D.Y .PATIL UNIVERSITY SCHOOL OF MANAGEMENT

NAVI MUMBAI

Consent compliance and interventions for quality improvement in hospital

SUBMITTED BY:

Dr Dipti Tawde

MBA Health & Hospital Management

UNDER THE GUIDANCE OF:

Dr. Amol Vaidya

Asst. Manager Medical Services

Fortis Hospital Mulund

ACKNOWLEDGEMENT

I would like to thank Dr Nitin Sippy, Associate professor Dr D.Y. Patil school of management studies for his constant support guidance and supervision during the course of internship.I am grateful to Dr Amol vaidya assistant manager medical services Fortis Hospital Mulund; for giving me an opportunity to study the Hospital as part of my Internship.I am indebted him for guiding me through and providing all the necessary support whenever required.I am grateful to Mrs lavina lal Quality coordinator Fortis Hospital Mulund For support and guidance for my project.I would also like to thank Dr Supriya amey Head of medical service Fortis Hospital Mulund for his valuable guidance. Last but not the least I would like to thank all the Department Heads, Executive and staff members of various Departments of the Hospital for extending their full support in completing my assignments and giving me the necessary time out of their busy schedule.I must conclude that my learning experience was very enriching and I got an opportunity to overview operational issues of departments while undertaking the case study.

INDEX.Table of Contents

Sl. No. Section Page1 Introduction to Fortis hospital 4-7

2 Abstract 8

3 Introduction of consent 9-15

4 Project work 16

5 Aim 17

6 Material and method used 18-19

7 Observation of retrospective consent data 20-21

8 Quality Improvement intervention used 22-23

9 Observation of live consent data 24-25

10 Results 26-27

11 Conclusion 28

Introduction of Fortis hospital Mulund.Fortis Healthcare Limited is an established chain of super speciality hospitals based in Delhi, also available in Amritsar, Kolkata, Navi Mumbai, Hyderabad, Mohali, Jaipur, Chennai, Kota, Bengaluru, Gurgaon, Noida, Faridabad, Mumbai, Odisha.

1.   Corporate Details

I.   About Fortis -

Fortis Healthcare Limited is a leading integrated healthcare delivery service provider in India. The healthcare verticals of the company primarily comprise hospitals, diagnostics and day care specialty facilities.

Currently, the company operates its healthcare delivery services in India, Singapore, Dubai, Mauritius and Sri Lanka with 55 healthcare facilities (including projects under development), approximately 10,000 potential beds and 270 diagnostic centers.

In a global study of the 30 most technologically advanced hospitals in the world, its flagship, the Fortis Memorial Research Institute' (FMRI), was ranked No.2, by 'topmastersinhealthcare.com, and placed ahead of many other outstanding medical institutions in the world.

      ii.            Vision

Saving and enriching values

 

 

   iv               Mission

To be globally respected healthcare organization known for clinical excellence and distinctive patient care.

Values-

Patient centricity Commit to “best outcomes and experience for our patients.

Integrity Be principled ,open and honest

Model and live our Values.

Demonstrate moral courage to speak up and do the right things.

Team work Proactively support each other and operate as one team.

Respect and value people at all levels with different opinions, experiences and backgrounds.

Put organization needs before departments/self interest.

ownership  

 

 

Milestones-

Fortis surgeons have performed many path breaking organ transplant surgeries.

·         The surgeons at Fortis Malar Hospital, Adyar, Chennai, performed India’s first permanent artificial heart implant (VAD) surgery. They have also been successful in carrying out a heart transplant with the use of an artificial heart pump or Extracorporeal Membrane Oxygenation (ECMO) to resuscitate the patient while waiting for a donor.

·         At Fortis Hospital, Mulund, Mumbai, the first successful live donor adult to adult liver transplant in West and Central India was performed in Sep 2006.

·         At Fortis Hospital, Kalyan, Mumbai, a cadaver kidney transplant was done without dialysis.

