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Standard Operating Procedures for QGPs
&
Quality Clinic Setting
1. “Detailed, written instructions to achieve uniformity of the performance of
a specific function” by International Conference of Harmonization (Ref: ICH
Guidance E6)
2. Every good quality system is based on its standard operating procedures
(SOPs)
Standard Operating Procedures (SOP)
Quality Clinic Setting
1. Keep the MMA Malaria quality signboard in easily visible place for the public
awareness
2. Display the diagnosis flow sheet in consultation room
3. Malaria health education pamphlets should be in pamphlet holders and
display in visible place for patient and their attendants
4. Keep sufficient stock of RDT, ACT, CQ, Primaquine and Inj Artesunate - stored
in cool and dry place . Store RDT SD at place where temperature less than
40 C
5. Other supplies from the project- weighing machines, lancing devices,
lancets, timer, gloves and etc… are in use
6. Malaria Manual booklet and SOP for QGPs should be kept standby for
reference
7. Certificates (Recruitment and Refresher training) should be displayed clearly
8. Used RDT strip, lancet and swab must be disposed in safe container and
properly trashed
9. Keep clinic clean and tidy
Quality Clinic Setting (Cont’d)
I. Recording Patient’s Particulars
 Ask and record the followings;
– Name
– Age
– sex
– Address/location
**Patient Record Register. It is very important for quality data collection.
II. Taking Proper History-1
Ask the patient whether he /she has the following common symptoms for
differential diagnosis including;
 Fever - duration
- specify which pattern (regular, irregular, intermittent, remittent)
- chills – feeling cold associated or not
 Shivering
 Sweating
 Headache – nature? severity?
Taking Proper History-2
• Muscle and joint pain
• Body weakness, to what extent
• Vomiting- how many times? How severe?
• Travelling history to malaria endemic areas last six week
• Past history of malaria
• Previous antimalaria treatment
• LMP for female patient
III. Thorough Physical Examination
A. General Examination
• Check whether the patient is well-conscious or not
• Measure temperature, blood pressure
• Check Anaemia & Jaundice by looking at conjunctiva, tongue and nails
B. Abdominal Examination
• Palpate Liver and Spleen
III. Thorough Physical Examination
IV. Exclude Others (Differential Diagnosis)
1. Meningitis (Severe headache, Neck stiffness)
2. Acute Respiratory tract Infection (Cough, Dyspnoea)
3. Typhoid (Coated tongue, pale stool, relative bradycardia)
4. UTI (Burning and frequent micturation)
5. Puerperial pyrexia (Breast congestion, bad smell of lochia)
6. Septicemia (Septic wound, ear discharge/infection)
7. Cholecystitis (Murphy’s sign, pain in right upper abdomen related to fatty
meal)
V. Testing with RDT (Combo) Test Kit
• Check with Rapid Diagnosis Test – SD (Combo)
• Follow step by step according to instruction
• Wait 15 minutes (up to 30 min) after adding buffer
If only the patient is suspected for malaria
VI. Differentiate with Severe &
Uncomplicated Malaria
By History Taking
• History of severe vomiting
• Presence of generalized convulsion
• Presence of high fever
• Presence of oliguria
• Presence of haemoglobinuria
Physical Examination
• Conscious level
• Measure blood pressure, check pulse rate (shock)
• Check for jaundice by looking sclera, conjunctiva and bed of the tongue
• Look for the presence of any infected skin lesions and wound (Septicemia)
 Non-per-os / unable to move without help
VI. Differentiate with Severe &
Uncomplicated Malaria
If the patient has any of above-mentioned clinical
features…Refer the patient to hospital or higher
health centre immediately
VII. Referral
• All QGPs are recommended to refer
1. All treatment failure cases
2. Severe malaria
• Pre-referral treatment (Inj Artesunate) should be given before referral
• Refer the patient together with treatment note.(Referral Form)
X. Health Education (Preventive measure)
While waiting for the test result, educate the patient on malaria prevention,
protection, benefits of EDET by using malaria pamphlet
• Malaria is transmitted only by mosquito bites at night
• Reduction of risk of getting malaria by sleeping inside a mosquito net or
treated net with insecticide tablet, LLIN
 Regarding the diagnosis and treatment, tell the patient as below;
1. If you have fever, it could be malaria. Go immediately to the nearest
‘Standard Malaria clinic’ or health care centre within 24 hours after the
onset of fever.
2. If you have malaria, it is curable.
3. It might be fatal if it is not treated properly
4. It is important to complete the course for radical cure
5. To come back immediately for check up if the illness worsens or if not
cured in 3 days
X. Health Education (Preventive Measure)
Personal protection and early diagnosis and standard
treatment of malaria are recommended utmost.
