CONFIDENTIAL
C O N T E N T S
Prove Team Members 02
Introduction 03
Methodology 05
Term of Reference No. 1: Any Deliberate Delay in the Evaluation
of the CyFlow Machine? 08
A. Chronology of Movements of the CyFlow Machine and the
Handling of Evaluation of CyFlow and Other Machines 06
B. Different Treatment of Various CD4 Cell Counting Machines 14
C. Evaluation of CyFlow was Completed by 30/8/2005, But the Report
Sent to Partec on 24/10/2004 Raised Many Question 16
D. The CyFlow Machine is Returned to Germany, and its Retrieved
Data is Claimed to Show MUCHS’ Manipulations of Data 19
Term of Reference No. 2: Were the Reagents Used Expired? 23
"Expiry Dates" versus "Shelf Life" 23
Term of Reference No. 3: What Types of CyFlow Exist in Tanzania,
Where, and How Did They Enter Tanzania? 25
Characteristics of CyFlows and Comparability with FACSCount s 27
Term of Reference No. 4: Which Type of CyFlow was Evaluated? 29
Term of Reference No. 5: Did MUCHS Follow Correct Procedures
While Evaluating the CyFlow Machine? 31
Term of Reference No. 6: Was Any Bribery Used to Influence
the Results of Evaluation Obtained? 32
Term of Reference No. 7: Has WHO Ever Done Any Multi-Center
Study of the CyFlow, and What Results Did They Get? 36
WHO Does Not Have Laboratories to Do Studies, But Recognizes
Studies Done by Good Laboratories, Procures Supplies for
Them, and Disseminate Information Useful for Human Life 36
Probable Conspiracy of Some Organizations Officials to Discredit
Some Manufacturers or Researchers, Helped by Individuals 39
Miscallaneous Questions Including the Latest Evidence Submitted 45
Term of Reference No. 8: Was There Any Unnecessary Delay in Evaluation So As to Enter SD Bioline in the National Algorithm








































PROBE TEAM ON EVALUATION OF CYFLOW CD4 COUNTING MACHINE AND THE SD BIOLINE HIV RAPID TEST KITS
( Dar es Salaam, September 2006 – January 2007)

Members:

1. Prof. Philip R.Hiza, Retired Consultant Surgeon/Chief Medical Officer,
Ministry of Health and Social Welfare, Dar es Salaam.Tanzania.
2. Prof. Raphael A.Lema, Retired Consultant Pathologist, now Vice
Chancellor of IMTU, Dar es Salaam. Tanzania.
3. Dr. Jumah P. Madati, Retired Chief Government Chemist,
Ministry of Health and Social Welfare, Dar es Salaam. Tanzania.

