COP - CARE OF PATIENTS

Page 1 of 18
COP 1: CARE OF PATIENTS IS GUIDED BY ACCEPTED NORMS AND PRACTICE

COP 1a: The care and treatment orders are signed and dated by the concerned doctor

Intent To ensure accountability and good practices in clinical documentation.

Engage the doctors in understanding the need for putting their signature, date
and time against the entries made in the medical records and all patient
assessments.
Continued orientation and training of the doctors to ensure that they sign,
Requirements / date and time their entries.
Implementation Regular check on the medical records to audit the process.
guidelines Providing feedback on a monthly basis to all doctors about incomplete
entries w.r.t. sign, name, date and time
Orient the in-house residents to ensure that the Consultants sign, date and
time the entries during the visits (within 24 hours of the admission of the
patient).
Documented policy for care and treatment orders in the apex manual, patient files,
Evidences
OPD records

COP 1b: Clinical practice guidelines are adopted to guide patient care wherever possible
To ensure that the clinical care is evidence based, clinical pathways are established
Intent
and followed for the management of patients.
List out the common ailments treated in the specific specialties in
consultation with the requisite clinicians.
Enumerate the clinical pathway for treating the ailment.
Requirements / Document the pathway in the apex manual.
Implementation Ensure that the pathway is adapted and followed for the management of
guidelines patients.
Discuss any variations or exceptions to the rule which need to be addressed.
Audit check and peer review of the patient files to ensure the pathways are
adhered to.
Evidences Documentation of clinical pathways in apex manual, audit reports

Page 2 of 18
COP 2: EMERGENCY SERVICES INCLUDING AMBULANCE ARE GUIDED BY
DOCUMENTED PROCEDURES

COP 2a: Documented procedures address care of patients arriving in the emergency including
handling of medico-legal cases
To ensure that immediate care is provided to patients arriving in emergency
Intent
department of the hospital
The emergency department/ area should be easily accessible for patients
preferably at the entrance of the hospital.
There should be a demarcated area for ambulance parking in front of the
emergency keeping in mind easy accessibility to offload patients and exit
quickly.
The hospital shall define minimum number of beds based on its specialty and
scope of services.
Documented policies for receiving patients, triaging, initial assessment of
patients, managing patients under observation, referring patients for further
management to specialty units, transfer of patients, managing cardiac arrest,
managing MLC, managing found dead on arrival, etc., should be available in
Requirements / the apex manual.
Implementation All patients arriving shall be provided first aid before transferring to other
guidelines centres.
The hospital shall define what constitutes MLC and all staff working in
emergency department should be aware of the same.
All medico-legal cases must be reported to police in the appropriate police
intimation format. Two identification marks to be documented in the form.
Manpower and other resources should be adequate and available to provide
services round the clock
All patients brought to emergency must be registered and the entries
maintained in the nominal registers.

Reference: Pre-Accreditation Entry Level Standards for SHCOs. (First edition, May
2015)
Documented policy for emergency management in the apex manual, list of MLC,
Evidences MLC register, brought dead register, triage register, staff training, staff awareness,
nominal register

COP 2b: Staff should be well versed in the care of emergency patients in consonance with the
scope of the services of hospital
Intent To ensure that the patients are managed well in the emergency department.
Staff should be aware of the services available in emergency department in
consonance with hospital scope of service.
Requirements /
All staff working in emergency should be aware of the management of patients
Implementation
presenting to emergency department. For eg.: Snake bite, poisoning, etc.,
guidelines
Staff should be trained in basic cardio pulmonary resuscitation and preferably
in advanced cardio pulmonary resuscitation.

Evidences Training records, staff awareness, CPR certification as appropriate

COP 2c: Admission or discharge to home or transfer to another organization is also documented
Intent To ensure appropriate documentation of transfers.

