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 ~  Abstract
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 ~  Reporting of the...
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  Table of Contents  
Year : 2019  |  Volume : 37  |  Issue : 2  |  Page : 163-172

Experience of Indian association of medical microbiology external quality assurance scheme centre, New Delhi: Challenges and quality assessment of clinical microbiology laboratories

Department of Clinical Microbiology, Sir Ganga Ram Hospital, New Delhi, India

Date of Submission24-Sep-2019
Date of Decision30-Sep-2019
Date of Acceptance30-Sep-2019
Date of Web Publication19-Nov-2019

Correspondence Address:
Dr. Chand Wattal
Department of Clinical Microbiology, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijmm.IJMM_19_356

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 ~ Abstract 

Introduction: EQAS program at New Delhi under IAMM was started in January 2014 across North and North east regions of India with 217 participants, which grew up to 540 by 2018. Materials and Methods: In 2014, 4 analytes per year were sent for 3 exercises, i.e. smear culture and serology. 2018 onwards PT analytes were increased from 4 to 12 and comparative performance of techniques analysed. Results: Out of the 22 smears sent for gram staining, ZN staining, Kinyoun staining and Albert staining, completely correct results ranged between 29.55% - 79.9%, 94.3% - 99.2%, 35.5% & 93.8%, respectively. Correct results for culture isolate identification & susceptibility testing and serology exercises varied between 70 & 92.4% and 73.1 & 98.59%, respectively. In the year 2018, 470 responses were received for bacterial culture identification & antibiotic susceptibility testing out of which manual and automated systems were used by 54% & 46% and 52.5% & 47.5% participants, respectively. Techniques used in BBV assays for HBsAg, HCV & HIV found all methods like ELISA, ELFA, CLIA and Card Test performing similarly. The major challenges in running the EQA program included requirement of large amount of specimens for PT item preparation, stability in hot and humid conditions and timely delivery of PT challenges in remote parts of the country. Conclusion: A large number of the participating laboratories (77%) had an overall score of >80% for all exercises, demonstrating acceptable baseline performance of EQAS registered laboratories. However, continued EQAS participation could further improve the quality of results.

Keywords: AST, BBV, EQAS, IAMM, PT provider

How to cite this article:
Wattal C, Oberoi JK, Goel N, Datta S, Raveendran R, Prasad K J. Experience of Indian association of medical microbiology external quality assurance scheme centre, New Delhi: Challenges and quality assessment of clinical microbiology laboratories. Indian J Med Microbiol 2019;37:163-72

How to cite this URL:
Wattal C, Oberoi JK, Goel N, Datta S, Raveendran R, Prasad K J. Experience of Indian association of medical microbiology external quality assurance scheme centre, New Delhi: Challenges and quality assessment of clinical microbiology laboratories. Indian J Med Microbiol [serial online] 2019 [cited 2021 Jan 28];37:163-72. Available from:

 ~ Introduction Top

In resource-limited countries, laboratory testing in a primary health-care setting contributes around 45% of decision-making.[1] Hence, there is a need for External Quality Assurance (EQA) programs. EQA scheme (EQAS) is a systematic assessment of the quality of analysis where unknown samples are tested at regular intervals.[2] The central concept behind EQA is the distribution of stable and consistent samples for participants to analyse. EQA programs can be organised at regional, national or international levels. Mostly, EQA programs are voluntary to achieve improvement in the laboratory. A summary is generally provided that allows comparison with the peers. In a typical proficiency testing (PT) program, challenge samples are provided at regular intervals. An optimal frequency is 3–4 times in a year. Mandy et al.[3] and Mukadi et al.[4] noted improved performance after several rounds of participation in PT schemes.

As an initiative of the Indian Association of Medical Microbiologists (IAMM) due to increase in number of participants, a second centre for EQAS in medical microbiology started functioning from January 2014 at Sir Ganga Ram Hospital (SGRH), Department of Clinical Microbiology and Immunology, New Delhi. After an elaborate training of the staff under the watchful eyes of Professor H. N. Madhawan and Dr. Mary Jesudasan, the centre was approved by the EQAS subcommittee of IAMM. A seed money of Rs. 5 lakhs was provided by IAMM and Rs. 18 lakhs was given by the management of SGRH to start the centre. The learning and findings of various cycles completed since January 2014, is being reviewed here for the benefit of the readers. Only one other centre at Lucknow is available for microbiology EQAS outside the umbrella of IAMM.