Rapporteur: Dr. Jumah P. Madati

Secretariat: Dr. Jumah P. Madati

















REPORT OF THE PROBE TEAM CONCERNING THE CYFLOW CD4 COUNTING MACHINE AND
SD BIOLINE HIV RAPID ANTIBODY TEST KIT

INTRODUCTION
MINISTERIAL APPOINTMENT OF THE PROBE TEAM
The Hon. Minister for Health and Social Welfare of the United Republic of Tanzania, Professor David Mwakyusa, M.P., by a letter Ref.No. WAUJ/V/C/09/2 dated 1st September 2006, which is appended herewith as ANNEX 0.1, appointed a three-men team to look into the allegations of corruption leveled against some officials of the Ministry of Health and Social Welfare (MoHSW), as well as some researchers and technicians of the Microbiology/Immunology of the Muhimbili University College of Health Sciences (MUCHS).
There are two separate promoters/suppliers of Health Laboratory Supplies and Products who are accusing MoHSW and MUCHS officials of dishonesty in performing the evaluation of their equipment and reagents according to the "Private Health Laboratory (Conditions Pre-Requisite to Registration and Management of Private Health Laboratories), of the Private Health Laboratory Regulations Act 1997".
The first supplier is Partec Essential Healthcare company of Munster, Germany, which markets the CyFlow SL Blue CD4 T-Cells counting machine, which Partec offered to MoHSW to evaluate and register, ostensibly with the ultimate hope and aim of entering their CyFlow machine in the Tanzanian market. They were disappointed when ultimately their machine was disqualified, and so they started alleging that some MUCHS and some MoHSW officials had been bribed by the suppliers of the rival CD4 cell counting machines, viz BD FACSCount and BD FACSCalibur, which are marketed by Biocare Health Products Ltd. of Dar es Salaam, and manufactured by Becton Dickinson company of USA. As if this were not enough, the Tanzania news media orchestrated strong and persistent support of the Partec CyFlow machine promoters’ allegations.
The second supplier is SD (AFRICA) Ltd. Of Dar es Salaam, a South Korean based company which markets the SD Bioline HIV 1/2 3.0 Rapid Antibody Test Kit, which SD (AFRICA) Ltd. submitted to the PHLB (Private Health Laboratories Board) of the MoHSW to evaluate and register, presumably with the ultimate aim and hope of entering their Kit in the Tanzanian market.
They were frustrated when, in spite of passing successfully both Phase I and Phase II of the mandatory evaluations stipulated by PHLB, and in spite of being registered by PHLB, and satisfying all the five conditions according to the Sub-Section 2.5.2, GN No. 226 of the "Private Health Laboratory (Conditions Pre-Requisite to Registration and Management of Private Health Laboratories), of the Private Health Laboratory Regulations Act 1997", the MoHSW kept on delaying entering their Kit into the National Algorithm, which is a pre-requisite for being invited to tender for the supply of HIV Test Kits. When finally the MoHSW insisted on inviting discriminatory Tenders using trade names of the unregistered HIV Test Kits of Capillus and Determine and excluding SD Bioline, although the MoHSW itself announced in a Press Release that thenceforth SD Bioline would be the front-line HIV Test Kit, the SD Bioline promoters and news media including some unnamed senior MoHSW officials cried foul. Ultimately the PPRA (Public Procurement Regulatory Authority) and the State House had to intervene and stop MoHSW Tender Board allowing Capillus and Determine win the Tender without being registered. Naturally, SD (AFRICA) Ltd. kept on purporting that some MUCHS and some MoHSW officials must have been influenced by suppliers of the HIV Test Kits Capillus and Determine. The local marketing company of Capillus and Determine happen to be the same Biocare Health Products Ltd. of Dar es Salaam, which has been for many years the suppliers of the BD FACSCount and BD FACSCalibur CD4 cell counting machines (see the above paragraph which introduces the "CyFlow saga", twin sister of the "SD Bioline saga").
In this (SD Bioline) saga too, the news media sided squarely with the SD Bioline suppliers in their allegations of corruption, and condemned the MoHSW and its affiliates for openly opting to "kill" prematurely HIV infected persons by insisting on testing them with the Capillus Test Kits which even MoHSW itself admitted in a Press Release of 10/11/2006 that it is not registered, and it is prone to giving wrong HIV test results. The SD Bioline promoters and news media also alleged that the Hon. Minister for Health and Social Welfare was being constantly misinformed or not informed at all about all this.
This prompted the Hon. Minister for Health and Social Welfare to appoint a team of independent, experienced professionals to investigate these and related allegations and find out how, if at all, any corruption or bribery has played a role in these two sagas. The Hon. Minister for Health and Social Welfare guided the Probe Team by giving them the Terms of Reference which are appended herewith as ANNEX 0.2.



The Probe Team comprised the following persons:
Prof. Philip R. Hiza, retired Consultant Surgeon, and once the CMO.
Prof. Raphael A. Lema, retired Consultant Pathologist and currently the Vice Chancellor of IMTU.
Dr. Jumah P. Madati, B.Sc. (Chem.), M.Sc. (Anal. Chem.), Ph.D. (Phyto.
Chem.), Fellow of the Royal Society of Chemistry (F.R.S.C); Chartered
Chemist (Ch.Chem.); who was Chief Govt. Chemist (1979-1987), retired
from civil service since 1992, and currently a free lance consultant.

