Interview with Dr. Rajiv Shah, India's first Foot and Ankle Surgeon

Mr. Sarfaraz Lakhani of Calibre Creators (CC) had the rare opportunity to interview Dr.Rajiv Shah, an accomplished Foot & Ankle Surgeon and the only one recognised in India for its treatment.  He has travelled around the world attending conferences as a guest speaker and doing podium presentations.   He is a Vice Chairman of Asia-Pacific   Foot and Ankle Council and also a Past President of Indian Foot and Ankle Society.  He has trained and mentored many young orthopaedic surgeons in the subject.


"It’s really very sad that in India, we have an epidemic of highly neglected foot and ankle diseases.Though Indian mythology has given the highest significance to touching feet of elderly, teachers and lords, sadly undergraduate medical curriculum in India has hardly touched Foot and Ankle as the area of the human body!"


Dr. Rajiv Shah is a practicing foot and ankle surgeon with over twenty years professional standing as an orthopaedist.  He obtained his fellowships in the subject from Columbus, OH, USA and Chicago, IL, USA.  He runs the first ever Foot and Ankle Centre of India at Vadodara and has a passion to develop this speciality in the Asian continent.  

He is a faculty member in various national & international level conferences and workshops with innovative techniques under his belt.  The ‘Foot School’ is a novel interactive educational model devised by him for spreading preventive care nationwide.  He also runs a project "Save the Foot" for diabetics and a project "We Walk" for leprosy victims.

He is the First foot and ankle surgeon of India.  He has been instrumental in establishing the first ever Foot and Ankle centre of India at Vadodara, Gujarat.  He has also launched the first ever foot and ankle website from India (www.footankle.in)

He did his advanced foot and ankle fellowships under world renowned foot and ankle surgeons like Dr. Thomas Lee, Dr. Greg Berlet and Dr. Weil at Columbus, USA and Chicago, USA. His book on the subject titled ‘Handbook of Foot and Ankle Orthopaedics’ was awarded with ‘Best Orthopaedic Book’ award for year 2015. This book is translated in to Chinese, Arabic and Portuguese.

To know more about him and some pictures of surgeries conducted by him, please scroll down to the bottom of this article.


Sir, It is an absolute delight to be meeting a very very accomplished surgeon of India who has achieved global iconic status and bringing pride and glory to India and at the same time relieving people from their foot and ankle ailments.You are a beacon of light and hope for those suffering from this ailment and itis a matter of honour and privilege for Calibre Creators to be having you with us sharing your views on the Foot and Ankle Diseases.


CC.1    Sir, despite advances in medical treatment and introduction of technology and doctors being able to treat almost any disease in India, (a) why has not much attention been paid to this condition of Foot and Ankle disease?  (b) Also, is this a medical condition related to some other health problem or is it a disease by itself?

Dr. RS: It’s really very sad that in India, we have an epidemic of highly neglected foot and ankle diseases.  Though Indian mythology has given the highest significance to touching feet of elderly, teachers and lords, sadly undergraduate medical curriculum in India has hardly touched Foot and Ankle as the area of the human body!  Today, if I ask a simple question pertaining to the anatomy and function of the human foot and ankle, the majority of medical students fail to answer.  Feeling of neglecting foot and ankle orthopaedics amongst the medical population is poured since the birth of a doctor.  On the side of patients, till the 19th century, our population hardly ever used footwear, because we never considered foot as an integral part of the human body.   Similar is the thought process of society towards problems of foot and ankle.    We never focused on our country’s performance at sports, hence we did never focus on augmenting the performance of sportsmen through diagnosing and fixing their foot and ankle problems.  In fact, foot and ankle problems are a large subset of problems in itself with its most vital secondary effects over every part of the body.


CC.2    If the awareness for this problem is so low in urban areas, what then would be the situation in rural India?  What are your plans to create awareness about this across the country?

Dr. RS:    Indeed awareness about foot and ankle problems is very low in urban areas of India.  Every city in the western world would have dedicated centres of excellence for foot and ankle care.  In the western world, foot and ankle diseases are being treated under one roof by a team of qualified medics and paramedics.  Every sports team has a foot and ankle specialist who periodically evaluates team members for the health of their feet.  Every possible effort is made to maintain the foot and ankle of sportsman in perfect shape, thereby to prevent injuries and to optimize performance.

