Chest Pain Center Accreditation

Chest Pain Center Accreditation Laboratory s Role Amy Cotner, RN Region Business Manager Critical Care Cardiac Copyright 2009 Siemens Medical Solutions USA, Inc. All rights reserved.

Objectives: Understand the Cornerstone of Chest Pain Center Accreditation Demonstrate the role of the Lab in Process Improvement on becoming an Accredited Chest Pain Center Learn the 8 Key Elements required for Accreditation Understand the requirements for Cardiac Biomarker testing in ED Illustrate the Outcomes from Alignment of Cost and Quality, on becoming an Accredited Chest Pain Center Page 2

Cornerstone of an Accredited Chest Pain Center CPC Accredited Fundamental to the goals of the CPC is a protocol-driven, systematic approach to patient management that promotes optimal application of current standards of care. Guidelines, or critical care pathways, are commonly utilized. These strategies afford --- 1) Rapid initiation of crucial therapy in patients with high risk acute coronary syndromes 2) Risk stratification of clinically low risk patients into those requiring admission and those who can be safely discharged and managed as outpatients. Page 3

Statistics of Clot Progression Prevalence Cardiovascular Disease 1 70 million Coronary Heart Disease 1 13 million Chest Pain 2 UA/NSTEMI 2 STEMI 2 CHF 1 8 million UA/NSTEMI 1.4 million 1.4 million 400,000 5 million 550,000 new case/yr Sieck HealthCare Consulting, LLC American Heart Association 2005 1 Centers for Disease Control and Prevention, Sieck 2002 HealthCare 2 Consulting, LLC Page 4

Definition of MI New Definition Universal Definition of MI: ESC/ACCF/AHA/WHF Task Force The development of more sensitive and specific serological biomarkers and precise imaging techniques allows detection of ever smaller amounts of myocardial necrosis. Page 5

Risk Stratification of ACS and Heart Failure Clot Progression Model of ACS High Sensitivity Troponin BNP/ NT-proPBNP Troponin BNP/ NT-proBNP BNP/ NT-proBNP Unstable Unstable Angina Angina NSTEMI STEMI STEMI CHF 411.1 411.1 410.7 410.7 410.1-410.6 410.0 428.0 428.0 Page 6

The Society of Chest Pain Centers Page 7

Society Of Chest Pain Centers What it is not! A room in the ED, just an observation unit Only pertaining to the ED What it is! An operational model like a trauma center / a process improvement initiative Starts with onset of patient s pain through discharge It pertains to the whole hospital (System-wide) Multidiscipline Approach Interdepartmental & Inter-departmental Patient Centric Page 8

MSOffice1 CPC ACCREDITATION SUCCESS FACTORS: CLEAR GOALS Accreditation Improved Care Processes Better Business Performance ORGANIZATIONAL COMMITMENT Buy-in on ALL levels Need Physician Champions (ED/Cardiology/Lab ) CPC Team to include: Core working group (later a permanent CPC committee) CPC Medical Director Designated CPC Coordinator (Item 5.10.0.0) Lab participation Lab Director &/or POCC Page 9

Slide 9 MSOffice1 cost aviodenace risk start ifcation right care right time right place, 4/5/2009

Chest Pain Center Accreditation Continuous Process Improvement lead to Improved Quality Outcomes Is the process of improving the hospital s approach to the Heart Attack problem. It greatly enhances the evidence-based medicine ----R.Barr,MD Chest Pain Center Accreditation Is Associated With Improved Heart Failure Quality Performance Measures Society of Chest Pain Center hospitals have greater compliance for all JCAHO quality indicators. In 2006, CMS reported $142.5 B estimated direct and indirect cost of treating CAD. The CPC Model has been recognized as a means of reducing an estimated $ 1 Billion savings annually. Page 10

Society Of Chest Pain Centers Page 11

Chest Pain Center Accreditation Accreditation Track: Cycle I Engagement, Education Cycle II Implementation/Operationalizing Guideline-driven care January 2006 to December 2009 Application must be in by December 1, 2008 Cycle III Process Improvement, Metrics and Outcomes Starts January 2009 thru December 2012 Types of Accreditation: 1. Full Accreditation with or without PCI (Percutaneous Coronary Intervention) 2. Provisional Accreditation met minimum requirements with written commitment to implement recommended changes 3. Education Track facilities that want or need guidance, receives recommendations that delineates areas of needed improvement 4. No Accreditation granted Page 12

