Exploring the impact of national laboratory accreditation on quality and practices: a qualitative study from a government medical college in western India

Abstract

Background

Medical laboratories play a crucial role in diagnostics and therapeutic decisions, with accreditation by bodies like the National Accreditation Board for Testing and Calibration Laboratories (NABL) ensuring technical competence. This study examines the impact of NABL accreditation on laboratory practices, highlighting benefits, challenges, and areas for improvement.

Methods

This qualitative study used six focus group discussions (FGDs) and five in-depth interviews (IDIs) to explore experiences of laboratory professionals at NABL-accredited laboratories in Government Medical College, Bhavnagar, Gujarat. Participants were purposively selected to ensure diverse perspectives. Thematic analysis, employing an inductive approach, was validated through member checking.

Results

The 29 participants reported NABL accreditation positively influenced quality control, standard adherence, and accuracy of laboratory reports. Maintenance of quality registers, equipment calibration, adherence to standard operating procedures (SOPs), and participation in External Quality Assessment Schemes (EQAS) promoted continuous improvement. However, significant challenges included excessive documentation, subjective assessments, workflow disruptions, and financial constraints. Participants recognized accreditation’s educational value, skill enhancement opportunities, and improved market credibility. Recommended improvements included digital documentation systems, reduced administrative burdens, clearer assessment criteria, and increased clinician involvement.

Conclusions

NABL accreditation significantly elevates laboratory standards, improving patient care and clinical decision-making. However, challenges such as excessive paperwork, subjective assessments, financial constraints, and data integrity issues must be addressed. Digital documentation systems, unannounced inspections, clearer assessor guidelines, and greater clinician engagement could mitigate these barriers. Accreditation also enhances educational outcomes and market perception. Policymakers and accreditation bodies should incorporate these findings to refine accreditation processes and sustainably improve laboratory quality and healthcare outcomes.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-025-13195-6.

Introduction

Medical laboratories play a critical role in evidence-based medicine, directly influencing diagnostics, prognostics, and therapeutic decisions, which in turn contribute substantially to patient care and safety [1, 2]. Because the accuracy of diagnoses hinges on high-quality laboratory reports, independent accreditation bodies are essential for ensuring that laboratories meet technical competence standards [1, 2]. In India, the National Accreditation Board for Testing and Calibration Laboratories (NABL) is a key accreditation body that formally recognizes a laboratory’s technical capabilities, ensuring alignment with international standards [1]. As healthcare continues to rely on evidence-based practices, the precision of laboratory results remains crucial for reliable diagnoses [3, 4]. NABL accreditation not only affirms a laboratory's competence but also fosters trust among clinicians, patients, and stakeholders [5, 6]. However, the accreditation process can introduce administrative complexities and added burdens that affect laboratory professionals at various levels. While accreditation serves as a mark of technical competence, there is a need to identify and address any potential loopholes to sustain continuous quality improvement [7].

The importance of quality assurance and accreditation in laboratories, particularly in low- and middle-income countries, is well-documented [8–11]. International studies from Croatia, Korea, the UK and Abu Dhabi highlight both the advantages and the challenges of accreditation. For instance, accreditation in Croatia has led to better identification of unusable samples, [12] though it also introduced excessive paperwork [13]. In Korea, accreditation significantly improved the accuracy of test results [14], while research from the UK noted improved laboratory performance, despite concerns about inefficiency, bureaucracy, and high administrative costs [15]. In Abu Dhabi, establishing a quality culture for quality management was highly rewarding, though laboratories there also grappled with manual documentation and method validation [16].

In India, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) has shown substantial improvements in healthcare delivery across diverse settings. Studies in Kerala and Uttar Pradesh found better patient satisfaction, quality of care, and compliance with standards such as patient rights and infection control in NABH-accredited facilities, compared to non-accredited ones [17–19]. The Manyata program, an NABH initiative for private maternity facilities in Uttar Pradesh, Maharashtra, and Jharkhand, reported a remarkable increase in compliance with care standards, from 9 to 80% [20]. Similarly, an assessment in Puducherry identified critical gaps and implemented corrective actions to meet NABH benchmarks [21]. A systematic review further emphasized that accreditation enhances safety, timeliness, and patient-centeredness, indicating its broader potential for quality improvement [22]. Collectively, these studies show that accreditation can positively transform healthcare delivery when accompanied by appropriate systemic enhancements.

Although NABH focuses on healthcare facilities, NABL accreditation (for clarity, “NABL” is the National Accreditation Board for Testing and Calibration Laboratories) specifically covers diagnostic and testing services in laboratories, ensuring compliance with stringent quality standards [1]. In India, much of the existing literature on NABL consists of opinion pieces and narrative reviews [9, 23–29]. Moreover, existing studies primarily emphasize error reduction and procedural compliance in laboratories [5, 30], while international research, such as from Croatia [13] and the UK [15] has largely relied on postal surveys to document attitudes toward accreditation. However, there is a significant gap in comprehensive qualitative research investigating the multifaceted impact of NABL accreditation—particularly in the Indian context and especially in resource-constrained government settings.

This study addresses these gaps through qualitative methods, examining how NABL accreditation shapes quality control practices, adherence to standard operating procedures, and the accuracy of laboratory reports. Using in-depth interviews and focus group discussions, it identifies both benefits and challenges, then offers actionable recommendations for policymakers, accreditation bodies, and practitioners to enhance laboratory services and promote sustained quality improvements. Additionally, it explores the difficulties laboratories face in attaining accreditation and discusses wider implications for patient trust and market perception [2, 8]. By analyzing the experiences of laboratory professionals, this study offers critical insights that may inform global efforts to improve laboratory systems.

