REPORT ON “TRAINING FOR TRAINERS” CONTRACT
Tony Badrick
This report details the time spent by Peter Graham and myself delivering the two “Training for Trainers” courses in Ho Chi Minh city from 6 October until 20 October 2007. This training was conducted with the co-operation of the Centre for Standardisation and Quality of Medical Laboratories, a department of the HCMc Department of Health.
On Monday 8th October Peter Graham and myself attended a meeting with Tran Huu Tam, Dr Potie and the CSQL group at their Office. At this meeting I went through the broad scope of the ‘Training for Trainer’ (TfT), and the daily content as we had planned at that time. We sought the feedback of Tam regarding content, level of talks, input from the CSQL and Tam indicated that the program as described would meet their expectations. We then spent some time with Tam, Dr Potie and the group discussing the people who would be attending, their role in their laboratory, their expertise and experience and their likely level of familiarity with the material we would be presenting. We discussed other issues such as the language problem, the role of CSQL and where this course fits in with that role, the training room and facilities. We then gave the CSQL the presentations for the first day of the course. The format of the days that we have adopted is that the first session is a lecture, the second an exercise and the last two consist of interactive sessions based on the standard clauses. The exercises allowed TB and PG to closely work with the students individually to assess understanding and improve communication. One strong theme of the entire workshop was the relative importance of pre and post analytical errors in laboratories and the importance of documented processes in reducing these non-analytical errors. Safety was chosen as a starter topic to introduce the concepts of rules, responsibilities and checklists.
Observations Group 1.
The first session was designed to serve as an overview of the course and quality management, with the topics of IQC, EQA, ISO 15189 covered. Day one of the course revealed problems with the language differences between the consultants and the students. This was not helped by the initial room size and problems with the audio. After lunchtime we were moved to a much smaller room and the interaction improved. We used an exercise on IQC which helped loosen up the group and improve the uptake of the concepts. Biosafety was covered and a set of safety rules was introduced. When the group were questioned about safety in their laboratories all the suggested rules and procedures appeared to be in place!
Day two concentrated on EQA and the relation between EQA and IQC when problem solving. The exercise reinforced IQC and the use of Levy Jennings plots to identify bias and imprecision. We also introduced the concept of an SOP by running through a method SOP. The students were then asked to work through individual SOPs utilising manufacturers kit inserts. The last session was a review of the HCMC lab survey to identify broad problems and start the group thinking about their role in quality improvement. The labs represented in the course were asked to fill in another Survey with the same questions to see if this group have special attributes that may be used in the ongoing HCMC plan. Communication with the group was much better and 95% of the group actively participated in the activities. As the program moved through the days greater emphasis was given to the use of the standard and the importance of documented processes and training.
Day three was focussed on Auditing and post analytical error. The broad principles of audit, nonconformance and corrective action were introduced and the structure and purpose of ISO 15189 was discussed. The activity consisted of a desk audit of Biosafety and pre and post examination procedures in the participants labs. These were performed for each lab but in pairs, with one person playing the role of the auditor, the other the auditee. It was interesting that in this session it was revealed that in fact none of the labs had the required rules and procedures in place. I took this to be an indication that the group had become more open and honest, and perhaps had a better understanding of the concepts. The afternoon consisted of experiences with audits from Australia, Malaysia and Vietnam with the assistance of Dr Potie. An exercise using service complaints was conducted to illustrate the benefits of a systematic approach to non-analytical error. By day 3, the level of interaction was very high.
Day four stated with a session on the other major concepts of a Quality System including Quality Manual, Equipment Inventory, Management Review, and Staff Training and Competence. With the first group we added a talk on alternatives to commercial quality control sera for IQC and EQA, namely pooled samples and shared patient pools. This was to provide alternatives for this group to consider as a first step towards setting up a local EQA progam.Frequency of testing and batch sizes with QC samples, and QC of units tests (dipstick, preg tests) was also covered. This talk also emphasized the different capabilities of assays and the shortcomings of IQC in these circumstances. This talk was inserted after the survey of this group revealed that most performed IQC daily. We finished the course with a session on what steps they should take next. The suggestion was that they appoint an appropriate person in each of their labs to be a quality manager and for them to begin a gap analysis against the cut down standard that they have. They were encouraged to begin intra laboratory audits and swapping pool samples for QA activities. The role of the CSQL was discussed with the group. It was proposed that the CSQL could get the resources from the department of health for quality managers.
