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& DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., 20071 Human Tissue Liability, Patient Safety and Regulatory Compliance DUKE.

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Presentation on theme: "& DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., 20071 Human Tissue Liability, Patient Safety and Regulatory Compliance DUKE."— Presentation transcript:

1 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Human Tissue Liability, Patient Safety and Regulatory Compliance DUKE KASPRISIN, M. D. Chief Medical/Scientific Officer Biomedical Synergies, Inc. DAVID A. BUCZEK, M.A. President DB&A Inc.

2 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Agenda Tissue Related Adverse Outcomes Overview of Tissue Banking Prevention of Disease Transmission Via Transplantation JCAHO and AABB Standards Case Study Activity Appropriate Holistic Response Approach Getting Started

3 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Duke Kasprisin, M.D. BSI Chief Medical Officer Board certified physician, and nationally recognized authority in all aspects of tissue transplantation Immediate Past President and current Board Member, American Association of Tissue Banks (AATB) Editor, Standards for Tissue Banking for AATB Member, CDC/FDA Organ and Tissue Safety Workshop Member, AATB Sentinel Committee on Tissue Associated Infections Member, American Association of Blood Banks (AABB) Tissue Working Group on JCAHO compliance for member blood banks 25 years experience with the American Red Cross, including 10 years as Chief Medical Officer for Transplantation Services

4 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Four charged in a plan to sell body parts for medical use - In New York, a Grisly Traffic in Body Parts Illegal Sales Worry Dead's Kin, Tissue Recipients - Washington Post TV host Alistair Cooke's bones allegedly stolen; Thieves sold venerable broadcaster's body parts for $7,000, report says - MSNBC Hospital asks judge to dismiss lawsuits over cadaver tissue BLOOMINGTON, Ind. -- Bloomington Hospital has asked a judge to dismiss lawsuits filed by patients who received tissue from human cadavers during surgery, saying the issue first should go before a state medical review panel.- Chicago Tribune Tainted Bone Scandal - (Ft Wayne, IN)- Last week, four people were charged with stealing body parts from corpses and selling those parts to distributors. - NewsChannel 15 (Ft. Wayne, IN)

5 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Prevention Of Disease Transmission Via Transplantation Donor History Screening Donor Physical Exam Donor Blood Tests Issues concerning cadaveric samples Autopsy Tissue Processing Steps Compatibility

6 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Case Study In 2004, a young male patient presented in the emergency room with nausea, vomiting, and difficulty swallowing. His mental status began to deteriorate and a subarachnoid hemorrhage was found on computerized tomography. His condition continued to worsen and he died four days later. He subsequently donated kidneys, lungs, and liver and these organs were transplanted into four patients.

7 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Case Study The patient receiving the lung transplant died of intraoperative complications. The three other organ recipients had successful surgeries and were discharged from the hospital. However, all three began to experience progressive neurologic problems and died within four to five weeks following the transplants. Laboratory investigations of the three recipients revealed they died of rabies. During later investigations it was revealed that the donor had been bitten by a bat.

8 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Case Study A fourth patient at the same transplant center who had not received an organ from this donor developed similar symptoms following a liver transplant. On autopsy it was discovered that this patient also died of rabies. There was no evidence of cross contamination of this patient and no additional cases of encephalitis consistent with rabies found at the hospital.

9 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Case Study Why did the fourth patient develop rabies?

10 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Case Study During the subsequent investigation it was discovered that the iliac arteries from the infected donor were not used during the liver transplant. They were placed in a sterile container and stored for later use. The vessel was used in another liver transplant patient who then died of rabies. Because of inadequate labeling it couldn’t be proven that the vessel absolutely came from the same donor.