Methods

Study design and duration

This qualitative study sought to capture the detailed experiences and perceptions of laboratory professionals regarding the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation in clinical laboratory settings. Because the study is qualitative, its aim was not to generalize findings across all laboratories, but rather to explore, in depth, the perspectives of professionals engaged in accreditation. Qualitative research provides rich, context-specific insights; readers can assess the transferability of these findings to similar settings.

The primary investigator’s prior involvement with NABL accreditation—first as a resident doctor in Ahmedabad and later as academic faculty in Bhavnagar—revealed ongoing challenges such as data fabrication and an excessive paperwork burden. These issues motivated this study, which explores both the advantages and shortcomings of NABL accreditation. Although centered on a single laboratory, the identified challenges are likely transferable to other facilities undergoing the same accreditation process.

Adhering to a constructivist paradigm (which holds that knowledge is co-constructed through social interactions and experiences), this study aimed to capture the subjective realities of participants. Focus group discussions (FGDs) and in-depth interviews (IDIs) were conducted over six months (December 2020 to June 2021), using a descriptive qualitative approach. Participants were recruited from clinical laboratories, and their contributions were analyzed through thematic coding to uncover both the positive and negative aspects of NABL accreditation. Although this work is single-centered, it provides valuable insights into how accreditation processes function in resource-limited settings, potentially offering lessons for similar laboratories elsewhere.

Study setting

The study was conducted at the NABL-accredited pathology laboratory of Government Medical College Bhavnagar, Gujarat, which is affiliated with Sir Takhtsinhji Hospital, a tertiary-care 750-bedded government hospital. The laboratory provides comprehensive diagnostic services, including hematology, microbiology, biochemistry, cytopathology, and histopathology. Participants were purposively selected from a pool of 14 faculty members, 32 resident doctors, and 45 technicians. Each group plays a distinct role in the NABL accreditation process: faculty members oversee laboratory operations and policy implementation, residents participate in quality assurance and documentation, and technicians handle routine diagnostic tasks and quality control measures. This recruitment strategy captured multiple viewpoints on how accreditation influences day-to-day operations.

Study population

Participants were purposively selected from NABL-accredited laboratories at Government Medical College Bhavnagar, ensuring a diverse representation of roles, expertise, and experiences in accreditation-related work. Selection focused on individuals actively involved in NABL tasks—such as external quality assurance schemes (EQAS), standard operating procedure (SOP) development, or internal audits—and included faculty members, residents, and technicians. Participants’ experience ranged from junior staff to senior faculty, encompassing expertise in hematology, microbiology, pathology, or biochemistry—a breadth that provided a wide array of perspectives.

To avoid overrepresentation of any single group, participants were carefully screened based on direct involvement in accreditation process. Of 30 individuals approached in person (with a detailed explanation of the study’s purpose, procedures, and confidentiality measures), 29 consented to participate (response rate: 97%). The study included five IDIs (with faculty members) and six FGDs (four to eight participants each). Focus groups comprised one group of resident doctors in pathology, one of hematology technicians, one of senior pathology residents, one of histopathology technicians, one of biochemistry technicians, and one of pathology faculty members. Some participants took part in both FGDs and IDIs, bringing the total unique participant count to 29. All interviews and discussions were conducted once, with no repeat sessions needed.

Data saturation was reached when no new codes or insights emerged. After each FGD or IDI, the research team reviewed transcripts and compared emerging codes with prior data. These discussions included examining field notes, coding memos, and interview recordings. Because the sample included a range of faculty, residents, and technicians, data triangulation confirmed that all key themes had been sufficiently explored. Once new interviews and FGDs no longer yielded novel categories or subthemes, data collection ceased.

Data collection

Data were gathered via IDIs and FGDs using a structured interview guide [see Additional file 1]. The guide explored participants’ experiences, challenges, and perceived benefits of NABL accreditation. Participants were recruited through personal visits, during which the study’s purpose and procedures were explained in detail. Both IDIs and FGDs were arranged at mutually convenient times; all sessions were audio-recorded and later transcribed for analysis.

Focus groups included resident doctors, laboratory technicians, and faculty members, who discussed their respective roles, challenges, and perspectives on NABL accreditation. A trained facilitator led each FGD, and data saturation was reached by the sixth FGD. Each discussion was audio-recorded and transcribed verbatim.

In-depth interviews with faculty members of the pathology department provided an additional level of detail regarding their NABL accreditation experiences. Four IDIs took place face-to-face in private settings, and one interview was conducted by phone due to COVID-19 limitations. Regardless of method, confidentiality was upheld, and participants were encouraged to speak openly. All interviews were audio-recorded and transcribed.

Interviews and FGDs were primarily conducted in Gujarati; audio recordings were transcribed and translated into English by the primary author, who is fluent in both languages. To verify accuracy, the research team reviewed transcripts to ensure they captured participants’ original statements. Following the Consolidated Criteria for Reporting Qualitative Research (COREQ), transcripts were shared with participants for feedback (member checking) [31]. All participants confirmed their transcripts as accurate, with no revisions suggested. Written informed consent, including permission for audio recording, was obtained from all participants.

