:
Signature: Signature: Signature:
The Original Procedure Manual with Signatures on the Title page is considered as ”Master Copy”,
and the photocopies of the master copy for the distribution are considered as “Controlled Copy”.
Distribution List of the Manual
Sr. No. Officials Signature of Officials receiving copy
Surgery Outdoor Patient Department GNCTD/ …………………./SOP/SUR/04
1- SURGERY OUTDOOR PATIENT DEPARTMENT
1.1 Purpose
To facilitate smooth and efficient transit of patients from the registration counter of OPD to their
respective destinations:
1. Entry to the hospital
2. Referral to emergency
3. Admitted to ward
4. Exit from the hospital
1.2 Scope
The SOP applies to OPD
1.3 Responsibility
Described in procedure at different levels
1.4 Procedure
Sr No. Activity Responsibility Reference
1.4.1 Identification of OPD & registration
a).Patient reaches the registration counter Estate manager

guided by various signages mounted at
different places of the hospital for easy
identification of route to the OPD
b).A ‘help desk’ manned by hospital staff Staff nurse

to guide them to the registration counters
would be available
c).All OPDs should display the services

which are provided and significant
services which are not provided.
1.4.2 Registration
a).At the registration counter there are Designated OPD

easy to read displays in all common supervisor / Estate
languages. manager
 New registrations
 Old registrations
 Senior citizens counters
 Ladies counters
 Staff counters
b).At each counter there will be computer Computer assistants/

literate staff who has been also trained on Staff nurse
screening patients based on their
complaints and other referral slips. The
staff should be periodically trained /
oriented to the methods of screening.
c).Timings of the functioning of the

registration counter should be clearly
displayed. It should be preferably till noon.
d).There should be security personnel

deployed at each counter to manage the
crowd and facilitate the smooth
movement of the line.
1.4.3 Registration
a).Patient will be given a Unique hospital Computer assistants/

Id. Used for various laboratory Staff nurse
investigations and radiological tests.
Computerized registration is preferable.
1.4.4 Documentation of vitals
a).From registration counters patients can Staff nurse

proceed to respective OPD for recording
of their weight, height, BP, Pulse. Use of
digital monitors would be preferred.
1.4.5 Doctor consultation
a).The patient reaches the respective Designated OPD

rooms clearly mentioned on the OPD slips supervisor / Estate
and also displayed on boards in the manager
registration counters
b).The slip is received by the hospital staff,

Staff nurse / nursing
who would enter the details on the OPD
orderly
computer/register (for census record) and
also provides a token number to the (Female staff is must)
patient. The staff will segregate the
patients to different OPD rooms
c).The patient is then asked to wait at the

waiting hall which has good ventilation / is PWD / Group D worker
well illuminated / is hygienic and clean .
The waiting hall should preferably have
television / posters containing health Designated OPD
advices for keeping the patient supervisor / Estate

entertained while waiting. manager
d).Each OPD room should have a display

screen for token numbers and alarm
1.4.6 a).After the patient receives the call on the Head of Dept
display board, he/she enters the OPD
/ Doctor
room where he will be evaluated by the
doctor. All female patients should be
examined in presence of a female hospital
employee.
b).There should be a curtain to ensure

privacy of the patient.
c).OPD should have basic diagnostic

instruments.
d).All OPDs should be under supervision of

the doctor with atleast a minimum degree
in the specialty.
e).All rooms of the OPD must be functional

during OPD hours.
1.4.7 a).All prescriptions should be written in the Head of Department /

generic form and the medicines should be
Doctor
available in the hospital pharmacy
b).All laboratory / imaging tests should be

written in the OPD slip for which additional
forms need not be given.
c).Interdepartmental referrals if needed

should be mentioned in the OPD slip. No
fresh slip for the referral department to be
made for that day.
d).All OPD slips should be signed followed

by the name of the doctor/ Stamp of the
doctor.
e).Patients should be sent back to the staff

nurse present in the room for explaining
the future course of action. Staff nurse
1.4.8 a).Patients who are treated on outdoor Security staff

basis need to go to the pharmacy and
maintain a queue.
b).Security personnel also required to

facilitate the queue Pharmacist
c).Pharmacist will dispense the medicines
as per the prescription and also maintain a
record of the same. He would need
assistance of a nursing orderly.
d).The pharmacist should clearly explain

the dose and frequency in which the drug
needs to be taken.
1.4.9 a).Patients who have been advised

admission should go to the designated
counter for completing the formalities of
admission as laid down in the SOP of
Indoor patients.
1.4.10 Investigations
a).Patients who have been advised Nursing staff / nursing

investigations go to the respective rooms / orderly
counters where SOP for the respective
department will be applicable.
b).Reports should be ideally dispatched on

internet which can be retrieved online or
should be provided to the patient at the
time of re-registration at the counter
during their visit on their respective days.
1.4.11 Minor OT
a).Patients who have been referred to Designated OPD

minor OT should go to the respective supervisor/ Estate
room. Proper signage are in place to help manager
identify.
b).Nursing staff should receive the patient

and make necessary entries. Patients who
are to be given dates , should be provided Nursing staff / dresser
a date for the procedure and explained the
procedure to be followed on that day.
c).All scheduled patients will come directly

to the minor OT as per the instructions Nurse / NO on duty
given earlier . Token number to be given to
the patients . She/ he should be explained
the procedure.
d).When the turn of the patient comes, the

doctor should take the informed consent.
After receiving consent patient undergoes
the procedure. Doctor on Duty
e).Minor OT should have proper
illumination and adequately equipped.
f).There should be a separate minor OT for

carrying out the procedure which comes PWD
under the National Programs like -- NSV.
g).All minor OTs should have a recovery Head of Department

area.
1.4.12 Patient Feed back Designated OPD

Supervisor / Estate
a).Before exiting the patient must be
Manager.
provided a feedback form and a box
where the filled form can be dropped.
b).Patient must be advised regarding their Nurse

next visit and the days which are assigned
to him.
Surgery Inpatient Department GNCTD/ …………………./SOP/SUR/04
2- SURGERY INPATIENT DEPARTMENT (IPD)

2.1. Purpose: a). Transit of patients from the admission counter to the respective wards
b). Consent of the Patients to undergo treatment for recovery
c). Indoor Management of the patient as per the the guidelines pertaining to the ward.
2.2. Scope: The scope applies to IPD
2.3. Responsibility: Described in the procedures at different levels.
2.4. Procedure: As follows
Sr. Activity/ Description Responsibility Ref.Doc./

No. Record
2.4.1 ADMISSION
a) After having being directed to be admitted, the patient shall Counter

visit the hospital admission counter which is situated near the Assistant
reception area, emergency area, OPD service counter area
which is clearly displayed.
Registration
b) Patient gets the requisite admission documents for the
Staff
respective ward area where he or she has been admitted. The
directions are clearly explained or the coloured floor marking
strips painted – that will serve as a guide to the desired
admission zone.
Registration
c) The respective area is clearly highlighted and the patient gets Staff
directed to Help Desk or the Nurse Station in the ward. Here
Sister Incharge
“NEW ADMISSIONS” could be displayed. Other areas of the
of the Ward.
ward are also clearly indicated viz. toilets, pantry with fridge
& heater or microwave, duty rooms, store rooms, dressing
rooms, drug stores, soiled linen segregation area, Nurses bay
with the refrigerator for drugs and other essentials, etc.
d) The duty nurse makes the entry of the admission in the

admission register. The nurse explains about the preliminary Staff Nurse
requisites of the ward – sort of orientation, eg. Restriction of

visitors and their unnecessary movement, disposal of waste
Doctor on duty /
in the proper bags, Visitor timings, follow simple civilized
traits, no consumption of alcohol, tobacco, socializing staff nurse

activities in the hospital premises, look after all the amenities
provided by the ward/hospital as their own, etc. These
instructions can be displayed in the ward.
e) Explain paper work formalities, consent, signatures,

preparation of the case record, bed allocation, etc
2.4.2. ADMISSION, SHIFTING, REFERRALS
a) Inform the doctor of the arrival of the patient and place it in Concerned
record - the date and time of information that was sent. Doctor not
below the rank
b) The doctor shall call on the patient and document the history,
of Sr. Resident
examination and make a provisional diagnosis and outline the
scheme of management. The nurse shall then take custody of
the care record file and carry out the treatment instructions.
Staff nurse
c) The nurse will also prepare to send the investigations that are
ordered by the doctor. The doctor and the nurse shall work
on this in close association so as to execute the work up of
the patient at the fastest pace. Doctor on duty
d) The appointments referrals from other departments are filled

in the proper forms by the doctor and the date and time
Staff nurse
fixed. The nurse will depute the ward Nursing orderlies or
multipurpose workers (MPW) to run errands to the
departments for collecting dates and appointments.
e) Explain to the patient where he is to go and for what

Staff nurse
purpose. Briefly explain what he expects there so that his or
her apprehensions are minimized. Staff
nurse/Doctor on
f) The NO or the MPW shall shift patients on a wheel chair or
duty
trolleys at the preset time and the nurse shall hand over the
case record with proper documentation for further patient
movement monitoring.
g) Inform the doctor from whom the referral is to be sought and

hand over the referral request and the case record for
Staff
evaluation and documentation. In case there is need, the
nurse/Doctor on
doctor incharge of the case may accompany or reach the
duty
referred department for discussion. The patient may be left if

the procedure is going to take some time and the NO or MPW
can return later to pick up the patient.
h) After the procedure the patient is brought back to the

primary ward or taken wherever the doctor has suggested –
with proper records and documentation of sequence of
events. The parent ward nurse must be kept informed of the
movement of the patient or requested to send the NO or
MPW to get the patient back.
2 .4.3 INVESTIGATIONS AND REPORT COLLECTION
a) The investigation forms must be properly filled with proper

identification. The samples once collected must be properly
Staff Nurse
labeled and matched with the form details. The data entered
in the proper register and sent through the NO or MPW to
the laboratory or department , where it is authentically
accepted and movement register is signed clearly with the
receiver’s name.
Staff Nurse
b) The reports will be sent back in the same fashion to the
parent ward where these shall be received by the duty nurse
and cross checked with the sending request register so that
the samples sent and sample reports received are cross
matched. Non receipt of report can then be checked for the
delay. Staff Nurse
c) Nurse shall attach the reports with the case records and
inform the doctor on duty.
2.4.4 PATIENT PROCEDURE
a) Inform the patient about the interventional /surgical Staff Nurse

procedure that is planned
b) Informed consent to be taken by the nurse or the doctor on

Treating
duty
physician
c) Pre operative orders to be prescribed and written by the
doctor, which shall include the orders detailed by other
departments especially anaesthesia (in their PAC papers or
case record)
d) All orders to be carried out by the nurse with the help of the Staff Nurse
NO or MPW (preferably females to work for female patients
or any female to be in attendance when the male workers are
on the job). Drugs, test dosing, must be properly
authenticated by the person who is executing, with the name
legibly readable. Identify by placing the ID band on the
patient’s wrist.
e) Personal belonging are to be handed over to the relatives

with proper record and documentation of the items removed Staff Nurse / NO
from the patient and handed over to which relative.
f) Shift the ID patient on the trolley to the respective operation

theatre or department with case record, material for the
procedure, with strict documentation of the movement. The
receiving nurse shall document the receipt of patient and all
the belongings sent by the nurse of the primary ward.
2.4.5 BLOOD TRANSFUSION PROCEDURE Doctor on duty
This is to be followed as per the prescribed practice of the

Blood Bank Services of the Hospital.
a) Blood transfusion consent form to be filled and signed by the

patient after explaining the need for transfusing blood.
b) Donor or replacement donor to be arranged and sent to the

blood bank for donation. Self donation can also be promoted
in case of routine procedures.
c) Blood grouping and cross matching form to be filled by the

doctor and sent under documentation from the ward
through the NO or MPW to the blood bank along with the
blood sample of the patient to whom the blood is proposed
to be transfused.
d) Ask the blood bank, if the blood has been arranged – in an

hour to 2 hr. time.
e) Send in the requisition slip for the release of the blood; which
must be transported responsibly in a container at precise

temperature through the hospital worker (NO or MPW). The
time of exit from the blood bank must be documented and
the time received in the ward along with the papers is
documented.
f) The doctor is informed and who cross checks the sent blood
and authenticates in the case record that the particular batch
number belongs to the same patient.
g) Since blood is usually not accepted back by the Blood bank

after its release ( if delay is > 1/2 hours), the transfusion must
start immediately ( if kept then blood may get spoilt)
h) Blood warmer, transfusion set, consent form reverification to

be done by the doctor. Blood transfusion notes to be entered
by the doctor. Any reactions and complications documented.
2.4.6 MAINTENANCE OF RIGHTS AND DIGNITY
a) Isolate patients of open tuberculosis for a period of 3 weeks Doctor/Staff

after initiation of treatment nurse
b) Case records to be kept in strict custody of the sister incharge Staff nurse
or staff nurse of the ward
c) Do not display or allow scrutiny of the sensitive documents

Staff nurse
pertaining to the patient. The person must take proper
consent from the doctor I/C and provide his / her identity for
this purpose
d) Constant reinforcement and repeatedly telling the co workers Staff nurse

about human dignity and values in respect to fellow humans.
The patients are dependant and need assistance and we must
learn to respect their privacy and help them in humane Staff nurse/NO
manner.
Doctor/Staff
nurse/NO
e) Provide privacy through curtains and screens
Staff nurse
f) Learn proper hand washing techniques and use rapid hand
cleansers
g) Practice barrier nursing to patient with HIV, Hepatitis B,
immune-compromised
2.4.7 CONSENT
As per the Informed consent methods.
a) General consent to be signed on the admit card for Doctor

agreeability of admission, to follow norms of any civilized
society, not indulge in alcoholism, smoking, drug abuse,
socially unacceptable activities, etc
b) Explain to the patient and relatives of the procedure.
2.4.8 COUNSELLING AT THE TIME OF DISCHARGE
a) Preferably the decision of discharge is to be made in the Doctor

morning round and the discharge slips are to be made in the
morning itself. There must be prior information to patient
and relatives. Check out time can be 3 p.m. (where payments
are involved). Staff Nurse
b) Discharge slip copy must be attached to the care record. Give Staff Nurse
photocopies of all documents when asked for.
c) Nurse must enter the data in the discharge register and get
Staff Nurse
signatures of the patient or relative on it.
d) Check all the ward belongings are received back and

document this in the discharge register. Staff Nurse
e) All instructions as noted in the discharge slip are reiterated by

the nurse and the time and date of next follow up is clearly
Doctor/ Staff
announced.
Nurse
f) In case of transfer to other hospital, a proper transfer
summary must be prepared and sent along with essential
investigations. A proper record of this is made in the case
record.
2.4.9 ENVIRONMENTAL CLEANING AND PROCESSING OF EQUIPMENT
a) All equipment necessary for the purpose of house keeping Sister in charge
and cleaning is to be indented from the hospital stores on
weekly / fortnightly basis.
Staff Nurse/NO
b) Free placement of hand sanitizers and their use. Staff Incharge
c) The staff (safai Karamcharis and NO’s) are clearly told of their Housekeeping staff
areas for cleaning. Area of domain must be clearly defined

and the person appointed must be accountable. A cleaning
schedule is to be made and this is to be practiced
mandatorily. This is to be supervised by the Sister Incharge of
Housekeeping staff
the ward.
Housekeeping staff
d) Toilets to be kept clean and dry all the time. There is a need
to clean them very frequently.
e) Patients bedside and surrounding to be cleaned 8 hourly, at Housekeeping staff
least. Housekeeping staff
f) The corridors and floors to be cleaned at least twice a day Staff Nurse
and whenever soiled.
g) Ceiling and walls, windows to be cleaned monthly

Staff
h) Sterilization of equipment as per the norms for chemical
sterilization.
i) Packing the sets for procedures and sending to CSSD under

documentation. Nurse/MPW
j) Prepare Dressing sets, Aspiration set, Cut Down set, Suturing

tray set, Intercostal tube drainage set, tracheostomy set, etc. MPW
k) Laundry servicing through Dhobhi services. Preferable to do a

prewash in the hospital or ward based fully automatic + 100%
Staff Incharge
dryer machine.
Housekeeping staff
l) If outsourced the liberal use of disinfectant and cleaning
material with dedicated staff who is responsible and realizes Staff
the need for high standards of hygiene. Incharge/Staff
m) Use of self protection by the staff doing the job of cleaning. Nurse
Wearing thick rubber gloves and boots and impervious apron.
n) Learn and practice proper disposal of waste. Point the wrong

doers and rectify by telling them the proper methods.
In case of spill or needle stick injuries or exposure to
contaminated fluid, follow the instructions of hospital

infection control committee guidelines.
2.4.10 BIOMEDICAL WASTE
a) As per the documented guidelines. Display of the posters and
Staff Incharge
placement of bins of appropriate colour codes with
/Staff Nurse
representative bags in many areas.
Staff Incharge
b) Constant vigil and tutoring the staff and the patients and
/Staff Nurse/
relatives / attendants of the proper waste disposal. Sorting at
the site of origin is the best way to segregate. Housekeeping
staff /Staff
c) Disposable use wherever appropriate, especially when
Incharge/Staff
managing the patients who are known to suffer from
Nurse/Doctor
communicable / contagious /transmittable diseases.
Pre-Anaesthesia Check up GNCTD/ …………………./SOP/SUR/04
3-PRE-ANAESTHESIA CHECK UP (PAC)

3.1 Purpose
To facilitate smooth and efficient functioning of the PAC clinic and for managing Pre-Anaesthetic
Check up (PAC) clinic
3.2 Scope
The SOP applies to PAC clinic
3.3 Responsibility
Described in procedure at different levels
3.4 Procedure
Sr. No Procedure Responsibility Reference
3.4.1 PAC must be done in a designated room as OPD

services.
3.4.2 It should start at nine in the morning and registration Anaesthesiologists and
should continue till forenoon. The PAC team should Nurse
consist of a consultant, Senior Residents (SRs), and will
supervise the working of Junior Residents (JRs), staff
nurse, and a non-technical staff.
3.4.3 Following the registration, weight, height and baseline Nurse

vitals including BP, HR and spO2 must be recorded in
the PAC form by a trained nurse staff.
A register recording the details of the patients coming

Non-technical staff
to the PAC and patients for bedside pre-anaesthetic
evaluation must be maintained.
3.4.4 Patients should be allotted a token number and Non-technical Staff

attended serially.
3.4.5 Patients who are sick, senior citizen, differently abled Anaesthesiologists and
etc and on wheel chair or trolley should be given Nurse
preference.
3.4.6 The calls for the bedside PACs for the bed-ridden or sick Anaesthesiologists and
patients should be noted at the registration counter Nurse
itself.
The ASA class under which the patient is accepted

should also be mentioned on the PAC sheet.
3.4.7 All cases must be attended by a senior resident (SR)or Anaesthesiologists

higher grade. Cases attended by the under-graduates
and post-graduates must be in supervision finally
opined by the seniors.
3.4.8 A clear instruction to the patient and the surgical team, Anaesthesiologists
whether the patient is being taken for routine surgery
or for emergency surgery.
3.4.9 The investigation slips for the investigations demanded Anaesthesiologists and
in the PAC must be filled in the PAC clinic by the doctor Nurse
or nurse and laboratory services to honour these and
send reports directly to the PAC.
Patients must be sent back to the parent department to

be listed in the OT list only when the general condition Anaesthesiologist
of the patient is optimized
3.4.10 All female patients must be examined in the presence Anaesthesiologists and
of a female hospital employee. Nurse
3.4.11 High risk patients with co-morbidities must be sent for Anaesthesiologist
a consultant referral 2-3 days prior to the surgery to the
consultant in-charge of the respective OT where the
case will be posted.
It is advisable to have those team posted in PAC who

shall give anaesthesia services to the respective patient
in OT.
3.4.12 All PAC forms must bear clear pre-anaesthetic Anaesthesiologists

instructions including investigations, referrals, fasting
orders, premedication and must be carried out in order
to avoid cancellation on the morning of surgery. It must
be duly filled and signed along with the name and
designation either written or stamped.
3.4.13 It is advisable to avoid follow up or review PAC on the Anaesthesiologists

morning of the surgery, unless it is absolutely essential.
3.4.14 The final decision or pre-anaesthetic orders must be in Anaesthesiologists

concurrence with the senior or PAC consultant in
charge.
3.4.15 Patients scheduled for elective procedures should be Anaesthesiologists and

reviewed on such dates so that the same doctor may Nurse
attend the patient.
3.4.16 Once the PAC clinic is over, the PAC consultant or the Anaesthesiologist (PAC
senior resident along with the PG or non-PG junior consultant and senior
resident must attend the patients for bedside pre- resident, junior resident)
anaesthetic evaluation and consult with the consultant
in-charge. In case of very high risk patients, the PAC
consultant must assess the patient on bedside.
CONSENT FOR ANESTHESIA SERVICES
I, _____________________________________, acknowledge that my doctor has explained to me

that I will have a diagnostic or treatment procedure for which I would be given anaesthesia. Ihave
also been explained the risks of the procedure and anaesthesia. Also, I have been advised of the
alternative treatments, and the expected outcomes.
It has been explained to me that almost all forms of anesthesia involve some risks and no
guarantees or promises can be made concerning the results of my procedure or treatment.
Although rare, unexpected severe complications with anesthesia can occur and include the remote
possibility of infection, bleeding, drug reactions, blood clots, loss of sensation, loss of limb
function, paralysis, stroke, brain damage, heart attack or death.
I understand that above stated risks are common to all forms of anesthesia and that additional
risks for different specific anesthesia techniques have been identified in the table given below and
must be appropriately ticked for the respective patient in consideration for surgery.
It has been explained to me that sometimes a particular anesthesia technique which involves the
use of local anesthetics, with or without sedation, may not succeed completely and therefore
another technique may have to be supplemented including general anaesthesia.
I understand that the type(s) of anesthesia service checked below will be used for my procedure
and that the anesthetic technique to be used is determined by many factors including my physical
condition (ASA grading), the type of procedure my doctor is to do, my doctor’s preference, and my
own preference.
General Anesthesia Expected Result Total unconscious state, possible placement of

a tube into the windpipe
Technique Drug injected into the bloodstream, breathed

into the lungs, or administered by other routes
Risks Mouth or throat pain, hoarseness, injury to

mouth or teeth, awareness under anesthesia,
injury to blood vessels, aspiration, pneumonia
Spinal or Epidural Expected Result Temporary decrease or loss of feeling and/or

Analgesia/ Anesthesia movement to lower part of body
□ With sedation Technique Drug injected through a needle/catheter
placed either directly into the spinal canal
□ Without sedation
immediately outside the spinal canal
Risks Headache, backache, , convulsions, infection,

persistent weakness, numbness, residual pain,
injury to blood vessels, High spinal ,"total
spinal" (Complete paralysis)
Major / Minor Nerve Block Expected Result Temporary loss of feeling and/or movement of
a specific limb or area of the body
□ With sedation
Technique Drug injected near nerves providing loss of
sensation to the area of the operation
Risks Infection, convulsions, weakness, persistent

numbness, residual pain, injury to blood
vessels
Intravenous Regional Expected Result Temporary loss of feeling and/or movement of

Anesthesia a limb
□ With sedation Technique Drug injected into veins of arm or leg while
using a tourniquet
Risks Infection, convulsions, persistent numbness,
residual pain, injury to blood vessels
Expected Result Reduced anxiety and pain, partial or total

Monitored Anesthesia Care amnesia
(with sedation)
Technique Drug injected into the bloodstream, breathed
into the lungs, or administered by other routes
producing a semi-conscious state
Risks An unconscious state, depressed breathing,

injury to blood vessels
Monitored Anesthesia Care Expected Result Measurement of vital signs, availability of

(without sedation) anesthesia provider for further intervention
Technique None
Risks Increased awareness, anxiety and/or

discomfort
I hereby consent to the anesthesia service checked above and authorize that it may be
administered.
I also consent to an alternative type of anesthesia, if necessary, as deemed appropriate by the
Anaesthesiologist.
BLOOD TRANSFUSIONS
The likelihood of needing a blood transfusion for this procedure is:

□ Highly unlikely □ Possible □ Probable
I understand that there are potential risks from blood transfusions, though rare, and that some of
these include transfusion reaction, hepatitis, and AIDS (Acquired Immune Deficiency Syndrome).
Initial in appropriate box:
□ I give consent to receive blood or blood products as deemed essential by the Anaesthesiologist
and doctor to be necessary for my well-being.
□ I give consent to receive blood or blood products only as an emergency life-saving measure.
□ I do not want to receive blood or blood products under any circumstance.
I certify and acknowledge that I have read this form or had it read to me; that I understand the
risks, alternatives and expected results of the anaesthesia service.
PATIENT IDENTIFICATION _______________________ ____________________
Patient’s Signature Date and Time _______________________ ____________________
Substitute’s Signature Relationship to Patient _______________________
____________________
(Witness)
(Doctor/Anaesthesiologist)
Policy on Consent GNCTD/ …………………./SOP/SUR/04
4 - Policy on Consent
For consent to be valid, it must be voluntary and informed and the person consenting must have,
the capacity to make the decision.
A. Elements of Informed Consent: Informed consent is a process in which the physician provides
adequate information to the patient or patient's legal representative for making an informed
decision on the proposed treatment, including medications or procedure.
B. Specifically the physician must disclose, in a reasonable manner, all significant medical
information in a language that the patient and relatives understand and disclose the material
that the physician believes is relevant to making an informed decision by the patient in
deciding whether or not to undergo the procedure or treatment. This information should
include:
1. The nature of patient's condition and reasons why it warrants surgery.
2. Brief description of the proposed treatment, possible treatment alternatives, or decision
about to not to undergo the surgical procedure.
3. The benefits and risks of the proposed procedure.
4. The consequences of no treatment as advocated by physician/surgeon.
5. Expectations during recovery period.
6. If applicable, the possible use in education and/or research of blood or tissue removed
from the patient and is not further needed for medical care.
7. The patient or patient's authorized representative should be given the opportunity to ask
questions and receive additional information as desired by him/her. The patient should
also be advised that it is not possible to predict or guarantee results in accordance to
patients expectations.
8. Name of the surgeon who will perform the requisite procedure
Techniques:
 An informed consent is obtained by the surgeon prior to the procedure. In case of adult
patient, his/her signature or with thumb impression is recorded in the consent form is duly
attested by signature and name of the witness.
 In case of patients aged below 18 years consent is obtained from his/her legal
Parents/Guardian.
 In case of mentally ill or unconscious patients Informed consent of nearest relatives or
guardian (if available) is obtained.
 All the unknown patients are treated as medico-legal cases and all the life saving measures
are undertaken in the best interest of patient. The left thumb impression (LTI) is recorded
in presence of two witnesses; not below the rank of Senior Resident. However, in the mean
time, every effort is made to trace the relatives or guardians of the concerned patient.
 There can not be a single universal Informed consent form for all the surgical procedure, as
the relevant information for different procedure will vary. Hence procedure specific
consent forms are to be generated.
Patient’s rights:
While taking informal consent, it must be understood that the patient’s rights are honoured.
1. Patients are to be given information, in a way that they can understand, to enable them to
exercise their right to make informed decisions about their care.
2. A patient has the right to give or withhold consent prior to examination or treatment.
3. Patients must be allowed to decide whether they agree to the treatment and they have the
right to refuse treatment or withdraw consent at any time.
4. In the case of Minors and incompetent adults, rights regarding informed consent are to be
exercised through their parents or legal representative.
5. Patients are informed of their right to withdraw from the treatment at any stage and one
made to understand also of the consequences (if any) of such withdrawal, whenever
applicable.
Documentation
1. The physician must document in the medical record, on an approved hospital form when
available, a consent for all therapeutic and diagnostic procedures. All disclosures of
significant medical information, including risks involved, would assist a patient in making
an informed decision whether to undergo the proposed treatment or procedure. Such
procedureres should include consent for transfusion of blood and/or blood products.
C. Role of Registered Nursing Staff in the Informed Consent Process

1. The registered nurse should verify with the patient and/or by specific documentation of
informed consent in the medical record that consent has been obtained by the
physician prior to the procedure or treatment.
2. In the event the nurse determines that informed consent has not been obtained or
documented, the nurse will contact the physician who will complete the consent
process, speak with the patient, and/or provide specific documentation of the
informed process which has previously taken place.
Treatments and Procedures where informed consent is necessary:

The patient’s consent must be obtained for treatments and procedures that:
1. Surgical or invasive procedures

2. Involve the use of sedation.
3. Involve the use of anesthesia or narcotic analgesia.
4. Can be reasonably expected to produce significant discomfort to the
patient.
5. Can be reasonably considered to have a significant risk of complication/ morbidity.

