Original Article QCI Medical laboratory program journey of quality in public medical laboratories : An experience though program evaluation Bhupendra Kumar Rana, Narendra Shekhar Behera, Sujeeth B. Nair National Accreditation Board for Hospitals and Healthcare Providers (NABH), Quality Council of India, Institution of Engineers Building, Bahadur Shah Zafar Marg, New Delhi, India. Address for correspondence: Dr. Bhupendra Kumar Rana, National Accreditation Board for Hospitals and Healthcare Providers (NABH), Quality Council of India, 2 nd Floor, Institution of Engineers Building, Bahadur Shah Zafar Marg, New Delhi, India. E-mail: bkrana@nabh.co Access this article online Website: www.nabh.ind.in DOI: 10.4103/2348-6139.132915 Quick Response code: Abstract Objective: Health being a subject of the state and Accreditation of Healthcare Organisations being a voluntary process, the Quality Council of India (QCI) through National Accreditation Board for Hospitals and Healthcare Providers is creating standards and promoting quality in healthcare. The Medical Laboratory Program, which is designed to improve the Quality of Medical Laboratories, is being implemented by both government and private Laboratories to ensure quality of test results. Materials and Methods: A small program Evaluation study was carried out over a period to understand the level of understanding, usefulness and feedback from the participating Laboratories regarding QCI - Essential Standards for Medical Laboratories 1 Program. The data was collected and analysed from 55 participating laboratories. Results: The study findings indicated 100% strongly agree that, training programs conducted were really helpful, 98% stated that, this program was instrumental towards Patient Safety and improved the Quality Indicators of laboratory activities. Around 89% of the respondents strongly support the fact that Educational Materials & technical Supports provided by Med-Lab Team were very useful & helpful to implement the standards & this Program has helped to achieve Quality Output with minimal effort & investment. Most of the respondents (4/5 th ) i.e. 80% of the respondents found that implementation of Med-Lab Program was easy & flexible. More than 80% of the respondents have felt either good, very good or excellent on all the parameters that have been spelt out regarding Post-Implementation impact of Med-Lab Program on various quality Indicators. 53 labs (96%) are satisfied with results on post implementation of the Med-Lab Program and agreed to recommend this program to other labs as well. This is the first such study in India. The findings may be an eye opener for the labs and the state governments who haven t yet participated in the Med Lab Program. Key words: Essential standards, Medical-Laboratory program, medical laboratories, QCI, quality Introduction The First step toward Quality was taken by Government of India one and a half decades ago. Born in 1997, Quality Council of India (QCI) [1] has been working for National Wellbeing. [2,3] The great Chinese Philosopher Lao Tzu said The journey of a thousand miles begins with a single step. In 2005, National Accreditation Board for Hospitals and Healthcare providers( NABH) was formed. In 2006, NABH standards for Hospitals were released. In 2007, QCI Standards for Medical Laboratories were released. It is a well-known fact that, medical laboratory services are the backbone of healthcare industry, where the tests are performed for prevention, diagnosis, and treatment of disease. The worldwide 7 The The Journal Journal of National of National Accreditation Board Board for Hospitals for Hospitals & Healthcare & Healthcare Providers Providers January-June Jan-Jun 2014 Vol 1? Issue 1?