The situation in urban India is just the opposite.  I fully agree about your worry. India lives in villages.  India is a world’s diabetic capital with our maximum diabetic population living in villages.  The situation is truly pathetic!  Many villagers are still not using footwear and are walking bare feet; working in farms; making themselves prone to foot and ankle problems.  A diabetic population with injuries in foot and ankle could be a waddle sign for salvage of feet!  Many of such cases end up in amputation of toes and foot.  The rate of amputation in diabetics in the western world is 2% to 4% while the matching rate in India is alarming at about 30%!

Prevention is always better than cure.  Creating awareness is the only way we can fight this issue out.  Since I started practicing foot and ankle orthopaedics, my only goal has remained ‘Education and Awareness’.  I have been doing ‘Foot Schools’.  Foot school is a novel interactive educational workshop that talks about the significance of foot and ankle, its common diseases and the prevention of these diseases.  For good foot and ankle health of society, large-scaled educational modules plus preventive foot and ankle check-ups are required.  I have already furnished a detailed concept paper to the health department of the government to set up various permanent health awareness programs.  They are as under:
•    Save the Foot for diabetics
•    We walk for the population at large
•    Let’s perform for sportsman
•    Catch them young for children

The details of these programs have already been passed with due remarks by Honorable Governor Sir to the Health Ministry of Gujarat State.


CC.3.     Sir, for the benefit of our readers, please explain the causes and consequences of the Foot and Ankle disease?

Dr. RS:    Foot and ankle is such an important ornament of the body that can get affected by trauma leading to sprains, strains, and fractures.  As the body’s 25% of total bones are located in the foot and ankle, every possible disease of bone can be seen to occur in the foot and ankle.  A wide spectrum of foot and ankle ailments range from congenital deformities, acquired deformities, Arthritis of joints, degenerative issues of tendons and ligaments, nerve problems, stress injuries and tumors.  The most important aspect of our understanding should be that problems in the foot and ankle could be the sole reason for problems in the spine, hip and knee!  In fact many of the diseases of the spine, hip and knee throw their first sign and symptom in the foot and ankle.  Today, the biggest health irony of developing countries like India is the steep rise in lifestyle diseases.  Such diseases include diabetes, obesity, hypertension and stress syndrome.  Control over these diseases is mostly by the way of maintaining the body’s fitness.  How can we control our diabetes and hypertension if our feet are not healthy?

CC.4.    Is it an age-related problem and what are the probable symptoms one should look out for and can early diagnosis help avoid surgery?

Dr. RS:    Age-related foot and ankle problems include arthritis, deformities, and stress injuries.  Development of pain, fatigue and deformation are the earliest symptoms.  After the age of 50, every individual must develop a habit of ‘Check-look’ at his/her feet after taking a bath.  This should be in a good light.  Any new symptom of pain or fatigue should never be taken casually.  Any deformation of feet should be consulted.  For a diabetic, I always advise having a complete foot examination with a magnifying mirror after a bath.  Sportspersons must periodically evaluate his footwear for wear and tear and deformation.  This would help in preventing sports injuries that can affect a sportsperson’s career from being cut short.

A watchful eye on any new symptom in the foot, regular exercises, and using correct footwear are the keys to control foot and ankle problems.  No question that these habits would only help in preventing surgeries.


CC.5.    How does corrective surgery help in treating the problem or can it be treated medically?

Dr. RS:    For foot and ankle problems surgery is not the only solution.  In fact, it is the last resort.  Most of the conditions can easily be treated with lifestyle modification, disciplined care of foot and ankle plus physiotherapy.  Orthotics which are the external devices or modifications made in footwear; helps a lot to support and balance the foot thereby reducing sufferings in most of the diseases.  Medical management in the form of drugs works well in many cases. Failing these conservative modalities only pushes a patient to option of surgery as the final answer. Surgery works in many ways like correcting the deformity, correcting the faulty axis, eliminating pain generating areas, removing offending focus, etc.


