OT MANUAL

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

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TABLE OF CONTENTS

DOCUMENT APPROVAL AUTHORITY: ..............................................................................1

AMENDMENT SHEET ...........................................................................................................2

OPERATION THEATRE – OBJECTIVES..............................................................................3

PROCESSES RELATED TO OPERATION THEATRE SUITE FUNCTIONING .................4

BOOKING AND SCHEDULING OF SURGERIES ..............................................................13

PROTOCOL REGARDING TRANSPORT OF PATIENTS FOR SURGERY/

PROCEDURES IN OPERATION THEATRE .......................................................................16

TRANSPORT OF PATIENTS TO OT FROM Ward/ ICUs ........................................................................ 16

TRANSPORTATION OF PATIENTS FROM OT TO RECOVERY ROOM/ ICU/ WARDS ...................... 16

OPERATION THEATRE NURSE is responsible for: ................................................................................. 17

PRE- OPERATIVE EVALUATION .......................................................................................18

APPENDIX I: ROUTINE PREOPERATIVE INVESTIGATIONS .......................................24

APPENDIX II: LIST OF INVASIVE, HIGH-RISK, OR SURGICAL PROCEDURES ........27

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

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DOCUMENT APPROVAL AUTHORITY:

Prepared By :

Sl.

No.

Name

Specimen Signature

Dr. Manoj Dokania

Dr. Namita Saraswat

Dr. Shalu Shah

Reviewed By:

Sl.

No.

Name

Specimen Signature

Dr. Manoj Jha

Approval By:

Sl.

No.

Name

Specimen Signature

Dr. B. L. Sherwal

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

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AMENDMENT SHEET

Sl.

No.

Date of

Amendment

Details

Reason of Amendment

Suggested By

Approved By

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

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OPERATION THEATRE – OBJECTIVES

 To provide skilled and efficient administration of anaesthesia for elective & emergency

operation throughout the year.

 Training of all Doctors, OT Technician & OT Sister.

 Safe & effective Sterilization & Fumigation Procedure.

 Improving coordination among the surgeons & the surgical team

 Having control on the stock available in the OT, by assigning the work to different people &

verifying them in regular intervals.

 Standardization of surgeries done in the Operation Theatre; specialty wise along with the surgery

code.

 Streamlining of various processes related to implant Procurement, Consumables and Non

Consumables

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

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Policy for Operation Theatre

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PROCESSES RELATED TO OPERATION THEATRE SUITE

FUNCTIONING

A. Purpose

To provide guideline instructions for Processes Related to Operation Theatre Suite Functioning

with the aims:

 Needs and expectations of patients are established,

 Patient satisfaction is enhanced on continual basis, and

 Feedback loop is established for continuous improvements

B. Scope

It covers the total functioning of the Operation Theatre with relation to the patient and other OT

specific processes

C. Responsibility

Head of the Department – Consultant OT Incharge

D. Quality Objectives

Quality

Objectives

Performance Indicators

Measurement Criteria

Criteria

Frequency

Service Level

Staff availability

(Doctors, Nurses & Support)

Duty Roster/

Attendance Record/

Monthly

OT availability & Turnover

time

OT cases register

Monthly

Investigation reporting time

Anaesthesia record

Patient treatment chart

Monthly

Drug Procurement &

administration time

Patient case file/ OT

Pharmacy drug Indent

Monthly

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Medication administration

(Right medication and dosage,

route, allergic/ adverse

reactions, drug interactions)

Anaesthesia record

Patient Treatment chart

Monthly

Coordination between all staff

for treatment and procedures

Patient feedback form

Monthly

Clinical

Excellence

Accuracy of Diagnosis

(Initial provisional diagnoses

and treatment plans)

Patient Medical

Records

Patient feedback form

Quarterly

Appropriateness of treatment

 Unscheduled return to OT

 Unplanned repair, removal,

injury or repair of an organ

during surgery

 Unplanned admission to

ICU after surgery

 Perioperative mortality

Operation

notes/Register

Anaesthesia record

Patient medical record

Quarterly

Quality of treatment

Surgery:

 Retention of instruments/

materials after procedure,

wrong procedure (site or

patient)

 Post operative

complications like surgical

site infection, wound

complications

Patient Medical

records

Operation notes

Anaesthesia record

Patient feedback form

Quarterly

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Quality of treatment

Anaesthesia:

interventional procedures

(Complications, infection at

site, measure of discomfort or

pain, awareness during

anaesthesia)

Anaesthesia record/ Pt

case record

Patient feedback form

Patient

Satisfaction

Courtesy level

Patient feedback form

Monthly

Wait time

Patient feedback form

Monthly

E. Description

Sl. #

Activity

Responsibility

1.0

Operation Theatre Booking

1.1

Advanced booking of OT slots for surgeries

Sister Incharge OT/OT

LIST

1.2

OT list finalized the day before at 4 pm

Floor I/C Anaesthesia

1.3

OTs allotted for anaesthesia consultants, checking & signing the OT list

Floor I/C Anaesthesia

1.4

OT list photocopied and distributed to all wards and residents on duty

Respective SR

1.5

Original OT list at OT

Sister incharge

2.0

Pre anaesthesia check up (PAC)

2.1

PAC done few days prior to surgery up to 3 months before surgery

Anaesthesia Consultant

2.2

Review PAC done and pre medication advised on the evening prior to

surgery

Anaesthesia Resident

with intimation to Floor

In charge Anaesthesia

3.0

Preparation for surgery

3.1

Sterilized instruments and linen collected and arranged in respective OTs

from CSSD, on the previous night

Evening OT Nurse

3.2

All OTs checked for readiness for surgery

OT SisterIn charge

3.3

 Anaesthesia trolley checked and drugs drawn up

OT Technician/

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Sl. #

Activity

Responsibility

 Anaesthesia machines, ventilators, central gas supply and cylinders

checked

 Suction Machine and Surgical Equipments

Anaesthesia resident

3.3

 All sutures needed for surgery listed and taken from OT Store;

 List entered into register with date, patient ID, surgery type, and

signed;

 Unused sutures returned to OT Store, cancelled from Indent register

OT Nurse/ OT

Technician

3.4

 Drugs needed for anaesthesia/surgery are listed out by OT

technician

 Entry made in OT Drug indent register with date, patient ID,

surgery type, and signed

 Unused drugs returned to OT Store, cancelled from Store register

OT Technician

4.0

Shifting Patient to OT

4.1

OT list checked for first patients in all OTs

Assigned OT Nurse

(Morning shift)

4.2

Ward nurse informed of patient shifting 30 minutes to One hour before

patient is to be shifted.