 

Fortis Healthcare’s Centre of Excellence for Bone and Joint was

·         The first in Europe and Asia to offer custom fit Knee Replacement Surgery; this innovative approach greatly reduces operating time and ensures perfect knee alignment

·         The first in South India to use iPod assisted navigation in Total Knee Replacement Surgery, another technical advancement towards more surgical precision

·         The first in the state of Karnataka to conduct a Minimally Invasive Joint Replacement Surgery; this procedure involves less blood loss, is less painful for the patient and leads to faster recovery

·         The first in the state of Karnataka to implement Fast Track Rehabilitation Protocol; a multidisciplinary team approach to provide early mobility, often as early as the day of surgery itself

·         a pioneer in single stage sequential Bilateral Knee Replacement; this procedure replaces both knees in one sitting, thereby leading to faster rehabilitation and reducing the hospital stay and costs

·         The first in the state of Karnataka to introduce a 5 day recovery programme … the name says it all …from the hospital bed to your own bed in just 5 days

·         The first in the state of Karnataka to perform Oxinium Total Knee Replacement with optimized prosthetic fit for longevity of the implant and improved function; this implant lasts for approximately 30 years

 

      V               Services

Cataract Services Refractive Surgery Services Cornea Services Glaucoma Services Retina Services Paediatric Ophthalmology and Squint Services Oculoplasty Services UVEITIS Neuro-Ophthalmology Vision Rehabilitation Services Computer Vision Syndrome Clinic Contact Lenses

Abstract: To achieve excellence in clinical practice and a high level of health care provision, consent processes need to be clear and precise. In particular, patients who are to undergo elective operations must be fully informed before consenting to treatment. The aim of this study is to assess the quality of consent form completion by different health professionals in our department and to identify areas for potential improvement.

Introduction

Consent to treatment is the principle that a person must give their permission before they receive any type of medical treatment or examination. This must be done on the basis of a preliminary explanation by a clinician.

Consent is required from a patient regardless of the intervention – from a physical examination to organ donation.

The principle of consent is an important part of medical ethics and the international human rights law.

It can be given:

Verbally – for example, by saying they are happy to have an X-ray.

In writing – for example, by signing a consent form for surgery.

Patients may passively allow treatment to take place – for example, by holding out an arm to show they are happy to have a blood test. However, since the capacity to consent has not been tested, and the benefits and risks have not been explained, this is not the same as consent (see below).

"Capacity" means the ability to use and understand information to make a decision, and communicate any decision made.

Defining consentFor 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:

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.

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 does not go ahead.

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.

If an adult has the capacity to make a voluntary and informed decision to consent to or refuse a particular treatment, their decision must be respected. This still stands even if refusing treatment would result in their death, or the death of their unborn child.

If a person does not have the capacity to make a decision about their treatment, the healthcare professionals treating them can go ahead and give treatment if they believe it is in the person’s best interests. However, the clinicians must take reasonable steps to seek advice from the patient’s relatives before making these decisions.

How to give consent

Consent should be given to the healthcare professional directly responsible for the person's current treatment, such as the nurse arranging a blood test, the GP prescribing new medication or the surgeon planning an operation.

If someone is going to have a major medical procedure, such as an operation, their consent should ideally be obtained well in advance, so they have plenty of time to examine any information about the procedure and ask questions. If they change their mind at any point before the procedure, the person is entitled to withdraw their previous consent.

If they are able to, consent is usually given by patients themselves. However, someone with parental responsibility may need to give consent for a child to have treatment. Read more about the rules of consent applying to children and young people

If someone with little or no chance of recovery requires treatment for the sole purpose of keeping them alive, and the person is unable to make a decision themselves, an agreement about continuing or stopping treatment will need to be reached between the healthcare professionals responsible for their care and the person's relatives and friends. Read more about consent and end of life issues.

When consent is not necessary

There are a few exceptions when treatment can go ahead without consent.

For example, it may not be necessary to obtain consent if:

Treatment is needed in an emergency, and the person is unable to give consent because they lack the capacity to do so.

When, during an operation, it becomes obvious that the person immediately requires an additional procedure to treat a life-threatening problem that was not included in their original consent.