Society Of Chest Pain Centers: 8 KEY ELEMENTS 1. ED Integration with EMS 2. Emergency Assessment: Diagnosis and Treatment of ACS 3. Low Risk Patients 4. Process Improvement 5. Personnel, Competencies, Training 6. Organizational Structure 7. Functional Facility Design 8. Community Outreach Page 13

Chest Pain Center Accreditation Chest Pain Center Committee Members: "A society without walls whose primary purpose is to significantly reduce heart attack deaths. -SCP Mission Statement- Radiology Laboratory Pharmacy EMS Nursing Units involved in the Care of the ACS patient Risk/Case Management Marketing/Community Outreach Administration, Physicians Page 14

8 Essential Key Elements for CPC Accreditation KE 1: Emergency Department Integration with the Emergency Medical System (EMS) pre-hospital process of care is an extension of the care provided by the hospital Formal relationship with local EMS. (joint meetings and case reviews) Hospital has formal Outreach program to local EMS (STEMI Practice Drills) EMS and Hospital use process improvement tools to show improvement in their process Facility addresses EMS education/training in its strategic plan supports EMS through funding or joint grants Page 15

8 Essential Key Elements for CPC Accreditation KE 2 : Emergency Assessment of Patients with Symptoms of ACS symptoms Page 16 Timely diagnosis and treatment of ACS ACS patient criteria-triage protocol Triage RNs trained on ACS patient recognition Guideline-driven, Written or pre-approved Order sets Flowchart the process & Written plan from triage, EKG, Biomarker,etc Pre-hospital EKG transmission to MD upon ED arrival Bed availability for ACS patient arriving in ED. PCI Facilities: Door to Balloon time Process Improvement (<90 min, >75%) - The ED MD activates the Cath lab for STEMI pts ONE CALL process. An Interventional Cardiologist is called FIRST for STEMI patients (10 min return call). ACC/AHA Guideline driven care and process (written) on medications, procedures and performance measures. Reperfusion protocols are developed jointly by Cardiologists and ED MDs Written process for patient admitted with ACS and becomes a STEMI Roles and responsibilities of STEMI team members

CPC ACCREDITATION & BIOMARKER TESTING: Cycle II Item Requirements: 2.10.1.0 2.10.7.4 3.3.0.0 3.3.1.0 = 8 items 3.3.2.0 3.3.3.1 3.4.0.0 3.4.4.0 Cycle III Item Requirements: 2.16.1.0 3.3.0.0 3.3.1.0 3.3.2.0 3.3.3.0 3.3.4.0 3.3.5.1 3.3.5.2 3.4.0.0 3.4.1.0 3.4.2.0 4.2.3.0 = 12 items (more emphasis on metrics for CBM) Page 17

8 Essential Key Elements for CPC Accreditation KE 2 : Emergency Assessment of Patients with Symptoms of ACS symptoms Timely diagnosis and treatment of ACS Page 18 Written plan to review patient s charts who did not receive reperfusion Defines procedure (written and Flowchart) procedure for patients presenting with Unstable Angina or NSTEMI Process clearly defines NSTEMI based on Biomarker criteria Facility s protocol on Cardiac Biomarkers NSTEMI and Unstable Angina process clearly defines a method of risk stratification based on peer-published tools Process defines and radiographic studies Process established medication protocols that follow the recommended ACC/AHA Guidelines for NSTEMI/UA patients Process of care to Observation or Inpatient setting. Process of care for inpatients who develop NSTEMI or STEMI during stay DC instructions specific to diagnosis Cardiac Rehab utilized for ACS patients Patient is given a copy of their EKG

