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Implementation of MALDI-TOF MS in the Routine Clinical Laboratory Robert C. Jerris Ph.D., D(ABMM) Children’s Healthcare of Atlanta, Emory University, Atlanta, GA Theresa Stanley Lars Westblade, Ph.D John Rogers, Eric Graves, Summer Interns Ankita DeSai, ID Fellow; Beverly Rogers, Chief Aurora Muhuza DB coordinator Maria Atuan-Lean, Six Sigma Jonelle McKey-Financial Analysis

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Implementation of MALDI-TOF MS in the Routine Clinical Laboratory

Robert C. Jerris Ph.D., D(ABMM)

Children’s Healthcare of Atlanta,

Emory University, Atlanta, GA

• Theresa Stanley

• Lars Westblade, Ph.D• John Rogers, Eric Graves, Summer Interns

• Ankita DeSai, ID Fellow;

• Beverly Rogers, Chief

• Aurora Muhuza DB coordinator

• Maria Atuan-Lean, Six Sigma

• Jonelle McKey-Financial Analysis

Disclosure:

2010, Database development Bruker

Reagent support

Children’s by the Numbers3 Hospitals

520 staffed beds17 neighborhood locations, including:

Four Immediate Care CentersOne Primary Care CenterMarcus Autism Center

More than 7,500 employeesAccess to more than 1,600 pediatric physicians

6,500 volunteers 2nd Largest pop. of pediatric CF patients in US

Objectives: MALDI-TOF

• Preanalytical

– Justification

– System selection

• Analytical

– How, What, Where, When, Why

• Postanalytical

– REPORTING

Doern, 2013 Clinical Microbiology Newsletter 35:69-785

Excellent Review

Clark et al., 2013 Clin Microbiol Rev 26:547-6036

Pre-Analytical

Cost Justification:

Direct comparison to phenotypic test

Assessment of outcomes

Reimbursement

Cost-effectivenesss of switching to MALDI-TOF MS for routine bacterial identification

Galliot O. e tal.JCM 2011. 49:4412

September 2009

Switched from conventional biochemicals (Vitek 2 and API) to MALDI-TOF MS (Bruker)

Cost analysis performed

October 2008-September

2009

October 2009-September

2010

Isolates Tested 33,320 38,624

BiochemicalCosts

$193,754 $5,374

MALDI-TOF - $15,836

TOTAL $193,754 $21, 210

Avg Cost/ID $5.81 $.54

Annual Savings = $177, 090 “allowed decrease of 89.3% of the cost of bacterial identification in the first year.”In addition:

Decreased waste from 1,424kg to 44kgDecreased subculture media of $1,102Decreased sequencing cost of $1,650

Impact of MALDI-TOF MS on Time to Identification and Cost-Effectiveness in the Microbiology Laboratory

Estimated annual costs for the standard protocol and MALDI protocol

Estimated reduction in reagent and labor costs of identification by $102,424 within 12 mo

Tan et al., 2012 J Clin Microbiol 50:3,301-89

Tran et al., 2014 Presented at the 114th General Meeting of the ASM, Boston, May 17th-20th, 2014

• Impact of MALDI-TOF MS on cost of identification: reagent and technologist

• Compared conventional identification (e.g., biochemicals) to MALDI-TOF MS identification over a 12 mo period

• 21,930 isolates: Gram-negative, Gram-positive and yeast Reagents costs:

Conventional identification, $84,491.61MALDI-TOF MS identification, $6,469.53Net savings, $78,022.08

• Significant reduction (95.2%) in reagent costs when identifying Weirdobacterspecies (Gram-negative glucose non-fermenters)

• Total savings including technologist time: $118,260.18

• Verification studies: $4,357.78

Impact of MALDI-TOF MS on Cost-Effectiveness in the Microbiology Laboratory

10

Desai and colleagues

• Analyzed 464 isolates from 24 unique CF specimens and

detailed 85% of complex organisms (non-fermentative Gram-negative rods including 29 Burkholderia species) identified within 48 h compared to only 34% by conventional methods.

