Implications of Corona Virus Disease-19 pandemic on cytopathology laboratory-Challenges and solutions in resource-limited settings.

Background: Corona Virus Disease-19 (COVID-19) disease which is still showing peaks and plateau with emerging new mutational viral variants has led to the modification of working of hospitals and medical institutes. Cytopathology laboratories geared up with the changing situation to cope up with not only the COVID-19 patients but also patients of other diseases, particularly oncology patients. It was also important to adopt changes in the cytopathology residency program so as to cope up with the changing scenario. Aim: The present study was conducted to study the various measures adopted and the changes made in the cytopathology laboratory during COVID-19 infection in a resource-limited setting while catering to a large population of COVID-19-positive patients in the north Himalayan region of India. It was also intended to study the methods adopted for effective cytopathology residency training during corona times. Setting and Design: The study was conducted from March 2020 to December 2021 in the cytopathology lab, and all the samples were analyzed and compared with the samples received in pre-corona times from March 2018 to December 2019. The different methods adopted during corona times for effective cytopathology residency training were also analyzed. Results: The total number of samples received in the cytopathology laboratory in pre-corona times from March 2018 to December 2019 were 6822, and samples received from March 2020 to December 2021 were 6567 with decrease of 1.9% of cases. There was increase in 17.4% for the samples of the respiratory tract received in the lab with an increase in cases of infections including aspergillosis, mucormycosis, and tuberculosis. There was 10.3% increase in cytological diagnosis of malignant cases during corona times. Use of 90% alcohol for fixation rather than air drying of smears, avoiding of pneumatic tubes, judicious use of personal protective equipment (PPE) kits along with access to the digital cytology slide database were included in the changes made in the lab. Conclusions: There was a marginal decrease in cytopathological diagnosis during COVID-19 with substantial increase in the malignancy rate of 10.3% in cytological diagnosis of different organs. Diagnosis of mucormycosis, aspergillosis, and tuberculosis infections of respiratory tract cytology increased during this period. Judicious use of limited available resources led not only to smooth functioning of the cytopathology lab but also prevented any infection in the working health personals. Newer online resources were explored and modified for continuous training of the cytopathology residents. Emotional support with effective communication was the key to alleviate any psychological stress among all health professionals in the cytopathology laboratory.

Extended blood group phenotyping of donors from the lower and middle Himalayan region of Uttarakhand India: A pilot study.

BACKGROUND: The state of Uttarakhand, bordering countries such as Tibet and Nepal, is a multi-ethnic region. Further, erythrocyte alloimmunization may arise from the incompatibility of major and/or minor blood groups between ethnically diverse donors and recipients. We aimed to screen Uttarakhand blood donors (UBDs) for extended phenotyping of their erythrocytes serologically. METHODS: This prospective cross-sectional analysis involved all UBD samples collected at the blood centre of our tertiary-care hospital. Samples were obtained over 9 months (Mar'22 to Nov'22). Donors who were O-typed, DAT-negative and non-reactive for TTI markers were processed further for serological testing using the column agglutination technique utilizing 21 different monoclonal antisera (Ortho diagnostics Pvt ltd, Mumbai India). The research was financially aided by UCOST, Uttarakhand, Government of India. RESULTS: Of the 5,407 blood samples collected, the total number of O-typed samples collected was 1622. Of these 1622, 329 (20.2 %) O-typed samples were selected based on our inclusion criteria and hence further phenotyped. Amongst these 329 UBDs, the average age was 32.7 ± 9.32 (18-52) years and the male-to-female ratio was (M: F = 12:1). The prevalence of high- and low-frequency blood antigens in our study was Rh (D 96.6 %, C 84.8 %, c 63.5 %, E 27.9 % and e 92 %), Lewis (Lea 6.3 %, Leb 31.9 %), Kidd (Jka 87.8 %, Jkb 63.2 %), Kell (K 1.8 %, k 96.3 %) and Duffy (Fya 63.5 %, Fyb 10.6 %). And in the MNS system we received 21.2 % as M, 10.9 % N, 37 % S and 51.3 % as s respectively. We also identified some very rare minor antigens such as Dia 1.8 %, Ina 1.8 %, Cw 0.6 % and, 1.2 % Mur positive donors, which are not common in our population, as per the published literature. Moreover, we also identified one Bombay blood phenotype (Oh) in one of our UBD recruits. CONCLUSION: To sum up, practically with the outcome of this research, we were also able to identify rare phenotypes among the local people and a rare blood donor registry was created. This repository shall also come in use for our multi-transfused patients having different oncological and haematological ailments.

