Robert Martin, MPH, DrPH President, Diagnostic Microbiology Development Program Kathmandu, Nepal, May 2018

Transcription

1 Laboratory Strengthening and the Robert Martin, MPH, DrPH President, Kathmandu, Nepal, May 2018

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3 Global Burden of Infectious Disease DALY = Disability Adjusted Life Year

4 Infectious diseases still cause ~40% of mortality in RLC s Morens et al Nature, July 2004; 430, Fauci and Morens,, N Engl J Med February 2012; 366:

5 From: IHME Global Burden of Disease Study - Nepal

6 From Himalayan News Service Saturday, May 5, 2108

7 Laboratory Testing Supports: Patient Care Public Health Disease Reporting International Obligations

8 Value of a Diagnostic Microbiology Laboratory Individual case management by detection and identification of microbial agents of bloodstream infections, pneumonia, wound infections, meningitis, diarrhea, urinary tract infections Detection of emerging antibiotic resistance and prevention of spread of resistance Antimicrobic stewardship (AMS) Hospital infection prevention and control (IPC) Early detection of microbial pathogens with public health importance Support of outbreak investigations

9 Regulatory Agencies and Professional Organizations

10 Complexity of a Laboratory System Reporting Patient/Client Prep Sample Collection Sample Transport Record Keeping Personnel Competency Quality Control Testing Sample Receipt & preparation

11 LQMS model Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety

12 Most Resource-Limited Countries: Limited or no gov t. oversight Few or no national policies No or weak laboratory network No registration of labs, no accreditation of laboratories No process for procurement of quality laboratory reagents/kits Few professional organizations Limited testing menu Weak academics for lab medicine

13 CDC Quality Management Workshop

14 DMDP background Created in 2008 Vision: To establish diagnostic microbiology laboratories in low resource settings Supported by DTRA since 2013 Media production and distribution Diagnostic microbiology mentoring Broadened to other laboratory disciplines in 2015 Clinical mentoring

15 DMDP-Diagnostic Microbiology DMDP Mission: Development Program To build capacity for reliable laboratory testing by strengthening the infrastructure of laboratories and the technical capabilities of laboratory technicians in resource-poor countries. In-country staff: 16 Visiting experts

16 DMDP supported laboratories Kampot 4 2 1, 7, 8 Province 1 National Pediatric Hospital Implement Microbiology Bed Number Kampong Cham Battambang Takeo Kampot Siem Reap CMML 2013 NA 8 NPHL US CDC 2010 DMDP 2016 NA

17 How DMDP Strengthens Diagnostic Laboratories 2017: Onsite mentoring- 6 laboratories 5 diagnostic laboratories Kampong Cham, Takeo, Siem Reap, Battambang, NPHL 1 media making laboratory Central Media Making Laboratory Remote assistance Support manager s meetings all government microbiology labs (NMMLN) 13 government microbiology laboratories Invite collaboration with with partners Leadership from Bureau of Medical Laboratory Services

18 Pathogen Identification & Antibiotic Susceptibility Testing (AST) Strategy: Mentoring in sustainable microbiology practices needed for health care at Provincial Hospitals Pathogen Identification: Bench-top Diagnostic Microbiology (Biosafety Level II) Flow charts developed by Dr. Ellen Jo Baron Train in the art of recognition of Gram stain and colony morphology AST Method-International standard: CLSI M100S and M02-A12 Disc diffusion testing Agar diffusion with E-test to determine Minimal Inhibitory Concentration (MIC) Beta-Lactamase testing with Nitrocefin-based test (cefinase)

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20 Ellen Jo Baron Visual Charts On bench Training

21 Sputum Specimen Primary pathogens: Streptococcus pneumoniae, Klebsiella species, Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa NOT pathogens: Yeast, viridans streptococci, coagulase negative staphylococci #1 Patient should rinse mouth with water, cough from deep in lung, do not spit Strep. pneumo #2 Make Gram stain to screen if acceptable for culture Call significant Gram stain results to Doctor ASAP Reject: Many squamous epithelial cells Good: Rare squamous epithelial cells Optochin disk Staph aureus Optochin + Klebsiella pneumoniae Bile solubility + #5 Identify & perform susceptibilities on significant pathogens #3 Plate to Choc, BAP, Mac #4 Incubate up to 48 hours in CO 2 Haemophilus influenzae