Page 3 of 18

If a patient requires admission in to ICU / ward from the emergency, the same
has to be documented in the patient case sheet and transferred to the
Requirements / appropriate area with transfer notes.
Implementation Discharge or transfer to another organization should be documented
guidelines appropriately in the patient case sheet with the vitals and condition of the
patient at discharge/ transfer.
A discharge note shall be provided to the patient.
Documented policy for admission/ discharge/ transfer from emergency in the apex
Evidences
manual, nominal register, transfer notes, discharge notes

COP 2d: Ambulance is appropriately equipped

To ensure that the ambulance has appropriate equipment to manage patients while
Intent
shifting.
The requirement of equipment is based on the scope of services of the hospital.
For eg.: If the hospital has cardiology services, it should have monitors, defibs,
ventilators, etc., If it is a trauma centre, it should have spine boards and
Requirements /
cervical collars along with basic life support equipment.
Implementation
On a minimum, equipment for providing basic life support should be available.
guidelines
(both adult and paediatric) and checked on a daily basis.
Emergency medicines are available in the ambulance and are daily checked for
expiry and functionality. They are also replenished as and when used.
Evidences Registers for equipment checks, medication registers

COP 2e: Ambulance(s) is manned by trained personnel

Intent To ensure that the patients are transferred safely by trained personnel.

Requirements / Only licensed driver and trained medical staff handle the ambulance service.
Implementation Depending on the patient condition, doctor/ nurse/ technician should
guidelines accompany during transfer.
All personnel should be trained in basic cardio pulmonary resuscitation.
Documented policy for transfer from emergency in the apex manual, drivers license,
Evidences
training records, CPR certification as appropriate

Page 4 of 18
COP 3: DOCUMENTED PROCEDURES DEFINE RATIONAL USE OF BLOOD AND
BLOOD PRODUCTS

COP 3a: Documented policies and procedures are used to guide the rational use of blood and
blood products
Intent To ensure rational use of blood and blood products.
Policy for conditions where whole blood and blood components can be used
should be documented.
Requirements / All policies and procedures pertaining to blood donation, consents, managing
Implementation the blood and blood components, storage, transfusion reactions, discard, etc,
guidelines should be documented in the apex manual.
Inventory and ordering schedules in blood bank for planned/ unplanned
transfusion
Documented policies for blood bank in the apex manual, stock register, blood
Evidences
requisition register

COP 3b: Documented procedures govern transfusion of blood and blood products
Intent To ensure that the blood and blood products are administered safety to the patients.
The order for blood or blood products transfusion should be written by the
doctor appropriately which includes blood type, amount and duration.
The request for blood group, Rh typing should be sent to the laboratory and
subsequently for cross matching to the blood bank.
Before connecting the blood, two healthcare workers should double check on
the components of the bag with the order and the expiry of the bag.
Requirements /
Implementation Blood can be connected by the doctor/ nurse.
guidelines One pre-transfusion vital should be recorded. Patient should be monitored
during transfusion every half an hour and recorded. Post transfusion patient
should be monitored for two hours.\

Reference:
1. Pre-Accreditation Entry Level Standards for SHCOs. (First edition, May 2015)
2. NABH standards for blood banks
Evidences Documented policy for blood transfusion in apex manual

COP 3c: The transfusion services are governed by the applicable laws and regulations
Intent To have valid license for the blood bank.
Requirements / License as per Drug and Cosmetics ACT
Implementation If blood bank is not available, shall have MOU with another blood bank
guidelines Blood shall be transported in such case in a safe and proper manner.
Evidences License of blood bank, If there is no blood bank - MOU with other blood banks

COP 3d: Informed consent is obtained for donation and transfusion of blood and blood products
To ensure proper information is provided to patients and their consent obtained for
Intent
donation and transfusion of blood products.
Consent is taken before blood donation or transfusion (single consent is valid
Requirements /
for multiple transfusion during the same admission and a validity period)
Implementation
For transfusion dependent patients, eg. Thalassemia, haemophilia, the consent
guidelines
can be taken once in 6 months.
Page 5 of 18
 Consent should be in detail to include risk, benefit and other possible
complication due to transfusion
Informed consent for transfusion should also include patient and family
education about donation.
Documented policy on consent for blood transfusion in the apex manual, consent
Evidences
forms

