Did the National Blood Centre, the heart of the National Blood Transfusion Service in the country, use expired kits to get platelets from trusting donors?
This is what President Mahinda Rajapaksa must order an absolutely independent and impartial committee or better-still a Commission of Inquiry to investigate and ascertain beyond the slightest doubt, to restore the public's faith not only in the National Blood Transfusion Service but also in the much-commended state health service.
|A platelet extraction underway. The expiry date on the apheresis kit is 19/03-08 and a technical evaluation of the photo by The Sunday Times indicates it was clicked on the morning of June 28, 2008. The code and lot numbers seem to tally with a label (see bottom pic) allegedly from a box holding these stocks of kits. The label also has other crucial information. The Sunday Times has blurred the face of the donor to keep his identity confidential.
The issues for such a commission to probe would be whether there was mismanagement, corruption or sabotage at the National Blood Centre (NBC) - very simply to find the truth.
The NBC located at Narahenpita is in the grip of a major crisis which has triggered probes by both the Auditor-General's Department and the Commission to Investigate Allegations of Bribery or Corruption and more recently by the Health Ministry.
The crisis follows shocking allegations that the NBC, set up with much fanfare in November 2006, used expired "apheresis kits" with widespread suspicions in medical circles that there is an attempt to cover-up the issue at the Health Ministry itself.
The Sunday Times is in possession of several crucial photographs, depicting a donor under apheresis with the expiry date on the kit being clearly visible as March 19, 2008.
When was the donor in these photographs subjected to apheresis? Was it before March 19, 2008 or after March 19, 2008?
An independent technical evaluation of the photographs indicates to The Sunday Times that they were taken on the morning of June 28, 2008.
Therefore, it is the bounden duty of the investigators to check out all available material , photographs and other documents including expired stocks allegedly hidden and once-and-for-all clear the NBC of wrong-doing.
What is platelet apheresis
In this expensive procedure called "platelet apheresis" different to "whole blood" donation, platelets are collected from donors for patients with rare blood groups which form Rh negative (rarest being AB Negative) and also for other groups if the necessity arises.
Under this delicate procedure, the donor is connected to the machine to which the sterile apheresis kit is also attached and blood taken out from the donor, after which a certain amount of platelets are isolated from this volume of blood.
Once the platelets are harvested this blood is pumped back into the donor. The donor undergoes many cycles at one time which could last about one hour.
However, if it is established that even one expired apheresis kit has been used, then those accountable and responsible have to be brought to book.
The apheresis kits, each costing around Rs. 26,000 imported from two American-based companies, The Sunday Times understands, are utilized along with high-tech machines to harvest only platelets from donors.
The platelets, thus harvested from donors that can be kept only for five days, are matched and infused to very ill men, women and children suffering from diseases including cancer, dengue and heart problems.
In another function, these sterile kits are also used as "therapeutic plasma exchange" kits to withdraw diseased plasma from very critical patients such as those with Guillain Barre Syndrome etc in the Medical Intensive Care Units and the Neuro-Intensive Care Units of the major hospitals, after which fresh plasma is introduced to their circulatory system.
The NBC is in the eye of the storm due to allegations that senior doctors in the Donor Section knowingly used one type of kit from one company even after the expiry date on the kits had lapsed.
"The doctors knew what they were doing and they used expired kits," a source, who for obvious reasons wished to remain anonymous, told The Sunday Times. The allegations by this source were corroborated by many other sources as well.
When The Sunday Times last Tuesday met the National Blood Transfusion Service Director Dr. R.M. Bindusara along with a team of doctors, headed by Dr. Champa Manchanayake, manning the 'Donor Section', all were vehement in their denial of any illegal or unethical activity on their part.
|A kit with the expiry tag and another with it torn off - who is responsible?
The National Blood Transfusion Service has under its purview the NBC operating from the state-of-the-art building at Narahenpita, the 10 main centres located across the country and sub-centres (blood banks) based in major hospitals.
"We will never use expired apheresis kits," was the answer echoed and re-echoed individually and in unison by all of them with the consensus being that allegations were part of a vendetta being carried out by vested interests against the NBC.
"I even check whether these kits have been approved by the FDA (Food and Drug Authority in the US)," assured Dr. Bindusara.
The Sunday Times also raised the following allegations, gathered from numerous sources, with the NBC team:
- When the controversy first came out into the open, did a senior doctor attached to the NBC allegedly come in the night and tear-off the labels indicating the expiry dates? (See photo of kit with torn labels)
- Did anyone "doctor" the ledger in which information regarding the donor and donation is entered?
To all these allegations it was a resounding "No" from the doctors, with Director Dr. Bindusara stressing that there has been an ongoing disciplinary problem with some minor staff attached to the Blood Bank of the National Hospital in Colombo since last year and it could be part of a plan to sling mud at her.
While the other doctors attempted to say that anyone could have torn the labels or doctored the ledger as the ledger had allegedly gone missing for some days, The Sunday Times wishes to point out that if "anyone" could do that at the premier blood collecting and storage facility in the country, there is an urgent need to rethink procedures there immediately.