Ideal PT samples should include appropriate sample types (e.g., urine, sputum, serum, etc.), available in sufficient volume, have analyte concentrations that include the expected clinical range, homogeneous across all the items produced, stable during transportation and storage, should not be costly and also simulate patient samples in clinical laboratory measurement procedures.[5]

 ~ Materials and Methods Top

Enrollment: The Northern zone of EQAS currently has 540 participants [Table 1]. The program focused on the most commonly done investigations in the clinical microbiology laboratories across the country. The activities included are (1) slides for staining, (2) bacterial cultures, (3) serology and blood-borne viral (BBV) serology [Table 2]. The participating laboratories can choose their scope [Table 3].
Table 1: State-wise distribution of participants

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Table 2: Number of proficiency testing analytes sent to participants

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Table 3: Scope of External Quality Assurance Scheme Delhi Centre

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Between 2014 and 2017 (quality control [QC] No. 1–16), yearly cycles consisted of four rounds containing one analyte only for each activity and were being sent in January, April, July and October. Subsequently, since January 2018, once NABL accreditation was achieved, the number of rounds in each cycle was reduced to 3 (April, July, November) [Table 2], but number of analytes increased, and various PT items provided are given in [Table 4]. In this study, QC 1–18 sent between January 2014 and July 2018 were included.
Table 4: Analytes provided under quality control 1 to quality control 18

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Staining exercises given to participants includes commonly used stains in clinical microbiology practice such as Grams, Alberts, acid-fast bacilli (AFB) staining (Ziehl–Neelsen/Direct Fluorescence) and Kinyouns. Once an appropriate patient sample [Table 3] in sufficient quantity is chosen from the NABL accredited clinical microbiology laboratory, SGRH, multiple glass slides (pearl microscope slides 1.3 mm) were prepared and evaluated by two independent observers to optimise the parameters under evaluation.[6] Approximately, 5% of the slides were examined to confirm homogeneity of sample (uniform distribution of cells and microorganisms). A suitable clinical scenario was given for each of the staining exercise for reporting and interpretation.

Microbiology culture, identification and susceptibility testing

The prior identified pure growth of the analytes was cultured in bulk using standard techniques.[7] The identification to species level and susceptibility testing following the current CLSI guidelines [8] of the organisms were verified by both manual as well as automated methods such as MALDI-TOF and VITEK-2 (bioMerieux, France). The required number of sterile screw capped 5 ml glass tubes were used for lyoplilisation using the lyophiliser, Free Zone Triad Freeze Dry System, Model 74000 series (Labconco Corporation, Kansas City, US). A clinical history of the patient and source of organism was provided to the participants.

Stability testing and packaging, labelling and distribution of proficiency test items

This is being performed as per the standard practice in conformity with UN3373, Biological Substance B criteria to prevent the leakage of QC packages in transit by using leak-proof sterile vials reinforced with cellophane tape.[6],[9]

 ~ Reporting of the Results Top

Laboratories were instructed to perform the tests, as they would do routinely. The microorganism identification is also expected to be done to the designed level (genus, species or serotype or serovar) and in the same way as reported for patient specimens.[6] Three-week time was provided to the participants to complete the QC exercise. Any result obtained after the specified date by the centre was not evaluated.

Scoring and evaluation of results

The EQA results sent by participating laboratories were handled confidentially. Method of scoring is given in [Table 5]. To address the heterogeneity in the specimen during specimen preparation or deterioration during transportation, the assigned value was based on 70% or more consensus agreement among the participating laboratories. If these criteria were not met for a particular analyte, then the analyte was considered as unsuitable for evaluation. The root cause analysis was done to ascertain the reasons attributable to homogeneity or stability or any other cause.
Table 5: Scoring method used

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After the evaluation was complete, each laboratory receives their score with correct answers and suggestions for improvement if applicable. In addition, a summary of evaluation of each test in that particular round was also shared with all participants. If a laboratory scored <80%, they were expected to investigate the root cause analysis followed by corrective and preventive actions which are to be documented.[10] At the end of each 1 year cycle, a scatter diagram was prepared by the centre showing all participating laboratories by their centre code numbers as percentage score.


