OBJECTIVES: Early diagnosis of tuberculosis (TB) and multidrug-resistant TB (MDR-TB) is a priority for Viet Nam's National TB Control Programme. In many laboratories, quality systems are weak; few have attained accreditation. We implemented a structured training and mentoring program for TB laboratories and measured impact on quality. METHODS: Six TB culture laboratories implemented the Strengthening TB Laboratory Management Towards Accreditation (TB SLMTA) program, consisting of three training workshops and on-site mentoring between workshops to support improvement projects. Periodic audits, using standardized checklists, monitored laboratories' progress toward accreditation readiness. RESULTS: At baseline, all six laboratories achieved a zero-star level. At exit, five laboratories attained three stars and another one star. Overall checklist scores increased by 44.2% on average, from 29.8% to 74.0%; improvements occurred across all quality system essentials. CONCLUSIONS: The program led to improved quality systems. Sites should be monitored to ensure sustainability of improvements and country capacity expanded for national scaleup.

Following the World Health Organization's (WHO) endorsement of the Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) assay in 2010, Viet Nam's National TB Control Programme (NTP) began implementing GeneXpert instruments in NTP laboratories. In 2013, Viet Nam's National Tuberculosis (TB) Programme implemented an Xpert MTB/RIF External Quality Assurance (EQA) programme in collaboration with the United States Centers for Disease Control and Prevention (CDC) and the Foundation for Innovative New Diagnostics (FIND). Proficiency testing (PT) panels comprising five dried tube specimens (DTS) were sent to participating sites approximately twice per annum from October 2013 to July 2016. The number of enrolled laboratories increased from 22 to 39 during the study period. Testing accuracy was assessed by comparing reported and expected results, percentage scores were assigned, and feedback reports were provided to sites. On-site evaluation (OSE) was conducted for under-performing laboratories. Results from the first five rounds demonstrate the positive impact of PT and targeted OSE visits on testing quality. On average, for every additional round of feedback, the odds of achieving PT scores of >/=80% increased 2.04-fold (95% CI 1.39-3.00). Future work will include scale up of PT to all sites and maintaining performance of participating laboratories, while developing local panel production capacity.

Objectives: In 2012, the Vietnam Ministry of Health sought to improve the quality of health laboratories by introducing international quality standards. Methods: Strengthening Laboratory Management Toward Accreditation (SLMTA), a year-long, structured, quality improvement curriculum (including projects and mentorship) was piloted in 12 laboratories. Progress was measured using a standardized audit tool (Stepwise Laboratory Quality Improvement Process Towards Accreditation). Results: All 12 pilot laboratories (a mix of hospital and public health) demonstrated improvement; median scores rose from 44% to 78% compliance. The public health laboratory in Hai Duong Province entered the program with the lowest score of the group (28%) yet concluded with the highest score (86%). Five months after the completion of the program, without any additional external support, they were accredited. Laboratory management/staff describe factors key to their success: support from the facility senior management, how-to guidance provided by SLMTA, support from the site mentor, and strong commitment of laboratory staff. Conclusions: Hai Duong preventive medical center is one of only a handful of laboratories to reach accreditation after participation in SLMTA and the only laboratory to do so without additional support. Due to the success seen in Hai Duong and other pilot laboratories, Vietnam has expanded the use of SLMTA.

OBJECTIVE: The objectives of this case report are as follows: to describe the process of establishing a national laboratory information management system (LIMS) program for clinical and public health laboratories in Vietnam; to evaluate the outcomes and lessons learned; and to present a model for sustainability based on the program outcomes that could be applied to diverse laboratory programs. METHODS: This case report comprises a review of program documentation and records, including planning and budgetary records of the donor, monthly reports from the implementer, direct observation, and ad-hoc field reports from technical advisors and governmental agencies. Additional data on program efficacy and user acceptance were collected from routine monitoring of laboratory policies and operational practices. RESULTS: LIMS software was implemented at 38 hospital, public health and HIV testing laboratories in Vietnam. This LIMS was accepted by users and program managers as a useful tool to support laboratory processes. Implementation cost per laboratory and average duration of deployment decreased over time, and project stakeholders initiated transition of financing (from the donor to local institutions) and of system maintenance functions (from the implementer to governmental and site-level staff). Collaboration between the implementer in Vietnam and the global LIMS user community was strongly established, and knowledge was successfully transferred to staff within Vietnam. CONCLUSION: Implementing open-sourced LIMS with local development and support was a feasible approach towards establishing a sustainable laboratory informatics program that met the needs of health laboratories in Vietnam. Further effort to institutionalize IT support capacity within key government agencies is ongoing.

BACKGROUND: The Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist is used worldwide to drive quality improvement in laboratories in developing countries and to assess the effectiveness of interventions such as the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. However, the paperbased format of the checklist makes administration cumbersome and limits timely analysis and communication of results. Development of e-Tool: In early 2012, the SLMTA team in Vietnam developed an electronic SLIPTA checklist tool. The e-Tool was pilot tested in Vietnam in mid-2012 and revised. It was used during SLMTA implementation in Vietnam and Cambodia in 2012 and 2013 and further revised based on auditors' feedback about usability. OUTCOMES: The SLIPTA e-Tool enabled rapid turn-around of audit results, reduced workload and language barriers and facilitated analysis of national results. Benefits of the e-Tool will be magnified with in-country scale-up of laboratory quality improvement efforts and potential expansion to other countries.