The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 1 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 1. Water,

Filtrated water, Portable water, Drinking water in sealed container, Ice

1.1. pH Standard Methods for the Examination of Water and Wastewater, APHA, AWWA, WEF. 22nd Edition, 2012. Part 4500-H+B

1.2. Hardness as calcium carbonate

Standard Methods for the Examination of Water and Wastewater, APHA, AWWA, WEF. 22nd Edition, 2012. Part 2340 C.

1.3. Total Solids

Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012.Part 2540 B.

1.4. Chloride

In-house method SOP 39-02-038 based on Standard Methods for the Examination of Water and Wastewater, APHA, AWWA, WEF. 22nd Edition, 2012. Part 4110 B

1.5. Fluoride 1.6. Chloride 1.7. Sulfate 1.8. Nitrate

In-house method SOP 39-02-347 based on Standard Methods for the Examination of Water and Wastewater, APHA, AWWA, WEF. 22nd Edition, 2012. Part 4110 B

1.9. Iron 1.10. Lead

Standard Methods for the Examination of Water and Wastewater, APHA, AWWA, WEF. 22nd Edition, 2012.Part 3030E and 3113 B.

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 2 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 1 Water,

Filtrated water, Portable water, Drinking water in sealed container, Ice

1.11. Total aerobic mesophilic microorganisms

1.12. Total bacteria count

Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012. Part 9215.

1.13. MPN Coliforms 1.14. Fecal Coliforms 1.15. Escherichia coli

Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012. Part 9221.

1.16 Staphylococcus aureus Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012. Part 9213 B.

1.17. Salmonella spp. Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012. Part 9260 B.

1.18 Salmonella spp. ISO 19250, 2010

1.19. Clostridium perfringens The Microbiology of Drinking Water Environment Agency, 2010. Part 6.

1.20 Vibrio cholera 1.21 Vibrio parahaemolyticus

ISO/TS 21872-1, 2007

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 3 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 2 Food 2.1. Benzoic acid

2.2. Sorbic acid In-house method SOP 39-02-342 based on Compendium of Methods for Food Analysis, Thailand, 1st edition, 2003

2.3. Propionic acid In-house method SOP 39-02-328 based on The Japan Analytical (Bunseki Kagaku). Vol 37(10),1988., P. 549-533

2.4. Lead 2.5. Cadmium 2.6. Arsenic

In-house method SOP 39-02-187 based on AOAC (2011) 999.10

2.7. Mercury In-house method SOP 39-02- 420 based on AOAC ( 2011) 974.14

2.8. Iron 2.9. Calcium 2.10. Sodium 2.11. Potassium

In-house method SOP 39-02-413 based on AOAC (2011), 999.11

2.12. Synthetic organic colors - Sunset yellow FCF - Tartrazine - Ponceau 4R - Brilliant blue FCF - Azorubine

In-house method SOP 39-02-419 based on Compendium of Methods for Food Analysis, Thailand, 1st Edition, 2003

2.13. Total nitrogen or protein

Kjeldahl Technique based on AOAC (2011) 991.20. Chapter 33. P. 10-12.

2.14.Sulfur dioxide

In -house method SOP 39-02-432 based on AOAC (2012) 990.28

2.15.Aflatoxin

In- house method SOP 39-02-453 based on AOAC (2012) 970.44,977.16 and 990.33

2.16.Rhodamine B

In -house method SOP 39-02-454 by HPLC Technique

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 4 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 2. Food (cont.) 2.17.Total aerobic mesophilic

microorganisms / Total bacteria count

FDA BAM Online, 2001 (Chapter 3)

2.18 Coliforms FDA BAM Online, 2013 (Chapter 4) 2.19 Fecal Coliforms

2.20 Escherichia coli

2.21 Yeast and Mold FDA BAM Online, 2001 (Chapter 18)

2.22 Staphylococcus aureus Compendium of Methods for the Microbiological Examination of Foods (APHA), 4th Edition, 2001.

2.23 Clostridium perfringens Compendium of Methods for the Microbiological Examination of Foods (APHA), 4th Edition, 2001.

