Incremental Dental Expenditures Associated With Diabetes Among Noninstitutionalized U.S. Adults Aged ≥18 Years Old in 2016-2017.

OBJECTIVE: Diabetes is associated with poor oral health, but incremental expenditures for dental care associated with diabetes in the U.S. are unknown. We aimed to quantify these incremental expenditures per person and for the nation. RESEARCH DESIGN AND METHODS: We analyzed data from 46,633 noninstitutionalized adults aged ≥18 years old who participated in the 2016-2017 Medical Expenditure Panel Survey. We used two-part models to estimate dental expenditures per person in total, by payment source, and by dental service type, controlling for sociodemographic characteristics, health status, and geographic variables. Incremental expenditure was the difference in predicted expenditure for dental care between adults with and without diabetes. The total expenditure for the U.S. was the expenditure per person multiplied by the estimated number of people with diabetes. Expenditures were adjusted to 2017 USD. RESULTS: The mean adjusted annual diabetes-associated incremental dental expenditure was $77 per person and $1.9 billion for the nation. Of this incremental expenditure, 51% ($40) and 39% ($30) were paid out of pocket and by private insurance, 69% ($53) of the incremental expenditure was for restorative/prosthetic/surgical services, and adults with diabetes had lower expenditure for preventive services than those without (incremental, -$7). Incremental expenditures were higher in older adults, non-Hispanic Whites, and people with higher levels of income and education. CONCLUSIONS: Diabetes is associated with higher dental expenditures. These results fill a gap in the estimates of total medical expenditures associated with diabetes in the U.S. and highlight the importance of preventive dental care among people with diabetes.

Using a RE-AIM framework to identify promising practices in National Diabetes Prevention Program implementation.

BACKGROUND: The National Diabetes Prevention Program (National DPP) is rapidly expanding in an effort to help those at high risk of type 2 diabetes prevent or delay the disease. In 2012, the Centers for Disease Control and Prevention funded six national organizations to scale and sustain multistate delivery of the National DPP lifestyle change intervention (LCI). This study aims to describe reach, adoption, and maintenance during the 4-year funding period and to assess associations between site-level factors and program effectiveness regarding participant attendance and participation duration. METHODS: The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used to guide the evaluation from October 2012 to September 2016. Multilevel linear regressions were used to examine associations between participant-level demographics and site-level strategies and number of sessions attended, attendance in months 7-12, and duration of participation. RESULTS: The six funded national organizations increased the number of participating sites from 68 in 2012 to 164 by 2016 across 38 states and enrolled 14,876 eligible participants. By September 2016, coverage for the National DPP LCI was secured for 42 private insurers and 7 public payers. Nearly 200 employers were recruited to offer the LCI on site to their employees. Site-level strategies significantly associated with higher overall attendance, attendance in months 7-12, and longer participation duration included using self-referral or word of mouth as a recruitment strategy, providing non-monetary incentives for participation, and using cultural adaptations to address participants' needs. Sites receiving referrals from healthcare providers or health systems also had higher attendance in months 7-12 and longer participation duration. At the participant level, better outcomes were achieved among those aged 65+ (vs. 18-44 or 45-64), those who were overweight (vs. obesity), those who were non-Hispanic white (vs. non-Hispanic black or multiracial/other races), and those eligible based on a blood test or history of gestational diabetes mellitus (vs. screening positive on a risk test). CONCLUSIONS: In a time of rapid dissemination of the National DPP LCI the findings of this evaluation can be used to enhance program implementation and translate lessons learned to similar organizations and settings.

Factors Contributing to Increases in Diabetes-Related Preventable Hospitalization Costs Among U.S. Adults During 2001-2014.