6. Require injections of any substance into a joint space or body cavity, including any
nonvascular space.
7. Involve testing for human immunodeficiency virus (HIV)
8. Blood product transfusion
9. Dialysis (haemo or peritoneal dialysis)
10. Genetic testing
11. Induction of essential, though toxic drugs (e.g., cancer chemotherapy, disulfiram,
methadone for narcotic dependence, naltrexone)
12. Admission
13. Research
Brief outline of Consent form:
1. The name(s) of all the practitioner(s) immediately responsible for the performance.
2. A brief description of the recommended treatment or procedure.
3. A statement that relevant aspects of the treatment, or procedure, including indications,
benefits, risks, and alternatives including no treatment have been discussed with the
patient in language that the patient could understand; and he/she authenticates this in
writing.
4. A statement that the patient had an opportunity to ask questions.
5. The written signature of the practitioner writing the note, including the
Practitioner’s legibly written name.
6. Signature/Thumb impression of Patient/Next of Kin/Guardian as applicable and their

names written legibly and duly attested by witness.
7. Date of Consent
Withdrawal of consent by Patient
Patients can change their minds about a decision at any time, as long as they have the capacity to
do so.
Refusal of Treatment by Patient
Patients are entitled to refuse consent to treatment even when doing so may result in permanent
physical injury or death. When the consequences of refusal are grave, it is important that patients
and immediate relatives understand this, and also that, for clinical reasons, refusal may limit
future treatment.
For further information on Statutory Requirements of Consent: Medical Council of India’s Code
of Medical Ethics: may be referred, which is placed at Annexure.
Annexure
Statutory Requirements of Consent: Medical Council of India’s Code of Medical Ethics:
1. Before performing an operation the surgeon/ physician should obtain in writing the
consent from the husband or wife, parent or guardian in the case of minor, or the patient
himself as the case may be.
2. In an operation, which may result in sterility, the consent of both husband and wife is
needed.
3. A registered medical practitioner shall not publish photographs or case reports of his / her
patients without their permission, in any medical or other journal in a manner by which
their identity could be made out. If the identity is not to be disclosed, the consent is not
needed.
4. No act of in-vitro fertilization or artificial insemination shall be undertaken without the
informed consent of the female patient and her spouse as well as the donor. Such consent
shall be obtained in writing only after the patient is provided, at her own level of
comprehension, with sufficient information about the purpose, methods, risks,
inconveniences, disappointments of the procedure and possible risks and hazards.
5. Research: Clinical drug trials or other research involving patients or volunteers as per the
guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind.
Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent
taken from the patient for trial of drug or therapy which is not as per the guidelines shall
also be construed as misconduct.
6. A Physician must attend to her/his pregnant patient in her confinement on terms agreed
upon. If exceptional circumstances prevent the Physician from providing services, another
physician may be sent for. When the delivery is accomplished, the visiting physician is
entitled to his/her professional fees, but he/she must obtain consent from the patient to
leave, when the primary Physician arrives.
7. Obtaining Consent
a. Successful relationship between doctors and patient depends on trust. The Physician
must respect the patients autonomy, their right to decide whether or not to undergo
any medical intervention.
b. Patients must be given sufficient information in a way they can understand to enable
them to exercise their right to make informed decision about their treatment.
c. The Physician must give patients details before he/she decides to consent to an
investigation or a treatment.
d. The Physician must give details of the diagnosis and prognosis of the disease, if left
untreated.
e. The Physician must inform the common and serious side effect for each option
available to the patient. And also of any lifestyle changes which may be caused by or
necessitated by the treatment.
f. The Physician must respond honestly to any question the patient raises. She/He must
answer such question as fully, accurately and objectively as possible.
g. The Physician must not exceed the scope of authority given to you by your patients,
except in an emergency.
h. The Physician must obtain consent from patients before testing for a serious
communicable disease. The information provided, when seeking consent, should be
appropriate to the circumstances and the nature of the conditions being tested for.
Some conditions such as HIV have serious social and financial as well as medical
implications.
i. When investigating / treating a child who cannot give or withhold consent, seek
consent from a person with parental responsibility for the child.
8. With reference to specific practice
a. The Physician may undertake in vitro fertilization and / artificial insemination with the
informed consent of the patient and her spouse in writing. They should be explained, at
their level of comprehension, about the purpose, method inconveniences, rate of
success as well as probable and possible risks.
b. The Physician must follow Guidelines laid down by the Indian Council of Medical
Research for research and therapeutics trials.
c. Special Consent provisions under PNDT Act (Form G)
d. Consent Requirements under MTP Act (Form C)
e. Consent Requirements for HIV investigations
Operation Theatre GNCTD/ …………………./SOP/SUR/04
5 - OPERATION THEATRE
5.1 Purpose: To ensure the optimal preparation of the patient for surgery and safe conduct of
anaesthesia/surgery and optimal recovery in the postoperative period.
5.2 Scope: Preoperative optimization of patient’s condition, transfer from ward to OT, informed
consent, pre-operative preparation and safe administration of anaesthesia, safe conduct of surgical
procedure and evaluation of patients’ general condition following reversal of anaesthesia.
5.3 Responsibility: Described along with the procedure at each step
5.4 Procedure
5.5 PREOPERATIVE PREPARATION
Sr. No Activity Description Responsibility Ref.

Doc./Record
5.5.1 A tentative OT list should be sent to the Nursing In-charge of surgical
department of Anaesthesia, OT and the post- Ward
operative ward.
5.5.2 For patients with co-morbidities, a consultant Consultant Anaesthesiologist

Anaesthesiologist referral must be sent at least 3
days prior to the surgery.
However, keeping in mind that the elective cases
can be deferred till the patients’ general
condition is optimized.
5.5.3 A bedside pre-Anaesthesiologist check-up must Anaesthesiologist (Senior
be done by an Anaesthesiologist a day prior to Resident). Not below the rank
surgery. Any investigation or inter-departmental of senior resident.
referrals or opinions may be sought, if deemed
necessary.
5.5.4 The informed consent shall be taken by the Anaesthesiologist / Surgeon.
operating surgeon and anaesthesiologist in
separate from explaining the consequences of
anaesthesia and surgery, respectively. The
informed consent for surgery may be signed a
day prior; whereas, the consent for anaesthesia
should preferably be signed on the day of
surgery considering the deterioration in case of
any pre-existing ailment, which may be best
evaluated in terms of perioperative risk on the
day of surgery itself. The written, informed
consent must explain both surgical and
anaesthesia risk and should be duly signed by
the patient or his/her immediate relative.
Common complications should also be
mentioned in the informed consent.
The consent should be in form of “Informed

consent” with patient and the relative in
counselling.
In case the patient refuses surgery this should
also be put in writing and should again be
signed by the patient or his/her relatives and
doctor.
5.5.5 The site to be operated should be marked and Ward Nurse
prepared i.e. shaved, nail paints & mehendi to be
removed, jewellery & dentures removed and
handed over to the relatives. The list of the
valuables should be clearly mentioned.
ASA guideline on “Nil per oral” (NPO) must be
followed and documented. *
Patients’ identity and type of surgery must be
marked on the patient.
5.5.6 The patients should be shifted to OT according to Ward Nurse
his/her turn in the OT list.
5.5.7 All pre medications & investigations shall be Ward Nurse
positively done and affirmation must be sent
along with the patients.
5.5.8 The patient shall be dropped from the list if the Surgeon/Anaesthesiologists
pre-anaesthetic order could not be followed e.g.
patient had not received medicines or the
advised investigation has not been done.
Compliance with above will prevent unnecessary
delays, wastage of time and resentment on part
of the patient for having the surgery deferred.
5.5.9 Containers for specimens shall be available with Ward Nurse
patients and shall be properly marked
beforehand showing the name, bed number,
ward and specimen name.
* ASA Protocol for pre-operative NPO status
Types of Food Minimum fasting period

Clear Fluids/Water 2 hours
Pulpy fruit juice/breast milk 4 hours
Infant formula milk 6 hours
Non human milk 6 hours
Light meal 6 hours
Fatty meal 8 hours
5.6 - PATIENT CARE IN THE OPERATION THEATRE (Do not apply to cases under local
anaesthesia)
Sr. NO Activity/ Description Responsibility Ref. Doc/

Record
5.6.1 In the pre-operative room, all patients must be Anaesthesiologist
evaluated again for their readiness for surgery. A
documented policy and procedure shall exist for
administration of anaesthesia. The pre-
anaesthesia assessment results in formulation of
an anaesthesia plan which is documented.
5.6.2 The identification of the patient and the site of Surgeon/Anaesthesiologist
surgery should be confirmed.
Informed consent explaining the risks associated
with the surgical procedure as well as Surgeon/Anaesthesiologist
anaesthesia must be rechecked and reinforced in
high risk patients.
5.6.3 The anaesthesia machine along with the Anaesthesiologist
availability of emergency resuscitation devices,
suction machine, breathing circuits, oxygen
supply, defibrillator and all emergency medicines
should be checked. A qualified anaesthesia
personnel must check the aforementioned items.
Only qualified surgeons are permitted to perform Surgeon
the procedures they are entitled to. Estimated
time for the surgical procedure is to be Surgeon/ Anaesthesiologist
documented.
Surgeons along with the Anaesthesiologist will
also reaffirm the patients’ identity, operation site
and procedure. OT staff nurse
Time of entry and time of exit from the operation
theatre (OT) must be documented. Anaesthesiologist
Nurse shall prepare operation trolley beforehand
All team members should have introduced
themselves to the patient by their names and
their roles.
During anaesthesia, American Society of
Anaesthesiologists (ASA) recommended minimal
mandatory monitoring must be instituted. It
includes continuous ECG, oxygen saturation, end
-tidal CO2 and intermittent NIBP. Temperature
monitoring where needed. Invasive monitoring
like intra-arterial blood pressure and central
venous pressure (CVP) monitoring where deemed
necessary.
5.6.4 Details of Anaesthesia and any adverse event Anaesthesiologist

must be recorded. Patient’s condition following
reversal of anaesthesia and before shifting to
PACU must be documented. Surgeon
In case, the procedure is changed intra-op (and
was not planned or an explicit consent taken for
the same) a fresh consent needs to be taken.
5.6.5 Patients with HIV, Hepatitis B & C, Tetanus, gas, Anaesthesiologist
gangrene, shall be operated according to set Sister in charge OT
protocol as per the local policies and infection
control committee of the hospital.
5.6.6 OT Staff assisting for the surgery must keep a Sister in-charge of OT
count of instruments, sponges and gauzes and
must match with the preoperative count before
closure. Sister in-charge of OT/
She should also give sponges and gauzes and in Surgeon
fixed aliquots. The abdominal sponges must have
a radio opaque line. In case of missed gauze or
sponge, all possible efforts must be maintained
to match the preoperative count and C-arm/X-ray
evaluation must be done before shifting the
patient.
5.6.7 Prior to transfer of the patient to PACU/Post Surgeon/Anaesthesiologist
operative recovery ward, a brief operative note
should be documented on the case file. The note
should provide information about the name of
the surgeons /anaesthesiologists, procedure
performed, salient steps of the procedure or any
key intraoperative observations, post-operative
diagnosis and the status of the patient
immediately before shifting to the recovery area.
It must be signed by the operating surgeon and
concerned anaestheologist.
5.6.8 In addition to the surgical notes, the operating Surgeon/Anaesthesiologists
surgeon must document the post-operative plan
of care e.g. IV fluid therapy, medications
including antibiotics, wound and nursing care etc.
In patients with preoperative co-morbidities,
requiring special postoperative care, this plan
could be written in collaboration with the
anaesthesiologist.
5.6.9 Maintenance of records:

Details of Anaesthesia should be recorded
1. In the PAC chart in the patients’ case sheet. Anaesthesiologist
2. In the Anaesthesia OT register
Details of surgical procedure should be recorded
1. In the patients’ case sheet (details Surgeon
aforementioned)
2. In the Surgery OT register
Details of specimen should also be recorded in a Staff Nurse
separate register
Patient’s condition following reversal of Anaesthesiologist
anaesthesia and before shifting to PACU must be
documented
5.6.10 Surgeons and Anaesthesiologist shall be jointly Surgeon/Anaesthesiologists

satisfied about the recovery of the patient before
shifting to PACU/ICU/ or postoperative ward.
5.6.11 The infection control in OT must comply as per Sister in charge OT

the local policies or Infection control committee
of the hospital.
5.7 - Patient care under short procedures requiring administration of moderate

sedation or monitored anaesthesia care (MAC)
Sr. No Procedure Responsibility Reference

5.7.1 Informed consent for the surgery as well as anaesthesia Anaesthesiologists/
in the form of moderate sedation must be obtained by
surgeon
the surgeon/anaesthesiologist, respectively.
5.7.2 If, parenteral route is used to administer sedation for a Anaesthesiologists/

surgical procedure, this shall be carried out by a trained
surgeon
and competent doctor. Nurse or technician should not
administer sedation here.
5.7.3 The administration / monitoring of sedation and Anaesthesiologists/

performance of surgery must be carried out by different
surgeon
persons. By no mean, patients’ monitoring under
anaesthesia should be compromised.
5.7.4 Intra-procedure monitoring includes at a minimum the Anaesthesiologists/

heart rate, ECG, respiratory rate, blood pressure,
oxygen saturation, and level of sedation. Other surgeon
parameters may be monitored as deemed essential
depending upon the case.
5.7.5 Patients must be shifted from the OT to recovery area Anaesthesiologist/
once the patient is conscious and responding to verbal
surgeon
commands and have stable vitals.
Patient’s vitals after sedation shall be monitored at Doctor/Nurse

regular intervals (as decided by the organisation) till
he/she recovers completely from the sedation.
5.7.6 Equipment and manpower to handle any complication Nurse/Surgeon/

intraoperatively under sedation must be available. It
Anaesthesiologist
includes emergency resuscitation drugs, equipment and
also an anaesthesiologist.
Post Anaesthesia Care Unit (PACU) GNCTD/ …………………./SOP/SUR/04
6 - POST ANAESTHESIA CARE UNIT (PACU)
6.1 PURPOSE
To ensure patient safety in the immediate postoperative period in the Post- Anaesthesia
Surgical Recovery Unit / Post Anaesthesia Care Unit (PACU)
6.5 SCOPE
Transfer of patient from OT to PACU, efficient monitoring and pain management in the
PACU, followed by safe transfer to the postoperative/recovery ward or general ward. In
case of ambulatory surgery, patient may be shifted to the lower level of recovery i.e.
postoperative ward/recovery ward without being shifted to the PACU.
6.3 RESPONSIBILITY
Described along with the procedure at each step
6.4 PROCEDURES
Sr. No Activity Responsibility References
6.4.1 The transfer of patients from the operating theatre to Anaesthesiologist

the PACU
The patient should have patent airway and be
physiologically stable on departure from the OT table
and must be accompanied by the Anaesthesiologist to
the PACU along with the oxygen by face mask.
The extent of mobile monitoring during transfer will Anaesthesiologist

6.4.2 depend upon the proximity of PACU from OT and
patients’ clinical status. If PACU is at a distance, a
minimum of pulse oximetry, ECG and non-invasive
blood pressure monitoring is must.
6.4.3 Supplemental oxygen should be administered to all Anaesthesiologist
patients during transfer from OT table to PACU.
6.4.4 It is essential that the Anaesthesiologist formally hands Anaesthesiologist

over the care of the patient to an appropriately trained
and registered PACU practitioner/nurse/on duty
anaesthesiologist.
6.4.5 The Anaesthesiologist must be satisfied with the Anaesthesiologist
competency of the PACU staff. If this cannot be
assured, the Anaesthesiologist should stay with the
patient in the PACU, until the patients’ condition is
optimized.
6.4.6 A formal handover checklist can improve the safety of Anaesthesiologist
handovers and should be developed for local use. Any
significant intra-operative event must be documented

and should be included in the handover.
6.4.7 Each patient must be observed by a registered PACU Anaesthesiologist

staff or Anaesthesiologist. Intense monitoring needed /surgeon/PACU
till they are awake and able to communicate, and have staff
stable cardiovascular and respiratory systems.
6.4.8 Monitoring, Equipment and Drugs

An appropriate standard of monitoring and clinical PACU
observation should be maintained until the patient is Practitioner/
fully recovered from anaesthesia. Anaesthesiologist
6.4.9 Clinical observation is supplemented with minimal PACU

standards of monitoring i.e. pulse oximetry, non- Practitioner/
invasive blood pressure monitoring, ECG and, if Anaesthesiologist
patients’ tracheas remain intubated or they have an
oropharyngeal /nasal airway or supraglottic or some
other similar airway device in situ, continuous end-tidal
capnography should also be done. However, a nerve
stimulator for assessing neuromuscular blockade, a
thermometer and patient warming devices should be
immediately available. Difficult airway cart should also
be ready all the time.
6.4.10 All lines should be flushed and adequately secured and PACU staff
protected.
6.4.11 Minimum information to be recorded for patients in PACU staff /

the post-anaesthesia care unit include Anaesthesiologist
/ Surgeon
• Level of consciousness
• Patency of the airway
• Respiratory rate and adequacy
• Oxygen saturation
• Oxygen administration
• Non-invasive blood pressure
• Heart rate and rhythm
• Pain intensity on a validated scale e.g. VAS
• Nausea and vomiting
• Intravenous drugs/ fluids
• Core temperature
• Other parameters depending on circumstances, e.g.
urinary output, central venous pressure, end-tidal

capnography , surgical drainage volume etc.
Patients must be kept under clinical observation at all

times, and all parameters should be recorded. The
PACU staff must call the doctor in case of any PACU staff
deterioration in the aforementioned parameters.
6.4.12 The frequency of the aforementioned observations will PACU staff/

depend upon the clinical condition of the patient and surgeon/
the nature of the surgery and clearly documented in Anaesthesiologist
post anesthesia recovery orders.
6.4.13 PACU staff nurse can administer intravenous PACU staff/ *Table 1
analgesics, e.g. paracetamol, non-steroidal anti- Anaesthesiologist Pain
inflammatory drugs (NSAIDs) and opioids prescribed by assessmen
the Anaesthesiologists as part of a specific protocol. t and
scoring
6.4.14 Transfer from the PACU Anaesthesiologist ** Table 2

/surgeon/ PACU Post
Standards for transferring the patients from the PACU
Practitioner Anasthetic
are ultimately established by the department of
Aldrete
Anaesthesiology. Criteria can vary according to
Recovery
whether the patient is going to be discharged to an
Score
intensive care unit (ICU), a regular ward, the recovery
ward (phase 2 recovery), or directly home. PACU will
function only in 2 shifts for routine surgeries for
enabling the last operated patient to satisfactorily
recover from anaesthesia. PACU must be free for the
next day, so as to receive fresh set of patient that are
to be operated on that day.
For all major surgeries, the patients should preferably
be shifted to the postoperative/recovery ward for at
least 24 hours and then to the general ward. The
patients are shifted from the PACU, if they
satisfactorily meet the criteria shown in Table 1 [Post
anesthestic Aldrete recovery score].
Following regional anaesthesia: recovery of
proprioception, sympathetic tone, bladder function
and motor strength should also be assessed.
OUTPATIENTS
In cases of ambulatory or day care procedures, these
patients may be fast-tracked i.e. allowed to safely

bypass phase 1 recovery i.e. PACU and may be directly
shifted to lower level of recovery area (phase 2
recovery). If indicated these patient are kept in PACU
and all PACU principles shall then be undertaken.
6.4.15 If the Aldrete criteria are not met, the patient should PACU staff/ **Table 2
remain in PACU and anaesthesiologist should be Anaesthesiologist
informed and patient is to be transferred to an
appropriate high dependency unit (HDU) or intensive
care unit (ICU).
6.4.16 An Anaesthesiologist must be available in PACU at all Anaesthesiologist

times when a patient is there who has not attained the
stated criteria of recovery.
6.4.17 Patients who have potential airway problems or Anaesthesiologist

complications should be reassessed by the
Anaesthesiologist before being transferred from the
PACU.
6.4.18 If there is any doubt as to whether a patient fulfils the Anaesthesiologist

criteria, or if there has been a problem during the
recovery period, the Anaesthesiologist who
administered anaesthesia or a senior Anaesthesiologist
must assess the patient in the PACU and uniformly
agree and document the transfer from PACU.
6.4.19 The anaesthetic record, together with the prescription PACU staff/
and recovery charts, must accompany the patient and Anaesthesiologist
the details of relevant drugs administered in theatre
and PACU, e.g. analgesics and antibiotics must be
conveyed to the ward staff both verbally and in
written.
6.4.20 Staff from ICU or trained PACU staff to accompany

when patient is being transferred to ICU.
PACU staff/
The handover of equipment accompanying the patient technical staff/
like infusion devices, syringe pumps, mobile monitors MPW
etc. must be done.
6.4.21 The PACU nurse must ensure that full clinical details PACU staff/ ward
are relayed to the ward nurse, with particular emphasis nurse/Anaesthesi
on ongoing problems and the management of infusions ologist
6.4.22 Formal handover checklists can improve the safety of PACU staff/ ward
handovers and should be developed for local use. nurse
6.4.23 Patients’ dignity and privacy should be respected at all PACU

times but patients’ safety must always be the primary staff/surgeon/
concern Anaesthesiologist
6.4.24 Education of PACU staff

Staff must be educated by holding frequent classes and Anaesthesiologis
seminars on the management of postoperative patient ts and surgeons
with special emphasis upon the monitoring, transfer
and pain management and it must be followed by
frequent evaluation of their knowledge and attitude.
Learning Charts:
Various educational learning material including Post
anaesthetic Aldrete scoring system, BLS/ACLS
algorithms and various other educational information PACU staff
relevant in context to management of patient in
postoperative period must be displayed on the boards
inside the PACU and must be revised time to time.
*Table 1. *Pain assessment and scoring

Paediatrics – 0 to 1 year behavioural/facial.
2 to 5 years – facial scale.
6 to 12 years - NRS/VAS
Adult - NRS/VAS – Static and Dynamic scores
**Table 2. Post-anesthetic Aldrete recovery score
Parameter Criteria Point value
SpO2> 92% on room air 2
Oxygenation SpO2> 90% on room air 1
SpO2< 90% on room air 0
Breathes deeply and coughs 2

freely
Respiration
Dyspnoeic, shallow or limited
1
breathing
Apnea
0
Blood pressure ± 20mmHg of 2

normal
Circulation
Blood pressure ± 20-50 mmHg
1
of normal
Blood pressure more than ±

50mmHg of normal
Fully awake 2
Consciousness Arousable on calling 1
Not responsive 0
Moves all extremities 2
Activity Moves two extremities 1
No movement 0
Discharge Criteria - Patient is discharged from the PACU when the total score is 10, but a minimum
of 9 is required.
Reference: Post-anesthesia Care. In: Morgan M, Mikhail M editors. Clinical Anesthesiology. 5th ed. New
York: Mc Graw Hill Education ;2013. pp. 1257-75
Postoperative Recovery Ward GNCTD/ …………………./SOP/SUR/04
7 - POSTOPERATIVE RECOVERY WARD
7.1 Purpose
To ensure patient safety in the postoperative period for around 24 hours
7.2 Scope
Receiving of the patient in the postoperative ward from PACU, where the patients stay for
around 24 hours, kept under monitoring, followed by safe transfer to the general ward.
7.3 Responsibility
Described along with the procedure at each step
7.4 Procedures
Sr. Activity Responsibility Reference
No s
7.4.1 The receiving of the patients from PACU to the Nurse/technical
postoperative ward staff/MPW
Patients who had received anaesthesia are
shifted from the PACU to the postoperative
ward accompanied with a nurse/technical staff.
It is1.essential that the staff formally hands over Anaesthesiologist /
the care of the patient to an appropriately Nurse
7.4.2
trained nurse in the postoperative ward.
The2.postoperative
3 ward must have a surgery Surgery Resident/
resident round the clock along with an Anaesthesiologist
7.4.3
Anaesthesiologist at hand. This area should
preferably be located near the ICU.
Clinical monitoring: All devices including
defibrillator must be available in postoperative
ward including pulse oximetry, non-invasive
blood pressure monitoring, ECG. A thermometer
and patient warming devices should be
immediately available. Intubation kit and
difficult airway cart should also be ready all the Staff Nurse/ Surgery
time. Resident
All vital parameters should be recorded with

special emphasis to postoperative pain.
Adequate measures must be taken to alleviate
the same.
All lines
3. 4 should be flushed and adequately Nurse
7.4.4 secured and protected.
Nurse4. can administer intravenous analgesics, Nurse
7.4.5 e.g. paracetamol, non-steroidal anti-

inflammatory drugs (NSAIDs) and opioids
prescribed by the Anaesthesiologist/surgeon as
part of a specific protocol as per the assessment
of the pain.
7.4.6 Transfer from Postoperative/Recovery ward
After
5. major
5 surgery- Patients are discharged
from the postoperative ward to the general
ward after around 24 hours depending on the
patients’ general condition. Anaesthesiologist/sur
After ambulatory procedures/ Day care surgery geon
In cases of ambulatory or day care procedures,
the patients may be fast tracked i.e. allowed to
safely bypass phase 1 recovery i.e. PACU and
may be directly shifted to lower level of clinical
recovery area (phase 2 recovery) or
postoperative ward.
Recovery from anaesthesia following outpatient
procedures include two additional stages: home
readiness and complete psychomotor recovery.
Postanesthesia Discharge Scoring System
(PADS)*. PADS score can be helpful for decision
making for discharge.
An Anaesthesiologist must take the round for all Anaesthesiologist /
the patients in the postoperative ward and can Surgeon
assist in decision for discharge.
7.4.7
The surgeon must be satisfied about the status
of patient to document transfer to General ward
or to home.
7.4.8 During transfer to the ward, each patient must Staff/MPW
be accompanied by a staff/MPW (excluding the
ones who had received local anaesthesia or
outpatients).
7.4.9 The recovery record, together with the Staff Nurse
prescription and recovery charts, must
accompany the patient and the details of
relevant drugs administered e.g. analgesics and
antibiotics must be conveyed to the ward staff
both verbally and in written. The use of a formal
handover checklists can improve the safety of
handovers and should be developed for local
use.
* Marshal S. Chung F Assessment of home readiness”: discharge criteria and post criteria and post
discharge complication. Curr. Opin. Anaethesiol. 1997:10:45
Postoperative Recovery Ward GNCTD/ …………………./SOP/SUR/04
Discharge Criteria - Patient is discharged after ambulatory surgery when the total PADS
score is ≥ 9
Reference: Post-anesthesia Care. In: Morgan M, Mikhail M editors. Clinical Anesthesiology. 5th ed.
New York: Mc Graw Hill Education ;2013. pp. 1257-7
Paediatric Anaesthesia GNCTD/ …………………./SOP/SUR/04
8 - PAEDIATRIC ANAESTHESIA
The guidelines for Paediatric Anaesthesia are intended to supplement rather than to replace the
standards of ASA for the perioperative care of paediatric patients receiving Anaesthesia
8.1 Purpose: To ensure the optimal preparation, safe conduct of anaesthesia/surgery and
optimal recovery in the postoperative period of the paediatric patient.
8.2 Scope: Preoperative optimization of patient’s condition, transfer from ward to OT, informed
consent, pre-operative preparation and safe administration of anaesthesia, safe conduct of
surgical procedure and evaluation of patients’ general condition following reversal of
anaesthesia.
8.3 Responsibility: Described along with the procedure at each step.
8.4 Procedure
8.5 Procedure for PAC Clinic
Sr. No Activity Description Responsibility Reference /Document
8.5.1 In children with co-morbid illness, Senior resident Reference form