Pre op Nurse

4.3

Patient called half hour before Operation time.

Anaesthesia resident for

that OT

4.4

Patient shifted from ward to OT.

Pre op OT Nurse

(assigned shifting duty

for the day)/ OT

attendant

4.5

Patient ID, nature of surgery, pre op check lists checked and handed over.

Ward nurse to OT nurse

4.6

Shifting of critically ill patients from ward/ HDU/ ICU with resuscitation

equipment and drugs

Anaesthesia resident/

Surgery

Resident/Nursing aid/

HDU/ ICU/ Ward Nurse

5.0

Receiving Patient in OT

5.1

Patient received in pre op holding area

Pre op Nurse (on duty in

pre op area)

5.2

Patient file and time patient received noted

Pre op Nurse

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Sl. #

Activity

Responsibility

Pre op checklists reviewed

5.3

Patient file, nature of surgery, vitals and reports reviewed in pre op

Anaesthesia Resident

5.4

Patient shifted to OT on sterile zone trolley

OT Technician

5.5

Patient transferred on to table and connected to Monitors

OT Technician/

Anaesthesia Resident

6.0

Intra operative process

6.1

All instruments and assisting nurses ready for surgery

Scrub & Circulating

nurse

6.2

Patient anaesthetized

Anaesthesia Consultant/

Resident

6.3

Patient’s surgical area cleaned and draped; surgery conducted

Scrubbed surgeon/

Surgical resident

6.4

Blood & Blood products required – Requisition slip filled and sent to Blood

Bank

Anaesthesia

Resident/Surgery

Resident/OT Nurse &

Nursing aid

6.5

Patient vital parameters, lines, fluid intake and output, anaesthetic gas and

drug administration, etc. monitored and appropriate records maintained

Consultant Anesthetist/

Resident

6.6

Surgery completed; patient awakened from anaesthesia

Surgeon/

Anesthesiologist

6.7

Pathology / other lab specimens collected appropriately, labeled, requisition

form filled and sent to lab

Circulating nurse,

surgical resident/

nursing aid

7.0

PACU care

7.1

Patient shifted out of OT to PACU

OT Technician/

Anaesthesia Resident

7.2

Patient attached to monitors, vitals checked and noted, patient made

comfortable, any required analgesia prescribed to be given, patient

reassured if awake

PACU nurse

7.2

Operation notes completed and post operative instructions list attached

and signed and any additions/ deletions made

Operating surgeon/

surgical resident

7.3

Anaesthesia chart during surgery completed and signed; blood/ Blood

Anaesthesia Consultant/

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Sl. #

Activity

Responsibility

products given duly noted including bag number and expiry

Resident

7.4

Recovery score form filled & recovery scoring is done and Pain scoring is

done as per the format (Appendix I)

Anaesthesia Resident/

PACU nurse

7.5

Decision made to shift patient to ward after ensuring patient stable, not in

pain and comfortable

Anaesthesia

Consultant/Resident

7.6

Post operative pain medication name, frequency and mode of administration

entered in case notes and signed

Anaesthesia

Consultant/Resident

7.7

Ward nurse informed about patient shifting

PACU nurse

7.8

Patient shifted to ward

HDU nurse/ Nursing aid

7.9

Patient handed over to Ward nurse

HDU nurse/ Ward nurse

8.0

Preparing OT for next surgery

8.1

Used instruments removed & shifted to Washing Bay in a covered trolley,

washed and handed back to TSSU in OT complex for sterilization

Scrub nurse

8.2

 Dirty linen removed through Dhobi Chaute from where it is

collected for sluicing and washing.

 Floors mopped with disinfectant

Housekeeping

staff/Laundry Personnel

8.3

OT table, suction bottles cleaned and laryngoscopes disinfected

OT Tech/MTS

8.4

Anaesthesia machine cleaned and cleared of used drugs and disposables

OT Technician

9.0

OT fumigation protocol

9.1

After an infected case, OT is closed, cleaned and fumigated

OT nurse-in-charge/ OT

technician

9.2

OT fumigated every Evening (60 minutes)

Chemical Use: 20% Ecoshield.

Method of Preparation: 200 ml Ecoshield+ 800 ml of water

Chemical Composition Ecoshield : Silver Nano Particle -0.01%,

hydrogen peroxide 11%

OT nurse-in-charge/ OT

technician

9.3

Routine fumigation of OT suite done weekly or After contaminated/Infected

Procedures

OT nurse-in-charge/ OT

technician

9.4

Culture from OT sent to microbiology laboratory after fumigation

(Monthly)