Significance of mandating a dedicated hemovigilance nurse and objectification of 'imputability' levels. Experience from a hospital-based blood centre in India.

BACKGROUND: National Hemovigilance Programme aims at improving patient and donor outcomes by monitoring adverse reactions. This requires an additional effort by existing manpower that is already a handful and may offer a leeway if not mandated and designated to a hemovigilance nurse. AIMS AND OBJECTIVES: To analyse the reported adverse transfusion reactions (ATR) and their subsequent uplink/upload into the Hemovigilance program of India (HvPI) and to observe subjective discrepancy in the diagnosis of ATR and their imputability to transfusion. MATERIAL AND METHODS: ATR were analysed from May 2016 to October 2021 in a hospital-based blood centre in India. Two groups were formed, Group I constituted ATR that were reported and uplinked to HvPI, and Group II constituted all reported ATR irrespective of the uplink/upload. All ATR were reanalysed for a subjective discrepancy in diagnosis and imputability levels. Results were analysed online statistical software MedCalc using the "Exact Poissons Method" and the Chi-square test with a significant p-value of <0.05. RESULTS: In total 169 ATR were reported in 166 patients and 89 (52.6%) were uplinked, with an incident rate of 1 in 1412 and 1 in 743 in Group I and Group II respectively. The difference was statistically significant (p < 0.0001). Allergic reactions were the most common type in both groups followed by FNHTR with PRBC as the most implicated blood product. A discrepancy of around 4.3% and 17.9% in diagnosis and imputability level respectively was observed. CONCLUSIONS: The difference in incidence rates in the two groups indicates a mandate for dedicated hemovigilance nurses in every centre to aid in accurate data sharing with the National hemovigilance systems. Discrepancies in diagnosis can be mitigated by identification and understanding of ATR through case-based objective approach. Discrepancy in assigning imputability levels to adverse reactions can be minimised by objectifying the scales followed by spreading awareness though campaigns. These initiatives can effectively be aided by the hemovigilance nurse.

Analytical and Post Analytical Phase of an ISO 15189:2012 Certified Cytopathology Laboratory-A Five Year Institutional Experience.

Objective: Analytical and post analytical phase are integral part of total quality management system and include steps from submission of slides till reports are dispatched. The present study was conducted to analyze the analytical and post analytical phase of the ISO15189:2012 certified cytopathology laboratory. It was also intended to study the various errors which were encountered and steps taken to reduce these discrepancies. Methods: The study included all documents of quality program from 1 November 2014 till 31 Oct 2019 in medical institute situated in north Himalayan region of India. All the data was recorded and analyzed for analytical and post analytical phase. Results: The number of samples received in cytopathology lab was 21,566 with total quality errors of 5.19%. Out of these pre-analytical errors were 55%, analytical 10.5% and post analytical errors constituted 34.4%. The maximum errors detected were due to typographical errors followed by delayed turnaround time. Cyto-histopathological discordance was 10.5% in non-gynecological cases and 2.2% in gynecological cases. Conclusion: Analytical and post analytical phase analysis is essential to minimize the errors and improve the quality of cytopathology lab. Cyto-histopathological correlation is valuable for continuous data tracking in the cytopathology with analytical errors analysis. Maintenance of external, internal quality program, turnaround time with documentation, continuous training and communication with clinician is fundamental for quality improvement in any cytopathology lab. Acknowledgement of nonconformance with root cause analysis and sincere efforts to minimize them is the basic key for successful quality management.

A Cross-Sectional Comparative Characterization of Hematological Changes in Patients with COVID-19 Infection, Non-COVID Influenza-like Illnesses and Healthy Controls.