OBJECTIVE: To examine changes in diabetes-related preventable hospitalization costs and to determine the contribution of each underlying factor to these changes. RESEARCH DESIGN AND METHODS: We used data from the 2001-2014 U.S. National (Nationwide) Inpatient Sample (NIS) for adults (≥18 years old) to estimate the trends in hospitalization costs (2014 USD) in total and by condition (short-term complications, long-term complications, uncontrolled diabetes, and lower-extremity amputation). Using regression and growth models, we estimated the relative contribution of following underlying factors: total number of hospitalizations, rate of hospitalization, the number of people with diabetes, mean cost per admission, length of stay, and cost per day. RESULTS: During 2001-2014, the estimated total cost of diabetes-related preventable hospitalizations increased annually by 1.6% (92.9 million USD; P < 0.001). Of this 1.6% increase, 75% (1.2%) was due to the increase in the number of hospitalizations, which is a result of a 3.8% increase in diabetes population and a 2.6% decrease in the hospitalization rate, and 25% (0.4%) was due to the increase in cost per admission, for a net result of a 1.6% increase in cost per day and a 1.3% decline in mean length of stay. By component, the cost of short-term complications, lower-extremity amputations, and long-term complications increased annually by 4.2, 1.9, and 1.5%, respectively, while the cost of uncontrolled diabetes declined annually by 2.6%. CONCLUSIONS: The total cost of diabetes-related preventable hospitalizations had been increasing during 2001-2014, mainly resulting from increases in number of people with diabetes and cost per hospitalization day. The underlying factors identified in our study could lead to efforts that may lower future hospitalization costs.

Primary Care Providers' Prediabetes Screening, Testing, and Referral Behaviors.

INTRODUCTION: Intensive behavioral counseling is effective in preventing type 2 diabetes, and insurance coverage for such interventions is increasing. Although primary care provider referrals are not required for entry to the Centers for Disease Control and Prevention (CDC)-recognized National Diabetes Prevention Program lifestyle change program, referral rates remain suboptimal. This study aims to assess the association between primary care provider behaviors regarding prediabetes screening, testing, and referral and awareness of the CDC-recognized lifestyle change program and the Prevent Diabetes STAT: Screen, Test, and Act Today™ toolkit. Awareness of the lifestyle change program and the STAT toolkit, use of electronic health records, and the ratio of lifestyle change program classes to primary care physicians were hypothesized to be positively associated with primary care provider prediabetes screening, testing, and referral behaviors. METHODS: Responses from primary care providers (n=1,256) who completed the 2016 DocStyles cross-sectional web-based survey were analyzed in 2017 to measure self-reported prediabetes screening, testing, and referral behaviors. Multivariate logistic regression was used to estimate the effects of primary care provider awareness and practice characteristics on these behaviors, controlling for provider characteristics. RESULTS: Overall, 38% of primary care providers were aware of the CDC-recognized lifestyle change program, and 19% were aware of the STAT toolkit; 27% screened patients for prediabetes using a risk test; 97% ordered recommended blood tests; and 23% made referrals. Awareness of the lifestyle change program and the STAT toolkit was positively associated with screening and referring patients. Primary care providers who used electronic health records were more likely to screen, test, and refer. Referring was more likely in areas with more lifestyle change program classes. CONCLUSIONS: This study highlights the importance of increasing primary care provider awareness of and referrals to the CDC-recognized lifestyle change program.

Utilizing Nurses to Staff an Ebola Vaccine Clinical Trial in Sierra Leone during the Ebola Outbreak.

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE).

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC's National Diabetes Prevention Program.

