| Abstract|| |
Background: The few studies on repeat aspiration focussed on accuracy of diagnosis following repeat. Numbers and documented reasons for repeat remain unaddressed.
Aim: To study factors associated with requests for repeat fine needle aspiration cytology (FNAC).
Settings and Design: Metropolitan hospital, clinical audit.
Materials and Methods: Audit of 5104 FNAC in 10 months.
Statistical Analysis Used: Univariate, and multivariate binary logistic regression.
Results: Seven hundred and six patients (13.8%) were advised repeat aspirates. Three hundred and twelve of these were actually repeated (44.1%). Carryover of actually repeated aspirates to subsequent months averaged 10.8 (34.2%). Maximum numbers of repeat requests were from thyroid 76/415 (18.3%), followed by lymph node 310/1856 (16.7%), and from breast 86/716 (12.0%). Outcome of actually repeated aspirates were: Diagnostic 181/312 (58.0%), and non-diagnostic 131/312 (41.9%). Reasons for repeat were inadequate aspirates 370/706 (52.4%), non-diagnostic descriptive reports 309/706 (43.7%); in 27/706 (3.8%), no reason was mentioned.
Conclusions: Inadequate aspirates, non-diagnostic descriptive reports, and FNAC/FNAB from thyroid, lymph nodes, and breast contribute to repeats. We suggest steps to reduce the number of repeat aspirates to eliminate extra work.
Keywords: Clinical audit; cytopathology; fine needle aspiration cytology
|How to cite this article:|
Goyal R, Garg PK, Bhatia A, Arora VK, Singh N. Clinical audit of repeat fine needle aspiration in a general cytopathology service. J Cytol 2014;31:1-6
|How to cite this URL:|
Goyal R, Garg PK, Bhatia A, Arora VK, Singh N. Clinical audit of repeat fine needle aspiration in a general cytopathology service. J Cytol [serial online] 2014 [cited 2020 Aug 14];31:1-6. Available from: http://www.jcytol.org/text.asp?2014/31/1/1/130612
| Introduction|| |
Clinical audit is "a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria, and the implementation of change."  Audit is a cyclical process that includes a selection of topic, setting standards, data collection, and analysis of results, and re-audit.  The aim of audit is to improve the quality of care. 
Pathology audits focus on uses, cost-effectiveness, adequacy, and quality improvement of laboratory procedures. Fine needle aspiration cytology (FNAC) audits have focused mainly on diagnostic efficacy of the procedure in different organs such as breast,  thyroid,  lymph nodes,  and salivary glands.  The issue of repeat aspiration in FNAC is largely unaddressed. Repeat diagnostic procedures may be distressful to the patient, and the aspirator, and impose unnecessary workload on the laboratory; therefore, this study was planned to determine factors associated with repeat aspiration.
| Materials and Methods|| |
This study was conducted in a tertiary care, teaching hospital in a metropolitan city. All the FNAC for 1 year were included. This was a retrospective, analytical, clinical audit of laboratory services. Clearance from the Ethical Committee of the institution was obtained and patient anonymity was maintained by coding the data. Data for the audit was collected from the cytology records. The following information was documented for this audit: Age and sex, site of FNAC, documented reasons for repeat and patient accession numbers. The data was classified by organ system, by months, by week of the month. We noted the documented reasons for repeats and the duration between the repeats. Carryover of requests for repeats to subsequent months was determined as follows: Those cases in the early phase of the audit which were repeats requisitioned in previous months were excluded. Data pertaining to repeat aspirations was collected for two additional months to determine repeat aspirates requisitioned in the last phase of the audit.
Ours is a general cytopathology service in a teaching hospital, where patients are referred from all the hospital departments to a clinic located in the out-patients department. During the period of the audit the cytopathology team would have typically comprised of a consultant, one of ten on a monthly rotation, and 5-6 residents with varying experience. Among the residents at least two could be senior residents on a 3 year rotation through the various sections of the department, the remaining - junior residents in the 1 st -3 rd year of the MD course. Trainees learn the skills of FNAC on the job, on real patients. Proportions of repeat aspirates and documented reasons for repeats (non-diagnostic descriptive reports, inadequate aspirates, and pathologist's recommendation) were taken as outcome measures. Data was entered in an Excel spreadsheet and analyzed statistically by univariate, followed by multivariate binary logistic regression analysis.
| Results|| |
During the 10 months period of audit 5104 patients were subjected to FNAC. Reporting practices varied. The report may have been unambiguous and explicit, e.g., "Inadequate aspirate, please repeat;" or what we have termed a "descriptive non-diagnostic" report with a clearly stated request for repeat, e.g., "The aspirate is poorly cellular with a few epithelial cells in a proteinaceous background. Please repeat." A third type of report, a descriptive, non-diagnostic report without a clearly stated request for repeat was also seen, e.g., "fine needle aspiration shows blood only." A fourth type clearly stated the need to repeat the aspirate, but did not divulge the reasons, e.g., "Please repeat."
