Resilience strengthening of tuberculosis diagnostic services under national tuberculosis program to withstand pandemic situations

Sample collection and transportation (SCT)

• There was decline in passive TB case finding of presumptive TB patients and referral for presumptive TB examination during the pandemic due to repurposing of TB program staff toward the COVID-19 response and non-availability of private courier and transportation services for sample transportation to TB laboratories. Community health workers worked relentlessly during the pandemic to collect sputum specimens from the door-step of presumptive TB patients for TB diagnosis

• There was also decline in diagnosis and notification of extrapulmonary TB (3.3 lakh cases in 2019 vs. 2.4 lakh cases in 2020) and pediatric TB (2.3 lakh cases in 2019 vs. 1.5 lakh cases in 2020)^[7] probably due to need for hospital visit or admission for performing gastric lavage and extrapulmonary specimen collection.

Deployment of existing and additional rapid NAAT machines toward COVID-19 testing

• In India, existing Truenat and GeneXpert machines available under National TB elimination program (NTEP) were mapped at biosafety level (BSL)-2 and BSL-3 facilities and were immediately deployed for COVID-19 testing.^[7] NAAT machines and laboratory technicians (LTs) were repurposed for COVID-19 testing which helped in sharing the burden of reverse transcription polymerase chain reaction (RT-PCR) laboratories and aided rapid screening of COVID-19

• However, the much needed reallocation of NAAT machines and TB program staff for COVID-19 testing, adversely led to reduction in capacity for TB testing during the pandemic. This impacted the detection and notification of new and recurrent Drug susceptible/drug resistant-TB (DRTB) cases despite upscaling of NAAT machines and rigorous mitigation efforts undertaken by NTEP.

Further, laboratory infrastructure set ups for culture and molecular drug susceptibility testing (DST) by line probe assay (LPA) and its laboratory staff were also engaged in COVID RT-PCR testing

Reallocation of NTEP NAAT machines, laboratory infrastructure, and program staff for COVID-19 testing led to reduced TB testing capacity and overall delayed testing and increased turnaround time for TB diagnostic services.

Potential stigma and panic in laboratory workers

Initially, panic and fear of contracting SARS-CoV-2 even among TB laboratory workers also who routinely handle Mycobacterium tuberculosis (MTB) harbored sputum specimens was too high due to missing gaps in transmission dynamics of COVID-19. Direct sputum smear microscopy was halted by laboratory technicians (LT) at designated microscopy centers (DMC) and in private sector citing inadequate personal protective equipment (PPE) and aerosol generation risk involved with smear preparation. This inadvertently led to upfront use of rapid automated NAAT as initial test for TB diagnosis which led to acute shortage of Cartridge Based NAAT (CBNAAT) cartridges in the country. Despite sustained administrative efforts toward strengthening standard precautions and infection control measures at personnel and laboratory levels, apprehension of staff working in laboratories was high, particularly where large numbers of respiratory specimens were being processed. Not only in TB laboratories, a global survey of clinical laboratories also reported that there were restrictions imposed in some laboratories on performing direct microscopy of specimens of patients who were clinically suspected or confirmed positive for COVID-19.^[8]

Overburdened TB staff

Reallocation of TB program staff to long-standing COVID-19-related duties along with continuation of essential TB services for over a year further accentuated by absenteeism of coworkers due to COVID-19 infection led to their mental, physical, and emotional exhaustion.

Acute shortfalls of PPE and essential laboratory consumables

There was acute shortfall of Personal protective equipment and critical laboratory consumables for COVID-19 and TB diagnostic testing and research activities due to breakdown of manufacturing and supply chain during the pandemic. Sudden requirement of PPE in such enormity was unwitnessed before the current pandemic. Inappropriate and excessive usage of various PPE by staff further intensified its shortage. Absence of or inadequate PPE was a legitimate cause of fear and anxiety among healthcare workers (HCWs).

Health staff

• First and foremost, it is essential to boost morale of TB program staff and other HCW who executed functions effectively during the peak of COVID-19 pandemic despite difficult field conditions

• Health system must ensure continuous supply of appropriate PPE to HCWs both in terms of quality and quantum

• Measures to address human resource apprehensions: Regular training of laboratory staff on standard precautions, rational use of PPEs, hand hygiene practices, disinfection and infection control policies, and biomedical waste management as per the local regulations is important for their safety and allaying fears of contracting SARS-CoV-2 infection or other respiratory pathogens

• Psychosocial counseling of TB staff: Provision of psychosocial support and counseling for those who need will help to prevent their mental breakdown and build their morale and lead to a safe environment for our workforce

• Retention policies for contractual TB laboratory staff: Administrators should make all possible efforts to fill vacant positions for TB laboratory staff in their districts

Furthermore, the formulation of policies aimed at retention of trained contractual personnel should be the emphasis of national program. Contractual workers’ salaries have to be at par with those of private sector workers along with regular increments. A health insurance plan or inclusion as beneficiaries for using empanelled health facilities like permanent government employees should be offered to skilled contractual staff who successfully finish their term. Through an annual health examination, NTEP’s contracted laboratory employees should be provided screening for TB and even extend this health benefit up to 2 years after leaving the job since TB is a chronic condition.