OT nurse-in-charge/

Infection control nurse

10.0

Day care surgery

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Sl. #

Activity

Responsibility

10.1

Patient reports to Ward if procedure under Anaesthesia/ to Respective OT

reception if under Local Anaesthesia

Ward Nurse/OT Nurse

10.2

Admission formalities to be checked, case sheet filled before shifting patient

to OT

Ward Sister/ Surgical

Resident

10.3

Sister-in-charge of OT informed about patient arrival

Sister Incharge of

Respective OT

10.4

Patient taken to change room and changes into OT clothes

OT nurse

10.5

Taken to pre operative waiting area and vitals, height, weight taken and pre

operative checklist run through

OT nurse/ sister-in-

charge

10.6

Systems and case review and consent taken

Surgical consultant/

senior resident

Anaesthesia and Surgery

10.6

PAC done and medications reviewed; pre anaesthesia administered, if

necessary/ relevant

Anaesthesia Consultant/

pre op nurse

10.7

Patient taken for surgery into OT

Pre op nurse/ nursing

aid

10.8

Taken to PACU after surgery

Anaesthesia Resident/

OT technician

10.9

Patient discharged directly from PACU

Anesthesiologist/

surgeon/ Sister in-

charge

11.0

Emergency surgery

11.1

Patient source-

 Ward

 ICU

 ER (Casualty)

11.2

Anaesthesia consultant on call informed about need for emergency surgery /

OT space

Surgical resident/

Consultant surgeon

11.3

Availability of OT checked and surgeon informed

Anaesthesia consultant/

anaesthesia resident

11.4

Ward sister informed about patient’s need for surgery and shifting to OT

and pre operative orders attached to case file

Surgery resident

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Sl. #

Activity

Responsibility

11.5

Nursing pre operative checklist and doctor’s orders carried out

Ward nurse

11.6

Call to ward nurse from OT when theatre is ready

OT nurse in charge

11.7

All other processes are as in activities 4.0, 5.0 and 6.0. Patient shifted to

ICU directly from OT

Anaesthesia consultant/

resident/ OT technician

12.0

Theatre Sterile Supply Unit (TSSU)

12.1

The TSSU is situated within the OT complex itself and consists of

– a dirty section with instruments receipt area

– Sterilization area

– Clean section with storage area

12.2

Used instruments removed, washed in OT side room and handed back to

TSSU.

Scrub nurse

12.3

Instruments received in TSSU by Nursing officer on duty

Scrub nurse

12.4

Entry made in TSSU receive register including date, time, type of

instruments, procedure used for, and case infected or not, name and

signature of person handing over, and name and signature of person

receiving.

Scrub nurse/ OT

technician

12.5

Instruments checked in front of scrub nurse for any damage, missing piece,

etc. with the help of the instruments stock / sets register

Floor Nursing Officer

12.6

Instruments washed with detergent (if applicable), sorted, packed, labeled,

and autoclave indicator pasted (if applicable and record made), and put

through sterilization process as in TSSU operations protocol

OT technician and Scrub

Nurse on duty for

sterilization

12.7

Instrument packs removed from autoclave / sterilization units checked for

Indicator (to be recorded) and arranged on shelf in clean area

OT Technician on duty

12.8

Clean instruments pack issued to scrub nurse after entry into issue register

OT technician on duty

12.9

Dirty linen picked up in the OT and sent to laundry directly

OT incharge/ OT

attendant

12.10

Clean linen receive from laundry to TSSU

Through laundery

attendant

12.11

Clean linen packed as per surgery requirements and autoclaved

OT technician

12.12

Linen stored and issued the same way as instruments

OT technician

12.13

Operations, maintenance and calibration of equipment in TSSU

Sr Nursing Officer

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Sl. #

Activity

Responsibility

maintainedand stock, maintenance, purchase indents against condemnation

of records maintained.

F. Records Generated

 Pre operative checklist in OT holding Area

 Duties of the OT Technician

 Anaesthesia case record

 Operations notes

 Protocol for shifting out of PACU

 OT fumigation protocol

 Anaesthesia duty roster

 Nurses’ Theatre duty roster

 OT Technicians’ duty roster

 Support staff duty roster

 Organizational chart and job description of all staff in OT

 TSSU operations manual including guidelines for operation of equipment

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BOOKING AND SCHEDULING OF SURGERIES

In order to book OT time for surgery, the following procedure may be followed:

The Senior Resident of the respective surgical discipline will send a OT list duly signed by the

consultant to the OT Sister incharge. The following particulars are to be entered in the OT list

PATIENT IS ADMITTED

 Hospital ID Number

 Name age, sex of the patient

 Place of Admission (Ward No/ Bed No/ room No.)

 Name of the Surgeon

 Name of proposed surgery/ Type of Anaesthesia and approx. duration of surgery

 Date and time of proposed surgery

 Special requirements in terms of equipment (if any)/ Blood or Blood product requirement

 Intimation of known infection, or any co morbid condition

3. When the patient is NOT ADMITTED in the hospital, the information required to be filled in

the advance posting register is as follows -

 Name of the patient

 Age & sex of patient

 Name of surgeon

 Name of proposed surgery/ requirement of type of anaesthesia

 Date & time of proposed surgery

 Operation Theatre to be booked

 Special requirements in terms of equipment (if any)

 Intimation of known infection.

 Under the column Ward/ Bed “TO BE ADMITTED (TBA)” will be entered.

a. The above booking will be provisional until Patient is admitted to the concerned unit.

b.Provisional booking will be cancelled if patient turn up late or unaccompanied by attendant

or has not followed the PAC instructions.

Note: - (a) & (b) apply for elective surgeries only.

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ARRANGEMENTS FOR STAFF FOR SURGERIES ATNIGHT (Emergency OT)

 Three Staff nurses on night duty in the Emergency OT Complex.

 One Technician &Two OT Paramedic/MTS would be available

 The OT technician for consumables required for anaesthesia/ Staff Nurse is responsible for the

arrangement of other consumables.

 On call list should be made in advance and displayed in Nursing Office/Notice board

 All keys of the Emergency cupboard should be with OT Night Sister on duty.