Paediatrician‘s opinion need to be Anaesthesia
sought.
8.5.2 In children with congenital Senior resident PAC review

anomalies / syndromes , other Anaesthesia
congenital anomalies should be
ruled out by Neonatologist before
giving fitness for surgery.
8.5.3 In case of major surgery /neonate Senior resident PAC review

/patient with co morbid illness / Anaesthesia
syndromic child , Consultant’s
opinion should be sought.
8.5.4 Fasting orders to be followed as Senior resident PAC review

per recent guidelines .Annexure Anaesthesia
attached 1
8.6 PROCEDURE FOR PRE-OPERATIVE AREA
S.no Activity Responsibility Reference /Document
8.6.1 Shifting from ward to OT to be done Nurse to accompany

preferably by a trolley with side Nursing orderly
rails /safety belts up to prevent
falls.
8.6.2 A pre-operative checklist has to be Pre-operative staff Checklist

filled nurse
Annexure 2
8.6.3 A pre-operative re-evaluation Senior resident PAC Review form

should be done on the morning of (Anaesthesia)
surgery in the pre –op room
especially in paediatric patients
8.6.4 Children having URI should Anaesthesiologist PAC chart

undergo proper evaluation before
taking a decision to proceed or
cancel the case and blanket
cancellations should be avoided
.Decision for cancellation should be
documented in chart .
8.6.5 Attempts should be made to Anaesthesiologist

reduce anxiety of parents and
family and ensure their child’s
utmost safety as their anxiety is
transferred to the child .
8.6.6 Premedication – Generally Not Senior resident Pre-operative pre-

necessary till 6 months of age. (Anaesthesia) medication notes.
Institutional Premedication policy
to be followed and vital parameters
should be monitored and recorded.
8.7 PROCEDURE FOR OPERATION THEATRE
S.no Activity Responsibility Document
8.7.1 WHO Surgical safety check list is filled WHO Surgical safety
which has 3 components check list
Sign in – Before induction Annexure 3
Anaesthesiologist
Time out – Before incision
surgeon and scrub
nurse
Sign out – Before shifting patient floor nurse
to post op
Completed check-list has to be
signed by Anaesthesiologist , Surgeon
and Floor nurse
8.7.2 Regular clinical privileges can be given Consultant

to the one who is Post graduate in Anaesthesia
Anaesthesia .
Special clinical privileges can be given
to one who has had special experience
of Paediatric Anaesthesia practice for at
least one year.
8.7.3 Special clinical privileges are needed for Consultant

patients who are at increased Anaesthesia
Anaesthesia risk like patients age ,
neonates ,Procedures where PICU /HDU
care requirement is anticipated,
patients having co-existing illnesses and
where there is an indication for invasive
monitoring / invasive procedures are
done , regional nerve blocks in neonates
and infants .
8.7.4 Man power planning in Paediatric OT -

At least two qualified
Anaesthesiologists trained in paediatric
Anaesthesia should be present in each
paediatric OT. Consultant
Anaesthesiologist should preferably
have Neonatal and Paediatric Advanced
Life Support Certification (PALS and
NALS)
8.7.5 Nursing and technical personnel Consultant

involved should also be trained and Anaesthesiologist
experienced in paediatric peri-operative

care by external / in house training.
8.7.6 Clinical laboratory and radiology Medical

services should be available round the superintendent-
clock 24/7 hospital
8.7.7 Paediatric Anaesthesia Equipments Medical

and drugs superintendent-
hospital and HOD
All Anaesthesia equipments applicable
anesthesia
for paediatric patients should be
available, easily accessible and well
maintained. (Annexure 4)
8.7.8 Intra operative monitoring – In addition Consultant

to standard monitoring Anaesthesiologist and
senior Resident
Precordial stethoscope should
(Anaesthesia)
preferably be used in all Paediatric
patients. Continuous HR,SPO2,Etco2,
ECG & temperature should be the basic
monitoring in all paediatric patients.
8.8 POST OPERATIVE ANAESTHESIA / SURGERY RECOVERY UNIT
S.no Activity Responsibility Document
8.8.1 Suction equipment and oxygen outlet along Anaesthesiologist

with appropriate O2 delivery device should
Senior resident
be available at each bed side. Multi para
(Anaesthesia)
monitor and crash cart is mandatory in
Consultant
PACU.
8.8.2 Policy on post operative recovery room stay Consultant

should be well defined. Patients should be Anaesthesiologist
monitored for Heart rate, spO2 ,
&
respiration, Blood pressure(in selected
cases)and pain. Any deviation in vitals( Senior resident
increase or decrease) ,duration of stay (Anaesthesia)
should be well justified accordingly.
8.8.3 All paediatric patients having undergone PACU staff

surgery should have an ideal properly
secured IV canula of appropriate size.
8.8.4 Post operative monitoring - Pain should be Anaesthesiologist Pain Assessment Tools
assessed as “fifth vital sign” (as per WHO and PACU staff (Annexure 5)
guidelines). Multimodal approach for
Pain score sheet
analgesia should be used
a) No individual measure can be broadly
recommended for pain assessment across
all children or all contexts
b) Children self-report of their pain is the
most preferred
c) Children’s pain should be assessed,
documented and appropriate action taken
as this contributes to prevention and relief
of pain
d) Health care professionals and
parents/care givers should receive
information, education and training in pain
assessment
e)Pain Management of postoperative pain
should include both pharmacological and
non-pharmacological strategies where ever
possible
8.8.5 Post operative fluid management should Staff nurse & Reference Miller ‘s
be on 2, 1, 0.5 rule with isotonic fluid . If Senior resident Text Book of
after 12 hrs, patient can not be shifted to (Anaesthesia) Anaesthesia latest Ed
oral ,then hypotonic solution can be given
at 4-2-1rule
8.8.6 Each paediatric patient should be PACU staff.

accompanied with at least one attendant
once patient is stabilised in PACU .
8.8.7 Modified Aldrete score should be used PACU staff and

for readiness for discharge from PACU Anesthesiologist
8.9 PROCEDURE FOR POST OPERATIVE WARD –
S. no Activity Responsibility Document
8.9.1 Pain monitoring should be continued Ward nursing staff Pain score sheet
even in post op period for another
72 hrs
8.9.2 All paediatric patients with epidural Senior resident Continuation sheet
or any other catheter needs to be Anaesthesiology
followed up in the ward .Epidural top
ups to be given with advise of
consultant .A brief note to be put
regarding the same and vitals
monitoring to be done at
appropriate time by
Anaesthesiologist
8.9.3 Epidural Catheter removal should be Senior resident Continuation sheet

done as per the institutional policy Anaesthesiology
and each epidural tip should be
checked for integrity and same
should be documented
ANNEXURES of Chapter 5 & 8 are given below :
Annexure – 1
Fasting Guidelines –
Type Fasting Time(Hrs)
Clear liquid 2
Breast milk 4
Infant formula 6
Solid 8
Clear liquids include – Fluids without pulp

Clear tea or coffee without milk
Clear liquid and plain toast can be allowed upto 6 hours before surgery.
Annexure – 2
PRE OPERATIVE CHECKLIST
1. CHILD IN OT DRESS, PROPER IDENTIFICATION BAND.

2. NAIL POLISH & JEWELLERY REMOVED, LONG HAIR TIED.
3. REMOVE THE PROSTHESIS AND LOOSE TEETH.
4. CONSENT - FOR ANESTHESIA
FOR SURGERY
5. PREPARATION OF PART
6. DRUG SENSITIVITY
7. NIL PER ORALLY
8. ALL THE RELEVANT INVESTIGATION AND SPECIAL REPORT SHOULD ACCOMPANY THE
PATIENT.
9. LABELLING OF INTRAVENOUS CANNULA.
10. BLOOD TO BE ARRANGED.
(SIGN. OF PRE-OPERATIVE ROOM NURSE)
Annexure – 3
SIGN IN FORM
(BEFORE INDUCTION OF ANAESTHESIA)
PT. NAME…………………………….. AGE/SEX……………… C.R. NO…………………..
1) PATIENT CONFIRMED
a) IDENTITY CONFIRMED : YES/NO
b) SURGICAL SITE: RIGHT/LEFT
c) PROCEDURE (FULL NAME) : ………………………..
d) LAST MEAL TIME
2) SITE MARKED
a) YES/NO
b) NOT APPLICABLE
3) ANESTHESIA SAFETY CHECK COMPLETED
a) YES
b) NO
4) ANESTHESIA EQUIPMENTS/PULSE OXIMETER FUNCTIONING
a) YES
b) NO
5) KNOWN ALLERGY
a) YES
b) NO
6) DIFFICULT AIRWAY/ASPIRATION RISK
a) NO
b) YES, EQUIPMENT & ASSISTANCE AVAILABLE / NOT AVAILABLE
7) RISK OF BLOOD LOSS>10% OF BLOOD VOLUME (APPROXIMATE 8 ml/KG)
a) NO
b) YES, ADEQUATE INTRAVERNOUS ACCESS & FLUID PLANNED/NOT
8) SURGICAL INSTRUMENTS/IMPLANTS READY
a) YES
b) NO
SIGNATURE OF ANESTHETIST……………………
NAME OF ANESTHETIST…………………………..
DATE & TIME………………………………………..
ANESTHETIZING TIME / TIME READY FOR INCISION
(BEFORE SKIN INCISION)
PT.NAME:……………...........AGE/SEX:……/…...C.R.NO…….........DATE:………......….
9) CONFIRM ALL TEAM MEMBERS BY NAME AND ROLE

a) YES
b) NO
10) SURGEON ,ANESTHETIST, NURSE & TECHNICIAN CONFIRM

a) RIGHT PATIENT
b) RIGHT SITE
c) RIGHT PROCEDURE
11) ANTIBIOTIC PROPHYLLAXIS HAS BEEN GIVEN WITHIN LAST 60 MINUTES

a) YES
b) NOT APPLICABLE
12) ANTICIPATED CRITICAL EEVNT

a) SURGEON REVIEW
b) ANESTHESIA TEAM REVIEW
c) NURSING TEAM REVIEWS : STRICTLY CONFIRM / NOT
13) ESSENTIAL IMAGING DISPLAYED

a) YES
b) NOT APPLICABLE
(SIGN. OF ANESTHETIST) (SIGN. OF SURGEON) (SIGN. OF FLOOR NURSE)
(TIME OUT……)
1) PATIENT NAME & PROCEDURE RECORDED

a) YES
b) NO
2) INSTRUMENTS, SPONGES & GAUZE PIECES & NEEDLE COUNT

a. CORRECT & COMPLETE
b. NO, SPECIFY……………………….
3) SPECIMEN LABEELED
a. YES
b. NO
4) WHETHER THERE ARE ANY EQUIPMENT PROBLEM TO BE ADDRESSED

a) NO
b) YES, SPECIFY………………………………..
(SIGN. OF SURGEON) (SIGN. OF SCRUB NURSE)

SURGEON NAME……………………. S/N NAME……………………….
DATE & TIME………………………... DATE & TIME…………………...
ANNEXURE- 4
Paediatric Anaesthesia Equipments and drugs
a) Anaesthesia work station with Paediatric ventilator and other related allied equipments.
b) Resuscitation cart and defibrillator with paediatric paddles.
c) Resuscitation cardiac drugs should be available in paediatric formulations.
d) A written paediatric dose schedule should be immediately available.
e) Airway equipment and difficult airway cart
f) Devices for maintenance of normothermia
g) Intravenous fluid administration equipment No individual measure can be broadly
recommended for pain
ANNEXURE -5
Post operative pain assessment tools-
• Wong and Baker FACES Pain Scale (Wong and Baker 1988): valid for 3-18 year olds.
• Faces Pain Scale-Revised (Hicks et al. 2001); see also (Goodenough et al. 1997; Hunter et
al. 2000): valid for 4-12 year olds.
• Visual analogue¦ and numerical rating scales (VAS Score ): valid for 8 years plus
• CRIES (Krechel and Bildner 1995) see also (McNair et al. 2004-for neonates
 Revised FLACC Scale ;Specially appropriate for cognitively impaired
FACES Score – It comprises of a series of diagrams of faces with expressions of increasing distress
with smiling or neutral faces representing “no pain “on one end of the scale.
VISUAL ANALOGUE SCALE (VAS )-It is a numerical rating scale from 0-10
0- No pain , 10- worst pain
CRIES Neonatal Pain Assessment Scale
SCORE
Indicators 0 1 2
Crying No High pitch but consolable Inconsolable
Required oxygen for sat No Fio2 <30% Fio2 >30%
>95%
Increased Vital Signs No HR or BP increased <20% HR or BP increased
<20%
Expression No Grimace Grimace & grunt
Sleepless No Wakes often Constantly awake
Score <4: Initiate nonpharmacologiical measures.
Score >4: Initiate pharmacologic and nonpharmacologic measures.
Minimum score -0 , Maximum score -10, Satisfactory -less than or equal to 5
Revised FLACC for Pain Assessment in the Cognitively Impaired
Indicators 0 1 2
Face No particular Occasional grimace /Frown; Consistent grimace or frown

expression or withdrawn or :frequent /constant quivering
smile disinterested(appears sad or chin, clenched jaw (distressed-
worried) looking face: expression of fright
or panic)
Legs Uneasy ,restless, Kicking ,or legs drawn up
Normal position tense(occasional tremors) (marked increase in spasticity,
or relaxed constant tremors or jerking)
Activity Squirming shifting back and Arched, rigid or jerking(severe
Lying quietly forth, tense (mildly agitated agitation, head banging;
normal position (e.g. head back and forth shivering(not rigors);breath-
,moves easily ,aggression);shallow, holding, gasping or sharp intake
splinting respirations, of breath; severe splinting)
intermittent sighs)
Cry No cry (awake or Moan or whimpers, Crying steady ,screams or sobs,
asleep) occasional frequent complaints(repeated
complaint(occasional verbal outbursts, constant grunting)
outburst or grunt)
Consolability Content ,relaxed Reassured by occasional Difficult to console or comfort
touching, hugging or talking: (pushing away caregiver, resting
distractible care or comfort measures)
0=Relaxed /comfortable;1-3=mild discomfort;4-6moderate pain;7-10=severe pain
Central Sterile Service Department (CSSD) GNCTD/ …………………./SOP/SUR/04
9 - CENTRAL STERILE SERVICES DEPARTMENT (CSSD)
CSSD
Service Name :
SOP
Date Created :
Medical Superintendent/Medical Director

Approved By : Name :
Signature :
Incharge CSSD
Reviewed By : Name :
Signature :
Medical Superintendent/ Medical Director

Issued By : Name :
Signature :
MO I/C Incharge CSSD

Name :
Responsibility of Updating :
Signature :
9.1 - Structure and Organization of CSSD
9.1.1 Purpose: The purpose of the Central Sterile Services Department is to prepare reliable and
certified sterilized items available at the required time and place for any agreed purpose in
the Hospital as economically as possible, having regard to the need to conserve the time of
users.
9.1.2 Objectives: To provide sterilized material from a central department where sterilizing
practice is conducted under conditions, which are controlled, thereby contributing to a
reduction in the incidence of hospital infection.
To avoid duplication of costly equipment’s, which may be infrequently used.

To maintain record of effectiveness of cleaning, disinfection and sterilization process.
To monitor and enforce controls necessary to prevent cross infection according to infection
control policy.
To maintain an inventory of supplies and equipment.
To stay updated regarding developments in the field in the interest of efficiency, economy,
accuracy and provision of better patient care.
To provide a safe environment for the patients and staff.
9.1.3 Scope: It is a centralized department catering to the sterilization need of the entire hospital.
9.1.4 Procedure: as follows:
9.1.4.1 Policy: CSSD Incharge, Chief CSSD

Technician
A. CSSD Area classification (zoning of CSSD)
a. General Considerations
 CSSD shall maintain uni-directional
flow of the items processed. Criss-
crossing of item must be avoided to
reduce accidental mixing of sterile
and non-sterile items.
 CSSD preferably be located in the
operation theatre complex or in
immediate vicinity of operation
theatre.
 CSSD has been divided into 3 zones.
There should not be cris-crossing of
processes within CSSD. The three
zones are:
• Protective zone
• Clean zone
• Sterile zone
b. Protective Zone includes:-
 Receiving Window (double door

window to contain contamination).
 Cleaning Area
 Decontamination Area
 Drying Area
 Assembling and Packaging Area
c. Clean Zone includes:-

 Autoclaving Area/ ETO /Gas plasma
Area
d. Sterile Zone includes:-

 Sterile storage room
 Issuing window.
 In addition to the zoning areas listed

above, CSSD must have provision of
Office area (for record keeping, file
upkeep etc), changing rooms (if not
centralized), lockers room, and store
room (to maintain inventory of
instruments, disinfectants and
consumables).
B. Reception CSSD Technician/assistant
 The reception deals with the receiving
of unsterile supplies and issuance of
sterile supplies. It contains rooms for
the CSSD workers to change and
proceed to working area. No
unauthorized person is allowed
beyond the reception area.
C. Decontamination area CSSD Technician/assistant
 In the decontamination area, all
reusable contaminated supplies are
sorted and decontaminated.
 The CSSD workers in the
decontamination area should wear
household-cleaning- type rubber or
plastic gloves when handling
contaminated instruments and items.
 Face mask, eye protection such as eye
shields/goggles, appropriate gowns
should be worn when exposure to
blood or body fluid may occur.
 Sharps should never be retrieved from
trays with gloved hands. Forceps may
be used for this purpose.
 At least six air changes per hour and a
negative pressure is recommended in

the decontamination area.
 The ceilings and walls should be
constructed of a non-shedding material
and the floors should be able to
withstand the chemicals and
disinfectants used in cleaning.
 Daily cleaning and maintenance of the
facility is needed.
 The instruments may be manually
cleaned (scrubbed using detergents
and appropriate brushes) or cleaned
using automated washers or
disinfectors.
 All instruments with dried secretions
should be first soaked in detergent
water to loosen up the debris. Ensure
the instrument is free of any debris or
proteinaceous deposits as this affects
the efficiency of the sterilization
process.
 After washing, each device should be
inspected for cleanliness, functionality,
breakage or defects and then
appropriately assembled.
 All items should be properly dried after
washing should be properly dried and
moisture-free as moisture impairs
many sterilization processes. Drying
may be done manually or using
automated dryers.
D. Clean packaging area CSSD Technician/assistant
 Packaging area is used for inspecting,
assembling and packaging of clean,
non-sterile articles.
 Wrapping of the articles before
sterilization should be done in such a
manner that tenting and gapping
should be avoided.
 Workers should wear gloves, gowns
and masks while packing.
 The packaging procedure and material
should be validated for the type of
sterilization.
 Double wrapping may be done
sequentially or non-sequentially.
 Each pack should be marked with the
name and contents of the pack, the
initials of the person who packed it and
the date and initials of the person who
carried out the sterilization.

E. Sterilization area CSSD Technician/assistant
 The sterilizer should be loaded in and CSSD Technican Incharge
accordance to the manufacturers‟
recommendations.
 Ensure that all the physical and
chemical parameters are checked
before and during the sterilization
cycle.
 Maintain complete records of each
sterilization cycle.
F. Sterile storage area CSSD Technician/assistant

 Following sterilization, all sterile items and CSSD Technican Incharge
should be moved aseptically to the
sterile area for the storage of items.
 The sterile area should be a limited
access area with controlled
temperatures 75 F and relative
humidity (30-60%).
 A record of the date of sterilization,
physical parameters of sterilization
cycle and microbiological tests reports
should be maintained for each batch.
 All sterile items should be kept in the
sterile area till they are supplied to the
clinical areas.
 Positive pressure and minimum of ten
air changes per hour is recommended
in the sterilizer equipment room.
G. Personnel requirements with their Job Medical Superintendent/
description and Job Responsibilities Medical Director
a. CSSD Incharge:
 Responsible for administrative aspects
of the department.
 Ensure that CSSD delivers superior
performance as per standards and
hospital policies.
 Monitor and control overall quality of
service provided by the department.
 Regularly updated in new
advancements and implementation of
same with regard to economy,
efficiency, reliability.
 Safety of procedures and safe working
of personnel
 Provides a comprehensive
departmental orientation to all new
personnel and required training to all

staff on an ongoing or periodic basis.
b. OT Technician(Senior / Junior):
 Receive and issue of sterilized items
requested by the various departments
 Establishes and maintains internal
inventory and monitors them for
proper utilization.
 Sterilize instruments, equipment, linen
and supplies using sterilizers/
autoclaves in prescribed manner and
set controls to specified time and
temperature according to the type of
items being sterilized.
 Ensure sterility of all materials received
in CSSD.
 Store all supplies and equipment, in
appropriate locations with proper
labels.
 Responsible to run microbiological and
chemical tests (sterility checks)
periodically.
 Perform as in-charge for various shifts
and ensure quality service
 Appropriate documentation of
sterilization process and Maintain all
registers and records.
 Maintenance and efficient working of
all machines & devices of CSSD
(autoclaves, sterlizers, working
computer)
 Manage complete work flow during
each assigned shifts and ensure
coordination with other departments.
 Perform all duties assigned by the
CSSD incharge
c. Staff Nurses:
 Responsible for timely receiving
sterilized items & handing over
instruments, equipment, linen and
supplies with proper labels and
packing.
 Disassemble, decontamination, and
clean equipment using resources
provided as per policy
 Assemble all instruments, procedure
trays, packs following prescribed

manner using content slip as guide.
 Responsible for proper segregation of
different categories of wastes
generated after every procedure and
handing it over to the Biomedical
Waste collection personnel
 Proper instructions to NO/MPW for
delivery to CSSD and receive back.
d. Nursing Orderly/Multi purpose worker:

 Time bound delivery and transfer of
items
 Maintain a log of said items
 Helping the staff nurse in packing,
labeling and other works as assigned
e. Housekeeping staff:
 Responsible for Cleaning CSSD and
associated area as per procedure
specifications provided by the
infection control program.
 Responsible for proper segregation of
different categories of wastes
generated after every procedure and
handing it over to the Biomedical
Waste collection personnel.
 Perform other works assigned by the
CSSD incharge, other staff.
H. Dress Code CSSD Technician/assistant
 All staff of the Central Sterile Supply and CSSD Technican Incharge
Department is required to follow a
strict dress code, no staff is allowed to
enter the department with the
external clothes. Prior to the entry of
the staff to the department, each and
every staff of the Central sterile Supply
department is required to change into
appropriate departmental dress code
with the required personal protective
equipment (Similar to operation
theatre).
 Staff moving into the wash area, who
will be engaged in the handling and
processing of incoming equipment, will
put on an extra protection gown,
gloves and protective goggles (when
splashing is anticipated) in addition to
Central Sterile Services Department (CSSD) GNCTD/...................../SOP/SUR/04
the departmental uniform

 When leaving the wash area staff will
remove and discard the gown and
gloves and wash their hands.
 Prior to entering the preparation area
all staff and visitors will wash and dry
their hands and put on the relevant
PPE
 Staff visiting from other areas will wear
the departmental uniform and must
comply with the dress code when
moving to other areas of the
department.
I. Receipt and Issue of Packs: CSSD Technician/assistant
 Receipt of items from various point of and CSSD Technican Incharge
generation: From 9.00 am to 12.30
pm. (Timings shall vary based on needs
of the healthcare units/hospitals
where CSSD is functioning).
 Issue of sterile packs from the CSSD:
• From 2.30 pm to 3.30 pm. (Timings
shall vary based on needs of the
healthcare units/hospitals where
CSSD is functioning).
 However in high-risk patient care units
like OT, ICU, Dialysis and Emergency
Department etc are exempted from the
above mentioned time dimensions
since it is difficult to restrict their
activity within specific time limit due to
the emergency nature of care provided
by them.
 Emergency staff shall make sure of all
resources for the emergency situations
and holidays in advance.
 Emergency/OT staff should be trained
periodically for the steam sterilization,
autoclave or available sterilizing
machine as a back-up for emergency
situations demanding high turnover of
resources.
9.1.4.2 Safety Considerations at CSSD All personnel that are
A. Purpose assigned or engaged in
 To establish an overview of guidelines Sterile service operation
and safety awareness procedures in the
Sterile service department.
B. General Procedure General Guidelines All personnel that are
 All personnel must follow established assigned or engaged in
work and traffic flow patterns. Sterile service operation
 Material Safety Data Sheets (MSDS) for
all chemicals used in the sterile service

department must be available in a
binder index. Risk matrix and first aid
procedures of all chemicals used
should be prepared based on
information in MSDS and prominently
displayed for the CSSD staff.
 Employee must be trained in a safe
work procedure and be aware of any
relevant procedures, policies.
 All employees must be trained in
appropriate personnel protective
equipment designated for each area.
 Employees must adhere to dress code
and policies before entering and when
leaving the area.
 Employees must follow and practice
hand-washing guidelines (before and
after each tasks) in accordance with
WHO guidelines.
 Eating and drinking is prohibited in all
workspaces including supply storage,
processing and decontamination
sections.
 Workspaces must be free from clutter
and have un-obstructed entrances and
exits.
 Visitors are prohibited from entering
CPD spaces without permission.
 If visitors must enter restricted areas,
appropriate attire is required and CSSD
staff should escort them.
C. Patient Safety All personnel that are
 Ensure that all items are processed assigned or engaged in
according to established guidelines Sterile service operation
(manufacturer’s instructions).
 All CSSD personnel should be trained in
Decontamination and Sterilization
Practices.
 Safe keeping of all items by ensuring
that storage areas are kept clean,
storage cupboards are locked, and
equipment is covered and preventive
maintenance is performed on all
equipment.
 Assure there is no contamination of
patient care areas during collection
and transportation ofcontaminated
items.
D. Employee Safety
 Prevent burn injuries when loading or
unloading steam sterilizers and washer
disinfectors by following procedure
and wearing appropriate PPE.
 Employees must use proper body
mechanics when carrying or handling
heavy items.
 Use care and caution when handling
sharps.
 Maintain “line of light “when handling
medical devices.
 In the decontamination area,
employees must wear proper personal
protective equipment(PPE) to prevent
direct exposure from contaminants
and injury that could result
whenhandling contaminated and sharp
instruments.
 Appropriate PPE must be worn when
handling chemicals used for cleaning
anddecontamination.
 When receiving or handling
contaminated items, always wear the
correct PPE for the task.
 Use of electrical extension cords is
prohibited in sterile service areas.
 All employees must be aware of fire
and safety regulations.
 Refer to MSDS before handling
chemicals. Matrix of all chemicals used
should be prepared and prominently
displayed.
 If spills occur, refer to policy
management of body fluids spillages or
consult safety representative.
 Regular training of all CSSD staff should
be done with regards to safety and
recall procedures.
E. Expected Outcomes Medical Officer incharge
 Safety audits must be carried out on CSSD and CSSD Technican
periodically (at least monthly) per Incharge
prescribed format). For model safety
audit sheet see Annexure 1.
 Feedback of the audit must be given to
all relevant CSSD staff and Hospital
infection control committee.
9.1.4.3 Cleaning and hygiene at CSSD CSSD Technican Incharge
A. Purpose
 To ensure an acceptable level of
hygiene and cleanliness throughout
the CSSD area for the upkeep a clean
environment for preparing items for
high level disinfection and sterilization,
to maintain the cleanliness in CSSD &
to reduce and minimize source of
infection.
B. General Cleaning of the Department: CSSD Technican Incharge
a. General Area
 The CSSD should be cleaned in
accordance with the cleaning
schedule
 Cleaning will take place before work
commences or after work is
completed, in the case of a 24hour
facility cleaning will be rotated
through areas when work is not in
progress
 The cleaning schedule will specify
frequency of cleaning
 A departmental cleaning inspection
report will be prepared each month
(at random times) by the Sterile
Services Manager or Senior Staff
 Designated cleaning equipment will
be stored in a designated area for
that area’s use only.
 Cleaning work will only be
undertaken by Staff trained to work
in that area
 CSSD staff are responsible for
making sure that all surfaces are
clean
 All cleaning procedures and cleaning
chemicals used in the department
will be in line with
 Recommendations by hospital
infection control department.
 The use of brooms is not

recommended and is strongly
discouraged. Only wet mops should
be used for housekeeping work.
C. Packing area
 Wipe working table, shelves and

trolleys with the recommended
disinfectant.
 Wipe the machines with damp cloth.
D. Sterile packs Storing