XI. Recording and Reporting
Myanmar Medical Association
"Quality Diagnosis and Standard Treatment of Malaria(QDSTM)" Project
Data Collection Form
Township:__________________
__
QGPs:_______________________ Month/Year: ___________________
No. Date Name Age
Sex
(M/F)
Address
(Village/Ward)
Age Group (Yr) RDT result Prescription
Refer to
Hospital
Treatmen
t seeking
hours
Remark
1-4
5-9
10-14
≥15
Pf(+)ve
Pv(+)ve
(-)
ve
Invalid
For Pf & mixed inf: For Pv
#
of
Primaquine
tab
#
of
Inj:
Artesunate
<24hr
>24hr
Weight Group (kg) ACT ( No. of strips )
#
of
CQ
tab
5-14
15-24
25-34
≥35
6's 12's 18's 24's
1 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â Â
2 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â
Pregnancy-
Refer
3 .15.3.2013 U Kyaw Zay Ya 60yr M Hle Tan W
Â
10 28 Â
4 17.3.2013 Ko Oakar Soe 30yr M Tar Kay Ta
Â
5 23.3.2013 Khine Thet Su 13yr F Ahlone A Â 1 4
6 3.4.2013
Khine Thazin
Mg
7yr F Dagon A Â Â 1 14 Â
7 5.4.2013
Baby Zar Zar
Naing
5
mth
F Tar Kay Ta A
Â
Refer
8 7.4.2013 Bo Bo 27 yr M Ahlone A
Â
2 amp
Severe &
Refer
Note: Tick(Â)in the column of treatment seeking and RDT result. Please write "A" if you prescribe by age or "W" if by weight.
Please write down the number of strips, tablets and ampoules in the prescription columns. Injection Artesunate is only for pre-referral treatment.
19
Myanmar Medical Association
"Quality Diagnosis and Standard Treatment of Malaria(QDSTM)" Project
Data Collection Form
Township:__________________
__
QGPs:_______________________ Month/Year: ___________________
No. Date Name Age
Sex
(M/F)
Address
(Village/Ward)
Age Group (Yr) RDT result Prescription
Refer to
Hospital
Treatmen
t seeking
hours
Remark
1-4
5-9
10-14
≥15
Pf(+)ve
Pv(+)ve
(-)
ve
Invalid
For Pf & mixed inf: For Pv
#
of
Primaquine
tab
#
of
Inj:
Artesunate
<24hr
>24hr
Weight Group (kg) ACT ( No. of strips )
#
of
CQ
tab
5-14
15-24
25-34
≥35
6's 12's 18's 24's
1 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar   Â
2 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â
Pregnancy-
Refer
3 .15.3.2013 U Kyaw Zay Ya 60yr M Hle Tan W Â Â Â Â
4 17.3.2013 Ko Oakar Soe 30yr M Tar Kay Ta A
Â
5 23.3.2013 Khine Thet Su 13yr F Ahlone A Â Â 6
6 3.4.2013
Khine Thazin
Mg
7yr F Dagon A
Â
4 14 Â
7 5.4.2013
Baby Zar Zar
Naing
5
mth
F Tar Kay Ta A Â Refer
8 7.4.2013 Bo Bo 27 yr M Ahlone A
Â
2 amp
Severe &
Refer
Note: Tick(Â)in the column of treatment seeking and RDT result. Please write "A" if you prescribe by age or "W" if by weight.
Please write down the number of strips, tablets and ampoules in the prescription columns. Injection Artesunate is only for pre-referral treatment.
20
Myanmar Medical Association
"Quality Diagnosis and Standard Treatment of Malaria(QDSTM)" Project
Data Collection Form
Township:__________________
__
QGPs:_______________________ Month/Year: ___________________
No. Date Name Age
Sex
(M/F)
Address
(Village/Ward)
Age Group (Yr) RDT result Prescription
Refer to
Hospital
Treatmen
t seeking
hours
Remark
1-4
5-9
10-14
≥15
Pf(+)ve
Pv(+)ve
(-)
ve
Invalid
For Pf & mixed inf: For Pv
#
of
Primaquine
tab
#
of
Inj:
Artesunate
<24hr
>24hr
Weight Group (kg) ACT ( No. of strips )
#
of
CQ
tab
5-14
15-24
25-34
≥35
6's 12's 18's 24's
1 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â Â
2 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â
Pregnancy-
Refer
3 .15.3.2013 U Kyaw Zay Ya 60yr M Hle Tan W
Â
10 28 Â
4 17.3.2013 Ko Oakar Soe 30yr M Tar Kay Ta A
Â
5 23.3.2013 Khine Thet Su 13yr F Ahlone A Â 1 4
6 24.3.2013
Khine Thazin
Mg
7yr F Dagon A
Â
4 14 Â
7 25.3.2013
Baby Zar Zar
Naing
5
mth
F Tar Kay Ta A Â Refer
8 27.3.2013 Bo Bo 27 yr M Ahlone A
Â
2 amp
Severe &
Refer
Note: Tick(Â)in the column of treatment seeking and RDT result. Please write "A" if you prescribe by age or "W" if by weight.