FORMAT OF MAINTAINING RECORDS (For Fumigation)

For each area:

Date

Time

of A/C

Off

Time of

Start

Time of

opening

Agent

used

Time

when

sealed

Cleanin

Cultures

taken

Time of

Re-

commissio

ning area

Sig. of.

In-charge

If fumigation has been done in any theater, the technician of O.T. will ensure that there is proper time

gap between the two operations for removing the used material and cleaning.

Cleaning of entire OT on weekends (Saturday Evening)

 Remove all equipment, OT tables, anesthesia machine, and heart lung machine (CTVS OT)

Ventilator etc.

 Wash each OT thoroughly with detergent and water paying special attention to the corner of OTs.

 Dry the OT and walls with dry duster and disinfect properly

 Disinfect all the equipment and place them properly in the OT.

 Close the OT and do not allow anybody to enter unless there is a surgical case.

Contents of Ecoshield

Silver Nano Particle -0.01%

Hydrogen Peroxide-11%

For Surface cleaning:

10% Ecoshield to be used (100 ml Ecoshield, 900 ml Water)

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For Spill management

1% Hypochlorite solution to be used.

PROTOCOL REGARDING TRANSPORT OF PATIENTS

FOR SURGERY/ PROCEDURES IN OPERATION

THEATRE

TRANSPORT OF PATIENTS TO OT FROM Ward/ ICUs

1. Telephonic information to be conveyed by OT recovery nurse to nurse In-charge or Ward Nurse of

concerned Ward.

2. The first case for surgery for the day will be shifted by nursing aide and accompanied by the relation

of the patient. The staff nurses of the ward must accompany all sick cases.

3. All cases for surgery will be accompanied by cases files and duly completed pre-opchecklist,

relevant X-rays, CTs and MRIs and all investigation reports.

4. In OT, nurse will receive the patients and check documents and investigations.

5. The relations accompanying the patient will be asked to be seated in waiting area close to OT

reception.

TRANSPORTATION OF PATIENTS FROM OT TO RECOVERY ROOM/ ICU/ WARDS

1. Circulating nurse/OT technician will inform recovery room nurse that patient is to be shifted from

OT to recovery room/HDU to I.C.U. The recovery room nurse to inform concerned ICU/ Ward to

prepare bed.

2. For ICU patients – anesthesia resident and technician will accompany patient and hand-over to

concerned Nurse/ Nurse in charge/ICU doctor on duty.

3. Level of consciousness and vital signs to be monitored in recovery room by staff nurse every 15

mins. When the patient is fully conscious and follows the command, with the written order of the

anesthesiologist patient is shifted to the concerned ward.

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OPERATION THEATRE NURSE is responsible for:

1. RESCHEDULING OF OT

 In case of a scheduled surgery being canceled, then the cases, which are next scheduled, can be

taken up for surgery.

 Ensure that the surgery is rescheduled in case of a medical cause being the reason of non-

performance of surgery.

 Intimate the concerned sister in the ward half an hour prior to the scheduled surgery for

preparing the scheduled case in advance.

2. Entering of done cases in the OT Register

Anesthesia resident doctor will enter the done cases in Anaesthesia Register.

 Surgery Residents will enter the cases done in his OT in the respective OT register.

3. SENDING LIST OF CONSUMABLES

 The circulating nurse and technician will prepare the list of OT consumables, which are used for

the patients during the surgery.

4 RESPONDING TO QUERIES AND GIVING INFORMATION

Resident Doctor of the concerned surgical Unit will inform the attendant of the patient about

completion of surgery, current status and the approx. time patient will be shifted to the ward/

ICU

5. SORTING, TRANSPORT & DISPOSAL OF BMW

 Sorting is done in the operating room (at source) waste is segregated into color coded bags.

Bags are sealed before shifting out.

 Transport is done in covered container by housekeeping staff with all necessary protection

Disposal is done according to the regulation of waste disposal

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PRE- OPERATIVE EVALUATION

Goals

The Ultimate goals of pre-operative and pre-procedure medical assessment of patients who are to

undergo anaesthesia care are to

1. Identify potential anaesthetic difficulties

2. Identify coexisting medical conditions

3. Improving safety by assessing and quantifying risks of peri-operative care

4. Allowing planning of peri-operative care

5. Allaying anxiety and fear

This will be achieved when all health professionals work as a team.

A good pre-operative assessment will help to

a. Reduce the morbidity of surgery

b. Increase the quality while decreasing the cost

c. Return the patient to desirable functioning as quickly as possible & more cost effective.

d. Increase efficiency of operation theater time.

Above actions should

 Reduce the number of patients who fail to attend on the day of surgery

 Reduce cancellation of surgery for clinical reasons

 Provide an opportunity to discuss with patient any self help measures that help to improve outcome

(e.g. stopping smoking or loosing weight etc.)

Role of the Anaesthesiologist

 The Anesthesiologist is responsible for deciding whether a patient is fit for anaesthesia.

 While other professional groups may be involved, it is the anesthesiologist who provides the

framework in which a valid assessment can be made.

 It is inappropriate for non-anesthesiologist to promise a particular type of pre-medication,

anaesthesia technique or post-operative pain management and the decision to proceed with

anaesthesia cannot be delegated.

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 With previously screened healthy patients, the anaesthesiologist, on the day of surgery, must check

the result of screening and of other pre-operative testing. Any test performed pre-operatively must be

available to the anaesthesiologist and read by him.

 Patient likely to present anaesthetic problems should have been previously identified and seen by an

anaesthesiologist prior to being scheduled for surgery.

 The anaesthesiologist should explain to the patient, the proposed anaesthetic procedure. There is

often a choice of anaesthetic technique and the anaesthesiologist must ensure that the advantage and

complications of each are explained to the patient.

Screening and assessment

The screening and assessment process is increasingly carried out by a specifically trained pre-assessment

team.

