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Dr Peter Cowling Chair Bacteriology SMI Committee

Dr Peter Cowling Chair Bacteriology SMI Committee

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Page 1: Dr Peter Cowling Chair Bacteriology SMI Committee

Dr Peter CowlingChair Bacteriology SMI Committee

Page 2: Dr Peter Cowling Chair Bacteriology SMI Committee

UK Standards for Microbiological Investigations (SMIs)

Steering CommitteeSyndromic Algorithm CommitteeVirology/ Serology SMI CommitteeBacteriology SMI Committee

Page 3: Dr Peter Cowling Chair Bacteriology SMI Committee

Our responsibility

..does not start at the laboratory door

Starts at the point the clinician considers the differential diagnosis

Page 4: Dr Peter Cowling Chair Bacteriology SMI Committee

Our involvement in specimen pathway

From start

To finish

Page 5: Dr Peter Cowling Chair Bacteriology SMI Committee

Partnership WorkingEqual partnersNominated representativesRegular two way reportingOptimal consultation processesIncreased joint ownershipIncreased authority

Page 6: Dr Peter Cowling Chair Bacteriology SMI Committee
Page 7: Dr Peter Cowling Chair Bacteriology SMI Committee

NICE AccreditationNHS Evidence accredited processes for SMIsFollows AGREE protocolSets the UK standard for diagnostic

microbiologyCovers whole specimen pathwayAlso certified to ISO 9001:2008

Page 8: Dr Peter Cowling Chair Bacteriology SMI Committee

SMI B 37Investigation of Blood Cultures

Issued 27 March 2013

Issue number 7

Page 9: Dr Peter Cowling Chair Bacteriology SMI Committee

Acknowledgements 1

Dr Shabnam Iyer

Dr Mike Weinbren

Mr Ian Sturgess

Page 10: Dr Peter Cowling Chair Bacteriology SMI Committee

Consultation

Consultation through usual process

Additional parallel consultation through BIA

Total responses 59Accepted 23Partially accepted 6Rejected 7No action 23

Page 11: Dr Peter Cowling Chair Bacteriology SMI Committee

B37 Amendments

Standards for TaTsInclusion of SIRS and neonatal sepsisRemoval of differential quantitative cultureDirect sensitivity testingInclusion of molecular methodologiesContamination target <3%Pre-incubation adviceLab management of transportation

Page 12: Dr Peter Cowling Chair Bacteriology SMI Committee

Dilemmas

TaTs and Transforming Pathology agendaMeeting the needs and expectations of users

(e.g paediatricians)Pre-loading handling of bottles (requesting/

transportation/ off site incubators/ off site culture)

Empirical blind antimicrobial treatmentExisting plate-based methodologies

Page 13: Dr Peter Cowling Chair Bacteriology SMI Committee
Page 14: Dr Peter Cowling Chair Bacteriology SMI Committee

Proposals for improvement

Mike Weinbren, Shabnam Iyer, Ian SturgessSet standards for TaTs Collection to loadingInitial positive reports and sens testingEndorse rapid tests on positive bottlesSet standards for satellite/peripheral labsRequest CPA to formally include b.c auditsRequest BSAC to recommend direct sens

testing

Page 15: Dr Peter Cowling Chair Bacteriology SMI Committee

Mike Weinbren’s auditsLoad delay average 7h (max 20h)Unload delay average 5h (max 14h)On site laboratoryWorst out of hours and weekends2nd audit of transport delays showed little delay on

site60% loaded within 2h of receipt but long tail on

graph (n=191). Bottles rec’d 24h but loaded only 08.00-19.00

Potential for saving up to 2 days of TaT if loading/unloading delays are reduced + rapid testing

Page 16: Dr Peter Cowling Chair Bacteriology SMI Committee

Kavi, Weinbren & Sturgess surveyTelephone survey of blood culture methods in UK43 respondents across UK4/16 off site blood cultures stored in incubator0/43 load during night21/43 pre-incubate overnight, 22/43 at RT31/43 have 24h on site shift systems (blood

sciences)1/43 rapid sens on GNBs, 41/43 do direct sens

discs

Page 17: Dr Peter Cowling Chair Bacteriology SMI Committee

Blood Culture Flags Positive

Removal and Initial Work

Receipt in Laboratory

Loading on Blood Culture

Machine

Time from Collection to LoadingTime from

Placement to Detection

Time from Flagging Positive to Identification and Susceptibility Results

Time from Receipt to Loading

Transport Time to Laboratory (TT)

Time from FlaggingPositive to Removal

Time from Removal to Results of Gram Stain,

Identification and Sensitivities

Variable Time – Opportunity to

Improve

Time Variable – NO Opportunity to

Improve

KEYTurnaround Time (TAT)

Laboratory Turnaround Time (LTAT)

Time to Detection(TTD)

Reporting of Results

Identification and

Sensitivities

Time to Reporting

Blood Culture Collection

Time from Results Availability to

Reporting Results

Time to Positivity(TTP)

Page 18: Dr Peter Cowling Chair Bacteriology SMI Committee

Time

Treatment ends

Patient seeks medical advice,

treatment initiated

Patient dependent time variable.

