It s Easier Than you Think How to Implement the Advanced Clinical Parameters

Transcription

1 It s Easier Than you Think How to Implement the Advanced Clinical Parameters Implementation of our New Hematology Platform ( 9 HST Lines - 9 Facilities - 9 Month) 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 1

2 Banner Health System (BHS) Is the largest non profit health care system in the country serving patients across 7 states. 22 hospitals 6 long term care centers Family Clinics Home care services Medical Equipment services Banner Health Arizona LIS Virtual Middle ware 9 Hospitals 2

3 On the Map 62 miles 22 miles 18 miles 5 miles 16 miles Laboratory Sciences of Arizona Sonora 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. 3

4 LSA/SQL Arizona Integrated Laboratory Network Partnership Vendor Medical Directors LSA/SQL & BHS 4

5 Our Selection Process Vendor Clinical Support Team Members LIS Medical Directors 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 5

6 Implementation Timeline for 2011 July Install virtual server Learn new instrumentation/parameters August Get approval for new parameters from Medical Directors September October November LIS Validation / Training December Implementation (3 sites before Dec. 24) Physician/Nursing Training Implementation Timeline for 2012 January February March CAP Inspection April May/June BIMC BDMC BTMC BEMC BBMC BGSMC 6

7 So What was the Approach? 1. Pre-Implementation Process Learn Approve Validation Requirements New Parameters Medical Directors Achieve Implementation In-service / training 7

8 Scope of the Project New instrumentation / Middleware HST Standalone XE5000/ XS1000 CellaVision DM96 WAM New Parameters (All FDA cleared) Automated NRBC s Immature Granulocytes (IG%, IG#) Immature Platelet Fraction (IPF) Reticulocyte Hemoglobin Content (RET-He) RDW-SD Technical Team Med. Directors Patient caregivers Clinical Support Learning Clinical Impact 8

9 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 9

10 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 disorder Improve Platelet Utilization Plts IPF= Destruction mechanism and Patient Outcome Which Population: All patients 10

11 Reticulocyte Hemoglobin content (RET-He) RET-He RBC 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 patients Pre op Geriatric OBGYN Pediatric Immature Retic Fraction (IRF) Clinical Usage: Indication of bone marrow response to decrease RBC in circulation. Which Patients: Oncology Pre-ops Geriatric OBGYN Pediatric Added Bonus: Possible decrease in RBC transfusions 11

12 NRBC- Automated Clinical Usage: 1. Mortality predictor 2. Bone marrow recovery 3. Correct WBC counts 4. One NRBC s in circulation Which patient groups?: ICU Oncology Babies < 30 days Other 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. ed all Medical Director s a summary report for review and voting. ed 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 12

13 Medical Director s Questions / Concerns What is our training plan for Medical Staff and Lab? Laboratory Memo Interpretative messages SBAR Lab Facts Flyers/Memo s In-services Clinical Rounds Support during week of go live. Facilitate Med. Exec. Committee meetings as requested and or different physician groups Next Steps Medical Directors Approved! Identified Key patient caregivers 13

14 Education Key Nursing Director Nursing Training We Developed S B A R for the System S = Situation B= Background A=Action R= Recommendation 14

15 From one of our Medical Director Medical Director s Advertising Talent 15

16 Laboratory Memo 16

17 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-He RET-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. IRF Values above normal range indicates an increase in RBC cellular response from bone marrow. 17

18 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 sites 10 normal males 10 normal females Identified Instrument # abnormal samples Validated Reference Ranges RDW-SD fl MPV fl IG% % IG# x 10 9 /ul Retic # k/ul IRF % IPF % RET-HE 0 3 yrs % yrs % 18

19 Custom WAM Rules Pre-flexed rules 1. Location: ICU, ONCO NRBC s 2. Age: < 30 days Reflex rules 1. Hgb < 9.0 & MCV < 78 & no Hgb w/in 30 days RET-He 2. NRBC? automated NRBC s 3. 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 19

20 Achievements We were able to standardized the following: Lab Memo SBAR WAM rules Auto-validation Workflow Procedures Training / competency Maintenance logs Pathology Reviews Reference Range Interpretative messages Report ACP with interpretative messages Six Sigma System Project 20

21 Control Phase CBC Monthly Average Minutes 2012 to 2013 BBWMC UCL Interface Problems Average Minutes CL Workflow 7.82 Instrument/WAM Delays 6.50 LCL Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct Nov 12-Dec 13-Jan Month 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) 21

22 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 1 st, 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 22

23 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 23

24 Questions 24