The Dream of Automating the Microbiology Lab

Transcription

1 The Dream of Automating the Microbiology Lab James E. Lee, Ph.D., MT(ASCP) Disclaimer The views expressed are those of the authors and do not reflect the official policy of the Department of the Army, Department of Defense or the U.S. Government. 1

2 Overview Objectives Brief History of Microbiology Current State The Future Justification for the Future Making the Plan Objectives Identify current and future clinical microbiology automation systems including positive and negative attributes of each. Learn how to develop a fiscal and patient outcome justification to introduce automation to your microbiology lab. Discover how to perform strategic planning for implementation of new microbiology testing systems. 2

3 Brief History of Clinical Microbiology 1600 s - Discovery of the Microbial World Microscope Robert Koch Germ Theory Robert Koch Agar Media Isolation of individual Pathogens Brief History of Clinical Microbiology 1940 s - Alexander Fleming Penicillin Antibiotic Era begins 1950 s Serological Detection and Typing 3

4 Brief History of Clinical Microbiology 1980 s ID and Susceptibility Automation 1986 Kary Mullis Polymerase Chain Reaction 2000 s Real-Time PCR Overall goal of a Microbiology Lab? What is the pathogen? How can we kill it? Time to diagnosis linked to outcome Shorter TAT = better patient care Antibiotic Susceptibility Testing (AST) linked to outcome. Automation should increase efficiency 4

5 Current State - Processing Manual Plating and Gram Stain Skill dependent Low tech but still the gold standard Current State - Processing 5

6 Current State - Staining Gram Stain Instruments Decrease tech to tech variability in colony isolation Usually faster High Cost Current State Gram Stain Reader 6

7 List of Automation Processors: Biomerieux - Previ Isola Copan Diagnostics WASP Becton Dickenson Kiestra Gram Stain Biomerieux Previ (centrifugal spray) GG&B Co. MGS-80, MGS-1000 (auto-decolorizer) Polystainer or Midas III (Dip-stainers) Current State Detection and ID Direct From Sample Antigen Detection > Lateral Flow Immunoassay > Semi-Automated Fluorescent Immunoassay Direct Fluorescent Antibody 7

8 Current State Detection and ID Nucleic Acid Detection > Probe FISH Blood Cultures > PCR > LCR Current State - Identification Pathogen Identification Manual Biochemical Identification > Traditional Algorithms > Special Media Automated Biochemical Identification: hrs > Semi-automated 8

9 Current State - Identification MALDI-TOF MS Matrix Assisted Laser Desorption/Ionization Time Of Flight Mass Spectrometry 9

10 Current State Antibiotic Susceptibility Kirby-Bauer Disk Diffusion E-test Semi-automated Minimum Inhibitory Concentration (MIC) Manual MIC Current State Antibiotic Susceptibility Chromogenic Agar Fluorescent Live/Dead Staining PCR Gene detection Real Time Microscopy 10

11 Current State Time to Result All Manual Methods ID and AST Final Result - three working days > ChromAgar One working day ID Automated Biochemical ID and AST Final Result two working days Rapid tests (serology or nucleic acid) Less than 2 hours Time to result can be shortened with more staff Future Detection and Identification Droplet Microencapsulation 11

12 Future Detection and Identification Droplet Microencapsulation Future Detection and Identification Droplet Microencapsulation 12

13 Future Antibiotic Susceptibility Testing MALDI-TOF or Electrospray Ionization MS Measure Minimal Profile Change Concentration Future Antibiotic Susceptibility Testing Flow Cytometry Live/Dead Analysis Microbial Cell Weighing using vibrating cantilevers 13

14 Future Antibiotic Susceptibility Testing Suspended Nanochannel Resonators Future Antibiotic Susceptibility Testing Isothermal microcalorimetry Measures Minimum Heat Inhibition Concentration 14

15 Future Antibiotic Susceptibility Testing Magnetic Bead Rotation in Microdroplets Break Slide 15

16 Justification Cost Internal Savings > Cost per test savings Labor Materials Equipment External Savings > Decreased bed days > Decreased/appropriate antibiotic use Justification Non-measurable Patient outcome > Length of stay > 30-day risk > Mortality Community Health 16

17 Example Justification 1 Positive Culture Workup Status Quo - Vitek Internal Cost per positive MALDI-TOF (First 2 yrs) MALDI-TOF (Year 3) Labor $10 $8 $8 Materials $19 $12.50 $12.50 Equipment $0 $10 $4 Internal Total $29 $30.50 $24.50 Positives/year 8,200 8,200 8,200 GRAND TOTAL $237,800 $250,100 $200,900 Example Justification 1 Positive Patient Result Status Quo MALDI-TOF External Cost per positive Reduced Bed Day Cost $0 $192,500 Antibiotic Cost Data not available Data not available External Total $0 $192,500 Bed Day Cost = $3500 x 0.05 x (ID Pat bed days/yr) Antibiotic Cost = Wide Variation ($1.70-$75.00 oral 10 day course) ($30-$200 IV/day) 17