COP 3e: Procedure addresses documenting and reporting of transfusion reactions

Intent To report any adverse transfusion reaction
Any suspected transfusion reaction including chills, fever, rashes, etc., should
be reported to the blood bank through transfusion reaction reporting form.
Patient should be managed immediately and the blood transfusion stopped.
The remaining blood in the bag, blood sample from the patient and the urine
sample should be sent to the blood bank along with the transfusion reaction
Requirements /
reporting form.
Implementation
guidelines The blood bank should do appropriate root cause analysis and the feedback of
the same should be sent back to the treating team. The same is applicable to
the outsourced blood bank.
The transfusion committee is a mandatory committee if it is a licensed blood
bank. The transfusion reactions and the usage, wastage of blood and blood
products should be presented to this committee atleast once in 6 months.
Evidences Transfusion reaction form, transfusion committee minutes

Page 6 of 18
COP 4: DOCUMENTED PROCEDURES GUIDE THE CARE OF PATIENTS AS PER THE
SCOPE OF SERVICES PROVIDED BY HOSPITAL IN INTENSIVE CARE AND HIGH
DEPENDENCY UNIT.

COP4a: Care of patients is in consonance with the documented procedures

To ensure appropriate care for patients admitted in ICUs and HDUs. These
Intent
procedures are guided by professional practice guidelines, laws and regulations.

The hospital shall have the documented policies and procedures for the
management of patients in ICU and HDU.
These procedures should be as per the current evidence based practices and
national / international guidelines. (CDC, Critical Care Society, WHO)
Admission and discharge criteria should be appropriately documented and
Requirements / followed in all ICUs. Staff must be aware of these criteria.
Implementation Appropriate infection control practices and monitoring of device related
guidelines infections, hand hygiene practices, environmental surveillance should be
performed.
Staff must be appropriately trained on infection control practices.
Patient relative counseling and documentation of the same should be done.
End of life care must be practiced in consonance with legal requirements and
good practices.
Documented policy for ICUs/ HDUs in the apex manual, staff training, staff
Evidences
awareness, audit reports.

COP 4b: Adequate staff and equipment are available

To ensure adequate availability of staff and equipment for safe management of
Intent
patients in ICUs and HDUs.
There must be atleast one duty doctor available in the ICU round the clock.
The number depends on the size of the ICU and its complexity.
For ventilated patients, nursing staff should be 1:1 and non-ventilated, upto
1:3 in all shifts.
Other area nurses should not be posted in ICUs.
There should be adequate number of ventilators, central medical gas, backup
cylinders, monitors and UPS backup for critical equipments.
All staff should be trained in basic cardio pulmonary resuscitation and
preferably in advanced cardio pulmonary resuscitation.
The admitting consultant should be available on call as and when required.
Requirements /
Well stocked crash cart with defibrillator should be available and checked
Implementation
every shift for contents.
guidelines
Equipment downtime should be monitored and followed up.
All critical equipment should have operational checklists and frequent
preventive maintenance
Equipment should be calibrated and checked for functionality of alarms.
The central medical gas lines should have alarms in ICU to notify when the
pressure drops.
Fire detection, firefighting equipment must be available and mock drills
should be conducted for patient evacuation. All staff should know their role
and the protocol for evacuating patients.
SOP for non-availability of beds and equipment must be available.
Staff list, duty roster, ICU register, equipment maintenance records, calibration of
Evidences
equipment.
Page 7 of 18
COP 5: DOCUMENTED PROCEDURES GUIDE THE CARE OF OBSTETRICAL PATIENTS
AS PER THE SCOPE OF SERVICES PROVIDED BY HOSPITAL.

COP 5a: The organization defines the scope of obstetric services

To clearly communicate to the patients and community, what the hospital can and
Intent cannot provide for pregnant women during the antenatal, intra-natal and postnatal
period to make informed decision and for safe delivery.
Display the scope/ list of obstetric services and specify those that are
available round the clock.
List out all the clinical services, diagnostic services, support services
available in the obstetric department.
Availability and display of qualified obstetrician and gynecologist with their
names and qualification.
Bilingual display of obstetrics services
Hospital has to define what constitutes high risk obstetrics case.
Requirements / Display in prominent locations (entrance, registration counter, OPD,
Implementation emergency department) whether the hospital can take care of high risk
guidelines pregnancies or not.
If high risk pregnancies are managed, the hospital should have the facility to
take care of such mothers and neonates.
MTP license should be available.
Records and registers including consents should be maintained as per the
MTP Act.
If ultrasound is available, licenses for the same, displays that sex
determination is not done in the prescribed manner, consents in the
prescribed format and reporting in the prescribed manner should be done.
Evidences List of obstetrics services in apex manual, displays in prominent places, records

