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1 The s of s and s Successfully implement the Advanced Clinical Parameters to benefit the patient, the lab and the Accountable Care Organization Model Disclosure Honorarium from Sysmex for this lecture 1

2 Holly McDaniel, MD AP/CP and Cytopathologist Clin Path Associates (CPA) Laboratory Medical Director Banner Estrella Medical Center (BEMC) Pathology Specialists of Arizona (PSA) Laboratory Sciences of Arizona (LSA) Banner Health (BH) Introduction Success! Banner Health 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 2

3 Banner Arizona Nine Medical Centers in the Phoenix Area Baywood Boswell Dell E. Webb Desert Estrella Gateway Good Samaritan Ironwood Thunderbird Sysmex XE 5000 Our Set Up WAM Reflex IPF RET He NRBCs Autoverification Cellavision Flag for smear review Release Results 3

4 The ABCs of ACPs Advanced Clinical Parameters Plan Reach out Connect with the BIG Picture Plan: Goals MAIN GOAL Patients: Improved patient care IG: Infection, sepsis, response to treatment RET He: Anemia management, improve transfusion practices, improve EPO utilization IPF: Assist with diagnosis of thrombocytopenia, improve transfusion practices, decrease unnecessary bone marrow biopsies NRBCs: Better triage of patients from ICU to floor 4

5 Plan: Goals SECONDARY GOALS Lab Improve quality Better tests WAM: Middleware Solutions Standardize rules Cellavision Improve efficiency Decrease waste time Fewer manual differentials Autoverification Goal: Decrease Waste Time SYSMEX PREVIOUS Previous instrument had more manual steps with longer wait time Sysmex s automation has less wait time Significant decrease in waste wait time 69% decrease in wait time 32.5% decrease in ave TAT METRIC PREVIOUS SYSMEX %CHANGE Wait Time 3.9 min 1.2 min 69.0% Ave Minutes 11.6 min 7.7 min 32.5 % 5

6 Goal: Improve Lab TAT Auto Verification Smear Reviews Auto verification speeds up the process with automatic release of uncomplicated test results Decreased number of cases requiring peripheral blood smear review (Scan and Manual Dif) Plan: Goals SECONDARY GOALS Hospital Improve patient care Save money Decrease length of stay Improve blood utilization Help identify infection/sepsis SIRS Identify infection present at admission, and not have counted as hospital acquired infection 6

7 How to reach goals Education! Questions to consider:? What are these ***NEW*** tests?? What do the results mean to my patient?? What do published studies say?? What in House studies should we do?? Where should the tests be added to Care Pathways? What are these ***NEW*** tests? White Blood Cells IG (Immature Granulocyte) Red Blood Cells 3-Part Retic 1) Retic 2) IRF (Immature Retic Fraction) 3)RET-He (Reticulated Hemoglobin Equivalent) NRBCs (Nucleated Red Blood Cells) Platelets Advanced Clinical Parameters IPF (Immature Platelet Fraction) 7

8 Immature Granulocytes IG Immature Granulocytes (IG)? What is IG? What does the IG result mean to my patient? Published IG studies? In House IG studies? Where should IG be added to Care Pathways Questions to consider 8

9 What is IG? Previous Instrument **New Instrument** Only counted mature Myeloid cells Flags if immature cells present Reflex to manual count (100 cells) Identifies & Quantifies Immature Myeloid cells Immature Granulocyte (IG) Promyelocytes Myelocytes Metamyelocytes Counts 32,000 cells Flags if atypical cells present (WAM) And reflexes to manual review (Cellavision) Neutrophil count Bands Neutrophils *Rapid, Accurate, Precise* How does IG compare to Band Count? Band Count is poorly reproducible Criteria for Bands is subjective Three different definitions How pinched is the nucleus? If TRUTH = 10 Bands per 100 WBC (10% Bands) 100 cell count 5% to 16% Bands 1,000 cell count 8% to 12% Bands The manual band count is imprecise Neutrophil Band Neutrophil? IG is better than the Band Count Band? 9