INTRODUCTION: Studies have documented the role of the "neutrophil-to-lymphocyte ratio" (NLR) in influenza virus infection. In addition, morphometric parameters derived from automated analyzers on the volume, scatter and conductivity of monocytes, neutrophils and lymphocytes in many viral etiologies have helped with their early differentiation. With this background, we aimed to characterize the hematological changes of coronavirus-positive cases and also compare them with the healthy controls and patients affected by non-COVID Influenza-like illnesses so that early isolation could be considered. MATERIAL AND METHODS: This was a cross-sectional analytical study carried out in the years 2020-2022. All cases with COVID-19 and non-COVID-19 Influenza-like illnesses and healthy controls above 18 years were included. Cases were diagnosed according to the WHO guidelines. All samples were processed on a Unicel DxH 800 (Beckman Coulter, California, USA) automated hematology analyzer. The demographic, clinical and regular hematological parameters along with additional parameters such as volume, conductivity and scatter (VCS) of the three groups were compared. RESULTS: The 169 COVID-19 cases were in the moderate to severe category. Compared with 140 healthy controls, the majority of the routine hematological values including the NLR (neutrophil-to-lymphocyte ratio) and PLR (platelet-to-lymphocyte ratio) showed statistically significant differences. A cutoff of an absolute neutrophil count of 4350 cell/cumm was found to have a sensitivity of 76% and specificity of 70% in differentiating moderate and severe COVID-19 cases from healthy controls. COVID-19 and the non-COVID-19 Influenza-like illnesses were similar statistically in all parameters except the PLR, mean neutrophilic and monocytic volume, scatter parameters in neutrophils, axial light loss in monocytes and NLR. Interestingly, there was a trend of higher mean volumes and scatter in neutrophils and monocytes in COVID-19 cases as compared to non-COVID-19 Influenza-like illnesses. CONCLUSION: We demonstrated morphological changes in neutrophils, monocytes and lymphocytes in COVID-19 infection and also non-COVID-19 Influenza-like illnesses with the help of VCS parameters. A cutoff for the absolute neutrophils count was able to differentiate COVID-19 infection requiring hospitalization from healthy controls and eosinopenia was a characteristic finding in cases with COVID-19 infection.

Reviewing the Ethical Concerns of the Convalescent Plasma Therapy in COVID-19.

The understanding of coronavirus disease 2019 (COVID-19) is evolving periodically. There is also a marked increase in COVID-19 patients' demand for the provision of COVID-19 convalescent plasma (CCP) therapy. With the review of the literature, the stage of speculation is quickly moving towards conformity, with the interim guidelines given by the Food and Drug Administration (FDA) in the United States, United Kingdom's blood transfusion services, Saudi's FDA, and the Indian Council for Medical Research, in addition to the European health authorities. It is prudent to address the ethical concerns that merit consideration while harvesting and utilizing CCP as a therapeutic tool in local hospital setting.

Locally harvested Covid-19 convalescent plasma could probably help combat the geographically determined SARS-CoV-2 viral variants.

The only effective way to provide individuals with herd immunity against the novel coronavirus [SARS-CoV-2] is to administer an effective vaccine that will help check the current pandemic status. In India, the central drugs standard control organization (CDSCO) has granted the emergency-use authorization [EUA] to three vaccines namely, Covishield (live vaccine, Oxford AstraZeneca, United Kingdom being manufactured by the Serum Institute of India), Covaxin (inactivated vaccine, Bharat Biotech, India) and Sputnik V (live vaccine, Gamaleya, Russia). However, there is a rising need for the efficacy of the vaccines to be proven against the "SARS-CoV-2 viral variants." Also, human plasma is polyclonal in nature with an inherent propensity to identify multiple epitopes of either an antigen or pathogen. With this context in mind, the researchers hypothesize that using COVID-19 convalescent plasma [CCP] harvested from the locally recovered individuals [i.e. potential CCP donors] may be particularly beneficial in combating not only the founder SARS-CoV-2 virus but also the geographically determined SARS-CoV-2 variants among the regionally affected COVID-19 patients.

Strawberry milky-white blood donor's plasma: signaling uncontrolled diabetic lipemia.

Intake of a fatty meal before donating blood can lead to an increased level of plasma triglyceride concentration for several hours. This may cause either turbid and or "milky-white" appearance of their venous plasma samples. We, however, report a peculiar case about a male blood donor from India, whose plasma appeared to be "strawberry milky-white" in colour. On inquiry, he gave a history of poorly controlled diabetes mellitus type-II. Further, this was affirmed by his high blood glucose concentration [nearly 326mg/dL] and HbA1c [13.7%] respectively. Moreover, his plasma triglyceride concentration was elevated up to 376mg/dL. His treatment was started at our hospital and the strawberry colour of his plasma, dramatically recovered to normal straw-colour after achieving a fairly good glycemic control with the insulin therapy.