• The cost per identification using lean six sigma hand motion analysis was $1.25 by MALDI-ToFMS compared to $28.00 by conventional methods for these organisms

Desai, Stanley, LiPuma, Jerris. 2012. J Clin Path. 65:835

Impact of MALDI-TOF MS Identification on Clinical Outcomes

• Impact of MALDI-TOF MS identification (from cultures) and antimicrobial stewardship team intervention on outcomes in adult patients with bacteremia and candidemia

• 501 patients : 256 in preintervention group and 245 in intervention group

Huang et al., 2013 Clin Infect Dis 57:1,237-4512

Impact of MALDI-TOF MS Identification on Clinical Outcomes

Clinical and treatment-related outcomes

Huang et al., 2013 Clin Infect Dis 57:1,237-4513

Impact of MALDI-TOF MS Identification on Clinical Outcomes

Perez et al., 2013 Arch Pathol Lab Med 137:1,247-54

• MALDI-TOF MS (Bruker RUO)-based identification of Gram-negative organisms directly from positive blood cultures

• Gram-negative AST set up directly from positive blood cultures (BD Phoenix)

• Preintervention (112) and intervention (107) groups

• Interventions:- Gram stain result called to appropriate member of the patient care team 24/7(same for preintervention and intervention groups)

- MALDI-TOF MS identification and AST data called to on-call pharmacist 24/7(only for intervention group)

• Significant reduction in length of hospitalization, 11.9 vs 9.3 days (P = 0.01)

• Significant reduction mean hospital costs/patient, $45,709 vs $26,126. (P = 0.009)

14

Pre-Analytical

• Selection of Instrument

Size/footprint

Electrical requirements

Data drops

Service contract

Connectivity

Workflow and volume

• Backup systems: plan for 3 days

Commercially Available Platforms:VITEK MS IVD System (bioMérieux)

Instrument: VITEK MS

Database (closed): Knowledge Base v2

Organisms claimed: clearance for 193 taxa with performance claims List available at http://clinicaltrials.gov/

(+ 562 non-claimed RUO species, Gram-negative, Gram-positive, yeast, filamentous fungi [few])

Preparation: - Bacteria, direct transfer - Yeast, on target extraction

Target: Disposable

Image: David Pincus/Marc van Nuenen, bioMérieux16

Commercially Available Platforms:VITEK MS RUO System (bioMérieux)

Instrument: VITEK MS

Database (open): SARAMIS SuperSpectra v4.13

Organisms contained: 1,427 taxa, Gram-negative, Gram-positive, yeast, filamentous fungi [many], mycobacteria

Preparation: - Bacteria, direct transfer- Yeast, on target extraction

Target: Disposable

Image: David Pincus/Marc van Nuenen, bioMérieux17

Commercially Available Platforms:VITEK MS IVD and RUO Systems Workflow

Image: David Pincus/Marc van Nuenen, bioMérieux

MylaTM

Server

Acquisition Station

Prep Station

RUO database v4.13

Research only

• Strain Typing

• Resistance testing

• Blood cultures

IVD database v2.0Reporting & BillingConnected to LIS

Patient samples

Research ApplicationsAdding species to RUO database

Connectivity to AST at Prep Station

18

VITEK MS IVD Knowledge Base v2.0• Uses a weighted bin matrix

• Features: No spectra comparison

No spectra embedded in the commercial software, only a matrix of bins and weights

• Default manufacturer’s confidence value:

60.0% to 99.9% and a single identification: accept identification (typically species level)

Low discrimination identification: >1 but not more than 4 organisms displayed (typically genus level)

Unidentified organisms: >4 organisms Peaks

1 2 3 4 5 6 7 8 9 10 ………………………….