10 How does IG compare to ITR? ITR = I:T Ratio = Immature neutrophils (bands, metamyelocytes, myelocytes, and promyelocytes) to Total Ratio (Manual Differential) ITR has been used as an index to predict neonatal sepsis Thought to be relatively stable, with results independent of birth weight and gestational age Controversial Generally accepted reference range < 0.2 Another study ITR calculation relies on Band Count Cannot be precise IG in neonatal population Needs more study Needs Physician buy in Variable by postnatal age (normal ranges) ITR Age < hours < to 120 hours < days Postnatal age of 4 hours Healthy babies ITR Age hours ITR and Neonatal Sepsis The band count is not sensitive enough to predict sepsis, Pediatric Literature: Ratio of ITR of <0.2 has a high negative predictive value Cut offs Band count >10 (One possible criteria for SIRS) IT Ratio <0.2 has high negative predictive value IG: >1% indicates a left shift >3% may predict positive blood cultures Patient A Patient B Diagnosis Admit Dx: Fever D/C Dx: No infection Admit Dx: Fever D/C Dx: Salmonella Band % Range ITR Range IG% % % 10

11 What does IG mean in my patient? IG% and IG# Early screen for sepsis Better indicator for infection than WBC Comparable to ANC IG% >1% indicates a left shift IG% >3% may predict positive blood cultures with: 98% specificity 92% PPV Detect myeloproliferative disorders Neutrophil count includes bands Automated Neutrophil Count = Manual Absolute Neutrophil Count = ANC 11

12 Published IG Studies In House IG Studies IG to help determine infection/sepsis 1. Chart review of patients with Sepsis Alerts Patients with sepsis (True Positives) Patients without sepsis (True Negatives) Compare IG% to determine cut off values 2. Patients with positive blood cultures IG and ANC as an indicator for infection/sepsis (SIRS Criteria) 3. What to expect in various disease states, does IG indicate chorioamnionitis? 4. IG versus ITR in pediatric patients. 5. Does IG/ANC/Bands correlate to Procalcitonin? 12

13 IG in Care Pathways LAB: Continue to make results easier to understand Currently report IG with auto dif We will be adding automated IG to manual dif Note: Neut# = ANC How to make more understandable? Determine important cut offs Interpretative messages Hospital SIRS criteria IG only reported with Auto Dif Where s IG? Neut# = ANC Neut# automated Better than manual SIRS (Systemic Inflammatory Response Syndrome) International Sepsis Definition Conference (ISDC) in 2001 Definition of Sepsis When an adult patient with an infection looks sick, septic or toxic and has any two or more of the following criteria: Fever 101 F or hypothermia (<96.8 F) Heart rate >90 beats/minute Respiration rate >20 breaths/minute White blood count >12,000 µl or <4,000 μlor with >10% bands Coding: CMS recognizes any two or more of the above criteria as indicative of sepsis Where s IG%? 13

14 International Sepsis Forum Improving Sepsis Outcomes Initiative to focus on management of patients with severe sepsis International consensus on the latest understanding of key scientific and clinical issues Data on patient management to improve outcomes Findings need to be evaluated and incorporated into existing treatment protocols Disseminatie emerging practice guidelines to researchers, intensivists, and other critical care professionals worldwide. International Sepsis Forum We re talking about them Are they talking about us? 14

15 IG in Care Pathways LAB: Report with auto and manual dif Determine important cut offs Interpretative messages Hospital SIRS criteria IG Needs to be added Computer alerts for sepsis Replace bands Replace or modify ITR Immature Platelet Fraction IPF 15

16 Immature Platelet Fraction (IPF) Questions to consider? What is IPF? What does the IPF result mean to my patient? Published IPF studies? In House IPF studies? Where should IPF be added to Care Pathways What is IPF? Previous Instrument **New Instrument** Platelet Count Platelet Count MPV (Mean plt volume) Ave size of plts IPF (Immature Plt Fraction) % Immature plt/total plt *Rapid, Accurate, Precise* 16

17 What does IPF mean to my Patient? Plts + Plts + IPF = Production disorder IPF = Destruction mechanism or BM Recovery Evaluate mechanism causing thrombocytopenia IPF recovers ~3 days earlier than platelet count Predict platelet count recovery Determine need for platelet transfusion Published IPF Studies 17