 Wipe the shelves and walls with
recommended disinfectant weekly.
 Mop the floor twice daily and ensure
that the mop that is used is only meant
for the sterile store.
E. Decontamination area
 Wipe the trolleys with recommended
disinfectant daily.
 Wipe the machines with a damp cloth
daily.
 Mop twice and as and when required
with the recommended disinfectant.
 The floors are cleaned thoroughly and
polished whenever required.
F. Expected Outcomes
 Housekeeping audits must be carried
out on periodically (at least daily as per
prescribed format). For model house-
keeping audit sheet see Annexure 2.
 Feedback of the audit must be given to
all relevant CSSD staff and Hospital
infection control committee at least on
monthly basis.
9.1.4.4 Collection of contaminated/soiled items from Staff nurse sending the

patient care units items from different
patient care unit,
CSSD technician
A. Scope manning the CSSD
 To define the process of receiving of receiving area,
contaminated/ soiled items from Helper/orderly/MPW
different patient care units of the transporting the
hospital to CSSD items to CSSD.
B. Purpose
 To ensure appropriate handling,
transport and receiving of
soiled/contaminated items is safe
manner and appropriate
documentation of the same.
C. Materials CSSD Technican Incharge,

 Puncture proof and leak resistant Nursing I/C Patient care unit
trolleys with removable bins, dedicated
instrument trolleys.
 Trolleys should have covers and should
be marked with “Non- sterile items”
and Biohazard symbol affixed.
 Personnel (Helper/Orderlies) shall
wear personal protective equipment
including clothing, mask, and safety
footwear.
D. Procedure
 Items are sent in appropriate trays
after primary rinsing (to remove gross
contaminants such as blood, urine,
feces etc) in the patient care unit using
all safety precautions mentioned in the
hospital infection control manual.
 Wash hands in accordance with
departmental procedures.
 Non-sterile gloves must be worn for
the collection of instruments and be
discarded into the medical waste
container at each collection point.
 Contaminated linen, gowns or sheets
can be packed in red bag whereas non-
contaminated linen can be kept in
black bag for easy identification.
 Collect used items in puncture
resistant containers; do not overload.
 Items are listed as in tray content list
with tray name, items and their nos.
under the name of the tray/pack in
CSSD dispatch register.
 Use allocated trolleys for transport of
items to CSSD
 Place heavy instrument containers at
the bottom of trolleys.
 Secure contaminated items and cover
prior to transportation.
 Transport / Deliver used items and
equipment to the cleaning area
 Follow designated collection route, and
timetable in accordance with
department guidelines.
 Do not leave contaminated goods
unattended during transportation.
 Unload and sort items in the receiving
area.
 Clean and disinfect collection trolleys
and bins and store appropriately.
 Remove gloves and wash hands
according to Policy.
 The CSSD technician receives the
unsterile packs, inspects them to check
the status of the item (torn, punctured,
cracked etc) and places them at the
unsterile packs storing platform. Entry
is made in CSSD receipts register
including date, time, type of
instruments in the pack, its source,
procedure used for, and case infected
or not, name and signature of person
handing over, and name and signature
of person receiving it.
 Receiving entries are also made into
the patient care unit register with
name, time and date of receiving at
CSSD.
 All effort must be made to facilitate
transport of contaminated equipment
to decontamination area as soon as
possible to facilitate cleaning.
 Prompt processing of items will likely
decrease potential hazards associated
with contamination.
E. Expected Outcomes Medical Officer Incharge

 Appropriate type and number of items CSSD and CSSD Technican
are received from the patient care Incharge
units in safe and secure manner.
 Safe handling, collection and
transportation of contaminated
equipment, ready for further
processing
 Turn around time can be monitored
with this initial point of receiving of
items.
 Items discard rates for the patient care
unit can be calculated as – Total no. of
trays/sets with deficient
instruments/items / Total no. of
sets/trays received X 100 during the
defined period of time.

9.1.4.5 Processing of the contaminated/soiled OT technician, staff trained
instruments Decontamination in decontamination
process
A. Purpose Decontamination done at
 To ensure that all soiled instruments & source
linen returned to the CSSD (OT/wards/procedu
decontaminated to acceptable level re rooms) by staff
nurse
B. Scope
 All instruments and equipment
returned to CSSD
 All new equipment prior to
introduction for use
C. Materials Staff trained in
 Personal Protective Equipment decontamination process
 gloves
 aprons, gowns, overalls (single-use,
fluid- repellent, disposable)
 masks
 face and eye protection
 footwear
 Washers, Washing Machines,
Ultrasonic cleaner
 Double sinks with plugs, Hot and Cold
running water, Elbow taps, High
pressure cleaner
 Detergent, Stain Remover,Brushes,
Enzymatic solutions
 Disinfectants
 Ironing devices
D. Procedure
 Maintain segregation of
decontamination area within the
department.
 Staff working in this area will wear
protective clothing at all times in
compliance with the
 Standard precautions dress. PPE is
additional to the uniform code for your
specific workingenvironment.
 Apply standard precautions for
infection control and other relevant
health and safetymeasures.
 Linen and waste must be separated
from reusable medical devices at the

point of use.
 Gross contaminants such as large
amount of blood, feces, urine, etc.
must be removed at thepoint of use, in
accordance with safety procedures.
 Use and store all equipment chemicals
and materials in accordance with
manufacturer’s
 Instructions and institutional policies
and procedures.
 Ensure that stock of chemicals and

materials that are rotated so that
oldest is used first.
 Comply with manufacturers' and
organization specifications when using
all appliances andprocessing of medical
devices.
E. Primary Processing –Decontamination

(Step 1)
 Decontaminate instruments and other
items by placing them in a plastic
container of 0.5% Hypochlorite
solution/Bleaching Solution. Let them
soak for 10 minutes. A container of this
solution should be kept in every
operating theatre and procedure
room, so that used items can be place
directly into the bucket.
 Users should put instruments and
other items into the solution as soon
as they are finished using each item.
Open or unlock jointed instruments,
such as hemostats and scissors.
Disassemble those instruments with
sliding or multiple parts.
 After 10 minutes, remove the items
from the Hypochlorite
solution/Bleaching Solution and either
rinse with water or clean immediately.
Do not leave items in the solution for
more than 10 minutes, since excessive
soaking in the solution can damage
instruments and other items. Always
wear gloves when removing
instruments and other items from a
chlorine solution. Dried out
instruments then can be taken for

further processing.
 STEP 1 has to be performed at User
area or at source. All other steps to be
performed at CSSD.
F. Primary Cleaning (Step 2)

 Cleaning is the removal of foreign
material (e.g., soil, and organic
material) from objects and is normally
accomplished using water with
detergents or enzymatic products.
 Thorough cleaning is required before
high- level disinfection and sterilization
because inorganic and organic
materials that remain on the surfaces
of instruments interfere with the
effectiveness of these processes.
 If soiled materials dry or bake onto the
instruments, the removal process
becomes more difficult and the
disinfection or sterilization process less
effective or ineffective.
 Surgical instruments should be pre-
soaked or rinsed to prevent drying of
blood and to soften or remove blood
from the instruments.
 Handle contaminated devices as little
as possible.
 Avoid contaminating hands with
soilage.
 Steps of Cleaning
 Always wear utility gloves, a mask, and
protective eyewear when cleaning
instruments and other items. Avoid
using steel wool or abrasive cleansers.
These products can scratch or pit metal
or stainless steel, resulting in grooves
that can become a nesting place for
microorganisms. This also increases
the potential for corrosion of the
instruments and other items.
Step 1
Soak or wipe with damp cloth at a point of use
to prevent drying of bio-soil on
instrument.
Step 2
Using a soft brush or old toothbrush,
detergent, and water, scrub instruments
and other items vigorously to completely
remove all blood, other body fluids,
tissue, and other foreign matter. Hold
items under the surface of the water
while scrubbing and cleaning to avoid
splashing. Disassemble instruments and
other items with multiple parts, and be
sure to brush in the grooves, teeth, and
joints of items, where organic material
can collect and stick.
Step 3
Rinse items thoroughly with clean running
water to remove all detergent. Any
detergent left on the items can reduce
the effectiveness of further chemical
processing.
Step 4
Allow items to air-dry (or dry them with a
clean towel).
Note: Instruments that will be further

processed with chemical solutions must
dry completely to avoid diluting the
chemicals; items that will be high-level
disinfected by boiling do not need to be
dried first.
G. Secondary Processing – Cleaning, washing

and drying
 LINEN(Laundry function essentially)
 Bags of soiled textiles should be taken
to a dedicated soiled linen area i.e. a
dirty area
 Standardized validated washing and
disinfecting processes should be used.
 Moisten soiled textiles to prevent
staining. Treat stains to prevent them
setting.
 Stains must be removed if possible,
holes must be repaired
 Soiled textiles should be sorted before
being loaded into washer, to prevent
damage to machines from sharps and

instruments.
 A cold prewash rinse cycle will remove
gross soilage preventing it from baking
onto the fabric.
 A hot detergent cycle of at least 91
degrees C will destroy microorganisms.
 A minimum wash time of 25 minutes is
commonly recommended. Soaps or
detergents loosen soil and also have
some microbicidal properties, so it is
crucial to use only recommended
detergents that will also not cause
irritation to skin.
 The drying cycle is an important part of
the cleaning process as it assists in
killing any remaining microorganisms
that may be left after the laundry
machine has done its work.
 Drying in a dryer is recommended, as
the heat can be very efficient in killing
microorganisms, air drying in direct
sun-light is also an option.
 Linen to be sterilized must be
appropriately wrapped before being
sent to the sterile processing
department. Linen must not be placed
or stored on the floor.
 Linen must be stored in a dedicated
clean storage area
H. Expected Outcomes
 Cleandecontaminated items when
inspected visually
 Clean linen when inspected visually
9.1.4.6 Inspection, repair and replacement of Incharge CSSD Technician

instruments
A. Purpose
 To ensure that all instrument are
inspected and to effect
repair/replacement of broken or
damaged instruments.
B. Scope
 All instruments before reaching CSSD
inspected at source
(OT/wards/procedure rooms)
C. Materials
 Quality Manual
 Relevant Repair/Condemning
documents
 Instruments
 Lubricant
 Good lighting
D. Procedure Designated Trained CSSD

 All instruments that needs repairs personnel
/replacement shall be done at CSSD
level. Different patient care units
including OTs shall send demand to the
CSSD for various instruments and tray
sets.
 Feedback from theatres regarding
repairable or damaged instruments is
vital. This information must be marked
on the checklist.
 Broken or damaged instruments will be
decontaminated prior to sending for
repair and a decontamination
certificate sent with the consignment.
 All instruments should be visually
inspected following the cleaning and
drying process.
 All parts of the instrument should be
inspected for visible soilage:
• blood
• protein and other residue
• body fluids
• feces, vomitus
 All instruments must be checked for
visible damage:
• breaks and cracks
• deformed
• signs of wear
• discoloration, rust, corrosion.
 All instruments with lumens must be
checked for blockages.
• cannulas and recessed areas
• hinges, joints
• serrations, shafts
 Functional Checks should be performed
on all instruments if possible:
 Always apply lubricants to the
instruments before checking function,
repeated
 opening and closing of the instrument

will spread lubricant.
 Lubricate joints, threads and gliding

surfaces prior to any function tests
 Instruments must operate smoothly
 Check for bent or broken tips or guide
pins or broken springs
 Check for bent jaws, ratchets and
shanks
 Grasping surfaces must be in firm
contact with each other.
 Serrations/grooves slot into each other
when the instrument is closed.
 All defective instruments should be
reported and sent for repair.
 Instruments identified as needing
repair are placed in a dedicated tray in
the preparation
 room after following the
wash/decontamination procedure
 The records will be maintained by the

technician in the area and any repair
received back
 will be issued to the technician who will
complete the documentation.
 Maintenance and care should be

routinely performed. This includes
targeted application
 of lubricants and stain removers.
 Replacement of instruments should be

done after their life and as per the
hospital policy.
E. Expected Outcomes
 Instruments must be free of visible soil Incharge CSSD Technician
 Instruments are suitable for their
intended use
 Regular servicing ensures optimal
instrument life and is economical
9.1.4.7 Checking, assembling instruments & Packing Designated Trained CSSD

materials personnel,
A. Purpose
 To ensure that all instrument sets are
complete and safely packed before
sterilization.
B. Scope
 All instruments intended to be
sterilized (at source & CSSD)
C. Materials
 All instrument sets for use in theatres
and ward procedure packs.
 Checklist.
 Stainless steel trays, protective device
covers.
 Packing materials.
 In pack indicators.
 Labels/Labeling Gun.
 Packaging Accessories e.g. Tape,
sealers.
Ideal Packaging systems should :
 provide an adequate barrier to
microorganisms, particulates, and
fluids,
 maintain sterility of package
contents until opened,
 allowsterilant penetration and
direct contact with the item and
surfaces, and removal of the
sterilant,
 be free of toxic ingredients and
nonfast dyes,
 permit aseptic delivery of contents
to the sterile field (eg, minimal
wrap memory, removal of lids from
containers);
 permit complete and secure
enclosure of item(s),
 protect package contents from
physical damage (eg, compression,
stacking),
 provide adequate seal integrity,
 resist tears, punctures, abrasions,
and prevent the transfer of
microorganisms,
 be tamper-proof and able to seal

only once,
 permit adequate air removal,
 be low-linting,
 permit identification of contents,
 allow ease of use by personnel
preparing and/or opening the
package or container,
 have a favorable cost/benefit ratio
or economical,
 include manufacturer's instructions
for use.
D. Procedure
 Staff working in this area will wear
protective clothing at all times in
compliance with the
 standard precautions dress code.
 Make sure that all work surfaces are

clean according to department
 procedure.
 It is critical that staff understand what

the instruments are used for, that they
are functioningcorrectly and that each
set is assembled in the proper manner
for any given procedure.
 Trays should be perforated to allow
penetration of the sterilizing agent and
efficient drying.
 The person checking should indicate
and sign that the quantities are correct
and that nothingis missing.
 Instruments must be laid out according
to the order on the check list.
 Trays are usually packed in the order
that instruments are used.
 The weight of packs must be taken into
consideration when assembling trays.
 Instrument trays must be assembled to
maximize instrument exposure to the
sterilant
 Choose the relevant tray checklist for
the instrument set
 Place a small strip of autoclave tape in
the margin on the front of the tray list,
making surethat no information is
covered.
 Check that all instruments are present
against the checklist, check

instruments one by one.
 Check instruments visually for
cleanliness and missing parts (tips,
screws, free movement,sharpness and
overall condition).
 Do functionality tests on all
instruments to check that they are
working effectively.
 Instruments with ratchets or hinges
should be held in an open and
unlocked position;
 extended/complex multiple-part
instruments should be disassembled or
sufficiently
 loosened to permit the sterilizing agent
to come into contact with all parts of
the instrument.
 Instrument should be left slightly open

to allow for sterilant penetration, rings
should be slightly separated.
 Tips of instruments should all be facing
the same direction the use of tip
protectors is oftenadvised by the
manufacturer.
 Always make sure that all parts of the
instruments are present
 Heavy instruments should be placed at
the bottom of the tray as the weight of
heavy
 instruments or retractors lying on top
or over other instruments can cause
the instruments atthe bottom to bend
and become misaligned.
 Placing the instruments in a single

layer will provide more protection to
the instruments.
 Place an in-pack chemical indicator
into the densest most challenging part
of the tray. This indicator will only
change color if the in pack sterilization
parameters have been reached, i.e.
depending on class of indicator used,
steam, time and temperature.
 Ensure that the tray checklist is dated
and signed by the packer and checked
 Sterile packaging must provide
protection against contamination
during handling as well asproviding an

effective barrier against microbial
penetration.
 An ideal packaging should have the
ability to allow sterilization agents to
penetrate and thenprovide a barrier,
which will maintain the sterility of the
wrapped devices.
 The packaging should allow air that is
in the pack to be driven out and the
sterilizing agent toreach all surfaces of
its content.
 The packaging should protect the
contents against damage during
handling and transport.
 The packaging should be able to
withstand the conditions during the
sterilization process suchas pressure
changes, high temperature and
humidity
 The packaging should bear a clearly
visible marking indicating whether or
not the product hasbeen through a
sterilization process.
 There are many different types of
packaging that can be used for
different items
 Packaging material used in steam
sterilization must be able to withstand
high temperatures,allow for adequate
air removal, be flexible considering
changes in pressure during theprocess,
permit steam penetration to the pack's
contents and allow for adequate
drying.
 Packaging materials used with low
temperature sterilization processes
(e.g., ethylene oxideand gaseous
hydrogen peroxide processes) must
have similar properties, particularly
beingcompatible with the sterilization
chemicals, moisture, pressure changes
and temperatureranges.
 The packaging system chosen should
be appropriate for the items being
sterilized andcompatible with the
specific methods of sterilization being
used.
 Choose packaging to suit the
dimensions of the instruments/tray and
type of sterilizationtechnique to be
used.
E. Medical Grade single Use Disposable
Sterilization Wrap
 Double wrapping creates a package
within a package.
 Two sheets of wraps are used providing
multiple layers of protection of surgical
instrumentsfrom contamination.
Double wrap = wrap and wrap
 It can be either Sequential Wrapping
Technique or Simultaneous double-
wrapping: envelope fold technique
 The use of two layers of wraps
reinforces the strength of the
packaging.Folding the two wraps
separately, one after the other makes
the pack more secure, as thegreater
the number of folds the more tortuous
the path becomes for micro-organisms
topenetrate into the packaging.
 The double wrap with two sequential
folds also affords a two-step
unwrapping process whichassists in
aseptic presentation and creation of a
sterile field for users in the operating
theatre;the outer wrap is removed
before entering the operating room or
by an assistant.
 Use a hospital grade masking tape and
autoclave tape when using wrap.
Double wrap technique (Sequential)
Double Wrap Technique (Simultaneous)
F. Disposable Peel-open Pouches and Reels

 Paper/Plastic peel-open packaging
materials are suitable for steam, steam
formaldehyde andlow temperature
sterilization processes such as ethylene
oxide. It is not suitable for use
inhydrogen peroxide gas and ozone
sterilizers, again due to the paper
(cellulose) content.
 Disposable peel-open pouches and
reels are designed to contain
lightweight or small itemsand are
available in various sizes, for single use
only.
 Pouches are available in many sizes or
can be cut to any size needed.
 The open end of the pouch is closed
with a sealing device. It is essential that
the heat sealer isfunctioning effectively
in order to get an adequate seal.
 When double pouching, the inner
pouch should be at least a size smaller
than the outer pouchto prevent folding
which may entrap air and inhibit the
sterilization process. They must
bepackaged paper against paper,
plastic against plastic in order to
enable sterilant penetration.
G. Reusable rigid container systems
 Sterilization containers are a durable
sterilization packaging system
constructed of a rigidmaterial such as
metal, or plastic.
 A variety of sizes can accommodate a
wide range of instrument sets.
 Containers must be cleaned in the
same way as any other reusable
device.
 Ergonomics of container design for
ease of carrying
 Ease of locking and closing the
container.
 Ability to stack containers for storage
and transportation.
H. Woven fabrics
 usually 100 percent cotton, cotton
polyester blends and synthetic blends,
either treated oruntreated
I. Nonwoven materials
 Made of plastic polymers, cellulose
fibers or washed paper pulp bonded
under pressure into sheets not woven
on a loom.
 These are usually designed for single
use.
J. Expected Outcomes
 Instrument sets are correctly
assembled ready for packaging and
sterilization
 Pack integrity is maintained through
correct use of packaging
9.1.4.8 Preparation of items for High level CSSD personnel, OT staff

disinfection (HLD) and the disinfection
process
A. Purpose
 To ensure high level disinfection of
equipments/instruments for their
intended use
B. Scope
 Delicate& heat sensitive instruments
which cannot be autoclaved
C. Materials
a. High Level Disinfectants: Ex.: 2%
Glutaraldehyde, Ethylene Oxide,

1%Sodium Hypochlorite (10,000ppm of
chlorine)
b. Intermediate Level Disinfectants: Ex.:
Isopropylalcohol (70%), ethylalcohol,
sodium hypochlorite (0.1%),
Chlorhexidine, hydrogenperoxide,
phenolic solutions
c. Low Level Disinfectants:Ex: Quaternary
ammonium compounds like
benzylkonium chloride, some soaps
D. Procedure
a. List of items to be subjected for HLD
Endoscopes, telescopes, laryngoscopes
Heat sensitive instruments
Light cables, gas tubings
vaginal specula, nasal specula, etc
E. Classification of Disinfectants
Definition: Disinfection is a process where
most microbes are removed from defined
object or surface, expect bacterial
spores.High level disinfection is that which
kills all microganism and high number of
bacterial spores.
a. High Level Disinfectants:

 They destroy all microorganisms
including vegetative bacteria, most
bacterial spores, fungi, viruses
including enteroviruses and
mycobacterium tuberculosis except
some bacterial spores.
 Ex.:-2% Glutaraldehyde, Ethylene
Oxide, 1%Sodium Hypochlorite
(10,000ppm of chlorine)
 Used for semi critical instruments

and equipments (those that are in
contact with intact mucous
membrane without penetration)
 For gastrointestinal endoscopes,
endotracheal tubes, anesthesia
breathing circuits, respiratory
therapy equipments.
b. Intermediate Level Disinfectants:
 They destroy vegetative bacteria,
Mycobacterium tuberculosis, most
viruses e.g. entero viruses and
fungi but not bacterial spores.
 Ex.: Isopropyl alcohol (70%), ethyl

alcohol, sodium hypochlorite
(0.1%), Chlorhexidine, hydrogen
peroxide, phenolic solutions.
c. Low Level Disinfectants:
 They destroy most vegetative
bacteria, fungi and enveloped virus
e.g. HIV but will not kill bacterial
spores, Mycobacteria and non
enveloped viruses like enterovirus.
 Ex: Quaternary ammonium
compounds like benzylkonium
chloride, some soaps.
F. Guidelines for Selection of Disinfectants:

There is no ideal disinfectant. Each
application requires careful view of
following:
 Type and number of organisms.