Selection of serum samples

Serum samples obtained from the clinical samples were allocated for PT for various serological tests and BBV serology as per the scope of EQAS [Table 3]. Pooling of the samples was done in case of limited sample. The samples selected for BBV/serology were also checked by nucleic acid amplification tests (NAT) for HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) by individual donor-NAT Procleix Ultrio Plus Assay (Novartis Diagnostics USA). Preparation and preservation of serum samples using sodium azide were done using a standard methodology.[9]

Minimum amount of 400 μl of serum was allocated for C-reactive protein and ASO and 500 μl for BBV serology and stored at 2°C–8°C till dispatch.

Quality control of the serology specimens

Before aliquoting the sera into the Eppendorf vials, 10 readings of the sera were taken, and subsequently, 20 readings were taken after dispensing the samples for the requisite parameter which should show the expected results. In case of unexpected results, the lot was discarded and the type of failure reviewed and the necessary corrective action taken and the whole procedure was restarted.

Packaging and dispatch

The serum samples were dispatched with preservative so that the samples can be transported at room temperature.[11] Individual specimen was packaged separately in small boxes which were again labelled and further packaged in outer big box. Addresses and labels of the participating laboratories were fixed after verification and the QC packages were finally dispatched by courier (Blue Dart) or Speed Post wherever courier facility was not available. An inventory control of the PT items was maintained.

Judging the judge

The centre is enrolled for external EQAS, Bacteriology and Immunology and Virology with CMC, Vellore, and blood bank external quality assessment scheme at Jaipur.


As an attempt to continually improve the EQAS program, a feedback was obtained from all the participants at the end of the EQAS cycle yearly on adequacy of the scope of EQAS, enrolment procedure, sample quality and packaging, sample transit time, evaluation scheme, timely receipt of assessment report and any other suggestions.

Ethics approval

The EQAS activity was granted exemption from ethical review and clearance by the “Institution Review Board” as per their letter No. EC/05/18/1346 dated 29 May 2018.

Accreditation as proficiency testing provider

Our EQAS centre has received NABL accreditation as PT provider for microbiology and serology in accordance with the standard ISO/IEC/17053:2010 on 16 October 2018.

 ~ Results Top

The program started with the enrolment of 271 centres in the year 2014 and since then the number of participants has grown to 540 in the beginning of the year 2018. The state-wise participation of centres is given in [Table 1]. The number of participants from states varies from 92 (Delhi) to 1 (Meghalaya).

As the EQAS program progressed, there were modifications made in the frequency of rounds and number of PT analytes sent in each cycle [Table 2]. This was done to enhance the quality of EQAS to international level and achieve NABL accreditation.[10]

[Figure 1], [Figure 2], [Figure 3] and [Table 4] illustrate the various PT analytes (QC 1–18) given and their cumulative performance for the years 2014–2018. Participant's answers were scored as per [Table 5]. Partially correct answers are the ones who do not report e.g., presence or absence of pus cells, organism morphology and its approximate numbers with interpretation wherever applicable. Similarly, in culture, it is partially correct if only identification is performed till genus and one or more antimicrobial susceptibility testing (AST) is wrong out of five antibiotics. However, in serology and BBV, there is no category of partially correct. No analytes were rejected for evaluation due to failure to meet the 70% consensus criteria of the participants.
Figure 1: Cumulative performance of the participants for staining

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Figure 2: Cumulative performance of the participants for culture identification

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Figure 3: Cumulative performance of the participants for serology and blood-borne viral

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Until QC 17, we were scoring AST assigning 1 mark for the correct answer and 0 marks for the incorrect answer. From 18th QC package onwards, we started classifying AST [Table 5] and used weighted scoring. The same information was given to all the centres for education and feedback purposes [Table 6].
Table 6: Cumulative antibiotic susceptibility analysis of the participants

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Analysis of the practices of various laboratories for bacterial culture showed that out of 470 responses received in the year 2018, 54% (n = 254) used biochemical methods for identification of bacteria and 46% (n = 216) used some or the other automated system. For AST, the figures were 52.5% and 47.54% for manual and automated methods, respectively. The categorisation of the various automated technologies used by various centres was Vitek-2 (42.3%), Microscan (1.48%), phoenix (1.9%) and DL96 (0.22%).