Seven hundred and six (13.8%) patients were advised repeat aspirates. Three hundred and twelve of these (44.1%) were actually repeated. In addition, repeat aspirates were done in 63 patients at the initiative of the clinician; these patients had not been advised repeat aspiration by the pathologist. Thus, a total of 375 repeat aspirates were done. The results by month, carryover of repeat requests, repeats according to organ system, diagnostic non-diagnostic reports and outcome of repeats are depicted in [Table 1],[Table 2],[Table 3],[Table 4] and [Table 5].
|Table 1: Month-wise requests for repeat and aspirates actually repeated in 10 months (n = 706)|
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|Table 2: Carryover of requests for repeats to subsequent months in 10 months|
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|Table 5: Outcome of non-diagnostic reports with and without repeat requests in 10 months|
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Reasons for repeats were inadequate aspirates −370 (52.4%), non-diagnostic descriptive reports −309 (43.7%). No reason was mentioned in 27 (3.8%). Data for a week-wise break up of requests (data not shown) did not show any noticeable weekly trend for increased or reduced requisitions for repeat aspirates.
The outcomes were evaluated up to two repeat aspirates; however, during the study four cases were diagnosed after multiple repeats. Some remained undiagnosed. Case 1 underwent 4 non-diagnostic aspirations over a period of 3 months. The diagnosis was made by ultrasound guided aspiration in the fifth attempt. Case 2 underwent 4 non-diagnostic aspirates over a period of 1 month and remained non-diagnostic after the fifth aspirate which was ultrasound guided. Cases 3 and 4 had 3 non-diagnostic or inadequate aspirates over a period of 1 month, then diagnosed on the fourth aspirate.
Using univariate analysis, (i) month of aspirate (ii) organ specificity, and (iii) age of the patient were found to be independent variables associated with the possibility of repeat FNAC. Multivariate binary logistic regression analysis was carried out using these variables to determine their ability to predict repeat FNAC request. Month 6 had statistically significant low repeat FNAC requests compared with other months. Keeping month 1 as constant, the consultant pathologist in month 6 was 0.63 times less likely to request for repeat FNAC (odds ratio [OR] 0.63 95% confidence interval [CI] 0.43-0.92). There was no statistically significant difference among the other months. There was no statistically significant difference in the repeat FNAC requests for organ 1 (breast) and organ 2 (lymph nodes); however FNAC of organ 3 (thyroid) and organ 4 (miscellaneous) was more likely to result in repeat FNAC request when compared to organ 1. Repeat FNAC was likely to be asked 1.72 times (95% CI 1.43-2.08) for organ 3 and 1.73 (95% CI 1.30-2.31) for organ 4 as compared to organ 1. For every 1 year increase in the age of the patient, the risk of repeat FNAC increased by 1.008 times (OR 1.008 95% CI 1.003-1.012).
| Discussion|| |
A 10 month period was chosen for the audit to reflect reporting practices across the spectrum of consultants in the sign-out roster. It was thought reasonable to assume that the consultant who signs all reports, is in agreement with the contents as she alone authorizes the reports. The consultant on sign-out is also responsible for supervising the work of the residents comprising the team for the month.
Repeat aspirates may be necessary because inadequate material for microscopy is obtained after the first, or subsequent attempts. Other investigators have found that experience of aspirators is important for adequacy of material.  Inexperience of the aspirator may result in inappropriate patient selection, or choice of lesion for the procedure. Often, however, the most experienced aspirator may be unable to obtain diagnostic material from an aspirate.
Other investigators have found that training of new personnel is important to decrease the inadequacy rate.  Inadequate aspirates, and the need to repeat the procedure are integral to our system because ours is a teaching institution; however, a balance needs to be achieved to protect the needs of the patient and the imperatives of training future cytopathologists.
