|Year : 2015 | Volume
| Issue : 1 | Page : 30-35
Utility of sample rejection rate as a quality indicator in developing countries
Vibha Gupta, Gita Negi, Meena Harsh, Harish Chandra, Amit Agarwal, Vikas Shrivastava
Department of Pathology, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India
|Date of Web Publication||8-Jul-2015|
Dr. Vibha Gupta
Department of Pathology, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Doiwala, Dehradun - 248 140, Uttarakhand
Source of Support: None, Conflict of Interest: None
Background: The present study aimed at assessing the sample rejection rate during the 1 st year of implementation of the quality management system in the laboratory of a tertiary care medical center in the developing world.
Materials and Methods: Retrospective analysis of data relating to rejections of the request forms and samples sent for hematological and biochemistry investigations from inpatients departments after 1-year of implementation of laboratory management system (ISO 15189; 2007) was done. The mean rejection rate was calculated. It was compared with rejection rates reported by various laboratories. The criteria followed for rejection in our laboratory were compared with those laid down by laboratories in previous studies. Descriptive statistics was used in the study.
Results: Of the 54,603 request forms and samples received during the study period, 3936 (7.2%) were rejected. Issues related to request forms and issues related to the sample, each accounted for nearly 50% rejections. Among the issues related to request from, the most common reason was "incomplete form" leading to 50% rejection. The most common reason for rejection of the sample was "clotted sample" (27.1%). When rejection rates as well as criteria followed by our laboratory were compared with other laboratories, it was found that 32 different criteria for rejections were followed across various laboratories. However, only one criterion (inadequate volume) was followed by all except one study (90%), suggesting a lack of uniformity over rejection criteria across studies.
Conclusions: We found that the rejection rates among various laboratories in developing and developed countries differ. Moreover, the rates differ among various laboratories in developing countries. And the criteria that were followed for rejection differed across studies.
Keywords: Accreditation, medical laboratory science, quality control
|How to cite this article:|
Gupta V, Negi G, Harsh M, Chandra H, Agarwal A, Shrivastava V. Utility of sample rejection rate as a quality indicator in developing countries. J Nat Accred Board Hosp Healthcare Providers 2015;2:30-5
|How to cite this URL:|
Gupta V, Negi G, Harsh M, Chandra H, Agarwal A, Shrivastava V. Utility of sample rejection rate as a quality indicator in developing countries. J Nat Accred Board Hosp Healthcare Providers [serial online] 2015 [cited 2020 Jun 3];2:30-5. Available from: http://www.nabh.ind.in/text.asp?2015/2/1/30/160245
| Introduction|| |
In the present medical diagnostic scenario, around 60-70% of medical decisions related to diagnosis and treatment planning are dependent upon the medical laboratory services.  This highlights the significance of testing to be done on correct sample (preanalytical phase) with accurate and precise techniques (analytical phase) at the earliest (postanalytical phase). "World Health Organization-World Alliance for Patient Safety" states that impressive improvement has occurred in the analytical stage of laboratory medicine, but the preanalytical and postanalytical phases are still vulnerable to errors.  There is a marked difference in medical laboratory services among the developed countries and developing countries. With the advent of full automation, the error rates have been reduced to a great extent even in laboratories of developing countries in the analytical phase. However, due to the discrepancy in the automation of the preanalytical phase, the laboratories of the developing countries lag behind the medical laboratories of the western world.
Many laboratories in the developing countries are now opting for accreditation protocols with the advantage that accreditation is improving their standards and at the same time these standards are making the results globally acceptable. The Bureau of Indian Standards laid the policy of continual improvement for medical laboratories. By adopting certain quality indicators (QIs) in the same, laboratory management system can monitor continual improvement in preanalytical, analytical, and postanalytical phases in the laboratory. 
