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Year : 2021  |  Volume : 64  |  Issue : 1  |  Page : 136-139
Audit in surgical histopathology at a tertiary healthcare center: Study of preanalytical and analytical phase


Department of Pathology, T.N Medical College and B.Y.L Nair Hospital, Mumbai, Maharashtra, India

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Date of Submission31-May-2020
Date of Decision09-Jul-2020
Date of Acceptance08-Sep-2020
Date of Web Publication8-Jan-2021
 

   Abstract 


Context: An audit aims to verify conformance to required processes, assess their implementation, and define the targets of quality control. Aims: To evaluate preanalytic and analytic phases of surgical histopathology in a tertiary healthcare center. Setting and Design: An observational retrospective and prospective study over 3 months each of year 2013 and 2014. Materials and Methods: Biopsy, small resections, large organ resections, bone marrow aspirate/biopsy (BMA/BMB), and frozen section samples received in surgical histopathology were categorized as I to V, respectively. A manual audit was done for preanalytical phase (adequacy of clinical information and grossing adequacy) and analytical phase [turnaround time (TAT) and tissue section quality]. Statistical Analysis: Qualitative data was assessed by Chi-Square test. Quantitative data was assessed using One-Way Analysis of Variance. Results: Among 3179 total cases, category I to V had 1558 (49%), 1099 (34.6%), 342 (10.8%), 124 (3.8%), and 56 (1.8%) cases, respectively. Category I had shortest TAT but maximum number of inadequately sent specimens and recuts. Category III had maximum cases with inadequate clinical history, grossing errors, additional sections, and longest TAT. Category IV had maximum cases with poor quality sections. Category V had maximum cases with inadequate demographic details and clinical investigations. BMB (114, 91.9%) was more useful than BMA for diagnosis. Mean TAT for fixed tissues and frozen tissues was 3.6 ± 1.8 days and 26.6 ± 11.2 min, respectively. Conclusions: Total 25% of annual workload was studied by an observational, manual audit. Quality indicators were achieved as per international norms despite limited resources. Remedial actions were suggested for technicians, clinicians, and pathologists to minimize errors.

Keywords: Audit, bone marrow, frozen section, quality, surgical histopathology, turnaround time

How to cite this article:
Shinde SV, Dhanve MJ. Audit in surgical histopathology at a tertiary healthcare center: Study of preanalytical and analytical phase. Indian J Pathol Microbiol 2021;64:136-9

How to cite this URL:
Shinde SV, Dhanve MJ. Audit in surgical histopathology at a tertiary healthcare center: Study of preanalytical and analytical phase. Indian J Pathol Microbiol [serial online] 2021 [cited 2021 Jan 16];64:136-9. Available from: https://www.ijpmonline.org/text.asp?2021/64/1/136/306529





   Introduction Top


Surgical histopathology deals with gross and microscopic analysis of tissues. Integrated quality maintenance is essential at preanalytical, analytical, and post analytical steps. Audit compares current practices against standard criteria and suggests steps for improvement.[1],[2],[3]


   Aims and Objectives Top


  1. To audit the preanalytical and analytical phases of surgical histopathology laboratory.
  2. To evaluate turnaround time (TAT) for formalin fixed and frozen tissues.
  3. To compare diagnostic utility between bone marrow aspirate (BMA) and biopsy (BMB).



   Materials and Methods Top


The audit of surgical histopathology work was conducted at a tertiary health center over a total of 6 months, namely, June to August 2013 (retrospective) and June to August 2014 (prospective).

Data was collected manually from archival histopathology forms. A daily documentation of section quality, special stains, recuts, and additional sections was maintained in year 2014.

Tissues were grouped as: Category I (biopsies), Category II (small specimens), Category III (organ resections), Category IV (BMA, BMB), and Category V (Frozen section).

Each tissue was audited for following Quality Indicators (QI) as adequate or inadequate.

Preanalytical phase

  1. Patient demographics: name, registration number, age, gender
  2. Clinical history and laboratory investigations
  3. Specimen adequacy: container labelling, formalin volume
  4. Grossing adequacy: description, relevant diagrams, etc.


