"Constrained Medical Oxygen Supply Chain in India During COVID-19: Red-tapism, the Elephant in the Room?"

BACKGROUND: Recent disruption of medical oxygen during the second wave of coronavirus disease 2019 (COVID-19) has caused nationwide panic. This study attempts to objectively analyze the medical oxygen supply chain in India along the principles of value stream mapping (VSM), identify bottlenecks, and recommend systemic improvements. METHODS: Process mapping of the medical oxygen supply chain in India was done. Different licenses and approvals, their conditions, compliances, renewals, among others were factored in. All relevant circulars (Government Notices), official orders, amendments, and gazette notifications pertaining to medical oxygen from April 2020 to April 2021 were studied and corroborated with information from Petroleum and Explosives Safety Organization (PESO) official website. RESULTS: Steps of medical oxygen supply chain right from oxygen manufacture to filling, storage, and transport up to the end users; have regulatory bottlenecks. Consequently, flow of materials is sluggish and very poor information flow has aggravated the inherent inefficiencies of the system. Government of India has been loosening regulatory norms at every stage to alleviate the crisis. CONCLUSIONS: Regulatory bottlenecks have indirectly fueled the informal sector over the years, which is not under Government's control with difficulty in controlling black-marketing and hoarding. Technology enabled, data-driven regulatory processes with minimum discretionary human interface can make the system more resilient.

Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study.

BACKGROUND: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. METHODS: We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 - odds ratio) × 100%. FINDINGS: Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33-62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22-62) and administered at least 42 days before testing was 57% (21-76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29-61). INTERPRETATION: This study shows the effectiveness of two doses of BBV152 against symptomatic COVID-19 in the context of a huge surge in cases, presumably dominated by the potentially immune-evasive delta (B.1.617.2) variant of SARS-CoV-2. Our findings support the ongoing roll-out of this vaccine to help control the spread of SARS-CoV-2, while continuing the emphasis on adherence to non-pharmacological measures. FUNDING: None. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

More from less: Study on increasing throughput of COVID-19 screening and testing facility at an apex tertiary care hospital in New Delhi using discrete-event simulation software.

BACKGROUND: One of the challenges has been coping with an increasing need for COVID-19 testing. A COVID-19 screening and testing facility was created. There was a need for increasing throughput of the facility within the existing space and limited resources. Discrete event simulation was used to address this challenge. METHODOLOGY: A cross-sectional interventional study was done from September 2020 to October 2020. Detailed process mapping with all micro-processes was done. Patient arrival patterns and time taken at each step were measured by two independent observers at random intervals over two weeks. The existing system was simulated and a bottleneck was identified. Two possible alternatives to the problem were simulated and evaluated. RESULTS: Scenario 1 showed a maximum throughput of 316. The average milestone times of all the processes after the step of "Preparation of sampling kits" jumped 62%; from 82 to 133 min. Staff state times also showed that staff at this step was stretched and medical lab technicians were underutilized. Scenario 2 simulated the alternative with lesser time spent on sampling kit preparation with a 22.4% increase in throughput, but could have led to impaired quality check. Scenario 3 simulated with increased manpower at the stage of bottleneck with 26.5% increase in throughput and was implemented on-ground. CONCLUSION: Discrete event simulation helped to identify the bottleneck, simulate possible alternative solutions without disturbing the ongoing work, and finally choose the most suitable intervention to increase throughput, without the need for additional space allocation. It therefore helped to optimally utilize resources and get "more from less."

How informed is the informed consent?

BACKGROUND: Informed consent is a cornerstone of the ethics of modern medical care. In an ideal world, informed consent is a process of education - a conversation between a surgeon and a patient or family that allows the patient or family to make the best possible decision regarding care. OBJECTIVE: The study was conducted with objectives of assessing information given to the patient before taking consent for surgery and determining the compliance to various contents of the consent forms. MATERIAL AND METHODS: This was a prospective study over a period of 12 weeks in wards of various surgical departments of a 1000+ bedded tertiary care hospital. Patient interviews were conducted to assess their level of information and the consent forms were reviewed to assess the compliance. OBSERVATIONS: The overall level of information r4egarding various aspects among the participants was 75.14%. The level of information varied statistically with age, literacy level, annual income and the type of surgery. All the patients (100%) stated that they were informed about the current clinical condition/ problem, while only 34% were informed about risk and 26% about the alternative options. All the forms (100%) had a statement regarding the explanation of procedure to the patient/ guardian and none of the forms (0%) contained names of all practitioners performing the procedure. CONCLUSION: There is need to create awareness among doctors and also to educate patients regarding the importance of informed consent.

War on waste: Challenges and experiences in COVID-19 waste management.

COVID-19 has posed formidable challenges including overwhelming bio-medical waste. Guidelines have been rapidly changing along with mounting pressure of waste generation. These challenges were managed by smart re-engineering of structure and processes for desired outcomes. Dedicated staff in PPE with appropriate training were deployed to collect waste using dedicated trolleys. A dedicated route plan was drawn with a dedicated lift meant for COVID-19. A new temporary holding area was created. Dedicated trucks with requisite labels were deployed to transport COVID-19 waste to CBWTF. Communication challenge was addressed through timely circulars, which were further reinforced and reiterated during various on-going training programs.Before the onset of COVID-19 pandemic Bio-Medical Waste generated was 1.93kg/Bed/Day and currently the quantum of COVID-19 biomedical waste generated is 7.76Kg/COVID Bed/Day. Daily COVID-19 waste generation data is maintained and uploaded in an android Application. Till date none of the worker handling COVID-19 waste has acquired Healthcare associated COVID-19 infection which reflects on the soundness of the new system and the infection control practices in the Institute. A responsive leadership harmonizing with a robust communication and training system has augmented timely re-engineering of structure and processes for better outcomes in the war on waste.

The information imperative: to study the impact of informational discontinuity on clinical decision making among doctors.

BACKGROUND: Informational discontinuity can have far reaching consequences like medical errors, increased re-hospitalization rates and adverse events among others. Thus the holy grail of seamless informational continuity in healthcare has been an enigma with some nations going the digital way. Digitization in healthcare in India is fast catching up. The current study explores the components of informational continuity, its impact on clinical decision-making and captures the general perception among the doctors towards a digital solution. METHODS: Cross-sectional study with snowball sampling. A survey questionnaire was developed and validated through a pilot study, then circulated through online platforms. Responses from doctors were obtained through an online Google form for a period of 3 months and analyzed using SPSS 20. The categorical variables were analyzed using Chi-square test. RESULTS: 1413 responses were obtained through a national level survey. Respondents were from a wide range of work experiences, locations, sectors, specialties and patient load. Components of patient records like clinical notes, investigation reports, previous diagnosis and treatment details were rated to be very important. 41% reported about half and 20% reported about 3/4th of their patients do not bring relevant records. Patients from rural areas, visiting state government hospitals and visiting general practitioners were less likely to bring relevant records during consultations. The fallouts of not having timely relevant patient information of the patients include more time per patient, repeat investigations, difficulty to arrive at definitive diagnosis, difficulty to take further treatment decisions and impaired overall clinical decision making which were said to be significant by respondents across the spectrum. The benefits of having timely relevant patient information were also reported consistently across the spectrum. An overwhelming proportion (83%), from across the spectrum, unequivocally expressed their willingness to use digital platforms for accessing patients' relevant medical records. CONCLUSION: Prevalence of informational discontinuity and its impact on clinical decision making is significant with definite benefits of having timely relevant medical history. There is strong willingness among the doctors to use digital solution(s) without any extra investment or effort on their part making customized solutions pertinent.