In the preanalytical phase, in order to get quality samples (may be defined as the blood samples that are reflecting the actual status of the patient's condition at the time, when the sample is drawn), certain criteria are laid down by the laboratory management system. Thus, laboratories accept only good quality samples. The rate of sample rejection is one of the QIs and can be used to monitor improvement in the preanalytical phase. It is measured by the fall in its rate over time, suggesting improvement in preanalytical phase. However, for a laboratory of developing world like India that has recently started following accreditation criteria, there is no system to analyze the rejection rate achieved by a laboratory and standards to match up to. If the sample rejection rate (0.62%) as suggested by the Q-tracks set by College of American Pathologists (CAP)  is considered as an available benchmark, the laboratories in developing countries lag far behind (reported sample rejection rate between 1.9% and 28%) with average of 14.15% as per documented literature. ,,,
The present study was carried out with the aim of reaching out to the above-mentioned issues. More ever, to the best of our knowledge, only few studies are available in literature that have reported the pattern of rejection in laboratories in developing world during the first crucial year of implementation of quality management system. Such a study would even help the other laboratories which are in the initial process of implementing quality management system in defining their systems.
| Materials and Methods|| |
This study was performed after approval from the Institutional Ethics Committee of our Institute.
This was a retrospective cohort study as part of audit done on all the rejected requests pertaining to routine hematology and biochemistry blood samples from the inpatient departments of all the specialties and super specialties at a tertiary medical center. The study was done at the end of the 1 st year of implementation of the quality management system from December 2011 to 2012 done at a tertiary care center. The technicians posted in collection room and nursing staff posted in the wards were trained by the laboratory consultants at regular intervals during the study period.
In order to establish the system of rejecting inappropriate requests and samples, the laboratory designed a rejection format. The criteria in this format were based on the proposals given under official document of National Accreditation Board for Testing and Calibration Laboratories (NABL-112) that had suggested these criteria [Table 1].  Twelve out of 19 criteria were included in the present study since the remaining seven criteria were related to microbiology. Each request form and sample sent to the laboratory was scrutinized against these criteria by the technician at the collection room. If any of the request form or the sample met any of these rejection criteria, the same was rejected, and the record was kept.
|Table 1: Criteria under which hematology and biochemistry requests and samples were scrutinized in present study|
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At the end of the study period, all the rejection records were analyzed. Total number of hematology and biochemistry samples and requests received in the laboratory during the study period was also recorded. The reasons for the rejection were segregated into two separate categories-those related to request forms/samples/and others.
The analysis was done with the help of Excel-2007 (Microsoft Inc., USA). Descriptive statistics was calculated. The rate was calculated for the sample rejection and reasons for rejection were expressed as a percentage.
| Results|| |
During the 12-month-period of initial implementation of the quality management system, a total of 54,603 requests and samples were received. Among these, 3936 requests and samples were rejected (Rejection rate = 7.20%).
On subdividing the rejections on the basis of "issues related to request forms" and "issues related to sample," it was found that 50.65% rejection were due to the "issues related to request forms" and 49.35% were related to "issues related to sample." Most common reason in the category of "issues related to request forms" was "missed time of sample collection" (52.1%). On the other hand, the most common reason in the "issues related to sample" category was "clotted sample" (27.1%) followed by "inadequate sample volume" (5.56%) [Table 2].
|Table 2: Proportions of rejections of requests and samples on each criterion of all rejected samples (n = 3936)|
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A comparison of the criteria used for scrutinizing the requests and samples across laboratories in developed and developing countries was done [Table 3] and [Table 4]. ,,,,,,,, None of the 32 different criteria used across different studies (developing as well as western laboratories) was consistent. Only one criterion (inadequate volume) was followed in all but one study (90%). When we compared studies from developing world (mostly Indian) with those of developed nations, it was found that out of total 32 different criteria, only 20 criteria were followed in Indian studies.
|Table 4: Comparison of rejection criteria across studies of developed countries|
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| Discussion|| |
Our study showed that nearly 7% requests and samples were rejected during the 1 st year of implementation of the quality system. The issues related to the request form and sample each accounted for nearly 50% rejections. In the latter category, clotted sample was the most commonly found cause for rejection.
In our study, the annual sample rejection rate was lower (7%) as compared to rejection rates reported across other Indian studies (average 14.15%). ,,, Such a large difference could be attributed to the difference in methodologies among these various studies. We have included the requests and samples from the inpatient departments only while all other studies done in laboratories of developing world as Indian studies have included requests and samples from both the outdoor and indoor departments. ,,, There was no mention of the status of training of doctors in these studies with reference to filling of request forms adequately. ,,, Thus including the rejections from the outpatients departments (OPD), without adequate training to the doctors could have been the reason for higher rejection rates in these the studies. ,, As no training was imparted to the physicians attending the OPD in our institute, we did not include the requests from OPD. It may be possible that if we had included the requests from OPD, the rejection rate would have gone higher, comparable to other Indian studies.