Analytical phase

  1. Technical performance: quality of sections and slides
  2. TAT (days): calculated from surgery (Ds) to tissue receipt (D0) to final reporting (Df), including delay due to tissue fixation and/or decalcification


  3. In our institution, all cases are screened by surgical histopathology faculty (D1). They sign off some cases (D1/Df), and others by organ-specific specialists (D2/Df). Frozen section TAT was the period (minutes) from D0 till frozen section diagnosis.

  4. Diagnostic utility was compared between BMA and BMB
  5. Concordance between Frozen section (Fz) and paraffin section (PF) report was noted. Any discordance was categorized as minor or major depending on its clinical relevance.[1],[4]


Statistical analysis

All data was compiled in MS Excel sheet and analyzed by PSPP version 0.8.5. Qualitative data was assessed by Chi-Square test, while quantitative data by One-Way Analysis of Variance. A P value of <0.05 was considered significant.

Ethics approval

Ethics committee approval (ECARP/2013/137) was duly obtained.


   Results Top


Total 3179 tissue samples were received in surgical histopathology over the 6-month period. Category I to V had 1558 (49%), 1099 (34.6%), 342 (10.8%), 124 (3.8%), and 56 (1.8%) cases, respectively. Among Category I and II, maximum cases (688, 44.2% and 246, 22.4%, respectively) belonged to gastrointestinal, category III (191, 55.8%) to female genital (FGT), and Category V (12, 21.4%) to central nervous system (CNS) (P = 0.0000013).

Preanalytical phase evaluation at clinician and laboratory level is shown in [Table 1]. Inadequate grossing was evidenced by incomplete description (41), no representative diagram (17), margins not inked (6), specimen size not mentioned (2), and specimen not oriented (1).
Table 1: Evaluation of preanalytical phase of surgical histopathology cases (n=3179)

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Analytical phase evaluation was done for technicians and pathologists [Table 2].
Table 2: Evaluation of analytical phase of surgical histopathology cases (n=3179)

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  1. Technical quality: This data was not documented in year 2013 archives. Among 1596 prospective cases of year 2014, inadequate section quality was due to bad Hematoxylin-Eosin (HE) stain (139), broken paraffin blocks (56), folds on slide (52), missing blocks (13), extraneous floater tissue on slide (13), and mislabeled slide (11)
  2. Total 6210 sections were taken. The maximum sections in category I to V were 11, 17, 21, 3, and 6, respectively
  3. The maximum number of additional sections taken were 7, 6, 13, 0, and 2, respectively, for Category I to V
  4. The reason for recuts was undocumented in all 249 cases of year 2013. Among 215 cases of year 2014, the reasons included bad HE stain (139), folds (52), extraneous floater (13), and mislabeled slide (11)
  5. Special stains were done for only 213 (6.7%) cases. Control slides were provided for 46 (49.7%) of 94 cases in year 2014, whereas no documentation was found for all 119 cases of year 2013 (P value 6.87E-45)
  6. TAT (days) was maximum for endocrine system (5.9 ± 10.4) and breast (4.1 ± 4.6) (P = 2.74E-12). The maximum delay was 9 days for Ds-D0 (P = 3.66E-90), 2 days for fixation/decalcification (P = 0.0001), 2 days for D0-D1/Df (P = 5.6E-20), and 2 days for D1- D2/Df (P = 0.002). Final diagnosis was given by surgical faculty in 1463 (46%) and by organ specialists in 1716 (54%) cases
  7. Category IV (n = 124): In 114 cases (91.9%), BMA was totally diluted with blood, while 10 (8.1%) cases had inadequate BMB sample
  8. Category V (n = 56): M ± SD was 26.6 ± 11.2 min. Maximum cases (19, 34.5%) were reported in 20 min. Maximum Fz cases belonged to CNS (12, 21.4%) and FGT (11, 19.6%). Discordance between diagnosis of Fz and PF was noted in 7 cases (16.1%).



