FOR IMMEDIATE RELEASE:
MONDAY - October 5, 2009
CALIFORNIA MAN RECEIVES SENTENCE FOR
FALSIFYING RECORDS FOR HARVESTING AND
SELLING HUMAN TISSUE FOR MEDICAL IMPLANTS
RALEIGH - United States Attorney George E.B. Holding announced that in federal court here today PHILIP JOE GUYETT, JR., 42, of Simi Valley, California, was sentenced today to 96 months imprisonment for three counts of mail fraud, committed in relation to his recovery and sale of human tissue for medical implantation. Restitution was also imposed.
Commenting on this case, United States Attorney George E.B. Holding stated: “The heinous nature of Mr. Guyett’s crimes cannot be overstated, and today’s sentence should give others working in industries critical to the public health a clear signal that this type of reckless dishonesty comes with serious consequences.”
The Criminal Information filed in this case on February 5, 2009, lays out the details of Mr. Guyett’s scheme. Mr. Guyett, acting through the corporate identity “Donor Referral Services, Inc.,” recovered human tissue from deceased individuals at funeral
homes in and around the Eastern District of North Carolina and sold such tissue to various tissue banks for subsequent sale to medical facilities for the eventual implantation in medical patients throughout the United States. Food and Drug Administration regulations require that certain medical information of the deceased tissue-donor be collected and analyzed by the tissue harvester, as certain medical conditions of the deceased would preclude their tissue from being used for implantation in medical patients. As part of the scheme to defraud, and to ensure the sale and purchase of the human tissue he harvested, Mr. Guyett knowingly falsified information on the medical history reports concerning the medical histories of the deceased donors from whom tissue was harvested. He would alter, omit, fabricate, and falsify material on the reports, including the deceased donors’ age at death, or their cause of death, so that the tissue he was attempting to sell would not be rejected from purchase by various tissue banks because of the disqualifying medical conditions of the donors. He would also resubmit for sale tissue under a false donor name that had been previously rejected for purchase under the actual donor’s name, and submit false blood samples (i.e. blood samples from a different deceased donor) for tissue he knew would be otherwise rejected for purchase.
Investigation of the case was conducted by the Office of Criminal Investigations of the United States Food and Drug Administration. Assistant United States Attorney Jason Cowley served as prosecutor for the government.
# # #
http://www.usdoj.gov/usao/nce/press/2009-oct-05_02.html
CALIFORNIA MAN RECEIVES SENTENCE FOR FALSIFYING RECORDS FOR HARVESTING AND SELLING HUMAN TISSUE FOR MEDICAL IMPLANTS, and exposing who knows how many via the pass it forward mode of transmission to Transmissible Spongiform Encephalopathy and who knows what else. ...TSS
Saturday, January 26, 2008
CJD HGH BODY SNATCHERS
Saturday, January 26, 2008 CJD HGH BODY SNATCHERS HORMONE DRUGS LED TO CJD DEATH
http://creutzfeldt-jakob-disease.blogspot.com/2008/01/cjd-hgh-body-snatchers.html
Monday, August 31, 2009
HUMAN BODY PARTS FOR SALE TO THE HIGHEST BIDDER Inside a Creepy Global Body Parts Business
SPIEGEL ONLINE - News - International ~~ August 28 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/human-body-parts-for-sale-to-highest.html
Subject: Human Tissues for Transplantation, Recall Nationwide and Internationally (CJD TSE RISK, among other infectious diseases risk)Date: July 25, 2006 at 10:21 am PST
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
http://blogs.nature.com/news/blog/2006/06/cjdrelated_disease_can_incubat.html
----- Original Message -----
From: "Terry S. Singeltary Sr."