studies have concluded that 70% of the clinical diagnosis is based on laboratory test results. Over the past 5 years we have realized that, the patient safety and quality of care still are being compromised at various stages of healthcare. One of the major areas is being the medical laboratory diagnostics services. Some of the reasons of this problem are due to lack of a standard antibiotic policy, prescription errors, and un-ethical diagnosis practices. In order to reduce the burden of errors in medical laboratory field, the first thing we need to have mass awareness campaigns among the general public (e.g., Jaago Grahak Jaago), secondly the laboratory owners and the laboratory in-charge must understand the rewards of good quality and penalty for compromising on quality. All these plans will only be successful through strong political will through Government Regulations and implementing it through dynamic leadership and innovative team work. Again in 2010, one historic step was taken by Government of India by Passing The Clinical Establishments Act [4] in the Lok Sabha. But as we all know, as per the constitution of India, Health is a State Subject, therefore it depends on the state government for its enactment and implementation. In absence of such a system, it is very difficult to control and monitor the operations of various healthcare organizations including medical laboratories. In order to fill this gap and maintain a balance between Practicality and Technicality to ensure Patient Safety and Quality of test results, Medical laboratory Program based on Essential Standards for Medical Laboratories was launched by QCI for the laboratories (regardless of size, sophistication, and location) that conduct biological, microbiological, immunological, chemical, hematological, pathological, cytological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, and treatment of disease. This was aimed to include the small and medium laboratories that are catering their services to a huge population. Therefore, to make Quality for Medical laboratories practically implementable, affordable, and sustainable, the Med-Lab Program was designed indigenously to suit our internal local factors, so that it will be a win win situation for all stakeholders. This Quality Platform is based on the concept of Education, Continual Onsite training, and Technical Support. In 2009, State Government of Kerala enrolled 362 Medical laboratories (which also include the laboratories from primary, secondary, and tertiary care healthcare institutions) to provide the quality medical laboratory service to its people in the State. With a sincere effort from the Kerala state Healthcare Team and the commitment from each of the Laboratory personnel, we have certified a total of 197 laboratories as on date. The Medical Laboratory Program has been open to Private Laboratories as well. As on date, we have enrolled 24 private laboratories across four states and out of these, 8 laboratories are certified. More number of private laboratories is in the pipeline. Now it is time for other state governments and the individual laboratories to be a part of this success story. Med-Lab Program Evaluation Study The Medical Laboratory Program, which was started in Kerala in the year 2009 to improve the Quality of Government Medical Laboratories of the Health Department of Government of Kerala, as per the QCI Essential Standards for Medical Testing Laboratories. A total of 362 laboratories were enrolled under the program. The laboratory staffs of all enrolled laboratories were trained to understand the requirements of Essential Standards and guided to implement and comply with the standards. They were trained to understand, implement, and sustain all the Technical and Management requirements of the Essential Standards. With a high degree of commitment from the laboratory staffs, cooperation from the Government of Kerala officials, and the high level support from the QCI-Med Lab Team, the laboratories have shown some remarkable improvements over the period of time. As on today, out of 362 enrolled laboratories, 197 Government laboratories have already been certified by QCI under this program. Looking to the successful implementation by the Government laboratories, we thought of making this program open to private laboratories as well, hence in February 2011, this program was launched for the private laboratories at a program conducted in Cochin (to spread the awareness of Quality and QCI Essential Standards certification among the private laboratories). Looking at the current scenario, in order to understand the ground realities about the program implementation, satisfaction level, difficulties during the implementation, and postimplementation Laboratory Improvement of Enrolled and Certified Laboratories, we decided to conduct a Survey in January 2012, called Med-Lab Program Evaluation. This is the first such study in India. Materials and Methods Data from 55 medical laboratories those were either enrolled or certified by Med-Lab Program was collected using feedback/ evaluation sheet [Figure 1], and analyzed. The Evaluation was aimed to get the response from the respondents on the following three aspects: Response on Process of Program Implementation. Response on PostImplementation laboratory Quality Improvement. 8
[Downloaded free from http://www.nabh.ind.in on Thursday, September 03, 2015, IP: 182.66.114.42] Figure 1: Feedback form used to collect information 9
Response on Whether they would recommend this program to other laboratories or not? Tables 1 and 2 depicts the feedback and evaluation criteria used in the study as given in Figure 1. Findings of the Evaluation Study are explained with the help of graphs, tables, and texts. same. The data in the table and graph clearly show that almost all the laboratories are satisfied with the implementation process of Med-Lab Program. Therefore they agreed to recommend this program to other laboratories as well [Figure 4, Table 5]. Results Findings of the response on Process of Program Implementation are shown in Table 3 and Figure 2. Similarly findings of PostImplementation Laboratory Quality Improvement are shown in Table 4 and Figure 3. It is clearly evident from the findings that all the laboratories (100%) strongly agree to the fact that, training programs have helped them to understand, implement, and achieve the requirements of the Essential Standards. Almost all the laboratories (98%) have stated that the implementation of Essential Standards has contributed toward ensuring patient safety and at the same