Data analysis

Transcribed data [see Additional file 2] from FGDs and IDIs were analyzed using a six-phase framework for thematic analysis, a recognized, systematic method for identifying, analyzing, and reporting patterns within qualitative data [32]. This approach is commonly used in both inductive and deductive analyses and is suitable for our study’s inductive focus [32]. Analysis began with multiple readings of the transcripts to ensure a thorough understanding of the content. Next, initial codes were manually assigned using the comment feature in Microsoft Word 2016, then transferred to Microsoft Excel 2016 for deeper comparison. Codes with similar meanings were grouped into broader categories, which were later consolidated into overarching themes. The research team then reviewed and refined these themes to ensure they faithfully reflected the data. Each theme was given a clear definition to capture its primary focus. The final themes were assembled into a narrative highlighting how the raw data connected to the study’s objectives. A detailed codebook, presented in Table 2, describes each code.

Table 2.

Codebook: Theme 1 (Impact of NABL accreditation on quality assurance)

Category	Code	Code description	Exemplar quotes from transcript
Quality control maintenance (QCM)	QC registers	Daily documentation of quality control material	“Quality of report is improved because of automation so clinicians can rely on the report. For example, if we do Hb estimation by manual method result will very but in machine it won’t very because we do QC every day.” (Technical staff, 49 years female, 20 years of experience)
			“Some registers has to be written every day for the ease and to maintain quality that we are doing” (Technical staff, 36 years male, 10 years of experience)
	Equipment calibration	Routine check of calibration of all the instruments	“…calibration of instruments which earlier was not done routinely now [is] done frequently because of NABL.” (Quality manager, 56 years male, 18 years of experience)
	AMC and CMC	Annual maintenance contract and comprehensive maintenance contract must be done routinely	“…because of NABL so they are like 3rd party control… AMC, CMC… overall it improves quality.” (Quality manager, 56 years male, 18 years of experience)
Adherence to Standards	SOP compliance	Standard operating procedures must be followed in accredited laboratories	“…SOP checking and updating… all the incomplete work…” (Senior technical staff, 52 years male, 23 years of experience)
	Policy implementation	Policy is made/revised every year, and must be followed	“…write down SOP, update policy.” (Resident, 26 years female, 3 years of experience)
Assurance of accurate reports	EQAS program	External Quality Assurance Program compares laboratory results with that of the standard laboratory	“External quality control is helpful as we get insight of our work.” (Resident, 28 years female, 4 years of experience)
	Quality improvement	EQAS feedback and accreditation requirements provide opportunities for ongoing improvement	“…we get new ideas, we can rectify our mistakes…” (Technical staff, 38 years female, 11 years of experience)

To ensure the trustworthiness of our findings, we used methodological triangulation, collecting data from residents, technicians, and faculty in multiple departments. This diversity of sources helped ensure the themes accurately represented the laboratory workforce’s varied perspectives. Researcher triangulation also took place, with two independent researchers involved in coding. Any differences were resolved through discussion to maintain interpretive consistency. While member checking was not repeated after the coding stage, the study’s rigor was upheld through triangulation and reflexivity. Throughout data interpretation, the researchers remained alert to potential biases, thereby enhancing transparency and credibility.

Results

Participant characteristics

In total, 29 participants (including residents, technicians, and faculty members) from laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in Bhavnagar, Gujarat, India, offered key insights on the accreditation process (Table 1). The participants’ median (interquartile range, IQR) age was 35 years (IQR: 28–43), and their median work experience was 9 years (IQR: 4–16), reflecting a diverse array of professional backgrounds. Because they held varied roles across different laboratory functions, they provided a well-rounded perspective on how NABL accreditation affects laboratory practices.

Table 1.

Demographic profile and role of study participants in NABL accreditation process

Participant ID	Role/Position	Age (Years)	Gender	Work experience (Years)	Department	Involvement in NABL accreditation
1	Resident	28	Female	4	Pathology	Actively involved
2	Technician	32	Male	10	Biochemistry	Actively involved
3	Faculty Member	40	Female	15	Microbiology	Lead role
4	Technician	35	Male	12	Hematology	Actively involved
5	Technician	37	Female	07	Histopathology	Actively involved
6	Resident	26	Female	3	Pathology	Observational role
7	Quality manager (Faculty)	43	Male	17	Pathology	Lead role
8	Head of laboratory	60	Female	30	Pathology	Lead role
9	Resident	28	Male	4	Pathology	Actively involved
10	In charge laboratory	52	Male	18	Biochemistry	Actively involved
11	Resident	27	Male	2	Pathology	Observational role
12	Technical staff	34	Female	9	Biochemistry	Actively involved
13	Technician	56	Male	25	Histopathology	Actively involved
14	In charge laboratory	38	Male	16	Pathology	Actively involved
15	Resident	28	Female	03	Microbiology	Observational role
16	Technician	36	Female	08	Biochemistry	Actively involved
17	Quality manager	56	Male	18	Biochemistry	Lead role
18	Resident	29	Female	04	Pathology	Actively involved
19	Resident	27	Female	03	Pathology	Actively involved
20	Resident	29	Female	04	Biochemistry	Actively involved
21	Resident	28	Male	04	Microbiology	Actively involved
22	Resident	27	Female	03	Pathology	Observational role
23	Resident	29	Female	04	Pathology	Actively involved
24	Resident	27	Female	03	Pathology	Observational role
25	Technical staff	36	Male	10	Pathology	Actively involved
26	Technical staff	48	Female	16	Biochemistry	Actively involved
27	Technical staff	49	Female	20	Pathology	Actively involved
28	Technical staff	38	Female	11	Pathology	Actively involved
29	Technical staff	52	Male	23	Biochemistry	Actively involved

Data analysis and codebook

A thematic analysis was conducted, guided by the approach of Braun and Clarke, to interpret perceptions of NABL accreditation among laboratory staff in diverse roles. After iterative coding and refinement, six overarching themes emerged, each containing several categories and codes. A visual coding tree (Fig. 1) illustrates how raw data were categorized into codes, sub-themes, and overarching themes. To further improve clarity, overarching themes are presented in tables, linking codes to verbatim quotes from participants (Tables 2, 3, 4 and 5).