To: Sent: Wednesday, May 31, 2006 4:13 PM
Subject: Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006
##################### Bovine Spongiform Encephalopathy #####################
MMWR Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006 Posted: 5/30/2006
Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006
On September 29, 2005, a human tissue-processing company discovered inaccuracies in donor records forwarded from a tissue-recovery firm and notified the Food and Drug Administration (FDA). An FDA investigation determined that the recovery firm, Biomedical Tissue Services, Ltd. (BTS) (Fort Lee, New Jersey), recovered tissues from human donors who might not have met donor eligibility requirements and who were not screened properly for certain infectious diseases. In October 2005, BTS and the five processors* that had received the tissues, working with FDA, issued a recall for all tissues recovered by BTS. The continuing FDA investigation determined that information for some donors (e.g., cause, place, or time of death) was not consistent with death certificate data obtained from the states where the deaths occurred. The investigation also determined that BTS had failed to recover tissues in a manner that would prevent contamination or cross-contamination and failed to control environmental conditions adequately during tissue recovery. These failures were violations of the Current Good Tissue Practice Rules? (effective May 25, 2005), which require manufacturers to recover, process, store, label, package, and distribute human cells, tissue, and cellular and tissue-based products (HCT/Ps) to prevent introduction, transmission, or spread of communicable diseases. In January 2006, FDA ordered BTS to cease manufacturing and to retain all HCT/Ps.
The tissues recovered by BTS had been sent to five processors, who distributed them through one or more sub-distributors or directly to clinicians and health-care facilities. CDC learned that, during June 2002--October 2005, approximately 25,000 BTS-recovered tissue products were distributed to all 50 states and internationally. Most of these tissue allografts were bone or demineralized bone matrix; others included skin and soft tissue (e.g., tendons or fascia lata). Before distribution, tissues were disinfected by tissue processors to reduce or eliminate contamination with bacteria, fungi, or viruses.
During September--October 2005, the five tissue processors recalled all products that had been produced from BTS tissues. Each of the processors and related distributors issued letters to consignees (i.e., health-care facilities or clinicians) to notify them of the recall and request return of unused products. The letters included a recommendation by FDA and CDC that transplant recipients be notified of the recall and offered access to testing for the communicable diseases for which donor screening is required: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis.
In March 2006, FDA determined that, in some instances, blood samples submitted for disease screening had not come from the persons from whom the linked tissues had been obtained. This finding cast doubt on the blood sample--screening status of the tissue donors, and FDA and CDC issued an update§ that strongly recommended health-care providers offer patients access to or referral for testing for HIV, HBV, HCV, and syphilis. CDC recommendations¶ for testing persons who received BTS tissues call for patients whose tissue implants have been in place >6 months to be offered the following tests: HIV antibody, antibody to hepatitis B core antigen, antibody to hepatitis C virus, a non-treponemal syphilis test (i.e., rapid plasma reagin [RPR] or Venereal Disease Research Laboratory [VDRL]), and a treponemal syphilis test (i.e., Treponema pallidum particle agglutination [TP-PA] or any enzyme-linked immunosorbent assay [ELISA] test). Patients whose tissue implants have been in place <6 href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000565/!x-usc:http://www.fda.gov/medwatch">http://www.fda.gov/medwatch), or CDC at telephone 800-893-0485.
FDA and CDC are continuing to investigate reports of BTS tissue recipients who have undergone screening and tested positive for one of the four tested diseases. Some positive results would be expected in any U.S. population tested; the prevalence of current or past infection with HIV, HCV, and HBV is approximately 0.5% (2), 1.8% (3), and 4.9% (4), respectively. Transmission of infection via tissue allografts is rare, but transmission of HIV (5) and HCV (6) to tissue recipients has been documented previously. However, the relationship between implanted BTS tissue and positive test results reported to FDA and CDC is difficult to ascertain because of inaccurate BTS donor records and, in some cases, the absence of properly linked donor blood samples.
Allograft recipients who are concerned that they might have received tissue recovered by BTS should contact the health-care providers who performed their implants. Clinicians with specific questions about the recovery history of tissues they have used in implants should contact the health-care facility or the distributor that provided the tissues. State or local health departments can determine 1) where BTS-recovered tissues were sent and 2) whether they were implanted by contacting the tissue processors and working with local hospitals and health-care facilities. Tissue processors and distributors maintain information they receive regarding tissue providers and health-care facilities in each state that received products associated with recalls. However, because information regarding the tissue recipient might not be available to tissue processors and distributors, state or local health departments might need to provide patient follow-up by contacting the health-care facilities where implantation occurred.