11 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., HIV From Bone & Tendon Allografts Case from unprocessed femoral head (live donor) prior to anti-HIV testing. Donor was IV drug user (MMWR 1988;37:587) Cases from anti-HIV Neg organ & tissue donor (donors in window period) (NEJM 1992;326:726) –Transmitted by unprocessed frozen tendon, two unprocessed frozen femoral heads, –Not transmitted by freeze-dried tendon(cells removed from bone ends, antibiotic soaked), freeze-dried bone(cells removed, ETOH soak) and irradiated dura

12 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., HCV From Bone & Tendon Allografts From frozen femoral head prior to anti- HCV test available Cases from 1990 anti-HCV 1.0 Neg donor(retrospectively Pos with anti-HCV 2.0) JBJS 1995; 77-A:214 –Transmitted by frozen, unprocessed tendon & bone –Not transmitted by freeze-dried irradiated bone

13 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Infectious Risks in Tissue Transplantation Window Period for Infection Before and After NAT Plus NAT Anti-HIV 22 days 7 days HBsAg 59 days 20 days Anti-HCV 70 days 7 days Zou, et al. N Engl J Med 2004; 351:

14 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Infectious Risks in Tissue Transplantation Probability of a Viremic Tissue Donor Before and After NAT Current Post-NAT HIV1/55,0001/173,000 HBV1/34,0001/100,000 HCV1/42,0001/421,000

15 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Allograft Associated Bacterial Infections - Clostridia Nov 7, Yr Old Male, St. Cloud, Minn. Knee Surgery Using Refrigerated “Fresh” Femoral Condyle. –Nov 10, Knee Pain, Then Severe Hypotension –Nov 11, Died. Postmortem Blood Culture: Clostridium sordelli Nov 13, Yr Old Male (Illinois) Knee Surgery Using “Fresh” Femoral Condyle and Meniscus –Nov 14. Fever, Unresponsive to Cephalosporin Antibiotic –Day 8. Readmitted to Hospital. Septic Arthritis, Temp F (39.7 C). Treated With Ampicillin, Sulbactam. Improved. –No Culture Done For Anaerobic Bacteria (For Clostridium ) 3 Allografts. Same Tissue Bank, Same Donor. CDC - Jernigan, Kainer, MMWR- 2002;51(Mar 15):207-10

16 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., C. Sordelli Infection Investigation Tissue Processed After Body Stored Room Temp 19 Hrs Plus 4 Hrs Refrigerated 19 Unused Tissue From Same Donor –2 Grew C. sordelli (Fresh Fem. Condyle, Frozen Meniscus) –Fluid Bathing Allografts Grew C. sordelli 10 Tissue Transplanted Into 9 Other Patients, 8 States –No Additional Infections Reported Tissue Bank Processing –Aseptic. No Disinfectant. No Sterilant –Antibiotic Soak –Companion Tissue (Cartilage) Cultured After Antibiotic Exposure - No Growth –No Other Final Sterility Tests –No Preprocessing Cultures MMWR 2002;51(Mar 15):207-10

17 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Clostridium Sepsis Tissue Processing Facility –Does Not Use Bacterial Testing of Tissues Prior to Processing (e.g. at Procurement) –Aseptic Processing, No Terminal Sterilization –Antibiotic Soaks Used and May Have Interfered With Detecting Clostridium –No Bacteriostasis Testing –Processing Not Validated to Ensure Sterility FDA Stopped Further Tissue Processing and Distribution

18 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Allograft Associated Bacterial Infections CDC CDC Solicited Other Cases of Surgical Site Infection Within 12 Months of Transplant 26 Reports (Include 4 Tendon and 2 Femoral Condyles Previously Reported) –13 (50%) Clostridium Infection (C sordelli-1, C. septicum-12) –11 of 13 Infections Involved Allograft From Same Tissue Processor MMWR 2002;51(Mar 15):207-10

19 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Invasive Streptococcus Healthy 17 yr old male Elective, anterior cruciate ligament repair (September) Hemi-patellar ligament allograft used Symptoms developed 1 day post-op –Pain, erythema at incision –Febrile (39°C) –Chills

20 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Recipient Outcome Re-admitted 6 days post- op and allograft removed; fasciotomy of affected thigh performed Blood, wound aspirate, and explanted allograft all grew same organism Identified as Strep. pyogenes (group A streptococcus - GAS) Treated and improved Example of blood agar plate w/GAS growth: beta hemolysis (complete lysis of red cells), bacitracin susceptibility (zone of inhibition around impregnated disk) Photo from

21 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Processor A Received assorted tendons, patellar ligaments, meniscus, and vascular tissues from donor –Pre-processing cultures performed on 14 tissues Positive for growth - GAS identified on each tissue –These allografts were aseptically processed by treatment with antimicrobial soaks –All final, post-processing cultures were negative