OBJECTIVE: To assess participant-level results from the first 4 years of implementation of the National Diabetes Prevention Program (National DPP), a national effort to prevent type 2 diabetes in those at risk through structured lifestyle change programs. RESEARCH DESIGN AND METHODS: Descriptive analysis was performed on data from 14,747 adults enrolled in year-long type 2 diabetes prevention programs during the period February 2012 through January 2016. Data on attendance, weight, and physical activity minutes were summarized and predictors of weight loss were examined using a mixed linear model. All analyses were performed using SAS 9.3. RESULTS: Participants attended a median of 14 sessions over an average of 172 days in the program (median 134 days). Overall, 35.5% achieved the 5% weight loss goal (average weight loss 4.2%, median 3.1%). Participants reported a weekly average of 152 min of physical activity (median 128 min), with 41.8% meeting the physical activity goal of 150 min per week. For every additional session attended and every 30 min of activity reported, participants lost 0.3% of body weight (P < 0.0001). CONCLUSIONS: During the first 4 years, the National DPP has achieved widespread implementation of the lifestyle change program to prevent type 2 diabetes, with promising early results. Greater duration and intensity of session attendance resulted in a higher percent of body weight loss overall and for subgroups. Focusing on retention may reduce disparities and improve overall program results. Further program expansion and investigation is needed to continue lowering the burden of type 2 diabetes nationally.

Changes in Disparity in County-Level Diagnosed Diabetes Prevalence and Incidence in the United States, between 2004 and 2012.

BACKGROUND: In recent decades, the United States experienced increasing prevalence and incidence of diabetes, accompanied by large disparities in county-level diabetes prevalence and incidence. However, whether these disparities are widening, narrowing, or staying the same has not been studied. We examined changes in disparity among U.S. counties in diagnosed diabetes prevalence and incidence between 2004 and 2012. METHODS: We used 2004 and 2012 county-level diabetes (type 1 and type 2) prevalence and incidence data, along with demographic, socio-economic, and risk factor data from various sources. To determine whether disparities widened or narrowed over the time period, we used a regression-based ß-convergence approach, accounting for spatial autocorrelation. We calculated diabetes prevalence/incidence percentage point (ppt) changes between 2004 and 2012 and modeled these changes as a function of baseline diabetes prevalence/incidence in 2004. Covariates included county-level demographic and, socio-economic data, and known type 2 diabetes risk factors (obesity and leisure-time physical inactivity). RESULTS: For each county-level ppt increase in diabetes prevalence in 2004 there was an annual average increase of 0.02 ppt (p<0.001) in diabetes prevalence between 2004 and 2012, indicating a widening of disparities. However, after accounting for covariates, diabetes prevalence decreased by an annual average of 0.04 ppt (p<0.001). In contrast, changes in diabetes incidence decreased by an average of 0.04 ppt (unadjusted) and 0.09 ppt (adjusted) for each ppt increase in diabetes incidence in 2004, indicating a narrowing of county-level disparities. CONCLUSIONS: County-level disparities in diagnosed diabetes prevalence in the United States widened between 2004 and 2012, while disparities in incidence narrowed. Accounting for demographic and, socio-economic characteristics and risk factors for type 2 diabetes narrowed the disparities, suggesting that these factors are strongly associated with changes in disparities. Public health interventions that target modifiable risk factors, such as obesity and physical inactivity, in high burden counties might further reduce disparities in incidence and, over time, in prevalence.

Prevalence of diabetes and impaired fasting glucose in Costa Rica: Costa Rican National Cardiovascular Risk Factors Survey, 2010.

BACKGROUND: The projected rising prevalence of diabetes and impaired fasting glucose (IFG) in developing countries warrants careful monitoring. The aim of this study was to present the results of the Costa Rican National Cardiovascular Risk Factors Surveillance System, which provides the first national estimates of diabetes and IFG prevalence among adults in Costa Rica. METHODS: A cross-sectional survey of 3653 non-institutionalized adults aged ≥20 years (87.8% response rate) following the World Health Organization STEPwise approach was built on a probabilistic sample of the non-institutionalized population during 2010. Known diabetes was defined as self-reported diagnosis, the use of insulin, or hypoglycemic oral treatment as consequence of diabetes during at least the previous 2 weeks before the survey. Unknown diabetes was defined no self-reported diabetes but with venous blood concentrations of fasting glucose >125 mg/dL determined by laboratory testing. Impaired fasting glucose was defined as fasting glucose between 100 and 125 mg/dL among those without diabetes. The prevalence of diabetes and IFG prevalence was estimated according gender, body mass index (BMI), waist circumference (WC), educational level, and physical activity level. RESULTS: Overall diabetes prevalence was 10.8% (9.5% known and 1.3% unknown diabetes) and IFG prevalence was 16.5%. The prevalence of known diabetes was higher among women >65 years compared with men of the same age group. Both known and unknown diabetes were significantly associated with higher BMI, increased WC, and low education level (P = 0.01). CONCLUSIONS: The prevalence of diabetes and IFG in Costa Rica is comparable to that in developed countries and indicates an urgent need for effective preventive interventions.