Chest Pain Triage Protocols Risk Factor Stratification-- EKG, TIMI Score EKG: ST >1mm limb ST > 2mm precord New Q waves LBBB ST >1mm Dynamic ST changes with pain Deep symmetric T Normal EKG Non Diagnostic EKG LAB: Troponin I Elevation Troponin I (-)or (+) Troponin I Negative TIMI Score: ED TRIAGE: TIMI RISK SCORE One point for each: Age 65 or older 3 or more CAD risk factors Known CAD ASA use in past 7 days Recent (24hours) severe angina Cardiac Markers ST elevation >.5 mm Page 19 Track I STEMI To Cath Lab ASAP/CCU Track II- TIMI 2-4 UA/NSTEMI Risk Stratify MI Serial Biomarkers Admit for Obs Track III- TIMI 1 Low Risk Risk Stratify MI Serial Biomarkers DC Home

CPC ACCREDITATION & BIOMARKER TESTING KEY ELEMENT 2: 2.15.0.0 - The facility has a process in place to identify, track, and measure processes that affect the care of the ACS patient 2.15.1.0 - A common identified arrival time This also applies to the lab to ensure analyzers (both POCT & Lab) are synchronized to ED time measurements Can greatly affect outcomes compliance & measurement variables 2.16.0.0 - The facility has a process in place that clearly defines the procedure for patients who present to the facility s ED with an NSTEMI or UA. 2.16.1.0 The process clearly defines NSTEMI based on biomarker criteria. Page 20

Risk Stratification Is A Requirement Non ST Elevation Ischemic Discomfort Troponin Presentation (admission and / 4h 6-12 & 8hhrs) Troponin Negative Low risk Other disease? OBS / CDU Troponin Positive NSTEMI - High Risk Admit to Hospital Adapted Page from: 21 ACC/AHA Guideline Update for the Management of patients Copyright with UA 2009 and Siemens NSTEMI. Healthcare 2002 / Dr. Frank Diagnostics Peacock USA, study Inc. and All interview rights 2007 reserved.

8 Essential Key Elements for CPC Accreditation KE 3 : Patients with Low Risk for ACS and No assignable cause for their symptoms- applies to all Low Risk ACS regardless if they are dc d from the ED Inpatient or Observation status A process of care that includes initial screening for non ACS pathology Risk Stratification process for low-risk patients based on peer published guidelines Baseline Cardiac Markers (Single marker Troponin) Tracking Cardiac Marker Turn Around Time (Order to result 30 min or less) Point of Care Testing for Cardiac Biomarker Cardiac Biomarker Turn-Around Time is measured DOOR to RESULT Serial Troponin Serial EKG (Nurse-directed for recurrent or worsening symptoms) Stress Testing (who is responsible for patient while undergoing diagnostic testing?) Stress testing availability (7 days per week) CT Angiography for risk stratification of low risk patients Nuclear stress testing, stress ECHO appropriate methodology Written order sets, policies/process, flowchart and standard of care for Obs area. Discharge Instructions and Follow up (medications, testing, referral) Page 22

CPC ACCREDITATION & BIOMARKER TESTING KEY ELEMENT 3: Biomarker turn-around-time (TAT) must be timely, defined and tracked 3.3.0.0 Process for ACS includes baseline cardiac biomarkers 3.3.1.0 Troponin as single-marker strategy 3.3.2.0 Multi-marker strategy to include Troponin 3.3.3.0 Cardiac biomarker TAT is tracked 3.3.4.0 Includes point-of-care testing for CBM 3.3.5.1 CBM TAT order to result in 30 minutes or less 3.3.5.2 CBM TAT door to result in 30 minutes or less 3.4.0.0 Serial CBM at set intervals w/ one of more of the following: (3.4.1.0) Serial single Troponin (3.4.2.0) Serial Multi-Marker or Delta Marker Stategy Page 23

8 Essential Key Elements for CPC Accreditation KE 4 : Process Improvement - process improvement initiatives that have proven merit to make changes that translated to improved care Original flowchart and present Facility s quality plan includes monitoring and evaluation of processes of care for ACS patients Identifies opportunities for improvement and implements appropriate projects based on metric results or patient outcomes. Education and training of the staff involved in Improvement projects Synchronized clocks throughout all areas that care for ACS patients Retrospective review of ACS cases that did not meet facility goals Facility definition of arrival time Use of process improvement tools that identifies variation in processes Facility measures at least 3 of the Tier Items, demonstrates process change resulting in improvement in the care. Root cause analysis for delays, change of process and metrics of outcome Flowchart with relationship diagrams Page 24