time this has also improved the Quality Indicators including overall functioning of the laboratory activities. Around 89% of the respondents strongly support the fact that Educational Materials and Technical Supports provided by Med-Lab Team were very useful and helpful to implement the standards and the Program has helped them to achieve Quality Output with minimal effort and investment. Most of the respondents (4/5 th ), that is, 80% of the respondents stated that implementation of Med-Lab Program was easy and flexible. From the collected data and its analysis, it is clear that more than 80% of the respondents have felt either good, very good, or excellent on all the parameters that have been spelt out regarding PostImplementation impact of Med-Lab Program on various quality Indicators. There is great accomplishment from the laboratories stating that, Essential standards program has helped them to improve on the turn-around time, which is usually most complained area in a government laboratory. Moreover, 38% of the respondents have a very good response, those who understands the usefulness of implementing the Essential Standards for their laboratory. As many as 44% of the respondents strongly support the fact and have given very good response on the implementation of Essential standards have lead to overall employee and customer satisfaction. Onethird of the respondents have declared that this program has helped them to implement the Quality control activities in a very good manner. Overall responses from the participating laboratories were very positive varying from good to excellent. One of the important aspect of this evaluation from the participating laboratories was to seek their feedback on Whether they would recommend this program to other laboratories or not?. It is worthy to note that 96% of the respondents favored it, which shows their confidence in the program and benefits in implementing the Figure 2: Percentage distribution of responses to Evaluation Questions on Implementation Stage Figure 3: Response on PostImplementation Laboratory Quality Improvement Figure 4: Response on willingness to recommend Essential Standards Program 10
Table 1: Reference table showing serial number and evaluation questions on Implementation Stage of Laboratory Quality Improvement Evaluation Question The implementation of the Med-Lab Program is easy and flexible Training programs helped to improve the quality management systems The educational materials and technical supports provided by Med-Lab Team was very useful and helpful to implement the standards QCI Med-Lab Program has helped to achieve quality output with minimal effort and investment The implementation of essential standards has improved the overall functioning and quality indicators of the laboratory The implementation of essential standards has improved the patient safety Table 3: Table showing percentage distribution of responses of evaluation questions on Implementation Stage of Laboratory Quality Improvement Sl. No. of Questions 1 2 3 4 5 6 Yes 80% 100% 89% 89% 98% 98% No 20% 0% 11% 11% 2% 2% Table 5: Percentage distribution table showing willingness to recommend Essential Standards program Do you like to recommend this program to other laboratories? Yes 96% No 4% Conclusion As per the data analysis of the feedback form received from the respondents (laboratories), the survey shows that, there has been mixed responses from the participating laboratories (from good to excellent). In few cases, the poor response recorded may be attributed to the factors related to lack of fulfillment of resource requirements in terms of manpower (laboratory technical staff), equipments (calibration, maintenance, and new equipments purchase) and laboratory working area. Some staff have either newly posted or transferred; as a result, they did not receive proper training. QCI s Med-Lab Team has been providing them all necessary technical and educational support to keep the momentum of Continual Quality Improvement especially in the areas of Equipment selection, calibration, and maintenance. There is also requirement of more technical and intensive training for laboratories to understand and implement Internal Quality Control and External Quality Assurance activities. From this very first study, it is evident that quality can be improved considerably with sustained efforts despite some limitations. It Table 2: Reference Table showing serial number and evaluation questions on PostImplementation Laboratory Quality Improvement Evaluation Question Impact on the turnaround time of the test results Improvement in the sample collection, storage, and transport system Effective implementation of IQC and EQA Improvement of laboratory data management Effective reduction in the cases of nonconformities Overall employee and customer satisfaction How do you rate the usefulness of implementing the essential standards for your laboratory Table 4: Percentage distribution of responses of evaluation questions on PostImplementation Laboratory Quality Improvement Sl. No. of Questions 1 2 3 4 5 6 7 Excellent 9% 4% 6% 9% 7% 2% 11% Very good 15% 22% 31% 24% 24% 44% 38% Good 58% 59% 52% 56% 52% 39% 45% Average 18% 15% 11% 9% 15% 15% 5% Poor 0% 0% 0% 2% 2% 0% 0% is therefore, pertinent to recommend implementation of this program to various State governments so that people of those states can reap the benefits of this cost effective, sustainable, and achievable program. Acknowledgments We sincerely acknowledge the continuous guidance of Dr. G.J. Gyani, Secretary General-QCI. Support from Dr. T. Venkatesh, Dr. H. S. Virupaksha, Dr. Dinesh Arora IAS, and Dr. Sandeep K is duly acknowledged. Support of Mr. Anil Kumar is greatly appreciated. All laboratories participated in the study deserve due acknowledgement for their support. References 1. Essential Standards for Medical Laboratories, 2 nd ed, October 2010, Quality Council of India. 2. Available from: http://www.qcin.org. [Last accessed on 2012 Jun 6]. 3. Available from: http://www.nabh.co. [Last accessed on 2012 Jun 6]. 4. Report on the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure For the 11 th Five-Year Plan. Available from: http://planningcommission. nic.in/aboutus/committee/wrkgrp11/wg11_hclinic.pdf. [Last accessed on 2012 Jun 6]. How to cite this article: Rana BK, Behera NS, Nair SB. QCI - Medical laboratory program journey of quality in public medical laboratories : An experience though program evaluation. J Nat Accred Board Hosp Healthcare Providers 2014;1:7-11. Source of Support: Nil, Conflict of Interest: None declared. 11