Improving quality in national reference laboratories: the role of SLMTA and mentorship

Background: The Nigerian Institute of Medical Research houses two reference laboratories: the virology and tuberculosis laboratories. Both were enrolled in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. Objective: To describe the impact of SLMTA and discuss factors affecting the results; with an emphasis on mentorship Methods: The SLMTA programme was implemented from April 2010 through November 2012. Participants attended three workshops and executed quality improvement projects; laboratory auditors evaluated performance using a standard checklist. The virology laboratory did not receive mentorship; however; the tuberculosis laboratory had an international mentor who visited the laboratory four times during the programme; spending two to four weeks embedded within the laboratory during each visit. Results: There was an overall improvement in the performance of both laboratories; with the virology laboratory increasing 13% (from 80% at baseline to 93% at exit audit) and the tuberculosis laboratory increasing 29% (from 66% to 95%). These scores were maintained nine months later at the surveillance audit. Conclusion: The SLMTA programme resulted in improved and sustained quality management performance for both laboratories. Mentoring was a possible factor in the substantial improvement made by the tuberculosis laboratory and should be considered in order to augment the training received from the SLMTA workshops

Maximising mentorship: variations in laboratory mentorship models implemented in Zimbabwe

Background: Laboratory mentorship has proven to be an effective tool in building capacity and assisting laboratories in establishing quality management systems. The Zimbabwean Ministry of Health and Child Welfare implemented four mentorship models in 19 laboratories in conjunction with the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme.Objectives: This study outlines how the different models were implemented; cost involved per model and results achieved.Methods: Eleven of the laboratories had been trained previously in SLMTA (Cohort I). They were assigned to one of three mentorship models based on programmatic considerations: Laboratory Manager Mentorship (Model 1; four laboratories); One Week per Month Mentorship (Model 2; four laboratories); and Cyclical Embedded Mentorship (Model 3; three laboratories). The remaining eight laboratories (Cohort II) were enrolled in Cyclical Embedded Mentorship incorporated with SLMTA training (Model 4). Progress was evaluated using a standardised audit checklist.Results: At SLMTA baseline; Model 1-3 laboratories had a median score of 30%. After SLMTA; at mentorship baseline; they had a median score of 54%. At the post-mentorship audit they reached a median score of 75%. Each of the three mentorship models for Cohort I had similar median improvements from pre- to post-mentorship (17 percentage points for Model 1; 23 for Model 2 and 25 for Model 3; p 0.10 for each comparison). The eight Model 4 laboratories had a median baseline score of 24%; after mentorship; their median score increased to 63%. Median improvements from pre-SLMTA to post-mentorship were similar for all four models.Conclusion: Several mentorship models can be considered by countries depending on the available resources for their accreditation implementation plan

The SLMTA programme: Transforming the laboratory landscape in developing countries.

