A better prestick prep will help reduce contaminated blood components.Platelet concentrates (PLT) are particularly susceptible as they are stored at 22C which is a temperature favorable for bacterial multiplication.
Some important web resources for this discussion:
Skin antiseptics in venous puncture-site disinfection for prevention of blood culture contamination: systematic review with meta-analysis.
Caldeira, D., et. al., 2011. Journal of Hospital Infection 77(3):223-32.
doi: 10.1016/j.jhin.2010.10.015
Interventions Implemented to Reduce the Risk of Transmission of Bacteria by Transfusion in the English National Blood Service.
McDonald, C.P., 2011. Transfusion Medicine and Hemotherapy 38(4): 255–258.
doi: 10.1159/000330474
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3190222/
Skin disinfection methods: prospective evaluation and postimplementation results.
Ramirez-Arcos, S., Goldman M., 2010. Transfusion 50(1):59-64.
doi: 10.1111/j.1537-2995.2009.02434.x. (abstract)
Reducing the Risk of Transfusion-Transmitted Bacterial Infections in Platelet Concentrates: Current Status and Developments.
Rood, I.G.H., et. al., 2008. LABMEDICINE 39 Number 9
doi: 10.1309/bdnbmdcn7tt2r9f5
http://labmed.ascpjournals.org/content/39/9/553.full.pdf (CE Update)
Bacterial Contamination of Blood Components.
Brecher, M.E., Hay, S.N., 2005. Clinical Microbiology Rev. 18(1): 195–204.
doi: 10.1128/CMR.18.1.195-204.2005
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC544173/Bacterial persistence on blood donors' arms after phlebotomy site preparation: analysis of risk factors.
Cid, J., et. al., 2003. Haematologica 88:839-840
http://www.haematologica.it/content/88/7/839.full.pdf (Letters to the editor)
Evaluation of donor arm disinfection techniques.
Mcdonald, C.P., et.al. 2001, Vox Sanguinis 80, 135-141
http://basiswebnet.chu-lyon.fr/cons/doc01/0009617.pdf
Evaluation of donor skin disinfection methods.
Goldman, M., et. al., 1997. Transfusion 37(3):309-12
http://www.ncbi.nlm.nih.gov/pubmed/9122905 (abstract)
I'm including in full the latest guidance issued by AABB:
Statement Before BPAC on Considerations for Options to Further Reduce the Risk of Bacterial Contamination in Platelets
21 September 2012 Considerations for Options to Further Reduce the Risk of Bacterial Contamination in Platelet. M. Allene Carr-Greer, Director, Regulatory Affairs
AABB
is an international, not-for-profit association representing
individuals and institutions involved in the field of transfusion
medicine and cellular therapies. The association is committed to
improving health by developing and delivering standards, accreditation
and educational programs that focus on optimizing patient and donor care
and safety. AABB membership consists of nearly 2,000 institutions and
8,000 individuals, including physicians, nurses, scientists,
researchers, administrators, medical technologists and other health care
providers. AABB members are located in more than 80 countries. AABB thanks you for the opportunity to speak today. We also wish to
thank the Food and Drug Administration for addressing the issue of
bacterial contamination of platelet components in a public venue. AABB
has addressed this issue on several fronts during the past decade and we
appreciate the opportunity to provide a record for this meeting of the
actions AABB has required member facilities to take to limit and detect
bacterial contamination in platelet components and of education provided
to the membership to support implementation of the various requirements
and recommendations.AABB strategies have been developed using the expertise of members of
its Bacterial Contamination Task Force, Transfusion Transmitted
Diseases Committee, and Blood Bank and Transfusion Service Standards
Program Unit. The method for AABB policy and requirements to be
communicated to accredited members is through publication of Association
Bulletins and development of Standards. The current requirements of an
accredited AABB member, applicable to today's discussion, as published
in Standards for Blood Banks and Transfusion Services (28th edition) are listed here. The standards were also applicable in the 27th edition.
| 5.1.5 | Sterility | |||
| Aseptic methods shall be employed to minimize the risk of microbial contamination of blood and blood components. Equipment and solutions that come into direct contact with blood or blood components shall be sterile and pyrogen-free. Single-use equipment shall be used whenever possible. | ||||
| 5.1.5.1 | The blood bank or transfusion service shall have methods to limit and to detect or inactivate bacteria in all platelet components. Standard 5.6.2 applies. | |||
| 5.1.5.1.1 | Detection methods shall either be approved by the FDA or be validated to provide sensitivity equivalent to FDA-approved methods. | |||
| 5.1.5.2 | When a true-culture positive result is obtained and an appropriate specimen is available, additional testing to identify the organism shall be performed. Additional testing and followup shall be defined. Standards 5.2.4 and 7.1 to 7.1.4 apply. | |||
| 5.6 | Blood Collection | |||
| 5.6.1 | Methods | |||
| Blood shall be collected into a sterile closed system. | ||||
| 5.6.2 | Protection Against Contamination | |||
| The venipuncture site shall be prepared so as to minimize risk of bacterial contamination. Green soap (USP) shall not be used. | ||||
| 5.6.2.1 | Blood collection containers with draw line (inlet) diversion pouches shall be used for any collection of platelets, including whole blood from which platelets are made. | |||
BB/TS Standard 5.1.5.1 was published in 2003 in the 22nd ed. with an effective date of March 1, of 2004. Practically, the result of implementation of Standard 5.1.5.1. was detection of bacterial contamination in apheresis platelets by culture-based methods. Eventually this included pre-storage pooled whole blood-derived platelets. Remaining whole blood-derived platelets were evaluated using a variety of methods including the use of pH and glucose readings, as well as observation of swirling.