 Type and amount of organic matter
 Contact time
 Type of surface (Rough / Corrugated)
 Type of water (hard / soft)
 Manufacturers data on efficacy
 Safety and environmental aspects
(chlorine is not free from toxicity)
 Cost, shelf life and convenience of use
 Residual activity
Two Approaches for Selection of Disinfectants:
i. Accept the manufacturers data

ii. Validate yourself
Guidelines for Use of Disinfectants
Name of Disinfectant Method of Dilution Contact Time In Use Span/ Use
Aldehyde Solutions:
a. Glutaraldehyde (2%) Add activator powder / Disinfection: 20-30 mins 14 days used for heat
liquid to the liquid in 5 sensitive instruments e.g.
Sterilization : 10 hours
liter jar and use undiluted Endoscopes
b. OPA (orthophthalyl Same as above

Same as above Long acting (28 days)
aldehyde)
c. Glutaraldehyde + water Disinfection : 15 min 24 hours

Formaldehyde + Benzyl
1 part : 49 parts Sterilization : 5 hours , 30 Used as surface
chloride
min disinfectant or 2% solution
(20 ml + 980 ml)
in operation theaters and
0.5% in wards, dressing
room.
Can be used in a low

pressure sprayer.
1% Sodium Hypochlorite 5%: 80 ml water + 20 ml 20-30 minutes 8 hours

bleach to make it 1%
Ex. : Polar Bleach 5% Used for blood spills and
solution.
laboratory
Polar Bleach10%
10%: 90 ml water + 10 ml decontamination
bleach
(2 propanol - 1 propanol, Ready to use 30 seconds Hand rub

macetroniumethylsulfate)
(Stabilized H2O2 11% w/v with 10 % w/v solution 60 minutes Surface disinfection
0.01% w/v diluted silver
nitrate solution)
20% w/v solution 60 minutes For fogging*
*(Fogging is not routinely recommended)
General Guidelines For Disinfection
 Critical instruments /equipments - (that are those penetrating skin or mucous membrane or
enter sterile tissue or vascular system) should undergo sterilisation before and after use. e.g.
surgical instruments and implants
 Semi-critical instruments /equipments - (that are those in contact with intact mucous
membrane without penetration or skin that is not intact) should undergo high level . e.g
laryngoscopes, Aneasthesia equipment.
 Non-critical instruments /equipments - (that are those in contact with intact skin and no
contact with mucous membrane) requires only intermediate or low level disinfection before
and after use.e.g. ECG electrodes
Classification Item Use Goal Appropriate Process
Critical item Items entering sterile tissue, Objects will be sterile Sterilization (or use of
the body cavity, the vascular single use sterile
(free of all
system and non-intact mucous products) (steam
membranes microorganisms
sterilization)
Eg surgical instruments including bacterial
spores)
Semi-Critical items Items that make contact, Objects will be free of all High level disinfection
directly or indirectly, with microorganisms, with the
· Thermal disinfection
intact mucous membranes or exception of high
non-intact skin. numbers of bacterial · Chemical disinfection
spores
E.g. endoscopes, anaesthetic (glutaraldehyde, OPA)
equipments,
It is always preferable to
Respiratory therapy sterilize semi-critical
items whenever they are
Equipment Endocavitory
compatible with available
probes
sterilization processes.
Tonometer Diaphragm
Non-Critical Objects that come into Objects will be clean Low level disinfection
Cleaning (manual or
items contact with intact skin but not
mucous membranes mechanical)
Eg crutches, BP cuffs,
Tabletops Bed pans,bed rail,

bedside table, ECG leads etc
Packaging of items after High Level Disinfection (HLD)

 Processed endoscopes should be stored by hanging them in the vertical position in a clean
area, preferably in a cabinet.
 Other items should be placed in clean packages or wrapped in clean cloth wraps and stored on
a clean shelf or in a clean drawer.
 Date of HLD and shelf life be clearly labelled on the packet or chamber.
Expected Outcomes
 All equipment is sterilized to an acceptable level before intended use.
9.1.4. Packaging of items for steam sterilization Trained

9 A. Purpose CSSD
 To ensure that the correct materials are used staff/Infectio
and that items are correctly packaged in order n Control
to maintain sterility Department
B. Scope
 Items meant for steam sterilization
C. Materials
 All instrument sets for use in theatres and ward
procedure packs.
 Checklist
 Stainless steel trays, protective device covers
 Packing materials
 In pack indicators
 Labels/Labeling Gun
 Packaging Accessories e.g. Tape, sealers
D. Procedure *Handbook of
a. Packing & Loading Infection Control.
 For effective sterilization, selection of
Acknowledgeme
packaging material plays important role
nt as on page
apart from sterilization parameters. The
following are keys in selecting a suitable 178
packaging material.
 The packaging material must be permeable
to sterilizing agent.
 The packaging material must be
impermeable to bacteria and other
contaminants.
 The packaging material must resist tears
and punctures.
 It should facilitate aseptic presentation of
packaged content.
Textile pack should not exceed 5kg or exceed 30cm wide by

30cm high by 50cm long.
Package the object loosely

Reference: - Acknowledgement page 179
 Proper loading of material inside sterilizer *Handbook of
is very critical for efficient sterilization. Infection Control.
Relative humidity in the processing area
Acknowledgeme
should be at least 35%.
nt as on page
 When loading sterilizer there should be
178
space between item to facilitate circulation
and penetration of sterilant.
 There should be no contact between items
and chamber wall.
 In mixed load linen should be kept on top
racks and metal on bottom
 Peel pouches should be kept on the edge
facing same direction
 Textile should be kept on the edge
 Instrument sets should be placed flat.
Reference: *
b. Monitoring:
 Mechanical, chemical and biological
monitors can be used to evaluate the
effectiveness of the sterilization process.
 Each load is monitored with mechanical
(time, temperature, pressure) and chemical
(internal and external) indicators.
 Biological indicators (spores) should be used

weekly to monitor the effectiveness of
sterilization. Vials are removed from
sterilizers and put in designated incubator in
CSSD. Monthly report are sent to ICN.
 Chemical indicators as strips should be used
with every batch.
 An expiry date is given for sterile articles
based on the packing material used.
E. Quality Indicators ( Before use & after use).
a. Monitoring protocol of Autoclave :
 Temperature, Pressure and time of each
cycle is recorded is followed according to
manufacturer’s recommendations. Records
should be maintained for each cyle.
 Various quality indicators are used to check
the efficacy of sterilization:
b. Exposure control:
 Autoclave indicators tapeis pasted on all
packs to be kept in autoclave.
c. Load Control:
 Biological indicators (spores of Bacillus
stearothermophilus) are used once a week
(Monday) in all autoclave machines in first
load and with every load which contain any
implant. This indicator gives us rapid
results, i.e. positive result in one hour and
negative result in 3 hours. If result is
positive means sterilization is not adequate
that whole load is recalled & re-autoclaved.
d. Pack control:
 Class 5 chemical integrator - It is used in
every pack.
e. Equipment control:
 Bowie-dick test pack – It is used once daily
in each machine.
f. Environmental monitoring in sterile zone:

c. Air cultures are taken once in a month from
sterile zone.
F. Important considerations:
 Wet pack is not accepted as sterile. These are

repacked and resterilized (even if the indicators
show the appropriate changes.
 There are different trolleys for carrying sterile
and unsterile instruments White (or Black)&
Red respectively.
 No person is allowed to enter in sterile room
without Personal ProtectiveEquipments (PPE)
(i.e. Cap, mask, gown, & slippers etc.)
 All sterile items must be used within 72 hours
after 72 hours items should send to CSSD for re
autoclaving
G. List of common trays and sets

 Needs to be defined at hospital level as
determined by types of procedures being done
in the organization.
 Examples of trays/sets include:
 Central line insertion set
 Urinary catheterization set
 Lumber puncture set
 Chest tube insertion set
 Venous Cut down set
 Clean – lacerated wound management Set
 Cholecystectomy set
 Exploratory laparotomy set
 Herniotomy set
 TURP set
 Cystoscopy set
 Tracheostomy set
 ORIF set
H. Lists for Name of the tray/set, Quantity, Packaging
check column, User Check Column
Please refer to Section 9.17.1
I. Expected Outcomes
 Ensure safe and sterile supplies to the HCO
 Ensure monitoring of steam sterilization
process in an objective manner.
9.1.4.10 Sterilization process for steam sterilization Trained CSSD

A. Purpose personnel
 To ensure that all allocated to
reprocessed medical devices are sterilized to an area
acceptable standard and ready for use.
B. Scope
 Metal instruments, items meant for steam
sterilization
 Sterilization of all critical and semi-critical items
that are heat and moisture resistant (surgical
instruments, surgical drapes, some respiratory
and anesthetic equipments, sharps).
C. Materials
 Steam Sterilizer (Autoclave),
Loading Trolleys, Log books
 Testing products: Bowie &
Dick test pack, Microbiology test vials
D. Procedure
a. General
considerations and precautions
 Follow the manufacturer’s instructions.
 Arrange items in a way to facilitate air removal,
and steam penetration of all surfaces.
 Do not stack items one on top of the other.
 Do not overload.
 Keep the loads at the sterilizing temperature for
the recommended holding time.
 Close and secure lock the autoclave door.
 Follow manufacturer’s directions for door
opening and load transfer In the event of a
cycle failure / cycle aborted, the entire load will
need to go through the full reprocessing cycle
 Before opening the door, thoroughly wash
hands according to Hospital Policy
 Open the door while standing towards the side
to avoid burns.
 Exercise care during opening (Sterilizer is hot,
potential for steam injuries and burns).
 Put on heat resistant gloves and remove carrier

from Autoclave.
 Allow to cool for 10 – 20 minutes before storage
or dispensing.
 Inspect packages to ensure integrity and
external chemical indicators have changed.
 Maintain a log of the load, parameters met and

autoclave cycle.
b. Essential parameters
 Steam (dry, saturated), time, temperature and
pressure.
 Time to sterilize: usual cycles: 121o C for 30
minutes, 132o C for 4 minutes at recommended
pressures.
E. Monitoring of steam sterilization process:

a. Physical/ Mechanical monitoring: Each cycle
 Monitoring includes all sterilizer components
that track and record time, temperature and
pressure during each cycle, rounds, etc.
 Documentation of critical cycle parameters
permits the earliest detection of equipment
malfunctions since they can be evaluated when
the cycle is in progress.
b. Chemical monitoring
 Internal indicators (placed inside the tray/pack)-
Provide an indication that the load has been
exposed to the conditions necessary to achieve
sterilization.
 External indicators-Placed on the outside of
each pack to be sterilized.
 Readily visible and color change provides a
quick indication that the load has or has not
been exposed to the sterilization process.
 Residual air detection for vacuum sterilizers
(Bowie- Dick test): Test daily.
 A commercially available Bowie- Dick type test
sheet should be placed in the centre of the
pack.
 The test pack should be placed horizontally in
the front, bottom section of sterilizer rack, near
the door and over the drain in an otherwise
empty chamber and run at 134o C x 3.5
minutes.
 Residual air in the chamber will interfere with
steam contact (the entrapped air will cause a
spot to appear on the test sheet due to inability
of steam to reach the chemical indicator).
 During processing, steam must displace the air
through the barrier material within the pack. A
uniform change from yellow to blue/purple on
the indicator sheet indicates that all the air was
removed and replaced by steam.
 If the sterilizer fails the test, do not use until
corrected.
c. Biological monitoring:
 Geobacillus sterothermopilus spores 105.
 Use at least weekly (preferably daily) and with
each load of implantable devices.
 Loads containing implantable devices should
ideally be quarantined until the results of
biological indicators are available.
 Consistent sterilization of items through quality
control checks of the autoclave
 All packs are sterile and safe to use
9.1.4.11 Sterilization process for ETO Trained CSSD

 To ensure that all reprocessed medical devices allocated to
are sterilized to an acceptable standard and area
ready for use.
 To ensure that the work environment is safe
for employees
B. Scope
 Medical and surgical items that cannot support
conventional high temperature steam
sterilization.
 For sterilization of heat and moisture labile
critical and semi-critical items.
 Assembled complex devices
 Catheters, stents
 Equipment with integrated-electronics
 Multi-lumen tubing products
 Wound care dressings
 Disposable items
C. Materials
 ETO Sterilizer
 ETO Cartridges
 Aeration Cabinet
 Monitoring equipment
 Emergency equipment
 Personal Protective equipment
 Manufacturer’s Manual
 Logbooks
 Emergency equipments and procedure manual
 Suitablepackaging materials for ethylene oxide
are
 woven polyester wraps
 paper bags and wraps
 cellulose based non woven wraps
 non cellulose based non woven wraps
 specific reusable rigid sterilization containers
 polyethylene film
 cellulose based flexible packaging material.
 Unsuitable packaging materials for ethylene
oxide include
 textile linen wraps
 sealed containers such as metal or glass
 aluminium foil
 porous non-cellulose flexible packaging
 non porous non cellulose based flexible
packaging.
D. Requirements for ETO Sterilization
 Ethylene oxide must have an unobstructed

path to be able to sterilize the interior of
devices. Complex instruments must be
disassembled for sterilization, so that the gas
may penetrate the most remote recesses.
Caps, plugs or stylets must be removed prior
to sterilization.
 Thoroughly wash and dry instruments prepared
for gas sterilization to remove biological
matter residues and meet the standard of
surgical cleanliness.
 Use appropriate wrapping materials for ETO
gas sterilization.
 A sufficient dose of ethylene oxide must be
used for an adequate length of time to kill the
most resistant microorganisms.
 Adequate humidity must be present to
facilitate the process. Desiccated organisms
may become resistant to ethylene oxide
sterilization.
 The dose of ethylene oxide required depends
on the temperature of the process. The higher
the temperature, the lower the dose of EO
that will be necessary to sterilize.
E. Procedure
 Packaging systems for ethylene oxide (ETO)
should be permeable to EO, moisture, and air;
permit aeration; be constructed of a material
recommended by the sterilizer and sterilant
manufacturer; and maintain material
compatibility (ie, non-degradable) with the
sterilization process.
 Ensure the work environment is safe for
employees before operating ETO sterilizer.
 Operators must know how to operate the ETO
sterilizer safely as well as the importance of
adequate aeration
 Operators need to understand the
environment requirements and safe work
practices.
 Operators must know what the emergency
procedures are in case of a leak or accident.
 The ETO sterilizer must be operated
accordance with the manufacturer’s
instructions
 The ETO sterilizer must be used in a well
ventilated controlled room with dedicated
exhausts, emission control, enclosed ETO
sterilizer/aerator room, ventilation, air

exchanges andenvironmental monitoring
provided.
 Complete test and record biological indicator
(BI) Test according to manufacturers
 Instructions.
 Check with gas manufacturer/supplier for

storage recommendations and MSDS sheet.
 ETO gas must be stored at the prescribed
temperature in a well ventilated area in a
cupboardmarked with Hazardous materials
label
 The cycle must be long enough to allow
thorough ETO penetration to kill
microorganisms.
 The sterilizer operating temperature is usually
preset by the sterilizer manufacturer; there
areusually two options: 100F (cold cycle) 130F
(warm cycle)
 The manufacturer of a device is responsible for
providing validated information regarding
proper sterilization and aeration of their
products, usually between 1 to 6 hours,
depending on the concentration, humidity,
temperature parameters, and the type of
sterilizer.
 The ETO cartridge must be discarded in a safe
manner according gas manufacturer/supplier
and hospital policy
 Average personnel exposure concentration
should be measured over a specific period of
time, usually 8 hours
 Employer must ensure that no employee is
exposed to airborne concentrations of ETO in
excess of the concentration recommended by
suppliers (<1 ppm)
 Material compatibility with ETO must be
validated by the device manufacturer
 Load items in a loose fashion to facilitate air
removal, humidification, ETO circulation and
penetration of all surfaces, and ETO removal
during aeration
 Packages must not contact walls or ceiling of
chamber, package damage from heat or
moisture may occur
 Process full loads to limit the number of cycles
you need to run
 Load the sterilizer according to manufacturers
instructions, make sure the door to the
chamber is locked, and the appropriate cycle is

selected based on the types of items
beingprocessed
 Aeration Cabinets are required to remove
residual ETO before patient contact with the
device.
 Follow manufacturer’s directions for door

opening and load transfer.
 When unloading some sterilizer manufacturers
recommend immediate removal if
transferringitems to a freestanding aerator
 Opening the door 2 inches for 15 minutes is
recommended…obviously no one should
remainin the area
 Aerate until potentially toxic ETO residues are
removed before storage and use of
medicaldevices.
 ETO residues if any should be exiting through a
vent, the specifications of which are provided
by manufacturer.
 Length of aeration depends on
Composition/materials, thickness, design and
weight of thedevice and it’s wrapping,
sterilization and aeration system used,
temperature, ETO,concentration, duration of
gas exposure, rate of air exchange, and air
flow pattern
 Device manufacturer’s recommendations must
be VALIDATED aeration parameters
 (time/temperature)
 The aeration time must be uninterrupted

 8 hours at 140° F (60°C)
 10 hours at 130° F (54°C)
 12 hours at 120°F (49°C)
 20 hours at 100° F (38°C)
 DO NOT remove prematurely, with premature
removal, personnel and patients may
beadversely affected.
 The sterilized items are properly labelled and
stored.
 A log is maintained of the cycle, load,
temperature, time, etc
F. Quality control- Monitoring ETO sterilization

a. Physical monitors
 Measures that ETO machine is functioning
effectively
 Monitoring includes all sterilizer components

that track and record time, temperature and
pressure during each cycle, rounds, cartridges,
etc.
 Documentation of critical cycle parameters
permits the earliest detection of equipment
malfunctions since they can be evaluated when
the cycle is in progress.
b. Chemical indicators
 Provide an indication that the load has been
exposed to the conditions necessary to
achievesterilization
 External indicators
 Placed on the outside of each pack to be
sterilized.
 Readily visible and color change provides a
quick indication that the load has or has not
beenexposed to the sterilization process
 If the process indicators have not changed, the
packages should NOT be released.
c. Biological indicators
 Indicates if sterilizing conditions are adequate
to achieve sterilization
 Bacillus atrophaeus: Microorganism of choice
for monitoring ETO sterilization as it offers the
best test challenge since it is most resistant to
kill; Non-pathogenic
 BI is placed into the center of a full load.
Consider placing the test pack into a small
metal basket or instrument tray for easy
retrieval if it must be removed before a load is
transferredto a separate aerator.
 Follow BI manufacturer’s instructions for
activation and incubation.
 For example, ETO (Bacillus atrophaeus) is
incubated at 37° C for 48 hours. Steam
(Geobacillus stearothermophilus) is incubated
at 55° C for 24 hours
 The BI manufacturer must be consulted for
recommendations regarding how to handle
theirBI
 Worker safety must be given primary
consideration.
 Proper and safe disposal practices for chemical
and biological indicators.
d. Safety Warnings
 ETO is a colorless odourless gas with high

reactivity.
 Skin Contact with liquid EO - immediately wash
affected area
 Eye contact with liquid EO - flush eyes with
copious amounts of water for at least 15
minutes
 Ensure staff have been educated regarding
safety precautions when working with ETO.
 Shift the person to open well ventilated area.
 Primary management should be highlighted
and displaying clearly in the working area.
G. Expected Outcomes
 All equipment is sterilized to an acceptable
standard
 ETO sterilizers are operated according to
manufacturer’s instructions
 The work environment is safe for employees
9.1.4.12 Sterilization process for Gas Plasma Sterilization Trained CSSD

 To ensure that all returned items are sterilized allocated to
according to an acceptable standard andready area
to use.
 To ensure the work environment is safe for all
employees.
B. Scope
 Items that cannot tolerate high temperatures
and humidity, such as some plastics, electrical
devices, and corrosion-susceptible metal alloys
C. Materials
 Sterilizer
 Cassettes / cartridges
 Wrap recommended by manufacturer
 Cassette collection boxes
 Instrument sterilization containers
recommended by manufacturer
 PPE
 Manufacture’s manual
 Suitable packaging materials for gas plasma
sterilization are
 Woven polyester
 Non-cellulose based non woven wraps
 Specific reusable rigid sterilization containers
 Porous non-cellulose based flexible packaging

material.
 Unsuitable packaging materials for gas plasma
include (gas plasma sterilization is affected by
absorbable packaging materials)
 Textile linen wraps
 Paper bags and wraps
 Cellulose based non woven wraps
 Sealed containers such as metal or glass
 Aluminium foil
 Polyethylene film
 Cellulose based flexible packaging
 Non porous non-cellulose based flexible
packaging.
D. Procedure
 This process inactivates microorganisms
primarily by the combined use of hydrogen
peroxide gas and the generation of free
radicals (hydroxyl and hydroproxyl free
radicals) during the plasma phase of the cycle.
 Packaging systems for low-temperature gas
plasma sterilization should
 allow sterilizing plasmas to penetrate
packaging materials;
 be compatible (ie, nondegradable,
nonabsorbable) with the sterilization process;
 be constructed of a material recommended by
the sterilizer manufacturer; and
 be used according to the packaging
manufacturer's written instructions.
 All items must be thoroughly cleaned and dried
before packaging
 Use packaging and containers recommended
by the manufacture
 Users should obtain documentation from the
manufacturer for appropriate use and
restrictions.
 Place chemical indicator in each packaged item.
 Arrange items in such a way as to ensure
sterilant will come into contact with all
surfaces.
 Do not allow any items to touch the walls or
the door
 Do not stack containers
 Manufacture’s manual for details of process.
 Hydrogen Peroxide Plasma / Vaporized
Hydrogen Peroxide involves the combined use
of hydrogen peroxide and low-temperature gas
plasma to safely and rapidly sterilize medical
devices and materials without leaving any toxic

residues.
 Plasma is a state of matter distinguishable from
a solid, liquid, or gas. Gas plasmas are highly
ionized gases, composed of ions, electrons, and
neutral particles that produce a visible glow.
 A solution of hydrogen peroxide and water
(59% nominal peroxide by weight) is delivered
to the sterilizer, concentrated to approximately
90%, vaporized and allowed to surround and
interact with the devices to be sterilized.
Hydrogen peroxide is a bactericidal, virucidal,
sporicidal, and fungicidal agent, even at low
concentration and temperature.
 Applying a strong electrical field then creates
plasma. The plasma breaks down the peroxide
into a cloud of highly energized species that
recombine, turning the hydrogen peroxide into
water and oxygen leaving no toxic residues.
E. Monitoring of Gas plasma sterilization.
 Physical/Process parameters
 The physical parameters are defined by the
manufacture (cycle time, etc).
 If any process parameter falls short of its
acceptable limits, which were established by
statistical analysis of microbiological efficacy
testing, the sterilization cycle will be canceled
and the printed record for the cycle will state
the reason for the malfunction.
 Biological monitoring
 106 G. stearothermophilus spores; to be used
in accordance with manufacturer instruction.
F. Warning
 Items that cannot be processed in a Hydrogen
Peroxide Plasma / Vaporized Hydrogen
Peroxide
 Any item that is not completely dry
 Items or materials that absorb liquids
 Items made from materials containing cellulose
e.g., cotton, paper, cardboard, linens, gauze or
items that contain wood pulp
 Manufacturer’s list of what can and what
cannot be processed
 Concentrated hydrogen peroxide liquid will
irritate skin and, like other oxidants, can cause
severe damage to eyes if direct contact occurs.
 Wash with copious amounts of water.
 Shift to open environment or well ventilated
area.
 Seek medical help as per institution policy.

G. Expected Outcome
 All equipment is sterilized to an acceptable
level and ready to use.
9.1.4.13 Storage of sterile items in sterile zone CSSD

A. Purpose Incharge
 To ensure the safe and organised storage of all technician
sterile packs up to release to other and CSSD
departments personnel
B. Scope
 All packed sterilized items and equipments
C. Materials
 Stainless Steel slatted Shelving
 Almirah racks
D. Procedure
 This is a clean area and should be kept clean
and tidy at all times with limited access
 Ensure that stock is rotated and monitor stock
levels
 Only CSSD staff should be allowed access to the
storage area
 Doors and windows must be kept closed
 Temperature should be controlled.
 Room temperature should be approximately
24ºC (75ºF).
 The room(s) should have at least 4 air
exchanges per hour.
 Humidity should be controlled so that it does
not exceed 70%.
 Products should be stored away from direct
sunlight and water
 The Sterile Storage area should be arranged to
make it easy to identify packs and be well lit
and easy to clean.
 There should be enough shelves and cupboards
available to store all sterile goods
withouthaving to stack them tightly or on top
of one another.
 Products should be stored away from outside
walls.
 There should be space between shelving and
floor and ceiling to allow air to circulate and to
allow cleaning of the floor area.
 Surgical and medical supplies should be stored
at least 25cms from the floor, 45cms from the
ceiling and 5cms from outside walls to allow for
air circulation in the room and to prevent
contamination during cleaning.

 Items should not be stored next to or under
sinks, on the floor or windowsills where they
are likely to get wet or damaged.
 Follow a system of use the First in First out
(FIFO) system. Rotate stock so that oldest items
are used first.
 Surfaces in contact with sterile goods should be
as clean as possible to prevent microorganism
penetrating the packaging of these items.
 Trolleys should be cleaned anddried after each
use, because even though they are used with
sterile items, contaminationcan be picked up
during transport outside the CSSD.
E. Shelf life
 The shelf life of a pack is dependent on
packaging, handling and storage conditions.
 This also applies to all commercially prepared
items which are labelled as “Sterile
unlessopened or damaged”.
 The date on a sterile package indicates the date
the item was sterilized or manufactured.
 Sterility is maintained as long as the integrity of
all barrier properties and seals aremaintained
 Expiration date is a reminder “Use Before”
/”Use First”
 Sterility of all packs is maintained whilst in the
CSSD
9.1.4.14 Issue of items from CSSD CSSD
 To ensure hospital staff receive sterile items in managing the
a safe condition and ready to use dispatch
B. Scope counter; Staff
 All sterile items from storage and dispatch receiving the
areas items
C. Materials
 Dispatch Log
 Clean Trolleys
D. Procedure
 All items will be checked for sterility before
they are released
 The following should be checked when
deciding if the pack is still sterile: -
• Holes or tears
• Wetness or stains
• Broken seals
• Dust
• Sterility seal
All items issued will be recorded so that a
tracking system is effected
 Various methods can be used in the transport
of sterile packaged items to their point of
use.This can range from hand carriage (in
particular where a decontamination area is
located closeor adjacent to a point of use), to
the use of trolley’s and other such transport
systems fortaking items to a remote location
(within a facility or at a different facility).
 Sterile supplies should be transported in
covered or enclosed trolleys with a solid
bottom
shelf. The solid bottom shelf prevents
microorganism on the floor being picked up by
the wheels of the trolley and then spun
upwards onto the sterile packs.
 Items must be placed onto a clean trolley that

can be covered
 Trolleys must not be overloaded
 Soiled items must NOT be loaded onto the
same trolley.
 Loaded trolleys should immediately move to
their respective areas.
 Sterility seals should also be checked by
receiver before accepting the items.
9.1.4.15 Recall Procedure All personnel
A. Purpose using CSSD
 To ensure that any item suspected of being items (Staff
substandard is identified, quarantined, nurses, OT
collected, investigated and the findings nurses,
recorded Surgeons,
B. Scope Physicians)
 All suspected items after issuance from CSSD and
 Inadequacy noticed by the end user CSSD
Incharge
C. Materials
 Item in question
 Checklist
D. Procedure
 In the event of sterilization failure, such as
positive biological indicators/Failed Load
 Controls or sterilizer malfunction, items from
that test and previous loads after the
lastknown good test must immediately be
recalled.
 All affected trays must be recalled in the event

of failed quality management tests i.e.
 Biological, Load Control
 A written Recall Procedure must be followed in

the event of a sterilization failure
 The sterilizer must be shut down and all staff
must be made aware that it is out ofoperation.
 The sterilization record sheets should be
checked for a list of “sterilized” items that
needto be recalled.
 The recall procedure should be documented on
the sterilization record sheets listingwhat items
have been retrieved and reprocessed and
which items had already be usedand on whom.
Note items that may have already been used
on the list.
 As it becomes apparent that items need to be
recalled reprocessing personnel
willimmediately notify users and retrieve the
supplies from storage and from user as soon
aspossible.
 A recall is usually authorized by the most senior
staff member on the shift.
 Affected departments should be advised
verbally as soon as possible, with a follow
upwritten confirmation advisory stipulating
which items, trays from a particular batch
aresuspect and should be returned.
 Departments should be requested to check
their sterile stock as well as used stock for
thesuspect batch.
 CSSD staff will confirm that the check has been
carried out for any breach in the cycle.
 Recalled items should be labelled ‘Under
Quarantine’ whilst in transit to the cleaning
areaof the reprocessing area where it will be
reprocessed or be put into quarantine.
 All items retrieved from a Recall must be
completely reprocessed.
 All items must be disassembled, processed with
fresh linen, assembled, rewrapped
andsterilized.
 Once the sterilizer has been repaired all
monitoring results must be checked before
thesterilizer is used.
 The cause of the recall should be investigated
and a report written.
E. Expected Outcome
 A quality management system is in place
confirming that all products leaving the CSSD
are sterile and safe to use.
S. No. Activity Responsibility Reference
9.1.4.16 Maintenance of CSSD equipment CSSD

technician
Incharge
A. Purpose CSSD Medical
 To ensure that all CSSD equipment are in good Officer
working condition with minimum downtime. Incharge
B. Scope
 Maintenance of:
 Ultrasonicator
 Water Jet machine
 Dryer
 Sealer
 Labeller
 Steam Sterilizer
 ETO sterilizer
C. Materials
 Equipment logs to be maintained on daily basis
by CSSD Technician Incharge/Supervisor
 Equipment logs to be verified on monthly basis
by Medical officer Incharge
D. Procedure
 All equipment records should have separate
file. The content of the file at least include:
 Equipment History (Name of Equipment, Make,
Model No., Date of installation, Order No.,
Date, Cost of machine, Warranty period, Date
of expiry of warranty period, Whether under
AMC/CMC, period of AMC, Contact No. of
Engineer).
 Installation Report
 IQ/OQ/PQ documents at the time of
installation
 Periodic calibration report (At least annually)
 Service reports
 AMC/CMC Contract sheet
 Equipment downtime log
 Call log in case of repairs or troubleshoot. This
log should include at the minimum following
information: Date and time problem was

noticed, description of nature of problem,
Name and contact no. of person contacted to
resolve the problem, Date and time of call to
person for resolution of problem, Name of the
person who contacted the engineer, response
of the person contacted, date and time of
resolution of the problem.
 Any other document pertaining to the

equipment.
 Improved and efficient utilization of CSSD
equipment.
 Timely service and calibration of equipment for
improved lives of the equipment.
9.1.4.17 Key performance indicators for CSSD – Data CSSD
collection and analysis technician
Incharge
CSSD Medical
A. Purpose Officer
 To measure the structure, process and Incharge
outcome of the CSSD in objective and
transparent manner.
B. Scope
 To define, measure and monitor various
performance indicators to monitor CSSD.
Indicators definition
Please use the following Matrix:
Indicator name Numerator (N) Denominator (D) Formula Remarks
Bowie-dick failure No. of Bowie-dick No. of Bowie-dick N/D x 100 See Appendix for
rates tests failed per tests done per monitoring reasons of
month month Bowie dick failure
Recall rates No. of loads whose No. of loads per N/D X 100 Recall may be due to
packs have been steriliser carried failure of indicators of
recalled per month out per month particluar load or packing
defects. (Rates for
indicator failure should
be calculated separatetly
for indicator failures and
damged packs).
Class V integrator No. of packs No. of packs with N/D X 100
failure rates where class V class V integrators

integrator failed issued per month
per month
Biological Indicator No. of loads where No. of loads N/D X 100

