|Year : 2022 | Volume
| Issue : 1 | Page : 8-12
Quality evaluation of sample collection facilities of resource-limited medical laboratories in various states of India: A comparison between accredited and nonaccredited laboratories
Manikchandra Ramkripal Tiwari1, Arti Rauthan2, Preeti Chavan3, Papagudi Ganesan Subramanian3, Sumeet Gujral4, Vivek Bhat3
1 Advance Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Mumbai, Maharashtra; Department of Clinical Research and Health Care Management, School of Pharmaceutical Sciences, Himgiri Zee University, Dehradun, Uttarakhand, India
2 Department of Clinical Research and Health Care Management, School of Pharmaceutical Sciences, Himgiri Zee University, Dehradun, Uttarakhand, India
3 Advance Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Mumbai, Maharashtra, India
4 Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India
|Date of Submission||05-Jul-2022|
|Date of Acceptance||13-Oct-2022|
|Date of Web Publication||28-Oct-2022|
Mr. Manikchandra Ramkripal Tiwari
Advance Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Sector-22, Kharghar, Navi Mumbai - 410 210, Raigad, Maharashtra
Source of Support: None, Conflict of Interest: None
Background and Aims: The majority of medical laboratory errors occur at the preexamination stage leading to poor patient outcomes. Very less information is available on the analysis of resource-limited medical laboratories (RLMLs) following the sample collection facility (SCF) checklist to improve their sample collection and handling practices and thus reduce occurring of such errors. The aim of this study is to find out the percentage SCFs complying with checklist criteria and to evaluate the importance of accreditation as a tool of quality improvement. Materials and Methods: SCFs of both accredited and nonaccredited RLMLs were compared for compliance with criteria given in the National Board for Accreditation of Testing and Calibration Laboratories 112 SCF checklist. Among 50 SCFs, seven were from accredited and 43 from nonaccredited RLMLs. Compliance was assessed for 43 criteria. The percentage SCFs complying with each criterion was evaluated; in addition, Chi-square testing with P value significant at P < 0.005 was calculated for each criterion. Results: All accredited SCFs showed compliance with most of the criteria. Out of 43 criteria evaluated for both accredited and nonaccredited SCFs, statistically significant difference in compliance was seen in 30 criteria with P < 0.005, whereas 13 criteria showed nonsignificant difference. Conclusion: Nonaccredited SCFs were found to be in poor compliance as compared to accredited SCFs. There is scope of improvement for deficiencies noted at multiple levels at such SCFs. Preexamination errors may be reduced by implementing criteria of the related SCF checklist.
Keywords: Accreditation, National Board for Accreditation of Testing and Calibration Laboratories 112 sample collection facility checklist, preexamination errors, resource-limited medical laboratories, sample collection facility
|How to cite this article:|
Tiwari MR, Rauthan A, Chavan P, Subramanian PG, Gujral S, Bhat V. Quality evaluation of sample collection facilities of resource-limited medical laboratories in various states of India: A comparison between accredited and nonaccredited laboratories. QAI J Healthc Qual Patient Saf 2022;3:8-12
|How to cite this URL:|
Tiwari MR, Rauthan A, Chavan P, Subramanian PG, Gujral S, Bhat V. Quality evaluation of sample collection facilities of resource-limited medical laboratories in various states of India: A comparison between accredited and nonaccredited laboratories. QAI J Healthc Qual Patient Saf [serial online] 2022 [cited 2023 Jan 28];3:8-12. Available from: https://www.QAIJ.org/text.asp?2022/3/1/8/359801
| Introduction|| |
Medical laboratory reports help clinicians in proper diagnosis and management of patients. Erroneous diagnosis due to laboratory reporting errors may lead to improper patient management and increased morbidity and mortality. Medical laboratory sample collection and processing is divided into three different stages: preexamination, examination, and postexamination.
Preexamination stage begins with test requisition form where the clinician raises a request to perform certain tests; accordingly, the patient's sample is collected in the sample collection facility (SCF) of the medical laboratory. This SCF is generally located within the testing laboratory premises in a hospital setting but at times it may be at a distance. Collected samples are transported to the examination area of the laboratory. After the samples reach the laboratory, samples are accepted or rejected depending on the suitability of the samples as per the tests requested by the clinician. The accepted samples are then sent further for prepreparation before they are finally sent for testing to the examination area.
It is well known that up to 75% of total errors generated at a medical laboratory are at preexamination stage and may have detrimental effects on patient care. They may also lead to unnecessary investigations and inappropriate treatment, which may further lead to an increase in the length of hospital stay, increased costs for the patient, and eventually dissatisfaction with the health-care services. The majority of these errors can be easily reduced by the use of staff training and implementation of relevant policies and procedures. The International Standards Organization (ISO) 15189 and ISO 17025 are internationally accepted standards for medical laboratory services which help in the development and implementation of quality systems and standards. In India, National Accreditation Board for Testing and Calibration Laboratories (NABL) is a body authorized to provide accreditation to medical testing laboratories as per this standard in conjunction with NABL112, the specific criteria document. A checklist for SCF is provided to assess the preexamination stage practice.
However, the majority of the population is being catered to by small, peripherally located, and resource-limited medical laboratories (RLMLs). Very few RLML constitute part of a total of 2501 accredited laboratories in the country. Not much-published data is available on the quality management system being followed in these RLMLs.
