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(NAR) VOL. 15 NOS. 3-4 / OCTOBER - DECEMBER 2004

[ BAI ADMINISTRATIVE ORDER NO. 27, October 06, 2004 ]

ACCREDITATION OF GOVERNMENT AND NON-GOVERNMENT VETERINARY DIAGNOSTIC LABORATORIES



WHEREAS, pursuant to Title IV, Chapter I, Section 3 of the Administrative Code of 1987, the Department of Agriculture is responsible for the planning, formulation and execution, regulation and monitoring of programs and activities relating to agriculture, food production and supply;

WHEREAS, the Department of Agriculture, through the Bureau of Animal Industry is implementing various Animal Disease Control Programs to decrease mortalities brought about by diseases, for the benefit of the livestock industry;

WHEREAS, animal disease diagnosis is a critical component of disease surveillance system and provides an indispensable support to the total animal health programs of both government and non-government enterprises;

WHEREAS, there is a need to standardize and harmonize numerous diagnostic protocols;

WHEREAS, cognizant of the goal of delivering accepted standards of quality, performance, technical expertise and competence of a Veterinary Disease Diagnostic laboratory and addressing the desire for quality assurance, it is imperative that only duly accredited veterinary diagnostic laboratories are allowed to render veterinary diagnostic services;

N OW, THEREFORE, I, ARTHUR C. YAP, Secretary of Department of Agriculture, do hereby order the accreditation of veterinary establishments engaged in offering diagnostic services to the livestock industry.  For this purpose, the following measures and directives are hereby issued:

SECTION I. Coverage - This order shall cover government and non-government establishments offering diagnostic services.

SECTION II. Legal Requirements -

A.  Applicant must be a registered business entity with SEC/DTI/ECC/Mayor's Permit.  The building that will house the laboratory must have a prior Standards Compliance Certificate as per DA-Administrative Order No. 6, s2004, Sections 1 and 3.

B.  Animal Disease Diagnostic laboratories under the Department of Agriculture, or laboratories of Government Universities and Colleges, must be part of the organizational structure of the Department/or their respective agencies.  The organizational structure, plantilla of personnel must be attached.  The application must also include a Standards Compliance Certificate, as provided for by Section II-A.

C.  For Animal Disease Diagnostic Laboratories of private universities/colleges, private organizations, or individuals, Section II-A applies.

SECTION III. Minimum Technical Requirements -

A. Private Laboratories/Government and Non-government Universities

1. Accreditation is applied for the whole laboratory and for specified tests.

2. Other data to be included in the application:

a. Laboratory design/floor plan
b. Personnel complement (number, qualifications, PRC License numbers) must be included.
c. Procedures (laboratory protocols)
d. List of equipment
e. Provision for disposal of infectious materials
f. Laboratory services and service charge

B. Department of Agriculture laboratories

1. Existing DA-Regional Animal Diagnostic Laboratories will be re-classified depending on

a. Performance for the last 3 years
b. Reports/records
c. Plantilla/organizational structure
d.Technical personnel compliment
e. Qualifications of personnel

2. Laboratories will be re-classified as

a. Sub-national laboratories
b. Regional laboratories
c. Provincial/satellite laboratories

3. Minimum Capabilities are as follows:

Sub-national laboratories:

a. Post-mortem examination: Necropsy/Histopathology
b. Bacterial/Fungal Isolation
c. Antimicrobial Sensitivity Test
d. Agglutination tests for bacteria
e. Parasitologic Examinations
f. Agar Gel Precipitation Test
g. Hemagglutination/Hemagglutination-Inhibition Test
h. Immunofluorescence Assay
i. Enzyme-linked immunosorbent Assay
j. Viral Isolation using Embryonated Eggs or Tissue Cultures

Regional laboratories

a. Post-mortem examination: Necropsy/Histopathology
b. Bacterial/Fungal Isolation
c. Antimicrobial Sensitivity Test
d. Agglutination tests for bacteria
e. Parasitologic Examinations
f. Agar Gel Precipitation Test
g. Hemagglutination/Hemagglutination-Inhibition Test
h. Enzyme-linked immunosorbent Assay
i. Viral Isolation using Embryonated Eggs or Tissue Cultures

Provincial/Satellite laboratories

a. Post-mortem examination: Necropsy/Histopathology
b. Bacterial/Fungal Isolation
c. Antimicrobial Sensitivity Test
d. Agglutination tests for bacteria
e. Parasitologic Examinations
f. Agar Gel Precipitation Test

C. Minimum Equipment Requirement-Equipment requirement depends on the accreditation being applied for.  For DA-regional and satellite laboratories, the current listings at the Bureau of Animal Industry as per BAI Circular No. 3, series of 1990 apply.

D. Minimum Personnel Complement

1. Veterinarian: 1
2. Laboratory Technicians: 2
3. Laboratory Aid: 1
4. Utility Worker/Janitor : 1

E. Laboratory Animal Facilities - Animal housing/environment should conform to the minimum standards set by the Animal Welfare Act. Applicants must secure a Certificate of Registration from the Animal Welfare Division, BAI (RA 8485 of 1998, Section 2).

SECTION IV. Validity - Accreditation is valid for 3 years. Spot inspection may be done by BAI anytime within the period. Accreditation may be suspended/withheld/cancelled for failure to comply with the provisions of this Order.

SECTION V. Fees - 
  
A. Application Fee PhP 100.00
B. Accreditation Fee PhP 2,500.00

C. Renewal Fee

PhP1,500.00

SECTION VI. Implementation
- The Philippine Animal Health Center of the Bureau of Animal Industry is tasked to over-see the implementation of this Order.

SECTION VII. Procedures for Accreditation -

A. Submit letter of intent to the Bureau of Animal Industry.
B. Attach data required as per Section II-A and B, Section III-A-2a to f, and Section III-C, D and E above.
C. For existing Government/DA Laboratories, University/College Laboratories, attach data as required by Section III-B, C, D, and E, above.  For new laboratories, additional requirements include data as provided for by Section IIIA-2a to f.
D. Ocular inspection/evaluation by representatives from the Bureau of Animal Industry.
E. Payment of corresponding fee/s.

Adopted: 6 Oct. 2004


(SGD.) ARTHUR C. YAP
Secretary
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