Bin

s1 2 3 4 5 6 7 8 9 10 ………………

+ + + + + + ++P

resence/A

bsen

ce Peaks

Weights for each bin:++ : highly species-specific (+15, +20….)+ : moderately species-specific (+3, +4….)-: peak absent (-3, -4….)--- : Absent and peak important for other species (-15)

Instrument: Microflex LT

Database (closed): v1

Organisms claimed: clearance for 100 species (in 40 claimed groups) with performance claims, Gram-negative

v2 in preparation: submission (Sept. 2014) of additional 190 species (in 170 claimed groups), Gram-negative, Gram-positive, (aerobic and anaerobic) and yeastList available at http://clinicaltrials.gov

(+ 940 non-claimed RUO species; Gram-negative, Gram-positive and yeast)

Preparation:- Direct transfer on target extraction full extraction - Direct transfer full extraction

Target: Non-disposable

Commercially Available Systems: IVD MALDI Biotyper CA™ System (Bruker)

Image: Markus Kostrzewa, Bruker20

Commercially Available Systems: RUOMALDI Biotyper™ System (Bruker)

Instrument: Microflex LT

Databases (open): - Main 5627 - Select agent v1 - Mycobacteria v2 - Fungi v1

Organisms contained:- Main, 2,297 species (Gram-negative, Gram-positive, yeast, filamentous fungi [few] and mycobacteria [few])- Select agent, 11 species- Mycobacteria, 131 species- Filamentous fungi, 128 species

Preparation: - Direct transfer on target extraction full extraction - Direct transfer full extraction

Target: Non-disposable and disposableImage: Markus Kostrzewa, Bruker

21

MBT CA (US IVD System)

• FDA cleared• Simplified user inteface• Closed system• MBT CA specific database

MBT RUO

• RUO main database 2,297 species(+ specialized databases)

• Open, user library generation and utilization• Sepsityper module (blood cultures)• Beta-lactamase module• Spectra analysis and statistical tools

Identical software architecture andpattern matching algorithm,spectra acquisition control

Connectivity to various AST and LIS systems via adopted solutions

MBT GalaxyMBT Pilot

Prepartation guidance and matrix spotting

Commercially Available Platforms: Bruker IVD and RUO Systems Workflow

Slide: Markus Kostrzewa, Bruker22

• Pickolo-MI, Robotic sampling, TECAN (Morrisville, NC);

• Copan WASP (Murrietta,CA);

• Copan, MALDI-Trace (Murrietta, CA)

• Becton Dickinson(BD) Kiestra (Franklin Lakes, NJ)

• These systems facilitate paperless, guided target preparation through one of several mechanisms including: up front data entry into a traceable log (e.g., BD Kiestra); bar coded sample entry (e.g., Bruker Pilot), or; radio frequency identification (RCID)(e.g., Copan MALDI Trace).

Default manufacturer’s score value:- 2.000 to 3.000: High confidence identification (species level)

-1.700 to 1.999: Low confidence identification: progress to on target/full extraction (report to genus/group/species based on available/additional [clinical/phenotypic] information)

- 0.000-1.699: No identification

MALDI Biotyper™ System Database

Slide (source): MALDI Biotyper 3.0 User Manual Revision 2Be aware of differing versions when comparing data-current 3.1 !! 24

Uses pattern matching: Features: Spectra comparisonSpectra embedded in a database that is connected to the commercial software

Optimizing Identification

• Gram positives: on plate formic acid >= 1.7

– (Patel- Mayo, Burnham-Wash U [JCM 51: 1421])

• Gram negative and non-fermenters >=1.9

– (Ford [JCM 51:1412])

• Yeast >=1.7

– (Jerris [ASM 2013])

• Rapidly Growing Mycobacteria >=1.7

– (Jerris [ASM 2014])

Can Different Databases Make a Difference?