(BI) failure rates BI have failed per subjected to BI per
month month
Return of expired Total No. of Total No. of items N/D X 100

items for re- expired items issued per unit per
sterilization in OT retured per unit month
per month
Critical Equipment Total no. of hours Total no. of hours N/D X 100
utilization rates equipment was the equipment was
used expected to be
used
Critical Equipment Total no. of hours equipment was not N/A

downtime rates used because it was out of order per
month
Disinfectant failure Total No. of times Total no. of times N/D X 100 It will be useful to
rates indicator strip indicator strip test monitor no. of days when
failed the test per was done per the indicator strip failed.
month month
Lost item rates Total no. of Total no. of items N/D X 100
instance where trays sent for
items did were processing in CSSD
missing in the tray per patient care
when sent for unit per month
processing in CSSD
per patient care
unit
Turn-around-time for Time of receiving of items to time it N/A Should be monitored for
Sterile items reaches sterile storage area of CSSD each method of
disinfection and
sterilisation separately.
CSSD Safety score See appedix for safety

audit
Sharps injury rates Total no. of sharp Total no. of N/D X 1000
injuries among mandays in CSSD
CSSD workers per per month
month
Blood and body fluid Total no. of blood Total no. of N/D X 1000
exposure rates and body fluid mandays in CSSD
exposures among per month
CSSD workers per
month
C. Data capturing procedure and templates

 Log registers should be prepared for each process to ensure capturing of relevant data on
real time basis.
D. Monitoring frequency
 The CSSD supervisor should sign all log registers on daily basis and countersigned by
Medical officer incharge on at least monthly basis.
 The data compiled through such indicators should be shared with concerned patient care
unit incharges, nursing incharges and medical superintendent/director of the hospital
 Trend analysis shared should result in root cause analysis.
 Regular training of nurses, paramedical workers, doctors to sensitize them about the
sterilization and its importance should be done and various deficiencies and challenges
encountered through monitoring of these indicators should be included as a part of
training of relevant technical, nursing staff and doctors.
 Indicators monitoring shall ensure implementation and monitoring of CSSD processes and
quality improvement of CSSD.
Annexure
**Annexure 1. CSSD Safety audit sheet

HEALTH FACILITY:
Date: Auditors:
Designated area:
Annexure 1. CSSD Safety audit sheet
Scoring System: AS Standard Interpretation: Scoring Process
0 = ACCEPTABLE • SHALL = Mandatory Score 0 or

1 as appropriate
1 = UNACCEPTABLE A B
☺SHOULD = Recommended
N/A = NOT APPLICABLE
Mark or
Note: These points are not

Column A = Achieved score
included in the scoring system.
Column B = Total Possible score
Section Standard Compliance Action Timeframe
0 1 N/A
2 HANDLING OF USED ITEMS
WATER QUALITY FOR CLEANING
2.1 • Clean water supply of good quality (0 or 1)
• Care taken with selection of detergents
☺Weekly testing on water hardness
2.2 TREATMENT OF USED ITEMS
• Gross soil is removed as close to the point of

use as possible b/f being returned to CSSD
• Standard precautions are used at all stages of

handling used items
• PPE is available and is used where

appropriate.
☺A written description of the procedures is

available in all areas
☺Reusable drainage bottles are emptied at the

user level, avoiding spillage.
☺Soiled drapes and linen are placed in soiled

linen containers and sent for laundering.
2.3 DETERGENT & RINSE ADDITIVE RESIDUES
• Check washing machines daily to ensure there

is no chemical residue
☺ Instruments and equipment are free from

residue after the cleaning process
Sub Total
Annexure 2. Audit sheet for Housekeeping in CSSD area.
Area Yes
1. Wet mops floors (vacuum first if necessary, do not sweep)
2. Damp wipe all low-level ledges, shelves, and skirting and window ledges.
3. Remove splash stains and finger marks from walls and paintwork using damp cloth.
4. Empty waste bins, replace waste bags, and wash bins if necessary.
5. Clean all internal glass surfaces.
6. Wet wipe walls, wall fittings and ceilings. Clean light fittings.
7. Clean all ceiling air vents.
8. Check and clean as necessary around sinks, doors, etc.
9. Empty waste bins and wash inside.
10. Clean and polish all frontages of Autoclaves with Stainless Steel cleaner.
11. Cream clean sinks taps and surrounds. Remove debris from waste outlet.
12. Clean inside washer disinfectors according to manufacturers’ instructions
13. Clean inside washer sterilizers according to manufacturers’ instructions
14. Damp wipe pipe works, doors, door-frames and door handles.
15. Polish washer’s exterior with stainless steel cleaner.
Annexure 3. Chemical indicator for monitoring steam sterilization process
Table 1.Chemical indicators: The devices used to monitor exposure to one or more sterilization
parameters.
Class I: Process indicator that demonstrates that the package has been exposed to the sterilization
process to distinguish between processed and unprocessed packages.
Class II: Process indicators that are used for a specific purpose such as the dynamic air removal
test (formerly called the Bowie-Dick test).
Class III: A single-parameter indicator that reacts to one of the critical parameters of sterilization.
Class IV: A multi-parameter indicator that reacts to two or more of the critical parameters of
sterilization.
Class V (integrating indicator): An indicator that reacts to all critical parameters of sterilization.
Table 2: International Classes of Steam Chemical Indicators
Class Definition Use Examples
CLASS I: Process indicators

differentiate processed from containers) to indicate that the
Process Indicators
non-processed items item has been directly exposed
to the sterilant
ed to the outside
of packages chemical indicator strips
variable
CLASS II: Indicator for use in specific -Dick test

test procedures as defined in and steam penetration in
Indicator for Use in
sterilization standards vacuum assisted steam
Specific Tests
sterilizers
CLASS III: Indicator that reacts to a single

critical parameter in the
Single Variable
sterilization process to indicate
Indicator sterilization processes depend indicator strips
when a stated value has been
on more than one critical
reached (e.g., temperature)
variable
CLASS IV: Indicator that reacts to two or

more critical parameters in the monitoring indicator strips
Multi-variable
sterilization cycle under the
Indicator
conditions specified by the
manufacturer
CLASS V: Indicator that reacts to all

critical parameters in the monitoring. indicator strips
Integrating Indicator
sterilization process (e.g. time,
PCD as an
temperature, presence of
additional monitoring tool to
steam) and has stated values
that correlate to a BI release loads that do not

contain implants before results
of a BI test are known
CLASS VI: Indicator that reacts to all

monitoring
Annexure 4:Common Causes for Failure of a Bowie-Dick Test
Cause of Failure Description Possible Solution
Air Leak If air is able to leak into the autoclave Run a Vacuum Leak Testf to further
chamber, the steam will be unable to determine if an air leak exists or not.
penetrate the load to the point of total
sterilization.
Unwanted Condensation Occasionally condensation will get trapped Check the steam traps on the
in the jacket of the autoclave, which can autoclave. Check steam quality and
lead to cold spots at the base of the wetness.
autoclave. This could also indicate a wet-
steam issue.
Faulty Test Pack From time to time, a Bowie-Dick Test pack Check the expiration date and make
can be faulty. sure the packs are being stored in the
proper environment.
No Warm-Up Cycle A warm-up cycle allows the sterilizer Run a 5 minute sterilization cycle prior
chamber and jacket to reach temperature. to running the Bowie-Dick Cycle.
Incorrect Procedures Test packs work under very specific Test packs should be placed in an
conditions. empty chamber directly over the drain
on the bottom rack or shelf. They are
designed for use at 270°-273°F (132°-
134°C).
Annexure 5. Characteristics and Clinical Goals of Sterilization Wrap
Characteristics Clinical Goal(s)
Barrier effectiveness Ability to prevent microbial penetration and maintain
sterility of surgical pack and prevent penetration of
liquids (ie, repellent)
Penetrability (steam) Allows steam to penetrate

Penetrability (eg, ethylene Allows sterilizing gases or plasmas to penetrate
oxide; low temperature
gas plasma)
Aeration Permits aeration post-sterilization (ie, allows ethylene
oxide to dissipate)
Non-toxic Promotes patient and personnel safety
Minimal wrap memory Permits aseptic delivery of the contents to the sterile field
Drapeability Conforms to equipment pack; contours smoothly and closely
Flexibility Adequate sizes to accommodate any sized or shaped item
Puncture resistance Resists puncture
Tear strength Resists tears
Toxicity Non-Toxic
Odor Odorless
Low linting Minimal linting during use
Cost Low cost during use
Waste disposal Adheres to local and state solid waste disposal guidelines
LIST OF ABBREVIATIONS
CSSD Central Sterile Services Department; Central Sterile Supply Department

PPE Post Exposure Prophylaxis
HLD High Level Disinfection
ETO Ethylene Oxide
MSDS Material Safety Data Sheet
OT Operation Theatre
OPA Ortho-phthalaldehyde
TURP Trans-urethral resection of prostate.
ORIF Open reduction, internal fixation
H2O2 Hydrogen Peroxide
SCORING SYSTEM
Scoring System: Scoring Process

0 = ACCEPTABLE AS Standard Interpretation:
•SHALL = Mandatory A B
Score 0 or 1 as appropriate
1 = UNACCEPTABLE
SHOULD = Recommended Column A = Achieved score
N/A = NOT APPLICABLE
Mark  or x Column B = Total Possible score
Note: These points are not

included in the scoring system.
Action
Section Standard Compliance
Timeframe
0 1 N/A
2 HANDLING OF USED ITEMS
2.1
WA TER QUALITY FOR CLEANING
Clean water supply of good quality (Sample) 0/1
0
Care taken with selection of detergents 1/1
1
 Weekly testing on water hardness  or x x7
2.2 TREA TMENT OF USED ITEMS

 Gross soil is removed as close to the point of use as possible b/f being returned to 0
CSSD
 Standard precautions are used at all stages of handling used items
1
 PPE is available and is used where appropriate. 0
 A written description of the procedures is available in al areas x
 Reusable drainage botles are emptied at the user level, avoiding 
spilage.
 Soiled drapes and linen are placed in soiled linen containers and sent for 
laundering.
2. DETERGENT & RINSE ADDITIVE RESIDUES N/A

3 Check washing machines daily to ensure there is no chemical residue
- Instruments and equipment are free from residue after the cleaning
process
Sub Total 2 6
Scoring System: AS Standard Interpretation: Score Process
0 = ACCEPTABLE A B
• SHALL = Mandatory
1 = UNACCEPTABLE Score 0, 1 or N/A as appropriate
N/A = NOT APPLICABLE Column A = Achieved score

 SHOULD = Recommended
Column B = Total Possible score
Mark x or 
Note: These points are not included
in the scoring system.

Section Standard Action
Compliance Timeframe
0 1 N/A
1 SCOPE AND GENERAL
1.1 SCOPE
• There is a copy of AS4187 – 2003 in the CSSD /sterilising area
• The standard is not applied to items intended for single use only, nor to
items that may be contaminated with unconventional infective agents e.g.
CJD, nor for goods such as dressings and bandages which should be
2
obtained from commercial sources, ready for use.
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.4 PROCESSING ENVIRONMENT
• The planning and construction of any new facility or major refurbishment of
existing facility includes the principles of environmental control to minimise
 Inparticulate
a new o renovated facilityand
contamination consideration
bioburden.is given to workflow, with
separated designated areas for cleaning, pack preparation, sterilisation and
- Existing
storage;sterilisng facilities
wal, floor, surface make everyairflows
finishes, endeavour
and to
airconform to the
conditioning.
requirements of clause 1.4

1
1.5 REPROCESSING OF INSTRUMENTS AND EQUIPMENT

• Prior to use or reuse, every item is cleaned, or cleaned and disinfected or
sterilised
• Any as appropriate
item used for intended
to enter a normally usesite/tissue
sterile is sterile for use
• Explanted medical/dental devices are not reprocessed
Implantable items are purchased in a sterile condition

3
Section 1 TOTAL 6
SECTION ONE TOTAL SCORE
SECTION 1 TOTAL 6
Section Standard Compliance Action

Timeframe
2 CLEANING AND HANDLING OF USED ITEMS 0 1 N/A
2.1 WATER QUALITY FOR CLEANING

 Clean water supply of good quality
 Care taken with selection of detergents and drying agents
Weekly testing on water hardness and records are kept

2
2.2 INITIAL TREA TMENT OF USED ITEMS
 Gross soil is removed as close to the point of use as possible, as soon as
possible before being returned to CSSD - dry wiping, damp wiping and rinsing
 Standard precautions are used at all stages of handling used items
 PPE is available and is used where appropriate.

 A writen description of the procedures is available in al areas
 Al single use items are discarded appropriately after use

 Soiled drapes and linen are placed in soiled linen containers and sent for
laundering.
3
2.3 COLLECTION PROCEDURES
 Procedures for the collection of used items from wards, OR and other
departments have been formulated.
 There is separate procedures/arrangements for the collection of used itmes
and the delivery of sterile items
2
2.4 COLLECTION EQUIPMENT
 Collection containers are puncture resistant, leak-resistant & have a lid that
can be closed
 Container or trolley is cleaned at the end of each round

 Containers and troleys are metal or plastic, capable of being cleaned
2
Section 2 Sub Total 9
Section Action
Standard
Timeframe
2.5 CLEANING AREA
 There is a physically separate cleaning area to prevent possible
contamination of processed items
 Written policy on the methods, and frequency of cleaning the area and
equipment
Equipment in cleaning includes (recommended):

 Separate hand washing facilities
 Adequate bench space
 Smooth surfaces without crevices
 Good lighting
 Efficient ventilation – min. 10 air changes ph with –ve pressure to
sterilising area - (AS 1668.2)
o o
 Temperature range maintained in the range 18 C to 22 C
 Adequate storage space for materials and equipment
 Adequate waste disposal bins
Non -slip flooring
 Sink suitable for disposal of liquid waste
 Cleaning sinks
 Ultrasonic cleaners (AS 2773
 Washer/disinfectors (AS 2945)
 Drying equipment
 Non-porous work surfaces for efficient cleaning
 Adequate plumbing with ease o f maintenance

 Appropriate workflow and traffic flow from reception to distribution of
items
2
2.6 SORTING OF ITEMS PRIOR TO CLEANING
 All items that have been unwrapped for use are considered to be
contaminated whether they have been used or not and are subjected to the
full cleaning process
 A check of completeness and defects is made during sorting.

 There is written procedures for handling specialised items, including loan
instruments and sets.
 On receipt, items are sorted according to type and cleaning method
Action
Section Standard
Timeframe
2.7 CLEANING PRECAUTIONS
• Care is taken to avoid direct contact with skin when using detergents,
disinfectants and other chemicals
Techniques of cleaning avoid generating aerosols
 Single use suction tubing is used (recommended)

 If accidental exposure does occur, the affected area is washed with copious
amounts of clean water and treated in accordance with MSD sheets
 There are documented procedures to minimise risk of damage to instruments
through inappropriate cleaning methods and materials
 Abrasive cleaners(steel wool or abrasive powders and pastes are NOT used
1
2.8 CLEANING AGENTS
• The Material Safety Data Sheet (MSDS) is read before using agent
• Cleaning agents are used to remove soil - Appendix D
• Product Data Bulletins and MSDS are obtained for all cleaning agents and
chemical and requirements are implemented
• Cleaning agents are dispensed in a safe manner which does not
promote contamination of contents.
• Common household detergents are not used –high foaming, high residue
• Cleaning agents do not leave a residue
 Chemical suppliers have provided evidence regarding agents compliance

with Appendix D
 Chemical suppliers have provided chemical testing kits to test pH, chlorine
content, chlorine residue, and presence of iron and water hardness.
 Chemical suppliers have provided training fo r staff

 Detergent used is a mild alkaline detergent – pH range 8.0 – 10.8 (Some
items may require the use of neutral detergents)
 Acid-based agents are only used for stainless steel surfaces only
6
Section
Action
Standard
Timeframe
2.8 ENZYMATIC CLEANERS
Contd
• Rubber or nitrile gloves are worn and standard precautions observed if
handling enzyme cleaning agents
 Enzymatic cleaners are no used routinely, but used to soak items where
debris is congealed on them (exception - flexible endoscopes)
 MSDS pertaining to enzymatic cleaners are clearly displayed in work area

 The enzymatic cleaners used have multiple enzyme activity and are used
at the correct temperature and time and within their shelf life.
 Different commercial products are not mixed.
Agents for Manual Cleaning
• Biodegradable, non-corrosive, non-toxic, non-abrasive, low foaming,
free rinsing, preferably liquid and mildly alkaline
Agents for Mechanical Cleaning
• Biodegradable, non-abrasive, low foaming, free rinsing and preferably
liquid
Product is appropriately labeled
• Product name, manufacturer’s name & address, description & purpose,

dilution instructions, batch number, manufacture or expiry date, advice
not to mix with other chemicals, safety & first aid instructions, storage
requirements.
4
2.9 CLEANING METHODS
2.9.1 GENERAL
 Care is taken to ensure the cleaning process does not add to bioburden
 Cleaning methods are appropriate to the design of the items cleaned
 Cleaning methods are documented

 After cleaning the items are clean to the naked eye (macroscopic) and free
from any protein residues
4
2.9.2 MECHANICAL CLEANING
2.9.2.1 GENERAL
 Washer/disinfectors and ultrasonic cleaners are routinely cleaned and
maintained to prevent colonisation and formation of biofilms
1
2.9.2.2 BA TCH-TYPE WASHER/DISINFECTORS
 Mechanical washer complies with AS 2945
o o
 Final rinse water temperature is between 80 C and 90 C to ensure effective
function of drying agent
 Where multi-programmable washer/disinfectors are used, strict protocols are
in place for their operation and ongoing maintenance
2
Section Action
Standard
Timeframe
2.9.2.3 WASHER CYCLES
The washer cycle includes:

 Pre-rinse, with water
 Warm water wash with cleaning agent added
o o
 One or more hot water (80 C & 90 C) rinses with drying agent added
 Drain, leaving contents at a temperature for quick drying
 Drying, either radiant heat from an element or a hot air blast
2.9.2.4 SPECIFIC CONSIDERA TIONS FOR BA TCH-TYPE WASHERS – AS 2945-1 998

 There is minimal handling of soiled items
 Automatic dispensers are used to add correct amount of cleaning agents
 Items are positioned to ensure surfaces are exposed to the cleaning process
 Machine is maintained by skilled personnel
 Internal cleanliness of machine is maintained
 Performance is continually monitored and documented
 Care is taken when unloading items capable of holding residual water
2.9.2.5 ANAESTHETIC AND RESPIRA TORY WASHER/DISINFECTORS (AS 2945)

 Machine/cycle is used to rinse, wash and disinfect anaesthetic and
respiratory
The machine operates within the temperature ranges:
equipment not required
o to
o be sterile (semi-critical items)
 Rinsing – 40 C to 50 C Thermal Disinfection
o o o
 Washing – 50 C to 60 C 90 C for 1 minute
o o o
 Disinfecting – 70 C to 95 C 75 o
80 C for 30
10 minutes
o
o o 70 C for 100 minutes
Final rinsing – 80 C to 90 C
Machine is routinely cleaned and maintained to prevent colonisation and
formation of biofilms
6
2.9.2.6 MECHANICAL CLEANING OF ANA ES THE TIC INS TR UMEN TS & EQUIPMENT
 All equipment place in the washer is processed for a complete cycle
 All surfaces, including internal lumens are exposed to cleaning process
 Clean techniques are use when handling processed anaesthetic items
 Items are not dried in ambient air –mechanical drying is used (2.10)
 Hands are thoroughly clean when handling processed items

 Appropriate connectors are used for drying tubing & other lumened items
 Items not for immediate use are reassembled in a clean area
 Items are packed and clearly labelled for supply to user area
8
Section Action
Standard
Timeframe
Table BA TCH WASHERS

7.2 CALIBRA TION OF MEASUREMENT DE VICES/S YS TEMS
• On commissioning
• 6-12 monthly
• After repair
• Quarterly thermocouple temperature check
MONITORING
• Documented time at temperature

• Check every cycle for thermal disinfection
• Continuous performance checks for temperature and cleanliness of items
• Documented daily test for detergent or rinse residue - processed items are
selected at random, placed in a clean bowl of water, agitated and pH of
water measured
4
MAINTENANCE
• Quarterly preventative maintenance
• Descaling is performed as required
2
ROUTINE CHECKING AND CLEANING
• The functions of the washer/disinfector are checked daily
• Check and clean jets, filters, door, door gaskets and external surfaces
• Check detergent and rinse dispensers are clear and functioning correctly
• Check filters and door seals
4
Section Action
Standard
Timeframe
2.9.2.7 UL TRA SONIC CLEANER AS2773.2 (BENCH TOP)
 Approved detergent is added after tank is filled with water
 Degassing is performed before instruments are processed

 Instruments are rinsed free of gross soil prior to immersion
 Instruments are placed in basket supplied by manufacturer
 Instrument are rinsed in warm-to-hot running water after removal
from
 machine
Where fitted, pump and associated tubing are purged of cleaning
solution
 when the is‘tub’
The unit is empty
operated with lid closed to prevent emission of
aerosols and to
 prevent damage
No part of to hearing
the operator’s body is submerged into water during
operation
The manufacturers’ instructions are considered re. suitability of equipment
for ultrasonic cleaning
8
Table CALIBRATION OF MEASUREMENT DE VICES/S YS TEMS
7.2
 Not applicable
MONITORING
 Daily performance testing (Section 6, AS 2773.2)

o Aluminium foil test
o Pencil load test
1
MAINTENANCE
 Annaul electrical safety check
1
ROUN TINE CHECKING & CLEANING
 Checking filters and base plate
 Wiping external surfaces
 Emptying of tank at least daily or more frequently, as necessary
 Continuous checks for correct functioning of switches, gauges and
lights
4
2.9.3 MANUAL CLEANING
2.9.3.1 GENERAL
 Delicate or complex instruments are carefully hand-washed and
rinsed
 Cleaning equipment is non-abrasive and maintained in good
condition
 Cleaning equipment is thermally disinfected or sterilised at the
end of each cleaning session
 When not in use, it is stored clean and dry
 Reusable cleaning brushes are cleaned and thermally disinfected
after each use
5
Section Action
Standard
Timeframe
2.9.3.2 The folowing are available (recommended):
 Clean water supply of good quality (Section 2.1)
 At least two sinks large and deep sinks
 Smal brush with firm plastic bristles, able to withstand cleaning agents
 Light grade nylon o r similar non abrasive scouring pad
 Cleaning agent
 Wire dental burr brush
 Non-linting clotr hes (adequate supply for f equent changing)

0
2.9.3.3 METHOD OF CLEANING (For iems that do not have electrical components, or
t
are not power tools operated by compressed air) – (recommended)
o o
 Item flushed with running water, 15 C – 30 C, to remove gross soiling
o
 Sink filed with warm water (approx 45 C) and detergent
 Al items dismantled or opened prior to placement in cleaning solution
 Items held low in sink to limit generation o f aerosols
 Al surfaces, including lumens and valves, are washed

 Stubborn stains are removed using a non-abrasive pad or soaking in stain
removing solution
 Items received a final rinse in warm-to-hot running water
 Items are dried in a drying cabinet (holowware is inverted)

0
2.9.3.4 MANUAL CLEANING OF ANAESTHETIC & RESPIRA TORY EQUIPMENT

• Anaesthetic and respiratory equipment is washed in a mechanical washer,
not washed manually
• Semi-critical anaesthetic and respiratory equipment is thermally
• Disinfected or sterilised (or both) between uses

• Where thermal disinfection is not available, semi-critical items are sterilised
or are single-use devices
4
2.10 DR YING OF ITEMS
2.10.2 DR YING METHODS
•A drying cabinet is used for tubing and anaesthetic equipment
o o
• The cabinet operates between 65 C – 75 C
• Drying cabinets complies with AS 2514 or AS 2774
 A drying cabinet is used for instruments and holowware
 When manual drying a lint free cloth is used
 Items are not dried in ambient air
 Alcohol o r other flammable liquids are not used as a drying agent (exception
– endoscopes)
3
Section Action
Standard
Timeframe
Table
DRYING CABINET
7.2 CALIBRATION OF MEA SUREMENT DE VICES/S YS TEMS
• On commissioning
• 6 –12 monthly
• After repair
• Annual thermocouple check

4
MONITORING
• Documented daily visual temperature check
1
MAINTENANCE
• Quarterly preventative maintenance
1
• Daily surface clean
• Filters and door seals checked and cleaned