   Discussion Top


The present audit of surgical histopathology covered 25% of annual workload, whereas 1%– 4% is the recommended minimum.[5],[6]

Preanalytical phase

Nwafor and Ekpo noted biopsies and amputations accountable for 62.5% and 20.5%, respectively.[7] Zuk et al. found 55% biopsy, 31.3% resections, and 12.5% frozens.[5] Likewise we found biopsies forming bulk of histopathology workload [Table 3].
Table 3: Quality Indicators in surgical histopathology: Comparison with other studies

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In our study, requisition forms showed the maximum inadequate demographic data and clinical investigations in category V, while inadequate clinical history in category III. Possibly in these cases clerical work was delegated to nonclinical personnel. Priyadharisini et al. found 12.2% requisition forms complete, while information related to unit, symptoms, and investigations was missing in 38.5%, 35.5%, and 30.7%, respectively.[8]

Tissue received without fixative in 10.2%–20%.[5],[8],[9] In our study, predominantly LN biopsies were divided into formalin and saline containers, based on the assumption that pathology would do tissue culture. Clinicians can be counselled to redirect culture samples to microbiology department.

Zuk et al. noted average score of 71% among pathologists for grossing description.[5] At our institute, grossing is done by postgraduate residents following standard textbook guidelines. A standard operating procedure (SOP) manual will further improve grossing techniques.

Analytical phase

Zuk et al. noted poor section quality in 3% cases due to holes, folds, debris, chatter, etc., while Malami and Iliyasu found 18.4%, similar to our study. Bhattacharya et al. noted processing/staining and grossing errors in 0.03% and 0.01% cases.[5],[10],[11]

In our laboratory, the sole embedding station was dysfunctional for a long period. Unavailable Zenker solution led to formalin fixation of BMB with consequent suboptimal sections. Brittle paraffin blocks and inadequate grossing technique led to additional sections, while poor HE stain and folds led to recuts. Administration should purchase better quality equipment, paraffin wax, and Hematoxylin stain. Daily documentation of additional sections/recuts can pinpoint problematic areas and thus initiate remedial actions.

ADASP mandates mentioning results of special stains.[4] In our study, control slides were not provided in 50.3% cases. No controls were provided for Periodic acid Schiff and Gomori methanamine silver since blood vessels act as internal control. For other stains, technicians had to be reminded, leading to waste of reagents and time. Daily documentation of controls and continued education of technicians can provide improvement.

Zuk et al. found TAT of 1.5, 2.1, and 1.3 days, respectively, for biopsy, resection, and frozen section.[5] Nwafor and Ekpo noted mean values of 1.6, 2.3, 5.1, and 2.9 days, respectively, for grossing, processing, reporting, and typing reports.[7] ADASP recommends 3 days TAT for biopsies and resections with an additional day for fixation, decalcification, recuts, more sections, and intradepartmental consultation,[4] which is compatible with our study.

We found highest TAT in endocrine and breast specimens. The endocrine pathologist insisted upon detailed radio imaging and hormonal details before signing off reports. Breast specimens needed additional sections for axillary tail dissection.

Supervised grossing of specimens and provision of multiheaded teaching microscopes to residents can further improve TAT.

Bone marrow

BMA and BMB were inadequate in 21% and 11.8%, respectively.[12],[13] We found alarming numbers of inadequate BMAs. Hematologists need to upgrade technique as BMA provide quickest BM information.

Frozen section

Khoo found 97.6% concordance between Fz and PF while mean TAT was 20 min, comparable to our study.[14] We found diagnosis delayed 35–45 min in 11 cases (18.9%). This was attributed to inadequate clinical details which necessitated repeated telephonic calls. Ahmed et al. noted delayed TAT due to single cryostat, paucity of trained technicians, and multiple frozen tissues.[15]


   Conclusions Top


The present audit was wholly manually conducted. It covered 25% of annual surgical histopathology workload. Our team achieved globally required standards in most QI, despite lack of automated staining, shortage of personnel, absence of multiheaded microscopes, and substandard reagents/equipment.