22 Province Implement Microbiology Bed Number 1 National Pediatric Hospital Oct Kampong cham Jan Battambang Jan Takeo May Kampot Dec Siem Reap June % 12% 10% 8% 6% 4% 2% 0% 13% 4% 2% 4% 2% 2% 2% 4% 5% 2% 1% 1% Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Fig 7: Percentage failed AST IQC, 2015 in 5 Cambodian Microbiology laboratory REPORTING/URGENT RESULTS 60% CULTURE INTERPRETATION 65% QUALITY ASSURANCE 67% MAKING MEDIA 70% ANTIBIOTIC SENSITIVITY TESTING (AST) SPECIMEN PROCESSING 87% 74% BIOSAFETY 81% OTHER MICROSCOPY/GRAM STAIN 80% PATHOGEN IDENTIFICATION Fig 8: 9 components of lab assessment Average result from 5 microbiology in Cambodia % 75% No problem (97%, 7532) Problem (3%, 273) Fig 9: AST IQC result (7805 tests) from 5 Microbiology labs in 2015 Implementation of international standard AST Implementation of CLSI M100S and M02 On site mentoring Development of Pathogen AST guidelines, updated annually Development SOPs and job aids Managers meetings, workshops (networking 13 microbiology laboratories) MONDAY-142 Implementation of Antibiotic Susceptibility Testing (AST) for resistance tracking using Clinical and Laboratory Standards Institute (CLSI) M100 and M02 in Cambodian Microbiology Laboratories S. Oeng 1, J. Letchford 1 1 (DMDP), Phnom Penh, CAMBODIA Diagnostic Microbiology Development Program Phone: info@dmdp.org Modified Abstract Methods Results Background: DMDP collaborates with the Cambodian Ministry of Health (CMoH) to build microbiology diagnostic capacity as part of the National Strategic Plan for Laboratory Services. We introduced CLSI M100 and M02 disc diffusion to 6 Cambodian laboratories to achieve quality AST result reporting to clinicians and to begin collection of surveillance data by CMoH. Methods: DMDP used a multi-strategy approach in which included 9 manager meetings, the CLSI annual AST update webinar and CLSI M100 and M02 documents to prepare AST guidelines adapted to fit Cambodia. Mentors, DMDP staff with expertise in diagnostic microbiology, provided regular on bench training at 6 sites. Results: 5 of 6 DMDP supported laboratories have implemented AST according to Mentoring in on bench diagnostic microbiology Bi-monthly microbiology manager meetings Interactive AST and pathogen identification workshops Review and feedback of Microbiology Activity Reports and clinician reports DMDP developed & implemented: AST guidelines adapted for Cambodia AST workshop practical exercise book Electronic tool for monitoring & troubleshooting AST IQC performance Monthly Microbiology Activity Reports 5 of 6 DMDP supported laboratories implemented AST according to CLSI M100 & M02 AST IQC failures diminished from 13% (77/598) in Jan to 1% (9/657) in Dec. (Fig 7). By Nov and Dec. 2015, 3 of 5 labs recorded no AST IQC failures. Laboratory assessments in Dec 2015 showed that AST was a top component (Fig 8). Of the 3% (273/7805) of AST IQC failures in 2015, corrective action in 45% (122/273) was not applied (Fig 9) In 2015, laboratories achieved scores of 85%-95% in the pathogen ID and AST EQA. AST Workshop Pre / Post test scores showed 13% improvement from mean 72% (range 43-90) to mean 85% (range 67-97) t-test p value= CLSI M100 and M02. In 2015, 5 of 6 laboratories performed weekly AST Internal Quality Control (IQC). Problems diminished from weekly to none over 12 months. Conclusions: The multi-strategy approach strengthened Cambodian laboratory capacity for AST. Regular on site mentoring was essential. Introduction DMDP have been strengthening microbiology diagnostic capacity in Cambodia since 2008 Fig 2: Dr Ellen Jo Baron Chart Disc Diffusion testing Fig 3: Salmonella Paratyphi A Disc diffusion & biochemical testing Table 2: DMDP AST guidelines 2015 Conclusions No Corrective action (45%, 122) Corrective action (55%, 151) (Fig 1, Table 1), using sustainable diagnostics according to Professor Ellen Jo Baron s A multi-strategy approach strengthened Cambodian government microbiology capacity. diagnostic flow charts (Fig 2 & Fig 3). In 2013, DMDP developed and implemented AST Regular on site mentoring was essential. guidelines adapted for Cambodia (Table 2). In 2014, DMDP chose to implement a training Practice, encouragement and cultural awareness were key components to success. of CLSI M02 and CLSI M100 (Fig 4), review of the AST guidelines and mentoring at 6 government hospitals. Laboratories were encouraged to perform weekly AST IQC. Sites electronically submitted AST IQC (Table 3) and a monthly Microbiology Activity Report (Table 4) for review. Mentors worked side by side with government staff (Fig 5). DMDP included AST in the agenda of training workshops and meetings (Fig 6). Fig 4: AST workshop 2015 Table 3: AST IQC-October 2015, week 2, all labs Access to CLSI M100S and M02 and American Type Culture Collection organisms was essential-dmdp & World Health Organization purchased CLSI M100S & M02. Now, CLSI M100S FREE is available. This activity provided stimulation and opportunity for Cambodia CMoH to collect National AMR surveillance data and enroll in Global AMR Surveillance System (GLASS). Table 1: Cambodian hospital microbiology laboratories Figure 5: DMDP mentor training Table 4: Monthly microbiology activity report Surveillance for priority pathogens, Typhoidal Salmonella, Burkholderia pseudomallei and Streptococcus suis highlights the importance of continued laboratory support in Cambodia. Support; consulting Figure1: Cambodia Ref - Figure 6: Follow up workshop training December 2015 James McLaughlin- Ph.D.; D(ABMM), Prof. Emerita Univ. of New Mexico SOM, President DMDP, Ellen Jo Baron- Ph.D., D(ABMM), Prof. Emerita, Stanford Univ., Janet A. Hindler- MCLS, MT (ASCP), Em Rattanak- DMDP Laboratory mentor, Morn Sineang- DMDP Laboratory mentor, Angelo Caon- DMDP Expert mentor.

