Audit in surgical histopathology at Wadia hospitals - Study of pre-analytical, analytical, and post-analytical phase
How to cite this article: Patwardhan LM, Sharma S. Audit in surgical histopathology at Wadia hospitals - Study of pre-analytical, analytical, and post-analytical phase. Wadia J Women Child Health 2023;2(2):66-9.
This audit of surgical histopathology aims to verify conformance to required processes, assess their implementation, and define the targets of quality control with appropriate changes in the existing system by evaluating pre-analytical, analytical, and post-analytical phases of histopathology.
Material and Methods:
This study was an observational retrospective study done over a year, from March 15, 2022 to February 28, 2023. Small biopsies, large organ resections, and second opinion samples like paraffin blocks or slides received in the surgical histopathology department were categorized as I, II and III respectively. Samples were also segregated as per the department it was received from, namely, gastroenterology, neurology, pulmonology, nephrology, orthopedics, gynepathology, and others. Manual audit was done as a pre-analytical phase including adequacy of clinical information and grossing adequacy, analytical phase to study the turn around time (TAT) and tissue section quality, and the post-analytical phase in the form of report verification, approval and dispatch, and amendment if any, were studied.
During this audit period, 1752 surgical histopathology samples were received of which 80% were small biopsies (category I), 19.6% were large organ resection samples (category II) and 0.4% samples were received for second opinion (category III). General pediatrics (n = 798) and Gynepathology (n = 569) were the main departments from which the samples were received. Incomplete request forms, errors in sample fixation, wrong payment/barcode were some of the pre-analytical errors. Training of staff on one to one basis was done. In the analytical phase errors such as nicks, folds or air bubbles in the mounted sample were seen. Histotechnical staff were retrained to reduce errors. In the post analytical phase, the turnaround time was achieved as per the hospital quality process indicator, feedback from cases on second opinion was received only in 25% of samples.
In this surgical histopathology audit of 1752 samples, quality indicators were achieved as per external quality assurance system (EQAS). Remedial actions were carried out to prevent errors.
Surgical histopathology deals with gross and microscopic analysis of tissues. Integrated quality maintenance is essential at pre-analytical, analytical, and post-analytical steps. Audit compares current practices against standard criteria as laid down by External Quality Assurance Scheme (EQAS) and suggests steps for improvement. Currently the Histopathology services at B.J. Wadia Hospital has been graded very good as per the EQAS.
This study was undertaken to audit the pre-analytical, analytical, and post-analytical phases of surgical histopathology samples received from Bai Jerbai Wadia Hospital for Children (BJWHC) and Nowrosjee Wadia Maternity Hospital (NWMH). This study also aims to find out alignment to EQAS indicators.
MATERIAL AND METHODS
This is a retrospective study of all specimens that were sent to the histopathology laboratory of Bai Jerbai Wadia Hospital for Children (BJWHC) from March 15, 2022 to February 28, 2023. This histopathology laboratory renders services to both the BJWHC and NWMH hospitals of the organization. These specimens were fixed in 10% formalin, processed on an automatic processor, embedded in paraffin, and stained with hematoxylin and eosin. Tissues that required special stains and additional processing were also included in the study.
Tissues were grouped as follows: Category I (small biopsies), Category II (large specimens), and Category III (slides and blocks for second opinion).
Following logs in the histopathology department were studied,
Arrival/accessioning, the nature, and type of tissue
The date of surgical cut up (grossing)
Duration of tissue processing/handling in the laboratory
Duration of handling of the slides by the technologists and the consultant pathologist, histological diagnosis
Duration of typing and verification of results.
Information from these logs were later entered into an excel sheet and analyzed. Simple results were calculated. Major limitations of this study include the lack of IHC which when done may increase the TAT. As our patients come from all over the country, compliance was many times poor and so the survey was not able to elicit an effect of histopathological diagnosis on their management. This audit was approved by the institutional ethics committee and quality committee review board of the hospital.
In this audit of 1752 samples, 1402 ( 80%) samples were small biopsy specimens and 344 (19.6%) samples were big samples [Table 1].
|Category I (small<1 cm)||80% (1402)|
|Category II (big specimens, more than 1 cm)||19.6% (344)|
|Category III (slides/blocks for second opinion)||0.4% (6)|
The various departments from where the samples were received is shown in Table 2.
|Department||Number of cases|
|Gynaecology (Biopsies and specimens)||569|
Each tissue was audited for the following quality indicators.
In this the criteria audited included adequacy of clinical information and grossing adequacy, way of transport to the laboratory and bar code generation.
The various observations found are shown in Table 3.
|Details of request forms (clinical history, lab investigations, referring doctors details)||6.0% (106)|
|Fixation process (adequacy of formalin)||0.3% (7)|
|Transport to the testing laboratory department (large specimen sent in a disproportionately small container)||0.2% (5)|
|Wrong payment or bar code||1.2% (17)|
The areas considered and the errors found are tabulated [Table 3].
Once the specimen arrives in the histopathology section, the specimen is examined at the tissue processing unit and work station for grossing of specimens (ISTOS@) with good monitoring over formalin vapors in the air.
