Navigating the Regulatory Issues of Blood Management

Transcription

1 Navigating the Regulatory Issues of Blood Management Bob Dyga RN, CCP, LP, CPBMT Vice President, Perfusion Operations UPMC/Procirca History of Transfusion Medicine Blundell s Blood Gravitator h2p://bloodjournal.hematologylibrary.org/content/112/7/2617/f5.large.jpg 2 1

2 Patient Blood Management Implementation of evidence-based transfusion guidelines to reduce variability in transfusion practice, and the employment of multidisciplinary teams to study, implement and monitor local blood management strategies. Blood Conservation Improved Patient Outcomes Patient Centered Appropriate Transfusion Practices 2007 Blood Management Six Point Patient Blood Management Strategy 1. Strict transfusion trigger Leverage computerized physician order entry (CPOE) systems for clinical decision 2. Eliminate iatrogenic blood loss Reduce all waste related to blood transfusion pracnces; POC tesnng, samples, PADB, & inventory 3. Periopera:ve blood recovery Promote alternanve methods and systems for blood transfusion 4. Promote pre and post surgical anemia management Encourage preoperanve assessment and follow- up post operanve visit. 5. Provide blood management educa:on Awareness and audinng for clinicians; panent- centered shared decision making tools 6. Offer bloodless medicine program Director available for consultanon 2

3 Terminology: Regulations vs Standards Regulations Requirement promulgated by national, state, or local agencies (e.g. a governmental entity) for the implementation of laws enacted by legislative bodies. Often lead to licensure. Standards Voluntarily adopted. Established by nongovernmental entities to promote best practices and provide basis for accreditation 5" A Regulation A Standard Regulations Mandatory, from government Can establish minimum basis to legally operate Failure to comply can result in shutdown or civil/criminal penalties Regulations often established to prevent harm but not necessarily to optimize technical and medical operations Rarely reversed but may be altered or improved Standards Voluntary, from private sector Often designed to promote quality of products, services, and to facilitate operations Basis for accreditation against peer-reviewed requirements that reflect best practice Failure to comply results in loss of accreditation, prestige/status and possible loss of access to markets Revision cycle ensures flexibility and helps drive standard of care 6" 3

4 Blood Management is Similar A common criticism of U.S. health care is the fragmented nature of its payment and delivery systems. Because in many settings no single group of participants-physicians, hospitals, public... takes responsibility for guiding the health of a patient... care is distributed across many sites, and integration among them may be deficient. Fragmentation leads to waste and duplication-and unnecessarily high costs. 7 Regulatory & Standards Agencies Blood Management" 4

5 Food and Drug Administration Food and Drug Administration (FDA) is responsible for writing the regulations (rules) and guidance documents to enforce the laws related to blood" Regulate drugs and medical devices under the Food, Drug, and Cosmetic Act. Blood products are included because they are intended to cure, mitigate, treat, or prevent disease " Provide license and registration " " Provide exemption from registration for transfusion services if CMS approved" " " Center for Biologics Evaluation and Research Initial inspection by CBER Routine inspections include the FDA s 5 required layers of blood safety 1. Donor screening 2. Donor testing 3. Quarantining 4. Monitoring 5. Investigating problems. 10" 5

6 Center for Biologics Evaluation and Research Within the FDA, the Center for Biologics Evaluation and Research (CBER) regulate blood products and most other biologic therapies. Biologic products include blood, blood components, derivatives, therapeutic serum, and vaccine applicable to the prevention or treatment of disease. 11" Blood Related Devices CBER has lead responsibilities in collaboration with CDRH for equipment marketed for the transfusion service and for the collection and processing of blood products, HSC, and autotransfusion. Serious adverse events related to medical devices must be reported (21 CFR 803). Report on Medwatch form 3500A and if death report to the FDA. 12" 6

7 Lab Licensing Agencies Peri-operative recovery A. Medical director B. Quality program C. Policy and procedure Lab management A. Inspection, quality, and safety License to function 13" Center for Medicare and Medicaid Services Reviews new products and service Approves or denies payment Sets reimbursement practice for third party insurance companies Assures new products are safe and beneficial 14" 7