Reported by: M Malarkey, R Solomon, MD, C Witten, MD, PhD, E Bloom, PhD, M Wells, MPH, M Braun, MD, R Wise, MD, C Zinderman, MD, Center for Biologics Evaluation and Research, Food and Drug Administration. DB Jernigan, MD, MJ Kuehnert, MD, A Srinivasan, MD, Div of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases (proposed); S Wang, MD, EIS Officer, CDC.
References
American Association of Tissue Banks. 2003 Annual Tissue Bank Survey. McLean, VA: American Association of Tissue Banks; 2003. CDC. HIV/AIDS surveillance report: Cases of HIV infection and AIDS in the United States, 2004. Atlanta, GA: US Department of Health and Human Services, CDC; 2005. Available at http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2004report/defa ult.htm. Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med 1999;341:556--62. McQuillan GM, Coleman PJ, Kruszon-Moran D, Moyer LA, Lambert SB, Margolis HS. Prevalence of hepatitis B virus infection in the United States: the National Health and Nutrition Examination Surveys, 1976 through 1994. Am J Public Health 1999;89:14--8. CDC. Transmission of HIV through bone transplantation: case report and public health recommendations. MMWR 1988;37:597--9. Tugwell BD, Patel PR, Williams IT. Transmission of hepatitis C virus to several organ and tissue recipients from an antibody-negative donor. Ann Intern Med 2005;143:648--54.
* Regeneration Technologies, Inc. (Alachua, Florida); LifeCell Corporation (Branchburg, New Jersey); Tutogen Medical, Inc. (Alachua, Florida); Central Texas Regional Blood and Tissue Center (Austin, Texas); and Lost Mountain Tissue Bank, Inc. (Kennesaw, Georgia).
? Available at http://www.fda.gov/bbs/topics/news/2004/new01137.html.
§ Available at http://www.fda.gov/cber/safety/bts030206.htm.
¶ Available at http://www.cdc.gov/ncidod/dhqp/tissuetransplantsfaq.html.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
---------------------------------------------------------------------------- ---- References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.
Disclaimer All MMWR HTML versions of articles are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.
**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.
Date last reviewed: 5/25/2006
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5520a6.htm
Body snatchers tied to allograft firms? Alleged New York-area ring investigated for selling parts to corpse tissue harvesters. October 7, 2005: 2:54 PM EDT By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that harvests body parts from corpses are being investigated for their alleged roles in a body snatching ring that sold parts to companies specializing in medical grafts, sources close to the investigation said Friday.
The Brooklyn district attorney's office declined to comment on the investigation. But sources close to the investigation acknowledged that it has been going on for about one and a half years, focusing on Michael Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who allegedly harvested body parts illegally from the Daniel George funeral home in Brooklyn.
The firms that bought the allegedly black-market tissue have not been accused of any wrongdoing. Human tissue is usually obtained from non-profit tissue banks. In the U.S., it's illegal to buy and sell human tissue.
Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66 to $7.28, Research), a company in Alachua, Fla., said her company has severed all ties with Biomedical Tissue Services, their former source for some of the body parts used to make medical grafts, or allografts.
"We had previously terminated the relationship with Biomedical Tissue Services and we are cooperating with the appropriate authorities on this issue," said Crites-Wacker, who declined to say when the termination took place.
Crites-Wacker also said that her company's BioCleanse process, in which bones and tendons are sterilized through a melange of chemicals, temperature and pressure, ensures that its products are safe.
Two other allograft companies have been identified as customers of Biomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research), of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research) of West Paterson, N.J.
LifeCell Corp. had issued a Friday statement saying it had voluntarily recalled some human tissue products after questions were raised about Biomedical Tissue Services.
"Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a release.
LifeCell, which markets products made from human tissues that are used in surgical procedures, said it recalled certain AlloDerm, Repliform and GraftJacket products on Sept. 30.
LifeCell's stock price slid about 5 percent this morning, and a Piper Jaffray analyst attributed the slump to a New York Daily News story that first reported on the investigation.
"We believe this morning's weakness in LifeCell's shares is related to a news article that alleges LifeCell inadvertently received tissue from an illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written report.
LifeCell said in the statement all other tissues supplied by Biomedical Tissue Services remain "on hold until the discrepancies in the donor documentation can be resolved."
Denhoy said that LifeCell did not appear to do anything illegal and that "LifeCell itself was the victim of fraud," referring to allegations that Biomedical Tissue Services forged death certificates and family consent forms.
Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of one will likely not impact the underlying business," though increased regulatory scrutiny could drive down the stock price.
"While LifeCell and the other tissue companies appear to have done nothing wrong, this event could increase regulatory and media scrutiny of the business," said Denhoy, who rates the company market perform. "We recently downgraded LifeCell shares on competitive concerns and today's revelations may pressure the stock further."
Eric Franz, the attorney representing funeral home owners Debora Johnson and Robert Nelms, said his clients "did not participate in any criminal conduct whatsoever."
Attempts to reach Mastromarino and his company Biomedical Tissue Services were unsuccessful. The Daily News reported that Mastromarino declined to comment.
Regeneration Technologies produces heart valves, bone and tendon implants and bone paste, which is used to plug holes. LifeCell specializes in AlloDerm, a "dermal matrix" made from human skin that is used in grafts. Tutogen focuses on bone and dental implants.
--from staff and wire reports
http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest
Order to Cease Manufacturing and to Retain HCT/Ps
January 31, 2006
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Michael Mastromarino, D.D.S. CEO & Executive Director of Operations Biomedical Tissue Services, Ltd. 2125 Center Avenue, Suite 300 Fort Lee, NJ 07024-5874
Dear Dr. Mastromarino:
The Food and Drug Administration (FDA or the agency) conducted an inspection of your establishment, Biomedical Tissue Services, Ltd. (BTS or Establishment), at 2125 Center Avenue, Suite 300, Fort Lee, New Jersey 07024, which manufactures human cells, tissues, and cellular and tissue-based products (HCT/Ps), between October 4 and 27, 2005. At the conclusion of the inspection, the FDA investigators issued you a Form FDA-483, Inspectional Observations. In addition to the inspection, the agency conducted a concurrent investigation of several funeral homes that provided you with potential donors of HCT/Ps for recovery. Our review of the information and records examined and collected during the inspection and investigation reveal that significant violations of Title 21, Code of Federal Regulations (21 CFR), Part 1271, issued under the authority of Section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264], exist at BTS. The agency has determined that these deviations, because of their serious nature, constitute a danger to health. This Order to Cease Manufacturing and to Retain HCT/Ps relates exclusively to conduct occurring on or after May 25, 2005, the effective date of these regulations. We note that the FDA retains authority to pursue other actions and remedies.
Therefore, pursuant to 21 CFR 1271.440(a)(1) and (3), both you individually, and your Establishment, 1) must immediately cease all manufacturing until compliance with the regulations in 21 CFR Part 1271 has been achieved, and 2) must retain all HCT/Ps recovered on or after May 25, 2005 that are in your possession until they are disposed of as agreed by the agency or until the safety of the HCT/P is confirmed. Pursuant to 21 CFR 1271.3(e), "Manufacture" means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any HCT/P, and the screening or testing of the HCT/P donor.
Deficiencies noted include, but are not limited to, the following:
You failed to implement the standard operating procedures (SOP or SOPs) that you have established for all steps that you perform in determining donor eligibility, as required by 21 CFR 1271.47(a), and you failed to review the certificate of death for each donor, a relevant medical record, regarding risk factors for, or clinical evidence of, relevant communicable disease agents and diseases, as required by 21 CFR 1271.75(a). More specifically, your standard operating procedure entitled "Donor Identification" requires that, when recovering HCT/Ps at a funeral home, you review the death certificate to confirm the eligibility of the donor. However, you recovered HCT/Ps from at least eight donors, obtained from --- different funeral homes, located in ------ different states, in which you failed to review valid death certificates. The documents purporting to be the certificates of death for these donors were collected from BTS during our inspection, are not authentic death certificates issued by the state, and are inaccurate. For example:
You confirmed the eligibility of donor ------------, who donated HCT/Ps at a funeral home in ----------. The donor is listed on the BTS version of the certificate of death as being 63 years of age, having died of acute myocardial infarction due to coronary artery disease, at ----pm on ------------, whereas the State of ---------------issued certificate of death lists this donor as being 69 years of age, having died of multi-organ failure, due to liver dysfunction, which in turn was due to thrombosis, at ----pm on ------------------;