18 In House IPF Studies Usefulness of IPF as a differential diagnosis of ITP/TTP IPF in transfusion practices Determine if IPF impacts prophylactic platelet transfusions Determine how to include IPF in transfusion protocol IPF as an aid to avoid unnecessary bone marrow biopsies IPF to determine bone marrow recovery and avoid ordering of HLA typed products IPF in Care Pathways LAB: What PLT result to trigger reflex IPF testing? Started with 30,000 Changed to 50,000 How to order IPF? Orderable: Platelet count with IPF Stand alone platelet count order will reflex to IPF Hospital Evaluation of thrombocytopenia Assess need for transfusion Assess bone marrow recovery 18

19 Reticulated Hemoglobin Equivalent RET-He Reticulated Hemoglobin Equivalent (RET-He) Questions to consider? What is RET He? What does the RET He result mean to my patient? Published RET He studies? In House RET He studies? Where should RET He be added to Care Pathways 19

20 What is RET-He? Previous Instrument Retic # & Retic% **New Instrument** RETIC Comprehensive (3 part Retic) 1. Retic # & Rectic % 2. Immature Retic Fraction (IRF) Quantitative measure of immature retics 3. RET He Qualitative measure of Hb in reticulocytes Same test as Reticulocyte Hemoglobin Content (CHr) Not affected by uremia or inflammation *Rapid, Accurate, Precise* What does RET-He mean in my Patient? Same test as Reticulocyte Hemoglobin Content (CHr) Qualitative measure of Hb in reticulocytes. Cellular evaluation of iron status Help diagnose iron deficiency Not affected by uremia or inflammation Faster response to treatment than routine iron tests Monitor response to treatment more closely (3 days) Improve EPO usage by identifying non responders earlier 20

21 Published RET-He Studies In House RET-He Studies Economic value of screening for iron deficiency in children RBC Transfusion protocol determine how to add RETIC Comprehensive (RET He) Economic value of screening for ID and IDA, medically treating prior to surgery and avoiding PRBC transfusion Pre Op Anemia elective Ortho surgery Pre Op anemia screening in Cardiac valve cases Hospital patients: Evaluate RET He in EPO/Iron treatment Identify Non Responders faster Adjust iron or EPO dosage 21

22 RET-He in Care Pathways LAB: How to order: Part of Reticulocyte Comprehensive Order Not a stand alone order Reflex to RETIC Comprehensive (includes RET He) if Hgb < 9.0 and MCV <78 No Hgb order within 30 days How often should it be tested? Interpretative messages Hospital Iron/Epo CareSet Add to anemia algorthm Pre operative work up for elective surgery Automated Nucleated Red Blood Cells NRBCs 22

23 Automated Nucleated Red Blood Cells (NRBCs) Questions to consider? What are Automated NRBCs? What does the Automated NRBCs result mean to my patient? Published Automated NRBCs studies? In House Automated NRBCs studies? Where should Automated NRBCs be added to Care Pathways What are Automated NRBCs? Previous Instrument Flag for possible nrbcs Reflex to manual review Manually count nrbcs Manually correct WBC count **New Instrument** Automated NRBCs Instrument checks for NRBCs on every patient Up front for ICU, Oncology, babies <30 days old Any CBC that flags possible NRBCs will reflex to rerun specimen for automated NRBCevaluation. Automatically corrects WBC count *Rapid, Accurate, Precise* 23

24 What do NRBCs mean to my Patient? One NRBC in an adult is important finding Indicates health of patient Changes in NRBCs important to follow New finding of NRBCs Increasing number of NRBCs Decreasing number of NRBCs Can use to help determine whether to move a patient into or out of the ICU Published NRBCs Studies 24

25 In House NRBCs Studies To be determined NRBCs in Care Pathways LAB: How to order: Not a stand alone order All patients evaluated for NRBCs Reflex Automatically test Patient location: ICU, NICU and Oncology Patient age <30 days Corrected WBC reported with automated NRBC. Instrument flag: NRBC? Rerun and report Automated NBRC and corrected WBC. Interpretative messages Hospital Include in decision for transferring patients from ICU to floor 25