Grossing of various specimens is conducted by strictly adhering to the techniques described in the grossing manual of surgical specimen by Tata Memorial Hospital. A latest copy of the same manual is kept at the grossing station for quick reference.
Following microscopic examination, reports are formulated by adhering to the guidelines in various system-wise datasets and World Health Organization (WHO) manuals.
Various errors found in this analytical phase of the audit are shown in Table 4.
|Fixation quality||0.02% (1)|
|Re-staining (special stains-1151 and routine hematoxylin and eosin staining-3095)||0.06% (1)|
|Section quality-air bubbles, nicks, folds in the sections, etc.||0.9% (12)|
The various factors like turnaround time of report, amendment of reports, feedback received from second opinion reports and others were analyzed.
The errors and inferences are shown in Table 5.
|TAT||On time: 99.7% (1746)||Exceeded the TAT: 0.3% (5)|
|Reports||Collected: 79% (1384)||Not collected: 21% (367)|
|Amendment of reports||0.06% (1)|
|Second opinion obtained from clinicians of our reports||1.9% (33)|
|Feedback given to us of those above mentioned second opinion reports||0.48% (8) Feedback given to us||1.41% (24) No feedback given to us about the second opinion|
|Comparison of the reports, wherein feedback was given||100% concordant to our reports; wherein feedback was given, that is in 7 reports|
Corrective And Preventive Actions (CAPA) taken for various errors and deviations from protocol/process is shown in Table 6.
|Errors||Corrective Action||Preventive action|
|Details of request forms (clinical history, laboratory investigations, and referring doctors’ details) not complete in 6% samples.||Forms were sent back and the
referring resident doctors were
made to enter necessary details.
|Importance of the exact
details in facilitation of the reports were explained.
|Tissue received without fixative in 0.3% samples.||Details of tracking of the sample
from the OT to the laboratory
were obtained and an incident report was made with reason explaining why formalin was not added.
|Purpose of making an incident report was explained to the OT staff and clinicians; as it helps
in documentation and quality improvement.
|Transport to the testing laboratory department
(Large specimen sent in a disproportionately small container) in 0.2% samples.
|Sample was immediately transferred to the larger, appropriate container and adequate (in the ratio of 0:1 proportion) formalin was added for good fixation of specimens.||The concerned OT and ward staff were explained the importance of adequate formalin for fixation and further processing of tissue for examination.|
|Wrong payment or bar code in 1.2% samples.||The request form was sent back to
the cash counter for correction
|Training session was conducted with the cash counter staff and they were explained the importance of correct code for generation of reports.|
|Tissue fixation, processing, and staining errors in 0.35% samples.||Re-embedding, restaining, and remounting were done wherever needed.||Histotechnical staff was
explained the importance and
trained to reduce these errors.
The present audit of surgical histopathology covered 25% of annual workload. Major limitations of this study include the lack of IHC which when done may increase the TAT.
Following inferences are drawn.
7.4% of requisition forms showed the maximum inadequate demographic data and clinical investigations and inadequate clinical history. Possibly in these cases clerical work was delegated to the junior most staff. The clinicians were intimated to write exact details along with the contact details of the referring doctor on the requisition paper.
In our study, it was found that lymph node biopsies were divided into formalin for histopathology examination and saline container for microbiology examination; however, a larger fragment was put in the saline container and a small fragment was put in the formalin container. Clinicians can be counseled to change this proportion and put in the bigger fragment in formalin container
In 0.3% cases, larger specimens were sent in a small container, not allowing enough formalin for fixation. Such specimens were immediately transferred to the bigger containers and kept for fixation after addition of fresh formalin
About 1.2% cases had the wrong barcode selected. Personal “one on one” training was conducted with the clerical staff in this regard.
Errors such as air bubbles, nicks, and fold were observed in few of the sections provided for examination. The histotechnical staff was trained to reduce these errors. However, as there are multiple levels of the section on one slide, no actual corrective action was required.
Most of the samples were reported in the stipulated time, for example,
Small biopsies - 4 days
Large specimens - 6–7 days
Specimens where decalcification is required - 10 days
1.9% of the cases were sent for second opinion to outside sources with our knowledge out of which 25% of the cases, feedback with the report of second opinion was provided to the laboratory which had 100% concurrence.
Clinicians were explained the benefits of the feedback and requested to give us the feedback of the reports of second opinion for knowledge enhancement and betterment of histopathology reporting.
Despite training there are still some errors in filling the histopathology request forms, selection of bar codes, delay in sending samples from OT or wards. This can be avoided by systemic regular induction training for newly joined doctors and frequent refresher training at regular intervals for completeness of information.
Electronic medical records – futuristic dimensions can help avoid these errors in manual information sharing. After communicating with the clinicians about the importance of the feedback (particularly in cases where a second opinion was sought); there is regular feedback from the clinician side.
We acknowledge complete support of the laboratory head Dr. Dhruv Mamtora in this audit.
Declaration of patient consent
Patient’s consent not required as patients identity is not disclosed or compromised.
Conflicts of interest
There are no conflicts of interest.
Financial support and sponsorship
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