This pre-assessment teamscreens patient for fitness for anaesthesia and surgery.

Anaesthesiologist can decide about fitness of anaesthesia.

Purpose of pre-assessment

It enables the identification of those patients who require.

 Few or no pre-operative investigations.

 Targeted investigations, the result of which must be available when the anaesthesiologist sees

the patient in the immediate pre-operative period.

 Further investigations or treatment, before being referred for anaesthetic assessment prior to

admission for surgery in case patient has potential medical problems

 Further assessment or referral after specific investigations.

An ideal system allows pre-operative assessment team to refer patients directly for optimization, to

medical specialist

Method of Pre-assessment

The surgical team (Consultant in charge of the case or Senior Resident or junior doctor from Surgery or

surgical specialities may perform the assessment and screening of the case before the patient is given a

date for surgical operation (may take guidance from anaesthesia department in this regard). The surgical

team may also refer the patient to department of anaesthesia immediately following the surgical

consultation along with relevant investigations. This fast track allows a date to be given for the proposed

surgery (subject to satisfactory laboratory and other investigations).

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The Pre anaesthetic checkup (PAC)

The PAC provides the opportunity for anesthetist to see those patients who have been identified by

screening and assessment as presenting potential anaesthetic problems

The PAC must involve Consultant Anesthesiologist's presence and to meet this requirement, preferably

be within operation theatre complex

Immediate pre-operative PAC is also done prior to wheeling the patient to OT as a safety measure.

For the PAC:

 The patient’s full hospital record must be available to the anesthesiologist.

 The patient should have an opportunity to talk to anesthesiologist, ideally the one who will

administer the anaesthetic.

 The patient (should the need arise) may be referred to other professionals, who will be involved

in their care, during hospital for example, Cardiologist, endocrinologist or a physician etc.

The advantage of assessment of patient in PAC includes:

 Patient identified by screening, if requiring further assessment, can be seen here.

 Patient’s can be examined during day time.

 Patient can be admitted on the day of surgery,if he/she have been assessed in the PAC earlier

and cleared for surgery.

 Risks and side effect can be fully explained and documented

 Elective post-operative admission to intensive care unit can be organized and explained.

Investigations

Medical and anaesthetic problems are identified more efficiently by taking a history and doing a physical

examination of patient.

Decision on which particular investigations should be ordered can be determined and based on algorithm

as in PAC Form

Routine Screening Investigations required prior to Surgery.

A clear demarcation is necessary between health screening and investigation that will add something to

the anesthetic management.

For guidance(appendix I)should be used as a guide as to which investigations is to be ordered for a

particular co-morbid condition. For example,or as a rule, ECG should be performed on every patient

with a cardiac or related history but is not indicated in asymptomatic healthy patients under 30yrs posted

for minor surgery.

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Fasting policies

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APPENDIX I: ROUTINE PREOPERATIVE

INVESTIGATIONS

A system of routine preoperative investigations for in-patients prior to elective surgery is suggested

below.

Routine Screening :All routine investigation/screening result will remain valid for 6 months if the

patient has not suffered any illness in the intervening period.

Complete blood count,

Fasting blood Sugar,

Serum urea and creatinine,

Serum sodium, Serum potassium

Serum Bilirubin, liver enzymes,

Viral Markers ( HBsAg, HCV and HIV),

Urine R/M

S. No

Tests

Indications

S Albumin

Liver Disorders

Malnutrition, Malabsorption

Kidney diseases

Infections

Inflammatory bowel disease

burns

S Calcium

Parathyroid disease

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Planned Thyroidectomy

Chronic renal and liver disease

Critical illness

Vitamin D deficiency/intoxication

Calcium disorders

Bone diseases

Thiazide diuretics

Lithium

Cns disorders

Coagulation Screen

(PT,APTT, Platelet count etc)

1. History of bleeding tendency

2. Major Surgeries

3. PT/PTT, Mandatory for regional cases

(Spinal/ Epidural)

4. Certain medications

5. Liver diorders

6.Coagulation disorders

Pregnancy Test

1. Whenever there is any chance of pregnancy

or a lady has missed her period

ECG TEST

1 Age more than 30yrs

2. Major or High-risk surgery

3. H/o heart disease, hypertension or chronic

lung disease

4 A normal previous trace within 6months is

accepted unless there is a recent cardiac

history.

5. Acute or chronic lung disease

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6. H/o COVID 19

7. Doubtful History

X Ray Chest

1. All patients above 40yrs

2. Acute cardiac or respiratory disease (e.g.,

asthma)

3.Chronic cardiac or chest disease

4. Suspicion of pulmonary tuberculosis

5. Malignant disease

6.H/O COVID 19

7. Malignancy/ Metastasis

8.Occupational Exposure

Thyroid Function Test

1. Based on previous history of hypothyroidism

2. Menstrual irregularities chronic

3. Obesity BMI >35

4. On drugs (like cardarone etc.)

Children upto 5 years

1. CBC, urine RE/ME

2. Other test depending on system

involvement

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APPENDIX II: LIST OF INVASIVE, HIGH-RISK, OR

SURGICAL PROCEDURES

 Any procedures involving skin incision

 Any procedures involving general or regional anesthesia, monitored anesthesia care, or

conscious sedation

 Injections of any substance into a joint space or body cavity

 Percutaneous aspiration of body fluids or air through the skin (e.g., arthrocentesis, bone marrow

aspiration, lumbar puncture, paracentesis, thoracentesis, suprapubic catheterization, chest tube)

 Biopsy (e.g., bone marrow, breast, liver, muscle, kidney, genitourinary, prostate, bladder, skin)

 Cardiac procedures (e.g., cardiac catheterization, cardiac pacemaker implantation, angioplasty,

stent implantation, intra-aortic balloon catheter insertion, elective cardioversion)

 Endoscopy (e.g., colonoscopy, bronchoscopy, esophagogastric endoscopy, cystoscopy,

percutaneous endoscopic gastrostomy, J-tube placements, nephrostomy tube placements)

 Laparoscopic procedures (e.g., laparoscopic cholecystectomy, laparoscopic nephrectomy)

 Invasive radiological procedures (e.g., angiography, angioplasty, percutaneous biopsy)

 Dermatology procedures (biopsy, excision and deep cryotherapy for malignant lesions –

excluding cryotherapy for benign lesions)

 Invasive ophthalmic procedures, including miscellaneous procedures involving implants

 Oral procedures including tooth extraction and gingival biopsy

 Podiatric invasive procedures (removal of ingrown toenail, etc.)