CC.6.    I read that you used 3-D printed titanium prosthetic /bone for one of the surgery?  Can such a treatment be made affordable for socially and economically challenged population and how?  Is this surgery covered under the PMJAY Ayushman Bharat Scheme, a pet scheme of our Honourable Prime Minister Shri Narendra Modi?

Dr. RS:    3=D printing technology has made a revolution in the world of foot and ankle orthopaedics.  By 3-D printing, one can make a body part similar to the original one!  The technology is used in foot and ankle trauma where a part or whole of a missing bone can be prepared with similar size and dimensions with the help of 3 D printing.  Even tailor-made jigs to put screws and plates for fixation of complex fractures can also be prepared.  It is also used extensively in correcting foot and ankle deformities.  A plastic bone model looking exactly like the original deformed foot can be made for a surgeon who plans and performs a virtual surgery on a bone model before the actual surgery.  You can imagine what wonders this technology can do.  Such a rehearsal of surgery would not only reduce the operating time of the surgeon but will also result in seamless execution and of surgery.

3-D printing technology is used extensively in the western world but the use in India is limited because of its high cost and a small number of service firms.  I wish special subsidies be given by the government to such 3-D printing firms to make this technology cheap and affordable.

I replaced lost talus bone of a tribal with 3-D printed titanium talus bone which saved a patient’s limb from being amputated.  This 3-D printed implant cost INR 1.5 lacs to the patient!  Obviously, this is the highly prohibitive cost.  The firm that prepared this implant took six weeks to supply this model!  Companies in the western world supply such models in a week's time, that too with three sizes (Plus two, zero and minus two) at a similar cost!

To make this technology available to every walk of population, coverage under government schemes would be worthwhile.  We need to work hard on this front very vigorously and I am striving hard to create an army of Foot and Ankle Doctors to handle this large scale pandemic situation.  We are running against time!


CC.7.    Sir, is this a simple or a very specialised surgery and what is the average length of this process?

Dr. RS:    3-D printed Talus replacement is a specialised surgery, more so whenever you are carrying it out for a case of trauma. After trauma, tissues are contracted and fibrosed. They do not ply as normal tissues. A surgeon should be able to accurately put new titanium bone into the place of the original bone. While implanting this artificial talus one has to be cautious of not injuring surrounding tissues as well as fracturing surrounding bones. The surgeon is supplied with only one size of such an artificial bone and he should be spot on to push this bone into the cavity where the original bone was lying. Failure to do so means the purpose of surgery is spoiled and all expenses and efforts are in vain. The surgery lasts for about two and a half hours. This is a replacement surgery and falls into major surgery.


CC.8.    For those who have never been in an OT in a conscious state (for procedure/ surgery/ delivery), what is a typical scene like in the OT?Are there any anxious moments?

Dr. RS: Operation theatre is a temple, mosque or a church and patient is God. The surgeon with his team has a unique opportunity to serve the Lord. No stones are left unturned to make prayers successful. There are multiple tenacious moments starting from the point of anaesthesia to the precise execution of surgery; as complications, can occur at every step. One has to be always thinking and anticipating in operation theatre. I always like to draw my plan for surgery beforehand which is communicated to the Surgical Team. “Plan B” should always be in mind for any surgery to take care of any complications or adverse situations. There is always peace and focused attention on the patient during the operation. No chatting, talking or unnecessary movements are permitted in the operation room. 


CC.9.    For a little while, let’s get on the lighter side of life. You must have come across many patients and some of them or situations must have been funny or provoked humour.  Can you recall any such incidents?

Dr. RS:    Yes, indeed. There are few moments in the operation theatre which generates humour. Let me site such an incident. Orthopaedic surgeons use equipment called “C-arm” or “Image Intensifier Television (IITV)”. This equipment gives live imaging of a part being operated and helps in speedy passage of nails and screws. In day to day language instead of calling it as C-arm or IITV, we call it ‘TV’! Once during surgery, I asked my resident ‘show me TV’. To our surprise, the patient who was little awake heard this and immediately said ‘Rajiv Sir, agar aapko TV hi dekhna hai to mera surgery khatam kareke dekhona’! (Sir if you indeed want to watch Television, please do so after completing my surgery!) We all laughed a lot and we still remember this incidence.


