Standards, Guidelines, and Regulations Theresa C. Stec BA, MT(ASCP) Biovigilance Program Manager Surgical System Administrator Perioperative Services Baystate Medical Center Springfield, MA
Standards, Guidelines, and Regulations 10-20 percent QIA* Exam content in following subjects A. Informed Consent B. Confidentiality C. Donor Selection D. Facility Licensure and Accreditation E. Training and Competency ASFA, AABB, CAP, FDA, FACT, HIPAA, TJC, etc. *Qualification in Apheresis Exam, offered by ASCP
Learning Objectives To provide an overview of the following topics Informed Consent Confidentiality Donor Selection Training and Competency Facility Licensure and Accreditation
Ultimate Goal Public Safety including the safety of patients, the blood supply both donors who donate products and patients who receive products, and the healthcare workers responsible for all aspects of procuring, processing, testing and releasing products.
Informed Consent The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). OHRP also has a tips sheet for informed consent available at http://www.hhs.gov/ohrp/policy/ictips.html.
Informed Consent Written consent is obtained before the procedure and on the day of donation. Elements include, Explanation of procedure in understandable terms/ language, Explanation about the risk of procedure, Tests performed for transmission of infectious diseases and requirements to report donor information/ test results to public health departments, Opportunity to ask questions and receive answers Opportunity to give or to refuse consent, For minor or legally incompetent adult follow applicable laws.
Health Insurance Portability and Accountability Act HIPAA The HIPAA Privacy Rule requires that covered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information (PHI), in any form. See 45 CFR 164.530(c).
Health Insurance Portability and Accountability Act HIPAA Protected health information (PHI) Information accessed only for treatment, payment, healthcare operations, as authorized in writing by patient and circumstances described in privacy rules PHI created in any medium, written, oral or electronic Demographic information that can identify someone Past, Present or Future information related to physical or mental health conditions Payment for health care Law enforcement, public health, FDA adverse event reporting, research
FDA Part 640.3: Suitability of Donor Determined by a qualified physician or by persons under his supervision and trained in determining suitability Determined on the day of collection by Means of medical history A test for hemoglobin level Physical examination as appears necessary to physician
FDA Part 640.3: Suitability of Donor Qualification of donor in good health Not a source of whole blood in last 8 weeks or double RBC in 16 weeks Normal temperature Systolic & diastolic blood pressure within normal limits Note: On site physician may qualify blood pressure Hemoglobin no less than 12.5 grams (38% HCT)
FDA Part 640.3: Suitability of Donor Freedom from acute respiratory diseases Freedom from any infectious skin disease at site of phlebotomy (risk of contamination of product) Freedom from any disease transmissable by blood Freedom of the arms and forearms from skin punctures or scars indicative of addition to selfinjected narcotics
FDA Part 640.3: Suitability of Donor No history of viral hepatitis (> age 11) No history within 12 months of donation of close contact with individual having viral hepatitis of receiving human blood or any derivatives
FDA Part 640.3: Suitability of Donor Qualifications; donations within less than 8 weeks. If at the time of donation the person is examined and certified by a physician to be in good health as indicated in the Qualification of donor in good health section
FDA Part 640: Subpart C-Platelets 640.21 Suitability of donor Plateletpheresis donors must meet the criteria as described in 640.3 Suitability of donor Or as described in an approved biologics license application (BLA) or an approved supplement to a BLA Informed consent must be obtained (640.61) Medical supervision (640.62)
If it s not documented it didn t happen
Training Key component to quality is training. Training program includes Written objections (competency based) Written training plan Documentation of training and competency assessment tools Checklist Direct observations Test of knowledge/ skills Critical thinking/ troubleshooting Continuing education Corrective action plan/ re-training
Competency Assessment Assessment of competence performed before independent performance of assigned activities and at specified intervals.
Competency Assessment Administration of a Written Evaluation: Written evaluations for verification of a participant s knowledge. Knowledge of theory or principles, problem-solving ability, logical sequence used, and independent or group decision making. Observation of Procedure, Process, or Outcome: Observation by a trainer of an employee performing task.
Competency Assessment Verification of Response to Situational Problems or Calculations Related to the Procedure: What would you do if A procedure-related situational problem or recommendation of procedure-related course of action that is consistent with policies and regulations. Response to Oral Queries Related to a Step or Procedure: Answers provided by the employee to questions asked by trainer.
