Monday, February 20, 2006

TRANSFUSION TRANSMITTED HIV INFECTION

TRANSFUSION TRANSMITTED HIV INFECTION
A PREVENTION MODEL FOR THE PERUVIAN CASE

INTRODUCTION

Many third world countries are being successful in getting good results in their blood safety problem .However having a national blood program , a national blood law and a local hospital blood bank promotion of the voluntary blood donation hasn’t been good enough to succeed in Peru.

We think it could be interesting for countries like us to learn from our experience and to be aware of the importance of designing a country tailor-made blood safety solution when applying scientific world recommendations.

PERU ‘S HIV BLOOD SAFETY FACTS
Less than 1 % of the 27 millions of people in Peru donate blood and only 5.3 % of them do it voluntarily. Peruvian population is not massively informed about HIV risk factors nor about HIV transfusion infection through window period.
Peru has 175 blood banks inside the labs of 175 hospitals each belonging to one of the four parallel and different resources – structure - rules health institutions ( Social Security, Health Ministry , Armed Forces and Privates ).Most of them collect between 50 to 200 blood donations / month. There is not a center for the national massive promotion of voluntary blood donation nor one for the standardized production of blood components nor one for the national external and regular HIV serology quality control of blood banks.

Although restricted to the functions of giving rules and supervision what we did have since 1997 was a National Blood Program supplied with the limited budget that corresponds to a Peruvian Ministry Health ‘s unit. This resource hasn’t been invested in creating one single national blood banks system however the program did succeed in getting all Peru blood bags stuck with the quality seal put on them after getting non reactive results in the mandatory seven to nine infectious markers tests run for each donated blood.

TRANSFUSION HIV PREVENTION PROPOSAL TRIGGER

In November 2004 , six newborns , one infant and one woman were all of them HIV transfusion infected by a single one donor who was non remunerated non voluntary blood donor , non reactive with a fourth generation HIV ELISA test , Ag. P24 , Ab. HIV 1 , 2 at the moment of the blood donation and reactive four and a half months later.

This serum conversion occurred at Lima’s Maternity Blood Bank Hospital ( 100 blood donations/month ) was confirmed by the National Committee of Experts the Peruvian Health Minister convoked in the country for this case. It was this committee that besides studying it , presented its specific HIV Blood Safety Peruvian Problem’s solution which represented a dramatic change in the solution focus used through several years and several governments.
COMMITTEE PROPOSAL
TO BUILT HIV TRANSFUSION RECEPTOR PROTECTION BARRIERS

PROPOSAL CONSIDERATIONS
For constructing the proposal the committee examined the HIV blood safety literature from WHO , ISBT , AABB , European Council and from the Canadian and French blood safety experience ( some of them with guidelines specifically dedicated to the third world ) in order to elaborate the chain of high quality requirements for each and all the steps involved in the process of prevention of an HIV transfusion transmitted infection .By selecting those that applied in Peru it begun with listing the tools needed to get the best quality insume entering the process – the repetitive voluntary blood donor – and in the same way it finished with listing all needs required to get the best use of blood units leaving the process - setting lower Hb. transfusion triggers , transfusion practice audit , alotransfusions alternatives – all of them looking to guarantee the society transfusion receptors protection.

Inspired in Dr .Reason 1 and Dr. Murphy 2 the committee considered errors as intrinsic to human activity as it certainly is to design a way errors can not be transferred to the patient by inserting protection barriers before passing to the next step in the chain .These will stop HIV in its way to the transfusion recipient ( Figure 1 ) so it won’t pass through the “holes of the cheese ” anymore.

