| Date Posted |
Subject |
| Mar. 29, 2012 |
Does reconstituting whole blood for neonatal exchange transfusion require FDA registration? |
| Dec. 4, 2011 |
How can a blood donor center ensure compliance with changes or new state and federal regulations? |
| Oct. 10, 2011 |
Managing bloody contaminated umbilical cord specimen collection tubes |
| July 12, 2011 |
Does the State of California require that blood component storage devices (refrigerators, freezers, platelet chambers) be labeled with a BioHazard label? |
| Aug. 1, 2010 |
Handling fully tested labeled blood products without wearing gloves ADDENDA Aug. 6 |
| July 20, 2010 |
Combining Quality Plan with the General Lab? ADDENDA July 31 |
| July 5, 2010 |
Proper controls for EDTA/glycine-acid (EGA) treatment of direct antiglobulin test (DAT) positive red blood cells |
| May 16, 2010 |
Must a manufacturer's package insert be followed as written, if it is written incorrectly? |
| Jan. 28, 2010 |
CLSI approved guideline I/LA33-A, Validation of Automated Systems for Immunohematological Testing Before Implementation |
| Jan. 2, 2010 |
Re-issuing thawed plasma products that have been returned to the blood bank more than 30 minutes after being issued |
| Dec. 20, 2009 |
Reporting Rh status of women in California |
| Nov. 19, 2009 |
How to perform periodic QC of antibody identification panel cells with an automated instrument? ADDENDA Dec. 20 |
| Oct. 14, 2009 |
Validation and revalidation required for performance of the electronic crossmatch ADDENDA Oct. 28, Nov. 7, 11 & 19 |
| Aug. 11, 2009 |
Under what circumstances can a hospital provide blood products for a community dialysis center which is 'free standing' and not associated with the hospital? ADDENDA Aug. 18 |
| July 29, 2009 |
Can a blood bank computer system be used for 'electronic' or 'computer' crossmatching if the computer system does not have a 'vendor-implemented computer crossmatch' ADDENDA Aug. 11 & 14 |
| July 29, 2009 |
Using DMSO for cryopreservation of bone marrow, peripheral blood stem cell and lymphocytes ADDENDA Aug. 11 |
| Apr. 28, 2009 |
Tracking the use of commercial fibrin sealants |
| Feb.
24, 2009 |
Temperature
ranges for mobile collections? |
| Feb. 26, 2009 |
CONTINUED DISCUSSION: Comments requested on Joint Commission meeting to determine the need to incorporate blood management performance measures into their survey and accreditation process ADDENDA Oct. 4 & Nov. 19 |
| Nov. 28, 2008 |
Can irradiated RBCs be irradiated a second time if the first irradiation dose was inadequate? ADDENDA Dec. 17 & 27 |
| Nov. 10, 2008 |
Management of non-human tissues by a tissue bank/transplant program ADDENDA Jan. 13, 2009 |
| June 29, 2008 |
Regulatory requirements for transferring crossmatched RBC units between facilities of a healthcare system/healthcare network ADDENDA July 11 |
| June 24, 2008 |
Is it permissible for Medical Assistants or trained individuals who have been certified as Donor Screeners to read Total Protein levels on donors, provided the personnel are under the direct supervision of a Physician? |
| Apr. 20, 2008 |
Should Blood Establishment Computer Software be regulated any differently than the manufacturing software used by drug and medical device companies? ADDENDA Apr. 26, June 13 |
| Oct.
17,
2007 |
Now
that California Senate Bill 'SB 250' has been signed
into law, will this create compliance problems
for donor collection centers that issue gift cards
as an incentive to the donor? ADDENDA Nov.
7 & 15 |
| Feb. 19, 2007 |
Comments
requested on Joint Commission meeting to determine
the need to incorporate blood management performance
measures into their survey and accreditation process ADDENDA Feb.
