Jane Mwangi

Reduced risk of transfusion‐transmitted HIV in Kenya through centrally co‐ordinated blood centres, stringent donor selection and effective p24 antigen‐HIV antibody screening

Background  Following a 1994 study showing a high rate of transfusion‐associated HIV, Kenya implemented WHO blood safety recommendations including: organizing the Kenya National Blood Transfusion Service (NBTS), stringent blood donor selection, and universal screening with fourth‐generation p24 antigen and HIV antibody assays. Here, we estimate the risk of transfusion‐associated HIV transmission in Kenya resulting from NBTS laboratory error and consider the potential safety benefit of instituting pooled nucleic acid testing (NAT) to reduce window period transmission.

Blood donors in Kenya: a comparison of voluntary and family replacement donors based on a population-based survey

Background and Objectives  Blood safety and sufficiency are major challenges in Kenya and other sub‐Saharan African countries forcing many countries to rely on family replacement donors (FRD). We analysed data from a national AIDS indicator survey to describe blood donors in Kenya and potential risks of transfusion transmissible infections (TTI) comparing voluntary donors and FRD.

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.

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

Comparison of HIV-1 detection in plasma specimens and dried blood spots using the Roche COBAS Ampliscreen HIV-1 test in Kisumu, Kenya

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.

Medical Injection Use Among Adults and Adolescents Aged 15 to 64 Years in Kenya: Results From a National Survey

The World Health Organization recommends screening donor blood for HIV in centralized laboratories. This recommendation contributes to quality, but presents specimen transport challenges for resource-limited settings which may be relieved by using dried blood spots (DBS). In sub-Saharan Africa, most countries screen donor blood with serologic assays only. Interest in window period reduction has led blood services to consider adding HIV nucleic acid testing (NAT). The U.S. Food and Drug Administration (FDA) mandates that HIV-1 NAT blood screening assays have a 95% detection limit at or below 100 copies/ml and 5000 copies/ml for pooled and individual donations, respectively. The Roche COBAS Ampliscreen HIV-1 test, version 1.5, used for screening whole blood or components for transfusion, has not been tested with DBS. We compared COBAS Ampliscreen HIV-1 RNA detection limits in DBS and plasma. An AIDS Clinical Trials Group, Viral Quality Assurance laboratory HIV-1 standard with a known viral load was used to create paired plasma and DBS standard nine member dilution series. Each was tested in 24 replicates with the COBAS Ampliscreen. A probit analysis was conducted to calculate 95% detection limits for plasma and DBS, which were 23.8 copies/ml (95% CI 15.1-51.0) for plasma and 106.7 copies/ml (95% CI 73.8-207.9) for DBS. The COBAS Ampliscreen detection threshold with DBS suggests acceptability for individual donations, but optimization may be required for pooled specimens.

Quantification of print, radio and television exposure among previous blood donors in Kenya: an opportunity for encouraging repeat donation in a resource-limited setting?

Background:Unsafe medical injections remain a potential route of HIV transmission in Kenya. We used data from a national survey in Kenya to study the magnitude of medical injection use, medication preference, and disposal of medical waste in the community. Methods:The Kenya AIDS Indicator Survey 2012 was a nationally representative population-based survey. Among participants aged 15–64 years, data were collected regarding medical injections received in the year preceding the interview; blood samples were collected from participants for HIV testing. Results:Of the 13,673 participants who answered questions on medical injections, 35.9% [95% confidence interval (CI): 34.5 to 37.3] reported receiving ≥1 injection in the past 12 months and 51.2% (95% CI: 49.7 to 52.8) preferred receiving an injection over a pill. Among those who received an injection from a health care provider, 95.9% (95% CI: 95.2 to 96.7) observed him/her open a new injection pack, and 7.4% (95% CI: 6.4 to 8.4) had seen a used syringe or needle near their home or community in the past 12 months. Men who had received ≥1 injection in the past 12 months (adjusted odds ratio, 3.2; 95% CI: 1.2 to 8.9) and women who had received an injection in the past 12 months, not for family planning purposes (adjusted odds ratio, 2.6; 95% CI: 1.2 to 5.5), were significantly more likely to be HIV infected compared with those who had not received medical injection in the past 12 months. Conclusions:Injection preference may contribute to high rates of injections in Kenya. Exposure to unsafe medical waste in the community poses risks for injury and infection. We recommend that community- and facility-based injection safety strategies be integrated in disease prevention programs.