22 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Investigation - Processor A Four tendons and one ligament from same donor were implanted in patients –No adverse outcomes reported from these surgeries –Remaining allografts from this donor were recalled or quarantined from distributable inventory All were cultured and GAS was not cultured from any –Temporarily suspended distribution of all similar allografts

23 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Processor B Received musculoskeletal and soft tissues from same donor Donor deferred due to travel history in UK –Exclusionary criterion for processor B –All cultures (swab cultures obtained at recovery) grew GAS - these results would have also disqualified donor for this bank

24 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Donor Information Previously healthy male in his 30s Had cervical spine fusion for degenerative disc disease 3 weeks prior to death 3 days before death, presented to an ER w/diffuse rash (thought to be medication reaction) Photo from Example of cervical DGD (arrows). This is an example only, not case patient’s.

25 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Investigation - CDC GAS isolated from unprocessed fascia lata (Processor B) and from archived blood specimen (Processor A) Special stains showed GAS in the skin, blood vessels, and lung of donor Emm gene typing proved same organism in donor and recipient

26 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Diseases Transmitted By Tissue Transplantation Bone TendonCartilage Cornea Bacteria Bacteria Hepatitis HIV Hepatitis B HCV HCV Rabies TB CJD HIV Yeast Skin Heart ValvePericardium Dura BacteriaBacteriaBacteria CJD HIV? TB? CJD ? CMVYeast ? Hepatitis

27 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., How often do major adverse outcomes happen? We don’t have surveillance systems than can define the true incidence Many some cases probably go undetected Organs: approximately 20,000 per year – 15 cases from or 0.02% Tissues: approximately 900,000 transplants per year and 19 cases from or % - excluding bone products the number is at least 10x higher

28 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Overview of Tissue Banking Skin Bone Tendon Fascia Heart valves Blood vessels Pericardium Corneas Cellular components (e.g. chondrocytes) Reproductive tissues Tissues Available

29 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Overview of Tissue Banking Purpose of the surgery Risks of the product Specifications of the tissue Alternatives engineered vs. non-engineered Instrumentation Cost Physician preferences Decisions in choosing what tissue to use

30 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Overview of Tissue Banking Spinal surgery Non-engineered Bone needs to be cut and shaped in OR Tricortical ilium block Bicortical ilium block Unicortical ilium block Types of tissues available and their uses

31 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Overview of Tissue Banking Spinal surgery Engineered Types of tissues available and their uses

32 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Overview of Tissue Banking Demineralized bone matrix – Used as a bone void filler Types of tissues available and their uses

33 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Prevention Of Disease Transmission Via Transplantation Processing –In surgery cases where donor was in the window period for HCV or HIV, those receiving unprocessed tissues or organs developed infections, while those receiving processed tissue did not

34 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Prevention Of Disease Transmission Via Transplantation Processing –Tissue Processing Steps: 1.Cleaning, dilution 2.Antibiotics 3.Biocleanse® 4.AlloWash® 5.Clearant Process® 6.Radiation – dose issues 7.Alcohol 8.Ethylene oxide –Limitations in transplants other than bone

35 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., The Joint Commission (formerly JCAHO) created tissue standards for hospitals effective 7/01/05 Evaluates and accredits more than 15,000 health care organizations and programs in the United States Independent, not-for-profit organization Nation's predominant standards-setting and accrediting body in health care Mission: To continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations

36 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) An organizational unit must be assigned that will be responsible for all steps involved in the utilization of tissue –Question: Who in a hospital is best suited to oversee this process? (lab or surgery) Validation of equipment Monitoring temperatures for storage Answer storage unit alarms during all shifts Tracking recipients

37 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Who Controls Tissues in Hospitals? In a study by the CDC surgical departments had responsibility for tissue use (76%) followed by the blood bank (51%). In some hospitals blood bank managed certain tissues while surgery handled others. Usually in those hospitals where surgery had responsibility this did not include stem cells. Infection control departments were most commonly the responsible party for adverse reaction reporting.