In the feedback from the centres at the end of the 2017 cycle, almost all the participants classified the EQAS satisfaction level as excellent followed by good. Only few centres received the QC package 1 week late.

The cumulative performance of the participants for serology and BBV is shown in [Figure 3]. An attempt was made to cover different serological analytes as per the scope of our EQAS program [Table 3]. Till 17th QC, only overall cumulative score for serology analytes was analysed. From 18th QC onwards, we also started giving the comparative performance of different methodologies for each analyte for better analysis of the results. The comparative performance of the most commonly used serological techniques used by participants in BBV assays i.e., enzyme-linked immunosorbent assay (ELISA), enzyme-linked fluorescent assay and chemiluminescence-linked immunoassay (Clinical Laboratory Improvement Amendments [CLIA]) is given in [Table 7].
Table 7: Comparative performance serological techniques in blood-borne viral assays

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 ~ Discussion Top

This report is a summary of the EQA performance of clinical microbiology laboratories across the North and Northeast regions of India over a 4½ years period (2014–2018). Although there was a continuous increase in the number of participating laboratories from 320 in 2014 to 540 in 2018 [Figure 1], it was noticeable that the enrolment from the regions of Bihar (7 participant labs), Jharkhand (9 participant labs) and Uttarakhand (6 participant labs) was inadequate considering the size and population of these states [Table 1]. From 2018 onwards, the number of PT analytes for each exercise i.e., smear, culture and serology were increased to 12 so that each participant could get more PT analytes for wider coverage of the scope and have more opportunities for corrective actions where improvements were needed.

Smears staining and reporting: [Figure 1] and [Table 4]

Between January 2014 and October 2018, a total of 22 smears from various clinical specimens were sent for Gram staining. The percentage of participating laboratories giving completely correct results ranged between 29.55% and 79.9% for Gram stain, 94.3–99.2 for Ziehl–Neelsen (ZN) stain, 35.5% for Kinyoun stain and 93.8% for Albert stain [Figure 1]. Urine samples for gram staining, got the minimum correct responses, (29.55%) as Gram-negative bacilli (GNB) causing urinary tract infection. Literature recognises the presence of GNB ≥1 per oil emersion field with pyuria (≥10 pus cells/μl) of uncentrifuged urine correlates with significant bacterial count of 105 cfu/ml on culture.[12] Most of the participants had mentioned the presence of Gram-negative bacilli but had not commented on its correlation with significant colony count.

Similarly, 36.3% completely correct responses were received for the Gram stain of sputum sample from a patient suffering from Haemophilus influenzae pneumonia sent in 2014. A repeat challenge of a BAL specimen with H. influenzae pneumonia was again sent in 2018, wherein 47.4% and 50% participants gave correct and partially correct results. However, most of the participants did remark about the presence of Gram-negative bacilli as the predominant flora but did not interpret on the morphology as Gram-negative coccobacilli, which was suggestive of H. influenzae infection. Such interpretative Grams reports of respiratory specimens can be of immense help to the treating physician.

Nocardia, as a challenge for Gram stain sent in 2014 again, had a poor response with only 47.6% correct results. On repeating the challenge in 2016, 78.32% correct responses were received showing the benefit of EQAS as a learning module leading to overall improvement. Same challenge was again sent in 2018 and responses were evaluated using stricter criteria, wherein 27.5% and 65.44% respondents gave completely correct and partially correct results. Most of the participants had recognised Nocardia spp. on Grams, but the description of branching filamentous bacteria was lacking. Jesudason et al.[13] in the analyses of microbiology EQAS results for Indian laboratories between 1993 and 1998 also reported that only 59.3% participants could report Nocardia correctly in gram stain.

Poor-quality sputum samples were also sent for staining and reporting. Although majority of the participants rightly reported about the cells and bacteria, in many cases, interpretative comments about the quality of the sample were lacking. It needs to be understood that besides reporting correctly on the cells and organisms, it is also necessary for patient care. Mizrachi and Valenstein [14] have shown that clinicians are more likely to persue poor-quality sputum specimens if an interpretive comment was not provided on the report besides looking for the quantitation of cells and bacteria.

