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| Dr. Lakshmi Vaswani, Pathologist |
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!
Good guidelines to health care providers
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