CPC ACCREDITATION & BIOMARKER TESTING KEY ELEMENT 4: Process Improvement 4.2.0.0 - The facility measures at least three of the green Tier III Items and demonstrates a process change that results in improvement in the care of the ACS patient.facilities must have a minimum of six months worth of data to show improvement trends. 4.2.3.0 An improvement in DOOR to BIOMARKER result time This variable looks at both pre-analytical nursing, pre-analytical lab and analytical variables for both POCT & Lab to ensure TAT do not lag Lab/POCC a key variable in this measurement Page 25

8 Essential Key Elements for CPC Accreditation KE 5: Personnel, Competencies and Training to ensure the Standard of Care at the facility regarding Physicians, Nurses, technicians and other healthcare providers who care for the ACS patients. Board Certified physicians or has 10 hours of CME (in 3 years) related to the pathophysiology, diagnosis and treatment of ACS. Interventional Cardiologists 30 hours of PCI CME every 2 years Credentialing process for physicians and medical practitioners CPC Medical Director is Board Certified (SCP member, ACS care competent) CPC Coordinator (competent in ACS treatment and diagnostics) has 10 CEUs ACS case reviews for continuing education and process improvement All Nurses caring for ACS patients have annual education and competencies. New employee orientation receives info on CPC. Education of ancillary personnel on sign and symptoms of ACS/Early Heart Attack Facility offers Early Heart Attack care education to its Executive Board Facility shows improvement in the health of internal employees thru metrics Page 26

8 Essential Key Elements for CPC Accreditation KE 6: Organizational Structure and Commitment leadership-driven, multidiscipline collaboration, participated and physician supported efforts to improve the care for the ACS patients Written facility commitment for Chest Pain Center Accreditation signed by the CEO Senior management team participates in CPC committee Has a formal process of communicating ACS Quality Initiatives to facility s senior management team Budget and funding Medical Staff s commitment to facility s reperfusion strategy CPC committee is multidisciplinary and multi skilled Formal relationship between medical staff and EMS medical directors Quality Improvement reports at Medical Executive meetings Page 27

8 Essential Key Elements for CPC Accreditation KE 7 Functional Facility Design clear and visible signage both externally and internally directing patients to the ED is important. Functional design that expedites care and promotes efficacy. ED easily accessible and clearly marked Internal signage from different entrances must be directional and clearly marked. External signage to the ED must be evaluated from all points of entry Secured or Closed ED entrances must have call boxes to request entrances Construction and temporary access Evaluate internal and external signage and identify areas to improve Triage is easily accessible and clearly marked Wheelchair and stretchers are easily accessible to ED walk in entrance Walk in patient is immediately greeted by a member of the health team Air transport Cardiac Catheterization lab transport is expedited Specific inpatient and observation areas are identified for ACS patients Valet services are in place for ED patients Page 28

8 Essential Key Elements for CPC Accreditation KE 8 Community Outreach The Accredited CPC is actively involved in educating the Internal and External community on the early signs and symptoms of Early Heart Attack Facility offers Education on the Signs and Symptoms of Heart Attack and Heart Disease education (Act In Time) Web-based education Risk assessment of the community Involved in National Initiatives Partners with PCP in educating them on latest technology on diagnostics for ACS care Provides written materials to PCP on Early Signs and symptoms of ACS Partnership of Cardiologists and PCP in education of Best Practices guidelines and research based ACS. Page 29

Go HGConsu ccmedica Explicit S1on 0fmedl SearchMe exact Where does Chest Pain Center Accreditation Lead You? Chest Pain Accredited Center with PCI Go HGConsu ccmedica Explicit S1on 0fmedl exact SearchMe MARKET LEADERSHIP in CARDIOVASCULAR CARE IMPROVE / INCREASE MARGIN EXCEED PATIENT SATISFACTION-CREATE RAVING FANS CONTINUE TO IMPROVE CLINICAL OUTCOMES Page 30