Fig. 1.

Coding tree for perceptions of medical professionals on NABL accreditation

Table 3.

Codebook: Theme 2 (Challenges in NABL accreditation)

Category	Code	Code description	Exemplar quotes from transcript
Excessive Paperwork	Register maintenance	Daily maintenance of registers is cumbersome with limited staff	“…There is lots of paperwork…” (Technical staff, 38 years male, 10 years of experience)
			“…it increases our burden of maintain register.” (Resident, 28 years female, 4 years of experience)
	Document compilation	Last-minute document compilation is burdensome for staff	“…we completed all the registers before one day and on the day of inspection when assessor asked us questions, we were clueless.” (Technical staff, 34 years female, 9 years of experience)
Subjectivity in assessments	Variability in assessors	Variable inputs from assessors cause confusion in the laboratory	“…some assessor says you should do in this way, next year new assessor says it is not mandatory…” (Technical staff, 38 years female, 11 years of experience)
	Interpretation differences	Assessors expect or interpret data the way their own labs operate	“…they expect to follow the rules they follow in their lab… it is a major subjective error.” (Faculty member, 40 years female, 15 years of experience)
Impact on routine work	Learning compromised	Residents compromise their learning to compile data	“…we do haphazard work during that day as we have to complete registers for that day.” (Resident, 28 years male, 4 years of experience)
	Stressful situations	Extra hours/duties to complete files/registers create stress	“…we work 9 to 5 and after 9 to 5 we have to complete NABL work…” (Senior resident, 29 years female, 4 years of experience)
Data fabrication	False entry in registers	Last-minute data compilation often leads to fabrication or backdating	“…we have to fill the feedback form by our own… data is modified and written by themselves only.” (Resident, 27 years female, 3 years of experience)
			“…sometimes we have to do data fabrication in order to complete the documents.” (Technical staff, 36 years male, 10 years of experience)
Financial burden	Fee payment	High assessment fees; maintenance fees also required	“…the fees for renewal and assessment is too much…” (Faculty member, 40 years female, 15 years of experience)
			“…the main disadvantage is the cost, the fees are more, so for medium sized laboratory the cost of accreditation is more so they might not afford the cost, for larger laboratories it might not be an issue but for small to medium sized laboratories it is not affordable.” (In-charge laboratory, 38 years male, 16 years of experience)

Table 4.

Codebook: themes 3–4 (learning and skill development; attitude and institutional change)

Category	Code	Code description	Exemplar quotes from transcript
Insight into accreditation process	Understanding of procedures	Gaining insight about the procedure of assessment, standards to be followed	“…we get to learn process of NABL accreditation… If I want to do [it] in my private lab I at least have the insight…” (Resident, 26 years female, 3 years of experience)
	SOPs and policies	Learning about Standard Operating Procedures to produce high-quality reports	“…we do not know what is NABL and how we should proceed… all the residents should be trained…” (Senior resident, 29 years female, 4 years of experience)
Knowledge enhancement	Quality control practices	Daily QC checks inspire confidence in the reports	“…at our technician level we get results of EQAS about the quality of slide staining… we definitely try to improve next time.” (Technical staff, 38 years female, 11 years of experience)
	Value and significance	Deeper knowledge of good quality reporting and its effect on patient care	“…also because of NABL the institute head approve some required instruments or reagents which was otherwise difficult to get…” (In-charge laboratory, 52 years male, 18 years of experience)
Perception of accreditation	Quality improvement strategies	Staff is motivated to think about raising quality standards	“…we get new ideas, we can rectify our mistakes.” (Technical staff, 34 years female, 9 years of experience)
			“…if the laboratory in-charge is interested in improving quality… only then the quality will improve.” (Faculty member, 40 years female, 15 years of experience)
	Commitment to quality	Staff awareness that they must follow the standards	“…staff will have exact idea about the procedure… there will be 10–20% improvement in the work, work according to SOP.” (In-charge laboratory, 52 years male, 18 years of experience)
Attitude shift	Adherence to SOPs	Staff compelled to follow SOPs can ultimately achieve better quality	“…it is beneficial, for the patients as well as for the lab because all the records are kept properly and you can trace every data of patient.” (Technical staff, 38 years female, 11 years of experience)
	Reliability for clinicians	Clinicians more confident in reports from accredited labs	“…in terms of market competition people will prefer the NABL accredited lab over non accredited…” (Senior resident, 29 years female, 4 years of experience)

Table 5.

Codebook: Themes 5–6 (Market perception and competition; Suggestions for improvement)