You confirmed the eligibility of donor --------------, who donated HCT/Ps at a funeral home in ----------------. The donor is listed on the BTS version of the certificate of death as being 44 years of age, having died of blunt trauma in a motor vehicle accident, at ----am on ----------------, whereas the State of -----------------issued certificate of death lists this donor as being 48 years of age, having died of congestive cardiac failure due to atherosclerotic cardiovascular disease, at ----am on ------------------;
You confirmed the eligibility of donor -------------, who donated HCT/Ps at a funeral home in ---------------. The donor is listed on the BTS version of the certificate of death as being 70 years of age, having died of cardio-pulmonary arrest due to acute myocardial infarction, at ---- pm on ------------------, whereas the State of ---------------------issued certificate of death lists this donor as being 74 years of age, having died of complications from the intravenous administration of medication due to a radical resection of a -----------------------------------------------------------------, at ---- pm on ---------------------;
You confirmed the eligibility of donor ------------------, who donated HCT/Ps at a funeral home in ---------------. The donor is listed on the BTS version of the certificate of death as having died of cardio-pulmonary arrest due to atherosclerotic heart disease, at ----pm on -----------------, whereas the State of -------------issued certificate of death lists this donor as having died of cardio-pulmonary asystole due to sepsis and shock, at ----pm on --------------;
You confirmed the eligibility of donor ---------------, who donated HCT/Ps at a funeral home in ----------------------. The donor is listed on the BTS version of the certificate of death as being 45 years of age, having died of blunt trauma due to a motor vehicle accident, at ----pm on ---------------, whereas the State of ----------------------issued certificate of death lists this donor as being 41 years of age, with a cause of death which was undetermined pending additional studies, at ----pm on -------------------;
You confirmed the eligibility of donor -------------, who donated HCT/Ps at a funeral home in -------------. The donor is listed on the BTS version of the certificate of death as having died of cardio-pulmonary arrest due to acute myocardial infarction, at ----pm on -----------------, whereas the State of ------------------issued certificate of death lists this donor as dying of probable ventricular fibrillation due to ------------------- failure, as a consequence of -------------------- disease, at ----am on ----------------------;
You confirmed the eligibility of donor -------------, who donated HCT/Ps at a funeral home in ------------. The donor is listed on the BTS version of the certificate of death as being 58 years of age, having died of acute myocardial infarction, at ----am on ----------, whereas the State of ---------------------issued certificate of death lists this donor as being 50 years of age, having died of diabetes mellitus and hypertension due to cardio-vascular disease, at ----pm on ---------------------------; and
You confirmed the eligibility of donor --------------, who donated HCT/Ps at a funeral home in ----------------. The donor is listed on the BTS version of the certificate of death as being 63 years of age, having died of acute myocardial infarction, at ----pm on ------------, whereas the State of -------------issued certificate of death lists this donor as being 79 years of age, having died of pneumonia due to a myocardial infarction, at ----pm on -----------------.
You failed to implement the SOPs that you have established for all steps that you perform in determining donor eligibility, regarding your assessment of risk factors for, or clinical evidence of, relevant communicable disease agents and diseases, as required by 21 CFR 1271.47(a). Furthermore, you failed to create and maintain accurate records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). More specifically, your "Documenting the Recovery" SOP requires that, if the donor had been admitted to a health care facility immediately prior to death, you were to document the date and reason for admission; check the appropriate boxes regarding availability of donor history, physical, and discharge summary; check the appropriate box regarding surgeries; check the appropriate boxes regarding availability of lab results (including blood cultures, x-rays, and lung biopsies); and check the appropriate boxes regarding documentation of HIV, Hepatitis and Tuberculosis infection. However, your Medical Evaluation forms for donors -----------------, ---------------, -------------------, ------------ -, ---------------, and -------------------- (who donated HCT/Ps in ---------- different funeral homes located in ---------- different states), do not contain any of this information. Instead, you incorrectly stated that these donors were ?not admitted to a health care facility immediately prior to death?,? which statements are contradicted by the state-issued certificates of death for each of these donors.