No opportunity to improve.

Appropriate Treatment

Symptoms Start

Therapeutic Window

Patient Survives

Page 19: Dr Peter Cowling Chair Bacteriology SMI Committee

Symptoms Start

Time

Treatment ends

Patient seeks medical advice,

treatment initiated

Patient dependent time variable.

No opportunity to improve.

Therapeutic Window

Patient Dies

Inappropriate Treatment

Page 20: Dr Peter Cowling Chair Bacteriology SMI Committee

Symptoms Start

Time

Treatment ends

Patient seeks medical advice,

treatment initiated

Patient dependent time variable.

No opportunity to improve.

Therapeutic Window

Patient Dies

Appropriate Treatment

Delayed Blood Culture Result

Critical Time

Inappropriate Treatment

Page 21: Dr Peter Cowling Chair Bacteriology SMI Committee

Symptoms Start

Time

Treatment ends

Patient seeks medical advice,

treatment initiated

Patient dependent time variable.

No opportunity to improve.

Inappropriate Treatment

Therapeutic Window

Patient Survives

Rapid Blood Culture Result

Critical Time

Appropriate Treatment

Page 22: Dr Peter Cowling Chair Bacteriology SMI Committee

Summary Table 1: Pre-Analytical StandardsInoculated bottles should be incubated as soon as possible, and within a maximum of four hours.

Investigative Stage: Standard:

Pre-Analytical Time Period

Collection to Incubation ≤4hr

The four hour turnaround time from collection to incubation for blood culture samples reflects their clinical significance.

Page 23: Dr Peter Cowling Chair Bacteriology SMI Committee

Summary Table 2: Analytical StandardsResults of the following identification and sensitivity tests (if performed) should be completed within the following time frames from flagging positive:

Investigative Stage: Criteria: Standard:Analytical

Flagging Positive to Microscopy, Identification and Sensitivities

Test (if test performed) Time Period to ResultGram Stain ≤2hrRapid Antigen Testing ≤2hrMolecular Assays same dayIsolate Identification (Direct/Automated) ≤24hrIsolate Identification(Conventional Methods)

24-48hr

Isolate Sensitivities (Direct/Automated) ≤24hrIsolate Sensitivities(Conventional Methods)

24-48hr

Page 24: Dr Peter Cowling Chair Bacteriology SMI Committee

Summary Table 3: Post-Analytical StandardsStandards have also been set for the laboratory turnaround time (the time between receipt in the laboratory and reporting):Investigative Stage: Criteria: Standard:Post-Analytical

Negative Report

(from receipt in laboratory to negative reporting)

Report Type Turnaround time

Preliminary Negative Report48hr *

(dependant on local policy)

Final Negative Report

≤5 days

(or greater if extended incubation required)

Positive Report

(from receipt in laboratory to positive reporting)

Preliminary Positive Report

(Telephone/Fax/Email)

Immediately, within 2hr of identity/sensitivity availability.

(see Summary Table 2 above)

Final Positive Report

≤5 days

(or greater if extended incubation required, or if isolates are sent to a reference laboratory for confirmation)

*Refer to neonatal sepsis section of the introduction for further information regarding negative reporting of neonatal blood culture.

Page 25: Dr Peter Cowling Chair Bacteriology SMI Committee
Page 26: Dr Peter Cowling Chair Bacteriology SMI Committee

Neonatal blood cultures

NICE guideline CG 149 Aug 2012Requirement for 36h reporting of a negative

cultureAllows cessation of antimicrobials, 2nd

gentamicin doseAllows timely dischargeIs cost effective

Page 27: Dr Peter Cowling Chair Bacteriology SMI Committee

Duration of antibiotic treatment: early-onset neonatal infection without meningitis

Positive blood culture or strong suspicion of infectionUsual antibiotic duration should be 7 days. Consider

longer if baby has not recovered or if advised.