A person with a severe mental health condition – such as schizophrenia, bipolar disorder or dementia – lacks the capacity to consent to the treatment of their mental health. However, in these cases, treatment for unrelated physical conditions still requires consent, which the patient may be able to provide, despite their mental illness.

Informed consent means that you understand your condition and any proposed medical treatment. You have a legal right to be told any information that relates to your medical condition and treatment. Without this information, you are not able to make a fully informed choice and give valid consent for treatment.

Doctor has a duty to explain patient his medical condition, the recommended treatment (including the other treatment options available) and the benefits, risks and possible complications of the recommended treatment. This is essential so that you can make a decision.

This is known as ‘informed consent’. Once the information is given, the doctor may ask patient to sign a consent form. When signed by the patient, this form gives the doctor legal permission to perform the procedure.

The information that must be given to patient includes:

The diagnosis and likely outcome (prognosis) of condition

An explanation of the recommended treatment

The risks of the procedure and common side effects

Possible complications

Specific details of the treatment; for example, where it will be performed and who will perform it

Any other options for treatment and their probability of success.

Informed consent is a process of finding out information about the recommended treatment, and weighing up the benefits and risks involved. It is not about just signing a form.

General consent form information

Before a planned surgical procedure, the surgeon will ask patient (or your legal guardian) to sign a consent form. The doctor, not the nurse, must obtain the patient’s consent.

The form will have information specifically about the procedure. Generally speaking, a typical consent form includes:

1. Your surname, given names, date of birth, sex and referring doctor

2. Whether or not an interpreter is required

3. An explanation of patient condition, in plain language

4. An explanation of the procedure, in plain language

5. General risks of anesthesia, which may be included in a separate form

6. General risks of surgery

7. Specific risks of this particular procedure, listed by the doctor

8. Whether or not the doctor has explained the risks and possible

Complications.

9. Whether or not the doctor has explained the risks of not having the proposed treatment

10. Patient agreement that information has been provided

Patient agreement means that patient has understood that the procedure may not work or may worsen the condition

Patient dated signature to confirm that he/she understand all of the above and want to undergo the procedure.

Patient understanding is crucial

The signed consent form is considered a legal document.

Generally speaking, ‘informed consent’ depends on whether or not you as the patient would have agreed to the surgery if he had known and understood the possible risks and complications.

Things to remember

Patients have a legal right to be told any information that relates to their medical condition and their treatment.

The signed consent form is considered a legal document.

Patients consent can be withheld or withdrawn

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

to:

i. Any procedure under any form of anesthesia/sedation                          

ii. Any form of anesthesia including conscious sedation and monitored

care                

iii. All invasive diagnostic tests and procedures

iv. Other diagnostic procedures like Stress test, Contrast imaging

v. Angiographic procedures                                                     

vi. Angioplasty & Intravascular Catheter procedure  

vii. All Interventional procedures (including Pacemaker insertion, Tumor

embolization etc.)                                                

viii. Aspirations (including FNAC)

ix. Biopsy and Bone marrow aspiration

x. Catheterization of major vessels (Arterial cannulation, Central line,

PICC)                                              

xi. Endoscopy procedures (Gastro Intestinal, Respiratory or others)

xii. High risk Consent where appropriate                                                                      

xiii. HIV testing 

xiv. Restraint                                                                

xv. Dialysis

xvi. Chemotherapy  

xvii. Blood transfusion                                                                 

xviii. Nuclear medicine tests

xix. Radiology investigations (X-Rays for female patients of child bearing age, CT,

MRI, Fluoroscopy, Mammography, Bone Densitometry etc.)

xx. Ultrasound (in Antenatal cases Refer PNDT Act)

xxi. Radiation therapy including Brachytherapy

xxii. Leaving Against Medical Advise (LAMA)

xxiii. Admission/General Consent

xxiv. Blood Donor consent

xxv. Termination of pregnancy (Refer MTP Act)

xxvi. Dental procedures like tooth extraction

xxvii. Invasive Cosmetic procedures including piercing of ear lobes

xxviii. Disposal of anatomical remains

xxix. Release of confidential information except as permitted or required by law

xxx. Any treatment/procedure/test where the treating doctor feels the need to obtain

consent

xxxi. Organ transplant (also refer THOA)

Consent is not required in the following conditions as per law:

i. Medical examination of persons brought for this purpose by police. Consent is

needed for treatment.

ii. When arrested person(s) are brought for collection of evidence (e.g. blood

sample)

iii. Medical examination directed by the Court (examination of genitalia in case of

rape victim needs consent in writing)

iv. Medical examination needed for statutory purposes (e.g. Armed Forces etc.)