COP 5b: Obstetric patients care includes regular ante-natal checkups, maternal nutrition and
post natal care
To ensure that the organization provides regular ante-natal checkups, maternal
Intent
nutrition and post natal care as per the National Guidelines.
Registration of Antenatal mothers are done.
Antenatal (ANC) checkups are done as per the National Guidelines (at least 4
antenatal checkups). 1st ANC Checkup: As soon as the period is missed or
within first three months of missing the period; 2nd ANC Checkup: 4th 6th
Month of pregnancy; 3rd ANC Checkup: 7th to 8th Month of pregnancy; 4th
ANC Checkup: 9th Month of pregnancy.
Immunization of antenatal mothers as per National Guidelines.
Ensure that Hb, BP, Urine, Weight and abdomen checked at every visit.
Requirements /
IFA (Iron and Folic Acid) tablets are given to Antenatal mothers.
Implementation
Two doses of Inj. Tetanus Toxoid (TT) is given.
guidelines
Preparation of mother for Normal delivery/ Caesarian sections etc.
Obtaining informed consents from mother/ family members.
Referral services to higher centers are available.
Mothers are educated regarding nutritional requirements during pregnancy,
lactation and post natal period.
Printed materials such as brochures, pamphlets, displays etc, video clips or
any other mode of communication may be used to impart nutritional
education.
Page 8 of 18
 Maternal and foetal monitoring as appropriate and documented.
Post natal care is provided to mother and the new born as per National
Guidelines, to ensure wellness of both mother and the baby.
ID band is affixed on the newborn immediately with the name of the mother
and UHID.
Foot print of the baby is taken and kept in the record.
Infant breastfeeding is initiated in right time (within 1 hour of delivery).
Immunization of the new born is done as per the National Immunization
schedule At Birth, BCG, OPV-0 Dose, Hepatitis B- 0 Dose.
Birth registration is done as per guidelines.
Family planning advice on temporary/ permanent methods is given to the
eligible couples.
CC TV / Entry restriction protocol in the facility.
Child abduction prevention measures are in place.
OPD registers, ANC registers, PNC registers, Normal delivery registers, OT
Evidences
registers, ANC Case records, Birth registers.

COP 5c: The organization has the facility to take care of neonates
To provide immediate care of healthy newborns as well as life saving care to sick
Intent
newborns.
Availability of new born care corner in the labour room.
Availability of equipments/ instruments, E.g. baby receiving tray, open care
radiant warmer, suction device, oxygen, two clean warm towels, clock,
weighing scale, phototherapy unit.
Calibration of equipment like phototherapy units and weighing scale to
ensure neonatal safety.
Resuscitation of asphyxiated newborns.
Requirements / Early initiation of breast feeding.
Implementation Staff are trained in resuscitation of newborns.
guidelines Kangaroo mother care is practiced.
Referral services are available.
Immunization services are available as per guidelines.
Sick newborn care unit is available with adequately trained pediatrician and
nursing staff.
Managing of low birth weight babies (<1800 gms).
CC TV / Entry restriction protocol in the facility.
Child abduction prevention measures are in place.
Evidences Newborn case records, Admission registers, Labour room registers

Page 9 of 18
COP 6: DOCUMENTED PROCEDURES GUIDE THE CARE OF PAEDIATRIC PATIENTS
AS PER THE SCOPE OF SERVICES.