• Devising strategy for relieving TB staff from extended duties toward disaster response as early as possible

• Annual preventive health check-up for TB screening (Symptoms, Chest X-ray, interferon gamma release tests [IGRA])

The incidence of TB among laboratory personnel involved in TB diagnostic testing is known to be 3–9 times higher as compared to personnel not working with this agent.^[9] This is of serious concern and necessitates a regular preventive health check-up program for health staff for occupational health and safety.^[9]

• The administrative authorities must ensure routine screening for comorbidities, active TB disease by symptom screening and chest X-ray, and establish links for treatment if positive. As a high-risk category, TB laboratory workers can also be administered yearly IGRA to test for TB infection. If IGRA is positive and active TB disease is ruled out, the staff can then be offered an appropriate TB preventative treatment to treat latent TB infection^[10]

• In addition, the administration must ensure that staff in TB laboratories has adequate access to necessary PPE supplies. Laboratory managers must strictly review PPE stock inventory and monitor consumption while maintaining a 2-month supply of buffer stock to do this. In the event when supply chain is projected to be disrupted, a contingency plan should be created to obtain PPE at short notice. A list of additional suppliers for emergency supply should also be in place.

It is important to do a risk assessment for prioritizing N95 masks and gowns for laboratory employees engaged in medium- to high-risk TB laboratory operations. Utilize N95 respirators for an extended period of time when necessary. Investigate the local supply options for necessary PPE.

• Establishment of national occupational health surveillance reporting system: TB remains one of the most common laboratory acquired infections. However, there are limited such laboratory reports in the literature. Therefore, there is a strong need to establish national occupational health surveillance reporting system and essentially report TB and other infectious diseases in workers to account for and analyze infections acquired in healthcare workers.

Laboratory infrastructure adequacy and functionality

It is important for TB program managers to undertake review of:

• Adequate coverage, accessibility, and functional status of existing TB diagnostic facilities under NTEP and private sector in the districts and need based augmentation of diagnostic facilities, testing platforms or arrangements for patient specimen pick up, and transportation from health-care facilities to nearby NTEP laboratory.

• Establish more effective and efficient patient referral systems –

  1. Educating private providers about the NTEP’s high-quality, free diagnostic TB services including DST, and links to DRTB services offered to both patients who visit public sector and those who are referred by the private sector.

  2. Involving private providers through prioritization and one-on-one communication about free TB services such as specimen collection and transport, access to free drugs, including newer drugs, chemoprophylaxis, and free human immunodeficiency virus (HIV) and blood sugar testing and links to their treatment; links for NIKSHAY Poshan Yojana and the provider’s direct benefit transfer incentive for notification and reporting treatment outcome

  3. In addition, partnership options for private sector engagement and end to end management can be explored.

Strengthening of specimen collection and transportation systems

• Consider integrated sample transportation with other disease programs (TB, HIV, Dengue, and Cancer) and adoption of hub and spoke model of sample transportation in districts with proactive approach for local innovations.

Enhancement of laboratory biosafety

• COVID-19 pandemic has provided an opportunity to re-visit biosafety measures in existing and new TB laboratories for compatibility with high aerosol generating activities involving MTB and newer pathogens in future

• As a long-term measure, thorough review of laboratory safety through careful site specific risk assessment of TB laboratories set ups and appropriate scaling up of biosafety measures where safety breach is observed, is the need of hour, in laboratory preparedness for better handling of current situation and any future pandemic

• It is critical to review all microscopy centers for efficient ventilation. If required, provision of mechanical ventilation (exhaust fans to allow frequent air changes) and biosafety cabinet class I may be considered, where feasible, to offer optimum protection to LT. This will help to safely resume direct smear microscopy halted at DMCs due to concerns involved with this pandemic over risk of exposure to aerosols and also keeping in view the unknown presence of multidrug-resistant/extensively drug TB strains in the sputum specimens

• Review of guidelines and robust supervision and monitoring for sputum collection at microscopy centers with strict emphasis on implementation of airborne infection control practices since these centers have potential of becoming sources of COVID/other airborne infections for presumptive TB and people living with HIV patients visiting health facility

• Further, considering the high biorisk in face of current and future pandemics, it is suggested that TB laboratories for culture and DST developed in future may be designed with one health approach for laboratory preparedness and response so that if required, they can be upgraded on short notice for handling Ebola virus, SARS-CoV-1, MERS, SARS-CoV-2, NIPAH virus, and other emerging pathogens of pandemic potential.

Ensuring laboratory logistics

The unforeseen material supply crisis during the pandemic has led to countries working on finding local resources or innovating on cost effective alternatives, optimal utilization of resources, as well as strengthening of procurement and supply chain management systems for laboratories.

• In such times, strategic planning and early forecasting of rise in demand for laboratory consumables such as PPE and diagnostic kits critical for TB case detection and universal drug susceptibility testing (UDST) is critical to prevent any delay and interruption in diagnostic services

• In particular, countries who have replaced direct smear microscopy with rapid NAAT test for all presumptive TB cases require strong monitoring and supply chain management of CBNAAT cartridges and Truenat Kits to keep up with the specimen load.

Use of laboratory infrastructure established for COVID testing

• RT-PCR laboratories: Districts can utilize BSL-2 laboratories equipped with certified biosafety cabinets 2A/2B and its extensively trained staff that were established during COVID-19 pandemic over short-time span in medical colleges at the district level, even in tough terrains^[11] for molecular detection of other infectious diseases including LPA testing for TB, where deficiencies of facilities exist

• Genome sequencing set ups (INSACOG laboratories): Whole-genome sequencing infrastructure and trained manpower established for COVID-19 can serve as important resources for determining molecular epidemiology and drug resistance surveillance of other infectious diseases.