Project work

We audited total 340 different consent forms, 170 retrospective form and 170 live consent form after quality improvement interventions using a set proforma to produce a final score for each form, in order to assess the quality of consent completion and to recommend changes.

We then implemented changes in our current clinical practice and subsequently re-audited our performance.

Time period

16 May 2015 to 15 July 2015 From 16 May 2015 to 31 May 2015 Auditing of retrospective consent forms.

From 1 June 2015 to 15 June 2015 Quality improvement Interventions

applied.From 15 June to 30 June 2015 Auditing of live consent form to see the

improvement.

Aim

To assess the quality of consent form completion by different health professionals in hospital and to identify areas for potential improvement.

Materials and methods Used

We audited total 340 different consent forms, 170 retrospective form and 170 live consent form after quality improvement interventions using a set proforma to produce a final score for each form, in order to assess the quality of consent completion and to recommend changes.

A special audit toll has been prepared and according to completion of consent form 0, 1, NA scoring is done.

And at the end compliance of consent form is calculated in percentage. The Following audit toll has been used to give the scoring.

 Audit to be done by MS. One file to be audited daily (25 per month). If for any audit

point either/any criteria is not complied, please mark 0  S. No.  DATE   UHID/IPID Number

1 Does the consent form bear the name and signature/thumb impression of person giving the consent (patient/surrogate) Check consent form

2 For surrogate consent, is the name of the signatory & relationship with the patient, recorded on the consent form

Check consent form

3 Does the consent form bear the name and signature/thumb impression of person witnessing the consent

NA for HIV and some other consents. Write NA if not applicable

4 Does the consent form bear the name and signature/thumb impression of interpreter

Applicable if interpreter used, else NA

5 Does the consent form bear the name and signature of person obtaining consent Check consent form

6 Does the consent form bear the Date and time for each signature on the consent Check consent form

7 Does the consent form contain the Name of procedure/treatment/test for which consent is being obtained Check consent form

8 Are the potential major complications of undergoing the planned procedure documented in the consent form Check consent form

9 Does the consent form contain the name of the person who will perform the procedure for which consent is being obtained Check consent form

10For procedure(s) carried out in the Ward/ICU, is the consent taken by either Treating Consultant or Registrar or Ward RMO?

Check consent form

11

Was the doctor/ team member who explained & obtained the consent, physically present during the surgical/invasive procedure, procedure or a member of the defined Team as per list available with Medical Admin

See consent form & OT/ Procedure notes

12 Is the anesthesia consent signed by the Anesthesiologist or an anesthesia team member

Check consent form & Anesthesia Notes

13Is the procedure/ treatment/ test actually performed by the person, named to carry out the procedure in the consent form or his team member (applicable only to post-op cases)

Check OT/Procedure Notes

14Is the actual procedure/ treatment/ test carried out same as the one named in the consent form (applicable only to post-op cases)

Check OT/Procedure Notes

15 Are any abbreviations used on the consent form Check consent form

16 In case the procedure was high risk, has a separate high-risk consent been obtained, in addition to the procedure consent

Applicable only for High Risk procedures, else NA

17 Does the High Risk Procedure bear the signature of both the Surgeon & Anesthesiologist?

Applicable only for High Risk procedures, else NA

18For procedures carried out frequently &/or regularly on the same patient (e.g. Dialysis), is a fresh written informed consent obtained at least once every 30 days

 

19For planned surgical/invasive procedures is the consent obtained before the patient is wheeled out from the ward to the OT

Check consent form

It contains total 19 different points to be checked in each consent form.

Observation

After auditing the retrospective consent form from by using audit tool the consent compliance is of following percentage.

