Should the California Donor Deferral Register be eliminated?

A transfusion medicine physician in California believes that the use of a donor deferral register is one of the overlapping safety procedures that protects patients from contaminated blood transfusions. California currently employs a Donor Deferral Register (DDR). However, proposed California Senate Bill 1081 would eliminate the California State Donor Registry. The inquiring California physician wonders how e-Network colleagues within and outside California would view such a change in policy.

The most current version of the [now chartered] California Senate Bill 1081 (PDF file, last update as of Sept. 17, 2003) can be found here.

The following response was received.

ADDENDA April 15, 2003

1. A colleague in Pennsylvania (Dr. Ron Domen, Penn State; with permission) reports that in his opinion the efficacy of a state-wide blood donor deferral registry will need to be proven if the blood banking community in California hopes to retain it. According to Dr. Ron Domen (verbatim): "The efficacy of donor deferral registries on a large scale (at the state or national levels) have always been controversial. There are privacy/confidentiality concerns, as well as logistical and financial concerns in maintaining the registry and in tracking mobile donors. Very little data is available to assess deferral registries from a scientific perspective. We performed a study in 1997 that looked at the potential efficacy of a local donor deferral registry (Domen RE, Grewal ID, Hirschler NV, Hoeltge GA. An evaluation of the need for shared blood donor deferral registries. International Journal for Quality in Health Care 1997;935-41). At a local/regional level, we demonstrated that donor deferral registries may have a role to help prevent deferred blood donors from deliberately donating at multiple sites within the regional geographic area. For example, we found that 11.9% of donors listed on two deferral registries donated, or attempted to donate, at the other blood collection facility despite knowing that they should not donate. Whether or not such efficacy translates to the state or national levels remains speculative and will require study. And, whether or not such efficacy translates into a meaningful decrease in transfusion-related disease transmission, an overall safer blood supply, etc., also remains speculative. I am happy to mail (or fax) a copy of our paper to those who do not have access to it." Requests may be emailed to Dr. Domen.
   
   
2. A California blood banker is of the opinion that the California State Donor Deferral Register (SDDR) was probably a good idea at the time of its inception; however, over the years the information available to blood centers has been of little value. She reports being aware of numerous incidents over the years of social security number matches with their donors and entries on the SDDR that were entirely different persons. They found some of their donors on the SDDR only for implication and for no other reason. They have spent extra time in sending letters requesting corrections. Some were corrected, others were not corrected. Additionally, many times they received electronic updates to the SDDR which were blank and or carried a computer virus (ironic, don't you think!!!). In her opinion, one of the biggest problems with the system is that it still relied on manual submissions of additions to SDDR. This resulted in information being transcribed incorrectly and/or not added in a timely manner. This is one blood banker that will not miss the SDDR as it is today. (Editor's query: If all the problems with the SDDR listed by the responding colleague could be corrected, would the concept of a donor deferral register be worth keeping? In other words, 'should the baby be thrown out with the bath water?')

ADDENDA April 16, 2003

3. A California blood banker with 13 years experience at his regional blood donor center reports that in his experience there has never been a time where they found a match on the DDR and did not have a positive test that prevented the unit from being used anyway. He believes (without providing data) that is the case throughout the state. He adds that it has been a frequent occurence to have incomplete and/or flat out wrong data in the donor deferral register. In addition, they have sent data that does not get on the system, despite numerous attempts. There is no quality control, and he does not believe there is any benefit at all in keeping the DDR, because it is beyond repair. It should be eliminated because it provides no benefit yet costs money to keep going.

ADDENDA April 17, 2003

4. A quality manager from a regional blood center in Central California reports that (verbatim) "Truly positive donors are detected nowadays by testing. At the time of the inception of the California State Donor Deferral Register (SDDR) that was not always the case - we had to rely on the reporting of other blood and plasma centers as well as public health departments to capture unsuitable donors. Having worked with this system for many years myself, I have seen its usefulness in determining donor suitability diminish to the point of inaccurate information and a burden to blood banks in having to check donors each and every time they donate."