Using several search strategies we were unable to find a similar study in the literature relating to a general cytopathology service. The western literature does describe inadequacy rates in specialized settings, such as in breast aspirates,  or related to the thyroid gland;  however, we wished to get an over-all view of the situation in our laboratory. In the absence of such literature, it is difficult to comment on the magnitude of repeats, or even how many are acceptable, or to compare with the situation in other institutions. We hope this study will serve as a database for future comparisons.
On average little more than 500 aspirates were done every month. The 706 repeat requests amount to almost a month and a half of duplicated work. Implications on patient harm due to anxiety and delay in diagnosis; on human resources and their workload in the laboratory;  on expenditure of glassware, reagents, and equipment; on the time expended in dealing with the phenomenon, are far-reaching. Only 44% of requests for repeat aspirates actually resulted in repeats [Table 1]. We do not know the outcome of the 56% that were not repeated. We could speculate that some of these were lost to follow-up, others might have recovered from their illness, while the rest might have undergone other diagnostic procedures, such as biopsy, hematological testing, or radiological, and biochemical investigations. Future audits could focus on these aspects. Sixty three repeat aspirations were requested by the physician even though they had not been recommended by the cytopathologist. Periodic meetings between physicians and cytopathologists should be advocated to address this.
There was a monthly variation in the numbers of requests for repeat aspiration [Table 1]. Possibly the change in postings of residents was responsible for much of this variation. If a careful mix of experienced residents and rank new comers could be maintained, perhaps the variation might be reduced.
The personality of the consultant on sign-out could contribute to repeat requests. This has been described to occur in thyroid cytopathology.  Possibly some consultants may be more inclined than others to persist in the effort to establish a cytological diagnosis, while others would more often prefer to proceed to other diagnostic tests such as biopsy. It is unlikely, however, that this could account for the majority of repeat requests.
We considered the possibility that the consultant on sign-out may wish to wind-up work in the last week of the month. Leaving too many repeat aspirates for the next month may not be thought desirable, while conceivably, the reverse may be true. To study this we audited the weekly break-up of requests (data not shown) for a repeat in each month. Reassuringly, there was no noticeable trend for increased or reduced incidence of repeat requests in any week of any month. We view this positively and contend that our consultants are objective, and consistent in their reporting practices.
When aspirates are repeated in subsequent months the patients become the responsibility of the consultant on sign-out for that month; this may result in conflict arising from individual variations in reporting practices [Table 2]. While one person may favor a repeat, the next may favor an alternate approach to diagnosis such as biopsy. Occasionally, repeat aspiration may be requested even when the first is cellular; with the possibility that the second consultant might be willing to offer a diagnosis where the first favored repeating the procedure in the hope of obtaining more material for further diagnostic work-up such as immunocytochemistry. Although numerically small, these may be situations with potential for conflict between reporting consultants. The numbers of aspirates actually repeated in subsequent months are small, but may vary substantially (4-17 in this series) [Table 2]. While most repeats are carried out within the week, some patients may report after several weeks, even months after a first aspirate. One resolution would be for the original consultant to retain charge until satisfactory conclusion of all sequence of repeats. We suggest that the interest of the patient should be paramount; a single dedicated professional should be responsible for her care.
Repeat requests were audited by organ system [Table 3]. The largest proportions of repeats were requested for thyroid aspirates. Other investigators have also found that the most important cause of inadequate material in thyroid aspirates is inadequate sampling.  This may be due to inexperience of the aspirator, cystic or hemorrhagic lesions, number of punctures, and technique of preparing the smears.  Aspiration of thyroid lesions is often regarded as difficult. The thyroid, being vascular, must be approached differently from other organs.  Investigators who have tried the non-aspiration technique found that it yielded more diagnostic material with less blood and more cells.  Proper positioning of patient, adequate fixing of lesion and single pass is ideal for vascular organs like thyroid. Fewer patients require thyroid aspirates (n = 415). While each resident may perform many aspirates from other organs in a given day, the opportunity for a thyroid aspiration probably occurs no more than once or twice a week. A possible remedy might be to designate separate days dedicated to thyroid aspiration, so that the trainees can get a greater exposure to the procedure. A thyroid clinic dedicated to triple diagnosis with a physician, a radiologist to assist with ultrasound guided aspirates, and a cytopathologist would indeed be welcome. , Organ-specific cytopathologists may also be less likely to ask for repeat aspirates.
To find out if there was any difference in the repeat FNAC requisitions for different organs, and to determine the odds of repeat FNAC requisitions for a particular organ, we needed to have one organ for comparison. Therefore, we calculated the odds of repeat FNAC requisitions keeping breast as constant. This does not reflect the absolute number of FNAC/repeat FNAC requests.