You failed to create and maintain accurate records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). More specifically:
The Medical Evaluation forms created and maintained by you for the following six donors are inaccurate in that you state that the donors were ?not admitted to a health care facility immediately prior to death?.? In so doing, you also failed to adhere to the following SOPs: Documenting the Recovery SOP; Quality Assurance Audit of Donor Records SOP; Quality Assurance Check-Off Form; and Audit Check List. These six donors donated HCT/P at -----different funeral homes, located in -------- different states. More specifically:
the State of --------------issued certificate of death for donor ----------------- states that at the time of her death she was a patient at ------------------- Hospital; the State of ------------issued certificate of death for donor ------------------ states that at the time of his death he was a hospital inpatient at ---------; the State of --------------issued certificate of death for donor ---------- states that at the time of his death he was a patient at --------------------- Hospital; the State of ----------------issued certificate of death for donor ---------- states that at the time of her death she was a patient at ------------- Hospital; the State of ---------------------issued certificate of death for donor ---------- states that at the time of his death he was a patient at -------------- Hospital; and the State of ---------------issued certificate of death for donor --------------- states that at the time of her death she was a patient in the emergency room of ----------------- Hospital.
The records created and maintained by you for donor --------------- are inaccurate in that you state in your Certifying Physician Interview form that the donor was a 44 year old male who died as a result of a blunt trauma to the head region in a motor vehicle accident; your Circumstances of Death form states that the donor was a 44 year old male who was involved in a motor vehicle accident, sustained blunt trauma, and expired at the scene of the accident prior to medical intervention; and your Donor Physical Assessment form includes an incorrect schematic of the donor, showing fractures to the anterior and posterior portions of the skull, together with bruises or contusions to the anterior and posterior portions of the neck. These records are contradicted by the State of --------------------issued certificate of death, which states that the donor died of natural causes (congestive cardiac failure, resulting from atherosclerotic cardiovascular disease), at his home, at the age of 48. The only other significant condition which is listed as contributing to the death of the donor in the State of --------------issued certificate of death is -----------------------. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Documenting the Recovery" SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
The records created and maintained by you for donor ---------------- are inaccurate in that you state in your Certifying Physician Interview form that the donor was a 45 year old female who suffered blunt trauma in a motor vehicle accident, and died at the scene of the accident prior to medical intervention; your Circumstances of Death form states that the donor was a 45 year old female who was involved in a motor vehicle accident, sustained blunt trauma to the head region, and expired prior to medical intervention; and your Donor Physical Assessment form includes an incorrect schematic of the donor, showing fractures to the anterior and posterior portions of the skull, together with bruises or contusions to the anterior and posterior portions of the neck. These records are contradicted by the State of --------------issued certificate of death, which states that the donor died at her home, at the age of 41, was -----, and with an undetermined cause of death, pending additional studies. There were no other significant conditions listed as possibly contributing to the death of the donor in the state-issued certificate of death. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Documenting the Recovery" SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
The records created and maintained by you for donor ------------- are inaccurate and incomplete in that your Certifying Physician Interview form for this donor fails to indicate the cause of death; your Circumstances of Death form for this donor incorrectly states that the donor was a 70 year old female, and fails to indicate the cause of death; your Medical/Social History Interview form incorrectly states that the donor never received an organ transplant; and your Donor Physical Assessment form for this donor fails to show on the schematic that the donor had a surgical procedure to her ------------------------ immediately prior to her death, and also fails to show that the donor had undergone a ------ transplant. These records are contradicted by the State of ------------issued certificate of death, which states that the immediate cause of death of this donor was due to complications related to the intravenous administration of medication due to a -------------------------------------------------------------------------- ----------------------------. The donor is also listed on the State of ----------------issued certificate of death as having undergone a status post-cadaver -------- transplant for ------------- disease, and as having died at the age of 74. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Quality Assurance Audit of Donor Records" SOP, your "Documenting the Recovery" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
The records created and maintained by you are inaccurate as concerns the identity of the funeral home from which donors -------, ----------------, and ----------------------were obtained and at which HCT/P recovery procedures were performed for these donors. In your Donor Demographics forms for these donors you state that their recovery location was a funeral home in -----------, -------------, and you also state that the director of the funeral home provided you with a positive identification of these three donors. However, in an affidavit provided to the agency by the director of the funeral home, while he estimates that his funeral homes have provided between --- and ---- donors to BTS, they did not provide BTS with these three donors. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Quality Assurance Audit of Donor Records" SOP, your "Documenting the Recovery" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
You failed to implement the SOPs you established for donor eligibility determinations specifically for documenting and confirming the identity of the donors' next of kin, including your Donor Medical Social History Interview SOP, your Quality Control Review of Donor Records SOP, your Quality Assurance Audit of Donor Records SOP, your Audit Check List, and your Quality Assurance Check-Off form, all as required by 21 CFR 1271.47(a), and you failed to create and maintain accurate records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a), in that you have inaccurately and incompletely recorded the donors' next of kin information. More specifically:
The records created and maintained by you for donor ------------ are inaccurate and incomplete in that your information on the donor's spouse differs from that found in the State of -------------issued certificate of death. More specifically:
while your Consent for Donation of Anatomical Gifts form for this donor lists the donor's spouse as the consenting next of kin, the donor's spouse is incorrectly listed as another individual, residing at an entirely different address than the donor; while your Medical/Social History Interview form for this donor lists the interviewee as the donor's spouse, the interview form incorrectly identifies the donor's spouse and residential address; your Circumstances of Death form for this donor also incorrectly identifies the spouse; and the BTS version of the certificate of death for this donor is incomplete in that it does not list any surviving spouse, and does not indicate whether the donor was married.