CC.10.     What was the turning point in your career when you decided that you want to focus on a specialty?

Dr. RS: I was a big-time spine specialist after starting off my orthopaedic private practice as a general orthopaedic surgeon. One fine day, one of my junior colleagues asked me, ‘Sir, who does good foot and ankle cases in India?’ I made a joke, ‘You!’ He immediately replied that there is a huge number of people suffering from it without any correct guidance and something needs to be done about it. The very same night I decided to carve my niche to become a foot and ankle specialist.


CC. 11    What career advice would you like to give to new medical graduates and those practicing as Orthopaedicians about specialising in the Foot & Ankle disease?

Dr. RS: Foot and ankle orthopaedics is a specialty where you have every sphere of orthopaedics under its umbrella. This covers trauma, deformity, replacement, arthroscopy, endoscopy, degenerative problems, tumors and paediatric orthopaedics. Why not shape a career in this young and emerging specialty? Least of competition, ease of learning and fun to practice! What one needs are focus and perseverance. If you really love the area of your specialisation, progress is deemed.


CC.12.    You recently had Dr.Amanda Fantry, Orthopaedic Surgeon of Brown University, US come to India to train under you for a month.  If Indian Doctors wants to do the same, how can they approach you?

Dr. RS: Training and mentoring US graduate was real fun. Western countries do not have exposure to kind of mangled and neglected cases we see day in and out. The western world always desires to learn about our methods based on our innovations with which we treat our cases in spite of limited resources and financial constraints. Mine is the first-ever centre in India, where a structured fellowship program for foot and ankle orthopaedics is being run from the last eight years. Young orthopaedic doctors apply well in time for the same. Every year, I train six such juniors in the subject. Looking to more than two years of waiting for such a fellowship program, I have now announced three days of capsule courses. Four such courses are planned per year. The doctor simply needs to write to me about this.


CC.13.     You juggle with multiple functions and social responsibilities and also have a family.  How do you maintain the balance between each of these?

Dr. RS:    Work-life balance is truly demanding. With my mission of establishing foot and ankle orthopaedics as the specialty of orthopaedics, I have to travel a lot. I make sure to take my better half with me during most of my trips. I start my day early by 4 am so that I can finish my academic work before my family members wake up. I try to make sure that I never carry the burden of my work at home. Frank discussions with family members before taking newer commitments has also resolved many of my issues. Fortunately, my family members being from medico background they have been truly accommodative.


CC.14.     Do you ever get restless or frustrated about not being able to accomplish enough and try to squeeze in maximum work activity in your working hours?

Dr. RS:    Like every other human being I do get frustrated when I am unable to finish my jobs in time. Though I plan way ahead of schedule and I also draw my plan B as a habit, still, things fall out of schedule. I do not try to squeeze work activity in limited hours but I like to delegate works to my team. I also love to finish all my work during travel.


CC.15.    Please list your top priorities to spread awareness about this health condition?

Dr. RS:    My top priority is to educate doctors. Doctors are primary touchpoints, if they are aware of early diagnosis and scientific management of foot and ankle ailments than my job is done. Doctors can only spread awareness amongst the population about preventive aspects. Trained doctors will also help in scrapping prevailing myths in society about foot and ankle disorders.


CC.16.    How you do relax?

Dr. RS:   Music, yoga and meditation are my buddies for relaxation.


CC.17.    Your Favourite Dish?

Dr. RS:   Sprouts


CC.18.    Your Favourite Song or Preference for Music?

Dr. RS:    “Hum Ko Man Ki Shakti Dena” (Oh Lord, bless us with the strength of spirit so that we emerge victorious”. I prefer live stage performances focused on old and classic Hindi movie songs.


CC.19.    A hobby you pursue in your spare time.

Dr. RS:   Dramatics and travelling.



Sir, I thank you for your time off from your hectic schedule and informing our readers about your work and the most neglected Foot and Ankle Diseases.  I pray that you succeed in your plans to help more and more people by treating them and training doctors across India and the world. 

Note: The views expressed by Dr.Rajiv Shah are his personal and do not represent the view of the organisation he is associated with.