• S. pneumoniae, 25; S. mitis, 34; S. oralis, 3 (62 isolates)

• Software:- Visual inspection of spectra: FlexAnalysis 2.4 - Comparison and identification of spectra: Biotyper 3.0- Database processing: ClinProTools 2.1 (perhaps not for the routine laboratory)

• Peak 6,949 m/z specific for nonpneumococcal mitis group species

• Differentiated between all S. pneumoniae and nonpneumococcal mitis group species

Ikryannikova et al., 2013 Clin Microbiol Infect 19:1,066-7127

Analytical

MEDIA

• Culture condition environment (aerobic, anaerobic, microaerophilic, microaerobic) , temperature, and media have little effect on accuracy of identification of organisms by MALDI-Tof MS.

• Organisms can be tested after storage:

5 days of storage at 35oC and 4o (McElvania, 2013).

our experience extends this to

10 days post routine incubation

(but not directly from the cold)

Preparation of Specimens: Direct Transfer

1.

Isolated colony

2.

Colony applied to target, less is more (~5 s)

3.

Matrix (1 μL) overlaid (~15 s)

4.

Mass spectrometric analysis

Air Dry (~60s)

Image: David Pincus/Marc van Nuenen, bioMérieux30

Disposable slides:• Barcoded for traceability

• Three acquisition groups per slide

• 1-16 samples per group

• Calibration spots embedded in each acquisition group

• No cleaning

• Low cost/test

VITEK MS™ Target Slides

Target plate assignment

for VITEK MS

Smart Carrier

assignmentFor VITEK2

VITEK MS™ Prep Station – Integrating ID+AST

• Flexibility:

– Multiple Benches (Urine, Stool, TB,….)

– Separate setup stations possible

– 1 – 4 slides analyzed per run.

• High Throughput:

– 4 x 48 spots = 192 samples/run

• Significant Time Savings

VITEK MS™ Streamlined Workflow

Three Steps for Microorganism Identification via MALDI BioTyper

TARGET PREPARATION

TOF MEASUREMENT

IDENTIFICATION

Research use only – not for use in diagnostic procedures

• Utilize (96, 48, 24) Spot Polished steel Target (reusable) or 48 Spot Disposable Target

• Different methods for spotting target: Direct smear method for routine bacteria Ethanol-formic acid extraction for Molds, Mycobacteria, and Yeast On-target (plate) formic acid extraction

BRUKER

Research use only – not for use in diagnostic procedures

Clean with ethanol;monthly TFA (hazard disposal $200/qtr)

Formic Acid Extraction

Direct Plate TechniqueRecommended for Nocardia, Yeast, GPR

Pick

70% Formic Acid

Matrix

dH2O

Ethanol-Formic Acid Extraction (if required - e.g. yeast)

Research use only – not for use in diagnostic procedures

Inactivation of pathogens

Ethanol EthanolFormic acid,acetonitrile

Analyze supernatant

10 min

$0.80 an isolate; 15 minutes for ID

1 ml

Positive blood culture

Lysis BufferSupernatantWash BufferSupernatant EthanolSupernatantFA/ACNAnalyze supernatant

~20 min.

Performing a MALDI Sepsityperrun

Mycobacteriology

2 ml

Positive culture

~60 min.

Sample Preparation

Water75% EtOH Water

Water50ul

95°C30 min

100%EtOH

50ulACN + silica

beads, vortex 1 min.

FA50ul

5% sBAP,3-5d, 35oC, 5-7% CO2

AFB15-A 0:A9 MS, BaselineSubtracted, Smoothed

0

2000

4000

6000

8000

Inte

ns. [a

.u.]

Mycobacterium sp AFB015 MCW 0:H8 MS, BaselineSubtracted, Smoothed

0

1000

2000

3000

4000

5000

Inte

ns. [a

.u.]