COP 6a: The organization defines the scope of paediatric services

To clearly communicate to the patients and community, the services the hospital can
Intent
and cannot provide for neonates, infants and children.
The scope will include paediatric sub-specialties and clinics. For eg.
Paediatric Cardiology, Paed. Nephrology, NICU, PICU, Well Baby Clinics,
etc.,
Requirements / Display the scope / list of paediatric services and specify those that are
Implementation available round the clock.
guidelines Availability and display of qualified paediatrician with their names and
qualification.
Bilingual display of the list of paediatric services in prominent locations
(entrance, registration counter, OPD, emergency department).
Evidences Displays

COP 6b: Provisions are made for special care of children by competent staff

To ensure that children have special amenities and qualified/ competent staff to take
Intent
care of the special needs.
Qualified and trained pediatrician and nursing staff are available.
It is ensured that nursing staff have adequate experience in handling
paediatric patients and are not rotated.
Staff are trained in paediatric emergencies.
Nurse Patient ratio is adequate.
Requirements / Adequate equipments are available to provide age specific special care of
Implementation children.
guidelines In paediatric OPD, provision for breast feeding and play room is made
available.
Environment should be child friendly. For eg.: Electrical plug points at
higher levels, sharp objects posing danger to children, etc.
Bedside medications storage should be avoided.
Staff are trained in prevention of child abuse.

Evidences Staff interview, Staff personal files, infrastructure.

COP 6c: Patient assessment includes detailed nutritional, growth and immunization assessment.
Intent To carry out proper assessments of patients to help in developing treatment plans.

Availability of standard nutritional assessment charts, growth charts,

immunization charts in OPDs, IPDs etc.
Adequate formats are available and easily accessible.
Requirements /
Adequate training is given to hospital staff Doctors, Nurses, Dieticians
Implementation
involved in patient assessment.
guidelines
Availability of weighing scale.
Availability of height measuring scale.
Availability of mid arm circumference scale.

Page 10 of 18
Evidences Patient OPD/IPD records, documented protocol in apex manual.

COP 6d: Procedures address identification and security measures to prevent child abduction
and abuse.
Intent To prevent child abduction and abuse in the organization.
All relevant staff are trained in prevention of child abduction and abuse, i.e.
staff belonging to paediatric ward, labour room, PICU, Post natal ward etc.
Installation of CCTV Cameras in relevant locations, i.e. at hospital entry,
hospital exit, labour room areas, PICU, post natal ward areas, etc.
Availability of adequate security personnel round the clock.
Availability of patient identification bands for newborns, children, mothers
etc.
Requirements / Establishing CODE PINK/ abduction management team.
Implementation Training of hospital staff regarding CODE PINK.
guidelines Conducting CODE PINK mock drills once in 6 months.
Restrict unauthorized persons entry to PICU, Labour rooms, paediatric ward
etc.
Follow visitors policy strictly, with visitors pass only.
Educating the parents about child abuse, and never leave the child
unattended.
Authorize only close family members of the baby to handle the baby.
Rapid response protocol in case of abduction.
Training records, availability of CCTV Cameras, security staff, CODE PINK
Evidences
protocol in apex manual, mock drill records

COP 6e: The children family members are educated about nutrition, immunization and safe
parenting.
To guide the childrens family members in a better manner for healthy growth of the
Intent
child.
Childrens family members are educated regarding age specific nutritional
requirements of the child.
They are educated about age specific immunization requirements as per the
guidelines.
Requirements / They are educated about safe parenting techniques, e.g. Teaching the child
Implementation about body safety, Good sleep habits, keeping child safe from sexual abuse,
guidelines preventing eating disorders, protecting child from stress, keeping kids safe
from online, healthy school habits, safety rules etc.
Printed materials such as brochures, pamphlets, displays etc, video clips or
any other mode of communication may be used to impart nutritional,
immunization and safe parenting education.
Childrens family member interview, general awareness of staff.
Evidences
This is mentioned in hospital Apex Manual.

Page 11 of 18
COP 7: DOCUMENTED PROCEDURES GUIDE THE ADMINISTRATION OF
ANAESTHESIA

COP 7a: There is a documented policy and procedure for the administration of anesthesia.
To ensure that the department of anaesthesia has a uniform policy for the
Intent
procedures followed in different types of anaesthesia.

Head of department of anesthesia along with the anesthesiologist in charge of

different OTs will be responsible for formulation and implementation of the
policy.
The said procedure will follow standard guidelines.
Requirements/
The procedure of anesthesia will take into consideration the type of surgery,
Implementation
duration, patients co-morbid conditions and risk involved.
guidelines
Procedure should mention all the steps right from the pre-anaesthesia
medication to induction, maintenance, reversal of anesthesia, and the drugs
that are used.
Post anesthesia care including post-operative anesthesia.