Although "Q-Probe program of Continuous Laboratory Monitoring" run by CAP provides a clue for the laboratories in the developing world to keep the rejection rates below 0.83%. However, this figure is based upon the data collected from the laboratories from the United States (98%), Canada, and Australia. Medical laboratories in these countries are well-equipped and follow advanced techniques such as bar coding, well-developed hospital information system (HIS), wrist band identification technique, and pneumatic tube system, which can reduce preanalytical errors.  However, these facilities are available at very few laboratories in developing countries, a reason for high rejection rates across various studies. Moreover, laboratories in the developing countries are expected to deliver services to a large number of patients in a given time duration at affordable rates; hence, technical consideration may sometimes acquire secondary position.
The accreditation body ISO 15189; 2007 states that each laboratory should identify and develop its own QIs.  In addition, these QIs should be monitored regularly.  However, the accreditation body does not define criteria and because of this reason we saw a marked variation in the criteria followed across studies. ,,, We propose that an attempt should be made to define a set of the criteria which can be followed by all laboratories and to treat these as QIs. This will help in determining the performance of different laboratories with regards to quality management. At the same time, some flexibility may be provided to accommodate the minor modifications according to the requirements specific to the individual laboratory.
On comparing the rejection criteria, it was observed that eight criteria were not followed by these laboratories as criteria of rejection which were followed by Indian studies. If we look to the criteria that were not followed by Indian study group, it was found that mostly these rejection criteria were related to services as paperless request, HIS, bar coding, and pneumatic tubes which are not available commonly to Indian laboratories were absent. On the other hand, the western study group did not include rejection criteria which can become the cause of rejection if bar coding system is absent or if pneumatic tubes not used. Hence, rejection rates from both groups cannot be compared in all aspects.
The above-mentioned significance of laboratory advancement in the preanalytical phase can be evidenced in one of the studies which showed the reduction in sample rejection rate (from 20.6% to 1.9% across 10 years) after acquisition of these techniques in preanalytical phase in a laboratory in a Western country. 
The present study also highlights the pattern of rejection in a laboratory in the developing world during the 1 st year of implementation of quality assurance policy in laboratory services. The observations suggest that nearly 50% rejections can be prevented by adopting certain plans and strategies especially laying emphasis upon issues pertaining to incomplete request forms like training the staff, use of information system to request test and bar coding system.
However, this study has few methodological limitations. First of all, although the intensive regular trainings were provided to the nursing staff responsible to for drawing the samples and filling the requisition forms and laboratory technician at collection room scrutinizing each request and sample send with it, their motivation was not assessed. This factor is important as this can confound the results as although a person may be trained for the job, but to implement that training on continuous basis needs staff's motivation toward quality work. This can be assessed in future studies. Second, we have only included the requests and samples from the inpatient departments. In our OPD set-up, most of the request forms are being filled by doctors who were not trained during the 1 st year of implementation of the quality management system. Future studies are required to assess the complete effectiveness of implementation of the quality management system by training the doctor staff.
| Conclusion|| |
For the laboratories of developing countries, the need of the hour is to establish two categories of criteria of rejection-those which may be laid down by accreditation bodies considering the regional facilities available and those that are laid down by the hospital according to their specific needs and may be separately documented. The rejection rates then can be analyzed separately from two categories. This will help not only the auditor to analyze the effectiveness of rejection policy but help the hospital itself to monitor both the categories of criteria and make or change policies. If this is followed universally and many such studies are performed, it may help the accreditation bodies to survey according to the area and facilities and provide a range of standard sample rejection criteria and a scale to monitor the same. By that time, the laboratories of developing countries may assess their progress against the efforts done, instead of assessing the laboratory efforts against the Western benchmarks.
| Acknowledgment|| |
We are thankful to Staff of collection room especially Mr. Jitendra for helping us in the data collection during this study.
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[Table 1], [Table 2], [Table 3], [Table 4]