5400 5600 5800 6000 6200 6400 6600 6800m/z

No Bead-beat step

Bead-beat step

Effect of Bead-Beat on MALDI Spectrum

Modified liquid broth cultivation→ new cultivation recommendation

Filamentous fungi – liquid culture

ID Filamentous Fungi, NIH -workflow

1. Direct Transfer of “Front Mycelium“ (1 min)

if successful: ID is FINISHED

e.g. A.niger

2. Ethanol Extraction of “Front Mycelium“ (10 min)

if successful: ID is FINISHED

3. Broth Cultivation (approx. 1 additional day) & extraction ID is possible for agar adhering filamentous fungi ID is possible for slow or fast sporulating fungi ID is possible for every kind of filamentous fungi

65

85

,21

67

44

,05

60

16

,93

80

49

,55

45

36

,96

90

74

,52

0

1000

2000

3000

4000

Inte

ns. [a

.u.]

4000 5000 6000 7000 8000 9000 10000 11000 12000m/z

ALL matches against the SAME Filamentous Fungi DB

• The order is automatically transferred to BD EpiCenter™ and can be used for worklist management.

Integration, BrukerPhoenix, [EpiCenter]

Sample EpiCenter – MBT Plate

Integration:MicroScan LabPro-MBT

• Interface software seamlessly integrates MALDI Biotyper processing with MicroScan® panel results to simplify mass spectrometry ID workflow.

• Combines MALDI Biotyper IDs with MicroScan® AST in LabPro, applying LabPro AlertEX Rules and interpretations to results

• Performs MALDI Biotyper Target assignment in LabPro with electronic transfer to MALDI Biotyper

• Allows for one LIS connection for MicroScan® and MALDI Biotyper systems

• No additional middleware or computer required

48

LabPro-MBT Overview

MALDI order

Combines Bruker MALDI Biotyper® identification with MicroScan® MIC values

• Performs target assignment

• Transfers high-confidence Bruker identifications to LIS

• Displays Bruker identification, biotype, organism text, score, and comments

• Applies AlertEX System rules to final identification

LIS

MALDI target assignment

MALDI IDID/MIC results

LabPro-MBT Bruker MALDI Biotyper* System

MALDItrace (optional)

*MALDI Biotyper is a trademark of Bruker Daltonics. Bruker MALDI Biotyper System is Research use only-USA.MALDItrace is a product of Copan Diagnostics Inc.

Integration:Sensititre, Aris, ThermoFisher

MALDI Biotyper 3.0 – tablet PC project setup

Project setup at every workplace using tablet PCswith MALDI Biotyper RTC client

New Orleans, 05/22/2011

MALDI Trace

Does MALDI Trace Help?• Ran urine bench in duplicate for 3 days with

one tech running IDs on MALDI with Trace and one on MALDI with manual plate mapping– Time to set up 30 cultures

– Use of MALDI Trace saves 3.54 seconds per culture

• Overall savings of ~100 technologist hours per year

TechnologistDecreased in Trace

Set-Up TimeP value

1 2.74 min <0.05

2 1.70 min <0.05

3 0.89 min 0.1

Automated Spotting – Copan WASP

Bruker Biotyper vs Vitek MS

57

Property Microflex LT Vitek MS RUO Vitek MS IVD Remarks

User friendliness

Ready-to use Matrix solution No Yes Yes

Facility of preparing smear Very easy Easy Easy For Vitek-MS systems, matrix solution must be deposed each two spotsDisposable targets Yes Yes Yes

Reusable targets Yes No No

Software Easy to use Not easy to use Very easy to use

Time for 96 identifications

Time to prepare work list (min)

<5 5–10 NDa

Time to load target and make vacuum

2 5

Time for analysis (min) 40 55

Time for 16 identifications (min)

ND ND 15No ID before success of QC at end of run (each 16 IDs)