Evidences Documented policy and procedure of anaesthesia administration in apex manual

COP 7b: All patients for anesthesia have a pre-anesthesia assessment by a qualified / trained
anaesthestist.
To ensure that only qualified/ trained person assess the patien tfor fitness for
Intent
anesthesia

The pre-anaesthesia assessment is performed prior to the day of surgery

Preferably an anesthesiologist does a pre-anaesthesia evaluation
Requirements/
Implementation The surgeon, physician (trained anaesthesiologist) can perform the pre-
guidelines anaesthesia assessment, order relevant investigations based on set criteria,
discuss with the qualified anaesthesiologist and keep the patient ready for
surgery.

Evidences Documented policy and procedure of pre-anaesthesia assessment in apex manual

COP 7c: The pre-anesthesia assessment results in the formulation of an anesthesia plan which is
documented
Intent To formulate the anaesthesia plan for the patient and prepare the patient

Page 12 of 18
Requirements/ There should be a documented pre-anaesthesia evaluation formwhich can be
Implementation in the form of printed questionnaire
guidelines Evaluation will involve history taking, examination, investigations
Expert opinion may be taken from a cardiologist, nephrologists, pediatrician
etc as the requirement of the case
Special investigations may be asked for where necessary which will help in
the formulation of the anesthesia plan
Assessment will lead to grading of the anaesthesia risk [ASA Grading]
After due assessment, the plan is finalized as general/ spinal etc and the
same is discussed with the patient
Assessment will involve instructions to the patient preoperatively and
postoperative regarding medication, NBM status etc

Evidences Pre-anesthesia evaluation form, documented anaesthesia plan endorsed by the

anaesthesiologist, supporting investigation reports, expert opinion etc.

COP 7d: An immediate preoperative re-evaluation is documented

Intent All patients undergoing anaesthesia should be reevaluated for fitness prior to
anesthesia, to prevent adverse aneasthesia event due to any new medical condition
which has arisen after the initial pre-aneasthesia assessment or missed during the
same.
Requirements/ This should be done by the concerned anaesthesiologist or member of the
Implementation anaesthesia team
guidelines It should involve checking of the vital parameters, NBM status, history of any
recent development in medical condition after the last assessment
Reviewing the investigation results specially in high risk patients
Detail review of medication history will include the following,
o Self medications or preoperative medicines, medications withheld
before surgery, medicines given in the ward, history of allergy to any
medicines, IV line integrity to be checked, if already present.
Mouth opening reassessed.
Evidences Documentation suggesting pre-op immediate evaluation in the patients IP
records, signed stamped dated and timed by concerned staff

COP 7e: Informed consent for administration of anesthesia is obtained by the anesthesiologist.
Intent Patient is made aware of the anaesthesia plan, other options for anaesthesia,
risk involved, post op recovery time, status and post opanalgesiamethods
Requirements/ Separate anaesthesia consent shall be taken for patients undergoing surgery.
Implementation It shall be taken by the anaesthesiologist, prior to the surgery and not on the
guidelines day of surgery
It shall include the type of anaesthesia, name of the anaesthesiologist, risk,
benefit and the alternatives explained and documented.
The patient has to sign the anaesthesia consent and the witness endorses the
same.
If ASA risk grading is above three, then separate high risk consent is
obtained from the patient.
The consent shall be bilingual and the patient should be explained in the
language he can understand

Page 13 of 18
Evidences Documented policy for anaesthesia consent in apex manual, bilingual consent
forms

COP 7f: Anesthesia monitoring includes regular and recording of heart rate, cardiac rhythm,
respiratory rate, blood pressure, oxygen saturation, airway security and potency and end
tidal carbon dioxide.
Intent To ensure that required monitoring is done at each stage of anesthesia for the
safety of the patient, to prevent any anaesthesia related adverse event
Requirements/ Availability of qualified staff / anaesthetist for adequate monitoring of
Implementation patient pre, during and post anaesthesia for amount of time as per type
guidelines of anaesthesia and status of patient post anaesthesia.
Monitoring: Basic monitoring of pulse. B.P[NIBP],SpO2,ETCo2, Temp,
Respiration, ECG, urine outputs hould be done and documented.
Advance monitoring like IBP, CVP, ABG analysis etc can be done as per
case requirement
Integrity of circuit to be checked
Air way monitoring ensured
Level of consciousness checked and documented