The largest number of aspirations performed in the FNAC clinic is from lymph nodes. Surprisingly, repeat aspirations from lymph nodes are almost as frequent as the thyroid (n = 1856) [Table 3]. Other investigators have found that in patients with suspected lymph node tuberculosis and non-diagnostic FNAC, repeat aspiration after 2-3 weeks helps in improving diagnostic accuracy.  In one study lymph nodes smaller than 1 cm had higher false negative rates. Too often cytopathology residents have too little clinical experience, and clinical residents have no cytopathology experience, to judge the appropriateness of patient selection for FNAC. An audit to address the appropriateness of selection of patients and lesion holds promise.
Aspiration of breast lumps is next in the list of requests for repeat. Other investigators have found that inadequate material in breast aspirates is also due to inappropriate patient selection and inexperience of aspirator. , Ill-defined, clinically benign lumps, usually yield acellular aspirates and are not suitable for FNAC. Sampling error is usually encountered with small deep seated lesions, or encysted carcinoma. Sometimes heavily blood stained smears, smears with drying and smearing artefacts resulting in cell disruption are difficult to interpret.  Many investigators have proposed triple diagnosis in specialized breast clinics. , We support the view that, like the thyroid, this is also a specialized field, ideally requiring a separate day or clinic dedicated to a triple diagnostic effort.
Repeat aspiration did result in diagnostic reports in more than half of the patients [Table 4]. For this reason alone it is well worth the effort. When carried out within a week, as indeed it was for most patients in this audit, it is probably an acceptable price to pay for avoiding the surgical procedure biopsy entails. For the 42% patients in whom the repeat aspiration was also non-diagnostic a quick decision to consider other modes of diagnosis should probably have been made. Unfortunately, lack of efficient patient tracking systems do not always permit identifying patients who have had a previous aspiration. We support the recommendation of other workers that an appropriate electronic patient record keeping system should be instituted to address this problem.  Computerized systems help to reduce workload, and prevent diversion of trained staff from essential work.
Inadequate aspiration was the most common documented reason for repeat; however, in a small proportion (3.8%) no reason was mentioned. We support the argument that a cytopathology report that does not assign a reason for a repeat request is erroneous,  or incomplete, and reflects indecision. On the other hand, insistence on documenting a reason for every repeat requested may restrict the cytopathologists' options, and freedom of expression. 
This audit also identified a subset of reports which only offer a description of the findings on the smear [Table 5]. They neither include interpretation of findings, nor recommendations for further action, such as a request for repeat aspiration, or biopsy. This transfers the onus of interpretation of cytological findings and decision on a future course of action to the referring clinician. These reports are clearly in error. It is the responsibility of the cytopathologist to interpret her findings because she is best equipped by training to do so.  The confusion caused by such reports is reflected in the audit where only 2-6 (3.5-11.3%) of these patients had repeat aspiration compared to 8-24 (38.1-75%) when the cytopathologist had requested the repeat. It would appear that our referring physicians take the cytopathologists' written advice seriously; and when no advice is offered, it is taken, without question, to mean that no action is to be taken. A repeat, or sometimes multiple aspirations did not necessarily establish a diagnosis. Although few patients are affected, it may be in the patients' interest to opt for other, perhaps more invasive diagnostic procedures.
There are limitations to this study. Consultants on the roster may take help from their colleagues to fill-in for them for short periods when they are on leave. This may have affected our audit because the pattern of reporting of the two consultants may have been different. Ours is a teaching hospital so there is a changing roster, and residents and consultants both cycle through it. It is possible that the variations in repeat aspirates are attributable to changing rosters. Finally, this is a partial audit. It covers codes 1, 2 and 3 of the Oxford classification.  A re-audit, following implementation of recommendations, will be required to determine the effects of changes in reporting practices.
| Conclusion|| |
We concluded that multiple factors contribute to repeat aspirates. In order of frequency these are: Inadequate aspirates, non-diagnostic descriptive reports and aspiration from organs like thyroid, lymph nodes and breast. We suggest appropriate steps to reduce the number of repeat aspirates, to reduce extra work.
| Recommendations|| |
Every cytology laboratory should evolve a policy to avoid large numbers of repeat aspirations: On-site evaluation of aspirates for assessing cellularity permits re-aspiration at a single setting. If the first re-aspiration is non-diagnostic, alternative diagnostic modalities of ultrasound guided aspiration or biopsy should be resorted to.
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Department of Pathology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi - 110 095
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]