Please write down the number of strips, tablets and ampoules in the prescription columns. Injection Artesunate is only for pre-referral treatment.
21
Summary
 Participating with MMA QDSTM project will not only improve accessibility of
local population (future patients) to quality diagnosis and treatment services
with FOC but also improve quality of the local GPs
 Participation of GPs is essential to improve accessibility of EDET in respective
project areas and success of the project
 Lastly but not least MMA malaria would like to request all participating GPs
for regular recording, reporting, coordinating, cooperating and strictly
following SOP of the project.
Selection Criteria of QGP
• M.B.,B.S with valid Sama
• Valid Clinic Registration (submitted)
• MMA life member
• Prefer private GP
• Clinic setting – neat and tidy
• Willing to participate in the project for the benefit of the community
• Must follow the SOP of the project
• Accept M&E by the project, MMA member, TWG member, WHO and donor
agencies
Selection Criteria of TC
• Must be a private GP (preferably local)
• Should have leadership role
• Should allocate some time for the project
activities
Benefits of a TC
• Project will provide travel cost (not more than
50 US$ per month)
• Priority will be given to attend the meetings
and trainings at head quarter
• A cabinet will be provided for proper storage
of project supplies.
Duties and Responsibilities of a Township
Coordinator (TC)
1. Organize GPs and others for implementing project activities (to follow SOP)
2. Organize/Participate/attend meetings/trainings
3. Report operational /technical issues/problems
4. Keep buffer stock to distribute to other QGPs according to their consumption
5. Visit 2-3 clinics in a week to supervise/inform/discuss and tackle issues/problems
6. To communicate with local health/authority for facilitating project activities
7. Support QAO/ TO/ PM/ TWG / donor agencies
(At least 5 QGPs in a region = 1 TC )
Thank You

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10. SOP of QGPs.pptx

  • 1. Standard Operating Procedures for QGPs & Quality Clinic Setting
  • 2. 1. “Detailed, written instructions to achieve uniformity of the performance of a specific function” by International Conference of Harmonization (Ref: ICH Guidance E6) 2. Every good quality system is based on its standard operating procedures (SOPs) Standard Operating Procedures (SOP)
  • 3. Quality Clinic Setting 1. Keep the MMA Malaria quality signboard in easily visible place for the public awareness 2. Display the diagnosis flow sheet in consultation room 3. Malaria health education pamphlets should be in pamphlet holders and display in visible place for patient and their attendants 4. Keep sufficient stock of RDT, ACT, CQ, Primaquine and Inj Artesunate - stored in cool and dry place . Store RDT SD at place where temperature less than 40 C 5. Other supplies from the project- weighing machines, lancing devices, lancets, timer, gloves and etc… are in use
  • 4. 6. Malaria Manual booklet and SOP for QGPs should be kept standby for reference 7. Certificates (Recruitment and Refresher training) should be displayed clearly 8. Used RDT strip, lancet and swab must be disposed in safe container and properly trashed 9. Keep clinic clean and tidy Quality Clinic Setting (Cont’d)
  • 5. I. Recording Patient’s Particulars  Ask and record the followings; – Name – Age – sex – Address/location **Patient Record Register. It is very important for quality data collection.
  • 6. II. Taking Proper History-1 Ask the patient whether he /she has the following common symptoms for differential diagnosis including;  Fever - duration - specify which pattern (regular, irregular, intermittent, remittent) - chills – feeling cold associated or not  Shivering  Sweating  Headache – nature? severity?