23 National Public Health Laboratory (NPHL) Strengthen NPHL microbiology Assessment February 2016 Placement of expat mentors at NPHL Activities: Establish National Reference Laboratorybeginning with national AMR surveillance Assist NPHL to develop a national microbiology EQA program NPHL AST guideline training

24 Microbiology meetings March days Sept/Oct days January days Takeo UHS NIPH Agenda topics Culture interpretation Antibiotic Susceptibility Testing (AST) Guideline Bioterrorism agents Pathogen identification CLSI update and orientation to use revised AST Guideline Specimen processing and culture interpretation Case presentations-lab presentation Peter H Gilligan, PhD Clinical case presentations Pathogen identification interactive quiz Antimicrobial Resistance

25 Central Media-Making Laboratory

26 Why are Resource poor Micro Lab results often wrong? One reason - use of human blood in blood agar Human blood is readily available (outdated human bank blood or volunteers) It is free Wool sheep too hard to maintain & bleed Staph aureus Strep. pyogenes

27 Central Media Making Laboratory DMDP supporting and strengthening production and distribution of quality media Brain Heart Infusion Adult 50ml Pediatric 25ml Biochemical tube media: Urea, Citrate, SIM, LIA, KIA Sheep Blood Agar Plates Internal Quality Control External Quality Control Sihanouk Hospital Centre of Hope Mueller Hinton II Sheep Blood MH II MacConkey agar Ashdowns agar

28 Units of media Media distribution 2016*, media units Media plate 29417, Blood culture bottle 10674, tube Kossamak NPH Kampot Battambang Takeo Kampong Cham Siem Reap Tubes Bottles Plates Private client

29 Benefit of blood culture: Detect pathogens in Cambodia Burkholderia pseudomallei Streptococcus suis You can gain valuable information from observation and simple initial tests

30 Streptococcus suis

31 Burkholderia pseudomallei Blood culture isolate Sheep blood agar, Day 3 Blood culture isolate MacConkey agar, Day 3

32 Burkholderia pseudomallei Sheep blood agar B. pseudomallei on sheep blood agar, Day 1 PB: Polymixin B resistant AMC: Amoxicillin Clavulanic acid susceptible CN: Gentamicin resistant

33 Major gaps and challenges Lack of quality pre-service training for Health Care Workers lab tech, clinician, nurse, pharmacist. Lack of clinician understanding of appropriate use of the microbiology service Lack of patient information and quality specimens to provide good data Lack of quality microbiology lab supply procurement Lack of capacity in data management and data analysis Limited dissemination of data to range of stakeholders

34 Thank you

35 Mt Baker National Park Washington State