2.24 Salmonella spp. ISO 6579, 2002. 2.25 Listeria monocytogenes ISO 11290-1:1996/Amd.1:2004 (E) 2.26 Vibrio cholerae ISO/TS 21872-1, 2007 2.27 Vibrio parahaemolyticus

2.28 Bacillus cereus FDA BAM Online, 2012 (Chapter14) 3. Beverages 3.1 Benzoic acid

3.2 Sorbic acid In-house method SOP 39-02 -342 based on Compendium of Methods for Food Analysis, Thailand, 1st edition, 2003

3.3 Sulfur dioxide

In -house method SOP 39-02-432 base on AOAC (2012) 990.28

3.4 Lead 3.5 Cadmium 3.6 Arsenic

In-house method SOP 39-02-187 based on AOAC (2012) 999.10

3.7 Mercury In-house method SOP 39-02- 420 based on AOAC ( 2012) 974.14

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 5 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 3. Beverages (cont.) 3.8 Iron

3.9 Calcium 3.10 Sodium 3.11 Potassium

In-house method SOP 39-02-413 based on AOAC (2012), 999.11

3.12 Synthetic organic colors - Sunset yellow FCF - Tartrazine - Ponceau 4R - Brilliant blue FCF - Azorubine

In-house method SOP 39-02-419 based on Compendium of Methods for Food Analysis, Thailand, 1st Edition, 2003

3.13 Caffeine In -house method SOP 39-02-436 based on Compendium of Methods for Food Analysis, Thailand, 1st Edition, 2003

3.14 Total aerobic mesophilic microorganisms / Total bacteria count

FDA BAM Online, 2001 (Chapter 3)

3.15 Coliforms 3.16 Escherichia coli

Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012. Part 9221.

3.17 Yeast and Mold FDA BAM Online, 2001 (Chapter 18)

3.18 Clostridium perfringens Compendium of Methods for the Microbiological Examination of Foods (APHA), 4th Edition, 2001

3.19 Salmonella spp. ISO 6579, 2002. 3.20 Listeria monocytogenes ISO 11290-1:1996/And.1:2004 (E) 3.21 Vibrio cholera

3.22 Vibrio parahaemolyticus

ISO/TS 21872-1, 2007

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 6 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 3. Beverages (cont.) 3.23 Bacillus cereus FDA BAM Online, 2012 (Chapter 14) 3.24 Staphylococcus aureus Compendium of Methods for the

Microbiological Examination of Foods (APHA), 4th Edition, 2001.

4. Milk and milk products

4.1. Fat In-house method SOP 39-02-219 based on AOAC (2012) 989.05

4.2. Total solids AOAC (2012) 990.19

4.3. Milk solids not fat AOAC (2012) 990.21

4.4 Coliforms 4.5 Escherichia coli

Standard Methods for the Examination of Water and Waste water, APHA, AWWA, WEF. 22nd Edition, 2012. Part 9221.

4.6 Total aerobic mesophilic microorganisms / Total bacteria count

FDA BAM Online, 2001

(Chapter 3)

4.7 Yeast and Mold FDA BAM Online, 2001 (Chapter 18)

4.8 Clostridium perfringens Compendium of Methods for the Microbiological Examination of Foods (APHA), 4th Edition, 2001.

4.9 Staphylococcus aureus Compendium of Methods for the Microbiological Examination of Foods (APHA), 4th Edition, 2001.

4.10 Salmonella spp. ISO 6579, 2002.

4.11 Listeria monocytogenes ISO 11290-1:1996/And.1:2004 (E)

4.12 Vibrio cholerae 4.13 Vibrio parahaemolyticus

ISO/TS 21872-1, 2007

4.14 Bacillus cereus FDA BAM Online,2012 (Chapter 14)

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 7 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 5. Urine 5.1 Ecstasy

- 3,4-Methylenedioxy methamphetamine(MDMA) - Methylenedioxy amphetamine (MDA) - Methylenedioxyethyl amphetamine (MDE)

TOXI – LAB, TLC system

5.2. Amphetamine 5.3. Methamphetamine

In-house Method SOP 39 02 273 by TLC technique

5.4. Morphine In house method SOP 39-02-395 by TLC technique

5.5. Cannabinoids TOXI – LAB, TLC system 6. - Biological

specimens - Seized materials

Pesticides; 6.1. Organochlorines 6.2. Organophosphates 6.3. Carbamates

In-house method SOP 39-02-108 by TLC technique

6.4. Paraquat In-house method SOP 39-02-141 by colorimetric spectrophotometry (dithionite test)

7. Unknown sample 7.1. Sulfuric acid

In house method SOP 39-02-392 based on Standard Solution and Reference Materials .Analysis of AOAC.18th Edition. 2005.