More than 90% of participants could report correctly the ZN-stained smear according to the RNTCP guidelines. In a study evaluating the performance of 29 laboratories participating in a Microbiology EQAS in India, Jesudason et al. also reported that the participants performed very well in ZN staining and its reporting.[15] Other workers have also reported good scores in AFB staining and reporting PT programs.[16],[17] The beaded morphology of AFB was recognised by most of the centres (90%). Albert's stain was not performed by 18% of the participants; however, most of the ones performing it correctly reported Corynebacterium diptheriae. It appears that the test for diagnosing C. diptheriae, a life-threatening infection though performed by 90%, but some have abandoned it.

Out of the total respondents performing Kinyoun stain (429), only 4.6% participants could not identify Cryptosporidium. The important differential for this organism are yeasts that are normally seen in stool and pose challenges in recognising Cryptosporidium. The other organisms that can be mistaken for Cryptosporidium could be Isospora and Cyclospora. However, on the basis of size one can easily differentiate Cryptosporidium (4–5 μm) from the rest that are much bigger than it. Acid-fast characters as an identification were missing from 60.14% reports for Cryptosporidium. Many centres may not have a positive control to standardise Kinyoun stains; and the EQA smear could be a source.

It was important to note that a large number of participants gave partially correct results for various staining procedures (19.13%–65.44% for Gram stain, 0.24%–2.65% for ZN stain, 60.14% for Kinyoun stain and 4.35% for Albert stain), whereas only a small number gave totally incorrect responses (0%–15.09% for Gram stain, 0.74%–3.05% for ZN stain, 4.66% for Kinyoun stain and 0.74% for Albert stain). This emphasises the fact that most laboratories are at some level of acceptable reporting for smears, and with a little hand-holding, they could achieve excellence.

Bacterial culture identification and susceptibility testing [Figure 2] and [Table 6]

Of the 22 culture isolates sent for identification and susceptibility testing between 2014 and 2018, commonly encountered bacteria in routine practice including  Escherichia More Details coli, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus faecium were correctly identified to the species level by most of the participants. However, majority of the participants did not identify  Salmonella More Details and Shigella spp. using serotyping. Jesudason et al.[15] also reported that many of the participating laboratories in microbiology EQAS in India missed identifying cultures of Salmonella typhi, Streptococcus pneumoniae and E. coli - S. aureus mixtures. Wonglumsom et al.[18] conducted an assessment of results of an EQAS for isolation and identification of in-house freeze-dried bacteria both in the form of pure cultures and mixed cultures in Thailand over a period of 2 years. They found that while 91% laboratories were able to correctly report commonly encountered bacteria like Streptococcus pyogenes, S. typhi, E. coli, S. aureus, Pseudomonas aeruginosa, and Corynebacterium species, Acinetobacter baumannii, Salmonella Paratyphi A and Listeria monocytogenes were identified by 84%, 79% and 68% of participants, respectively, which is similar to our findings. The authors also found that most of the participants used serological techniques for identifying S. typhi and S. paratyphi A, which is in contrast to our results.

In a WHO-initiated External Quality Assessment Programme to test the proficiency of microbiological testing for epidemic-prone diseases by laboratories in the African region between 2002 and 2009, it was reported that among the bacterial enteric diseases and meningitis components, bacterial identification was acceptable in 65% and 69% of challenges, respectively, but antibiotic susceptibility testing and reporting were frequently unacceptable which is in contrast to our results. Only a minority of laboratories had the capacity to serotype Salmonella and Shigella species which was also seen in our EQAS results. Few laboratories performed minimum inhibitory concentration testing. Tuberculosis microscopy was satisfactorily performed, with 87% of responses receiving acceptable scores.[19]

Many participants were reporting susceptibility to vancomycin for S. aureus and colistin for Klebsiella spp. using disc diffusion though CLSI has withdrawn zone criteria for disc diffusion in both cases, only MIC testing is recommended.[8] This again emphasises the need for microbiologists to continue updating their knowledge. Three centres even reported vancomycin-resistant S. aureus (VRSA) using automated systems. Probably, this could be due to poor QC control testing of the equipment, the organism tested had purity issue or the laboratories were not aware of the significance of the results. VRSA is a rare phenotype with only few reports from India.[20],[21] Similarly, creep in Salmonella to ceftriaxone has been noticed, but resistant isolates from India are rare.[22]

An attempt was made to analyse the susceptibility results of automated versus manual methods in second round of 2018 [Table 6]. Overall automated AST performed marginally better over other manual methods for majority of the antibiotics (92.7%–100% vs. 83%–100%). Very major error (VME) though below 5% was noticed in ciprofloxacin AST for S. typhi. Out of 12 such centres reporting VME, 1 had performed AST using Vitek-2 and the rest 11 had used manual method, needless to emphasise the role of QC in AST. Moreover, Vitek-2 AST has inbuilt software automated expert system which at times overrules the sensitive MIC for resistance. This was seen in the Ampicillin Sensitivity Testing in Salmonella (Vitek card AST-N280), where more resistant isolates were reported by centres using automation for AST than the ones using disc diffusion in Salmonella.