BACKGROUND: Efficient and reliable laboratory services are essential to effective and well-functioning health systems. Laboratory managers play a critical role in ensuring the quality and timeliness of these services. However, few laboratory management programmes focus on the competencies required for the daily operations of a laboratory in resource-limited settings. This report provides a detailed description of an innovative laboratory management training tool called Strengthening Laboratory Management Toward Accreditation (SLMTA) and highlights some challenges, achievements and lessons learned during the first five years of implementation (2009-2013) in developing countries. PROGRAMME: SLMTA is a competency-based programme that uses a series of short courses and work-based learning projects to effect immediate and measurable laboratory improvement, while empowering laboratory managers to implement practical quality management systems to ensure better patient care. A SLMTA training programme spans from 12 to 18 months; after each workshop, participants implement improvement projects supported by regular supervisory visits or on-site mentoring. In order to assess strengths, weaknesses and progress made by the laboratory, audits are conducted using the World Health Organization's Regional Office for Africa (WHO AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, which is based on International Organization for Standardization (ISO) 15189 requirements. These internal audits are conducted at the beginning and end of the SLMTA training programme. CONCLUSION: Within five years, SLMTA had been implemented in 617 laboratories in 47 countries, transforming the laboratory landscape in developing countries. To our knowledge, SLMTA is the first programme that makes an explicit connection between the performance of specific management behaviours and routines and ISO 15189 requirements. Because of this close relationship, SLMTA is uniquely positioned to help laboratories seek accreditation to ISO 15189.

Laboratory system strengthening and quality improvement in Ethiopia.

BACKGROUND: In 2010, a National Laboratory Strategic Plan was set forth in Ethiopia to strengthen laboratory quality systems and set the stage for laboratory accreditation. As a result, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme was initiated in 45 Ethiopian laboratories. OBJECTIVES: This article discusses the implementation of the programme, the findings from the evaluation process and key challenges. METHODS: The 45 laboratories were divided into two consecutive cohorts and staff from each laboratory participated in SLMTA training and improvement projects. The average amount of supportive supervision conducted in the laboratories was 68 hours for cohort I and two hours for cohort II. Baseline and exit audits were conducted in 44 of the laboratories and percent compliance was determined using a checklist with scores divided into zero- to five-star rating levels. RESULTS: Improvements, ranging from < 1 to 51 percentage points, were noted in 42 laboratories, whilst decreases were recorded in two. The average scores at the baseline and exit audits were 40% and 58% for cohort I (p < 0.01); and 42% and 53% for cohort II (p < 0.01), respectively. The p-value for difference between cohorts was 0.07. At the exit audit, 61% of the first and 48% of the second cohort laboratories achieved an increase in star rating. Poor awareness, lack of harmonisation with other facility activities and the absence of a quality manual were challenges identified. CONCLUSION: Improvements resulting from SLMTA implementation are encouraging. Continuous advocacy at all levels of the health system is needed to ensure involvement of stakeholders and integration with other improvement initiatives and routine activities.

Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems.

BACKGROUND: The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme is a large-scale effort to improve the quality of laboratories in resource-limited countries. OBJECTIVES: This study sought to evaluate the first four years (2010-2013) of SLMTA implementation. METHODS: Country-level data were submitted by SLMTA programme leads and compiled globally. Performance was measured before (baseline) and after (exit) SLMTA implementation using an audit checklist which results in a percentage score and a rating of zero to five stars. Some laboratories continued to monitor performance in post-exit surveillance audits. We evaluated score improvements using two-tailed t-tests for equal variances and estimated the number of tests performed by SLMTA laboratories based on star level. RESULTS: SLMTA was implemented in 617 laboratories in 47 countries in Africa, the Caribbean, Latin America and Southeast Asia. At the baseline audit, the laboratories scored an average of 39% on the checklist and 84% of them were rated below one star. As of December 2013, 302 laboratories had completed the SLMTA programme; mean checklist scores increased from 39% at baseline to 64% at exit (p < 0.001) over an average 16-month programme duration. Ninety-two laboratories conducted a surveillance audit at a median of 11 months after their exit audit; 62% further increased their performance. Six SLMTA laboratories have achieved accreditation status. In total, the 617 SLMTA laboratories conduct an estimated 111 million tests annually. Only 16% of these tests were conducted by laboratories with at least one star at baseline, which increased to 68% of tests after SLMTA training. Thus, approximately 23 million tests are conducted annually by laboratories previously at zero stars that now have one to five stars; this number is projected to increase to 58 million when currently-enrolled laboratories complete the programme. CONCLUSION: SLMTA has transformed the laboratory landscape in resource-limited countries worldwide and has the potential to make a substantial and sustainable impact on the quality of laboratory testing and patient care.