8. Serum 8.1. Cholinesterase In-house method SOP 39-02-163 based on spectrophotometry

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 8 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 9. Seized materials 9.1. Diphenhydramine

9.2. Dextromethorphan 9.3 Chlorpheniramine

In house method SOP 39-02-397 based on Clarke’s analysis of Drugs and Poisons.3rd Edition, Vol.1.

9.4 Diazepam 9.5 Alprazolam

In-house method SOP 39-02-372 based on United Nations, 2012. Clarke’s Analysis of Drugs and Poisons. 3rd Edition, Vol. 1.

10. - Narcotic drugs - Narcotic seized

materials

10.1. Amphetamine 10.2. Methamphetamine 10.3. Caffeine

In-house method SOP 39-02-340 based on United Nations, 2006. Clarke’s Analysis of Drugs and Poisons. 3rd Edition, Vol. 1.

10.4. Ephedrine 10.5. Pseudoephedrine

In-house method SOP 39-02-345 based on United Nations, 2006. Clarke’s Analysis of Drugs and Poisons. 3rd Edition, Vol. 1.

11 Cannabis seized materials

11.1 Tetrahydrocannabinol 11.2 Cannabinol 11.3 Cannabidiol

In-house method SOP 39-02-371 based on United Nations, 2009. Clarke’s Analysis of Drugs and Poisons. 3rd Edition, Vol. 1.

12 Mitragynine seized materials

12.1. Mitragynine In-house method SOP 39-02-001 by Thin Layer Chromatography

13 Traditional drugs 13.1 Dexamethasone 13.2 Prednisolone

In-house method SOP 39-02-296 by Thin Layer Chromatography and Spectrophotometry.

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 9 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 14. -Herbs

-Herbs drugs -Traditional

drugs

14.1. Total aerobic Microbial count 14.2. Total combined yeasts and moulds count 14.3. Bile-tolerant gram- negative bacteria 14.4. Escherichia coli 14.5. Staphylococcus aureus 14.6. Pseudomonas aeruginosa 14.7. Candida albicans 14.8. Salmonella spp. 14.9. Clostridium spp.

Thai Pharmacopoeia supplement 2010. Appendix 10, p. 11-31.

14.10. Lead In-house method SOP 39-02-354 based on WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues, 2007

14.11. Cadmium In-house method SOP 39-02-355 based on WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues, 2007

14.12. Arsenic In-house method SOP 39-02-356 based on WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues, 2007

15. Herbs

15.1. Curcuminoids In -house method SOP 39-02-410 by UV –Vis Spectrophotometry Technique

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 10 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 16. Cosmetics 16.1. Hydroquinone

16.2. Retinoic acid In-house method SOP 39-02-385 by High Performance Liquid Chromatography.

16.3. Ammoniated mercury In-house method SOP 39-02-384 based on The United State Pharmacopeia, 2006.

16.4. Lead 16.5. Arsenic 16.6. Cadmium

In -house method SOP 39-02-459 by AAS Technique

16.7. Mercury In -house method SOP 39-02-455 by AAS Technique

16.8. Total aerobic bacteria count

ISO 21149: 2006 (E)

16.9. Yeast and Mold ISO 16212: 2008 (E)

16.10. Staphylococcus aureus ISO 22718: 2006 (E)

16.11. Psuedomonas aeruginosa

ISO 22717: 2006 (E)

16.12. Clostridium spp. ISO 18416: 2007 (EO

16.13. Candida albicans USP 38 NF 33: 2015

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 11 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 17

General diagnostic X-ray machine

17.1 Reproducibility of Kilovolt peak

AAPM Report no 74, 2002

17.2 Accuracy of Kilovolt peak

17.3 Reproducibility of exposure time

17.4 Accuracy of exposure time

17.5 Reproducibility of radiation dose

17.6 Linearity of radiation dose

17.7 Radiation dose magnitude

17.8 Half Value Layer (HVL) FDA, 21 CFR Subchapter J, Part 1020, 2007

17.9 Light beam overlap

17.10 Radiation beam alignment

17.11 Light intensity

17.12 Radiation dose leakage

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 12 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 18

General diagnostic X-ray machine (Mobile/portable)