2
2.11 MONITORING OF CLEANING PROCESSES
• Detergent and rinse additive containers are replenished when necessary
• There is a continuous visual inspection of cleaned items
 Instruments and equipment are free from residue after the cleaning process
 Commercialy available soil tests are used to verify cleaning efficiency
2
Section 2 Sub Total
10
Section Action
Standard
Timeframe
App B CARE AND HANDLING OF POWERED TOOLS – INCL UDE DENTAL
B2 HANDPIECES CLEANING OF POWERED INS TRUMEN TS AND HOSES
 Instruments kept free of gross soiling during procedure by wiping with dry
sponge or a sponge moistened with sterile water
 In CSSD instrument is cleaned with a non-linting cloth moistened with
detergent and water
 Powered surgical instruments and hoses are NOT immersed in water or
placed in automated or ultrasonic cleaners
 Unless otherwise recommended by manufacturer, hoses remain attached
to hand pieces during cleaning
 Hoses and cords are inspected for damage and wear
 All traces of detergent are rinsed from instruments
 Instruments and air hoses are wiped with a clean non-linting cloth to
remove excess water
 A drying cabinet or second non-linting cloth is used to dry powered
instruments and hoses
8
B3 LUBRICATION
 Items are lubricated only when necessary and according to
manufacturer’s
written instructions
 Lubricants are not allowed into the hose when lubricating external
movable
fittings on air hose
 If required, instruments are operated after lubrication to ensure dispersal of
lubricant
Care is taken not to generate aerosols during lubrication process
2
B4 INSPECTION AND TESTING
 Instrument is tested before packaging and sterilisation
 Triggers and handles are in the safety position when changing attachments
 Medical grade compressed air or compressed dry nitrogen is used
 Instruments are operated at the correct pressure
 The rate is set while the instrument is running
 Damaged instruments and hoses are sent to an appropriately qualified
 technician or returned to the manufacturer for repair
 Powered tools requiring repair are cleaned and disinfected or sterilised
 If it is not possible to clean and decontaminate the item it is packaged in a
 container, sealed and labelled with the relevant hazard warning
 The health care facility complies with requirements for transporting
 biohazardous goods
9
B5 STERILISATION
 Powered surgical instruments are disassembled before sterilisation
 These items are packaged prior to sterilisation
 Delicate and sharp parts are protected
 Hoses are coiled loosely when packaged for sterilisation
4
Se c t io n 2 Su b T o t a l 23
SE C T I O N 2 T O T A L 131
Section
Compliance Action
Standard
Timeframe
0 1 N/A
3 PACKAGING AND WRAPPING OF USED ITEMS PRIOR TO STERILISATION
3.1 GENERAL
 Each material used is tested to establish penetration times and drying
characteristics
 Materials used are compatible with the items being packed and the
sterilising method selected
 Textile wraps are laundered prior to use
 Single wraps are used once and discarded
 Combinations of hollowware, instruments, dressings, drapes or tubing are
not
incorporated into a single pack
5
3.2 PACK SIZE
• Maximum size of packs has been established during the performance
qualification process (Section 8 and Appendix H)
• If contents of pack are wet, the pack is deemed unsterile and is not used
2
3.3 LABELLING PRIOR TO STERIL ISA TION
 Prepared labelling or non-toxic solvent-based felt-tipped pens and rubber
stamps
are used
 Labelling includes contents of pack, batch control data
 Sharp-tipped, water- based or ball-type pens are not used.
3
3.4 SPECIFIC REQUIREMENTS
3.4.1 INSTRUMENTS
• Ratchet instruments are remain open and unlocked
• Multi-part instruments are disassembled or sufficiently loosed prior to packaging
to allow contact with sterilisation agent
 Sets are packed to prevent damage to delicate items
 Instrument trays are perforated
2
3.4.2 HOLLOWWARE
• All openings face the same direction
• Items cannot move inside pack
• Stackable
hollowware packaged together are separated by non-porous spacers
when nested
 Holowware is placed with opening against the paper and not the plastic
(Section 3.4.3.3)
3
3.4.3 TYPES OF PA CKING & WRAPPING MA TERIALS
3.4.3.1 -Appropriate packaging materials are selected for the different sterilisation
processes (See Table Page 25)
15
Section 3 Sub Total
Section Action
Standard
Timeframe
3.4.3.2 WRAPS
 Textile linen wraps comply with AS 3789.2

 Linen with defects such as holes and threadbare patches are not used
 Heavy woven fabrics such as canvas, are not used
 Recyclable barrier fabrics comply with AS 3789.8
 Paper wraps conform with AS 1079.2
3.4.3.3 FLEXIBLE PACKAGING MATERIALS

 Tips of sharp instruments are protected to prevent damage to laminated
 Laminated packaging is placed on its side in the steriliser

Pouches
 Holowware is placed with opening against the paper and not the plastic
3.4.3.4 NON-POROUS, NON-CELLULOSE BASED MATERIALS
• Except for dry heat sterilisers, nylon packaging is not used
1
3.4.3.5 Celulose-based and non-celulose based non-woven wraps
• Where used they conform to AS 1079.5
1
3.4.3.6 RIGID REUSABLE STERILISA TION CONTAINER SYSTEMS
 Containers allow penetration and removal of sterilising agent, and maintain
sterility following the process
1
App E SELECTION AND USE OF RIGID REUSABLE STERILISA TION CONTAINERS

E3 SPECIFIC CONSIDERA TONS
E3. 1 ACQUISITION
 Filters adequate to ensure sterility maintenance
 All components are easily disassembled for cleaning, drying and storage
 For DD and benchtop steam sterilisers, the base and lids are perforated
 Containers are compatible with cleaning and sterilisation methods and equipment
 Cleaning, drying, storage and transport systems are compatible with additional
bulk of containers
 Adequate trials have been undertaken to assess use of container systems

 On-site testing using physical and biological testing, and efficiency of drying cycle
have established compatibility of container system with sterilising process
7
E3.2 INSPECTION AND MAINTENANCE

 After cleaning and drying a visual inspection is made to establish that the
trays and lids are not dented and seals/gaskets are intact
 A check is made that correct filters are properly fastened in place
Section Action
Standard
Timeframe
E3.3 LOCKING MECHANISMS
 Containers have a locking device which is tamperproof, non-resealable and

has a built-in chemical indicator
 The manufacturer has provided education re. use of locking device
2
E3.4 VALIDATION
 On-site testing using physical, chemical and biological testing, has
established
that container system will achieve sterilisation of contents
 Seals, gaskets and filter-retention plates are visually inspected after
cleaning and before each use.
 Any change in the use of container system is validated by biological and
physical testing
3
E3.5 PACKING TECHNIQUES AND PROTECTION OF INSTRUMENTS
 Containers packed to allow for penetration of sterilising agent
 Containers are not overloaded
 Hollowware and textiles are not mixed in the same tray
 Lids are able to be removed without contaminating the contents
 Where used, internal wraps can be opened without risk of contamination
of the contents
 Filters and retaining mechanisms are easily visible and secure
 Instrument retaining mechanisms are used to protect instruments
7
E3.6 MASS
 The mass of the container and content allows for sterilising parameters to
be met
 The mass of container and contents complies with manual handling
standards
2
E3.7 STORAGE
 Containers are compatible with storage shelving systems and space before
and after sterilising process
1
E3.8 ERGONOMICS
 Design allows for ease of use
 Handles allow containers to be lifted easily
 Design allows for easy removal of basket and trays without contamination,
damage to contents and strain to operator
3
E3.9 FIL TERS – where required

• Single use filters are discarded after use
• For reusable filters - Written data from manufacturer has been obtained
regarding validation for re-use
• Method for affixing filters provides reliable integrity of system
Section Action
Standard
Timeframe
E3.10 TRANSPORT
 Transport systems prevent damage to containers, their lids and contents
 Transport system has adequate weight bearing capacity for number and
type of
container system used
2
TABLE 3.1 NOTE 1
 Packed and wrapped items are not sterilised in a “flash” steriliser
1
3.6 SEALING OF PACKS
3.6.1 GENERAL
 Staples, pins, inappropriate tape or taping methods are NOT used
 String, non-adhesive tape and elastic bands are NOT used
2
3.6.2 HEA T SEALING - APPENDIX F (Page 115)
 Seals are checked to ensure complete seal
 Laminated pouch sealing complies with AS1079.4
 Suitable heat sealing equipment is used
2
Table 7.2 HEAT SEALER
CALIBRATION OF MEASUREMENT DE VICES/S YS TEMS
 On commissioning
 6-12 monthly
 After repair
3
Monitoring
 Daily check of seal integrity pre and post sterilisation
1
MAINTENANCE
 Adjustment of gap between heating elements at least quarterly (according
to
manufacturers specifications
1
 Daily wipe of external surfaces
 Continuous checks for correct functioning of switches, gauges and lights
2
Section
Action
Standard
Timeframe
3.6.3
STERILISING INDICA TOR TAPE
 Tape is appropriate for the mode of sterilisation
 Tape is compatible with wrapping material used
 Tape colour change after exposure is clear, distinct and uniform and markedly
different to unprocessed tape
 Tape has name of manufacturer, batch number and date of manufacture on
the core
 Tape is heat stable, moisture stable and permeable to sterilising process
 Indicator tape is removed from textile wraps before returning to linen service
 Tape adhesive is pressure-sensitive, non-toxic and adheres to clean surfaces

and leaves no adhesive residue on removal
 The use o tape to seal bags and pouches is only used in the absence o a heat-
sealing machine or when the machine is broken down.
 Where tape is used to seal a bag, the bag is sequentialy folded over 2 – 3 times
prior to taping across the entire folded edge with one continuous piece of tape
extending at leat 25 mm around the back of bag on both sides
6
SECTION 3 TOTAL 73
Section Action
Standard Compliance
Timeframe
0 1 N/A
4 STERILISING EQUIPMENT
GENERAL
 Heat bead devices, microwave ovens, pressure cookers, incubators, UV
cabinets, boiling water units, ultrasonic cleaners and similar appliances are
4.1
not used as sterilisers – they will not sterilise
1
4.2 STEAM STERILISERS
 An operators manual is in the vicinity of the steriliser at all times
 Operator has verified that the items is suitable for steam sterilisation
 The cycle time and temperature reflects the type of load and packaging
material being processed
 Steam – dryness fraction of 97% or above

 Steam is not heated beyond 2oC above sterilising temperature
(superheated)
 Penetration times have been established and added to the holding time
o o o
(121 C-15 mins, 132 C-4 mins, 134 C-3 mins)
 Manufacturers instructions for operating steriliser are folowed
6
DOWNWARD DISPLACEMENTSTERILISER (HORIZONTAL)
 Complies with AS 2192
 Ability of steriliser to achieve sterilisation of cannulated instruments has
4.2.2 been established at the time of validation.
 Drying time is determined by size and density of packs
3
 ‘FLASH’ STERILISER
 Used for dropped, single instruments where there is no sterile duplicate

available only
 Cannulated, complex instruments, suction and other tubing are not ‘flash’
sterilised
4.2.3
 Used for unwrapped non- porous items only
 The ‘flash’ sterilising process is monitored to ensure efficiency
‘Flash’ steril ising is not used as a convenience o as a cost saving
mechanism – adequate instruments are available
5
BENCH TOP STERILISER
 Without a drying cycle – sterilise unwrapped items only
4.2.4  Drying process via mild heating of chamber while door remains closed –
used for small numbers of simple packs (scissors, forceps) packed in paper
bags
 Portable pre vacuum sterilisers – appropriate requirements of AS 1410 are
applied
4
Section
Action
Standard
Timeframe
4.2.5 PREVACUUM STERILISER
1
4.3 DRY HEA T STERILISER (HOT AIR TYPE)
 The door of the steriliser is not opened during the cycle
2
4.4 LOW TEMPERA TURE STERILISERS AND LIQUID STERILANTS
4.4.2 ETHYLENE OXIDE STERILISERS ISO 11135

 Gas concentration not less than 400 mg/l
o
 Temperature not less than 36 C on cool cycle
o
 Not greater than 60 C on warm cycle
 Relative humidity greater than 40% but less than 100%

 Time is appropriate for temperature and gas concentration
 Reference has been made to instrument manufacturer’s instruments
when using EO – gases can adversely affect some materials
5
4.4.3 HYDROGEN PEROXIDE PLASMA STERILISERS
4.4.4 PERACETIC ACID STERLISING EQUIPMENT

4.4.5 LIQUID STERILANTS
• Any liquid sterilant used is registered with the TGA

Section 4 Total 28
Section Action
Standard Compliance
Timeframe
0 1 N/A
5 LOADING OF STERILISERS
5.1
STEAM STERIL ISA TION
5.1.1
GENERAL
The sterilising load is commences immediately after loading
Loads are not pre-heated

2
5.1.2 LOADING PORTABLE, DOWNWARD DISPLACEMENT AND PRE- VACUUM
STERILISERS
 Hollowware is tilted on edge in a draining position
 Packs of drapes are loaded with layers vertical
 Items do not touch chamber walls

 Laminated pouches are loaded on edge with paper to laminate or flat
with paper surface down
 Hollowware items are packed with the opening against the paper
 Loading carts are loosely loaded to capacity
 Only a single layer of packs is placed on each tray

 Racks are used to alow for adequate separation of packaged
instruments
 Packs of holowware and trays of instruments are NOT place above

textile packs
7
5.1.2.2 ‘FLASH’ STERILISERWITHOUT A DRYING STAGE
 Items are not bagged or wrapped
 Items placed on a perforated or mesh tray
 Tray placed flat on steriliser shelf

 A new chemical indicator is place in each tray being processed
 Performance of specificaly designed containers for sterilising and
transporting ‘flash’ sterilised instruments has been established
4
5.2.2 DRY HEAT STERILISATION
 Space is left between items to allow adequate circulation of air
 Items are not in contact with chamber walls

2
5.3 ETHYLENE OXIDE GAS STERIL ISA TION
5.3.2 BASKETS AND LOADING CARS
 Items are placed in a metal basket or on a metal rack or loading
cart
1
Section Action
Standard
Timeframe
5.3.3
LOADING OF BASKETS AND LOADING CARS
 Items are placed loosely within the confines of the basket or loading car
 Packages do not touch chamber walls

 Items in flexible packaging materials are loaded on edge with paper to
laminate, or flat with paper down
3
5.4 HYDROGEN PEROXIDE PLASMA STERILISA TION
5.4.2  Space is left between items to allow adequate circulation of the sterilising
agent
 Items are well away from chamber walls

2
5.5
PERACETIC ACID LIQUID CHEMICAL STERILISA TION
5.5.2.1
DIRECTED FLOW PROCESSING CON TAINER/TRAY
 Care is taken to load machine in a manner that wil alow penetration of
liquid sterilant to al surfaces
5.5.2.2 FLEXIBLE PROCESSING TRAY

 Each instrument channel is directly connected to the machines fluid
npathways via a purpose-designed tubing adaptor kit
 Instrument manufacturer’s insructions regarding leak and pressure

testing are considered before loading flexible endoscopes into the machine
1
5.6 • Care is taken to ensure load content and manner of loading facilitates
air removal and steam penetrations
- For al other methods of sterilisation consideration is given to
manufacturer’s instructions regarding load content and loading techniques
1
Section 5 Subtotal 7
Section 5 Total 23
Section Action
Standard Comliance
Timeframe
0 1 N/A
6 UNLOADING OF STERILISERS
6.1 STEAM STERILISERS
6.1.1 WITH DR YING STA GE
 On completion of drying stage the load is immediately removed
from steriliser
 A visual inspection is made to ascertain that the load is dry, and
the sterilising indicators have made the required colour change
 On removal of load the recording charts or printouts are
checked and designated record sheets are signed that required
parameters have been met
 Supervisor is notified if deviation of any parameter is detected
 Loading carts with cooling items are kept away from high
activity areas
 Forced cooling with fans or boosted air conditioning is NOT
used.
 Cooling items are NOT placed on solid surfaces
 Damaged, wet or dropped items are considered unsterile and
are reprocessed
 Where unwrapped items are sterilised, appropriate handling
procedures for unloading have been developed and documented
9
FLASH STERIL ISA TION (without a drying stage)
 Wrapped items are not sterilised without a drying stage
 Procedures for unloading ‘flash’ have been developed and
6.1.2 documented
 Sterile ‘set up’ personnel wear a surgical mask and full sterile
attire when transferring items from steriliser to point of use
3
PERACETIC ACID LIQUID CHEMICAL STERILISA TION
 When complete the air seal is released to access instruments
 Chemical indicator strip is visually inspected for colour change
 Load print out is checked to confirm parameters have been met
 Where instruments are transferred directly to sterile field,
6.5
procedure in 6.1.2 is followed
 Attachments for purging of chemical steriliant are checked to
ensure they have remained attached to instrument throughout
cycle
5
MONITORING OF UNLOADING PROCEDURE
• Procedures for unloading each type of steriliser have been
developed and documented
6.6
• Compliance with procedures are monitored (section 8)
2
TOTAL SECTION 6 19
SECTION SIX TOTAL SCORE Section 6 Total 19
Action
Section Standard Compliance
Timeframe
0 1 N/A
7 PURCHASING, COMMISSIONING,
CALIBRATION, PERFORMANCE TEST, MAINTENANCE AND VALIDATION
7.1 GENERAL
Al stages of the sterilisation process have been developed and
documented to ensure that the items can be sterilised
 Cleaning
 Inspection
 Assembly
 Packaging
 Loading
 Sterilisation Cycle
 Calibration, routine monitoring and recording
 Unloading
 Storage
 Distribution
 Validation of the process
 The process can be reliably reprocessed
 The process is routinely monitored to the desired probability of a 13
non-sterile item
7.2 PURCHASING
 All new sterilisers and associated equipment purchased complies with
appropriate Australian Standards
 AS 1410
– Pre vacuum Steriliser 
 AS 2182
– Sterilisers-Steam-Benchtop 
 AS 2192
– Sterilisers-Steam-Downward displacement 
 AS 2437
– Flushers/sanitisers for bedpans & urine bottles 
 AS 2487
– Dry heat sterilizers 
 AS 2514
– Drying cabinet for medical equipment 
 AS
2773.1 – Ultrasonic cleaner-non portable 
 AS
2773.2 – Ultrasonic cleaner-benchtop 
 AS 2774
– Drying cabinet for respiratory equipment 
 AS 2945
– Batch-type washer/disinfector 
 AS 3836
– Rack conveyor washers 
 Instalation qualification and operational qualification are included as
part of the purchasing agreement with the supplier of al associated
equipment
1
VALIDATION
COMMISSIONING OF STERILISERS
7.3 GENERAL
7.3.2  The tests and check to be performed during commissioning are
7.3.2.1 specified, documented and recorded
1
Section Carried
Action
Standard Forward
Timeframe
7.3.2.1  These include:

Contd  calibration of all gauges, recording equipment and indicators,
 parameter monitoring,
 specific steriliser performance tests, and
 any process indicator tests
1
7.3.2.2 INS TALLA TION QUALIFICATION
 IQ demonstrates the steriliser and the area in which it is installed comply
with the manufacturer’s specifications
1
7.3.2.3 OPERA TIONAL QUALIFICATION
 OQ demonstrates that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
1
7.3.3 PERFORMANCE QUALIFICATION
 PQ demonstrates the attainment of the required sterilising conditions
throughout the specified load(s)
 PQ has been achieved through:
o Verification of physical parameters
o Demonstration of microbiological lethality
 If used – process challenge devices are in accordance with EN 867-5
 Each sterilisation process and each type of steriliser load and loading
pattern for the PQ process is specified and documented
 PQ is performed after completion of commissioning and
 On the introduction of new or modified items,
 New or modified packaging/loading patterns,
 New or modified or processing parameters (unless equivalence, either
to validated reference loads or cycles or to a previously validated
product, packaging or loading pattern, is demonstrated)
5
7.3.4 CERTIFICATION OF PERFORMANCE QUALIFICATION OF STERILISER
 Reports on commissioning, PQ, recommissioning and performance
requalification have been prepared and signed and a copy filed in the
sterilising processing facility
1
7.4 RECOMMISSIONING AND PERFORMANCE REQUALIFICA TION
7.4.1  The recommissioning and performance requalification process is documented
and a copy filed in sterilising facility
1
Section Action
Standard
Timeframe
7.4.2 RECOMMISSIONING
 Recommissioning is performed if:
 Changes or engineering work is carried out on equipment which could
effect the performance of the steriliser
 A review of records indicated unacceptable deviation(s) from data
determined during validation
 The responsibility for determining the necessity and extent of repeating
elements of commissioning is assigned to a designated person trained in this
speciality
 Recorded data for each type of test or check during recommissioning is within
specified limits of the data recorded during commissioning
3
7.4.3 PERFORMANCE REQUALIFICA TION (PReQ)
 PReQ is performed at least annually and whenever a change is made to a
steriliser load which is not within the limits specified in the performance
qualification report
 The responsibility for determining the necessity and extent of repeating
parts of PReQ is assigned to a designated person trained in this speciality
2
7.5 CALIBRA TION OF STERILISER
 A calibration schedule, based on the steriliser history, has been established
and maintained
 Documentation is requested from the service provider that includes:
o Actual and adjusted values
 When faults arise corrective action is taken
 Routine calibration checks and maintenance o al measuring devices,
timers, gauges and displays on steriliser are checked by a trained
competent person
 Measuring equipment is certified by a recognised certification body e.g. (NATA)
 The report is made available and includes the certification number of the
calibration device used
3
7.6 MONITORING OF STERILISER
 Routine sterilisation cycle performance is monitored accordance with the
test frequencies specified in Table 7.1 (attached)
1
Section Action
Standard
Timeframe
7.7 MAINTENANCE OF STERILISERS
A preventative maintenance schedule, based on the history of the
equipment is established and maintained.
 Where faults arise, corrective action is undertaken
 A preventative maintenance contract is entered into with a trained
competent maintenance contractor or the equipment manufacturer
 Where this is not possible a skilled person has been trained for the task
 Filters on equipment are checked every 6 months and results recorded
 A program of routine replacement or revalidation of filters has been
established
 A cleaning and maintenance program is in place
 After repairs testing is done to establish compliance with original
installation or operation qualification specifications
 Repairs are assessed to establish if they have altered the performance of
the equipment since most recent validation
8
7.8 ASSOCIA TED EQUIPMENT
7.8.1 GENERAL
 This may include:
 Drying cabinets
 Aeration cabinets
 Batch washers
 Rack conveyor washers
 Ultrasonic cleaners
 Heat sealer
1
7.8.2 VALIDATION OF PROCESSES
 Processes for associated equipment have been established, documented
and validated
1
7.8.3 COMMISSIONING
 All associated equipment has under gone a commissioning process
 Reference is made to the applicable Standard and the manufacturer’s
operational instructions for guidance on the commissioning procedue for each
type of associated equipment
1
Section Action
Standard
Timeframe
7.8.4 PERFORMANCE QUALIFICATION
 The PQ consists of the following three steps:
 Choice and performance and practical test(s) to evaluate proper
functioning
 Determination that operating conditions are being reliably achieved
 That gauges, where fitted, are indicating accurately
 Test results are documented
(Not all associated equipment can undergo PQ – refer to applicable
Standard for guidance)
1
7.8.5 RECOMMISSIONING AND PERFORMANCE QUALIFICATION
 Where performance or qualification procedures are not applicable
recommissioning (usually only OQ) is undertaken at least annually
 Where applicable, performance requalification is undertaken annually
2
7.8.6 CALIBRA TION, MONITORING AND MAINTENANCE
 A preventative maintenance contract is entered into with a trained
competent maintenance contractor or the equipment manufacturer
 Or a skilled person has been trained for the task
 Calibration, monitoring and maintenance of associated equipment is
performed in accordance with Table 7.2 (attached)
3
TOTAL SECTION 7 51
CALIBRATION, MONITORING AND MAINTENANCE OF ASSOCIATED EQUIPMENT Pre-
vacuum Steriliser –
Table 7.1 ACTION REQUIRED
CALIBRATION OF IQ, OQ, PQ, recommissioning and PReQ
MEASURMENT
3, 6, 12 monthly – depending on calibration history
DEVICES/SYSTEMS
MONITORING Daily: External chemical indicator
Leak rate test where no air detector
Bowie Dick test
Weekly: Leak rate test if air detector fitted
Every Pack: External chemical indicator
Every Cycle: Electronic printout
Optional: Biological/enzymatic indicator
Internal chemical indicator
Process challenge devices
Electronic data loggers
AFTER REPAIR OR Recommissioning or PReQ as required depending on
MODIFICATION the extent of the repairs or modification (7.4)
MAINTENANCE Monthly, quarterly or annually – as established by HCF
in conjunction with manufacturer or maintenance
contractor
ROUTINE CHECKING AND Daily Check: Floor is free of debris
CLEANING Chamber drain and filter are clear
Correct functioning of recording
devices, gauges and timers
Door gasket – undamaged
Cleaning: Loading tray and external surfaces
cleaned daily
Steri liser chamber cleaned weekly
CRITERIA FOR RELEASE OF Achievement of set cycle parameters
PROCESSED ITEMS Correct colour change of chemical indicators
Packaged items dry and intact
Correct result of BI/EI, process devices or data loggers
DOWNWARD DISPLACEMENT (JACKETED) (AS 2192) AND PORTABLE BENCHTOP (AS

2182) WITH DRYING CYCLE

MEASURMENT
DEVICES/SYSTEMS
MONITORING Every Pack: External chemical indicator

Internal chemical indicator


contractor

Cleaning: Loading tray and external surfaces
cleaned daily
Water reservoir emptied and cleaned –
portable type

Packaged items dry and intact
DOWNWARD DISPLACEMENT (NON JACKETED) (FLASH) WITHOUT DRYING CYCLE

(AS 2192)

MEASURMENT
DEVICES/SYSTEMS
MONITORING Every Cycle: Electronic printout

Chemical indicator (Class 4,5,or 6)


contractor

Water reservoir (portable types)
Cleaning: Loading shelves and external surfaces
cleaned daily
Water reservoir emptied and cleaned –
portable type
CALIBRATION OF According to manufacturer’s recommendations

MEASURMENT
DEVICES/SYSTEMS
MONITORING Every Cycle: Electronic printout

Chemical indicator
Daily: Diagnostic cycle
Weekly: Biological indicator


contractor (or both)
ROUTINE CHECKING AND Daily Check: (According to manufacturer’s

CLEANING recommendations)
May include: Drip pan, Chamber drain, Water filter,
Air filter, Recording device, Lid seal and
carrier
Cleaning: Carriers, containers and external
surfaces cleaned daily

COMMENTS:
…………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………..
H Y D R O G E N P E R O X ID E P L AS M A
CALIBRATION OF According to manufacturer’s recommendations

MEASURMENT
DEVICES/SYSTEMS
MONITORING Every pack: External chemical indicator

Weekly: Biological/enzymatic indicator
Optional: Internal chemical indicator
Process challenge device


contractor (or both)

CLEANING (According to manufacturer’s recommendations)
May include: Chamber drain, Air filter, Recording
device, Lid seal and carrier, Vaporizer
system
Cleaning: Carriers, containers and external
surfaces cleaned daily

Packaging intact
Correct result of process challenge devices
COMMENTS:
………………………………………………………………………………………………………………………………………………………..
……………………………….…………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………………
BATCH WASHER – AS2945 -1998
CALIBRATION OF On commissioning
MEASURMENT
DEVICES/SYSTEMS 6 - 12 monthly
After repair
Quarterly thermocouple temperature check
MONITORING Documented time at temperature

Check every cycle - thermal disinfection required
Continuous performance checks for:
- temperature
- cleanliness of items
Documented daily test for chemical residue
MAINTENANCE Quarterly preventative maintenance

Descaling preformed at required
ROUTINE CHECKING AND Daily: Check and clean jets, filters, doors, door
CLEANING gaskets and external surfaces
Check detergent and rinse dispensers are clear
and functioning correctly
Check door seals
COMMENTS:
……………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………
…..……………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………
U L T R A S O N I C C L E AN E R – A S 2 7 7 3
CALIBRATION OF Not applicable

MEASURMENT
DEVICES/SYSTEMS
MONITORING Daily performance testing

 Aluminium foil test or
 Pencil load
MAINTENANCE Annual electrical safety check
ROUTINE CHECKING AND Daily: Check filters

CLEANING Check base plates
Wipe external surfaces
Empty tank at least daily or more
frequently, as necessary
Continuous: Correct functioning of switches, gauges
and lights
COMMENTS:
……………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………
…..……………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………..
CALIBRATION, MONITORING AND MAINTENANCE OF ASSOCIATED EQUIPMENT
D R Y IN G C A B IN E T – A S 2 5 1 4 o r A S 2 7 7 4
MEASURMENT
DEVICES/SYSTEMS 6 - 12 monthly
After repair
Annual thermocouple temperature check
MONITORING Daily visual temperature check
MAINTENANCE Quarterly preventative maintenance
ROUTINE CHECKING AND Daily: Surface cleaning