Although the NBC has to be accessible to the public for easy blood donation is it not of paramount importance that a log book is maintained of who enters including staff, for what reason, where they had access to and what time they left.
|Director Dr. Bindusara
Amidst suspicions that the Health Ministry is attempting to cover-up this serious issue, well-informed sources challenged investigators to check the printed company Lot No. and Code No. available not only on the full pack containing the kit but also the individual bags to which the platelets are collected with official documents filed at the NBC, MSD and also the SPC, when importing stocks.
"Compare these numbers on the documentation with those on the kit and the individual platelet collecting packs used in June and July. The documentation would clearly reveal the expiry date. Look also at the official label (see pic) with government logo and all information which is pasted on the boxes with the kits sent to the NBC," the source challenged.
Unfortunately, the crisis has reduced the number of platelet donors coming in each day to one or two, whereas earlier there were 5-7 donors daily, the NBC doctors lamented.
That is why a thorough and quick investigation is the need of the hour. Investigators must find out the truth.
The public has a right to know.
How apheresis kits are ordered
The requirements for the next year are estimated by the NBC on the number of kits used this year to which is added 10% more, The Sunday Times was told by the doctors at the NBC.
However when specifically asked how many kits were ordered for this year, the figure varied with some saying 500-650 and others saying 1,000.
The procedure followed is for the NBC to send the estimated requirement to the Medical Supplies Division which would place the order with the procurement agency, the State Pharmaceuticals Corporation (SPC), The Sunday Times understands.
The SPC, in turn would call for open and competitive bids. These bids would be submitted to the Technical Evaluation Committee (TEC) of which one member would be an "expert" on the kits from the NBC or the ministry. The TEC would check out the bids and make a recommendation to the Procurement (Tender) Board which would be the final decision-maker, a highly-placed SPC source said.
|Donor Section Head Dr. Manchanayake
If the purchases are less than Rs. 25 million, the Procurement Board would be from the SPC, if more than Rs. 25 m. but less than Rs. 100 m. it would go to a Health Ministry Procurement Board. If it is more than Rs. 100 million then it would be a Cabinet-approved Procurement Board, the source added.
Meanwhile, The Sunday Times learns that there had been some issues when an order was placed for some kits in recent times.
A well-informed source said that usually a shelf-life or expiry date of two years into the future is requested but a particular company had offered a stock with a shelf life of 10 months.
When the NBC was asked whether that would be okay, it had given the greenlight for it, the source added.
The NBC doctors while explaining that the maximum shelf life one can get for such kits is 12 months, did not seem to know about the stock with a 10-month shelf life.
They claimed that when stocks were ordered they sometimes did not come on time. Thus the shelf-life would be halfway through when stocks are finally delivered.
Points to ponder
- Did the NBC doctors, in the light of allegations made and photographs being circulated, knowingly use expired apheresis kits? Was the Director aware?
- If allegations of expired kits are proven, were they imported with a short shelf life or were they imported after they had expired? If either of them was so, were any other officials, in addition to those at NBC responsible for such malpractice?
- Was there corruption in the form of pay-offs or foreign trips by the companies from which these stocks are being purchased to anyone involved in this whole issue, to dump expired or short expiry stocks in Sri Lanka?
- Is a "vendetta", as alleged by NBC, being carried out by any disgruntled staff member or members trying to sling mud at the tough-talking Director? Are they trying to frame the NBC doctors by tearing off labels, doctoring the books etc? If not, who actually tore off the labels?
- Is a company producing substandard kits attempting to bring the NBC to disrepute to gain a mean advantage?
- Is there a more sinister hand behind it - to prevent the proposed Blood Act from being passed in Parliament which would give sole authority to the NBC, as opposed to privatized blood banks like in India where there would be no control on whether the blood is screened well or not?
- Did someone genuinely make a mistake and order surplus stocks but is now attempting to cover it up by using expired kits?
Investigations so far
One hundred and thirteen unused but expired "therapeutic plasma exchange" kits were found in some stores of the National Hospital by the Auditor-General's Department when it conducted an "audit" there in July, The Sunday Times learns.
|A bag with a donor's platelets. The handwritten dates at the top indicate the platelets were collected on July 2, 2008 and would expire on July 7, 2008. The code and lot numbers at the bottom of the bag seem to tally with inset pic, the alleged label from a box holding the kits. The Sunday Times has erased the name of the brand and the manufacturer to keep that identity confidential.
"We have instructed the Secretary to the Health Ministry, in writing, to look into this matter, find out who is responsible for such expired stocks being there and report back to us," said Auditor-General S. Swarnajothi, adding that the kits had an expiry date in March.
The audit was carried out in July and the Health Ministry Secretary was sent the instructions on July 22.
The Commission to Investigate Allegations of Bribery or Corruption is probing whether there has been corruption with regard to the controversy at the National Blood Centre, said Director of Investigations SSP Neville Guruge, adding that eight statements have been recorded while certain documents have also been collected from the NBC.
"We have given priority to this investigation," he added.
The Sunday Times understands that the Health Service trade union has informed the Commission that three of the people who made statements to the Commission have been issued with transfer orders .
Meanwhile, Health Ministry sources said that a three-member committee from the Investigation and Flying Squad Unit had been appointed to investigate allegations against the NBC and also see to the Auditor-General's report.