18.1 Reproducibility of Kilovolt peak

AAPM Report no.74, 2002

18.2 Accuracy of Kilovolt peak

18.3 Reproducibility of exposure time

18.4 Accuracy of exposure time

18.5 Reproducibility of radiation dose

18.6 Linearity of radiation dose

18.7 Radiation dose magnitude

18.8 Half Value Layer (HVL) FDA, 21 CFR Subchapter J, Part 1020, 2007 18.9 Light beam overlap

18.10 Radiation beam alignment

18.11 Light intensity

18.12 Radiation dose leakage

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 13 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 19

Intraoral dental X-ray machine

19.1 Reproducibility of Kilovolt peak

Department of Medical Sciences. Notice of Routine Control of Diagnostic X-ray Machine. B.E.2550

19.2 Accuracy of Kilovolt peak

19.3 Reproducibility of exposure time

19.4 Accuracy of exposure time

19.5 Reproducibility of radiation dose

19.6 Half Value Layer (HVL) FDA, 21 CFR Subchapter J, Part 1020, 2007

19.7 Focal spot to the end of beam limiting device distance

Department of Medical Sciences. Notice of Routine Control of Diagnostic X-ray Machine. B.E.2550

19.8 Beam limiting device diameter

19.9 Radiation dose leakage

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 14 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 20

Fluoroscopic X-ray machine (including C-Arm)

20.1 Reproducibility of Kilovolt peak

Department of Medical Sciences. Notice of Routine Control of Diagnostic X-ray Machine. B.E.2550

20.2 Accuracy of Kilovolt peak

20.3 Reproducibility of absorbed dose rate

20.4 Maximum absorbed dose rate of manual system

20.5 Maximum absorbed dose rate of automatic brightness control system (ABC)

20.6 Maximum absorbed dose rate of High level control system (HLC)

20.7 Half Value Layer (HVL) FDA, 21 CFR Subchapter J, Part 1020, 2007

20.8 Beam overlap of Spot film collimation

AAPM Report no.74, 2002

20.9 Beam overlap of Fluoroscopic collimation

20.10 High contrast resolution

Department of Medical Sciences. Notice of Routine Control of Diagnostic X-ray Machine. B.E.2550

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 15 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method Fluoroscopic X-

ray machine (including C-Arm)

20.11 Radiation dose leakage NCRP report No.99, 1998

(cont.) 20.12 Accumulative time limit

20.13 Fluoroscopic exposure switch

21 X-ray room 21.1 Scatter radiation NCRP Report 147, 2004

22 Mammographic X-ray machine

22.1 Reproducibility of Kilovolt peak

Department of Medical Sciences. Notice of Routine Control of Diagnostic X-ray Machine. B.E.2550 22.2 Accuracy of Kilovolt

peak 22.3 Reproducibility of

exposure time

22.4 Accuracy of exposure time

22.5 Reproducibility of radiation dose

22.6 Linearity of radiation dose

22.7 Half Value Layer (HVL) 22.8 Light intensity

22.9 High contrast resolution

European Guidelines, the 4th edition, 2003

22.10 Low contrast resolution

Gammex. A user’s guide, Mammographic Accreditation phantom, RMI 156

The Laboratory of Regional Medical Sciences Center 12/1 Trang, Department of Medical Sciences has been accepted as an accredited laboratory in the field of health products testing for the following scopes.

Bureau of Laboratory Quality Standards page 16 of 16 pages Accreditation Number 4020/49 Revision 00 Date of Accreditation : 23 July 2015 Revised date 23 July 2015 Date of Expiration: 22 July 2017

No. Type of Sample Test Method 23 Computed

tomography X-ray machine

23.1 CT number accuracy EPA, Radiation Guideline 6, Part 5, 2004

23.2 Scan localization light accuracy

AAPM report no.39, 1993

23.3 Distance measurement accuracy

NCRP no 99, 1988

23.4 Slice thickness accuracy

EPA, Radiation Guideline 6, Part 5, 2004

23.5 CT number linearity AAPM report no.74, 2002 23.6 Table increment

accuracy AAPM report no.39, 1993

23.7 High contrast resolution NCRP no.99, 1988 และ Catphan 500 and 600 manual, 2009

23.8 Low contrast resolution Catphan500 and 600 manual, 2009

23.9 CT number uniformity EPA, Radiation Guideline 6, Part 5, 2004

23.10 Noise

Catphan 500 and 600 manual, 2009