Serology and blood-borne viral [Figure 3] and [Table 7]

All participants have consistently performed with more than 94% reporting correct results throughout the study period similar to the findings reported by Jesudason et al.,[15] except for one challenge of a RPR-positive sample where only half of the participants reported correct results. This was probably due to the low antibody titre (1:4) given as an analyte, which was missed. Most of the participating laboratories in our EQA showed excellent results for BBV serology. Similar findings have been reported in national external quality assessment scheme for transfusion transmissible infections (HIV, HBV, HCV, syphilis and malaria) among Blood Service Facilities in the Philippines in 2015, with 147 participants with over 99% of the participants giving correct results.[23]

In the second PT round of 2018 cycle, it appeared that CLIA had performed suboptimally than the other technologies, probably due to QC issues. It is essential for all participating centres to maintain their QC graphs like Levy Jennings charts for monitoring their results continuously. Bloch et al.[24] in assessment of EQAS results for TTI in 12 African countries found that rapid tests showed significantly lesser sensitivity in comparison with ELISA. However, in our study, no such difference was observed. The United Kingdom National External Quality Assessment Service for Microbiology in a pilot EQAS for HIV point-of-care testing among 20 laboratories in UK also reported overall excellent performance with 97% laboratories reporting correct results.[25]

It was also noticed that the laboratories across the country had very few serology tests in their scope. Only 193 of 498 laboratories participating in serology exercise performed CMV IgG determination, though most of them got the values correct.

As per the CLIA, USA, the participating laboratories should obtain 80% correct score on each testing event to achieve satisfactory performance for each of the microbiology subspecialities (bacteriology, mycobacteriology, mycology, parasitology and virology) and perform satisfactorily on two out of three testing events for successful performance.[26] Of the laboratories who had analysed all the three PT schemes (smear, culture and serology) between 2014 and 2018, 77.3% (884/1143) had scores >80%.

Challenges in external quality assurance program

Preparation of proficiency testing items

In practice, we have realised that it is difficult to achieve all goals together. Preparation of ideal smears and serology PT items is limited due to large amount of sample required for more than 500 participants. An alternate approach could be to provide images of stained smears, but then these may have problems like quality of photomicrographic images, especially for Gram stain, will not assess staining capability and results would be given on only one field rather than examining multiple fields. Another option is preparation of simulated slides that resemble typical clinical specimens appropriate for Gram stain. For these to be realistic, not only bacteria, but also other host materials such as epithelial cells or neutrophils, need to be added, which again need to be standardised.[5] In some cases, bulk volumes of serum may not be available for particular analyte testing (e.g., syphilis serology testing). Transport stability of PT items is also an issue because of heat and humidity in tropical countries like India.

Delivery and communication challenges

India is a large country with quite a few remote areas where last-mile connectivity is an issue. Delivery of PT items, therefore, sometimes may get delayed. Furthermore, frequent change of address by the participants and/or contact person not informed regularly to the PT provider hinders smooth delivery of the PT package as well as the important communication regarding the EQAS.

Future directions

Our EQAS was started by making analytes with simple challenges. As our program progresses and as participating laboratories become increasingly more familiar with the scheme, PT items can be made more complex like of simulated samples for isolation of mixtures of microorganisms, sending rare bacteria, more challenging susceptibility testing results and/or more intricate interpretation of results. The lypholisation of serum samples will also be done once the capacity building of the centre is enhanced.

New Delhi EQAS has gone completely online w.e.f. January 2019, meaning enrolment, questionnaire, result entry, evaluation as well as reporting would be online and all participants would be able to download their own results. This would cut down on the cost as well as increase efficiency and also decrease turnaround time for reporting. The current EQAS needs to move further in the direction of providing molecular EQAS also if the demand is significant. The communication skills also can be further strengthened with electronic interfaces. The number of analytes also could be increased from 3 smears and culture to 5; similarly, serology also from 3 to 5 analytes depending on the resources and infrastructure by way of human resources.