About Dr. Rajiv Shah:

He is :
1.    Honorary Foot and Ankle Surgeon to Governor of Gujarat (2017-2019)
2.    The Managing Director of Sunshine Global Hospitals, Vadodara, Bharuch-Surat
3.    Member of the Executive Council, Global Foot & Ankle Community
4.    Vice Chairman, Asia Pacific Foot & Ankle Council (Chapter of APOA)
5.    Vice President, Asia-Pacific Society for Foot & Ankle Surgery (APSFAS), International Advisory Board Member & South-Asia coordinator, Foot Innovate, International webinars.
6.    Past President, Indian Foot and Ankle Society (2014-15)
7.    National Chairman, Indo-US foot and ankle courses (2009 onwards)
8.    Co-Chairman, Parekh African Foot and Ankle courses (2014 onwards)
9.    Member, editorial board, Journal of Asia-Pacific Foot and Ankle Society
10.  Reviewer for Foot and Ankle section for four indexed medical journals.
11.  Acclaimed radio, stage and television drama actor, radio announcer and a creative writer

He has successfully carried out more than 3500 Foot and Ankle surgeries on patients from India and from other countries like USA, UK, Gulf countries, African Countries and SAARC countries.
 

• Has authored chapters in ten international books in the subject of Foot & Ankle Orthopaedics
• Editor for Foot & ankle section for ‘Textbook of Orthopaedics & Traumatology’ published by Indian Orthopaedic Association
• Author of book titled ‘Handbook of Foot and Ankle Orthopaedics’ published by Thieme publications which was awarded the ‘Best Orthopaedic Book Award’ for year 2014-15.  The same has been translated in Portuguese, Chinese & Arabic languages.  The books is available on Amazon.in
• Delivered more than 350 podium presentations in International and National Foot and Ankle meetings
• Only Indian Foot and Ankle Surgeon, who as an invited guest speaker, has delivered many scientific presentations at international platforms in countries like USA, Canada, China, South Korea, Turkey and Mauritius.
• Has more than 20 publications and research paper presentations in reputed international journals to his credit.
• Has developed own classification ‘ADEINO classification’ for calcaneus malunion’ being recognized widely across the world.
• Trained and mentored many young and upcoming orthopaedic surgeons in the field of foot and ankle by fellowships, workshops and courses.

https://drrajiv.in
http://www.footankle.in/Dr.%20Rajiv%20Shah.pdf
http://www.ifas.in


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3-D Printed Bone

Talus Bone

One of the many press clippings

Electronic Media Coverage - Dr. Amanda Fantry's Visit to India

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Interview of Dr. Lakshmi Vaswani, Pathologist, Bhatia Hospital on Healthcare Quality

Dr. Lakshmi Vaswani, Pathologist

"The community that we are catering to needs to understand the significance of what we are doing and should see that reflected in our services provided; otherwise these stamps and logos are just going to look like letters on a board, with no tangible meaning."



Dr. Lakshmi Vaswani has been a Pathologist at Bhatia Hospital Laboratory, Tardeo, Mumbai, since 2013 She has been avidly interested in laboratory management, with an MBA in Healthcare Services, then venturing into quality assurance and service improvement in the laboratory, as well as in the hospital.  She is a Certified Internal Auditor for NABL ISO 15189:2012, with certifications in Laboratory Quality Management Systems (MIOT, Chennai & WHO) and Good Clinical Laboratory Practices (KEM Hospital, Mumbai). She has experience with the laboratory’s role in maintaining NABH standards in a tertiary care hospital, intra-departmental co-ordination in quality improvement projects and serves as the Junior Editor for the Bhatia Hospital Laboratory E-Newsletter.  She has national and international publications to her credit and has also done paper and poster presentations at various forums in her areas of interest.

Dr. Vaswani, it is a pleasure meeting and interacting with an advocate for Quality Assurance in Laboratories.  I thank you for your time and look forward to your interesting perspectives.  Let’s start.

CC.1    You seem to have committed yourself to spreading awareness about Quality.  What goals have you set for yourself?

