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Implementation of our New Hematology Platform

( 9 HST Lines - 9 Facilities - 9 Month)

“It’s Easier Than you Think – How to Implement the Advanced Clinical

Parameters

Outline The Organization

Banner Health System/LSA/SQL My role

System Technical Specialist for Hematology Our Selection Process

Team members to include LIS Hematopathologist/Medical Director’s involvement Six Sigma (DAMIC) approach

Pre- Implementation process Implementation process Grass Roots to Implement New Parameters Support Team Looking ahead Questions

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Banner Health System (BHS) Is the largest non profit health care system in the country

serving patients across 7 states.22 hospitals6 long term care centersFamily ClinicsHome care servicesMedical Equipment services

Banner Health Arizona

Virtual Middleware

9 Hospitals

LIS

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On the Map

5 miles

62 miles

16 miles

18 miles

22 miles

Laboratory Sciences of ArizonaSonora Quest Laboratory (LSA/SQL)

LSA/SQL was formed by an integration of Banner Health and Sonora Quest Laboratories.

51% owned by Banner Health

49% owned by Quest Diagnostics

LSA manages Banner Health Laboratories in AZ.

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LSA/SQL Arizona Integrated Laboratory Network

Partnership

Vendor

LSA/SQL & BHS

Medical Directors

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Our Selection Process

Vendor

Team Members

Medical DirectorsLIS

Clinical Support

Our Goals Increase Hematology Productivity

Improve Process through “automation” Develop LEAN layout and reduce non value added tasks

Validate new instrumentation & “new technology” Minimize false positive flagging (decrease scan/mdiff) Reliability and accuracy Automated Digital Cell Reader (DM96)

Implement Middleware Solutions Standardize rules Implement system wide auto-verification

Improve Patient Care (VOC) New Parameters – FDA cleared Maintain/Improve TAT for ED and Non ED patients

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Implementation Timeline for 2011

July Install virtual server Learn new instrumentation/parameters

August Get approval for new parameters from Medical Directors

September

October LIS

November Validation / Training

December Implementation (3 sites before Dec. 24)

Physician/Nursing Training

Implementation Timeline for 2012 January BIMC February BDMC March CAP Inspection

April BTMCBEMC

May/June BBMCBGSMC

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So What was the Approach?

1. Pre-Implementation Process

Learn

Approve

Achieve

• Validation Requirements

• New Parameters

• Medical Directors

• Implementation• In-service /

training

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Scope of the Project

New instrumentation / MiddlewareHST Standalone XE5000/ XS1000 Technical Team CellaVision DM96 WAM

New Parameters (All FDA cleared)Automated NRBC’sImmature Granulocytes (IG%, IG#) Med. DirectorsImmature Platelet Fraction (IPF) Patient caregivers Reticulocyte Hemoglobin Content (RET-He) Clinical RDW-SD Support

Learning Clinical Impact

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Immature Granulocytes

Clinical Usage: Possibly incorporate into “Sepsis Protocol” Rapid indication of “left shift” and or bone marrow disease Possible inflammation response Replace I/T Ratio and Bands

Which Patient Groups? All patients

Manual Differential vs. IG%

WOW – Instrument counts > 32,000 cells

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Another Selling Tool for IG%

Immature Platelet Fraction (IPF)

Clinical Usage: Helps determine if thrombocytopenia is due to consumption or decreased production.

Potential utilization in HIT (Heparin Induced Thrombocytopenia) patients

Plts IPF = Production disorderImprove Platelet Utilization

Plts IPF= Destruction mechanism and Patient Outcome

Which Population:All patients

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Reticulocyte Hemoglobin content (RET-He)

RET-HeRBC hemoglobinization

Clinical Usage: Early indicator of iron deficiency Helps monitor iron therapy. (30% are non-responders – 3 day window)Monitor drug therapy in pharmacy. E.g. Erythropoietin Stimulating Agent (ESA) therapy.

Which Patients?:ER patients Chemo patients Surgical patientsPre op GeriatricOBGYN Pediatric

Immature Retic Fraction (IRF)

Clinical Usage:Indication of bone marrow response to decrease RBC in circulation.

Which Patients:Oncology Pre-opsGeriatric OBGYNPediatric

Added Bonus: Possible decrease in RBC transfusions

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NRBC- Automated

Clinical Usage:1. Mortality predictor2. Bone marrow recovery3. Correct WBC counts4. One NRBC’s in circulation Which patient groups?:ICUOncologyBabies < 30 daysOther patients

Axel Stachon’s Research paper – “The routine analysis of NRBCs in blood is of high prognostic power with regard to mortality of critically ill patients”.

Seeking Medical Director Approval Site visits - Medical Director’s Prepared a power point presentation explaining new

parameters and added to August Medical Director’s meeting agenda.

Emailed all Medical Director’s a summary report for review and voting.

Emailed all “White Papers/Reference Material” Scheduled an additional in-service by Clinical Support Team

for September’s meeting. Special site visits by TIS/Clinical Support Team with site

Medical Directors

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Medical Director’s Questions / Concerns

What is our training plan for Medical Staff and Lab?Laboratory Memo Interpretative messagesSBARLab FactsFlyers/Memo’s In-servicesClinical Rounds Support during week of “go live”.Facilitate Med. Exec. Committee’ meetings as requested and or

different physician groups

Next Steps…………

Medical Directors

Identified “Key” patient caregivers

Approved!

