(NAR) VOL. 21 NO.2 APRIL - JUNE 2010
a. Preliminary assessment shall require submission to the panel of the following documents:1. Application form embodying the letter of intent addressed to the BFAR Director;b. On-site evaluation of the laboratory shall be conducted based on the documents submitted and its compliance to the protocols.
2. Analysis reports for the preceding three (3) months for independent analysis by the Central Laboratory; and
3. Certified true copy of applicant laboratory’s Manuals.
a. Level 1 – Capable of microscopic analysis of PSP causative organismsRequirement: Ability to identify and quantify the following organisms:Level II – Full level accreditation is for the capability to analyze PSP. TTX and CFP but shall be further categorized depending on present capacity of the laboratory
Paralytic Shellfish PosionPyrodinium bahamense variety compressumDiarrhetic Shellfish Posion
Alexandrium tamiyavanichii
Alexandrium minutum
Gymnodinium catenatumDinophysis caudataAmnesic Shellfish Poison
Dinophysis fortii
Dinophysis miles
Dinophysis rotundata
Prorocentrum concavum
Prorocentrum limaPseudonitzchia spp.Ciguatera Fish Poison
Nitzschia spp.Gambierdiscus toxicusMicroalgae associated with Fish KillsChatonella marina
Cochlodinium polydrikoides
Gonyaulax polygramma
Gymnodinium sanguineum
Gyrodinium galatheanum
Heterosigma akashiwo
Noctiluca scintillans
Prorocentrum micans
Prorocentrum minimumLevel II-A - Capable of PSP and TTX analysis by mouse assayLevel III – Full level accreditation is for the capability to analyze DSP and ASP (domoic acid) but shall be further categorized depending on present capacity of the laboratory.Requirements:- Level I accreditation
- Test Kits readily in the laboratoryLevel III-A – Capable of ASP analysis commercially available assay methodsLevel IV – Capable of analyzing PSP, ASP, DSP, TTX, CFPRequirements:Level III-B – Capable of DSP analysis by mouse assay or commercially available assay methods- Levels I and II accreditation
- Availability of required test kit/materials if employing assay method other than bioassayRequirements:- Levels I and II accreditation
- Availability of required test kit/materials if employing assay method other than bioassayRequirements:- Levels I and II accreditationLaboratories may apply for accreditation upgrading upon meeting the requirements.
- Capable of ASP analysis by High Performance Liquid Chromatography
- Availability of required test kit/materials if employing assay method other than bioassay
a. The analysis result of an accredited biotoxin laboratory shall be recognized and accepted at the national level which shall be the basis for issuance of appropriate shellfish bulletins and advisories.
b. The personnel of accredited marine biotoxin testing laboratories shall have access to advanced training by BFAR.
c. Laboratories applying for accreditation shall be provided with the initial set of breeders, a supply of test mice and the saxitoxin standard needed for the required mouse calibration.
d. Laboratories applying for accreditation shall be provided with the basic reagents needed for their analysis.
e. An accredited marine biotoxin testing center in any given locality will increase the confidence of the local community with regards to its food safety.
a. To conform with established monitoring protocols. Conformance shall be checked through the following documents to be furnished by BFAR:1) Weekly analysis results if the area within the jurisdiction of the subject center has been placed under shellfish advisory.b. Calibration of mice within the specified time period.
2) Monthly analysis results if the area under the jurisdiction of the center is free from toxic red tide.
c. Shall be subject to periodic audit by accreditation panel.
a. First time accreditation shall have a validity of two (2) years only from date of issuance to the end of the second calendar year.
b. Extended validity of accreditation may be granted with consistent conformity to established protocols.
c. Upon expiry of accreditation, renewal shall follow the same procedure in Section 4 hereof.
d. Mouse calibration is waived for the first accreditation but shall be mandatory to be performed within the first year. Failure on this aspect shall automatically result to non-renewal of accreditation.
e. Accreditation shall be subject to revocation for non-compliance with the terms thereof.
f. Guidelines for monitoring processes and analytical methods shall be provided the accredited laboratories.
g. Periodic review of guidelines and analytical methods shall be regularly conducted by the Central Laboratory.