38 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Advantages of Assigning Tissue Management to the Laboratory Blood Bank has the appropriate education and training to validate equipment and processes and monitor compliance with the procedures Present 24/7 to monitor refrigerated and frozen products Greatest knowledge of quality assurance Most experience with tracking and tracing human products and managing recalls

39 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Disadvantages of Assigning Tissue Management to the Laboratory Blood Bank already overtaxed. Will additional resources be allocated to manage the complexity of tissue Does not have intricate knowledge of tissue banking Can Blood bank be given authority to oversee training, monitor products, reconstitution and use in the OR Will the Blood Bank get cooperation to manage investigations if there is an adverse reaction

40 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Musculoskeletal tissue Cardiovascular tissue Skin Reproductive tissue Orthopedic unit Burn unit Surgical Specialty units Fertility clinic Autologous ? Organizational Design to Meet Joint Commission Standards Look Familiar?

41 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Musculoskeletal tissue Cardiovascular tissue Skin Reproductive tissue Centralized Control And monitoring Autologous Organizational Design to Meet The Joint Commission Standards

42 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) Vendor validation Single or multiple points of entry into hospital –Blood (red cells, plasma, platelets, albumin, clotting factors, etc.) Blood bank/pharmacy –Tissue (bone, tendons, reproductive cells, stem cells, skin, vessels, corneas, heart valves, etc.) Surgery or surgical specialty units, reproductive clinics, blood bank, others

43 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) Vendor validation Identify all significant criteria for suppliers –AATB accredited? –How tissue is processed –Availability of hard to obtain products –Price –Timing of shipments –If using tissue distributor: how do they store products? Are they FDA registered?

44 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) Vendor validation Question: Are all suppliers registered with the FDA? –Obtain documentation of FDA registration from source facility and/or FDA web site: https://www.accessdata.fda.gov/scripts/cber/C FAppsPub/tiss/index.cfm https://www.accessdata.fda.gov/scripts/cber/C FAppsPub/tiss/index.cfm –Document state licensure if applicable –Ensure that FDA registration validation is applicable and available for each tissue type from source facilities

45 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) Transport, handling, storage and use is consistent with manufacturer’s written directions (package insert) –Maintain file of package inserts –SOPs, training and audit of all steps involved in tissue utilization –Create procedure for transport and monitoring of tissue when it leaves the storage site and criteria for accepting it back if not used –Many tissues are reconstituted in the OR, how to audit that this is done properly?

46 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) Incoming tissue from source facility –Create a policy and procedure for how tissue will be accepted into your organization and who will be responsible for logging incoming tissue. Maintain file of package inserts –Maintain a log of incoming tissue that includes but is not limited to the following elements: unique ID number, expiration date, package integrity, acceptable temperature range

47 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., QC (PC 17.10) Monitoring –Continuous temperature monitoring for storage refrigerators and freezers –Alarms and backup equipment –Maintain records to prove tissue was stored properly –Computerized systems exist for tissue monitoring as well as recipient tracking

48 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., The Joint Commission Standards for Tissue Published July, 2005 QC (PC 17.20) The organization’s record keeping permits the traceability of all tissues from the donor or source facility to all recipients or other final disposition.

49 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., AABB – Traceability Standards 23rd Edition (2005) Traceability The blood bank or transfusion service shall ensure that all blood, components, tissue, derivatives, and critical materials used in their processing, as well as laboratory samples and donor and patient records, are identified and traceable

50 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Case Study In 2000, an organ/tissue donor, negative for anti-HCV, was in the window period for HCV. HCV was transmitted to multiple organ and vein allograft recipients. The bone and tendons were not processed until 16 months later. Before these contaminated tissues were distributed, the lung recipient was diagnosed with HCV and died 4 months before any bone or tendons were distributed. In addition, the distributor of cardiovascular tissue from this donor had already been notified of HCV infections in a vein recipient. If these infections had been reported to the tissue processor recipients would not have been infected.

51 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., HCV From Seronegative Organ & Tissue Donor Donor: Anti- HCV neg Oregon man, died of CVA in 2000 and donated 6 organs and 80 tissues. Five organ recipients died by 2002 –Lung recipient, HCV infected, liver failure in 2 nd yr –HCV RNA found on day 4 but not pre-transplant blood sample (tested in 2002) One kidney recipient - living asymptomatic of HCV infection Tissue bank, eye bank were not notified Tugwell, ASM Mtg Oct 2002