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Education……

Key Nursing Director – Nursing Training We Developed S B A R for the System

S = Situation B= Background A=Action R= Recommendation

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From one of our Medical Director

Medical Director’s Advertising Talent

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Laboratory Memo

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Interpretative Messages

IG %Immature granulocytes (promyelocytes, myelocytes, metamyelocytes) > 1.0% indicates that a left shift is present. BANDS are included in the

automated neutrophil count and not in the immature granulocyte count.

IPF %Low PLT + low IPF suggests a bone marrow production disorder.

Low PLT + high IPF suggests peripheral destruction (e.g. ITP, TTP, HIT, DIC, autoimmune) or bone marrow recovery. Trending of serial IPF measurements is recommended when evaluating for bone marrow response.

Interpretative Messages

RET-HeRET-He (for Adults)

The RET-He threshold for defining iron deficiency in adults is < 29 pg. (KDOQI Guideline Changes).

RET-He (pediatrics)Less than 27.5 pg is indicative of iron deficiency.

IRFValues above normal range indicates an increase in RBC cellular response from bone marrow.

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Grass Roots to Implement Our New Platform

Choose “main site” Validate 220 samples which included the IG, IPF, IRF, RET-He,

NRBC (automated), RDW-SD and MPV Perform 200 manual differential on each sample Validate DM96 with 200 cell differential on all 220 samples

Round Robin Validation for all other sites10 normal males 10 normal females Identified Instrument #51120 abnormal samples

Validated Reference Ranges

RDW-SD 36.0 – 55.0 fL MPV 11.7 – 14.4 fL IG% 0.0 – 1.0 % IG# 0.0 – 0.1x 109/uL Retic # 0.0 – 150.0 k/uL IRF 2.5 – 16.0 % IPF 1.1 – 7.1% RET-HE 0 – 3 yrs 27.5 – 35.5 %

4 – 140 yrs 29.1 – 37.1%

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Custom WAM Rules Pre-flexed rules

1. Location: ICU, ONCO NRBC’s2. Age: < 30 days

Reflex rules1. Hgb < 9.0 & MCV < 78 & no Hgb w/in 30 days – RET-He

2. NRBC? – automated NRBC’s3. PLTC < 30,000 – IPF *4. PLTC < 50,000 – IPF ( All sites as of December 2012).

Note: IG% reported with CBC with Autodiff.

Support Team LSA/BHS Staff

LIS

Medical Directors

BHS Nursing Directors

BHS CMO’s

Sysmex Clinical Support Team

Sysmex Technical Team

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Achievements We were able to standardized the following:Lab Memo SBARWAM rulesAuto-validationWorkflowProceduresTraining / competencyMaintenance logsPathology ReviewsReference Range Interpretative messagesReport ACP with interpretative messages

Six Sigma System Project

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Control Phase

Interface Problems

Workflow

Instrument/WAM Delays

UCL

10.30

CL

7.82

LCL

5.33

4.50

5.50

6.50

7.50

8.50

9.50

10.50

11.50

12.50

Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 12-Nov 12-Dec 13-Jan

Ave

rag

e M

inu

tes

Month

CBC Monthly Average Minutes 2012 to 2013BBWMC

Looking Ahead Studies in Progress Determine IG% cut off for sepsis RET-He for reduction in RBC utilization IPF for reduction in PLT utilization Evaluate the removal of mandatory manual differential for < 1

year olds. Test utilization for CBC in 24 hours Pharmacy RET-He (EPO/Oral vs. IV Iron Therapy)

IPF (HIT – Heparin vs. Levenox)

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Approved and in Progress: CORE Program at BDWMC Incorporation of RETIC Comprehensive (RETICC)

Hip Fracture Joint Certification at BBMC * Incorporation of RETICC

ER admissions at BBMC Incorporation of RETICC

* BBMC received Joint Commission Accreditation in March 2013!

Coding for Iron Deficiency

Definition ICD-10 The International Classification of Disease tenth revision (ICD-10) is a system of coding

created by the World Health Organization that notes various medical records including diseases, symptoms, abnormal findings and external causes of injury.

The ICD-10 was created in 1992 as the successor to the previous ICD-9 system. In the United States, an official use of the ICD-10 system will begin on October 1st, 2013. It will be split into two systems: ICD-10-CM (clinical modification) for diagnostic coding and ICD-10-PCS (procedure coding system) for inpatient hospital procedure coding

ICD-10-CM for Iron Deficiency is E61.1

ICD-10-CM for Iron Deficiency Anemia: D50.0 Iron Deficiency Anemia Secondary to Blood Loss (Chronic) D50.9 Iron Deficiency Anemia Unspecified D50.8 Other Iron Deficiency Anemias

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Clinical Impact - IG

Infection or Steroids?

Baby Study to Remove Bands / ITR

• The band count is not sensitive enough to predict sepsis,• Pediatric Literature: I/T Ratio of < 0.2 has a high negative predictive value

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Questions