26 Reach Out: Who to educate? Everyone! Lab: Pathologists and techs Clinical: Physicians, nursing, pharmacy Administration: CEOs, CMOs, CFOs, CNOs, Quality Groups: Functional Teams, Clinical Consensus Groups, Strategic Clinical Initiative Teams, Clinical Performance Groups, Discipline Teams Informatics: LIS and HIS Reach Out: How to educate? Written material Articles Handouts Table toppers SBAR Laboratory Memo Integrate into care pathways and caresets Interpretative messages in EMR Return On Investment (ROI) Where s LAB? 26

27 Reach Out: How to educate? Talks Sysmex Clinical Support inhouse training sessions Webinars Lectures/In services Meetings: Repeat! Medical Executive Departments 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. RET-He Adults: The RET He threshold for defining iron deficiency in adults is < 29 pg. (KDOQI Guideline Changes). IPF Values above normal range indicates an increase in RBC cellular response from bone marrow. Pediatrics: Less than 27.5 pg is indicative of iron deficiency. 27

28 Connect with the Big Picture Rapid growth in health care spending Now over 17% of GDP 30% of health care costs are generated by Overuse Underuse Misuse Nace D, Gartland J. Providing accountability: accountable care concepts for providers. McKesson/Relay Health white paper. Published Accessed March 14, Connect with the Big Picture Accountable Care Organization (ACOs) Most recent trend to Restrain the growth in US health care spending Improve quality of care Improve health care outcomes Coordinated care systems in which Providers are incentivized based on outcomes, not number of services The Affordable Care Act allows for the establishment of ACOs within Medicare and in the private sector How do the Lab and Pathologists fit in this model? 28

29 Connect with the Big Picture Pathologists/Lab must share accountability for the larger process Extend beyond traditional boundaries Engage in activities that improve clinical outcomes Special knowledge to contribute Designing clinical pathways Informatics and communication tools Improve clinical performance 29

30 Geisinger Health Systems: Role of the pathologist in improving laboratory clinical effectiveness Banner Health/ LSA/PSA Sharing accountability for patient outcomes and performance of the health care system Establishing and using a standardized laboratory database for outcomes research and health care improvement Participating in design of standardized practice algorithms for things such as laboratory test ordering, test interpretation, and therapeutic recommendations Developing patient health information tools that are designed to improve patient care Extending laboratory reporting to include improvements in how the data are presented to clinicians as well as clinical recommendations Montefiore Medical Center: Model of How Pathologists Add Value Banner Health/ LSA/PSA Working with clinical colleagues to optimize testing protocols Reducing unnecessary testing in both clinical and anatomic pathology Applying personalized therapy to help guide treatment Designing laboratory systems to allow quick data mining by pathologists and clinicians Administering cost effective laboratories 30

31 Connect with the Big Picture Greater collaboration with other clinicians Pathologist/Lab leadership Collaboration with other physicians and ACO leaders Rectify lack of understanding: Analytic role and expertise of pathologists not appreciated Pathologists know most effective applications of laboratory medicine Pathologists/Lab easily overlooked during the development of ACOs Pathologists/Lab should proactively assert their ability to help the ACO meet its goals Connect with the Big Picture How to pay for pathologist contributions? Traditional fee for service model not appropriate Adoption of guidelines may decrease the volume of laboratory tests And decrease income derived from fee for service payments Pathologists/Lab add value Not to specific patients To the development of systems and guidelines that globally reduce costs and potentially improve patient care 31

32 What s Next? Lab Continue education Continue to evaluate when to reflex tests Determine best work flow for Lab and Physicians Hospital Continue education Work on Care Pathways and Order Caresets Anemia Transfusions Infection/Sepsis Studies to determine how to best utilize tests Report improvements to administration and physicians Blood Service Provider United Blood Services: incorporate RET He blood donor testing International Sepsis Forum Need to incorporate IG into SIRS criteria Evolution of the Complete Blood Count Early Technology Updated Technology **Cutting Edge Technology** 32

33 Questions? 33