 ~ Conclusion Top

An increasing number of laboratories had participated in the microbiology EQAS for bacteriology and serology over 2014–2018. Majority of laboratories performed well, with >77% of those enrolled for all exercises i.e., smear, culture and serology obtaining more than 80% scores. A large number gave partially correct responses for staining and reporting of smears, thereby implying there is a large potential for improvement towards excellence in our country for an exacting science like clinical microbiology and immunology. The performance in serology was very good with >85% participants reporting correctly. However, majority of the participating laboratories had the limited scope in serology. The study demonstrates that baseline performance of these 500 or so microbiology laboratories in India which was acceptable and participation in EQAS did make a difference to the participating laboratories in further improving the quality and reliability of their results.

Financial support and sponsorship

The study was funded by the Indian Association of Medical Microbiology and Sir Ganga Ram Hospital.

Conflicts of interest

There are no conflicts of interest.

 ~ References Top

Carter JY. External quality assessment in resource-limited countries. Biochem Med (Zagreb) 2017;27:97-109.  Back to cited text no. 1
World Health Organization. Overview of External Quality Assessment (EQA): Module10, Content Sheet 10-1. Geneva, Switzerland. World Health Organization. Available from: [Last accessed on 2018 Jun 03].  Back to cited text no. 2
Mandy F, Bergeron M, Houle G, Bradley J, Fahey J. Impact of the international program for quality assessment and standardization for immunological measures relevant to HIV/AIDS: QASI. Cytometry 2002;50:111-6.  Back to cited text no. 3
Mukadi P, Gillet P, Lukuka A, Atua B, Sheshe N, Kanza A, et al. External quality assessment of giemsa-stained blood film microscopy for the diagnosis of malaria and sleeping sickness in the democratic republic of the Congo. Bull World Health Organ 2013;91:441-8.  Back to cited text no. 4
Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: Current challenges and future directions. Clin Chem 2011;57:1670-80.  Back to cited text no. 5
World Health Organization. Policy and Procedures of the WHO/NICD Microbiology External Quality Assessment Programme in Africa Years 1 to 4, 2002-2006. World Health Organization; 2007.  Back to cited text no. 6
Collee JG, Marr W. Culture of bacteria. In: Collee JG, Fraser AG, Marmion BP, Simmons A, editors. Mackie and McCartney Practical Medical Microbiology. 14th ed. London: Churchill Livingstone; 1996. p. 113-29.  Back to cited text no. 7
Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing. CLSI Document M100-S28. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.  Back to cited text no. 8
World Health Organization. WHO Manual for Organizing a National External Quality Assessment Programme for Health Laboratories and other Testing Sites. World Health Organization; 2016 Available from: [Last accessed on 2019 Jun 15].  Back to cited text no. 9
Stang HL, Anderson NL. Use of proficiency testing as a tool to improve quality in microbiology laboratories. Clin Microbiol Newsl 2013;35:145-52.  Back to cited text no. 10
Guidelines for Organizing National External Quality Assessment schemes for HIV Serological Testing: UNAIDS/96.5;1996. Available at: [Last accessed on 2018 Jun 21].  Back to cited text no. 11
Sobel JD and Kaye D. Urinary Tract Infections. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 7th edition. Philadelphia: Churchill Livingstone Elsevier; 2010. p. 957-85.  Back to cited text no. 12
Jesudason MV, Mukundan U, Ohri VC, Badrinath S, John TJ. External quality assessment scheme in microbiology in India. Ind J Med Microbiol 2001:19:20-5.  Back to cited text no. 13
Mizrachi HH, Valenstein PN. Randomized trial interpreting sputum quality in a clinical laboratory. J Clin Microbiol 1987;25:2327-9.  Back to cited text no. 14
Jesudason MV, Mukundan U, John TJ. External quality assessment scheme in microbiology in India. Ind J Med Microbiol 1995:13:26-9.  Back to cited text no. 15
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  [Figure 1], [Figure 2], [Figure 3]

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]


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2004 - Indian Journal of Medical Microbiology
Published by Wolters Kluwer - Medknow

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