Filariasis presenting as a solitary testicular mass.

In an endemic country like India, the occurrence of filariasis is very common, especially in the states of Uttar Pradesh, Bihar, Jharkhand, Odisha, Andhra Pradesh, and Tamil Nadu. The present study describes the case of a male from a nonendemic state who presented with a testicular lump. Fine-needle aspiration cytology (FNAC) of the lump revealed many adult filarial worms. The appearance of adult filarial worms in different sites, other than lymph nodes and lymphatic vessels, are relatively rarer and should always be reported. Filariasis remains asymptomatic for a long time and responds very well to treatment if diagnosed early. Despite the availability of multiple diagnostic options, FNAC holds a great importance in diagnosing filariasis, especially in cases where there are normal eosinophil counts and no peripheral filarial parasite. Finally, careful examination of cytological smear for the parasite in high-risk groups is helpful in labeling the disease in early asymptomatic states.

Study of the Pre-Analytical Phase of an ISO 15189: 2012-Certified Cytopathology Laboratory: A 5-Year Institutional Experience.

OBJECTIVE: Total quality management, which basically involves pre-analytical, analytical, and postanalytical phases, is relatively more difficult in cytopathology due to descriptive reports and subjective variability. The pre-analytical phase of total quality management constitutes a major burden of errors in the laboratory and it has not been widely studied in cytopathology except in cervical Pap smears. The present study was therefore conducted to study the pre-analytical phase over 5 years from April 2013 until May 2018 at an ISO 15189: 2012-certified cytopathology laboratory, in a resource-limited setting. It was also intended to study the level of satisfaction of the patients and the training of the professionals provided in the cytology lab so as to improve and maintain high quality standards. METHODS: The study included all the documents relating to the quality program used in the last 5 years in a medical institute situated in the north sub-Himalayan region of India. All the data were recorded and analysed for pre-analytical analysis of the total quality management system. RESULTS: In total, 20,130 samples were received for cytological investigation. The total number of errors which were detected in the cytopathology lab were 1,430, constituting 7.1% of the total investigations done. The pre-analytical phase errors comprised 57% of the total errors (815/1,430), analytical errors constituted 11% (157/1,430), while postanalytical errors represented 32% (458/1,430). Incompletely filled requisition forms constituted the most common pre-analytical error (38%). There was a gradual decrease in the errors with time, but with a sudden increase between January to June 2015 due to new technicians joining during that period. CONCLUSION: Pre-analytical quality management is an essential component for maintaining the quality and reducing the errors in the cytopathology lab. Documentation, continuous training, and maintenance of internal and external quality control with quality charts are the key for successful quality management. The identification of non-conformance with root-cause analysis and provision of scope for continuous improvement is vital for quality improvement in the lab. Patient satisfaction is an important aspect of quality in the lab, which should be combined with the satisfaction of the personnel working in the lab.

Familial Hepatocellular Carcinoma- First Reported Case from India.

Familial clustering of Hepatocellular Carcinoma (HCC) is commonly observed in various parts of the world including China and Eastern Asia where HBV is endemic while in western world, genetic factors and metabolic disorders may play an important role. In India, HCC is considered to be a rare tumour and till date no case of familial HCC has been reported here. Therefore the present case demonstrates rare occurrence of familial HCC which is being reported for the first time from India on cytology. The case also highlights an unusual feature that it was not associated with any risk factor including HBV, HCV infection, alcoholism, obesity, diabetes or smoking suggesting its independent association with genetic factors. Cytology is uncomplicated diagnostic tool for HCC and may be useful for its early diagnosis. This case also highlights the importance of early surveillance and follow up of blood relatives for every case of HCC so that early diagnosis and management of familial HCC is possible.

Implementation of an education development project in pathology to improve student competency-lessons learnt.

