Specs_Scope_ISO17025 Accreditation_2023.pdf

STATE OF HAWAIʻI

DEPARTMENT OF HEALTH

KA ʻOIHANA OLAKINO

P. O. BOX 3378

HONOLULU, HI 96801-3378

August 31, 2023

The Department of Health, State Laboratories Division (SLD), Laboratory Preparedness and Response

Branch (LPRB) is soliciting for bids for the services of a nationally and internationally-recognized accrediting body for International Standard ISO/IEC17025:2017 “ General requirements for the competence of testing and calibration laboratories” that has undergone multiple, rigorous, peer evaluations and been found to meet or exceed the requirements as set forth in ISO/IEC 17011 since the inception of these requirements.

Surveillance Assessment (Renewal) utilizing the current standard: ISO/IEC 17025:2017 and the

National Animal Health Laboratory Network (NAHLN) Quality Standard Harmonization Checklist.

The accrediting body must meet the following at the time of solicitation:

• Demonstrate capability of assisting the State Laboratories Division (SLD), Laboratory

Preparedness and Response Branch (LPRB) in renewing and expanding accreditation in microbiology by providing experienced staff to assess the LPRB, provide materials with an explanation about the process, and a contact person to address LPRB’s questions, allowing LPRB quick and easy access to assistance and support when needed.

• Demonstrate capability to provide a full range of comprehensive laboratory and laboratory related accreditation services.

• Provide proof of recognition and/or membership with the Asia Pacific Laboratory

Accreditation Cooperation (APLAC), the International Laboratory Accreditation

Cooperation (ILAC), and the International Accreditation Forum (IAF) Multilateral

Recognition Arrangement (MLA).

• Shall have a minimum of five (5) years in accreditation business, and two to five (2-5) years of experience providing accreditation to Food Microbiology and veterinary testing laboratories.

• Describe the process by which the Contractor accredits laboratories (e.g., fields of study, test methods, technology, or other).

• Have tools and training mechanisms available to assist with the basic needs of achieving, implementing, and maintaining the ISO/17025:2017 accreditation.

• Provide information on how assessors are selected.

• Have accessors that meet the required minimum years of experience in their selected fields.

• Have assessors that meet minimum requirements for training, experience and certifications and attend training in auditing and the interpretation of the standard to which they are assessing.

• Have assessors that have demonstrated experience in auditing NAHLN member laboratories and understand the requirements and interpretation of the standards of the

JOSH GREEN, M.D.

GOVERNOR OF HAWAIʻI

KE KIAʻĀINA O KA MOKUʻĀINA ʻO HAWAIʻI

KENNETH S. FINK, MD, MGA, MPH

DIRECTOR OF HEALTH

KA LUNA HOʻOKELE

In reply, please refer to:

File:

American Association of Veterinary Laboratory Diagnosticians (AAVLD) and/or the OIE

Quality Standard and Guidelines for Veterinary Laboratories: Infectious Diseases.

• Have rigorous and regular oversight over the assessors, resulting in the highest quality of assessment for accredited facilities.

• Provide a list of resources (e.g., guidance documents on specific pieces of the standard

(interpretation), or other technical support in gaining and maintaining accreditation to the

LPRB.

• Disclose any program specific requirements that are in addition to the basic standard for the ISO 17025 accreditation process and provide updates as they occur.

• Provide a fee structure for continuing accreditation.

• Provide a fee structure for the addition of fields of study, test methods, or technology based on how the Contractor accredits laboratories.

• Provide a list of additional consultation services offered, if applicable, which will be an option for the LPRB to consider.

• Provide a copy of their measurement of uncertainty policy.

• Provide a copy of their proficiency sample policy.

• Provide inspection schedule.

Tasks

The Contractor shall:

• Provide technical support for the ISO 17025:2017 application, and accreditation process, Monday through Friday as requested by the LPRB, excluding federal and State holidays.

Support shall be offered via multi-forms of communications to include at a minimum, a telephone line with specified coverage times and e-mail.

• Provide a secure access point, available at all times, to allow LPRB to upload required documents during the accreditation process. Downtimes shall be communicated to the

LPRB by e-mail to the primary contact(s).

• Provide an easily accessible place to check on the status of LPRB’s assessment, and to upload additional information or respond to inquiries related to the accreditation.

• Conduct additional assessment using the NAHLN Quality Standard Harmonization Checklist.

The Contractor shall provide a Point of Contact who shall, at a minimum:

• Serve as a primary day-to-day contact with the LPRB.

• Ensure all necessary components are completed during the application/renewal process.

• Provide technical support for questions and issues related to the accreditation.

• Designate an alternate contact should the primary point of contact becomes unavailable.

• Provides guidance on inspection cycles and processes.

Requirements for the Contractor/Assessor:

Security and Safety Requirements:

• The SLD is a secure building. The Contractor shall ensure that all employees and subcontractors are aware of the need to abide by the SLD’s and LPRB’s security requirements.

• All Contractor employees and subcontractors shall be required to check in at the security desk and obtain a visitor badge.

• The assessor shall be escorted at all times in the building.

• The assessor shall abide by the LPRB's current Personal Protective Equipment Policy when entering LPRB areas.

• The assessor shall abide by any additional security or safety items as relevant to the inspection of the LPRB.

• The LPRB performs methods with confidential analyte lists requiring additional security measures. When a signed confidentiality statement that indicates that the contents of the

LPRB Procedure Manual are confidential and shall not be released to a third party is presented by the assessor, the assessor will be able to review the analyte list while on-site.

Deliverables:

The Contractor shall submit to the SLD-LPRB:

• The background on the inspectors assigned to the LPRB and on their inspection experience.

• An inspection date once a Surveillance Assessment schedule has been determined.

• Inspections within the required timeframes once the Surveillance Assessment is scheduled.

• Provide an updated plan and timelines for any consultation (optional), and additional inspections which both parties agree upon

Please submit your price quotation by 12pm (Hawaii Time), September 15, 2023 on HiePRO.

Award will be made to the lowest responsive, responsible offer. Bidders must be “Compliant” with the Hawaii Compliance Express (HCE) at 12:00pm (Hawaii time), on the date of award, September

15, 2023 and for final payment.

Price shall include all applicable taxes and fees. HiPro may charge transaction fees that the awarded bidder shall be responsible for paying, For information on the Certificate of vendor Compliance, please refer to the SPO website:

www.spo.hawaii.gov.

All vendors, bidders, and offerors are required to comply with all applicable statutes (e.g., AG-103D, General Conditions), administrative rules and procedures. AG-103-D, General Conditions must be met and shall not be modified by the vendor, bidder or offeror.

No modifications to any part of this solicitation by any party other than the State of Hawaii or its representatives are allowed. Any offer that contains any modifications to any aspect or part of this solicitation will be deemed unacceptable.

If you have any questions or require more information, please contact Ms. Elsie Cristobal at (e-mail:

elsie.cristobal@doh.hawaii.gov or phone:(808) 453-5990) or Ms. Remedios Gose at

(e-mail: remedios.gose@doh.hawaii.gov or phone:(808) 453-5993).

http://www.spo.hawaii.gov/ mailto:elsie.cristobal@doh.hawaii.gov%20or%20phone:(808)%20453-5990 mailto:remedios.gose@doh.hawaii.gov%20or%20phone:(808)%20453-599