|Year : 2021 | Volume
| Issue : 1 | Page : 25-28
Laboratory accreditation and customer satisfaction
D Abhijith, KS Kusuma, MN Suma
Department of Biochemistry, JSS Medical College and Hospital, JSS Academy of Higher Education and Research, Mysore, Karnataka, India
|Date of Submission||08-May-2020|
|Date of Decision||25-May-2020|
|Date of Acceptance||06-Jun-2020|
|Date of Web Publication||03-Feb-2021|
Dr. M N Suma
Department of Biochemistry, JSS Medical College and Hospital, JSS Academy of Higher Education and Research, Mysore - 570 015, Karnataka
Source of Support: None, Conflict of Interest: None
Laboratory accreditation is a process by which an authoritative body gives formal recognition of technical competence for specific tests or measurements usually following international standards such as ISO/IEC 15189/17025. The process checks on inaccuracy or imprecision that may crop up during the preanalytical, analytical, or postanalytical phases, which could have an impact on the patient's reports and thereby the treatment aspects. The process itself helps the personnel of the laboratory to be alert, be quality conscious, and provide the best to the customers, namely patients and health-care providers, thereby helping the health-care providers to give the best of their services to the patients. This enhances the quality of the health-care services on the whole due to quality management system being in place in laboratories. The accreditation agency which takes interest in the laboratories of India and ensures quality in them is National Accreditation Board for Testing and Calibration Laboratories. The developed countries already have the system in place, and it is mandatory for every lab to be accredited before releasing patient reports. We are not far behind in this process, and shortly it may be considered to be mandatory for all labs to obtain the accreditation to run the tests. However, there are several challenges one needs to address in the process of accreditation, with the most important being the finances, team work, and planning.
Keywords: Accreditation, customer satisfaction, laboratory, National Accreditation Board for Testing and Calibration Laboratories
|How to cite this article:|
Abhijith D, Kusuma K S, Suma M N. Laboratory accreditation and customer satisfaction. APIK J Int Med 2021;9:25-8
| Introduction|| |
A well-equipped laboratory is a strong foundation for the optimal functioning of any health-care system. Ensuring the quality and efficiency of the laboratories is of utmost importance in this era of evidence-based medicine, where laboratories play a pivotal role in establishing and confirming most of the diagnoses made by the clinicians. Laboratory quality can be defined as accuracy, reliability, and timeliness of the reported test results, which includes delivery of the right report to the right individual at the right time. Laboratory accreditation is basically a third-party attestation of the laboratory, wherein the laboratories are insisted to develop and strengthen the quality management system, thereby minimizing the probability of issuance of erroneous reports and also ensuring the timely dispatch of reports, which would be timely verified and certified by the accrediting authority. The inaccurate results provided by the laboratory may produce serious consequences such as unnecessary or improper treatment and treatment-related complications, improper diagnosis or delaying in making the right diagnosis, and additional and unnecessary burdening of the customers with various diagnostic tests.
| What is Accreditation of Medical Laboratories?|| |
Accreditation is a process by which an authoritative body gives formal recognition to a medical laboratory and the personnel involved in running the laboratory, as being competent to carry out specific tasks, and there is only one recognized national accreditation body in each country. Examples of some accreditation bodies include National Accreditation Board for Testing and Calibration Laboratories (NABL) in India, COFRAC in France, and UKAS in UK. The accreditation process does not identify as to who is the best among the laboratories, but it indicates those laboratories who have a system of standard procedures that helps them to improve quality and patient safety. Quality system is about people, with people, and for people.
| Need for Accreditation of Labs|| |
Accreditation helps the PDCA cycle or the total quality management to be in place, which includes Plan, Do, Check and Act. In this process, the first step is to set a target for improvement (quality planning), implement the plan (quality laboratory processes and quality control), ensure whether the plan is working as intended (quality assessment and quality improvement), and, if it is found working appropriately, then make this the new standard. The provision of right results to the right individual at the right time for quality accreditation assessment compels the laboratory staff to stay on the cutting edge of technology developments as these evaluate the efficiency of the laboratory to carry out its functions in a scientific manner employing? qualified personnel who are responsible and accountable following metrological traceability and using tests producing reproducible results maintaining transparency. Undergoing regular assessments enhances staff discipline and sense of professionalism and also leads to providing a high standard of quality service to the customers such as patients and health-care providers.