Quality

IVD Yes No Yes

RUO Yes Yes NoNeed for validation before clinical reporting

Quality management Easy Easy Very easy

Costc

Device + NAb ++

Reactants +++ NA + Based on catalog prices

Maintenance ++ NA +++

Implementation

Noise Silent Noisy Noisy

Size Smaller Bulkier Bulkier

Connectivity Via LIS NA Via Myla

Capacity 1 × 96 4 × 48 4 × 48 Martiny, et al, JCM, 2012, 50

Post-Analytical

• Reporting is the deal

CHOA and friends• Shigella is not identified by MALDI-TOF mass spectrometry. Organisms

identified as “Escherichia coli” should be examined for lactose fermentation and subjected to spot indole test and, if negative, an identity of Shigella species should be considered. An agglutination assay with Shigella antisera Group D should be performed; colony morphology and lactose fermentation should also be observed and taken into consideration when making a species level identification. Serotyping in group D antiserais needed to call Shigella sonnei. If the isolate does not serotype in Group D antiserum, perform Microscan identification and discuss next steps with supervisor.

• Salmonella species identified by MALDI-TOFA Microscan identification should be performed on all. If identified as Salmonella Typhi, report as Salmonella Typhi. All other Salmonella species should be reported as Salmonella species .

Enterobacter cloacae complex =

Enterobacter asburiae

Enterobacter kobei

Enterobacter ludwigii

Enterobacter hormaechei

Enterobacter nimipressuralis

Acinetobacter baumanii-calcoaceticus complex

Acinetobacter genomospecies 3Acinetobacter genomospecies 13

Acinetobacter lwoffi report as such

Acinetobacter ursingii report as such

Citrobacter freundii complex =Citrobacter braakiiCitrobacter freundiiCitrobacter gilleniiCitrobacter murliniaeCitrobacter rodenticumCitrobacter sedlakiiCitrobacter wekmaniiCitrobacter youngae

• Stenothrophomonas maltophiliaThe following organisms are

synonyms and will be called S. maltophilia if obtained from the MALDI-TOF with an acceptable score:Pseudomonas hibiscicolaPseudomonas beteliPseudomonas geniculata

• Burkholderia cepacia complex[C1]

The following organisms will be called B. cepacia complex if obtained from the MALDI-TOF

with an acceptable score:Burkholderia cepaciaBurkholderia multivoransBurkholderia cenocepaciaBurholdieria stabilisBurkholderia vietnamiensisBurkholderia dolosaBurkholderia ambifariaBurkholderia anthinaBurkholderia pyrrocinia

Pseudomonas fluorescens Group

The following organisms will be called Pseudomonas fluorescens Group if obtained from the MALDI-TOF with an acceptable score:

Pseudomonas antarcticaPseudomonas azotoformansPseudomonas blatchfordaePseudomonas brassicacearumPseudomonas brenneriPseudomonas cedrinaPseudomonas corrugatePseudomonas fluorescensPseudomonas gessardiiPseudomonas libanensisPseudomonas mandeliiPseudomonas marginalisPseudomonas mediterraneaPseudomonas meridianaPseudomonas migulaePseudomonas mucidolensPseudomonas orientalisPseudomonas panacisPseudomonas proteolyticaPseudomonas rhodesiaePseudomonas synxanthaPseudomonas thivervalsensisPseudomonas tolaasiiPseudomonas veronii

Pseudomonas aeruginosa GroupThe following organisms will be called Pseudomonas

aeruginosa Group if obtained from the MALDI-TOF with an acceptable score

Pseudomonas alcaligenesPseudomonas anguillisepticaPseudomonas argentinensisPseudomonas borboriPseudomonas citronellolisPseudomonas flavescensPseudomonas jinjuensisPseudomonas mendocinaPseudomonas nitroreducens/multiresinivorans groupPseudomonas ochraceae

Pseudomonas oleovoransPseudomonas pseudoalcaligenesPseudomonas resinovoransPseudomonas straminea

Pseudomonas putida GroupThe following organisms will be called

Pseudomonas putida Group if obtained from the MALDI-TOF with an acceptable score:

P. putidaP. fulvaP. oryzihabitansP. plecoglossicidaP. monteiliiP. mosseliiP. cf. putida CH-B107P. cf. monteiliiP. syncyanea

MALDI-TOF is unable to distinguish Streptococcus mitis group and Streptococcus pneumoniae. Colony morphology, bile solubility , and optochin disk susceptibility should be performed prior to reporting an isolate as S. pneumoniae or S. mitis.