The records created and maintained by you for donor ------------- are inaccurate and incomplete in that your information on the donor's spouse differs from that found in the State of --------------issued certificate of death. More specifically:
while your Consent for Donation of Anatomical Gifts form for this donor lists the donor's spouse as the consenting next of kin, the donor's spouse is incorrectly listed as another individual, residing at an entirely different address than the donor; while your Medical/Social History Interview form for this donor lists the interviewee as the donor's spouse, the interview form incorrectly identifies the donor's spouse and residential address; your Circumstances of Death form for this donor also incorrectly identifies the spouse; and the BTS version of the certificate of death for this donor is incomplete in that it does not list any surviving spouse, and does not indicate whether the donor was married.
You failed to implement the SOPs you established for donor eligibility determinations, as required by 21 CFR 1271.47(a), and to assure the timely refrigeration of donors and recovery of HCT/P, as required by 1271.180(a). You failed to recover HCT/P in a manner that does not cause contamination or cross-contamination during recovery, to adequately control environmental conditions, and to provide proper conditions for operations, all as required by 21 CFR 1271.145, 21 CFR 1271.195(a)(1), and 21 CFR 1271.215. Furthermore, you failed to create and maintain accurate records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your SOPs require that donors be refrigerated within ----- hours and that HCT/P excision begin within ----- hours post cardiac asystole. However, you did not meet these standards for the following donors:
your Donor Demographics form for donor ------------- states that the donor was "?refrigerated within --- hours and tissue excision began within ---- hours post cardiac asystole" and that the donor?s refrigeration time was at ----am on -----------, which, according to the State of --------------------issued certificate of death's time of death (----pm on ----------------), is more than 33 hours post-cardiac asystole. Also, according to your Tissue Recovery Log form for this donor, HCT/P excision of the donor began at ----pm on --------, almost 48 hours post-cardiac asystole. As a result, your Donor Demographics form is inaccurate; and
your Donor Demographics form for donor ---------------states that the donor was "?refrigerated within ----hours and tissue excision began within ---- hours post cardiac asystole" and that the donor?s refrigeration time was at --------------------------------------------, which, according to the State of ------------------------------------------------------------------------- ------------------------issued certificate of death (---------------------------------------------), is almost 48 hours post-cardiac asystole. Also, according to your Tissue Recovery Log form for this donor, HCT/P excision of the donor began at ----pm on -------------, more than 54 hours post-cardiac asystole. As a result, your Donor Demographics form is inaccurate.
You failed to implement SOPs you established to assure that HCT/P recovery takes place in a suitable environment, as required by 21 CFR 1271.180(a). You failed to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery, and you failed to adequately control environmental conditions and to provide proper conditions for operations, all as required by 21 CFR 1271.145, 21 CFR 1271.195(a)(2), and 21 CFR 1271.215. Furthermore, you failed to create and maintain accurate records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your SOP requires that the HCT/P recovery site ensure a maintained and controlled, closed airflow system so that there is no direct access to the outside of the building. However, you recovered HCT/P from donors ---------- and ------------ at a funeral home in ------------, ---------- that is not equipped with any refrigeration units in which to hold the deceased. The embalming room where HCT/P recovery took place was equipped with an exhaust fan that delivered air to the adjacent garage/outside. There was no air filtration system in the room. Moreover, you recorded in your Nonstandard Tissue Recovery Site Assessment form for these donors that the recovery site ensured a maintained and controlled, closed airflow system so that there was no direct access to the outside of the building.