Attaining ISO 15189 accreditation through SLMTA: A journey by Kenya's National HIV Reference Laboratory.

BACKGROUND: The National HIV Reference Laboratory (NHRL) serves as Kenya's referral HIV laboratory, offering specialised testing and external quality assessment, as well as operating the national HIV serology proficiency scheme. In 2010, the Kenya Ministry of Health established a goal for NHRL to achieve international accreditation. OBJECTIVES: This study chronicles the journey that NHRL took in pursuit of accreditation, along with the challenges and lessons learned. METHODS: NHRL participated in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme from 2010-2011. Improvement projects were undertaken to address gaps in the 12 quality system essentials through development of work plans, team formation, training and mentorship of personnel. Audits were conducted and the scores used to track progress along a five-star grading scale. Standard quality indicators (turn-around time, specimen rejection rates and service interruptions) were measured. Costs of improvement projects and accreditation were estimated based on expenditures. RESULTS: NHRL scored 45% (zero stars) at baseline in March 2010 and 95% (five stars) after programme completion in October 2011; in 2013 it became the first public health laboratory in Kenya to attain ISO 15189 accreditation. From 2010-2013, turn-around times decreased by 50% - 95%, specimen rejections decreased by 93% and service interruptions dropped from 15 to zero days. Laboratory expenditures associated with achieving accreditation were approximately US $36 500. CONCLUSION: International accreditation is achievable through SLMTA, even for a laboratory with limited initial quality management systems. Key success factors were dedication to a shared goal, leadership commitment, team formation and effective mentorship. Countries wishing to achieve accreditation must ensure adequate funding and support.

Building local human resources to implement SLMTA with limited donor funding: The Ghana experience.

BACKGROUND: In 2009, Ghana adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme in order to improve laboratory quality. The programme was implemented successfully with limited donor funding and local human resources. OBJECTIVES: To demonstrate how Ghana, which received very limited PEPFAR funding, was able to achieve marked quality improvement using local human resources. METHOD: Local partners led the SLMTA implementation and local mentors were embedded in each laboratory. An in-country training-of-trainers workshop was conducted in order to increase the pool of local SLMTA implementers. Three laboratory cohorts were enrolled in SLMTA in 2011, 2012 and 2013. Participants from each cohort attended in a series of three workshops interspersed with improvement projects and mentorship. Supplemental training on internal audit was provided. Baseline, exit and follow-up audits were conducted using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. In November 2013, four laboratories underwent official SLIPTA audits by the African Society for Laboratory Medicine (ASLM). RESULTS: The local SLMTA team successfully implemented three cohorts of SLMTA in 15 laboratories. Seven out of the nine laboratories that underwent follow-up audits have reached at least one star. Three out of the four laboratories that underwent official ASLM audits were awarded four stars. Patient satisfaction increased from 25% to 70% and sample rejection rates decreased from 32% to 10%. On average, $40 000 was spent per laboratory to cover mentors' salaries, SLMTA training and improvement project support. CONCLUSION: Building in-country capacity through local partners is a sustainable model for improving service quality in resource-constrained countries such as Ghana. Such models promote country ownership, capacity building and the use of local human resources for the expansion of SLMTA.

Improving quality in national reference laboratories: The role of SLMTA and mentorship.