Competency Assessment Wet Testing Testing Blind QC Samples: Employees are unaware when blind test samples are assigned. They appear identical to other samples Testing of Known Samples: External proficiency surveys and commercially prepared quality control samples. Participants know and often plan for such testing events. This competency is assigned and rotated to all staff on all shifts.
Competency Assessment Testing Previously Analyzed Samples: Duplicate or replicate testing provides comparisons and contributes to the validation of the analytical phase. Sources may be previously tested samples run at pre determined intervals, samples of known constituents (spiked sample), or already reported proficiency testing samples.
Food and Drug Administration FDA Registration Human blood components regulated as drug and biologic Title 21 of Code of Federal Regulations(CFR), Part 640 Facilities collecting products for transfusion must register Blood Establishment & Product Listing: Form FDA 2830 Registrants subject to inspection every two years. Registrants must comply with CFRs, cgmp, and cgtp Registered, non-licensed facilities number must appear on components label as part of facilities identification
Food and Drug Administration FDA Registration Tissue Establishment & Product Listing: Form FDA 3356 Human Cells, Tissues, and Cellular & Tissue Based Products (HCT/Ps) At the beginning of each inspection, a Form FDA-482, Notice of Inspection, should be issued to the most responsible individual available at the HCT/P establishment. At the close of the inspection, observations focusing on the requirements of 21 CFR Part 1271, should be listed on a Form FDA-483 and issued to the most responsible individual.
Food and Drug Administration Inspection of HCT/P Current good tissue practice (CGTP) regulations ten core requirements [21 CFR 1271.150(b)]: 1. Donor requirements relating to: Donor eligibility determinations, 21 CFR 1271.50 Donor screening, 21 CFR 1271.75 Donor testing in 21 CFR 1271.80, and 1271.85 2. Facilities requirements in 21 CFR 1271.190(a) and (b) 3. Environmental Controls requirements in 21 CFR 1271.195(a) 4. Equipment requirements in 21 CFR 1271.200(a) 5. Supplies and Reagents requirements in 21 CFR 1271.210(a) and (b)
Food and Drug Administration 6. Recovery requirements in 21 CFR 1271.215 7. Processing and Process Controls requirements in 21 CFR 1271.220 8. Labeling controls requirements in 21 CFR 1271.250(a) and (b) 9. Storage requirements in 21 CFR 1271.260 (a) through (d) 10. Receipt, predistribution shipment, and distribution requirements of an HCT/P in 21 CFR 1271.265 (a) through (d). COMPLIANCE PROGRAM GUIDANCE MANUAL. Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002
Licensure FDA Licensure To engage in interstate commerce of biological products Complete Form FDA 356h for biologic license application (BLA) Submit supporting documentation as directed Approval of BLA indicates both establishment and products meet requirements Contact FDA for requirements for your facility and products
Regulatory Agencies Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Centers for Medicare and Medicaid Services (CMS) Office of Civil Rights Center for Biologics Evaluation and Research (CBER) Public Health Service (PHS) HIPAA Department of Labor Occupational Safety and Health Administration (OSHA) Department of Transportation Shipping of products
Accreditation Agencies AABB Foundation for the Accreditation of Cellular Therapy (FACT) The Joint Commission (TJC) College of American Pathologists (CAP)
Why Accreditation? Assesses quality systems and operational areas for compliance with organization s standards. Assists in preparation for other inspections, and serves as an external audit providing a valuable tool to improve both compliance and operations. Offers both educational and peer review opportunities.
Inspections Who can inspect? FDA: Form FDA-482, Notice of Inspection AABB FACT (Stem Cell Facilities) Joint Commission Center for Medicaid and Medicare Services (CMS) CAP (College American Pathologists) CLIA/OSHA State and local agencies (Public Health)
Your Facility AABB/ CAP/ FACT TJC DPH CMS FDA
Parts: FDA Regulations Title 21 CFR 210, 211: cgmp (Drugs) 600, 601, 610: Biological Products 606: cgmp for Blood and Blood Component 607: Establishment Registration 630, 640: Requirements for Blood, Blood Component and Blood Derivatives 660: Diagnostic Substances for Laboratory Tests 820: Quality System
FDA Regulations (continued) Title 21 CFR Parts: 1270: Human Tissue Intended for Transplantation 1271: Human Cells, Tissues, and Cellular & Tissue Based Products Title 42 CFR Part 493: Laboratory Requirements FDA web site Search CFR Title 21 Database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
FDA Quality System Requirements (QSR) Quality policy: commitment to quality by management with executive responsibility to ensure that quality policy is- 1. Understood 2. Implemented 3. Maintained at all levels of the organization
FDA QSR (Continued) Management representative documented authority over and responsibility for- 1. QSR established and maintained 2. Report performance of quality system 3. Review suitability and effectiveness at defined intervals with sufficient frequency to ensure QSR are satisfied 4. Documents results and dates of quality system reviews (820.20)
FDA QSR (Continued) Quality system procedures: outline of the structure of the documentation used in the quality system (820.20e) Quality audit: procedures to conduct audits to assure compliance with QSR and determine effectiveness of quality system Quality audits shall be conducted by individuals who do not have direct responsibility for matters being audited.