  • 7. Taking Proper History-2 • Muscle and joint pain • Body weakness, to what extent • Vomiting- how many times? How severe? • Travelling history to malaria endemic areas last six week • Past history of malaria • Previous antimalaria treatment • LMP for female patient
  • 8. III. Thorough Physical Examination A. General Examination • Check whether the patient is well-conscious or not • Measure temperature, blood pressure • Check Anaemia & Jaundice by looking at conjunctiva, tongue and nails B. Abdominal Examination • Palpate Liver and Spleen III. Thorough Physical Examination
  • 9. IV. Exclude Others (Differential Diagnosis) 1. Meningitis (Severe headache, Neck stiffness) 2. Acute Respiratory tract Infection (Cough, Dyspnoea) 3. Typhoid (Coated tongue, pale stool, relative bradycardia) 4. UTI (Burning and frequent micturation) 5. Puerperial pyrexia (Breast congestion, bad smell of lochia) 6. Septicemia (Septic wound, ear discharge/infection) 7. Cholecystitis (Murphy’s sign, pain in right upper abdomen related to fatty meal)
  • 10. V. Testing with RDT (Combo) Test Kit • Check with Rapid Diagnosis Test – SD (Combo) • Follow step by step according to instruction • Wait 15 minutes (up to 30 min) after adding buffer If only the patient is suspected for malaria
  • 11. VI. Differentiate with Severe & Uncomplicated Malaria By History Taking • History of severe vomiting • Presence of generalized convulsion • Presence of high fever • Presence of oliguria • Presence of haemoglobinuria
  • 12. Physical Examination • Conscious level • Measure blood pressure, check pulse rate (shock) • Check for jaundice by looking sclera, conjunctiva and bed of the tongue • Look for the presence of any infected skin lesions and wound (Septicemia)  Non-per-os / unable to move without help VI. Differentiate with Severe & Uncomplicated Malaria
  • 13. If the patient has any of above-mentioned clinical features…Refer the patient to hospital or higher health centre immediately
  • 14. VII. Referral • All QGPs are recommended to refer 1. All treatment failure cases 2. Severe malaria • Pre-referral treatment (Inj Artesunate) should be given before referral • Refer the patient together with treatment note.(Referral Form)
  • 15. X. Health Education (Preventive measure) While waiting for the test result, educate the patient on malaria prevention, protection, benefits of EDET by using malaria pamphlet • Malaria is transmitted only by mosquito bites at night • Reduction of risk of getting malaria by sleeping inside a mosquito net or treated net with insecticide tablet, LLIN
  • 16.  Regarding the diagnosis and treatment, tell the patient as below; 1. If you have fever, it could be malaria. Go immediately to the nearest ‘Standard Malaria clinic’ or health care centre within 24 hours after the onset of fever. 2. If you have malaria, it is curable. 3. It might be fatal if it is not treated properly 4. It is important to complete the course for radical cure 5. To come back immediately for check up if the illness worsens or if not cured in 3 days X. Health Education (Preventive Measure)
  • 17. Personal protection and early diagnosis and standard treatment of malaria are recommended utmost.
  • 18. XI. Recording and Reporting
  • 19. Myanmar Medical Association "Quality Diagnosis and Standard Treatment of Malaria(QDSTM)" Project Data Collection Form Township:__________________ __ QGPs:_______________________ Month/Year: ___________________ No. Date Name Age Sex (M/F) Address (Village/Ward) Age Group (Yr) RDT result Prescription Refer to Hospital Treatmen t seeking hours Remark 1-4 5-9 10-14 ≥15 Pf(+)ve Pv(+)ve (-) ve Invalid For Pf & mixed inf: For Pv # of Primaquine tab # of Inj: Artesunate <24hr >24hr Weight Group (kg) ACT ( No. of strips ) # of CQ tab 5-14 15-24 25-34 ≥35 6's 12's 18's 24's 1 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A   2 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A  Pregnancy- Refer 3 .15.3.2013 U Kyaw Zay Ya 60yr M Hle Tan W  10 28  4 17.3.2013 Ko Oakar Soe 30yr M Tar Kay Ta  5 23.3.2013 Khine Thet Su 13yr F Ahlone A  1 4 6 3.4.2013 Khine Thazin Mg 7yr F Dagon A   1 14  7 5.4.2013 Baby Zar Zar Naing 5 mth F Tar Kay Ta A  Refer 8 7.4.2013 Bo Bo 27 yr M Ahlone A  2 amp Severe & Refer Note: Tick(Â)in the column of treatment seeking and RDT result. Please write "A" if you prescribe by age or "W" if by weight. Please write down the number of strips, tablets and ampoules in the prescription columns. Injection Artesunate is only for pre-referral treatment. 19