BACKGROUND: The Nigerian Institute of Medical Research houses two reference laboratories: the virology and tuberculosis laboratories. Both were enrolled in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. OBJECTIVE: To describe the impact of SLMTA and discuss factors affecting the results, with an emphasis on mentorship. METHODS: The SLMTA programme was implemented from April 2010 through November 2012. Participants attended three workshops and executed quality improvement projects; laboratory auditors evaluated performance using a standard checklist. The virology laboratory did not receive mentorship; however, the tuberculosis laboratory had an international mentor who visited the laboratory four times during the programme, spending two to four weeks embedded within the laboratory during each visit. RESULTS: There was an overall improvement in the performance of both laboratories, with the virology laboratory increasing 13% (from 80% at baseline to 93% at exit audit) and the tuberculosis laboratory increasing 29% (from 66% to 95%). These scores were maintained nine months later at the surveillance audit. CONCLUSION: The SLMTA programme resulted in improved and sustained quality management performance for both laboratories. Mentoring was a possible factor in the substantial improvement made by the tuberculosis laboratory and should be considered in order to augment the training received from the SLMTA workshops.

Using standard and institutional mentorship models to implement SLMTA in Kenya.

BACKGROUND: Kenya is home to several high-performing internationally-accredited research laboratories, whilst most public sector laboratories have historically lacked functioning quality management systems. In 2010, Kenya enrolled an initial eight regional and four national laboratories into the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. To address the challenge of a lack of mentors for the regional laboratories, three were paired, or 'twinned', with nearby accredited research laboratories to provide institutional mentorship, whilst the other five received standard mentorship. OBJECTIVES: This study examines results from the eight regional laboratories in the initial SLMTA group, with a focus on mentorship models. METHODS: Three SLMTA workshops were interspersed with three-month periods of improvement project implementation and mentorship. Progress was evaluated at baseline, mid-term, and exit using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) audit checklist and scores were converted into a zero- to five-star scale. RESULTS: At baseline, the mean score for the eight laboratories was 32%; all laboratories were below the one-star level. At mid-term, all laboratories had measured improvements. However, the three twinned laboratories had increased an average of 32 percentage points and reached one to three stars; whilst the five non-twinned laboratories increased an average of 10 percentage points and remained at zero stars. At exit, twinned laboratories had increased an average 12 additional percentage points (44 total), reaching two to four stars; non-twinned laboratories increased an average of 28 additional percentage points (38 total), reaching one to three stars. CONCLUSION: The partnership used by the twinning model holds promise for future collaborations between ministries of health and state-of-the-art research laboratories in their regions for laboratory quality improvement. Where they exist, such laboratories may be valuable resources to be used judiciously so as to accelerate sustainable quality improvement initiated through SLMTA.

Progressing beyond SLMTA: Are internal audits and corrective action the key drivers of quality improvement?

BACKGROUND: Kenya has implemented the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme to facilitate quality improvement in medical laboratories and to support national accreditation goals. Continuous quality improvement after SLMTA completion is needed to ensure sustainability and continue progress toward accreditation. METHODS: Audits were conducted by qualified, independent auditors to assess the performance of five enrolled laboratories using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. End-of-programme (exit) and one year post-programme (surveillance) audits were compared for overall score, star level (from zero to five, based on scores) and scores for each of the 12 Quality System Essential (QSE) areas that make up the SLIPTA checklist. RESULTS: All laboratories improved from exit to surveillance audit (median improvement 38 percentage points, range 5-45 percentage points). Two laboratories improved from zero to one star, two improved from zero to three stars and one laboratory improved from three to four stars. The lowest median QSE scores at exit were: internal audit; corrective action; and occurrence management and process improvement (< 20%). Each of the 12 QSEs improved substantially at surveillance audit, with the greatest improvement in client management and customer service, internal audit and information management (≥ 50 percentage points). The two laboratories with the greatest overall improvement focused heavily on the internal audit and corrective action QSEs. CONCLUSION: Whilst all laboratories improved from exit to surveillance audit, those that focused on the internal audit and corrective action QSEs improved substantially more than those that did not; internal audits and corrective actions may have acted as catalysts, leading to improvements in other QSEs. Systematic identification of core areas and best practices to address them is a critical step toward strengthening public medical laboratories.