52 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., HCV From Seronegative Organ & Tissue Donor Most Other Tissue Not Processed Until March 2002 –80 Tissue Allografts Made April 17, Woman Received Patellar Ligament –Six Weeks Later Acute Symptomatic Hepatitis C Developed June 27, Tissue Bank Notified –Stored Donor Serum Found Positive for HCV RNA –Immediate Quarantine of Unused Tissue –44 Tissues Had Been Distributed and Were Recalled –34 Tissues Had Been Implanted –4 Recipients With Hepatitis (3 Before Transplant) –21 Recipients Not Yet Found

53 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Traceability Track all tissues from time of login from source facility to final disposition Training of staff who receive tissue in OR and document the unique identifying number for tissue on chart, tissue usage information cards or log tissue return to storage Computer software exists to track all phases of tissue utilization

54 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Traceability Based on the package insert, what supplies are used to reconstitute for transplantation (e.g. syringes, heparin, saline, etc.) Document that all supplies are in date Establish methods for tissue preparation based on package insert Document staff training in proper preparation techniques and documentation If tissue is not used in OR, there must be documentation that the storage conditions in the OR allow the tissue to be returned to the central storage area Reduce product loss in OR

55 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Management of Autologous Tissue Types – skull flaps, iliac crest wedges, parathyroid glands, ribs, skin Do procedures exist to collect, prepare, store, test, culture tissue? Record keeping Will the surgeon ever use this tissue again? When can it be discarded? Notification to discard or of positive tests

56 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Autologous Tissue Preservation Ensures standardized packaging and storage protocols Stored in OR for immediate availability Self contained package Written instructions Service Request Form acts as physician order Tissue Preservation Kit

57 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., The Joint Commission Standards for Tissue Published July, 2005 QC (PC 17.30) The organization has a defined process to investigate adverse events to tissue or donor infections

58 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Prevention Of Disease Transmission Via Transplantation Variables in Tissue Safety –Tissue cellularity, viability and processing –Limitations in processing tissues other than bone –Orthopedic practices –Physician preference for certain proprietary products –Pre and postoperative antibiotics –Incidence of infections with allograft versus metallic devices –Gram stains and cultures

59 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Investigating Adverse Events Define a reaction: –Clinical symptoms –Tissue cultured or gram stained –Tissue or surgical infection –How was tissue treated Most tissue related infections are in tendons, ligaments, and cardiovascular tissues; not bone

60 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Investigating Adverse Events Create procedures for reporting potential adverse reactions from a tissue transplant Who is responsible for receiving information concerning adverse outcome? How are these events documented (e.g. evaluation report, log, etc.)? Who is responsible for determining if the event was secondary to the tissue implanted? Who notifies the source facility and receives their evaluation and report?

61 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Investigating Adverse Events Who is responsible for requesting additional information, testing and completion of investigation? All other tissues from this donor that the institution may possess need to be traced and quarantined Adverse event records shall be periodically reviewed for completion Who will report findings to clinician? Who determines if the event must be reported to regulatory agencies?

62 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Biomedical Synergies Suspected Adverse Outcome Record

63 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Tissue Storage and Issuance Standards. Nursing Management. 36(4):14-15, April Ulaskas, Cherie J. 2. Decreasing Latitude and Increasing Regulation in Transplantable Tissue Programs. AORN Journal, 82(5): , Nov Humphries, Linda 3. Meeting JCAHO's New Tissue Standards. OR Manager 21(6):19-20, June 2005 Sawchuk, Megan 4. Tissue Banking Regulations and Oversight. Clin Lab Med. 25(3):487-98, Sep Eisenbrey AB, Frizzo, W. Articles

64 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Does your institution have to register with the FDA as a tissue bank?

65 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Does Your Institution: Produce HCT/Ps including stem cells, reproductive cells or tissue / surgical bone? Store purchased tissues and ship to another institution not part of your organization - e.g. Does your institution supply a VA Hospital or other community hospitals? Perform additional processing on incoming tissue (e.g. Gas sterilize bone for further use?) Test tissue donors samples for communicable diseases? Does your lab test specimens for organ donors and the results are then used to determine eligibility for tissue donors?