METHODOLOGY
The Probe Team started work on 14th September 2006 by deliberating on the Strategies of the Enquiry, and decided that it would attempt to gather all sorts of documents such as: Air Waybills, Bills of Lading, Invoices, Import Declaration Forms; Requisition, Issue, and Dispatch Vouchers/Notes, in order to establish the exact movements and transit stops made by the CyFlow machine, the SD Bioline Test Kit, and their reagents. The Probe Team endeavoured, by this way, to establish any delays that occurred, when, why, and whether the dalays were deliberate, identifying each stop over and persons who handled them, and when and how their evaluations commenced, were performed, and the Evaluation Report issued. All these documentary evidences were assigned end-note numbers and appended herewith as ANNEX 2... The Probe Team also scrutinized the letters and Reports exchanged between different stakeholders, and Minutes of the various Board and Committee Meetings and those, including all those letters and newsprints of complaints from the suppliers/promoters and their agents and responses to them by the various officials of MoHSW, MUCHS, AMREF and their affiliates. All the documentary evidence is assigned end-note numbers and appended as ANNEX 2. …. At the end of this Repot.
The Probe Team interviewed a number of persons who carried these items from one spot to the other, who ran samples of patients’ blood in the CyFlow machine and SD Bioline HIV Rapid Test Kit, in the course of evaluating the machine and the Kit, before submitting the evaluation results to the PHLB and subsequently sending the Final Evaluation Report to the MoHSW and thence to the suppliers/promoters. The Probe Team read through several documents given by the interviewees and some which were downloaded from the internet. The names of the persons who were interviewed are given hereunder, and their Interview Reports are appended herewith as ANNEX 0.3. …
These Reports are not in chronological order, since many of the interviewees were too busy with their routine chores to talk to the Probe Team exactly when the Probe Team wanted to interview them. The following is the list of intrviewees.
1. The Hon. Minister for Health and Social Welfare, Professor David Mwakyusa.
2. The previous Hon. Minister for Health and Social Welfare, Mrs. Anna Abdallah
3. The Permanent Secretary Mrs. Hilda Gondwe (it wasn’t possible to consult her).
4. The previous Permanent Secretary of the MoHSW, Mrs. Mariam Mwafisi.
5 The Chief Medical Officer of MoHSW, Dr. Gabriel L. Upunda.
6. The Director of Hospital Services, Dr. Zechery A. Berege.
7. The Registrar of the Private Health Laboratories Board, Mr. Sabas Mrina.
8. The Programme Manager of National Aids Control Programme,Dr.Roland Swai
9. Mr. Hasan S. Khalid, Laboratory Technologist of NACP.
10. The former Ag. Head of the Diagnostic Section of MoH, Dr.Faustin Ndugulile.
11. Dr.Carnelia Atsyor, Ag. WHO Resident Representative.
12. Dr.Magani,WHO Representative to Tanzania (it wasn’t possible to consult him
13. Prof. Eligius F.Lyamuya,Assist. Professor and Head of Microbiology,MUCHS
14. Professor Fred Mhalu, Professor of Microbiology, MUCHS.
15. Mr. Sufi, Head Technologist, Microbiology Laboratory, MUCHS.
16. Mr. Severin Mgonja, Technologist, Microbiology Laboratory, MUCHS.
17. Mr. Charles Kagoma, formerly with MUCHS, but currently with WHO.
18. Mr. Mbena, Technologist, MUCHS (it wasn’t possible to interview him)
19. Mr. Joseph Mgaya, Director General, Medical Stores Department (MSD).
20. Ms.Lucy Nderimo, MSD Quality Assurance Manager.
21. Mr. Hezron Shayo, MSD Quality Assurance Officer (Diagnostics).
21. Mr. Msemu, Procurement Officer, MSD (It was not possible to interview him).
22. Dr. R.S. Mlinga, Chief Executive Officer, PPRA (Public Procurement
Regulatory Authority).
23. Mrs. Ndomondo-Sigonda, MD of TFDA (It was not possible to interview her).
24. Dr. Benedict P. Mbawala, Managing Director, Oysterbay Hospital, DSM.
25. Lt. Mr. Hamisi Gabriel Chifupa, Director General, Tega International, DSM.
26. Dr. Urasa, CDC (it wasn’t possible to consult him).
27. Dr. Wictor, CDC (it wasn’t possible to consult him).
28. The AMREF Country Director (it wasn’t possible to consult or his affiliates).
29. Dr. Florence Temu Mbaga, Head of Programmes, AMREF.
30. Dr. Msolla, AMREF
31. Dr. Ocheng, AMREF
32, Mr. Barhat Rajani, Managing Director, Biocare Health Products Ltd.
33. Dr.Rainer Brandl, Bulongwa Hospital (It wasn’t possible to interview him).
34. Several Technicians working in Health Facilities all over Tanzania which possessed CD4 counters and HIV Rapid Test Kits, were interviewed about the status of these Health Laboratory Supplies, and asked to remain anonymous.
Unfortunately, we were unable to visit Health Facilities which possess and use CyFlow CD4+ T-cell counting machines in Tanzania, and in some neighbouring African countries, at least. This was a pity since some of these Health Facilities or Centers apparently are very happy with the performances of their CyFlow machines that are manufactured by Partec of Germany, and which exhibit no shortcomings – certainly not like what MUCHS observed in this one CyFlow which they evaluated in mid 2005. These proud owners of various CyFlow machines have written several Reports praising their performances and even comparability to other CD4+ T-cell counting machines made by companies like Becton-Dickinson of USA, namely FACSCount, FACSCalibur, FACScan, etc.

