  • 20. Myanmar Medical Association "Quality Diagnosis and Standard Treatment of Malaria(QDSTM)" Project Data Collection Form Township:__________________ __ QGPs:_______________________ Month/Year: ___________________ No. Date Name Age Sex (M/F) Address (Village/Ward) Age Group (Yr) RDT result Prescription Refer to Hospital Treatmen t seeking hours Remark 1-4 5-9 10-14 ≥15 Pf(+)ve Pv(+)ve (-) ve Invalid For Pf & mixed inf: For Pv # of Primaquine tab # of Inj: Artesunate <24hr >24hr Weight Group (kg) ACT ( No. of strips ) # of CQ tab 5-14 15-24 25-34 ≥35 6's 12's 18's 24's 1 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar    2 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A  Pregnancy- Refer 3 .15.3.2013 U Kyaw Zay Ya 60yr M Hle Tan W     4 17.3.2013 Ko Oakar Soe 30yr M Tar Kay Ta A  5 23.3.2013 Khine Thet Su 13yr F Ahlone A   6 6 3.4.2013 Khine Thazin Mg 7yr F Dagon A  4 14  7 5.4.2013 Baby Zar Zar Naing 5 mth F Tar Kay Ta A  Refer 8 7.4.2013 Bo Bo 27 yr M Ahlone A  2 amp Severe & Refer Note: Tick(Â)in the column of treatment seeking and RDT result. Please write "A" if you prescribe by age or "W" if by weight. Please write down the number of strips, tablets and ampoules in the prescription columns. Injection Artesunate is only for pre-referral treatment. 20
  • 21. Myanmar Medical Association "Quality Diagnosis and Standard Treatment of Malaria(QDSTM)" Project Data Collection Form Township:__________________ __ QGPs:_______________________ Month/Year: ___________________ No. Date Name Age Sex (M/F) Address (Village/Ward) Age Group (Yr) RDT result Prescription Refer to Hospital Treatmen t seeking hours Remark 1-4 5-9 10-14 ≥15 Pf(+)ve Pv(+)ve (-) ve Invalid For Pf & mixed inf: For Pv # of Primaquine tab # of Inj: Artesunate <24hr >24hr Weight Group (kg) ACT ( No. of strips ) # of CQ tab 5-14 15-24 25-34 ≥35 6's 12's 18's 24's 1 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â Â 2 12.3.2013 Daw Me Me 40yr F Hlaing Thar Yar A Â Pregnancy- Refer 3 .15.3.2013 U Kyaw Zay Ya 60yr M Hle Tan W Â 10 28 Â 4 17.3.2013 Ko Oakar Soe 30yr M Tar Kay Ta A Â 5 23.3.2013 Khine Thet Su 13yr F Ahlone A Â 1 4 6 24.3.2013 Khine Thazin Mg 7yr F Dagon A Â 4 14 Â 7 25.3.2013 Baby Zar Zar Naing 5 mth F Tar Kay Ta A Â Refer 8 27.3.2013 Bo Bo 27 yr M Ahlone A Â 2 amp Severe & Refer Note: Tick(Â)in the column of treatment seeking and RDT result. Please write "A" if you prescribe by age or "W" if by weight. Please write down the number of strips, tablets and ampoules in the prescription columns. Injection Artesunate is only for pre-referral treatment. 21
  • 22. Summary  Participating with MMA QDSTM project will not only improve accessibility of local population (future patients) to quality diagnosis and treatment services with FOC but also improve quality of the local GPs  Participation of GPs is essential to improve accessibility of EDET in respective project areas and success of the project  Lastly but not least MMA malaria would like to request all participating GPs for regular recording, reporting, coordinating, cooperating and strictly following SOP of the project.
  • 23. Selection Criteria of QGP • M.B.,B.S with valid Sama • Valid Clinic Registration (submitted) • MMA life member • Prefer private GP • Clinic setting – neat and tidy • Willing to participate in the project for the benefit of the community • Must follow the SOP of the project • Accept M&E by the project, MMA member, TWG member, WHO and donor agencies
  • 24. Selection Criteria of TC • Must be a private GP (preferably local) • Should have leadership role • Should allocate some time for the project activities
  • 25. Benefits of a TC • Project will provide travel cost (not more than 50 US$ per month) • Priority will be given to attend the meetings and trainings at head quarter • A cabinet will be provided for proper storage of project supplies.
  • 26. Duties and Responsibilities of a Township Coordinator (TC) 1. Organize GPs and others for implementing project activities (to follow SOP) 2. Organize/Participate/attend meetings/trainings 3. Report operational /technical issues/problems 4. Keep buffer stock to distribute to other QGPs according to their consumption 5. Visit 2-3 clinics in a week to supervise/inform/discuss and tackle issues/problems 6. To communicate with local health/authority for facilitating project activities 7. Support QAO/ TO/ PM/ TWG / donor agencies (At least 5 QGPs in a region = 1 TC )