You failed to implement SOPs you established for donor eligibility determinations, specifically to confirm whether an autopsy was performed, as required by 21 CFR 1271.47(a). In particular, your Quality Control Review of Donor Records SOP requires that "[t]he team leader will assure a physical exam was performed and the information documented on the recovery paperwork is included in the donor chart?" and your Physical Assessment of a Cadaveric Donor SOP requires that the team leader physically check the donor in their entirety. Furthermore, you failed to create and maintain accurate records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your Donor Demographics forms for donors -------- and ----------------------- state that no autopsies had been performed on these donors, and the Donor Physical Assessment forms for these donors provide schematics of the donors which fail to show that autopsies had been performed. These documents are contradicted by the State of ----------------issued certificates of death for these donors, which confirm not only that autopsies were performed on these two donors, but also that the autopsy findings were available to complete the cause of death. The fact that an autopsy had been performed should have been obvious to you upon your physical assessment of the donors at the time of HCT/P recovery. The above-identified deficiencies are not intended to be an all-inclusive list of violations by you and your Establishment. Nevertheless, they indicate serious noncompliance with many of the regulations under 21 CFR Part 1271, which are designed to protect against the risks of communicable disease transmission. Of particular concern are the serious deficiencies involving:
1/ your failure to create and maintain accurate records; 2/ your failure to implement SOPs for all steps in determining donor eligibility; 3/ your failure to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery; and 4/ your failure to adequately control environmental conditions. These deficiencies involve donors from numerous funeral homes located in different states. Based on the foregoing, the agency finds that there are reasonable grounds to believe that HCT/Ps manufactured by you are violative because they were manufactured in contravention of the regulations under 21 CFR Part 1271 and, therefore, the conditions of manufacture of the HCT/Ps do not provide adequate protections against the risks of communicable disease transmission. Moreover, these deficiencies, including your failure to create and maintain accurate records, are so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health.
This letter confirms the telephone conversation on January 31, 2006, in which notice was given that, pursuant to 21 CFR 1271.440(a)(3), you individually, and your Establishment, 1) must immediately cease all manufacturing, as defined in 21 CFR 1271.3(e), until compliance with the regulations in 21 CFR Part 1271 has been achieved, and 2) must retain all HCT/Ps recovered on or after May 25, 2005 that are in your possession until they are disposed of as agreed by the agency or until the safety of the HCT/P is confirmed. Instructions were given at that time not to recover or ship HCT/Ps. Neither you, nor your Establishment, can resume operations without prior written authorization from FDA. Any shipment of HCT/Ps in violation of this order constitutes a violation of section 368 of the PHS Act [42 U.S.C. § 271], for which criminal penalties may be imposed.
Within five (5) working days from the receipt of this Order to Cease Manufacturing, you may request a hearing on the matter in accordance with 21 CFR Part 16 (copy attached), to Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, 1401 Rockville Pike, HFM-600, Rockville, MD 20852 (telephone: 301-827-6190). Failure to request a hearing within the specified time period constitutes a waiver of the right to a hearing. You may also wish to inform yourself with respect to the agency's guidelines regarding electronic media coverage of its administrative proceedings, which can be found at 21 CFR Part 10, Subpart C.
Sincerely,
----- signature -----
Jesse L. Goodman, M.D., M.P.H. Director Center for Biologics Evaluation and Research
Effective Date: 31 January Time: 11:25 AM Eastern
Updated February 1, 2006
http://www.fda.gov/cber/compl/bts013106.htm
TSE i.e. CJD and the legal stealing of tainted tissue
http://www.rense.com/general62/don.htm
http://disc.server.com/discussion.cgi?disc=7498;article=2820;title=CJD%20Voice%20Discussion%20Group
http://mad-cow.org/~tom/dec99_news.html#bbb
TSS
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