The Laboratory s Responsibility In Quality 30 min TAT OUTCOMES Page 31

Troponin Guide 99 th Percentile 0.1 ng/ml 0.6 1.5 ng/ml Acute Myocardial Infarction (WHO) High Risk Cardiac Patient Negative Positive for Myocardial Injury/High Risk The ESC/ACC have always recommended a SINGLE cutoff for Troponin testing. The NACB recommended DOUBLE cutoffs (one for positive, one for AMI) until 2007. NACB now recommends a single cutoff at the 99 th percentile of a normal population. Physicians should continue using the NEW Universal Definition of MI shown here on the right. Page 32

My Troponin Tool Negative Less than the 99 th percentile. The patient would be considered low risk for death or non-fatal MI. Based on the new 2007 NACB/IFCC Guidelines. Positive Myocardial Injury. At intermediate and/or high risk for death or non-fatal MI >0.1 ng/ml ACC/AHA Guideline (2003) driven decision limit. Any patient with a troponin in this level is considered at high risk for death or non-fatal MI. AMI Decision Limit Based on the historical WHO criteria for MI. Point at which a patient with a troponin in this level would be considered as having a Myocardial Infarction (MI). Page 33

High Sensitive Troponin Benefits Early Presenters Findings 2007 Study at Brigham and Women s Hospital (Boston) Comparison of a high Sensitive Troponin (hstni) assay to a standard assay (TnI) Specimens where initially negative, then positive on serial testing Serial markers drawn at presentation, 6-9 hrs & 12-24 hrs. hstni showed positive results before TnI in 64% of samples Conclusion: reporting (hstni) results would allow the diagnosis to be made an average of 9 hours sooner The ability to provide earlier detection for 50% of confirmed ACS pts. has the potential to substantially enhance early triage in the emergency setting and treat high-risk patients as early as possible. American Page Society 34 of Clinical Pathology 2007: 128,282-286

Cardiac POCT must comply with Practice Guidelines Guidelines Recommendations Stratus CS Acute Care ctni NACB ACC/AHA NACB ESC/ACC ESC/ACC NACB Assay TAT of < 30 minutes Plasma or anticoagulated whole blood are the specimens of choice An increased value for troponin should be defined as a measurement exceeding the 99 th percentile of a reference control group Acceptable precision (CV) at the 99 th percentile for each assay should be defined as 10% 1 test ~ 14 minutes 2 tests ~ 18 minutes 3 tests ~ 22 minutes 4 tests ~ 26 minutes Whole blood and plasma samples are accepted 0.06 ng/ml (97.5% Upper Reference Interval) 0.07 ng/ml (99% Upper Reference Interval) 5.9% @ 0.12 ng/ml 10% @ 0.06 ng/ml 20% @ 0.03 ng/ml Status CS for POCT The ONLY analyzer that meets every guideline recommendation Page 35

The process: Who Is responsible? DOOR DATA DECISION DRUG 60 Minutes, preferably 30 Minutes Wu,HB, et al. National Academy of Clinical Biochemistry Standards of Laboratory Practice: Recommendation for the Use of Cardiac Markers in Coronary Artery Disease. Clinical Chemistry. 1999:45:7:1104-1121. Braunwald E, et. al. ACC/AHA guideline update for the management of patients with unstable angina and non-st-segment elevation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). 2002 Page 36

A Multidisciplinary Approach C ardiology Patient M ultidisciplinary A pproach Business O ffice L A B E ducation B est Practice A DM Case M anagers/u M D ietary Pharm acy R N C M S M edical R ecords C V Surgeons Em ergency D epartm ent Finance C ardiologist Radiology Page 37

Systems Approach To ED POCT To the extent that laboratory test turn-around-time is only one factor impacting Emergency Department (ED) length of stay and patient outcome, it is unlikely that POCT alone, in the absence of an interdepartmental approach to ED operations, will produce measurable improvements in outcomes. Lewandrowski, E. et al. Cardiac Marker Testing As Part Of An Emergency Department Point-of-Care Satellite Laboratory In A Large Academic Medical Center. Practical Issues Concerning Implementation. Point of Care. The Journal of Near Patient testing & Technology. Vol. 1, No.3, pp. 145-154. Page 38