 Skin or wound debridement performed in an operating/procedure room

 Electroconvulsive treatment

 Radiation oncology procedures

 Central line placement • Kidney stone lithotripsy

 Colposcopy, and/or endometrial biopsy

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APPENDIX II: INFORMED CONSENT POLICY

DEFINING CONSENT

For consent to be valid, it must be voluntary and informed, and the person consenting must

have the capacity to make the decision. These terms are explained below:

a. Voluntary – the decision to either consent or not to consent to treatment must be

made by the person themselves, and must not be influenced by pressure from

medical staff, friends or family.

b. Informed – the person must be given all of the information in terms of what the

treatment involves, including the benefits and risks, whether there are reasonable

alternative treatments and what will happen if treatment doesn't go ahead.

c. Capacity – the person must be capable of giving consent, which means they

understand the information given to them, and they can use it to make an informed

decision.

PURPOSE

 To ensure that patient and/or the family membersare explained in a language clearly

understood by them regarding -

– patient's Diagnosis, if known;

– Nature and Purpose of the proposed treatment/s or procedure/s;

– Risks and Benefits of the proposed treatment/s or procedure/s;

– Alternatives, if available, with their risks and benefits, irrespective of their cost

or the extent to which the treatment options are covered by health insurance

companies;

– The risks and benefits of NOT receiving or undergoing a treatment or procedure,

– In turn, the patient should have an opportunity to ask questions to elicit a better

understanding of the treatment or procedure, so that he or she can make an

informed decision to proceed or to refuse a particular course of medical

intervention.

 to enable them to exercise their right of informed decision making,

 Also it is to define the obligations in obtaining and documenting informed consent and

that good consent practices are followed within the hospital.

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POLICY:

 The underlying principle of informed decision & informed consent is that patients have

the right to be told what to expect and to determine what will be done with and to

their bodies and the consent shall be signed when in a language that is clearly

understood by the patient and their relatives. All queries of the patient and his

attendant must be answered using non-medical terms and only after having

understood the details should the consent form shall be signed.

 Foe certain special procedure, like CABG, specific consent form shall be used for

recording consents.

 Consent Form should be considered as documentation of the discussion between the

patient, and/or the family members and the physician proposing the procedure or

surgery.

 Except in Emergencies, medical or surgical treatment or procedures shall not be

administered to any patient until informed consent has been obtained from the patient

or one legally authorized to act on behalf of the patient.

 All Consent Form shall be available in bilingual language, i.e., Hindi & English.

SCOPE

Treatment and procedures requiring prior Informed Consent shall include but are not limited

to:

- Any procedure under any form of anaesthesia/sedation,

- Any form of anaesthesia including conscious sedation and monitored care,

- All invasive diagnostic tests and procedures,

- Angiographic procedures,

- Angioplasty & Intravascular Catheter procedure,

- All Interventional procedures (including Pacemaker insertion, tumour

embolization etc.),

- Any aspirations (including FNAC),

- Biopsy and Bone marrow aspiration,

- Catheterization of major vessels (Arterial cannulation, Central line, PICC, etc),

- Intubations,

- Endoscopic procedures (Gastro Intestinal, Bronchoscopy or others),

- High Risk Consent, where appropriate,

- HIV testing,

- Restraints,

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- Dialysis,

- Blood & Blood product transfusions,

- Radiology investigations (CT, MRI, Fluoroscopy, etc.),

- Other diagnostic procedures like Stress test, Contrast imaging,

- Leave Against Medical Advise (DAMA/LAMA) or Discharge on Request (DOR),

- General Consent at the time of admission,

- Termination of pregnancy,

- Male & Female Sterilization,

- Dental procedures like tooth extraction, trauma cases, etc,

- Disposal of anatomical remains,

- Release of confidential information including taking photographs/ video

recordings except as permitted or required by law,

- Any treatment/procedure/test where the treating doctor feels the need to

obtain consent.

KEY DEFINITIONS: -

 Minor: A minor is a person under eighteen (18) years of age.

 Consent: Information about and consultation on any proposed Clinical/ Surgical/

Non-Surgical procedural initiative, it’s likely Risks, Benefits, Cost, Duration,

Discomfort, Alternatives and its likely impacts.

 High Risk Consent: Informed consent for procedures which have a high probability

of Death, Permanent Structural Damage or Permanent Functional Damage

 General Consent: Consent taken at the time of new admission with regards to

authorizing the hospital and treating physician for history taking, physical

examination, general investigations like X-Rays, routine Blood Investigations &

Treatment.

 Implied Consent: Granting of permission for health care without a formal

agreement between the patient and health care provider

PATIENT’S RIGHTS

 Patient and/or the family members shall be given information, in the language that

they can easily understand,

 They have the right to ask and ensure that all their doubts are clarified,

 to enable them to exercise their right to make informed decisions about their

proposed care,

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 Patient has the right to give or withhold consent prior to examination or treatment,

 Patients shall be allowed to decide whether they agree to the proposed treatment

and they may refuse treatment or withdraw consent at any time,

 Patient and/or the family members have the right to be updated if there is any

modification in the proposed care,

 Patient and/or the family members shall have the right to be informed as early as

possible regarding the results of the diagnostics tests performed earlier or whenever

the diagnosis is confirmed,

 Patient and/or the family members shall have the right for a second opinion.