Administration should strive to provide computerized data management and excellent quality reagents/equipment. Technicians should be encouraged to update knowledge via conferences. Faculty should provide feedback by daily documentation of special stains and section quality. Residents should be provided with detailed SOPs and guided supervision at grossing. Continued dialogue with physicians for clinical details, adequate tissue fixation, and appropriate BMAs will further improve quality.

Our study did not cover postanalytical phase. Future audits can focus on pathologists' peer review for SNOMED terminology, diagnostic accuracy, and contribution of immunohistochemistry.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Karki S. Errors: Detection and minimization in histopathology laboratories. J Pathol Nepal 2015;5:859-64.  Back to cited text no. 1
    
2.
Omorodion NT, Achukwu PU, Ebo N. Review on laboratory auditing in histopathology laboratory. Sokoto J Med Lab Sci 2017;2:124-8.  Back to cited text no. 2
    
3.
Iyengar JN. Quality control in the histopathology laboratory: An overview with stress on the need for a structured national external quality assessment scheme. Indian J Pathol Microbiol 2009;52:1-5.  Back to cited text no. 3
[PUBMED]  [Full text]  
4.
Nakhleh R, Coffin C, Cooper K; Association of Directors of Anatomic and Surgical Pathology. Recommendations for quality assurance and improvement in surgical and autopsy pathology. Am J Surg Pathol 2006;126:334-7.  Back to cited text no. 4
    
5.
Zuk JA, Kenyon WE, Myskow MW. Audit in histopathology- Description of internal quality assessment scheme with analysis of results. J Clin Pathol 1991;44:10-6.  Back to cited text no. 5
    
6.
Qureshi A, Loya A, Azam M, Hussain M, Mushtaq S, Mahmood T. Study of parameters to ensure quality control in histopathology reporting: A meta-analysis at a tertiary care center. Indian J Pathol Microbiol 2012;55:180-2.  Back to cited text no. 6
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7.
Nwafor CC, Ekpo MD. Timeliness of surgical pathology results: A departmental audit of histopathological services. Sub-Saharan Afr J Med 2019;6:96-100.  Back to cited text no. 7
    
8.
Priyadharisini, Porko S, Barman PP. Audit of histopathology request forms submitted in laboratory of a tertiary care hospital. J Med Sci Clin Res 2019;7:1085-9.  Back to cited text no. 8
    
9.
Akinfenwa TA, Raphael S. Role of surgeons in determining outcome of histopathology specimens. Niger J Surg 2013;19:68-72.  Back to cited text no. 9
    
10.
Malami SA, Iliyasu Y. Local audit of diagnostic surgical pathology as a tool for quality assurance. Niger J Med 2008;17:186-90.  Back to cited text no. 10
    
11.
Bhattacharya AB, Bohara S, Das R, Sharma P, Vidyadhar S. An audit of diagnostic surgical pathology: A tool for quality assurance. Original study in a rural teaching hospital in Eastern Uttar Pradesh, India. J Dent Med Sci 2015;14:32-3.  Back to cited text no. 11
    
12.
Zanna JV, Soilleux EJ. Audit of the value of bone marrow aspirates when a bone marrow trephine is used for lymphoma staging. J Hematopathol 2011;4:113-6.  Back to cited text no. 12
    
13.
Sah SP, Matutes E, Wotherspoon AC, Morilla R, Catovsky D. A comparison of flow cytometry, bone marrow biopsy, and bone marrow aspirates in the detection of lymphoid infiltration in B cell disorders. J Clin Pathol 2003;56:129-32.  Back to cited text no. 13
    
14.
Khoo JJ. An audit of intraoperative frozen section in Johor. Med J Malaysia 2004;59:50-5.  Back to cited text no. 14
    
15.
Ahmed Z, Barakzai MA, Idrees R, Bhurgri Y. Correlation of intraoperative frozen section with final diagnosis at referral centre in Karachi. Indian J Pathol Microbiol 2008;51:469-73.  Back to cited text no. 15
    

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Correspondence Address:
Sweety V Shinde
Department of Pathology, B.Y. L Nair Hospital, Mumbai - 400 008, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/IJPM.IJPM_640_20

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