66 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., David A. Buczek. M.A. President, DB&A Inc. 24 years enterprise level business and technology consulting experience Working with the Armed Services Blood Program Office since 2002 Principal Investigator of three Small Business Innovative Research projects for OSD / MHS Lead designer for the Blood Bank Surveillance System, automated system to capture and analyze rare event data and automatically report out results to users Designed RFID solutions for blood banking, transfusion services, plasma industry, and patient safety applications Led effort to develop a strategic business plan for the DoD Patient Safety Program in 2006

67 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., How to Respond Understand tissue management lifecycle Understand the standards “Audit” your environment for compliance Define and Implement an improvement project Initiate a holistic approach to compliant tissue management Where do I begin?

68 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Tissue Management Lifecycle Trusted Source Bank / Distributor Validation Tissue Ordering Tissue Receipt Tissue Inventory Management Tissue Implantation Tissue Usage Info Tracking Adverse Reaction Look-Back Patient Needs Tissue Preparation

69 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Subgroup “Audit” Activity Break up into three groups Facilitated “Case Study” discussion Analyze your environment against a new standard Report back to large group STATION 3 STATION 1 STATION 2

70 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Implications for Existing Operations PEOPLE - unfamiliar with tissue-related management activities required to meet new standards. PROCESS - of tissue receipt, handling, tracking and look- back may not meet new standards. TECHNOLOGY - currently does not provide an enterprise view of the tissue lifecycle within the organization required by new standards. ORGANIZATION - has stove-piped groups handling tissue with little incentive to work across organizational boundaries.

71 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., A View Towards a Holistic Solution Mission / VisionStrategic GoalsObjectivesActionsValuesProcessesBehaviorsResults THECHANGETHECHANGE THECULTURETHECULTURE

72 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Tissue Management Change Model Process People Technology Organization Scope Time Current State Change Objectives Compliance Gap Future State Compliance

73 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Tissue Management Reengineering Project Phases DiscoveryAnalysisDesignDevelopmentImplementation In the Discovery Phase the project team defines the need for change, at a high level examines the current state and desired future state, defines change objectives, then maps out a phased project plan to achieve the change objectives. Analysis plan is completed. In the Analysis Phase the project team documents the current state processes, technical environment and staff skills; creates a people, process and technology map of the desired future state; and defines the gaps between current and future states. Design plan is completed In the Design Phase the project team identifies the best way to close gaps between current and desired future states. New processes, supporting technology and staff skill requirements are defined. Detailed designs are created for the new business architecture. Development plan is completed In the Development Phase the project team creates detailed process maps and Standard Operating Procedures, technology components are built to spec, and staff are trained on new technology enabled business processes and SOPs. Full testing is completed. Implementation plan is completed In the Implementation Phase the project team implements the new business architecture in the client environment. Staff with new skills, use new processes, enabled by new technology to operate in the desired future state, according to the new SOPs. Change Objectives analysis completed

74 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Getting Started – Define Gaps Independent audit of current written policies and procedures to determine the extent of current compliance with standards On-site inspection and audit to evaluate “real world” adherence to written procedures Comprehensive plan to address deficiencies to include SOPs with version control (including adverse reaction procedures), assistance with implementation of SOPs, training and education, and technology component (s) Post-implementation audit to ensure compliance Joint Commission and AABB Tissue Standards Compliance Evaluation for Hospitals

75 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Tracking / Tracing Recall Adverse Reaction Compliance Software TRACSTRACSTRACSTRACS 4CellsTissuesOrgansImplants Life!

76 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Key Features Vendor qualification Inventory management Barcode generation and scanning capability Tracing of product handling and storage conditions Tracks products used in reconstitution of tissue Automatically completes tissue utilization records for tissue processors

77 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Key Features Integration available for most existing hospital systems (OR system, A/P system, etc.) to reduce duplicate data entry Maximizing effectiveness of data entry process (reporting, recalls, PI, adverse reaction) Centralizes all tissue management information in one database to improve workflow Database architecture can accommodate all tissues and implants types Tissue banks may interface to assist in the tissue management process (ordering, consignment, TUICs, and adverse reactions) Assigns accountability in tissue management process

78 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc.,

79 & DBA & DBA & DBA SAFMLS – 26 February 2007 © Biomedical Synergies, DB&A Inc., Questions ? We’re here to help DUKE KASPRISIN, M.D. Chief Medical/Scientific Officer Biomedical Synergies, Inc. (802) DAVID A. BUCZEK, M.A. President DB&A, Inc. (703) JEFF WINSTEAD, M.S. Senior VP, Business Development Biomedical Synergies, Inc. (317)


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