Category	Code	Code description	Exemplar quotes from transcript
Market impact	Patient preference	Patients often prefer accredited labs, assuming higher reliability	“…that creates the good impression in the mind of the customers that the reports are reliable.” (Faculty member, 40 years female, 15 years of experience)
Competition and accreditation	Private labs vs. NABL accredited	Smaller private labs may find accreditation costly; some maintain quality independently	“…for private laboratory the financial burden for accreditation is more… so they don’t want NABL accreditation.” (Resident, 27 years female, 3 years of experience)
			“…they maintain quality on their own so they don’t want NABL accreditation.” (Resident, 26 years female, 3 years of experience)
Reduction in paperwork	Streamlined documentation	Proper labeling and file/register maintenance	“…some registers which NABL asks for daily maintenance are not meaningful we feel…” (Technical staff, 48 years female, 16 years of experience)
	Online data entry	A robust software to enter daily data; avoids duplicate manual registers	“…we have to write patients’ details at 4 different places… online data entry would be a good option.” (Technical staff, 52 years male, 23 years of experience)
	Consistency in assessments	Ensuring uniform application of standards across different assessors	“…there is difference of opinion between the assessors about the NCs…” (Faculty, 43 years male, 17 years of experience)
			“…some in-charge removes one kind of register… new in-charge demands for the same…” (Technical staff, 36 years female, 8 years of experience)
Stricter criteria	Surprise inspections	Not declaring the inspection date can reduce data fabrication	“…they should conduct surprise NABL inspection.” (Resident, 26 years female, 3 years of experience)
			“…the date of inspection should not be given beforehand.” (Senior resident, 28 years male, 4 years of experience)
	Clinician involvement	Systematic integration of clinicians’ feedback to improve patient care	“…also if we want to improve the quality we can ask clinicians about the quality of export and how much variation they see in the reports…” (Senior resident, 28 years male, 4 years of experience)

Theme 1: impact of NABL accreditation on quality assurance

NABL accreditation was widely described as a catalyst for improved quality control, emphasizing accurate record-keeping, regular equipment calibration, and adherence to standard operating procedures (Table 2).

Quality control maintenance

Participants unanimously underlined the importance of maintaining quality control registers for tracking and verifying quality control measures, thereby upholding accurate laboratory results. They also described regular equipment calibration as essential for sustaining the precision of analytical instruments.

"Yes, paperwork is too much but we do not have any problem because it is beneficial to us on long run."(35-year female, senior technical staff, 7 years of experience)

Adherence to standards

Many participants emphasized strict adherence to standard operating procedures (SOPs) and policy implementation. Compliance with SOPs was viewed as the foundation for consistent, standardized practices.

"If we follow the standards of NABL properly, we can improve the patient care and quality of report. It benefits the patient care, and improves the quality of report that ultimately benefits the patients."(43-year male, Quality manager, 17 years of experience).

Assurance of accurate reports

Participants cited the External Quality Assessment Scheme (EQAS) as a key element for ensuring accurate laboratory reports. This program provides ongoing evaluation and fosters report quality improvement. The accreditation process itself was often seen as a driver for proactive measures and continual enhancement.

"For assessment one has to participate in the EQAS program and the good score is expected for the same so that one can compare the report to that of higher body. So that is the biggest advantage of accreditation is that compulsion will improve the quality."(60-year female, head of laboratory, 30 years of experience).

Theme 2: challenges in NABL accreditation

Although accreditation reinforced structured procedures and quality benchmarks, participants reported several hurdles, including burdensome documentation, subjective assessments, and disruptions to routine workflow (Table 3).

Excessive paperwork

A prominent challenge was managing the large volume of paperwork required. Participants described detailed documentation (including quality control logs, equipment usage records, and related procedures) as both time-consuming and labor-intensive.

"For us NABL is register completions, cover the registers and not more than that."(Senior resident doctor, 28 years female, 4 years of experience)

Subjectivity in assessments

Another significant issue was subjectivity in how assessments are carried out. Differences in assessor interpretations and varied application of accreditation criteria created unpredictability in outcomes.

"Every in charge has different opinion on NABL criteria so they made us work differently that is very problematic for us, we don’t know if they are having different perceptions about the criteria but they force us to work differently according to NCs [non-conformities]."(In charge of laboratory, 52 years male,18 years of experience).

Impact on routine work

The accreditation process sometimes disrupted routine laboratory operations, creating haphazard workflows and raising stress levels. Participants also reported that accreditation tasks limited opportunities for on-the-job learning and skill development.

"Our learning is hampered if we are posted for 2 months in particular section and if NABL inspection is coming we are doing its work only we cannot learn in that particular section."(Resident doctor, 27 years male, 2 years of experience).

Data fabrication

Participants identified data fabrication before NABL inspections as a critical vulnerability that undermines the reliability of the accreditation process. To counter this, they proposed real-time digital recording and monitoring of quality control logs and equipment usage, which would limit opportunities for tampering or backdating and ensure that submitted data accurately reflects actual laboratory practices.

“We do data modification and that’s the reality.” (Resident doctor, 29 years female, 4 years of experience)

“Data fabrication can be the issue in quality control data. So that can be improved by local authority checks.” (Quality manager, 56 years male, 18 years of experience)

Financial burden

Financial implications were especially heavy for small and medium-sized laboratories, with private facilities expressing concerns over high accreditation costs. At the same time, government labs struggled with budget constraints that complicated the procurement of quality control materials. Despite these challenges, participants noted that the requirement for NABL accreditation often prompted the allocation of necessary resources, acting as a catalyst for improved funding.

“For private laboratory the financial burden for accreditation is more in my knowledge plus they maintain quality on their own so they don’t want NABL accreditation.” (Faculty of laboratory, 43 years, 17 years of experience).

“Standardization will increase the price of report and not everyone can afford that.” (Resident doctor, 27 years male, 2 years of experience)

"I feel in government set up if there won’t be any accreditation this much quality had not been maintained……. Because of NABL, the institute head approved some required instruments or reagents that were otherwise difficult to get, so that can be included in the advantages."(In charge of laboratory, 52 years male, 18 years of experience).

Themes 3 and 4: learning and skill development & attitude and institutional change

Beyond compliance, participants noted how accreditation fosters professional growth, building awareness of best practices and encouraging a collective commitment to quality (Table 4).

Insight into accreditation process

Many participants reported gaining a deeper understanding of the accreditation process, including assessment criteria, laboratory protocols, and SOPs. This engagement often increased commitment to maintaining high standards.