Negative blood cultureConsider stopping antibiotics at 36 hours.If continuing beyond 36 hours, review the baby at

least once every 24 hours to consider whether antibiotics can be stopped.

NICE (CG 149) Aug 2012

Page 28: Dr Peter Cowling Chair Bacteriology SMI Committee

Duration of antibiotics treatment:decisions 36 hours after starting antibiotic treatment

To fully implement the guideline, hospital systems to provide real time blood culture results at 36 hours are needed.

Consider stopping antibiotics at 36 hours: if • blood culture is negative and• initial suspicion of infection was not strong

and• baby’s clinical condition reassuring (no

clinical indicators) and• levels and trends of C-reactive protein are

reassuring. NICE (CG 149) Aug 2012

Page 29: Dr Peter Cowling Chair Bacteriology SMI Committee

Rationale for 36h decision

“Since the health economic analysis conducted for the guideline showed that stopping antibiotic treatment at 36 hours in the babies listed above will be cost saving, and one of the criteria for stopping treatment depends on the result of blood culture, the cost savings can be realised only if the blood culture results are available within 36 hours.”

NICE (CG 149) Aug 2012

Page 30: Dr Peter Cowling Chair Bacteriology SMI Committee

Use intravenous benzylpenicillin with gentamicin as first-choice.

Benzylpenicillin 25 mg/kg every 12 hours.

Gentamicin, starting dosage of 5 mg/kg.

If a second gentamicin dose is required, give 36 hours after the first (interval may be shortened based on clinical judgment).

(My emphasis) NICE (CG 149) Aug 2012

Antibiotics for suspected infection in the baby

Page 31: Dr Peter Cowling Chair Bacteriology SMI Committee

Therapeutic monitoring for gentamicin

Trough concentrationsMeasure trough immediately before second dose.

Concentrations should be available in time to inform the next dose (If not, do not withhold dose unless renal dysfunction is evident).

Consider repeating measurement of trough concentrations at least before every third dose.

NICE (CG 149) Aug 2012

Page 32: Dr Peter Cowling Chair Bacteriology SMI Committee

Neonatal blood cultures 36h rule:UK experience 4/31 significant isolates >36h incl. 1 baby

discharged home11/119 +ve cultures >36h post loading (9

contaminants, 2 CNS infections already on treatment). 23/119 >36h post collection (4 significant but on antibiotics pre b.c. and clinically septic)

92% 4410 cultures +ve <36h (100% of paediatric)18/76 +ve cultures post collection (16

contaminants, 2 significant, 1 on treatment)“nearly all signalled within 18h, never mind 36!”

Page 33: Dr Peter Cowling Chair Bacteriology SMI Committee

Acknowledgments 2

Dr Tom LewisDr Sarah Abu HassanDr John CheesbroughDr Alaric ColvilleDr J KaviDr Martin Sheppard

Page 34: Dr Peter Cowling Chair Bacteriology SMI Committee

Future dilemmasEmergence of multi-resistance

Less effective & more toxic blind treatment

Need for replacement of 19th Century Microbiology

Rapid, molecular methodology for whole specimen pathway (“Star Trek” vision)

Near patient testing

Page 35: Dr Peter Cowling Chair Bacteriology SMI Committee

The Embarrassing Truth?

Blood Sciences

Microbiology

Page 36: Dr Peter Cowling Chair Bacteriology SMI Committee

Laissez faire

Long TaTs generally accepted as the norm by laboratories, users and patients

Technology available to revolutionise Microbiology

Insufficient challenge to status quo

Page 37: Dr Peter Cowling Chair Bacteriology SMI Committee

Wrong focus

Laboratory accreditation-focussed

Not patient-focussed

ISO standards are an improvement

Page 38: Dr Peter Cowling Chair Bacteriology SMI Committee

Purchaser Provider Model

Page 39: Dr Peter Cowling Chair Bacteriology SMI Committee

Voice of the Customer

Purchaser - Provider (adversarial)

Customer involvement and joint ownership

(partnership)

Page 40: Dr Peter Cowling Chair Bacteriology SMI Committee

Acknowledgements 3The Standards Unit, PHERuhi Siddiqui, Head of UnitClare Harris, Standards MicrobiologistAyuen Lual, Standards MicrobiologistIjeoma Ezeajughi, Research ScientistNicola Day, Technical Support OfficerCaroline Lawson, Information OfficeShirley Boland, Administrative Assistantand……….Val Bevan and Brian Duerden

Page 41: Dr Peter Cowling Chair Bacteriology SMI Committee

Thank you