Findings of Phlebotomy Practices in Kenya in 2010: Need for Action

Blood services in sub‐Saharan Africa experience blood shortages and low retention of voluntary, non‐remunerated donors. To boost collections by encouraging repeat donations, the Kenya National Blood Transfusion Service is exploring the likelihood of reaching previous donors through targeted print, radio and television advertising. We analysed data from a national AIDS Indicator Survey to determine whether previous donors have significant exposure to media. Respondents reporting history of blood donation had significantly higher exposure to print, radio and television media than those without history of blood donation. Targeted media campaigns encouraging repeat donation are likely to reach previous donors even in resource‐limited settings.

Implementing SLMTA in the Kenya National Blood Transfusion Service: lessons learned

BACKGROUND Phlebotomy, a commonly performed medical procedure in healthcare, is essential for disease diagnosis and patient management. However, poorly performed phlebotomy can compromise patient safety, healthcare worker (HCW) safety, and specimen quality. We carried out a study between June and July 2010 to assess knowledge, quality and safety of phlebotomy before implementation of a public-private partnership between Becton, Dickinson and Company and the US Presidents Emergency Plan for AIDS Relief. METHODS This was a cross-sectional observational study in 8 healthcare facilities within 4 regions of Kenya. HCWs were observed conducting venous and capillary blood collections, and pre- and posttests were offered during HCW training. RESULTS Of 283 blood samples obtained, 194 were venous draws conducted by 72 HCWs and 89 were capillary draws performed by 33 HCWs. Based on 12 preset quality-associated criteria, none of the 194 observed phlebotomies met the standard. In total, 91 HCWs were trained in phlebotomy. The mean knowledge increase between pre- and posttraining test was 41%, ranging from 39% to 45% (95% confidence interval, 29.3%-53.5%;P< .001). CONCLUSIONS Inadequate knowledge and imperfect phlebotomy procedures were noted. This formed the basis for the safe phlebotomy partnership to address these deficiencies. To ensure sustainability, safe phlebotomy practices were integrated into preservice training.

Author response to: letter to the editor HIV safety in sub-Saharan Africa

Background The Kenya National Blood Transfusion Service (KNBTS) is mandated to provide safe and sufficient blood and blood components for the country. In 2013, the KNBTS National Testing Laboratory and the six regional blood transfusion centres were enrolled in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. The process was supported by Global Communities with funding from the United States Centers for Disease Control and Prevention. Methods The SLMTA implementation at KNBTS followed the standard three-workshop series, on-site mentorships and audits. Baseline, midterm and exit audits were conducted at the seven facilities, using a standard checklist to measure progress. Given that SLMTA was designed for clinical and public health laboratories, key stakeholders, guided by Global Communities, tailored SLMTA materials to address blood transfusion services, and oriented trainers, auditors and mentors on the same. Results The seven facilities moved from an average of zero stars at baseline to an average of three stars at the exit audit. The average baseline audit score was 38% (97 points), midterm 71% (183 points) and exit audit 79% (205 points). The Occurrence Management and Process Improvement quality system essential had the largest improvement (at 67 percentage points), from baseline to exit, whereas Facilities and Safety had the smallest improvement (at 31 percentage points). Conclusion SLMTA can be an effective tool for preparing a blood transfusion service for accreditation. Key success factors included customising SLMTA to blood transfusion activities; sensitising trainers, mentors and auditors on operations of blood transfusion service; creating SLMTA champions in key departments; and integrating other blood transfusion-specific accreditation standards into SLMTA.