Observations Group 2
Group two consisted of a greater proportion of CSQL staff including Tan Tam. From Day one this entire group appeared to be more involved and asked a lot of probing questions about the material, seeking as much information as possible about all topics. The CSQL staff all actively participated in the exercises. It was worth noting that some CSQL staff reappeared in this course from last course. When asked why, one stated that he wanted to learn as much as possible. Tan Huu Tam was actively involved with the discussion and showed a good understanding if the concepts introduced in the course, in fact he often lead the questioning and helped with explaining and translating to the group many of these concepts.
We followed the same daily format as with group one, however because this group were far more interactive, some adjustments to the timings of the talks was made. This group seemed to consist of staff who were more focused on the specific detail of our talks and they asked many questions about the examples we presented. There was much discussion with us and between themselves about many of the talks.
General Comments
In Dr Potie’s presentation she made a number of pertinent points regarding the adoption of quality management systems in Vietnamese medical laboratories. I quote literally (with permission) from her presentation. The difficulties with adopting widespread Quality Assurance activities in Vietnam can be summarized under three major themes; educational, financial and cultural. The educational challenge is to teach what quality assurance is and how it differs from quality control. There is a perceived lack of time and human resources but this is a common concern in all industries and all countries. The control of the collection staff is generally not a laboratory function so this is an additional problem not always found overseas. The relationship between physicians and laboratories is not always a partnership. The need for laboratories to be seen to be responsive to clinical needs is important. This aspect of ISO 15189 should be emphasized as a positive from the laboratory, the physician and the patient. There appear to be problems with Suppliers, stock management and reliability, and perhaps commitment to customers in Vietnam. Some reagents, often of poor quality, seem to be ‘dumped’ on this market. These comments are anecdotal, but based on strong local experience and insight. Patient expectations may be unrealistic in relation to turn around, and may represent poor laboratory quality rather than poor quality. There will be a financial burden experienced by laboratories adopting improved quality standards with gloves, QC, EQA, single use materials. Dr Potie presented an insight into some of the cultural aspects of the Vietnamese people in that they are reticent to admit mistakes and errors may be blamed on astrological influences. There is a lack of discipline and a reliance on age, respect, relationship rather than ability when choosing senior and responsible roles. Teamwork is not a national characteristic, but Vietnamese are patient, willing to learn and enthusiastic. I think it is important as we move on that we encourage all the groups to continue to communicate regularly about their progress and successes.
The hospitality of the Vietnamese was overwhelming and genuine, as was their desire to learn as much a s possible from us. We would also like to thank Dr Cecile Potie for her involvement, support and assistance. Dr Potie was in attendance for the majority of both courses assisting us with the exercises and providing a useful channel between the students and ourselves, reporting back on the students’ perceptions of our speed and clarity.
I would also like to recognize the leadership demonstrated by Tan Tam. He was actively involved in the second course and demonstrated a real understanding of the principles of IQC, EQA and laboratory processes. There were points in the discussion between the laboratory personnel and members of the CSQL where Tam showed he had a better understanding of the implications on patient care of certain laboratory practice than the lab staff did. He also effectively led his team, demonstrating a close relationship with CSQL staff. I fully realize the size of the task that faces the CSQL team and they are inexperienced, but I suspect Tam has the organizational, intellectual and personal attributes to achieve success.
On the Friday 20th we had a meeting at the CSQL with Tam and his team, Minh Ly and Cecile Potie. We suggested that the group of students from these courses be supported and that continual meeting of the CSQL and this group would be beneficial in maintaining momemtum. We suggested monthly or bimonthly meetings and that any further workshops should have at least some of these people presenting. We suggested that there be setup a system of audits between these labs with additional training being given to the CSQL staff.
CSQL invited us back from 3-15th December to conduct a number of activities including audits of a series of labs, training for the CSQL staff and assistance for the CSQL in drafting some standards for labs in HCMc. We will also assist in the intervening period with the development of some generic SOPs covering key lab processes.
RECOMMENDATIONS FOR FURTHER ACTION
The success of this course should be followed to see if any of the represented laboratories started implementing quality management systems. The presenters will do this informally, but it would be worthwhile following this group.