Evidences Documented policy for anaesthesia monitoring in the apex manual,

Anaesthesia record, Equipment available for monitoring is available at
appropriate areas

COP 7g: Each patients post-anesthesia status is monitored and documented

Intent To ensure that post op monitoring is done according to set criteria to prevent any
untoward events.
Requirements/ To be done at all areas of post op care E.g. PACU, ICU, CCU, NICU, HDU,
Implementation ward.
guidelines To be done by an anesthesiologist or a qualified and trained person like a
staff nurse or intensives.
Post anesthesia care criteria to be formulated and documented.
All vitals and specific criteria as per case to be monitored and the same will
be documented
Any events to be documented
Evidences Documented policy on post anaesthesia monitoring in the apex manual, Post
anaesthesia status monitoring details available in IP document, staff interview
on awareness

COP 7h: Defined criteria are used to transfer the patient from the recovery area.
Intent To prevent transfer of an unfit patient to ward where monitoring might not be
adequate
Requirements/ Transfer criteria which follow established guidelines like the PAD Scoring or
Implementation the modified ALDERATE Scoring can be used
guidelines The same can be in printed format and documented
The nurses in the recovery can monitor and document the score.
Anaesthesiologist checks on the patient, when the patient is ready,
evaluates the patient again and writes the order for shifting of the patient
to the ward
Staff trained on the transfer criteria

Page 14 of 18
Evidences Documented policy for transfer from recovery in the apex manual, equipment for
monitoring available, staff awareness

COP 7i: Adverse anesthesia events are recorded and monitored

Intent To ensure that all adverse events are recorded and monitored. This will help in
immediate action and preventive actions taken to avoid such events in future.
Requirements/ Document the list of adverse anaesthesia events that could occur.
Implementation Documentation format to record and monitor events if they occur.
guidelines To be documented by the concerned anesthesiologist
RCA and CAPA to be done and documented
Evidences List of adverse anaesthesia events, adverse event documentation format, RCA
and CAPA of the events, staff awareness of the above protocol and training and
how to go about it.

Page 15 of 18
COP 8: DOCUMENTED PROCEDURES GUIDE THE CARE OF PATIENTS UNDERGOING
SURGICAL PROCEDURES

COP 8a: Surgical patients have a pre-operative assessment and a provisional diagnosis
documented prior to surgery
Intent A clear diagnosis of condition, after thorough evaluation, investigation is made
so that there is no room for discrepancy.
Requirements/ Equipment needed to examine the patient thoroughly commensurate to the
Implementation scope of services of the hospital
guidelines Diagnostics facilities commensurate to the scope of services present in the
organization
Trained and qualified doctors available for routine as well as emergency
consultation
Pre-operative assessment is documented
Provisional diagnosis has to be documented along with differential
diagnosis
Investigations with reporting wherever applicable to support the diagnosis
should be documented
Evidences Documented care plan format with provisional diagnosis, investigation/
diagnostic test report

COP 8b: An informed consent is obtained by a surgeon prior to the procedure

Intent Patient is aware of his condition and surgery options in details so that he is in a
position to take a decision and give consent with complete knowledge

Requirements/ Patient is explained of his condition and a informed consent is been

Implementation provided which has patients details with
guidelines Consent form shall be bilingual
Signature/ thumb impression of the patient, name, time and date
In case of patient being unconscious or not in physical or mental state to
give consent, signature of next of kin with ID proof
Name and signature of interpreter, if such services are used
Name and signature of witness
Provisional diagnosis date of surgery/ surgery details other options
conservative/ surgical with advantages and disadvantages
Details of implant type chosen with other options, advantage sand
disadvantages
Any high risk involved in surgery special mention of the same, surgeons
signature, time date and Medical council registration number

Evidences Documented policy for surgical consent in apex manual, availability of

informed consent in bilingual with requisite details, patient interview, staff
awareness, audit reports.

