Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative.

Background: Since 2010, Kenya has used SLIPTA to prepare and improve quality management systems in medical laboratories to achieve ISO 15189 accreditation. However, less than 10% of enrolled laboratories had done so in the initial seven years of SLMTA implementation. Objective: We described Kenya's experience in accelerating medical laboratories on SLMTA to attain ISO 15189 accreditation. Methods: From March 2017 to July 2017, an aggressive top-down approach through high-level management stakeholder engagement for buy-in, needs-based expedited SLIPTA mentorship and on-site support as a rapid results initiative (RRI) was implemented in 39 laboratories whose quality improvement process had stagnated for 2-7 years. In July 2017, SLIPTA baseline and exit audit average scores on quality essential elements were compared to assess performance. Results: After RRI, laboratories achieving greater than a 2-star SLMTA rating increased significantly from 15 (38%) at baseline to 33 (85%) (p < 0.001). Overall, 34/39 (87%) laboratories received ISO 15189 accreditation within two years of RRI, leading to a 330% increase in the number of accredited laboratories in Kenya. The most improved of the 12 quality system essentials were Equipment Management (mean increase 95% CI: 5.31 ± 1.89) and Facilities and Biosafety (mean increase [95% CI: 4.05 ± 1.78]) (both: p < 0.0001). Information Management and Corrective Action Management remained the most challenging to improve, despite RRI interventions. Conclusion: High-level advocacy and targeted mentorship through RRI dramatically improved laboratory accreditation in Kenya. Similar approaches of strengthening SLIPTA implementation could improve SLMTA outcomes in other countries with similar challenges.

The status of HIV testing and counseling in Kenya: results from a nationally representative population-based survey.

BACKGROUND: HIV testing and counseling (HTC) is essential for successful HIV prevention and treatment programs. The national target for HTC is 80% of the adult population in Kenya. Population-based data to measure progress towards this HTC target are needed to assess the country's changing needs for HIV prevention and treatment. METHODS: In 2012-2013, we conducted a national HIV survey among Kenyans aged 18 months to 64 years. Respondents aged 15-64 years were administered a questionnaire that collected information on demographics, HIV testing behavior, and self-reported HIV status. Blood samples were collected for HIV testing in a central laboratory. Participants were offered home-based testing and counseling to learn their HIV status in the home and point-of-care CD4 testing if they tested HIV-positive. RESULTS: Of 13,720 adults who were interviewed, 71.6% [95% confidence interval (CI): 70.2 to 73.1] had been tested for HIV. Among those, 56.1% (95% CI: 52.8 to 59.4) had been tested in the past year, 69.4% (95% CI: 68.0 to 70.8) had been tested more than once, and 37.2% (95% CI: 35.7 to 38.8) had been tested with a partner. Fifty-three percent (95% CI: 47.6 to 58.7) of HIV-infected persons were unaware of their infection. Overall 9874 (72.0%) of participants accepted home-based HIV testing and counseling; 4.1% (95% CI: 3.3 to 4.9) tested HIV-positive, and of those, 42.5% (95% CI 31.4 to 53.6) were in need of immediate treatment for their HIV infection but not receiving it. CONCLUSIONS: HIV testing rates have nearly reached the national target for HTC in Kenya. However, knowledge of HIV status among HIV-infected persons remains low. HTC needs to be expanded to reach more men and couples, and strategies are needed to increase repeat testing for persons at risk for HIV infection.

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.