"At technician level we get results of EQAS about the quality of slide staining, if we get some remarks in it, we definitely try to improve next time, so I feel yes the quality does improve."(Technical staff, 34 years female, 9 years of experience).

Knowledge enhancement

NABL accreditation significantly boosted knowledge among participants. Familiarity with SOPs and policies improved through hands-on involvement, reinforcing the role of accreditation in developing laboratory expertise. Regular quality control measures became integral to their workflow, ensuring accuracy and reliability in laboratory results.

"I feel quality of work improve because we have SOPs of everything and if we follow that we can give good quality slides."(Senior technical staff, 52 years male, 23 years of experience).

Perception of accreditation

NABL accreditation shifted participants’ views on its value, underscoring quality assurance as a central aim. They saw it as instrumental in gaining trust from clinicians and patients, although they noted that the public may not fully understand accreditation’s benefits.

"If we follow the standards of NABL properly, we can improve the patient care and quality of report. It benefits the patient care, and improves the quality of report that ultimately benefits the patients."(In charge of laboratory, 38 years male, 16 years of experience).

Attitude shift

Beyond mere compliance, participants expressed a growing sense of responsibility to consistently follow standard operating procedures (SOPs). While initially viewed as a set of required tasks for inspection, SOPs gradually became part of a larger commitment to sustaining high-quality laboratory practices.

“The guidelines which are given in NABL should be routinely followed… only then the quality of work will improve. If the laboratory in-charge is interested in improving quality and follows the given protocol, only then the quality will improve; otherwise it all goes in vain.” (Faculty member, 40 years of age, 15 years of experience).

Themes 5 and 6: market perception and competition & suggestions for improvement

Accreditation influenced participants’ perceptions of market competitiveness, as accredited labs were seen as more trustworthy by both clinicians and patients. Participants also offered suggestions for minimizing paperwork, introducing surprise inspections, and integrating clinician feedback to sustain meaningful improvements (Table 5).

Market impact

NABL accreditation greatly influences market dynamics by establishing accredited laboratories as more reliable in the eyes of both clinicians and patients. This reputational boost can sway patients toward accredited facilities. Many individuals display a clear preference for accredited laboratories, associating them with higher quality and more reliable services.

"In terms of market competition people will prefer the NABL accredited lab over non accredited that is the general thought."(Resident doctor, 27 years female, 3 years of experience).

“One advantage is that you get the certification of good quality that your lab is certified lab by the NABL that creates the good impression in the mind of the customers that the reports are reliable.” (Faculty member, 40 years of age, 15 years of experience).

Competition and accreditation

Participants noted that while accreditation often enhances credibility, it does not by itself define overall laboratory quality. Smaller or private laboratories sometimes struggle with the financial burden of accreditation. This novel dynamic highlighted the various factors laboratories must consider when striving for quality assurance amidst competitive pressures.

"We feel that we work better in comparison to those labs which are not NABL accredited, we work confidently and speedily."(Technical staff, 36 years female, 8 years of experience)

Reduction in paperwork

Participants proposed digital data entry systems as a transformative way to minimize manual documentation and reduce administrative overhead. By moving to digital platforms, they believed laboratories could significantly cut down on the extensive paperwork required for maintaining compliance with NABL standards. They also recommended streamlining record-keeping procedures to ensure accuracy and completeness while avoiding an excessive burden on staff. Such more efficient documentation processes, they noted, would support both quality and workflow in the accreditation process.

"We have to write patients details at 4 different places because of registers so online data entry would be the good option it will reduce the burden on us."(Quality manager, 43 years male, 17 years of experience).

Stricter criteria

Participants called for stricter, more transparent evaluation criteria to foster uniformity and objectivity in NABL assessments, reducing discrepancies in how different assessors interpret standards. They further recommended unannounced (“surprise”) inspections to prevent laboratories from making only short-term improvements ahead of scheduled visits. Such random checks, participants noted, could ensure continuous compliance rather than temporary performance boosts, ultimately promoting a more equitable and reliable accreditation system.

"They should conduct surprise NABL inspection."(Resident doctor, 29 years female, 4 years of experience)

“Surprise data sending can be asked to reduce data fabrication” (Quality manager, 56 years male, 18 years of experience)

Clinician involvement

Participants underscored the critical role of clinician feedback in the NABL accreditation process, highlighting how collaboration with medical staff ensures laboratory reports are both technically sound and clinically relevant. By incorporating clinician reviews, labs can better address report accuracy, turnaround times, and real-world patient care needs. This interdisciplinary approach was viewed as essential for achieving a more holistic, patient-centered model of quality improvement.

"Clinicians review should be included in NABL parameters like what they are thinking about the reports and what parameter need to get improved in the reports and what are the problems they are facing."(Resident doctor, 27 years female, 3 years of experience).

Discussion

Summary of main findings

This study evaluated how the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation affects laboratory services in a government setting, focusing on quality control practices, compliance challenges, and broader implications for patient trust and market dynamics. The results show that while NABL accreditation increases trust among patients and clinicians and promotes quality control, it also poses challenges—such as excessive paperwork, data fabrication, and financial strains, particularly in private laboratories. Participants also highlighted the need for surprise inspections and standardized evaluation criteria to address these issues. The study’s reliability stems from rigorous data collection and thematic coding that identified key patterns. Since NABL accreditation is uniformly applied across Indian laboratories, the findings may be relevant to other resource-constrained, government-run laboratories. A unique aspect of this study is its focus on underreported issues, including data fabrication and high administrative workloads.