_________________________________________
ANNEX 0
Letter Ref.No. WAUJ/V/C/09/2 dated 01/09/2006 of appointment of the Probe Team.
2 Terms of Reference (Hadidu za Rejea) of the Probe Team concerning the CyFlow CD4 counting
machine and the SD Bioline HIV Rapid Antibody Test Kit.
3 Interview Reports – 1-34





























THE UNITED REPUBLIC OF TANZANIA









EVALUATION OF THE CYFLOW CD4 COUNTING MACHINE AND THE SD BIOLINE HIV TEST KITS



A Report of the Ministerial Probe Team on
Evaluation of the CyFlow CD4+ T-Cells Counting Machine
And the SD Bioline HIV Rapid Antibody Test Kits

Dar es Salaam
Ministry of Health and Social Welfare





February 2007




THE UNITED REPUBLIC OF TANZANIA









EVALUATION OF THE CYFLOW CD4 COUNTING MACHINE AND THE SD BIOLINE HIV TEST KITS



A Report of the Ministerial Probe Team on
Evaluation of the CyFlow CD4+ T-Cells Counting Machine
And the SD Bioline HIV Rapid Antibody Test Kits

Dar es Salaam
Ministry of Health and Social Welfare





February 2007

THE UNITED REPUBLIC OF TANZANIA




Ministry of Health and Social Welfare





EXECUTIVE SUMMARY OF
EVALUATION OF THE CYFLOW CD4 COUNTING MACHINE AND THE SD BIOLINE HIV TEST KITS









February 2007
Dar es Salaam












ANALYSIS OF DISCUSSIONS WITH INTERVIEWEES
By virtue of being the Head of the Microbiology/Immunology Department until very recently, August 2006, Prof Lyamuya is a key interviewee who should know better than almost anyone else about this CyFlow machine saga, as well as the SD Bioline HIV Rapid Antibody Test Kit saga.
Professor Lyamuya said that the CyFlow Easy Count machine (CyTecs Gmbh Ser.No. 040814517) was delivered to MUCHS with NACP Local Stores Requisition and Issue Voucher Nos. ………………. by the Laboratory Technician of the NACP (National Aids Control Programme), Mr. Hasan S. Khalid, on 24/12/2004.
Evaluation of this CyFlow machine could not commence immediately because MUCHS had no reagents for the reference assay method, flow cytometry. Since the supplier of the machine, Partec or Prof. Roland Gohde had not sent the reagents with this machine, the MoH offered to provide them. These reagents were not delivered to MUCHS until 24/06/2005, six months after the arrival of the CyFlow machine itself.
Even then, the evaluation could not commence because it was discovered that calibrating beads were missing. When he was informed about this, the Registrar of the Private Health Laboratories Board (PHLB), Mr. Mrina delivered the calibrating beads on 12/7/2005, one month later, and then MUCHS started operating the machine on 19/7/2005, when this CyFlow screen was observed to give no display at all. When he was informed about this, Mr. Mrina called in the CyFlow engineer from Nairobi, Mr. Khisa Joseph, who arrived on 23/7/2005, and rectified the problem. He also instructed the MUCHS Technician, Mr. Sufi how to operate the machine properly. Then MUCHS proceeded to evaluate the CyFlow machine till late August 2005, analyzed the data, and issued a final Evaluation Report on 6/10/2005, only two months since the start of the evaluation.
This refutes one allegation made by Prof Gohde that "the CyFlow machine lied idle for 14 months before its evaluation started". If the CyFlow reached MUCHS on 24/12/2004 and the evaluation did not start until 19/7/2005, and the Evaluation Report was issued on 5/10/2005, this evaluation took 2 months and not 14 months as claimed by Prof Gohde, unless we can discover other Local Stores Requisition and Issue Vouchers showing that the CyFlow reached MUCHS much earlier than 24/12/2004.
Prof Lyamuya briefed the Probe Team on the assay methodology they used, demonstrating the operation of the CyFlow machine, and showed it the printouts (See Appendix 2) obtained for the sample No. 6137 which were tested on 2/8/2005 using this machine running parallel to BD Facs count and Beads count, as follows:
CD4 Counting Machine Used
CyFlow SL
FacsCount
Bead
CD4 T Lymphocytes Counts
191
64
57
This clears another allegation that MUCHS evaluators never produced any printouts which are usually kept at the evaluating laboratory, and also demonstrates how the CyFlow machine gives a falsely inflated CD4 T-lymphocyte counts of 191 for samples which are as low as 57 and 64. This kind of performance of the CyFlow machine is catastrophic, because blood samples with lower CD4 T-lymphocytes count of less than 200 cells/µl will read on the CyFlow machine well above 200 cells/µl, a fact that will disqualify them to start AntiRetroviral Therapy, which will send them to unduly early deaths.