Dr. LV:    When I started looking into quality aspects both in the lab and in the hospital set up, it was largely unchartered waters for me. These are concepts that are not taught in our medical curriculum, which means that we are learning about them on the job. With accreditation being the order of the day this can be challenging to implement, especially in organizations where staff is set in a predictable and comfortable working pattern.  In my opinion the sooner the authorities in all levels of healthcare education, from doctors, to nurses, paramedical and administrative staff, are introduced to quailty concepts in their curriculum, the  less resistance we will face to the introduction of these concepts, when we start working in the industry.  Quality and the efforts to track it, maintain it and improve upon it, will be considered as part of the job profile as opposed to additional tasks.
   
I realise that such an approach will take time and patience. So in the meantime, I hope to imbibe as much as I can and in turn share my experiences so everyone learns from each other along the way. There is so much to be learnt just by listening to another person’s view points or experiences, so much that resonates, rather than reading standards or guidelines from a book.
              
I also firmly believe in teaching these concepts from the grass roots especially to the technical staff, exposing them to a quality oriented organization, whether through lectures in colleges, or through internships, meeting them at their level where they are, will hopefully shape the way they work in the industry in the future.

Working in a hospital as opposed to a standalone lab, has also made me realise that the quality of our services depends upon so many other departments in our organization. For example, the accuracy of the reports will be dependent on the quality of sample collected for analysis. Therefore, it is in our best interest to cross departmental borders, break silos and reach out to the nurses, doctors and staff to encourage and train them to improve their processes so that we can in turn improve ours. 


CC.2    As per NABL, there are more than 1 Lakh Laboratories in India of which about only 1000 Labs have been Accredited or Certified.  Why is the coverage so less and how can it be improved?

Dr. LV:     Out of the large number of laboratories in India, very few of them are large scale, multi-city companies. Smaller labs may not be able to justify investment in time and labour to fulfil accreditation standards with the workload they currently have.  There are labs that are family owned small businesses that have earned the trust of the patients and the doctors in their own neighbourhoods.  They may not see the advantage of implementing standards at a cost, to obtain an accreditation that is largely unknown and not really a point of concern, to the patients who come to them.
              
The NABL board has already made a significant and welcomed effort to improve accreditation numbers by introducing the “Quality Assurance Scheme for Basic Composite Medical Laboratories (Entry Level)” which is aimed at smaller labs, maybe in Tier II and Tier III cities with a basic standard that is more cost effective as well.  Hopefully it will make accreditation more appealing and feasible to smaller labs.


CC3    There are misconceptions, even amongst medium and large sized labs, that implementing Quality process leads to increase in costs.  How can those myths and fears be allayed? 

Dr. LV:   The way that I would choose to explain the concept of implementing quality concepts in your organization is to think of the cost incurred as an investment that should be able to show returns in the future.
   
At the very least, the standards give a blue print for people who want to set up their own labs or who want to re-haul the current processes in their labs, just to improve efficiency and get organised. The steps you take may be small at first, but unless you map out and at least note down your processes, you could never figure out where your loopholes are and what you need to do to close them.  An organised lab may already be fulfilling most of what the standards says.  It’s a matter of compilation, consolidation and presentation of routine tasks, with a stress on complete documentation, which is always a good thing, as it helps with accountability.

For example, in our lab, we had to find a cost effective way to track the turnaround time for our tests, without upgrading our current software.  Our in-house IT team developed a middleware at no additional cost to track and calculate the average turnaround time of the tests so that we could begin to track and standardise them.

The decision to follow the standards without going for accreditation is also an option that many labs choose, simply because of the misconception of extreme costs involved.  However, in that case, we have to be completely motivated to follow them diligently without the apprehension of outside third party inspections for accreditation to inspire them.
   
Accreditation acts as the proverbial pot of gold at the end of the rainbow and can spur staff morale to get them through data collection and tough CAPA decisions!


CC 4:     Are there any studies that indicate that Quality leads to efficiency and reduced costs?

Dr. LV:  While the advantages of establishing a quality management system are many, it might help to better understand the implications of failure to implement one.
 