Accreditation gives a credential to the laboratory, designating the laboratory as “Qualified and Competent” to provide services in the field in which it is accredited, thereby boosting the confidence of clinicians and public, that reports issued by the accredited laboratory are reliable and trustworthy. Accredited laboratories can become more accountable and less dependent on external support. Health insurance companies always try to tie up with accredited hospitals and laboratories for providing services and usually give early and easy clearance for any bill claims, thereby enhancing the comfort zone of insured patients. Fundamentally, any laboratory would go for accreditation mainly to ensure customer satisfaction.
| Accreditation Agencies for Labs|| |
As already mentioned, every country has a single recognized national accreditation body. In India, it is the NABL, a constituent board of the Quality Council of India. The NABL involves a third-party assessment of technical competence of testing including medical and calibration laboratories, proficiency testing providers, and reference material producers by using Conformity Assessment Body's accreditation. The gold standard and the most recognized standard for clinical laboratory accreditation used at present is ISO/IEC 17025: 2005 and 2017 “General Requirements for the Competence of Testing and Calibration Laboratories” and ISO 15189: 2012 “Medical laboratories – Requirements for quality and competence. The accreditation to proficiency testing providers is based on ISO/IEC 17043: 2010 “Conformity assessment – General requirements for proficiency testing” and to reference material producers based on ISO 17034: 2016 “General requirements for the competence of reference material producers.”,
| Laboratory Accreditation – Advantages to the Customer/Client Using the Laboratory Services|| |
The accreditation process has several advantages as listed earlier, however the most important among them is the advantages to the customer/client(s) using the laboratory services. The advantages could be an increased confidence of the customers in the test reports issued by the laboratory, and this leads to a potential increase in the business due to enhanced customer confidence and satisfaction. To achieve this objective, any laboratory will make continual improvements in its functioning and service. This requires regular feedback from the customers pertaining to their satisfaction. The primary external customers of laboratory services are physicians and their opinions form key elements in providing the opportunities to the laboratory managers to identify areas for improvement. The efforts put in by the laboratories to achieve the accreditation will never go a waste and leads to plenty of improvement in the management of various laboratory networks by aiming attention on the areas that need improvement such as supply chain, training of technicians and staff members, instrument maintenance, as well as release of appropriate results after clinical correlation. The positive influence of the accreditation does not stop with an improvement in the laboratory. Its efforts are visible in the other areas of health-care delivery too. They include an improvement in clinician's services toward patients and less hospital stay for the patients (short-term benefits) and cost-effectiveness and sustainability of public health programs (long-term benefits).
A few studies conducted in the earlier years evaluating the laboratory accreditation and customer satisfaction are as follows: A study published in January 2009, evaluated around 138 laboratories using questionnaires pertaining to 15 different service categories of the laboratories which were distributed to around 4300 physicians mainly in the United States (97%) and remainder in Australia, Singapore, and Spain, and the overall mean satisfaction score was found to be 4.1 out of 5. In this study, with an exception for the esoteric test turnaround time, all the other laboratory service categories had excellent-to-good mean percentage values. All physicians surveyed from 57 of the 138 participating laboratories indicated that they would recommend that laboratory to another physician, but the remaining 81 laboratories did not do so. Private institutions tended to have a higher level of physician satisfaction as compared to public/governmental institutions which had the lowest level of satisfaction with laboratory services. The first most important factor which made most of the clinicians recommend the laboratory was the quality and reliability of results followed by the routine test turnaround time.
A study published in 2013, in Yemen, evaluated laboratory services of six hospitals in Aden Governorate by a questionnaire-based survey similar to the above study. This study involved around 200 physicians and found out that the overall mean satisfaction score was 3.3 out of 5. Among the services scored, phlebotomy services had the highest mean score and esoteric test turnaround time had the least, and the physicians scored quality and reliability of results to be below average as the highest rating. Yemen being a developing country, it was found that there was no authority to monitor the laboratories with respect to their adherence to international standards, to establish an integrated and advanced clinical laboratory by upgrading to automated analyzers and recruiting qualified technicians and to ensure occupational safety of workers.
Another study published as a Brief Communication in 2014 in Annals of Laboratory Medicine, considered customer satisfaction with respect to clinical laboratory services as one of the most important quality indicators in laboratory medicine. Their survey included all the customers – doctors, nurses, and the patients. About 370 physicians, 125 nurses, and 347 outpatients participated in the survey by using an online or paper questionnaire. The outpatients were surveyed only for phlebotomy services, whereas the doctors and nurses were given question regarding various aspects of lab, which could have an impact on the patient treatment and outcome. According to this study, physicians' and nurses' mean satisfaction score was 58.1 and the outpatients' mean satisfaction score was 70.5. This study had some limitations such as they did not collect the data for patient waiting time, number of needle stick injuries, and bruise size in their phlebotomy service. However, it helped them to find out the weak areas and work on those to improve the quality of laboratory.
Yet another study conducted in 2017-2018 and published in March 2020, argued that it was highly important to consider the customer's satisfaction for any laboratory to succeed and for this to be achieved, the laboratory had to continuously make every effort to attain a very high level of quality with the help of laboratory accreditation. According to them, the clinician was an important customer and their dissatisfaction rate was =20% (according to March 2017 survey) in the clinical laboratories of Cameroon. They observed that the waiting time with the laboratory services was a major cause for dissatisfaction among the clinicians of Cameroon. Studies of these kind with a feedback from customers, which is a part of the laboratory accreditation process, which include both physician and the patient, will help in identifying the crucial areas that need improvement and can be beneficial to the laboratories in all aspects.