Compliance of different consents.

Surgi

cal

Anaesthesi

a

highris

k HIV B.T

Radiology

Proced

ure 76%78%80%82%84%86%88%90%92%94%96%

82%

87%

82%

86%

89%

94%

86%

Compliance according to different Consent

Compliance according to dif -ferent Consent

Compliance of different consents according to department

Cardiology

Orthoped

ic

Oncology

Urology

Neruro

logyOBGY

Genera

l Sx0%

10%20%30%40%50%60%70%80%90%

100%89%

78% 78%83%

73%

90% 87%

Compliance according to Department

Compliance according to Department

Quality Improvement intervention applied.

1. Editing the consent forms.2. Awareness and informative lecture session are conducted for RMO, Surgeon,

anesthetics, nurses, counselors who are involved in consent taking.3. Prepared dos and don’ts list to be keeping in each file.4. Ideal fully complete consent form displayed in each nursing station for reference.5. Daily auditing of consent form.

Do’s

1. The consent form to be filled by eligible person in legible handwriting only.

2. Name of the patient to be mentioned which is to be signed by the patient himself.

3. Name of the surgery/procedure to be mentioned for which the consent is taken.

4. Name and signature of the witness to be obtained in the specified column only.

5. Name of the surgeon performing the procedure to be mentioned and to be signed by him only.

6. High risk consent to be signed by both surgeon and anesthetist with date and sign.

7. Each signature on the consent form bear the date and time.8. Mention the Name of the person obtaining the consent.

Don’ts

1. Strictly no abbreviations allowed.2. No consent form to be filled in the operating suite.3. Don’t leave the complications space blank, please mark it N/A.4. Don’t wheel the patient to operating suite without filling the

consent form completely.5. Don’t Leave the tick boxes in the consent form blank, please tick

which and where ever applicable.

After application of Intervention, following things are observed in consent compliance.

Compliance of different consents. After application of Intervention.

Surgi

cal

Anaesthesi

a

Highris

k HIV B.T

Radiology

Proced

ure91%92%93%94%95%96%97%98%99%

100%101%

95%

99%

95%

98%

100%

94%95%

Compliance of different consent form

Compliance of different consent form

Compliance of different consents according to department after application of Intervention.

Cardiology

Orthoped

ic

Oncology

UrologyObGy

Neuro

logy

genral

Sx82%84%86%88%90%92%94%96%98%

100%102%

94%

99% 99%

89%

92%

100%

96%

consent complience according to department

consent complience according to department

Results

After comparing retrospective consent form and live consent form compliance, after implementation of Quality improvement interventions following results are seen.

CONSENT TYPECOMPLIANCE

Retrospective data %

Live data % after intervention

Improvement achieved %

Surgical 82 95 13Anesthesia 87 99 12High-risk 82 95 13HIV 86 98 10Blood Transfusion 89 100 11Radiology 94 100 6Surgical interventional procedures

86 95 9

If we put this data in graphs then it shows.

Surgi

cal

Anesthesi

a

High-ris

k HIV

Blood Tran

sfusio

n

Radiology

Sx inter

ventional

procedures

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

82%87%

82%86% 89%

94%86%

95%99%

95% 98% 100% 100%95%

Retropective data consent com-plianceAfter intervention consent com-pliance

CONSENT COMPLAIANCE DEPARTMENTWISE

Retrospective data %

Live data % after intervention

Improvement achieved %

Cardiology 89 94 5Orthopedic 78 99 11Oncology 78 99 11Urology 83 89 6Neurology 73 100 27OBGY 90 92 2General Sx 87 96 9

If we put this data in graphs then it shows.

0

10

20

30

40

50

60

70

80

90

10089

78 7883

73

90 8794

99 99

89

10092

96

complience before interventioncomplience after intervention

Conclusion

After auditing retrospective data we found that consent compliance was not up to the mark and after applying necessary intervention compliance of consent is increased and awareness and importance of taking complete consent is created among the clinical stuff.

This is very useful in tackling the medicolegal issue which may occur in day to day working of hospital