The challenge is, how do we as lab professionals convince our stakeholders to invest in quality maintenance, and demonstrate that it will fetch a return?  An exercise using “Cost of Poor Quality“ (COPQ) may help.  There have been many studies on COPQ in different industries since the 1950’s.  However, it entered into the clinical lab domain only in 2014.  The idea of calculating COPQ is to demonstrate that if a lab invests in prevention costs (like training or establishing quality management systems) and appraisal costs (like proficiency testing programs, inter lab comparisons, regular audits), it will not have to spend on Internal and External Failure costs (like money spent on re-runs or recalled reports, addressing repeated customer complaints and the blow to reputation and test numbers as a result). There are many studies available online. However a standardized COPQ worksheet, referred to as the COPQ Calculator, was developed and tested by seven leaders from multiple facilities across the USA, by an eminent lab professional, Ms Jennifer Dawson along with Roche. It is a free online tool and perfect for beginners and can be used to determine for each individual lab or organization if improved quality will lead to decreased costs for them in the long run.  Another tool in the quality arsenal, i.e. Risk Management, is beneficial in identifying and analysing potential lapses in a process helping lab personnel to add an element that will reduce the possibility of that failure, making residual risk acceptable.


CC.5    Small and standalone laboratories do not see much merit in implementing Quality Assurance Programmes (QAP).  What are they losing out on and how can it help their business?

Dr. LV:   There are laboratories which  are small but superbly organised, without using the standards but with a well honed system that works for them and is profitable as well.  I  would say, take a look at the standards anyways, just to see what the competition is up to and who knows, maybe you pick up something to make your processes even better, or catch some hitches in your set protocols that you could correct.  After all, there’s no finish line in good services.  Implementation of Quality Assurance Programs (QAPs) may lead you to applying for accreditation if one chooses to do so.  However, the benefits of quality awareness and following the standards have a long standing effect in the working culture of an organization and its staff.
 
Accreditation, while fulfilling its role as a standardization tool for services provided, as well as building confidence in a doctor and a patient about the accuracy of a lab’s reports and its services, also serves as a great motivational tool for the staff actually working towards quality improvement.

An accreditation logo may inspire doctors to refer patients to you and the community to use your services- it can get paying customers through the door. However, the onus of fulfilling their expectations and to maintain them as recurring loyal customers falls on the staff and the daily processes of the lab.


CC.6    Carelessness, negligence and ignorance are big factors and human being’s are prone to such behaviour.  How can even minor lapses on these counts affect performance and quality with detrimental consequences? 

Dr. LV:   In a clinical lab, we can face the effects of minor lapses in our processes in all three phases of our testing cycle, pre-analytical, analytical and post analytical.  With improved technology and automated systems, analytical and post-analytical errors have reduced.  70% of all errors are generally in the pre-analytical phase which largely has manual processes like phlebotomy.  Most common areas are wrong labelling, diluted and lysed samples, unsuitable for testing.

In my opinion, ignorance needs to be corrected as soon as possible through training and re-training.  Carelessness and negligence are tougher to combat.
              
Even though to err is human, in most instances the errors are not person driven, they are system driven.  Which means that there is a lacuna in a set process that is increasing the chances of errors.  For example, we had an increased incidence of reporting errors, typing errors for a particular test parameter.  After root cause analysis, we determined that the sequence of the parameters on the analyser did not match with the sequence on the printed reports.  So we changed the sequence on the report to match and this simple change drastically reduced the incidence of this typing error, without jumping to an interfacing solution, which would have been an expense.

The challenging part is actually catching the minor lapses in time to correct them before more harm is done. That can be improved with a robust, non -punitive incident reporting system, to avoid them being brushed under the carpet in fear.


CC.7    Poor and good quality of Lab impacts a Doctor’s line of treatment and care. Please comment. 

Dr. LV:      When we discuss labs which are good quality, we are really talking about labs who have imbibed the idea of maintaining quality as part of their daily work, churning out accurate and timely reports, consistently, irrespective of accreditation.  I think the key word here is consistency, because consistency builds trust.