Association Bulletin #03-12 issued October 1, 2003 – Further Guidance on Methods to Detect Bacterial Contamination of Platelet Components – was a comprehensive document that provided the membership with 1) background information on the risk to recipient safety posed by bacterial contamination of platelets and the underpinnings of the approaches that had been considered to limit and detect contamination, 2) practical guidance on the implementation of some of the techniques, and 3) sample plans and algorithms.
Association Bulletin #04-07 issued October 14, 2004 – Actions Following an Initial Positive Test for Possible Bacterial Contamination of a Platelet Unit – is still an active bulletin.
Association Bulletin #09-04 issued July 20, 2009 – Developments in Bacterial Testing and BBTS Standard 5.1.5.1. – reviewed what was then the current status of technology available to meet the intent of Standard 5.1.5.1 and provided an update on new technologies in development that would offer an alternate method for meeting the standard. It also informed members that once studies demonstrated the efficacy of an alternate method in detecting bacteria in whole blood-derived platelets (similar to the studies required for FDA approval), AABB would likely adopt a more prescriptive interim standard.
BB/TS Interim Standard 5.1.5.1.1 was announced in Association Bulletin #10-02 issued May 3, 2010 and became effective January 31, 2011. The Standard was subsequently published in the 27th edition.
Association Bulletin #10-05 issued August 19, 2010 – Suggested Options For Transfusion Services and Blood Collectors to Facilitate Implementation of BB/TS Interim Standard 5.1.5.1.1 – was published to assist transfusion services with making a complete transition away from surrogate testing (pH and glucose) to culture-based or rapid immunoassay (point-of-issue) bacterial screening. Another option provided was use of approaches or methods that were not FDA-cleared but that had been validated to be of equivalent clinical sensitivity to an approved assay.
In July of this year AABB provided the opportunity for public discussion of issues surrounding the remaining residual risk of bacterial contamination of platelet components. While a variety of experiences and data were presented and discussed, the focus of the workshop was apheresis platelets and the impact secondary screening for bacterial contamination has had and might have if more broadly applied. FDA did not co-sponsor the workshop but was represented on the planning committee. As follow-up to the public conference AABB is reviewing its current policy and will issue further recommendations in an Association Bulletin.
Because AABB recognizes the remaining residual risk of bacterial contamination in apheresis platelets, the association welcomes guidance from FDA on ways to reduce this risk. Multiple approaches, in addition to those proposed by FDA today, require careful consideration. Any further actions, however, must be validated as to their efficacy and impact on patients who depend on platelets for treatment. Specifically, no change should be advocated in the absence of a careful evaluation of the impact on platelet availability.
http://www.aabb.org/pressroom/statements/Pages/statement092112.aspx as viewed Feb 12, 2013.
As I understand the current status of India's SOPs governing phlebotomy procedures for blood banks, each blood bank has to develop and have approved their own SOPs. The guidelines do refer to phlebotomy as follows:
D. MAINTENANCE ;
The premises shall be maintained in a clean and proper manner to ensure adequate cleaning and maintenance of proper operations. The facilities shall include –
( 1) Privacy and thorough examination of individuals to determine their suitability as donors.
(2) Collection of blood from donors with minimal risk of contamination or exposure to activities and equipment unrelated to blood collection.
G. GOOD MANUFACTURING PRACTICES (GMPs)/STANDARD OPERATING PROCEDURES (SOPs):
Written Standard Operating Procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage and sale or distribution of blood and/or preparation of blood components for homologous transfusion, autologous transfusion and further manufacturing purposes. Such procedures shall be available to the personnel for use in the concerned areas. The Standard Operating Procedures shall inter alia include :
1. (a) criteria used to determine donor suitability.
(b) methods of performing donor qualifying tests and measurements Including minimum and maximum values for a test or procedure, when a factor in determining acceptability;
(c) solutions and methods used to prepare the site of phlebotomy so as to give maximum assurance of a sterile container of blood;
(d) method of accurately relating the product(s) to the donor;
(e) blood collection procedure, including in-process precautions taken to measure accurately the quantity of blood drawn from the donor;
H. CRITERIA FOR BLOOD DONATION :
Conditions for donation of blood :
( 1) General -No person shall donate blood and no blood bank shall draw blood from a person, more than once in three months. The donor shall be in good health, mentally alert and physically fit and shall not be inmates of jail, persons having multiple sex partners and drug-addicts. The donors shall fulfill the following requirements, namely :-
(a) the donor shall be in the age group of 18 to 60 years.
(b) the donor shall not be less than 45 kilograms;
(c) temperature and Pulse of the donor shall be normal;
(d) the systolic and diastolic blood pressures are within normal limits without medication;
(e) haemoglobin which shall not be less than 12.5 grams;
(f) the donor shall be free from acute respiratory diseases;
(g) the donor shall be free from any skin diseases at the site of phlebotomy ;
(h) the donor shall be free from any disease transmissible by blood transfusion, insofar as can be determined by history and examination indicated above;
(i) the arms and forearms of the donor shall be free from skin punctures or scars indicative of professional blood donors or addiction of self injected narcotics
http://cdsco.nic.in/html/guideline.htm as viewed on Feb 12, 2013.
I welcome suggestions for inclusion of other articles or copies of SOPs that may be helpful to this discussion.