An exploratory study of pathology laboratories in Jaipur conducted by Agarwal and Singh threw light onto the fact that there were studies conducted to measure the health-care services in India, however no studies are available for assessing laboratory services. The study also showed that there were no established scales to measure the service quality at pathology laboratories in Jaipur and hence the authors developed a reliable and valid instrument to measure the patients' perception toward the quality of service in the pathology laboratory. Another study conducted at a NABH-accredited neuropsychiatric hospital in Delhi, analyzing patient satisfaction with phlebotomy services alone, indicated that the customer satisfaction survey could be an effective tool to improve the service quality provided to the patients and it was a continuous process. Patient satisfaction surveys of various microbiological tests conducted at G. B. Pant Hospital, Delhi, indicated that repeating the studies at 6-month intervals would be a useful managerial intervention aimed at delivering and maintaining quality health care. The survey helped the laboratory managers to identify the areas of concern and revealed a positive feedback from customers and along with the estimation of the patient satisfaction scores. However, according to the authors, the study does not compare patient satisfaction in two or more hospitals and the findings may not be generalizable. Yet another study conducted by Aubid et al. by using a pretested questionnaire in Sher-I-Kashmir Institute of Medical Sciences, Srinagar, concluded that the physicians felt that the communication of relevant information and notification of the abnormal or critical results was the weak area in their hospital that needs to be addressed in order to improve the customer satisfaction.
Every study conducted above indicates that customer (patients or health-care providers) satisfaction survey is indeed a continuous process and a good quality indicator that helps the laboratories to improve themselves in various aspects of preanalytical (phlebotomy services) and postanalytical phases (report dispatch at appropriate time). Physician satisfaction with laboratory services in developed countries wherein there will be accreditation of health-care systems is more as compared to developing countries wherein accreditation is a rare process as visualized by comparing the outcomes of the above studies. Some physicians do not consider the quality and reliability of results as an important parameter in an accredited laboratory to improve customer satisfaction because they are assumed to be an integral part of an accreditation process and by default it will be good. Hence, they would be more interested in looking into the improvements in other service categories of laboratories such as turnaround time, critical value notification, scope of laboratory services, notification of new investigations, laboratory information system, and courtesy of the clinical laboratory staff, being some of the important aspects. Laboratory management should focus on all of the above aspects and in particular the improvement of overall turnaround time - routine, STAT and esoteric tests. The turnaround time for esoteric tests mainly depends on the test ordered and the distance, location, and commitment of the tie-up laboratories. Rare tests are to be sent to distant laboratories sometimes, wherein the time taken for the delivery of sample could take days and therefore, educating physicians to manage their expectations is of equal importance as compared to working with the tie-up laboratories. Undue expectation is also an important factor that could bring down customer satisfaction and therefore, laboratory management should clearly educate the customers that common things are common and uncommon things are uncommon, what is there, is there and what is not there, is not there. However, patient satisfaction mainly aims at low cost of the test, easy accessibility to laboratory, and early dispatch of reports. Patients also appreciate the courtesy of the laboratory staff in answering their queries and taking a quality report to the doctor which would help them in getting better treatment, especially in a developing country like India, where further testing due to ambiguity in the results may actually be detrimental to the patient and his/her family in terms of finances. Laboratory accreditation though not mandatory is essential in a developing country like ours to remain on par with international laboratories, to authoritatively satisfy the end users namely clinicians and patients, to ease off the insurance claims, to achieve higher standards, and to be involved in continual improvements by strengthening the quality management system regularly as there is always chance for advancement and improvement.
| Challenges Associated with Accreditation|| |
No process is bereft of challenges. Accreditation process is a prolonged and time-consuming process which at times drain the individuals involved in it. It is a team work and long hours need to be put in by the quality team initially during the planning stages. Once the planning is done, the process of writing the standard operating procedures and the manual also is a time-consuming process. Once the quality processes are in place, educating the other staff members and instilling confidence in each one of them and removing any of the fears associated is a team work. Making everyone a part of the team involves plenty of micro - management skills and soft skills training. Once everyone feels that he/she is a part of the system in providing quality and understands that it is a continuous process, it is easy to deliver. However, there are other issues such as competition with other labs who are not accredited and are not worried about quality, continual improvement of turnaround time, attrition of staff, and staff refresher training which needs to be addressed as and when they arise. Each of them can affect the quality of results.
| Conclusion|| |
Quality is doing right even when nobody is watching, said Mr. Henry Ford. In a developing country like ours, one needs to remember these three F's – (1) Fineness of preparation – right from quality planning and implementation to its assessment and improvement, the quality core team plays an important role in ensuring that all steps are understood by all and all are well prepared to provide quality reports to the customers; (2) Finances – almost all the processes which aim to provide quality depend on the investment of finances (procurement of internal quality check, registering for external quality assurance scheme (EQAS), recruitment of staff members, continual improvement programs, etc.), (3) Full participation of all stakeholders – every person involved in the lab, right from an attender transporting the sample to the lab to the doctor who releases the report and the customers involved, should participate so as to provide a good quality service. Any weak link in the chain can affect all the reports and thereby the quality. One needs to be alert for any weak links and immediately take action to correct it so as to provide a quality report to the right person at the right time.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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