A treating physician starts and edits his line of management based on laboratory reports.  So they have to have faith in the lab that has issued the report.  If the number of incidents of wrong reporting or proficiency testing failures have increased, it should be followed by adequate corrective actions, as the lab becomes accountable for any harm to the patient as a result of poor quality reporting.  This has a major impact on the diagnosis and clinical management of a patient’s illness.  For example, a wrongly labelled sample will lead to erroneous results for a patient’s actual condition and increases chances of a medication error if not caught in time.  Critical values and patient deterioration may be missed till it is too late.  A normal platelet count given to a patient with actually low platelets, could result in missing timely intervention with a platelet transfusion. 



CC.8    What are the minimum and basic things that Labs should do incrementally to enhance their quality of service being offered? 

Dr. LV:    From the multitude of quality indicators suggested in standards and commonly used in the lab, there are three that we have tracked in our department that I felt made the most impact:
1.    Pre-analytical errors and Phlebotomy techniques
2.    Turn Around Times (TAT)
3.    Invest in a third party proficiency testing program or inter-lab comparisons, track non- conformities and correct them.

If an organization can just track these factors and improve upon these Parameters, it will make a difference as these directly affect the patient or doctor using your service.


CC.9    Awareness being low, how can the general public be educated about the importance of seeking services at Quality Certified Labs? 

Dr. LV:   The challenge to spreading awareness about what an NABL or NABH accreditation means for the patients or their care takers is that they are largely laymen.

The community that we are catering to needs to understand the significance of what we are doing and should see that reflected in our services provided; otherwise these stamps and logos are just going to look like letters on a board, with no tangible meaning.  They have to be educated by experience.  That means, for example, if by following the standards and getting accredited, you have improved your turn around time to a point where the patients can get their reports earlier than before, the impact of it is felt in the service you provide.  Or if the technician you hired was credentialed and trained to check quality controls regularly, as per your schedule, the number of re-runs that you use reagents on due to faulty results caught later on, will decrease, and with that so will your costs. Phlebotomy is a skill based manual process and if the technician is well trained; number of repeat collections due to faulty collection of samples will also reduce, leading to improved patient satisfaction.

Spreading awareness to people in the healthcare industry may sometimes be like preaching to a choir.  However, treating physicians also need see the difference in accuracy and dependability of reports from a quality-oriented lab, as opposed to one that isn’t.  Doctors refer patients to laboratories, and they need to be confident about the quality of reports they are getting.  One approach taken in the United States of America, is the creation of “diagnostic management teams,” comprising of experts in specialty areas of medicine, primarily based in the clinical laboratory, who can advise physicians on the selection of necessary tests and the interpretation of complex test results, thereby building confidence and rapport between the physicians and lab professionals.  That may work in a hospital set up or in local physician organizations for standalone labs, where they are catering to patients in a common location.


CC.10    What will be your 5 key recommendations, especially to small Labs?

Dr. LV:  1.    Look into accreditation, with the basic standards now introduced by NABL, catering to small labs specifically, i.e. the Quality Assurance Scheme for Basic Composite Medical Laboratories (Entry Level);
2.    The standards of any program are a great starting point to organise and consolidate a lab. There are so many small changes, that if implemented, can radically improve your processes.  Start small, take 3 quality indicators at a time and consolidate those before choosing the next ones;
3.    Striving for quality cannot be a forced idea on your staff.   It has to be part of the work culture.  Building a quality oriented team, sending them for trainings and conferences will open them up to the concept of quality management.  Invest in your quality culture, even though it may be an uphill climb;
4.    Reach out to your stakeholders, whether it is other departments in an organization like a hospital, physicians and customers who patron your lab.  Customer feedback is great if taken positively and constructively;
5.    Be open to technology advancements and stepping up your systems.  There are a lot of free or minimally priced options available online. Get trained in basic programs that will make documentation easier and more efficient.



Dr. Vaswani, on behalf of Calibre Creators, I thank you for these deep insights and I am sure that this message reaches out to those hundreds of labs who are doing a wonderful job and will surely help them to further strengthen their processes.  You have shared some wonderful insights based on your own personal experience which is highly valued and I am confident people will take benefit of your knowledge.

With best wishes.

Sarfaraz Lakhani,
Calibre Creators

Disclaimer: The thoughts expressed by Dr. Lakshmi Vaswani here are her personal and do not represent or relate to any person or organization!