Streptococcus anginosus GroupThe following organisms will be called Streptococcus anginosus Group if obtained from the MALDI-TOF with an acceptable score and is clinically relevant:S. anginosusS. constellatusS. intermedius

Streptococcus gallolyticus subspecies gallolyticus (formerly Streptococcus bovis biotype I) and Streptococcus gallolyticus subspecies pasteurianus (formerly S. bovis biotype II.2). Any MALDI-TOF identification of S. gallolyticus, S. gallolyticus subsp. gallolyticus, or S. gallolyticussubsp. pasteurianus should be confirmed with Microscan to determine mannitol fermentation. If mannitol fermentation positive, report S. gallolyticus subsp. gallolyticus (formerly Streptococcus bovis group). If negative, consult with supervisor or medical director.

Bacteroides fragilis GroupThe following organisms will be called Bacteroides fragilis Group if obtained from the

MALDI-TOF with an acceptable score:

B. caccaeB. eggerthiiB. finegoldiiB. fragilisB. intestinalisB. massililensisB. nordiiB. ovatusB. salyersiaeB. stercorisB. thetaiotaomicronB. uniformisB. vulgatus

MALDI-TOF detection of carbapenemase in B. fragilisCarbapenem resistance in B. fragilis in most cases is due to the presence of

cfiA gene responsible for metallo-ß-lactamse production. Nagy et al.

CAP MIC.11375

• If an organism identification result is noted to be discrepant with current standard nomenclature (e.g., as represented in proficiency testing results), taxonomic conventions used in organism identification reporting will be changed on a continuous basis.

• On a yearly basis (January 1st of each year), and concurrent with databse updates, the medical directors will review clinically relevant taxonomic changes to validly published names in the International Journal of Systematic and Evolutionary Microbiology. In the case of homotypic changes, the new name will receive priority. For heterotypic changes, names will revert to the previously accepted name. Orthographic corrections will be

incorporated for individual species.

When necessary, changes

in organism nomenclature

will be incorporated into

the organism cascades

when antimicrobials

choices or interpretive

breakpoints are affected.

PCC January 16, 2015

• The Pathology Coding Caucus met on January 16, 2015. A unique code for matrix assisted laser desorption ionization mass spectrometry (MALDI-TOF MS) was presented for microbial identification. The decision was made that existing codes would accommodate MALDI-TOF MS coding. The recommendations are below.

HCPCS Code CPT DECRIPTION (Anotated) Comments

87015 Concentration To be used as additional code when full

extraction required

87076 Anaerobe identification

87077 Aerobic identification

87106 Organism identification, yeast

87107 Organism identification, mould

87118 Organism identification,

mycobacteria

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/clinlab.html

4386/

tab 67

Robert C. Jerris

ASM

1752 N Street NW

Washington, DC 20036

202-942-9262

[email protected]

( [email protected] )

Microbial

Identification

(MALDI-ToF-

MS)

●87XXX Microbial

identification by

Matrix Assisted Laser

Desorption Ionization

Time of Flight Mass

Spectrometry

(MALDI-ToF-MS)

●87XXX1 Matrix

Assisted Laser

Desorption Ionization

Time of Flight

(MALDI-ToF)

extraction

The PCC believes that current codes

exist to codify this service

(culture definitive identification

codes and

87015 [concentration (any type),

for infectious agents] and

hence does not support the proposal .

Clinical Microbiology PortalEngaging, enlightening, empowering our clinical community

http://clinmicro.asm.org

The only comprehensive online resource for clinical microbiologists.

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