Considering this fact, we conducted a small study on various aspects of the preexamination stage in RLMLs. We compared current practices at SCF of both accredited and nonaccredited RLMLs with the recommendations in NABL112 checklist to understand the quality gaps in accredited versus nonaccredited laboratories.
| Materials and Methods|| |
We studied a total of 50 RLMLs which included both NABL-accredited (n = 7) and nonaccredited laboratories (n = 43) from various zones of India. Those laboratories which had limited resources such as staff, space, equipment, and consumables were considered RLML. Laboratories were selected from the following four geographical zones of India as follows: West zone (Mumbai, Navi Mumbai, Palghar, Boisar, and Thane), North zone (Lucknow, Jaunpur, Varanasi, East [Kolkata]), East zone (Guwahati), and South zone (Goa and Kerala). The selection of the laboratory was random and depended on the willingness of the laboratory management to participate in this study. Data collection was done either by physical visit and virtual sessions or telephonic conversations with prior permission of the head of the laboratory. The anonymity of the laboratory in publication was assured to the RLML.
At least one SCF of each RLML was assessed for 43 criteria of NABL-112 SCF checklist. If the SCF was found to be in compliance with one point, a score of one was given. A score of 0 was allotted for noncompliance. The scores of NABL accredited versus nonaccredited laboratories were compared using the Chi-square test. P = 0.005 was considered statistically significant.
| Results|| |
All the accredited SCFs were found to be compliant for the majority of the criteria assessed except for power backup for equipment (29%), presence of expired materials (15%), temperature monitoring during sample transport (43%), and review and redressal of feedbacks (29%).
Out of 43 nonaccredited SCFs, the majority (96%) complied with premises, accommodation, and environmental requirements. However, zero compliance was observed for staff training and documentation, vaccination, safe transport, storage of samples collected, and patient feedback. Only partial compliance was observed for equipment-related guidelines (5%–56%), biomedical waste disposal practices (16%–21%), and handling of emergency protocols (23%) in nonaccredited laboratories.
A significant P was observed for all these areas when scores for accredited and nonaccredited laboratories were compared [Table 1].
|Table 1: Evaluation result of quality compliance of SCFs based on NABL112 criteria checklist of accredited and non-accredited RLMLs|
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| Discussion|| |
Preanalytical errors are a major contributor to erroneous laboratory reports with 46%–68.2% of the total errors. This makes it important to address the issues responsible for these errors and take preventive actions for the same. The main reasons noted in various studies for these errors include inadequate staff training and lack of knowledge by the staff in safe laboratory practices., This was the primary difference in our study between the accredited and nonaccredited laboratories.
The onus to reduce these errors is on the laboratory management by making available relevant resources in terms of standardized guidelines and policies for the preexamination stage of testing. However, it has been noted that the main hurdles faced by laboratories in RLML settings are lack of resources. This in turn leads to a subpar performance in reporting which further reduces the trust of clinicians in laboratory services.
The international standard for medical laboratory testing ISO15189:2012 and NABL112 guidelines provides a continuous improvement tool for the maintenance and monitoring of quality practices for accredited laboratories. Periodic internal and external audits which are part of the accreditation process, further contribute to monitoring the performance of laboratories. However, these initiatives were not evidenced in the nonaccredited laboratories in our study.
Not much literature is available on the comparison of facilities and adherence to safe laboratory practices between accredited and nonaccredited laboratories. However, studies have established the advantages of staff training and laboratory audits as per the international guidelines in reducing laboratory errors at the preexamination stage and improve the overall functionality of the laboratory.,
Among the many benefits of accreditation which help improve the quality of services is improved documentation of laboratory processes and sense of responsibility for the staff. Documentation in medical establishments is also an essential legal requirement. In our study, 100% compliance to documentation was observed in accredited laboratories, whereas no compliance for the same was seen in nonaccredited laboratories.
Another important aspect where major differences were observed in our study between accredited and nonaccredited laboratories is safe storage and transport of specimens. Safe storage and transportation of samples play an important part in the preanalytical process. It is important to maintain the integrity of samples and deliver reliable, quality reports in time for the clinician to start appropriate treatment of the patient.
The results when compared between the accredited and nonaccredited laboratories showed a great disparity in quality initiatives, processes, and commitment to quality in these two groups. As accreditation process in India remains voluntary the number of accredited laboratories remains low. The awareness regarding the benefits and importance of accreditation was observed to be low among laboratory management. It is essential to draw the attention of these laboratories to the benefits of accreditation. Some of the benefits of accreditation include increased accountability and responsibility sharing by the staff. It also improves the quality of reports and in turn increases the reliability of laboratory reports for clinicians and patients., The process of accreditation itself starts a system that identifies areas for improvement and tackles them in a systematic manner. Accreditation also improves staff participation in quality and increases accountability. The benefits of implementation of accreditation standards are thought to be more visible in resource-limited laboratories as compared to laboratories with high resources.
However, some of the major reasons for resistance to accreditation among laboratories that are documented are additional costs for investment in equipment, workforce, other facilities, training including expenses for consultants, and cost of accreditation itself. All these concerns were shared by the management of nonaccredited laboratories in our study as well. In addition, the high attrition rate for trained staff and lack of any benefits in terms of clinician and patient appreciation were the reasons observed for not opting for accreditation in this study.
As observed in our study, there is a wide gap in the adherence to quality assurance practices in sample collection facilities of accredited versus nonaccredited laboratories. Government regulations identifying and making the implementation of minimum guidelines mandatory for sample collection facilities can go a long way in improving the performance and quality of these laboratories.
| Conclusion|| |
Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors can be significant and may adversely impact the quality of testing and patient safety. This study reveals areas of improvement at multiple levels in the SCFs in the preexamination stage. SCFs of NABL-accredited laboratories were found in compliance with most of the criteria as compared to nonaccredited laboratories. Thus, poor quality performance of SCFs may be directly related to more preexamination errors. To reduce multi-level preexamination errors at SCFs, accreditation may be used as an important quality improvement tool by RLMLs.
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Conflicts of interest
There are no conflicts of interest.
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