COP 8c: Documented procedure address the prevention of adverse events like wrong site,
wrong patient and wrong surgery.

Page 16 of 18
Intent Patient does not suffer due to lack of policy, protocol and training which can
lead to an adverse event in the OT
Requirements/ There should be at least two identifiers to identify the patient. Eg. UHID
Implementation number in the patient medical records and name tag on the patients wrist
guidelines The operating site, side, organ should be marked
The operating team should have a sign-in, timeout protocol and sign out
protocol
The organization should have a documented surgical safety list with
signature of anesthetist and OT staff.
All adverse incidents to be documented
Adverse events to classified in to nearmiss, no harm, adverse event and
sentinel events
CAPA to be done for all adverse incidents

Evidences Documented policy for surgical safety checklist in apex manual, surgical
consent, surgical safety checklist, staff interview to ascertain awareness about
protocols

COP 8d: Qualified persons are permitted to perform the procedures that they are entitled to
perform
Intent Surgery is not conducted by an unqualified, qualified person without experience,
or without proper expert supervision in case of trainee surgeon
Requirements/ Doctors with valid qualification, registration and experience to perform
Implementation procedures and surgery
guidelines
Evidences Documented policy in the apex manual

COP 8e: The operation Surgeon documents the operative notes and post- operative plan of care.

Intent Records of details of surgery and post op plans are clear to all, for future
reference and effective management of patients condition
Requirements/ Post-operative Notes should have detailed account of surgery, post-
Implementation operative diagnosis and status of patient
guidelines Post-operative notes will contain , Name of the surgery, Salient steps of
procedure, including key steps and any complication surprise finding, or
diversion from routine steps
Implant details with batch number, expiry date, name, signature,
registration number of the surgeon and members of surgery team including
other surgeons and nursing officers
Post-operative care plan shall include IV fluids, medication, care of
wound, nursing care and any complications
Post op plan of care should include criteria for fitness for discharge of
patient
Post-Op care should be written by surgical team in consultation with
Anesthesiologist
Evidences Documented policy in the apex manual, completeness of post operative notes

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COP 8f: The operation theatre is adequately equipped and monitored for infection control
practices.
Intent To effectively manage life threatening medical emergency and to prevent
infections
Requirements/ The OT should be well equipped to provide surgical services
Implementation commensurate to the scope of services
guidelines The OT should be equipped to handle medical emergency : Boyles
apparatus, oxygen, emergency drugs, defibrillator
The OT layout should allow for unidirectional flow of people and
material
Documented procedure is available for sterilization of
instruments and disposables
Documented procedure is available for cleaning, fogging/ terminal cleaning
of OT
Documented procedure is available to monitor the Asepsis of OT
The organization has a recall procedure in case of infection
Staff is trained on Universal precautions
Staff has been given adequate Prophylaxis
The OT has a hand washing area, area for collection of waste & linen and
storage
Evidences Documented policy for theatre management in apex manual, OT register, culture
report, maintenance record of OT equipment, staff training and awareness, audit
of theatre infrastructure and cleanliness

COP 8g: Patients, personnel and material flow conform to infection control practices
Intent To ensure patient safety and to prevent infections
Requirements/ OT Zoning
Implementation ZONE 1-PROTECTIVE AREA: Restricted entry, changing rooms,
guidelines stores, prep and recovery room
ZONE 2-CLEAN AREA: Entry only after changing (PPE),
Sterilization room
ZONE 3-STERILE AREA: Operating room Scrub area
ZONE 4-DISPOSAL AREA: Dirty utility

The OT layout should allow unidirectional flow of people and material

Sterile and unsterile personnel, patients and instruments not to be mixed.
Linen and unsterile items including biomedical waste should be handled
in closed containers.
Area designated for unsterile activities like changing, washing of
instruments, collection of used linen and waste.
Documented procedure for use of Linen, ETO and other consumables
Documented procedure for collection, transportation and disposal of used
laundry and waste
Staff is trained on all of the above
Evidences Nurses, doctors and housekeeping staff adhere to zoning activities, staff
interview

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