CLEANING Check and clean filters
Check and clean door seals
COMMENTS:
……………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
INCUBATORS FOR SELF CONTAINED BIOLOGICAL INDICATORS
CALIBRATION OF Annual temperature check

MEASURMENT
DEVICES/SYSTEMS
MONITORING
MAINTENANCE Following of manufacturer’s guidelines
ROUTINE CHECKING AND Following of manufacturer’s guidelines

CLEANING
COMMENTS:
……………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………… ……..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
H E A T S E A LE R
ACTION REQUIRED
Table 7.2
MEASURMENT 6 - 12 monthly
DEVICES/SYSTEMS After repair
MONITORING
Daily check of seal integrity pre-and post-
sterilisation
MAINTENANCE Adjustment of gap between heating elements in
accordance with manufacturer’s specifications, at
least
quarterly
ROUTINE CHECKING AND Daily: wiping of external surfaces
CLEANING Continuous checks for correct functioning of
switches,
gauges and lights
COMMENTS:
……………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
AUTOMATED ENDOSCOPE REPROCESSOR (WASHER/DISINFECTOR)
MEASURMENT
DEVICES/SYSTEMS After repair
Annually
MONITORING Daily check of chemical levels

Every cycle: Check process recorder for critical
process parameters – time, temperature, chemical
concentration, and, where possible, flow rate and
pressure
Monthly: Microbial monitoring of rinse water
quality of the automatic endoscope reprocessor (refer
to GENSA guidelines)
MAINTENANCE Check and change internal water, chemical and air
filters according to manufacturer’s instructions
Treatment of external water filters by heat or
chemical
means is essential – frequency depends on local
conditions and water quality
Descaling of machine lines and tanks according to
manufacturer’s instructions
ROUTINE CHECKING AND Daily: Cleaning of soak basins

CLEANING Lids and
All surface areas of machine
COMMENTS:
……………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………………………………..
Section Action
Standard Compliance
Timeframe
0 1 N/A
8 QUALITY MANAGEMENT
8.1 FACILITY MANAGEMENT
 The person in charge of sterilising facility has specific qualifications
and experience in sterilising technology
 Person in charge has the authority to implement the requirements of
AS4187
 Is actively involved in supervising the day-to-day activities of the CSSD
 The sterilising services line of responsibility is directly to the executive
director (or director) of clinical services to ensure neutrality of service
3
8.2 DOCUMENTA TION
 Policies and procedures for all activities in the processing of sterile
items are documented
 Records are maintained and reviewed at frequent intervals and dated
 Records are kept for a period of time not less than that defined by
regulatory authorities or Health Care Facility
 Records include:
o Daily production statistics
o All tests performed on equipment
o Steriliser cycling records
o Employee training records
o Staff work rosters
o Incident reports
o Quality and procedure/operational manual
o Maintenance records
o Certification of validation – IQ, OQ and PQ data
o Tray/instrument tracking records
4
8.3 PERFORMA NCE MA NA GEMENT
• Staff qualifications and staffing levels are sufficient to ensure
ontinuous, safe and efficient operation
• There are written job descriptions for each category of staff
• The manager is qualified to appropriate level by education, training
and experience in sterilising processes
 There is a system for assessing staff performance after orientation and
at regular intervals
3
8.4 EDUCATION AND TRAINING
 There is a formal orientation program in place for new staff
 Formal orientation is followed by on-the-job practical training
 Staff members are encouraged to participate in appropriate external
education courses
2
Section Action
Standard
Timeframe
8.5 MATERIAL MANAGEMENT
• There are protocols for inventory control
1
8.5.2 PRODUCT IDENTIFICA TION AND TRACEABILITY
8.5.2.1 BATCH CONTROL NUMBERS
Procedures are in place to link steriliser cycle batch information to items
that have been sterilised, to the patient
• Each packaged item is labelled with a batch control identification:-
o Steriliser number or code
o Date of sterilisation
o Cycle or load number
o Manufacturers batch/lot no. of any unsterile commercially
prepared implantables placed in pack
1
8.5.2.2 STERIL ISA TION CYCLE RECORDS
• Date of cycle
• Steriliser number or code (if > one steriliser)
• Cycle or load number (if > one load)
• Exposure time and temperature
• Name of loading operator
• Name of person releasing load
• Specific contents of load
• Results of physical, chemical and biological monitoring
8
8.5.3 DEVIATION AND FAULT ANALYSIS
• A procedure is in place to review any quality or procedural problems
1
8.5.4 PRODUCT COMPLAIN TS
• A complaints procedure is in place and corrective action taken is
documented
1
8.5.5 RECALL PROTOCOL
Recall policies and procedure are in place and include:-
• Criteria for issuing recall notice
• Person responsible for issuing notice
• Person responsible for reporting on recall activities
• Persons to be notified when recall event occurs
4
Section Action
Standard
Timeframe
8.5.6 RECALL NOTICE includes:
 Name of person or department for which notice is intended
 Sterilisation batch information
 Product name and quantity of products returned
 Specifies action to be taken by persons receiving the notice, e.g.
return or destruct or hold
4
8.5.7 RECALL REPORT includes:
 Circumstances that initiated need for recall
 List of total number of products for recall and actual number located
and recalled
 Identifies the number of patients potentially exposed and action taken
 Provision to document the actions taken to prevent a similar situation
from occurring in the future (if necessary)
4
8.6 MONITORING STERILISER CYCLES (see table 7.1 attached)
8.6.1 PHYSICAL INDICATORS
 Parameters are measured with continuous automatic permanent
monitoring
 No permanent record – readings from gauges and devices are
documented for every cycle at intervals of 10 seconds (steam)
 Record chart is examined and labelled with operators identification at the
end of each cycle
 Any variations from normal is noted and action taken
 Where no record of physical parameters is obtained a BI/EI or a Class 4,
5 or 6 chemical indicator is used with each load
5
8.6.2 CHEMICAL INDICATORS
 Used as recommended in table 7.1
1
8.6.3 BIOLOGICAL/ENZYMATIC INDICA TORS
 Used as recommended in table 7.1
1
8.6.4 SPECIAL PERFORMANCE TESTS FOR PRE- VACUUM STEAM STERILISERS
- Used as recommended in table 7.1
8.6.4.1  Leak rate test
8.6.4.2  Bowie Dick type test
8.6.4.3  Air detector function test
8.6.4.4  Air detector performance test
4
Section 8 Sub Total
19
Section
Action
Standard
Timeframe
8.7 VALIDATION PROCESS – detail of process in Appendix H

• The sterilisation process has been validated
• The results have been documented

2
8.8 CRITERIA FOR RELEASE FOR PROCESSED ITEMS

8.8.1 • Prior to release there is evidence to indicate that the process has met all
specified requirements
• The person responsible for authoring release has full knowledge of all
aspects of the validation process
• The person responsible for authoring release is satisfied that monitoring
and control of the entire process has met specifications
3
8.8.3 PA RA ME TRIC REL EA SE (if used)
• The process record shows compliance with all processing specifications

achieved during performance qualification
• The process record shows compliance with processed used in:-

o Cleaning
o Packaging
o Loading
o Unloading
o All cycle parameters
• There is evidence that the equipment control and any associated
monitoring devices have continuously recorded all stages of the
sterilisation cycle – record comply with specifications
• Equipment and component parts are current in terms of calibration and
maintenance
4
8.8.4 NON-PARA ME TRIC REL EA SE
• Biological/enzymatic and chemical indicators are used to determine that

the sterilisation process has met processing specifications
• The load is not released until the results of tests are interpreted as
successful
2
8.8.5 RELEASE DOCUMENTA TION
• The are records of items released

• The record includes identification of items, identification of cycle, time of
release and name of person authorising release
2
Section
Action
Standard
Timeframe
8.9 MONITORING OF PACKAGING PROCESS

Continuous checks are made of:
 Integrity of outer wrap & seals
 Correct labelling
 Correct colour change of external indicator

In addition, the end user knows to check sterilised packs for:
• Integrity of outer wrap & seals and correct labelling
• Ease of opening
• Correct packaging techniques
• Correct contents
• Correct layout of contents
• Condition of contents – cleanliness, alignment and function

• Correct performance of internal indicator (if used)
10
8.10 OCCUPA TIONAL HEALTH & SAFETY

8.10.1 • Staff are immunised in accordance with immunisation guidelines
• Immunisation records are kept in staff files
If immunisations are declined this recorded
Staff health is monitored to ensure:

• Superficial skin lesions are covered by an occlusive dressing and staff
are made aware of cross infection hazards
• Accidents are recorded and treatment is provided as required

Staff with dermatitis, skin infections or infected lesions are examined by
a MO
4
8.10.2 STAFF ATTIRE
• A clean uniform is worn for each shift
• Hair is safely secured and covered while preparing items for
sterilisation
• PPE is worn when handling used/soiled items

Hand and wrist jewelery including plain wedding bands are NOT worn
Nail polish or acrylic nails are not worn, nails are kept short
Uniforms worn in sterilising department are not worn outside the

health care facility
3
Section
Action
Standard
Timeframe
8.10.3 HA ND WASHING
• Handwashing techniques and the importance of handwashing are

taught to all staff during orientation and reiterated regularly
• Single use towels are used
• Hand creams are NOT used by staff on arrival at work & whilst on duty
- Mechanical hot air drying is NOT used
3
8.11 ENVIRONMENTAL CONTORL
• Work practices and stock control ensure that sterile and clean items
are separated from soiled items
• Environment is in a hygienic state at all times
• Adequate facilities for personal hygiene are readily accessible
• Efficient ventilation is in place
• Lint production is minimised
5
8.12 EVALUA TION, FEEDBACK & OUTCOMES
• Processes and procedures are evaluated
• Regular audits provide a mechanism for analysis, feedback and quality
improvement
2
SECTION 8 Sub Total 10

TOTAL C3ECTIO N 8 87
Section Action
Standard Compliance
Timeframe
0 1 N/A
9 STORAGE & HANDLING OF STERILE ITEMS
9.1 GENERAL
9.1.1 STERILE ITEMS
• Sterile items are stored and handled in a manner that maintains the
integrity of pack and prevents contamination
• This applies to items sterilised by facility and commercially procured
items
• Policies and procedures for storage, handling and issuing of sterile
stock have been developed and documented
• Items to remain sterile for use are NOT stored in ultraviolet cabinets
or in disinfectants
4
9.1.2 STORA GE OF UN WRAPPED CRITICAL MEDICAL ITEMS
• Items stored unwrapped are cleaned and sterilised before storage
• Items are cleaned and resterilised immediately prior to use
2
9.1.3 STORAGE OF UNWRAPPED SEMI-CRITICAL AND NON-CRITICAL MEDICAL
ITEMS
• After processing, items are stored in clean, dry, dust free, dedicated
containers/drawers to protect them from environmental contamination
• If necessary they are reprocessed prior to use
2
9.2 STORAGE AREA
• Sterile storage areas are dedicated to that purpose only
• Clearly sign-posted & traffic flow controlled/restricted
• Dust free, insect free & vermin free
• Open shelves - 250mm above floor level & 440mm below ceiling level
• Items protected from sunlight
• Storage containers are kept clean, dry and in good condition
• Cardboard boxes are NOT used as storage containers (porous, cannot be
adequately cleaned and may harbour organisms)
• Commercial dispenser boxes are not topped up or reused
• Walls, floors, ceiling lights and work surfaces are constructed so that
difficult-to-clean corners are minimised
• Surfaces non-porous & smooth & easily cleaned
Overhead lighting is fitted flush with ceiling to minimise dust entrapment
O O
Air-conditioning – 18 C – 22 C (Complies with AS 1668.2)
Ventilation – RH 35% – 68% (Complies with AS 1668.2)
10
Section Action
Standard
Timeframe
9.2.2 ACCESS TO STORED ITEMS
 Access to sterile store area is restricted to those who have had adequate
education and training in handling of sterilised items
 Who do not have discharging or open wounds, abrasions or scaling skin
disorders and;
 Who have washed and dried their hands
 Access is restricted
Trafic within area is controled – minimise movement of airborne
contaminants
4
9.3 PLASTIC DUST CO VERS
 Plastic (polyethylene) used is new, clean and intact and of sufficient
strength
 Covers are applied immediately they are cool, in a clean environment
using clean techniques
 Dust covers are sealed (sealing by hermetic means is recommended)
 All batch information is marked on the packaged and not on dust cover
Items are placed in dust covers within 2 hours of sterilisation
4
9.4 TRANSPORT/DISTRIBUTION OF STERILE ITEMS
 Sterile items transported outside the HC facility are packaged securely
and protected against damage and contamination during transport
 All transport equipment is maintained in a clean, dry state and in good
working order
A system has been instituted that pro vides a record as to stock levels
and to the disbursement of items to users
Transport vehicle has adequate segregation and meets the requirements
of Clause 9.2.1
Equipment used to move and transport items is dedicated to that
purpose and is kept clean
It is not used to colect used items, transport food or garbage
Where unsterile but clean linen, such as instrument wraps, are
transported with sterile items, the sterile items are separately protected
e.g. in a plastic bin with lid
Care is taken to ensure stock is not tightly packed into storage
containers or shelving, o r wrapped with elastic bands
2
Section Action
Standard
Timeframe
9.5 COMMERCIALL Y PREPA RED ITEMS
• Dust is wiped from the store pack before it is opened
• Sterile items are removed from the store pack before entering clean
area
• Sterile items from external suppliers are inspected for cleanliness
and/or damage to unit packs or their contents
Grossly soiled or damaged store packs are not accepted – return to
supplier for replacement or refund
3
9.6 SHELF-LIFE/STOCK ROTA TION
9.6.1 GENERAL
• Shelf life is event related
• A stock rotation system is based on the date of sterilisation
• Stock is maintained at adequate levels (do not overstock)

3
9.6.2
STOCK WHICH IS NONCONFORMING
 A package is considered nonconforming (non sterile and not fit for use)
when: -
 It is incorrectly wrapped
 Damaged or open
 Water after the sterilisation cycle or comes in contact with wet
 surface
 Is placed or dropped on a dirty surface (e.g. floor or sink area)
 It has no indication of having been through a sterilising process
 Nonconforming stock is totally re processed as soon as identified
2
9.6.3 FACTORS WHICH COMPROMISE STERILE STOCK
• Processes and procedures are in place to protect sterile stock from the
following factors that will compromise sterile stock
 Incorrect cleaning procedures in storage areas
 Moisture or condensation
 Incorrect temperature
 Excessive exposure to sunlight and other sources of ultraviolet light
 Vermin and insects
 Inappropriate packaging materials
 Incomplete sealing
 Sharp objects or rough handling or use of elastic bands which may
 cause damage to packaging materials
 Incorrect handling during transportation
1
SECTION 9 Sub Total
9
TOTAL SECTION 9
37
Section Action
Standard Compliance
Timeframe
0 1 N/A
10 DISINFECTION
10.1 GENERAL
 Sterilisation is used for all reusable instruments and equipment that
can withstand the process
 Disinfection is not carried out as a substitute for sterilisation –
disinfection is not a sterilising process
 Items for disinfection are clean and able to withstand the process
 Items are not stored in disinfectant before or after any form of
processing
4
10.2 MEANS OF DISINFECTION
10.2.1 THERMAL DISINFECTION
 Item is thoroughly cleaned before disinfection
 All parts of the item is subjected to moist heat at or above the
recommended temperature for the recommended duration (see below)
Surface temperature Minimum disinfection time (minutes)
o
90 C 1
80 oC 10
75 oC 30
70 oC 100
2
10.2.2 CHEMICAL DISINFECTION
10.2.2.1 GENERAL
 Chemical disinfection is only used when thermal disinfection is
unsuitable
 Any chemical disinfectants used are registered with the TGA in
Australia
2
10.2.2.2 INSTRUMENT GRADE DISINFECTANTS
 Only disinfectants labelled as ‘instrument grade disinfectant’ are
used for reprocessing reusable instruments
 A high-level instrument grade disinfectant is the minimum level used for
semi-critical instruments which contact unbroken mucous membranes
that are not normally sterile
 A intermediate-level or low-level instrument grade disinfectant is used
for disinfection of non-critical instruments which contact unbroken skin
 Care is taken to follow manufacturers specific instructions
 Directions for use are not interchanged between formulations
 Relevant OH&S regulations are follow MSDS are available
 Extreme care is taken when using instrument grade disinfectants
Where practicable, the concentration of the solution is monitored at least

daily in line with manufacturer’s instructions
7
TOTAL SECTION 10 15
Section Action
Standard Compliance
Timeframe
0 1 N/A
11 CLEANING OF THE STERILISING PROCESSING FACILITY AND
ASSOCIATED EQUIPMENT
11.1 GENERAL
 Routine and special-purpose cleaning is performed to prevent cross-
contamination
 There is a policy documenting areas and equipment to be cleaned, the
methods used and the frequency of cleaning
 Completion of cleaning activities is documents
 Surfaces are impervious and intact to allow effective cleaning
 Blood and body spills are wiped up and the area washed with detergent
and water
 Standard precautions are taken
6
11.2 EQUIPMENT
There is written procedures for all sterilising and ancillary equipment
indicating:-
 Method,
 Frequency,
 Manufacturer’s instructions and
 Cleaning agents and materials
4
11.3 WASTE DISPOSAL
 Waste disposal is in accordance with local regulations
 Waste is placed in appropriate containers
 Waste is not transferred from bag to bag during collection
 Sharps containers are available (comply with As4031 or AS/NZS4261
Waste is removed via designated disposal exits
4
Total Section 11 14
TOTAL SECTION 11 14
Section Action
Standard Compliance Timeframe
0 1 N/A
12 SELECTION AND CARE OF INSTRUMENTS
12.1 GENERAL
 Those responsible for reprocessing instruments are involved in the
selection process
 It is established that the cleaning methods used are compatible with
the instrument to be purchased
 It is established that the cleaning agents or available water will not
cause removal of surface finishing, corrosion or pitting
 Where manufacturers make claims or recommendations for
reprocessing of their items, details of validation of the reprocessing
procedure is obtained in writing
4
12.2 GENERAL CONSIDERATIONS
12.2.1 GENERAL
 Staff responsible for instrument reprocessing have had appropriate
education and training
 Instrument repairs are performed by qualified instrument technician

2
12.2.2 IDENTIFICATION
A system for identifying instrument is established
Engraving is not used
High quality etching is used to mark instruments
Care is taken when using colour coded devices – may detach during
surgery and may habour m/organism beneath adhesive layer
12.2.3 REMOVAL OF SOIL
• Removal of soil is performed at point of use
• Cannulated instruments are not allowed to become dry
Saline is not used to rinse o r wipe instruments

2
12.2.4 SORTING INSTRUMENTS AND INSPECTION

 Light or delicate instruments are kept separately from heavy
instruments
 Instruments that can be taken apart are disassembled prior to
terminal cleaning and inspected
 Any defective instruments are cleaned, dried and sterilised prior to
being sent for repairs
 A validated and documented process is used for multi-part
instruments and equipment designed not to be disassembled -
according with manufacturer’s instructions
4
12.2.5 INSTRUMENT (FLASH) STERILISATION

Cleaned items are not ‘flash’ sterilised prior to further cleaning
Section
Action
Standard
Timeframe
12.2.6 LUBRICATION
 When required lubricants are water miscible, compatible with the

sterilising process and used according to manufacturer’s instructions
 Lubrication is not used to overcome inadequate cleaning practices

Note: Stiffness may be due to -
 ‘flash’ sterilisation
 exposure to saline solutions
 inadequate cleaning
 malalignment and will not be corrected by lubrication
2
12.3 SPECIAL CONSIDERATIONS
The following are considered in the continued care and maintenance of all
instruments: -
 Instruments are free from soil, rust or line

 Lumens, grooves and articulations are free of debris. A stillette is able to
be passed through the lumen wherever applicable
 Joints are free of debris and move freely

 All surfaces and edges are smooth, well finished, un-pitted and free of
burrs
 Tips of instruments are not hooked, snagged and approximate
accurately
 Jaw serrations are visible along length – instruments with worn areas
are sent for repair (qualified repairer)
 Stiff or loose instruments are sent for repair (qualified repairer)

 Cutting edges are sharp – sharpness is tested according to
manufacture’s instructions
 Valves move freely and are left in the ‘on’ position
 All multi-part components of instruments are present
 Components are reassembled correctly
 Instruments are tested to ensure they are functioning correctly

 Fine instruments and their tips are protected in a manner that does not
inhibit the sterilisation process
 Templates are used to check shape and tips of fine instruments

14
12.4 SPECIALISED INSTRUMENTS
12.4.1
MICROSURGICAL INSTRUMENTS – care according to manufacturer
12.4.2
INSULATED INSTRUMENTS - care according to manufacturer
Section
Action
Standard
Timeframe
12.4.3 INSTRUMENTS ON LOAN

 Loan instruments undergo a complete routine cleaning and processing
prior to sterilisation by the wrapped method
 Perceived lack of time does not permit the cleaning process to be
bypassed
 Any soil or debris found on the instruments is reported to the supplier

 All instruments are subjected to the full cleaning process and sterilised
before being returned to their source
 Loan instruments are not interchanged between human, necroscopy and
animal use
There is a contracted arrangement in place to define the responsibilities
of the supplier and the health care facility
12.4.4
HANDPIECES - care according to manufacturer
12.4.5
ASPIRATION SYSTEMS FOR DENTAL PROCEDURES - care according to
manufacturer
12.4.6
TRIPLEX SYRINGE FOR DENTAL PROCEDURES - care according to
manufacturer
12.4.7
ULTRASONIC SCALERS FOR DENTAL PROCEDURES - care according to
manufacturer
12.5 USE OF INSTRUMENT SHEATHES/SLEEVES
 Sheaths/sleeves for instruments and equipment are not used as a
substitute for cleaning, disinfection or sterilising procedures
TOTAL SECTION 12 34
Section Action
Standard Compliance
Timeframe
0 1 N/A
13 USE OF OPERATING ROOM TEXTILES
13.1 GENERAL
 Where the laundry is attached to the HCF the processing of operating
room textiles is under the direction of the sterilising manager
 Laundry processing is in accordance with AS/NZS 4146
 Textiles used for draping and surgical gowns comply with As 3789.2 and
AS 3789.6
3
13.2 SPECIFIC CONSIDERATIONS
 Inspection, folding and assembly of linen is performed in a dedicated
area which is separated from others
 Air conditioning and air extractors are installed to assist in removal of
airborne lint
 Linen is discarded if patches exceed more than 1% of total drape or
garment
 Linen is discarded if there are signs of deterioration (threadbare)
 Linen is re-laundered if there are visible signs of dirt, stains, grease or oil
 Gauze swabs and abdominal sponges are not incorporated into linen
packs
6
13.3 INSPECTION
 Linen required to be sterile, including wrapsper, is inspected over an
illuminated table to determine presence of holes or other damage
1
13.4 MENDING
 Mending is done using textile patches with thermally-setting adhesive
 Patches are round in shape, 10mm – 20mm in diameter and attached to
 one side only – they do not represent more than 1% of total area
 Patches are not applied to seams but re-seamed if in need of repair
 Fenestrated openings are not repaired – when in need of repair a new
 fenestration is fitted or item is condemned
 Patches that are lifting are not accepted
 Linen is laundered after repair
6
13.5 EQUIPMENT
 Light table complies with AS 3789.2
 Patching machine complies with AS 3789.2
 Machines have preventative maintenance in accordance with
manufacturer’s recommendations
 There are handwashing facilities within the OR textile area
4
TOTAL SECTION 13 20
OVERALL SCORE SHEET

TOTAL SCORES A B %
COLUMN A = TOTAL ACHIEVED SCORE
COLUMN B = TOTAL POSSIBLE SCORE
Section One 6
Section Two 131
Section Three 73
Section Four 28
Section Five 23
Section Six 19
Section Seven 50
Section Eight 87
Section Nine 37
Section Ten 15
Section Eleven 14
Section Twelve 34
Section Thirteen 20
TOTAL SCORE 537
% = A ÷ B x 100 A B
The audit can be scored to provide a basis for comparison over time and to answer the question ‘do
we comply with AS/NZS 4187-2003?’
The scoring system is based on the Cleaning Standards for Victorian Public Hospitals audit system
where compliance with a criteria is deemed to be acceptable then no demerit points are
deducted. If a criteria is deemed to be non compliant then it will score 1 or one demerit point.
AUDITORS COMMENTS:
SECTION COMMENTS
ONE
TWO
THREE
FOUR
FIVE
SIX
SEVEN
EIGHT
NINE
TEN
ELEVEN
TWELVE
THIRTEEN
ACKNOWLEDGEMENT:
*Handbook of Infection Control. Safe-I; National Board for Accreditation of Hospitals and Healthcare
Providers (NABH)
**Mary Smith, Regional Infection Control Practioner, March 2001, Revised May 2001 October 2003.
( In pages 123 to 180 )

Surgery SOP

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Delhi State Health Mission, Department of Health & Family Welfare, GNCTD Page 1

SOP for Surgery Department, Ist Edition: August; 2016

Professor (Anaesthesia), UCMS & Guru

Specialist (Anaesthesia), MAMC & Lok

Specialist (Surgery), Sanjay Gandhi

Specialist (ENT) Acharya Bhikshu Govt.

Assistant Professor (Surgery), MAMC &

Associate Professor (Anaesthesia),

Assistant Professor (Pediatric Surgery),

Specialist, Anaesthesia, Chacha Nehru

Responsibility of Updating : Name :

S. No. Title Pages

2 Surgery Inpatient Department 13-20

3 Pre-Anaesthesia Check up (PAC) 21-26

4 Policy on consent 27-33

5 Operation Theatre 34-39

6 Post Anaesthesia Care Unit (PACU) 40-46

9 Central Sterile Services Department (CSSD) 62-178

Signature: Signature: Signature:

Sr. No. Officials Signature of Officials receiving copy

1- SURGERY OUTDOOR PATIENT DEPARTMENT

The SOP applies to OPD

Described in procedure at different levels

Sr No. Activity Responsibility Reference

1.4.1 Identification of OPD & registration

a).Patient reaches the registration counter Estate manager

b).A ‘help desk’ manned by hospital staff Staff nurse

c).All OPDs should display the services

a).At the registration counter there are Designated OPD

 Senior citizens counters

b).At each counter there will be computer Computer assistants/

c).Timings of the functioning of the

d).There should be security personnel

a).Patient will be given a Unique hospital Computer assistants/

1.4.4 Documentation of vitals

a).From registration counters patients can Staff nurse

1.4.5 Doctor consultation

a).The patient reaches the respective Designated OPD

b).The slip is received by the hospital staff,

c).The patient is then asked to wait at the

advices for keeping the patient supervisor / Estate

d).Each OPD room should have a display

b).There should be a curtain to ensure

c).OPD should have basic diagnostic

d).All OPDs should be under supervision of

e).All rooms of the OPD must be functional

1.4.7 a).All prescriptions should be written in the Head of Department /

b).All laboratory / imaging tests should be

c).Interdepartmental referrals if needed

d).All OPD slips should be signed followed

e).Patients should be sent back to the staff

1.4.8 a).Patients who are treated on outdoor Security staff

b).Security personnel also required to

d).The pharmacist should clearly explain

1.4.9 a).Patients who have been advised

a).Patients who have been advised Nursing staff / nursing

b).Reports should be ideally dispatched on

a).Patients who have been referred to Designated OPD

b).Nursing staff should receive the patient