ADDENDA April 22, 2003

5. A colleague who has administrative oversight for a large regional donor center operation reports that he agrees with the comments that the California State Donor Deferral Registry has outlived its usefulness and should be allowed to peacefully assume its rightful place in cyberspace limbo. Here is his opinion (verbatim) "While blood banking has continued to rigorously adopt policies and processes appropriate to a regulated, cGMP environment, the CSDDR continues to look and operate pretty much like it did at its inception. While this could be construed as a positive conclusion if its initial and subsequent operation had proved flawless, that has hardly been the case. At the core of the problem, to my knowledge, the Registry has not been subjected to the requirements of today which include detailed definition of requirements and specifications, testing, worst-case scenarios, validation, user acceptance, periodic QC checks and QA audits, etc., etc. Are there regular QC checks of the data that are manually entered? Are these reviewed and corrective actions taken? Are there built-in safeguards to ensure the validity of data? What "duplicate donor" utilities are used? Is the Registry periodically inspected by an outside agency? When, if ever, has the Registry been through a comprehensive "clean-up" to eliminate outdated and incorrect information? My impression is that over time, the database has been seriously degraded from lack of attention. Information is supplied by a number of sources (not just regional blood centers). There is only limited information on its use, limited instructions that could be construed as an "SOP" and limited training material on the proper use of the Registry. The Registry also has no impact on the blood components obtained from out-of-state, which, of course, are not subject to the CDDR. The money, time and effort that would be required to conform this database to meet cGMP requirements would be significant and would be far better spent on other initiatives that would enhance blood transfusion safety. For example, the continuing challenges of proper patient I.D. and avoiding sample mix-ups would seem to be much more appropriate problems to be targeted. Of the several overlapping layers of safety that we are all familiar with, the SDDR would seem to be the most inconsequential. Let's not fall into the trap of confusing any activity as progress. California should dump the SDDR."

ADDENDA April 23, 2003

6. A colleague in California who inspects laboratories for compliance with California regulations is of the opinion that the California Donor Deferral Register should NOT be eliminated, unless it can be replaced with access to the NATIONAL Donor Deferral Register for all facilities.
   
   
7. A physician who practices in Chicago is of the opinion that he would like the Californians to indicate specifically how the registry is flawed, and he would agree that improving the registry would be better than deleting it.

ADDENDA July 5, 2003

8. Editor's Notes:
   • For those interested in the progress of the bill to eliminate the California Donor Deferral Register, see the history here.
   • The most current version of proposed California Senate Bill 1081 (PDF file), if passed in its current form, would have an impact on donor identification requirements (also see discussion on donor identification). Specifically, existing California regulations state that blood banks must require photographic identification, as specified, from all donors of human whole blood who receive payment, as defined, in return for the donation of that blood. This bill would also apply these requirements to plasma centers, and would expand the category of donors required to present photographic identification to include donors of blood components.

ADDENDA Sept. 23, 2003

9. A compliance officer at a Southern California hospital network is aware that the California Donor Deferral Registry is no longer being supported by the State of California. The new bill (SB 1081) signed by Gov. Gray Davis on Sept 17, 2003 has eliminated the DDR. However, in reviewing the bill, she could not find an effective date. Are all of these recently signed bills effective Jan. 1, 2004? Does anyone know?

ADDENDA Sept. 24, 2003

10. Two politically savvy board members of CBBS state that the effective date is Jan. 1, 2004.

ADDENDA Sept. 25, 2003

11. A colleague in Southern California comments on the Editor's note (#8, above) where it states: 'This bill would also apply these requirements to plasma centers, and would expand the category of donors required to present photographic identification to include donors of blood components.'
    
    The colleague's reading of the bill is that the requirement for photographic ID has indeed been expanded to donors of blood components, but it only applies if the donor is paid.

    SEC. 2. Section 1603.2 of the Health and Safety Code is amended to read:

    1603.2. (a) Each blood bank or plasma center shall require as identification either a photographic driver's license or other photographic identification that is issued by the Department of Motor Vehicles, pursuant to Division 6 (commencing with Section 12500) of the Vehicle Code, from all donors of human whole blood or blood components who receive payment in return for the donation of that blood or blood components.

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Ira A. Shulman, MD
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W. Tait Stevens, MD
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Elizabeth M. St. Lezin, MD
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