Current Good Manufacturing Practice (cgmp) 21 CFR Part 606 606.3: Definitions Processing means any procedure employed after collection, and before or after compatibility testing of blood Includes unit ID, components made, serological testing, labeling and associated records Control means having responsibility for maintaining the continued safety, purity, and potency of the product Distributed means the blood or blood components have left the control of The licensed manufacturer, Unlicensed registered blood establishment, or Transfusion service or, Licensed manufacturer has provided product for use in manufacture of a licensed biological product
Universal Protocol TIME OUT Performed immediately before invasive procedure Verify correct: patient, procedure & site Should involve patient or patient advocate (RN) Consider performing Time Out for any procedure that your facility requires a separate informed consent be obtained.
TRACER METHOD The Joint Commission Follow patient/ chart through various services Transfusion/ Transplant Follow product from storage to patient Follow adverse event back to processing Processing / Testing Follow supplies to results Follow product to storage
Showcase Quality Program Activities Prepare and maintain documentation evidence of all the quality activities performed Meeting minutes Quality Control/ Quality Monitors Schedules competency assessment, equipment maintenance Event management, corrective & preventative actions Process improvement Internal and external assessment summaries Executive management review & involvement
To err is human Event management Process Improvement New process New equipment New procedures
Available Resources Professional societies Annual meetings Web site Publications Network with colleagues Ask the experts
Professional Organizations AABB (formerly American Association of Blood Banks) American Society for Apheresis (ASFA) American Society of Clinical Pathology (ASCP) College of American Pathologists (CAP) Foundation for the Accreditation of Cellular Therapy (FACT) ICCBBA (formerly International Council for Commonality in Blood Banking Automation) ISBT 128 global standard for label information Blood, Blood Components and Cellular Therapy Products The Joint Commission (TJC) World Apheresis Association (WAA)
Web sites http://www.aabb.org AABB accreditation http://www.iccbba.org ISBT labeling http://www.factwebsite.org FACT accreditation http://www.cap.org CAP accreditation (laboratory) http://www.jointcommission.org The Joint Commission
Web sites http://www.hhs.gov/hipaa/index.html Health Insurance Portability and Accountability ACT (HIPAA) http://www.fda.gov U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332)
Publications Accreditation Standards Federal Government FDA Code of Federal Regulations Guidance Documents State Government Department of Public Health
Summary Standards, Guidelines, and Regulations compliance should be viewed as an opportunity for process improvement to protect patients and donors.
Life is an ever changing landscape. We lay our heads down to rest never knowing what the next day will bring, but for its sunrise and sunset. Among life s joy and content, there are unexpected events that shatter our peace. Life changes in an instant. Yet, in the midst of chaos and confusion, special helpers always emerge. Life s special helpers include our doctors, our nurses, all caregivers and health care workers. You are hear 24 hours a day, every day of the year, never knowing who will be treating and what circumstances will challenge you. Yet, you rise to every occasion. Yet rise to natural disasters and man made ones. You keep calm, draw upon your specialized knowledge and training, are driven by unrelenting passion to help people in their times of need. You guide. You heal. You save lives. Baystate Health extends appreciation to every one of our health care workers and our brothers and sisters in health care throughout our state and nation who also do this every day. We expand our circle of gratitude by honoring all first responders, law enforcement and soldiers who, like health care workers, have an internal calling to selflessly serve. You say you are just doing your job. We say you are doing more than you know. Thank you. May those two words be enough to inspire you to do it again tomorrow.
Questions? My Contact e-mail theresa.stec@baystatehealth.org