WHO CAN GIVE CONSENT -

A. Adult patients who are capable of making decisions

– Adult patients who are capable of making decisions regarding proposed treatment

may give, withhold or revoke consent for themselves.

– They may also refuse to give consent to treatment.

– Spouses and other relatives may not give, withhold, or revoke consent for adults

who are capable of making decisions regarding proposed treatment for self.

B. Consent for patients who are not capable of making medical decisions

– If an adult is unable to understand all relevant facts related to his condition and

/or proposed treatment, his capacity to give informed consent must be

questioned.

– Finding of incapacity must be made by an attending physician in consultation

with another attending physician (preferably a Psychiatrist).

a. This lack of capacity may be temporary or permanent and may be due to a

natural state, age, anxiety, illness, injury, drugs or sedation, intoxication,

or other cause,

b. An adult patient shall not be considered incapable to make a decision

regarding proposed treatment based solely upon the fact of his or her

refusal of medical care,

c. The attending physician shall document the basis of such finding in the

patient's record.

These include but not limited to:

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 Patient who is unconscious/delirious,

 Patient who is mentally incapacitated or mentally incapable of making

decision by himself as decided by the treating doctor,

 Patient under sedation,

 Minor Individuals.

– If the patient lacks the ability to make an informed decision then consent shall

be obtained by the spouse or adult children or parent or adult sibling or other

family member, in this order of priority.

– In the absence of above, the authorized legal representative, as declared by

court may give consent.

C. Emergency Consent (Implied Consent)

An emergency is defined as a situation, where in competent medical judgment, the

proposed surgical or medical treatment or procedures are immediately or imminently

necessary and any delay caused by an attempt to obtain consent would jeopardize the

life, health or safety of the person affected or would result in disfigurement or

impaired faculties.

Emergency consent shall not be used to over-ride the patient’s health care directives

whether those directives be communicated by Living Will and/or through discussions

with the patient as documented in the patient’s medical record.

Consent to surgical or medical treatment or procedures may be implied if:

1) An emergency exists, and

2) The patient is not capable of giving or withholding consent for himself or

herself; and,

3) There is no one immediately available who is authorized, empowered, or

capable of giving consent for the patient.

D. Obtaining consent from or for a Minor: Consent for the treatment of a minor must be

obtained from one of the following:

1) A guardian or custodian;

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2) A parent, whether the child is of parent's blood, is an adopted child, is a

stepchild,

3) Any adult sibling;

4) Any maternal or paternal grandparent; provided, however, the parents are

absent.

PROCEDURE FOR OBTAINING CONSENT

1. Responsibility of the Physician:

 As consent is a process centered on discussing diagnosis, nature and purpose of

the proposed treatment, prognosis of the proposed treatment, risks and possible

complications of the proposed treatment (where the risk is low but the

consequence of the rare occurrence is extremely severe, that risk should be

disclosed), reasonable alternatives to the proposed treatment including the option

of no treatment, Prognosis of alternatives including no treatment, the person who

takes consent shall also be able to provide all necessary information to the patient

and so, ideally, the person taking consent should be the same person performing

the procedure or surgery.

 In cases where it is not possible for the person performing the procedure or

surgery to take the consent, then in such cases the responsibility for obtaining

consent may be delegated to others, but not less than the rank of Senior Resident,

provided they are suitably trained and qualified, have sufficient knowledge of the

proposed investigation or treatment and understand the risks involved.

 Doctors who delegate responsibility for obtaining consent, shall remain

responsible for ensuring that their patients have been given sufficient time and

information to make an informed decision before embarking on treatment, and

that their consent to proceed is valid.

 Any religious, cultural and spiritual requests from the patient and/or family

members, provided it adheres to the statutory norms, shall be considered by the

treating team,

 patient or patient's authorized representative shall be given the opportunity to ask

questions and receive additional information as requested,

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 The patient or patient's authorized representative shall also be advised that it is

not possible to predict or guarantee results,

 In case if a procedure requires more than one doctor from different specialties,

then the same shall be explained to the patient and consent shall include the

name of the principal surgeons from each specialty who are performing the

procedure. Each doctor shall explain his role and address all aspects required for

an informed consent,

 Once Consent Form is filled, it shall be signed by the Patient or patient's

authorized representative. If signed by patient's authorized representative, then

in all such cases, the name & relationship to the patient shall be clearly

mentioned alongwith the signature,

 Finally, the physician shall sign the Consent Form and place it in the patient

medical record.

2. Witness To The Signature

 The patient's signature on the consent form shall be witnessed by another

employee of RML Hospital or patient’s attendant

 The witness' signature on the consent form only signifies that the patient's

signature is indeed his own,

 Witnessing the signature implies nothing about the witness’s knowledge of the

patient's ability to give consent or completeness of the information shared by the

physician with the patient.

NOTE:For all consents for HIV testing, signature of the witness must be avoided to

respect patient confidentiality.

3. Responsibility of Nursing Staff -

a. Assigned Nurse posted in the Wards / ICU / HDU:

 Assigned Nurse shall ensure that properly documented Consent Form has

been obtained by the concerned physician or his team and is available in the

patient record,

 If Assigned Nurse finds that the Consent Form is not filled, then it shall be

the duty of the assigned nurse to inform the concerned physician or his team

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and get the form filled much before the scheduled time of

procedure/surgery,

 Under no condition, the assigned nurse shall shift the patient to the

procedure room /operation theatre without a properly filled consent form,

except in life-threatening situations.

b. Staff posted in Procedure Room/ OT Receiving Area:

 It shall be the responsibility of the nursing staff posted in the Procedure

Room/ OT Receiving Area to receive patients with properly filled and signed

Consent Form from the Ward Nurse.