8 Regulatory Influence On 6 Point Plan 1. Strict transfusion trigger FDA, CBER, CAP, CMS, CLIA, STATE Leverage computerized physician order entry (CPOE) systems for clinical decision 2. Eliminate iatrogenic blood loss FDA, CBER, CAP, CMS Reduce all waste related to blood transfusion pracnces; samples, PADB, & inventory 3. Periopera:ve blood recovery FDA, CBER, CAP, CMS, CAP Promote alternanve methods and systems for blood transfusion 4. Pre and post surgical anemia management FDA, CMS, CAP, CLIA Encourage preoperanve assessment and follow- up post operanve visit. 5. Provide blood management educa:on Awareness and audinng for clinicians; panent- centered shared decision making tools 6. Offer bloodless medicine program Director available for consultanon CMS Reimbursement and Accreditation Why accreditation?" A. Improve risk management and risk reduction" B. Provide education on best practices to improve " business operations" C. Improve staff recruitment and development" D. Receive CMS Certification Number (CCN)" " Three accrediting agencies:" - Joint Commission (TJC)" - Healthcare Facilities Accreditation Program (HFAP)" - National Integrated Accreditation for Healthcare " Organizations (NIAHO)" 8

9 Joint Commission Standards 17 Standards address the organization s level of performance in key functional areas. Standards set forth performance expectations for activities that affect the safety and quality of patient care. The Joint Commission develops its standards in consultation with health care experts, providers, measurement experts, purchasers, and consumers. Joint Commission 9

10 JC 7 Blood Management Performance Measures #" Measure Name BM 1" BM 2" BM 3" BM 4" BM 4b" BM 5" BM 6" BM-7 " 19 Transfusion consent" RBC transfusion indications" Plasma transfusion events" Platelet transfusion events" Prophylactic platelet transfusion indications" Blood administration documentation" Preoperative anemia screening " Preoperative blood type screening " 20 10

11 21" Provided by Miriam A. Markowitz, CEO, aabb 22" 11

12 AABB Standards & Guidelines Guidance Document available for Standards 23" AABB Standards 1 st Edition 10 quality system essentials 20 areas of responsibility 3 levels of participation 24" 12

13 25" Provided by Miriam A. Markowitz, CEO, aabb Professional Organization Guidance Society of Thoracic Surgeons American Society of Anesthesiologists Society of Cardiovascular Anesthesiologists Society for the Advancement of Blood Management International Consortium for Evidence based Perfusion 26" 13

14 27" ITxM & UPMC BURC Collect, store, and deliver Special testing Clinical expertise Reputation Business expertise Quality systems AABB accreditation Regulatory compliance Evidence based practice Safe, Evidence Based, Value-added PBM TX demand Patients Procedures Clinical expertise Reputation Business expertise Quality demand AABB accreditation Regulatory compliance Cost containment Patient outcomes Bloodless medicine 28" 14

15 Patient Blood Management Program Local Transfusion Committees (11) Support 6 point PBM Program Review Local Blood Utilization Monitor TX Adverse Events Risk Management Patient Blood Management Committee (PBMC) Support UPMC Patient Blood Management Goals Develop System Wide TX Guidelines Drive 6 Point Strategy Promote Bloodless Medicine Monitor Local Strategies Encourage PBM Innovation & Research 29 Standards Influence On 6 Point Plan 1. Strict transfusion trigger 2. Eliminate iatrogenic blood loss 3. Periopera:ve blood recovery 4. Promote pre and post surgical anemia management 5. Provide blood management educa:on 6. Offer bloodless medicine program AABB, JC, ASA, SCA, STS, SABM, ITxM, UPMC 15

16 Perfusion Blood Management Anesthesia and Perfusion work to preserve hematocrit Coated circuitry Circuit volume reduced to < 1,000ml Colloid and Mannitol prime Retrograde autologous priming Precise Heparin and Protamine management Utilize alpha drugs to maintain SVRI Limit cell washing to pre and post heparinization Utilize hemofiltration during & after bypass Use POC coagulation testing & transfusion algorithms Use CardioPAT in collect first mode for post-op salvage Use antifibrinolytics systemically and topically Use autologous biologics such as platelet gel POC washing allogeneic RBC s PBM Regulations Around the Globe Australia - the National Blood Authority (NBA), Canada - ONTrac under the Ontario Ministry of Health and Long term Care Germany - Transfusion Act of 1998 Netherlands - Society of Blood Transfusion (NSBT) Spain - adding PBM to Hemovigilence program England - NHS Blood and Transplant 32" 16

17 2/4/15 ` PBM" Ac cr ed ita tio n YOU HOSPITAL & TRANSFUSION SERVICES Conclusions Too many participants Limited regulatory influence on PBM practice Significant standard, accreditation, & guideline influence Coordination of effort would improve progress Significant success has resulted at local level Blood utilization review committee Navigation begins and ends with YOU AND I 34" 17

18 THANK YOU 18