20 & Mar. 17; July 25, 30 & 31, Aug. 12,
17, 21 & 22, 2008 |
| Feb. 13, 2007 |
Using bar codes to link blood products to the correct recipient: Is using a bar code that only encodes a single number a compliant and a safe practice? |
| Dec. 6, 2006 |
How do laboratories label test tubes that are used in manual tube tests, to assure 'traceability' and compliance with AABB Standard 5.1.6.2? ADDENDA Dec. 8, 16 & 26 |
| Dec. 5, 2006 |
What audit/tracking systems do trauma centers use to assess the adequacy of transfusion support for emergent and massive transfusion events in their facility ADDENDA Dec. 16 & 19; June 27, 2007 |
| Nov. 20, 2006 |
Is there any regulation or accreditation requirement for the temperature at which a blood product should be cultured, when the blood product is considered as a possible cause of an adverse reaction due to suspected bacterial contamination? ADDENDA Nov. 26 & 27 |
| Nov. 7, 2006 |
Is "reinjection" of radiolabeled white cells by a nuclear medicine department considered a transfusion, and if so, does the transfusion service track or regulate this procedure? ADDENDA Nov. 8 |
| Aug. 4, 2006 |
Management and ensuring compliance of "tissue banking/tissue dispensing services" ADDENDA Aug. 9 |
| May 25, 2006 |
Is it compliant for a hospital transfusion service to operate with a commercial computer system that is validated, but no longer supported by the vendor that sold the system to the hospital? ADDENDA June 6 & 7 |
| May 21, 2006 |
What methods are used to measure the pH of donor platelets when doing routine QC activity required by the 23rd edition of AABB Standards (5.7.5.16 and 5.7.5.19)? ADDENDA May 29, 2006 |
| Oct. 27, 2005 |
Accreditation and criteria for development of a "bloodless" hospital or surgery center ADDENDA Oct. 28, 31 & Nov. 7 |
| Sept. 1, 2005 |
Proficiency testing requirements for hemoglobin testing performed in donor suitability determination |
| May 18, 2005 |
Does an unlicensed, unregistered transfusion service need to report Biological Product Deviations to the FDA? ADDENDA May 18 |
| April 10, 2005 |
Compliance with Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments ADDENDA Apr. 10 & 21 |
| Mar. 22, 2005 |
Interpretation of AABB Standards for pre-transfusion compatibility testing of two-unit red cell apheresis products from the same donation ADDENDA Mar. 23 |
| Feb. 6, 2005 |
Does Biologic Product Deviation Reporting for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P) include non-human source tissue, such as skin grafts? ADDENDA Feb. 8 |
| Nov. 11, 2004 |
Is there a JCAHO requirement to perform ABO/Rh testing on the post-reaction patient sample and repeat ABO/Rh testing of the implicated RBC unit in transfusion reaction investigations? ADDENDA Nov. 12 & 16 |
| Oct. 6, 2004 |
Can expired panel cells be used in a manner that would be considered compliant? ADDENDA Oct. 7; Aug. 19, 28 & 30, 2005 |
| Sept. 9, 2004 |
What quality assurance indicators are best to use for perioperative blood salvage? ADDENDA Sept. 19 & 30, Oct. 6; Jan. 13, 2009 |
| Aug. 4, 2004 |
Maintaining control of lot release function when transferred to a centralized department within collections |
| Dec. 9, 2003 |
If electronic images of testing instrumentation data are validated to show that the data is identical to those of hard-copy printouts from the instrument, would a facility be required to keep the printouts from the instrument? |
| Sept 9, 2003 |
Complying with AABB HPC Standard 9.1.7.2. (Cleanliness of Human Progenitor Cell Facilities) |
| June 25, 2003 |
Does a hospital transfusion service need to register with the FDA to perform therapeutic phlebotomy? ADDENDA June 26 |
| June 2, 2003 |
What criteria are used to decide when a change to an SOP requires an updated version number? ADDENDA June 11 |
| June 1, 2003 |
Comments on the Federal Register proposed rules "Safety Reporting Requirements for Human Drug and Biological Products", Docket No. 00N-1484, CDER 199665, posted March 14, 2003 |
| May 3, 2003 |
What is a reasonable parallel testing scheme for verifying equivalence between a manual tube technique and a gel automated technique? |
| Mar. 30, 2003 |
Is monitoring of transfusion reactions by a hospital committee required by any regulatory or accrediting agencies? ADDENDA April 1, 9 & 15 |
| Mar. 10, 2003 |
How are blood banks or transfusion services planning to address the new AABB requirement to have methods to limit and detect bacterial contamination in all platelet components? ADDENDA Mar. 10 & 11 |
| Feb. 16, 2003 |
Is simultaneous crossmatching of multiple patients by the same technologist permissible under current JCAHO requirements? ADDENDA Feb. 17; Jan. 16, 2007 |
| Oct. 22, 2002 |
Does the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) require hospitals to have a Transfusion Committee? ADDENDA Jan. 8, 2006 |
| April 18, 2001 |
Does JCAHO Accreditation Require Compliance with AABB Standards? |
| Dec. 14, 2000 |
Does QA review all manufacturing records prior to release of blood products? ADDENDA Dec. 15 |
| May 16, 2000 |
JCAHO Advises Against Simultaneous Crossmatching of Multiple Patients? |
| March 19, 2000 |
Two Audit Questions:
1. Upper Hb limit for transfusions?
2. Increasing compliance with Paul Gann Act? |
| Feb 17, 1999 |
AABB written comments to FDA about ISBT 128 draft document |