VALIDITY OF CONSENT

1. A general consent for admission shall be valid for the duration of the hospitalization.

If the patient is discharged and needs to be readmitted, a new consent form for

admission must be signed by the patient or one legally authorized to act on behalf of

the patient.

2. A procedure-specific consent form is considered valid for one (1) week after the date

of signature as long as the patient's condition has not materially changed during the

interim period. The same consent form, however, cannot be reused when a procedure

is repeated.

3. Informed Consent for Continuing Therapy

Informed consent shall generally be obtained before each new procedure. However,

patients in certain therapeutic programs involving a course of multiple treatments

may consent to an entire course of routine therapy prior to the first treatment, and a

single consent form may be signed for the entire course of treatment (not to exceed

six months), if:

i) The entire course of treatment is disclosed, consented to, and documented in

accordance with this policy, and

ii) No material change occurs in:

a. the risks, benefits of and alternatives to the treatment;

b. the mode of treatment;

c. the patient's medical condition; or

d. the patient's capacity to consent; and

iii) Patient does not revoke consent; and

iv)Consent is re-obtained and re-documented at least in 6 months.

Such Consent form should be endorsed by the patient at each repeat treatment.

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Examples of therapeutic programs covered by this exception include, but are not

limited to the following: chemotherapy, repetitive blood or blood products

transfusions; peritoneal dialysis, and hemodialysis; and plasmapheresis procedures.

WITHDRAWL OR REFUSALS OF CONSENT:

An adult patient who is conscious and capable of making a medical decision has the right to

refuse any surgical or medical treatment or procedures.

A. A patient may, before treatment is begun, specifically prohibit a procedure that might

become necessary during treatment or withdraw a consent previously given for such

procedure. In the event of such refusal, two (2) alternative courses are possible:

 The physician may refuse to admit the patient on the grounds that proper care

cannot be rendered because of the patient's refusal to allow procedures that the

physician believes may be necessary for the preservation of life or health; or

 The physician can admit the patient and provide only such services and procedures

as are within the limits stated by the patient. If the patient has already been

admitted when the refusal to consent is expressed, the services or procedures

should be provided within the limits imposed by the patient or the physician

should offer assistance to the patient in finding another physician who is willing to

provide treatment within the patient's limitations.

B. MS or Unit Head to be contacted immediately if the patient is:

 A minor;

 Pregnant;

 An adult with minor children; or

 A person who appears to be under the influence of drugs, delirious or comatose,

or otherwise incapable of exercising rational judgment.

C. A patient who imposes limits by refusing certain procedures should be required to

execute a release, Patient's Release upon Refusal of Treatment. The progress notes in

the medical records should reflect the discussion with the patient and the patient’s

refusal to consent to specific treatment. The consent form shall remain in the patient's

chart.

STATUTORY REQUIREMENTS OF CONSENT:

Medical Council of India’s Code of Medical Ethics:

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

Issue No.

Issue Date:

06.01.2022

Rev. No.

Rev. Date:

Nil

Page 37 of 40

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 Before Performing an Operation the physician should obtain in writing the consent

from husband or wife, parent or guardian in case of minor, or the patient himself as

the case may be.

 In an operation, which may result in sterility, the consent of both husband and wife is

needed.

 As registered medical practitioner shall not publish photographs or case reports of

his/her patient without their permission, in any medical or general in a manner by

which their identity could be made out. If the identity is not to be disclosed, the

consent is not needed

 Research: clinical drug trials or other research involving patient 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.

 Obtaining Consent

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.

 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.

 The Physician must give patients details before he/she decides to consent to an

investigation or a treatment.

 The Physician must give details of the diagnosis and prognosis of the disease, if

left untreated.

 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.

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

Issue No.

Issue Date:

06.01.2022

Rev. No.

Rev. Date:

Nil

Page 38 of 40

Prepared by

Reviewed by

Approved by

 The Physician must respond honestly to any question the patient raises. She/He

must answer such question as fully, accurately and objectively as possible.

 The Physician must not exceed the scope of authority given to you by your

patients, except in an emergency.

 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.

 When investigating / treating a child who cannot give or withhold consent, seek

consent from a person with parental responsibility for the child.

 With reference to specific practice

1. 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.

2. The Physician must follow Guidelines laid down by the Indian Council of Medical

Research for research and therapeutics trials.

3. Special Consent provisions under PNDT Act (Form G)

4. Consent Requirements under MTP Act (Form C)

TRAINING

Staff shall undergo regular training sessions on -

 Clinical conditions under which an informed consent must be taken,

 personnel authorized to give the detail information regarding proposed medical or

diagnostic procedure/surgery to the patient and attendants to be able to reach an

informed decision, and

Atal Bihari Vajpayee Institute of Medical Sciences and

Dr Ram Manohar Lohia Hospital

Baba Kharak Singh Marg, New Delhi-110001

Policy for Operation Theatre

Issue No.

Issue Date:

06.01.2022

Rev. No.

Rev. Date:

Nil

Page 39 of 40

Prepared by

Reviewed by

Approved by

 regarding the procedure to be followed for documenting an informed consent.

KEY CTQ /PERFORMANCE INDICATORS:-

S No.

Indicators

Compliance

level

Consent Forms Accuracy in terms Details of Name of Procedure, who

shall perform the Surgery/Procedure, Benefits, Complications, Risks,

Alternatives, Signatures of Doctor / Witness & Patient / Patients-

relative with stated relationship with the patient)

100 %

Type of Consent Form usage (use of Surgery/Procedure Specific Forms for

documenting consents)

100 %

Interviewing Patient/patient relatives regarding explanation of the

procedure before signing the Consent Form by the performing physician or

their team member

100 %