Probably thinking in the same way of Dr. Kenneth A. Clark 3 the committee preferred to point to a completely change of the donor’s pool instead of inserting more and more barriers (two HIV tests - one of them rapid - for each blood donation and others ) that adapt us to our unsuitable non voluntary blood donor pool but didn’t cure us.
This pool’s change is even more important for developing countries than for developed ones because we can’t afford the each time more numerous and more expensive technologies used to diminish transfusion infectious risks ( viral inactivation and others ) but we certainly can diminish them by operating a cheaper option opened through this change : the quarantine storage.
PROPOSAL GOALS
1. Setting the focus of HIV blood safety solution in all nation levels implied instead of the only one focus level ( hospital blood banks ) used until now. This means to go outside them to the whole nation levels implied.
2. Constructing one single blood banks system instead of the parallel four systems we’ve been keeping. This means to take the process of production of blood components outside hospitals restricting their blood banks to the single function of transfusion units.
The success of designing the single blood banks system the country requires demands first getting the diagnosis of the peruvian blood problem situation : blood banks resources , donor’s offer , patient’s blood demand , population’s epidemiology / culture / economic levels and also the geography , accessibility and communication information of all areas in order to determine served and serving units for the blood delivering net.
3. Because there is no success in voluntary blood donation without success in the HIV prevention program , first getting a massively well informed population about HIV infection risk factors and window period is a must of this proposal.
4. To point to a complete change of the donor’s pool to a 100 % voluntary and repetitive blood donor one.
There must be a central brain in charge of getting this change with tasks than include the market field investigation in national voluntary blood donation (where is , how much is and what are the incentives to make the healthy population to donate blood ) .To built this donation brain is another must of the proposal and so it is to discontinue assigning the whole charge of blood donation to the hospital blood banks. This task is certainly beyond their capabilities.
A model inspired in the South African one that can work in a country like Peru is presented in Figure
HIV TRANSFUSION RECEPTOR PROTECTION BARRIERS
1. You can see the 21 HIV Transfusion Receptor Protection Barriers Peru should rise in Table 1 , for each one the critical points were determined , you can see one of them in Table 2.
2. The position where most of these Barriers should be placed were outside the responsibilities of hospital blood banks ( more details on http:www.awgla.com ) see however until present they were the only one level of pressure for getting national blood safety through rules and supervision issued by the National Blood Program.
To get the 21 Barriers risen in Peru there are several tasks that should be done. They are presented in Figures 2 and 3.The most important of all of them is to set a national autonomous brain organization in charge of the voluntary blood donation. The Committee think a model that can work in a developing country like ours is the one ( Figure 4 ) inspired in the South African model of D. de Coning 4 .
WHAT WE HAVE LEARNED
A - Not to continue following ways that didn’t work with us

A reactive instead of proactive behavior to face our blood safety problem
This HIV prevention proposal was given in response to a several HIV transfusion transmitted neonates. The National Blood Program and the Peruvian Blood Law were born together in 1995 when a young woman was HIV transfusion transmitted.

Copying and Pasting good blood safety solutions without first fitting them to the country
The Peruvian Blood Law resembles the one proposed by the Pan American Health Organization in May of 1995.It has the same regulation about Financing Supply , Hemoderivatives Plants and Quality Seal. The first wasn’t ever enough accomplished , the second was never needed ( we still don’t have these plants ) and the third one should’ve been very carefully copied.

The Quality Seal regulation demands to put this label on blood units after getting negative results in their blood donor screening. We must say in the light of the facts ( the blood unit that HIV infected several neonates in Peru had the Quality Seal put on it ) that the Quality Seal means different in a developing country with a non voluntary blood donor pool and in a developed one with a repetitive voluntary blood donor pool so to copy and paste this procedure in Peru without first being transformed the nation blood donor’s pool to a 100 % repetitive voluntary blood donor one is certainly not advisable (we’re not trying to cover the window period ) and what is worst is not ethical because we’re giving the public opinion the false sensation of blood safety

We copied and pasted the National Blood Program concept however with a limited budget it was restricted to only two functions : giving rules and supervision These were enough to succeed getting a 100 % of the country blood units with the Quality Seal but to achieve the goal of Blood Safety you needed more. We know there is an order to follow : 1- Objective , 2 - Financing , 3 - Structure , 4 –Organization , 5 - Human Resources , 6 - Area , 7 - Equipment , 8 – Material Resources , 9 - Normes , 10 - Standard Operating Procedures , 11 - Human Resources Training , 12 - Supervision and finally a Continuous Improvement inside the 14 – Complete Quality Assurance Program .The Blood Program made a by pass jumping from the 1 to the 9 and 12 positions of this sequence.
Keeping the same blood banks system structure
It was no real trying to get high quality standardized blood units keeping the same structure of 50 – 200 blood donations/month hospital blood banks more even than that it was a waste of money to keep them working.
It was a tie to keep blood banks inside four parallel different budgets/ organization health institutions. To pretend them efficiently obeying the National Blood Program norms was like to pretend to efficiently drive a stagecoach with four different horses : a normal horse , a race horse , an undernourished horse and a pony.
To keep parallel systems drove us to a non rational use of blood banks , places with none or two blood banks , so not to apply correct concepts incorrectly is a knowledge we certainly should respect in the future.
4. Getting a 100 % National Voluntary Blood Donor Pool by only strengthening Hospital Blood Banks Voluntary Donation
This goal requires a national command , a multidisciplinary group of professionals and an budget that hospital blood banks don’t have however we asked them to accomplish this huge task by their own. We have been not working the brain but the limbs of a centipede instead.
We know now that to succeed in Voluntary Blood Donation doesn’t mean to be congratulated for a successfully one day hospital blood bank campaign , for the donor’s day campaign or for less than five blood banks in the country increasing their number of voluntary blood donors. It isn’t even enough to succeed in one health institution we need to do it in the whole nation , we need not to need to organize campaigns but to get committed groups of voluntary blood donors that cover the blood quote of the day health centers need instead.
B - We dare to name paradigms the following blood safety concepts developing countries superficially adopt.
· Safe Blood – even in a developed country this concept is not a 100 % true
· To get blood safety is enough to have a national blood policy and a national blood program – Peru had them together with a problem of financing that never could change its blood banks system’s structure.
· The National Net of blood and the Hemocenter are the way to the blood safety solution - Even now there is a tendency in the country to built a blood net system by assigning some hospital blood banks inside the four health institutions the task of the centralized production of blood components but what we do know is that this task should be assigned to an Hemocenter specifically designed to cover its customers needs , with enough independent budget and without the hospital or health institutions ties that impede it to accomplish an efficient operation. We doubt an Hemocenter Project or a Blood Net System designed without considering these characteristics could ever succeed in Peru.