If CSQL is to become the basis for an accreditation agency, then staff need further training in auditing and accreditation. There is a strong need to provide ongoing assistance to the CSQL to continue the work they have started. The model used in Thailand could be a suitable model to follow, and perhaps assistance could be given by the Thai DMSc to this group. The model of using a cutdown Standard rather than ISO 15189 has obvious benefits and in this course we used the draft quality standard developed by David Browning. The concepts are introduced by in a simpler form both in content and language.
The development of formal intra-laboratory audits is strongly suggested with a team consisting of CSQL and peer scientific and medical staff much like the RCPA/NATA Medical Testing model used in Australia. This allows an ongoing exchange of best practice and co-operative improvement to occur without government interference.
On behalf of Peter and myself, I would like to thank you for this unique opportunity.
VIETNAM TRAINING PROGRAM
DAY / TIME / CONTENT1 – IQC/Biosafety / 1 / Introduction to ISO/QA/QC – TB talk 1
Introduce Trainers
- where from, size of lab, discipline
2 / IQC – Exercise – given data draw L-J chart
IQC Biorad book
QC Exercise – problems – bias/precision specific examples – develop flowchart
3 / Pre-analytical Errors
-patient
-specimen
4 / Laboratory Safety
Roles and Responsibilities
2 – External QAP
Method SOPs / 1 / External QAP
2 / Using Internal and External QA to troubleshoot
3 / Method SOPs –
Draft – Potassium
Haemoglobin
Glucose
Ast
4 / Results of Survey of HCMc labs – actions from group
3 – Auditing / 1 / Responsibilities of Management
Management Meetings
Complaints
2 / Reports
ReferenceRanges
Accommodation
3 / Auditing
SOP checklist?
4 / Common Problems with Audits
Experience of adopting standards – Dr Potie
4 – Standards/actions / 1 / Standards – what will trainers do in their labs
The results of a survey of labs in HCMc
2 / Training Program for trainers to use
Based on this Course
3 / Auditing your lab – dry session
What to do when
Audits on other labs
Role of Department
4 / Feedback
Table 2: List of Attendees
October 09,2007 – October 12, 2007
No / Name / Office / Oct 09 / Oct 10 / Oct 11 / Oct 12M / A / M / A / M / A / M / A
1 / Ass.Prof., PhD. Võ Thị Chi Mai / MedicalUniversity
2 / Ass.Prof., PhD. Phạm Thị Mai / MedicalUniversity
3 / PhD. Phạm Hùng Vân / MedicalUniversity
4 / PhD. Hà Anh / MedicalUniversity
5 / PhD. Nguyễn Thị Hoàng Lan / PreventiveHealthCenter
6 / MD. Nguyễn Văn Vĩnh Châu / TropicalDiseasesHospital
7 / Dr. Trần Phủ Mạnh Siêu / TropicalDiseasesHospital
8 / Dr. Phạm Thị Huỳnh Giao / TrungVuongHospital
9 / Pharm. Phan Thị Thu Hồng / BinhDanHospital
10 / Dr. Nguyễn Thị Hoàng Phương / Tu Du Hospital
11 / Dr. Lê Quốc Thịnh / Pediatric I Hospital
12 / Dr. Nguyễn Thị Hoàng Ninh / NguyenTriPhuongHospital
13 / Pharm. Tô Văn Phú / HungVuongHospital
14 / Dr. Trần Thoại Uyên / CSQL
15 / Ba. Bùi Thúy Nga / CSQL
October 15, 2007 – October 18, 2007
No. / Name / Office / Oct 15 / Oct 16 / Oct 17 / Oct 18M / A / M / A / M / A / M / A
1 / PhD. Vũ Quang Huy / MedicalUniversity
2 / MD Cao Mỹ Hà / Traditional Medicine Institue
3 / Dr. Nguyễn Thị Thanh Thúy / LabGroupDiagCenter
4 / Dr. Lữ Phúc Phi / Thu ĐucGeneralHospital
5 / Dr. Phạm Văn Hưng / PreventiveHealthCenter
6 / Dr. Nguyễn Thị Hảo / GiaĐinhHospital
7 / Ba. Nguyễn Thị Phương / OrthopedicsHospital
8 / Pharm. Trần Hữu Tâm / CSQL
9 / Dr. Trương Thần / CSQL
10 / Dr. Trần Thị Mỹ Hạnh / CSQL
11 / Dr. Nguyễn Hoàng Vỹ / CSQL
12 / Ba. Lê Thị Bạch Tuyết / CSQL
13 / Ba. Lê Trung Phương / CSQL
14
15