CONTEXT: Basic medical sciences and clinical teachings are not coordinated in the present medical education system. They are not taught keeping in mind the outcomes required at the time of actual handling of patients in the community. AIMS: An educational development project was implemented in the Department of Pathology with the aim that it will result in the student learning to link the pathophysiology of the disease to clinical scenarios and become fully competent for lifelong medical practice. SUBJECTS AND METHODS: The pathology teaching of the second professional batch was modified by starting with defining the desired outcomes/competencies in the student's knowledge, skills, and attitude which were then addressed by lectures, demonstrations, practical classes and small group activities where case scenarios and laboratory reports were included. The outcome was assessed by Objectively Structured Clinical/Practical Examination and multiple choice questions. Force field analysis, faculty and student interviews, and questionnaires were used to assess the factors affecting its implementation and impact. RESULTS: Totally 80 students of the 2(nd) Professional MBBS were exposed to a competency-based education development project. It was found that the system was appreciated by faculty and students, especially the integration with clinical scenarios. There were many factors which influenced the execution of this program, including motivation level of students and faculty, time, logistics and meticulous planning. CONCLUSIONS: There was a significant improvement in student's performance and satisfaction. Many factors including prior planning were a major determinant for the success of this education development project.

Transbronchial needle aspiration with rapid on-site evaluation: a prospective study on efficacy, feasibility and cost effectiveness.

BACKGROUND: Transbronchial needle aspiration (TBNA) has an established role in diagnosis of hilar and mediastinal lesions. Rapid on-site evaluation (ROSE) of TBNA smears can determine the adequacy of TBNA smears that can obviate the need for repeat procedures, thus avoiding added cost. There is paucity of data from India showing efficacy and cost-effectiveness of ROSE. Hence, this study was carried out to assess the efficacy, feasibility and cost implications of ROSE assisted TBNA. METHODS: Forty consecutive patients undergoing TBNA were enrolled and ROSE was performed on TBNA smears. The results were analysed using a comparative study design. RESULTS: It was found that 45% of patients would have required a repeat bronchoscopy due to inadequacy of material, if ROSE was not used. Inadequate smears were more common in benign aetiologies than malignant ones. TBNA of mass lesions and lesions with endoluminal bulge give better results than TBNA of lymph nodes and without endoluminal bulge. CONCLUSIONS: ROSE was found to increase the yield of TBNA and help to prevent repeat procedures. It proved to be simple, cost-effective and feasible in Indian settings.

Clinico-pathological profile of sinonasal masses: An experience in tertiary care hospital of Uttarakhand.

BACKGROUND: The purpose of this study was to classify various types of non-neoplastic and neoplastic lesions presenting as sinonasal mass and characterize their clinico-pathological profile in a tertiary care center in the state of Uttarakhand. MATERIALS AND METHODS: This was a prospective study where 110 cases of sinonasal masses were included over a period of 12 months. Clinico-pathological study was carried out in these cases. A provisional diagnosis was made after clinical assessment and radiologic investigations, but final diagnosis was made after histopathologic examination. OBSERVATIONS: The number of non-neoplastic lesions were more than the neoplastic lesion, 60% versus 40% respectively. In the neoplastic group, 19.8% and 23.76% patients presented with benign and malignant lesion, respectively. The incidence was more predominant in the age group of 11-20 years (22.72%) with male to female ratio of 1.08:1. In our study, among non-neoplastic lesions the occurrence of sinonasal polyps was highest seen in 80.30% cases. In neoplastic lesions, angiofibroma was most common benign lesion seen in 35% cases. Carcinoma nasal cavity was the commonest malignant lesion seen in 45.83% cases. In 3.63% patients, clinical and radiologic diagnosis was not correlated with histopathologic diagnosis. Only two cases required immuno-histocytochemistry to confirm the final diagnosis. CONCLUSION: We concluded that for proper evaluation of a sinonasal mass, clinical, radiologic, and histopathologic evaluation should be carried out conjointly in all the cases. Histopathology always gives a confirmatory diagnosis but in few cases immuno-histocytochemistry becomes the ultimate diagnostic technique for correct and timely intervention.

Utilization of blood and components in a tertiary care hospital.

PURPOSE: Blood transfusion is an important part of patient management. Indications for blood use must be clear in the mind of ordering clinicians, to avoid its misuse and also to avoid unnecessary exposure of the patient to donor blood antigens, adverse reactions and transfusion transmissible diseases. METHODS: In a retrospective pilot study, details of whole blood and components transfused were noted and correlated with the patient's diagnosis and indications for transfusion, during 1 month. RESULTS: The blood units supplied were 720. Whole blood was the most utilized product; followed by packed red blood cells. Supply of blood was maximum to the surgical wards. The patients of trauma followed by malignancy and surgery required whole blood mostly. Anemia was the most common indication for blood products. CONCLUSIONS: Periodic review of blood component usage is very important to assess the blood utilization pattern in any hospital.