LOOKING TO THE FUTURE

Until now we’ve been constructing HIV Protection Barriers inside the hospital blood banks , this is the easy HIV infection way shown at the right in Figure 1 , we should work in the difficult HIV infection way at the left by constructing them in all the necessary levels in the nation.
The message in this article is to remark the importance of fitting good blood safety concepts to the country’s reality to get a tailor-made solution that works for that nation , it is in this way that this 21 HIV Protection Barriers in the National Experts Committee’s proposition for blood safety is issued.
Like Rocío Sapag 5 we certainly believe in the international financing supply for developing health in the third world countries but this will not help us if we don’t look at ourselves first to elaborate a situational diagnosis , a plausible plan and a national commitment to execute it.
We have observed that countries like us advance not in the slow progressive increasing line of developed ones but by jumps between intermittent ascending spikes.In the field of Immunohematology for example we jumped from the glass plate blood group to the gel card blood group by passing the tube blood group because we lacked enough trained professionals to do it. In Africa because of the high HIV level of its population the South African Council has authorized the use of a Bovine Hemoglobin as a transfusion autologous alternative for specific clinical indications by passing for those cases the need to produce blood units.
Perhaps developing countries should strength efforts in transfusion alternatives ( hemodilution , hemoglobin substitutes , blood less surgery etc. ) passing for working hard in diminishing transfusion triggers and in the national recruitment of repetitive voluntary blood donors that able them to use the quarantine storage instead of unsuccessfully trying to follow developed countries in its unreachable and interminable way of incorporating each time many more and much more expensive technologies to inactivate plasma or decontaminate platelet concentrates in the goal of blood safety.

GRATITUDES

To Transfusion Today that has let us to share our experiences with the rest of the world , we perfectly know that there are many options to publish the abstracts of clinical studies but not for the sort of articles we have shown here , our article is not about clinical research you can resume in numbers , it’s not for an abstract , it’s about ideas you must explain and justify to present , this article is also a part of our transfusion history and we hope it may contribute to enrich Transfusion Medicine.
To the Peruvian Ministry of Health which for the very first time convoked a National Committee of Experts to get a solution proposal for the Peruvian Blood Safety Problem.

BIBLIOGRAPHY

1 - Reason J : Human Error : Models and management. BMJ 2000 , 320 : 768 –70
2 - M.F. Murphy et J.D.S. Kay : Patient identification : problems and potential solutions.
Vox Sanguinis (2004 ) 87 ( Suppl.2 ) , S 197 – S 202
3 - Kenneth A. Clark , MD : Editorial about Predonation testing of potential blood donors
in resource – restricted settings. Transfusion ,Volume ,Issue 2 , page 130 – February
2005
4 – D. de Coning .Finding blood donors : challenges facing donor recruitment in South
Africa. Vox Sanguinis ( 2004 ) 87 ( Suppl. 2 ) , S 168 – S 171
5 – Letter from Rocío Sapag and Jaime Bayona. Learning from low income countries :
what are the lessons ?.BMJ 2004 – 329 : 1186.
http : // bmjjournals.com/cgi/content/full/329/7475/1186

This is an specifically prepared version for Transfusion Today – courtesy of Dr. Saditt Ramos who was the President in charge of the Peruvian Committee of Experts convoked for the Peruvian Ministry of Health to make this proposal - you can get the full HIV Prevention Proposal article in spanish at

All inquiries to
mdperu@bonus.com.pe

Thanks for reading.