As regards the allegation of reagents’ Expiry Date having elapsed by the time MUCHS evaluated the CyFlow machine with them, Prof Lyamuya showed the Probe Team the reagents whose bottles show clearly (see photographs of them in Appendix 3) that they were all used long before their expiry dates elapsed taking into consideration that the evaluation assays were performed up to August 2005, as shown below:
NAME OF THE REAGENT
EXPIRY DATE
TIME USED
BEFORE
EXPIRY
CyTecs CD4 Easy Count Dilution Buffer
Code No. CY-R-1004; Lot No. 041020wd
December 2005
Four
Months
CD4 Easy Count CD4 PE
Code No. CY-R-104; Lot No. X27008
February 2006
Six
Months
Calibration Beads
Code No. 9544000
October 2005
Two
Months
Therefore the allegation of using the reagents after their expiry dates had elapsed, is null and void.
Even the excuse which was raised by the suppliers’ agent, Dr. Mbawala, those reagents had two types of "Expiry Dates", the above mentioned Expiry Dates which have been proven adequately not to have elapsed by the time MUCHS carried out the CyFlow machine evaluation. Another "Expiry Date" which they called "Shelf Life of 6 months if well stored under a refrigerator" which they claim was "applicable only to assays performed for purposes of the evaluation of the CyFlow machine", while the real Expiry Dates are applicable only to assays that are performed on patients in the field. This is not a "Standard Operation Procedure" nor is it a "Standard Nomenclature". What is known internationally is that delicate or sensitive items are normally labeled clearly like "To be stored at temperature xoC" so that even Airlines and the Airport Cold Rooms automatically keep the items refrigerated, ofcourse at a nominal charge. And if the suppliers seriously wanted those reagents to be used before their "Shelf Life" elapses, they should have labeled them:
"To be stored at a temperature of xoC, and must be used before 6 months", and in the covering letter which was accompanying them, and even in manuals of instructions, it should have emphasized this type of warning. There were no such warnings at all!
Prof Lyamuya, in his rebuttal of Partec’s, Prof Gohde, and Dr. Mbawala’s allegations, wrote a detailed 9 pages letter Ref. No. MIM/022/01/06 dated 30/1/2006, and another 7 pages letter Ref. No. MIM/022/06/06 dated 23/6/2006, which answered the remaining allegations which show clearly that:
(a)The MUCHS Microbiology/Immunology Department staff, including Prof Lyamuya himself are well learned, experienced; and doubtlessly performed the evaluations not only to international standards but exactly to the letter i.e. exactly according to the instructions given by the suppliers of the CyFlow machine including the instrument manuals and analytical manuals.
Apart from seeing and inspecting the CyFlow machine which MUCHS received from Germany to evaluate, whose full name is "CyFlow Blue, 5 Parameters" which goes by the name label of "CyTech`", the Probe Team did not have the opportunity to see about ten other CyFlow machines scattered all over Tanzania, except the smaller version known as CyFlow Green possessed by Dr. Benedict Mbawala, the proprietor of the Oysterbay Hospital, Dar es Salaam. Dr. Mbawala used this machine to complain that he sent doubles of blood samples to MUCHS which he had assayed in his CyFlow Green and assay results of MUCHS’ CyFlow Blue he says, agreed very well with assay results of the CyFlow Blue of MUCHS. We thought that it was wrong of Dr. Mbawala to compare results of machines and perhaps settings which were not comparable.
From the investigations we have thus far carried out, we have yet to find evidence of deliberate delay or tampering of any sort, or demand or receipt of any bribe on the part of MUCHS evaluators, although claims by Prof. Gohde and Dr. Mbawala that the CyFlow Blue did come with the "Starter Kit" of reagents with which the Nairobi based Partec engineer, Mr. Joseph Khisa trained MUCHS’ Technicians in Dar in November on how to operate the CyFlow Blue machine seems so far convincing. Therefore, up until now, the Probe Team is in no position to state that MUCHS was responsible for all or part of the delay in evaluating the CyFlow Blue or not. The Probe Team could neither confirm what caused the lower +precision of CyFlow Blue machine when determining blood samples with lower CD4 T-lymphocytes count of less than 200 cells/µl, if at all such an imprecision exists. Now that Prof Godhe and Dr. Mbawala have taken away the CyFlow Blue to Germany to retrieve all results from its "Black box" i.e. its Hard Disk, we shall have to wait until they and we scrutinize its print-outs to see if there is any evidence of tampering with or sabotaging the CyFlow Blue, and where, when, and how that might have taken place.