These findings underscore the tension between the requirements set by accreditation bodies (e.g., maintaining extensive records and following standard operating procedures [SOPs]) and how they actually affect trust, efficiency, and workflow [33]. Donabedian’s model of healthcare quality (structure, process, outcome) provides a framework for understanding how accreditation standards (structure) shape laboratory procedures (process), which then influence trust and reliability (outcome) [33]. However, participants noted that accreditation alone does not guarantee long-term quality improvements.

The findings of this study can also be interpreted through established frameworks of organizational change and continuous quality improvement (CQI). Kotter’s model of organizational change emphasizes steps such as creating urgency, forming guiding coalitions, communicating vision, empowering action, and consolidating gains into sustainable practices [34]. Our participants underscored the critical role of committed leadership, clear communication of accreditation goals, and sustained institutional support—key elements within Kotter’s framework—to ensure accreditation processes move beyond mere compliance to transformative quality improvement. However, our data reveal that when leadership and institutional commitment are inadequate or superficial, processes like documentation can become perfunctory tasks rather than genuine quality enhancements.

In response, this study suggests an adapted organizational change model specifically suited to laboratory accreditation in resource-constrained settings. Firstly, leadership must clearly communicate that accreditation is not solely an administrative obligation but a core component of laboratory culture aimed at improving patient care. Secondly, laboratories should invest in capacity-building activities, including ongoing training for all personnel on quality management systems and accreditation standards. Thirdly, implementation should be iterative, guided by continuous monitoring and feedback loops, aligning closely with the Plan-Do-Study-Act (PDSA) cycles commonly used in CQI initiatives [35, 36]. This combination of Kotter’s leadership-driven approach with PDSA’s iterative cycles could offer laboratories a more dynamic, responsive framework that supports continuous improvement rather than episodic compliance.

Further, applying Donabedian’s healthcare quality model, our study highlights the interdependence between accreditation standards (structure), actual laboratory practices (process), and clinician-patient trust (outcome) [33]. For accreditation to lead to meaningful outcomes, laboratories must carefully align structural resources (such as trained personnel, digital documentation systems, and financial investments) with operational processes (regular quality control practices, adherence to SOPs, and active clinician feedback integration). Our findings suggest extending Donabedian’s model by explicitly emphasizing"organizational culture"as a mediating factor between structure and process. A quality-oriented culture appears essential for effectively translating accreditation standards into sustained practice improvements, thereby enhancing patient trust and clinical decision-making.

These theoretical extensions reinforce the idea that successful accreditation is contingent not only upon clearly defined structures and processes but also upon cultivating an internal environment committed to continuous improvement. Future research might further refine these frameworks through broader, multi-institutional studies, potentially offering actionable insights for policymakers and accreditation bodies in diverse healthcare settings.

Implications for local context

These findings apply primarily to Bhavnagar, Gujarat, where government laboratories face significant resource constraints. Nevertheless, because the same NABL standards govern other government-run laboratories in India, many of the identified challenges—like administrative burdens and data fabrication—are likely to recur in similar settings. However, local factors like institutional culture, administrative practices, staffing, and regional resource availability may influence how these challenges manifest and are managed. Readers may judge how best to adapt these insights to their specific contexts, especially the risk of procedural shortcuts taken solely to meet accreditation benchmarks.

Thus, the transferability of this study's qualitative insights relies on clearly described contextual details, which allow readers to judge applicability within their specific settings. Laboratories differing significantly in resource availability, administrative support, or sector (private versus public) may experience NABL accreditation differently. Consequently, adaptation of these insights should be context-sensitive, taking into account local operational realities and constraints.

Comparison with existing literature

Participants emphasized quality control as central to laboratory accreditation, noting how NABL standards remain stringent despite limited resources [3, 23, 37]. This mirrors findings from other studies showing that accreditation compels labs to uphold high quality even in challenging contexts [6, 38]. In particular, the External Quality Assurance Scheme (EQAS) emerged as vital in confirming report accuracy and in guiding further improvements [8]. Overall, NABL accreditation has proven essential in sustaining quality practices, especially for government laboratories with fewer resources.

Excessive paperwork and administrative burdens were identified as major obstacles, aligning with previous research documenting the impact of onerous documentation on laboratory operations [6, 25, 39]. Others also have shown that meeting these administrative requirements can divert attention from core tasks [8, 15]. Addressing this paperwork problem could streamline accreditation and reduce strain on staff.

Participants generally believed that NABL accreditation increases clinician trust in laboratory reports, consistent with studies on accreditation’s role in clinical decision-making [40]. However, public awareness remains limited, as many patients place cost above accreditation status. This finding indicates a need for public education on the benefits of accredited services. Participants also observed that maintaining quality depends on internal commitment rather than just formal accreditation, in line with literature showing that quality is possible without official certification, [9, 25, 30, 41]—provided the right principles are fully integrated [10].

Engagement in NABL accreditation was viewed as a powerful learning opportunity, improving participants’ knowledge of laboratory protocols. Past studies likewise report that accreditation fosters skill development and continuous improvement [4, 28, 42]. Additionally, NABL accreditation enhances market perception by distinguishing laboratories in competitive healthcare settings [43, 44]. As accreditation awareness grows, patients may increasingly prefer accredited facilities, spurring further market competition [39]. These results demonstrate that embedding quality control into daily activities fosters a “learning organization,” supporting ongoing skill development and incremental improvements rather than periodic compliance alone [35, 36].

Secondary findings

A secondary theme is the low public awareness of NABL accreditation, despite clinicians appreciating its rigorous checks [15]. Many patients, however, prioritize affordability and may opt for cheaper, non-accredited labs [37]. Participants’ perspectives on accreditation also evolved: initially, they viewed accreditation as bureaucratic but eventually recognized its value and adopted higher standards, highlighting the transformative effect of active engagement.