18 Example Justification 2 Positive Blood Culture Workup Status Quo - Vitek BioFire FilmArray (First 2 yrs) BioFire FilmArray (Year 3) Internal Cost per positive Labor $20 $5 $5 Materials $19 $109 $109 Equipment $0 $134 $16 Internal Total $39 $248 $130 Positives/year GRAND TOTAL $11,700 $74,400 $39,000 Example Justification 2 Positive Patient Result Status Quo BioFire FilmArray External Cost per positive Reduced Bed Day Cost $0 $374,500 Antibiotic Cost Data not available Data not available External Total $0 $374,500 Bed Day Cost = $3500 x (ID Pat bed days/yr) Antibiotic Cost = Wide Variation 18

19 Strategic Planning Confounders to Automation Micro is complex > Diverse Specimens > Diverse Transport Containers > Media Types > Processing Requirements Human Hubris > Automation can t make decisions > Tech resistance Cost Back-up Plan? Space Strategic Planning Communication Strategy Strategic Planning Committee Mission and Vision Statements Guiding Principles and Values Areas of Focus Goals > Objectives Tasks Implementation Strategy Monitoring the Strategic Plan 19

20 Strategic Planning Mission: Provide high quality, timely and accurate clinical microbiology services for MAMC and WRMC in a customer-focused and safe working environment. Graduate microbiology proficient Medical Laboratory Technicians as a Phase II clinical training site for the 68K Course. Collaborate with Infectious Disease, Infection Control and Preventive Medicine staff as subject matter experts. Strategic Planning Vision: Keep Madigan Army Medical Center at the forefront of clinical microbiology by leveraging new technologies and giving the best possible information to the clinician. 20

21 Strategic Planning Guiding Principles and Values: Clinical Care Standards Staff Customer Service Sense of Ownership Attitude and Communication Appearance Service Recovery Standard Madigan Code of Conduct Strategic Planning Areas of Focus SERVICE PEOPLE QUALITY FINANCE and GROWTH Destination Points Your goals Constantly tracked objectives using accurate metrics Have a clear end state for each task Not too many! 21

22 Example - DPALS-Specific Goals 2015 SERVICE (40%) Provide full-circle care for patients and providers. Targeted service improvement for higher use/acuity patients. PEOPLE (30%) Decrease personnel turnover through improved retention practices rewarding high performers, motivating middle performers, and marginalizing low performers. QUALITY (20%) Focus on quality improvement, rather than just quality assurance. Drive responsibility for QA/QI to ALL employees. Improved organization. FINANCE (10%) Reduce cost through improved laboratory utilization. Modest growth through recapture of high-volume sendout testing and appropriate volume referral testing. Example Microbiology Objectives SERVICE (30%) Provide full-circle care for patients and providers: Acquisition of equipment for rapid molecular-based identification of pathogens. Part of a two year study to determine if faster identification can result in cost savings and improved patient outcome. METRIC: Percent of completion. Ends with submission of research protocol. 25% - Validate the BioFire FilmArray before 1 June % - Submit research protocol by 1 July 2015 for case matching study to determine patient outcome and fiscal impacts of faster diagnosis. 75% - Obtain and validate a MALDI-TOF before 31 Oct % - Submit a research protocol by 30 October 2015 for case matching study to determine patient outcome and fiscal impacts of faster diagnosis. 22

23 Example Microbiology Objectives PEOPLE (30%) Decrease personnel turnover through improved retention practices rewarding high performers, motivating middle performers, and marginalizing low performers. Propose establishing some GS-9/10 or just GS-10 positions in the laboratory to allow for more upward mobility for staff and a mechanism to recognize excellence. METRIC: Percent of completion. Ends with submission of positions. 33% - Perform TDA review with Lab Manager by 1 April 2015 to determine number of positions to reclassify. 66% - Rewrite or find GS-10 job descriptions by 1 June % - Submit positions for reclassification by 30 September Example Microbiology Objectives QUALITY (20%) Drive responsibility for QA/QI to ALL employees: Increase involvement of the staff in the daily QA activities like review of peer s work sheets. METRIC: >90% of worksheets peer reviewed daily. Improved organization: Monitor specimen viability e.g. track specimens that are delayed, rejected or have no time of collection for reference. Determine trends within the data to indicate where efforts for improvement are best spent. METRIC: After establishing baseline for 30 days, identify the top three clinics sending erroneous samples. Perform Rounding for Outcomes with these clinics and continue monitoring. Overall goal of <5 erroneous samples per week. 23

24 Example Microbiology Objectives FINANCE AND GROWTH (20%) Improved timeliness and accuracy of DMHRSi: (Commander) Adhere to Commander and DPALs guidelines for submission of DHMRIS by constant monitoring input. Educate staff about correct DHMRSI codes/activity when there are variances. METRIC: 100% compliance with DMHRSi data quality per pay period. 24