Lab s Leadership in Chest Pain Accreditation Protocol Development: Cardiac Biomarker (single or multimarker) Performance Measure Data: TAT <60 min, (Goal<30 min) Is there a need for Cardiac POC testing?- selection of instrument Process Improvement in flow mapping process Are serial markers being done? (90 min, 2hr,3hr,4hr) Is risk stratification being done? (low risk-obs, high risk-admitted) ED Staff competencies on POC testing Outcomes Measurement did improvement in TAT impact Clinical and Economic Outcomes? Page 39

Lab s Collaboration with ED Impact Cost and Quality Process delays and Work Re-do s are co$tly! Inappropriate patient admission is expen$ive! Cardiac POCT verified in the lab doubles cost Lab results are trusted by Physicians and are basis for clinical treatments and disposition. Are you putting your patients at risk? Page 40

Lab Opportunity for Leadership Point of Care Testing offers laboratory Medicine professionals a unique opportunity to participate in bedside care of patients. Such an opportunity is a terrific way of bringing the expertise, knowledge and wisdom that laboratory professionals have to more direct patient care. Point of Care Cardiac Biomarkers is an excellent way to enhance respect for laboratory medicine, the old fashioned way --- by earning it! - Robert H. Christenson, PhD, DABCC, FACB NACB Point of Care Laboratory Practice Guidelines Page 41

In Summary: Lab provide leadership & guidance in the decision of choice of POCT instrumentation Quality test focus Lab provide education and guidance on protocol development (What tests are needed for POC) Lab must have Continuous Process Improvement Program that includes multidiscipline, inter- department collaboration Lab to provide phlebotomy training to Nursing staff and EMS Lab to standardize phlebotomy procedures (including specimen labeling) in all nursing units Lab to conduct annual competency check. Lab to be an active committee member, participating in PI committees Provide on going clinical education and Lab bulletin for new, updated subjects like: New tests, new guidelines, update on compliance and regulatory standards Conduct periodic customer-focused surveys to evaluate performance and identify process improvement opportunities. Page 42

ACS Clinical OUTCOMES Criteria 2002 Pre-POCT 2004 Post POCT Difference TAT(Vein to Brain Time) 90 minutes <20 minutes 450% ED Volume 32,945 patients 36,832 patients 11.8% CDU Volume No CDU 2,366 New added volume ALOS DRG 143 (pts) 2.35days (n=294) 2.16days (n=132) (8%) ALOS APC 0339(pts) ----- 18 hours (n=712) ------- ED STEMI Volume 47 38 (19%) ED NSTEMI Volume 21 105 500% ED Patient Satisfaction HCA ranking # 123 (out of 167HCA hosp)q2, #26 (out of 179HCA hosp) Q2, 59% Presented by West Houston Medical Center at the 8 th Congress of the Society of Chest Pain Center, Jacksonville, FL Page 43

Economics of POCT Cardiac Testing: Low Risk ACS Study examined impact of POCT cardiac testing to determine impact on: Hennepin County Medical Center Minneapolis, MN. Ranked US News and World Report 2004 Best Hospitals 325 Beds 97,642 Annual ED visits Turn around time Length of stay Patient outcomes Patient financial matrices Pre SCS 271 patients, Post SCS 274 patients Utilized 0.10 ng/ml cut-point TAT reduction pre 76 minutes, post <20 minutes Financial Outcomes: Savings: $ 4,821.00 per patient Page 44

Cardiology Perspectives Vignette Video This video highlights how one hospital has been able to diagnose and treat chest pain patients more effectively by utilizing a high-sensitivity troponin assay. Includes expert testimonials from a Chief of Emergency Medicine and an interventional Cardiologist, describes how high-sensitivity troponin testing has helped them to rapidly differentiate MI in chest pain patients and institute appropriate care more quickly and presents a case where the highsensitivity troponin testing helped identify a critical lesion in a patient who did not fit the typical picture of an MI patient. Page 45

Cardiology Perspective Video Page 46

Thank you for your attention! Q&A amy.l.cotner@siemens.com Page 47