Recommendations based on findings

From a managerial viewpoint, participants suggested digital solutions for real-time data entry and photographic documentation to ease paperwork burdens and reduce data fabrication. This aligns with prior research on the effectiveness of such technologies [2, 37, 45].

Participants also endorsed unannounced inspections, which they felt would reflect genuine daily operations and deter last-minute document completion [6, 27]. Clearer guidelines and additional assessor training may lessen subjectivity and inconsistency, helping managers conform to accreditation requirements more effectively.

From a societal standpoint, raising public awareness of NABL accreditation is crucial. Educating patients about its importance can spur demand for higher-quality diagnostic services and motivate more laboratories to seek accreditation, ultimately improving healthcare outcomes. Adopting these recommendations could also enhance trust in diagnostic services by ensuring consistent quality.

Unannounced inspections can be theoretically understood using institutional theory, specifically the concept of institutional isomorphism, where external pressures (like accreditation requirements and surprise inspections) prompt organizations to genuinely adopt new standards [46]. Such regulatory pressures help shift laboratories from superficial compliance towards authentic adoption of quality practices, directly addressing participants'concerns about inspection-related shortcuts.

Broader theoretical implications

These findings reinforce organizational readiness for change concepts, showing that long-term improvements hinge on cultivating a quality-focused organizational culture in addition to structural modifications (e.g., new equipment or SOPs) [47]. Effective leadership, staff engagement, and ongoing feedback loops are all key to aligning accreditation mandates with internal motivations, ensuring transformation that endures beyond the inspection period [47].

Strengths and limitations

A key strength is the qualitative design, guided by Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines [31], enabling an in-depth exploration of laboratory professionals’ perspectives on NABL accreditation. The diverse participants—residents, technicians, and faculty from accredited labs—yield a holistic view of accreditation. With researchers experienced in qualitative methods, data analysis was rigorous, and member checking strengthened the study’s credibility. Furthermore, using both in-depth interviews and focus group discussions allowed methodological triangulation, enhancing the credibility and depth of the findings. Although rooted in the Indian context, these insights may inform discussions on laboratory accreditation improvements worldwide.

Nevertheless, our study has several methodological limitations. Primarily, being a single-institution study conducted at a government medical college in Bhavnagar, Gujarat, the findings'generalizability is inherently limited. Specific contextual factors such as institutional culture, available resources, staffing patterns, and regional administrative practices may influence how NABL accreditation is perceived and implemented. Although NABL accreditation standards are uniform nationally, these local contextual variations can affect the transferability of findings to other settings. We thus recommend caution when extrapolating these results beyond comparable institutions or regions sharing similar operational constraints and contexts.

Another limitation was the methodological inconsistency introduced by conducting one of the five in-depth interviews remotely, due to COVID-19 restrictions. Remote interviews can potentially limit non-verbal communication cues and affect rapport-building, possibly influencing participant responses. However, steps were taken to minimize these effects by ensuring a comfortable setting and adequate rapport prior to and during the conversation, alongside member checking procedures to validate transcript accuracy. Despite this effort, some subtle differences in data quality or richness compared to in-person interviews cannot be entirely ruled out.

Future studies incorporating multiple institutions across different regions and sectors (e.g., private versus government laboratories) could substantially improve understanding of how context shapes accreditation experiences and perceptions. Additionally, fully consistent methodological approaches, ideally entirely face-to-face or entirely remote, could minimize the impact of inconsistencies on findings.

Conclusions

This study provides critical insights into how National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation enhances laboratory quality, compliance, and reliability, thereby increasing trust among clinicians and patients. However, substantial challenges persist, including heavy administrative workloads, financial constraints, data integrity concerns, and variability in assessments. Solutions such as digital documentation systems, unannounced inspections, clearer assessor guidelines, and enhanced clinician engagement can significantly improve the accreditation process. Professional development and a supportive organizational culture are also essential for sustaining accreditation-driven improvements. While centered on the Indian context, these recommendations—streamlining procedures, strengthening quality standards, and fostering continuous improvement—hold global relevance. Policymakers and accreditation bodies should leverage these insights to optimize accreditation practices, promoting sustained excellence and reliability in laboratory services.

Abbreviations

AMC

Annual Maintenance Contract

CMC

Comprehensive Maintenance Contract

EQAS

External Quality Assurance Scheme

FGD

Focus Group Discussion

IDI

In-depth Interview

NABL

National Accreditation Board of Testing and Calibration Laboratory

QC

Quality Control

SOP

Standard Operating Procedure

Author’s contributions

Both the authors contributed significantly to the conception, design, definition of intellectual content, literature search, data collection, data analysis, manuscript editing, and manuscript review. K.P. took the lead in preparing the transcript, and both K.P. and M.R. independently coded the transcript. The coding was then compared for similarity, and consensus building was achieved through collaborative efforts. Both the authors approve the final version of the manuscript.

Funding

This work did not receive any funding.

Data availability

All data generated or analyzed during this study are included in this published article [and its supplementary information files].

Declarations

Ethics approval and consent to participate

Ethical approval was obtained from the Institutional Ethics Committee of Government Medical College, Bhavnagar (no. 937/2020, dated 21/08/2020). Participants were assured of confidentiality, and all data were anonymized to protect their identities. Written informed consent was reaffirmed at the beginning of each FGD and IDI along with permission for audio recording. The Declaration of Helsinki was followed in the research's execution. The confidentiality of data was maintained and the data was accessible only to the research team.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.