Pipette SOW_20220202.docx

STATEMENT OF WORK

1. SCOPE

The U.S. Department of Health and Human Services (DHHS) is seeking a qualified Contractor to provide offsite (mail in) pipette calibration with preventative maintenance to designated laboratories across the country. The contractor will provide timely pipette calibration, with 5 day or less turnaround time for each lab, regardless of lab location, that conforms to ISO 17025 calibration standards and meets manufacturer’s specifications unless otherwise specified. The contractor will provide quotations for pipette repairs and return repairs in 10 days or less to the participating laboratories. Contractor must be in good standing with and accredited under ISO 17025 by an accreditation body that is signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA) and operate in accordance with all applicable guidelines to maintain accreditation. Contractor must publish a 30, 60, and 90 day schedule of a reoccurring forecast of turn-ins for flexibility and budgeting purposes. Comment by FORSHEY, BRETT: Leslie – any concerns here?

2. BACKGROUND

The laboratories are the analytical components responsible for the detection and identification of infectious biological agents that may pose a threat to public health. Work performed by these laboratories requires the use of multiple, accurate, and reliable pipettes. Reasonable turn-around time is critical to avoid disruptions in daily operations and up-to-date status via tracking mechanisms is required. These laboratories are located in multiple sites across the continental United States.

Upon award, the contractor shall be required to sign a Non-Disclosure Agreement and instructions regarding the recipient for deliverables will be provided.

3. PERFORMANCE AND SURVEILLANCE PLAN REQUIREMENTS

3.1 Performance Requirements: The contractor must provide calibration and preventative maintenance services for repeater, single channel, and multi-channel pipettes from all major national brands including but not limited to Rainin, ThermoFisher, and Eppendorf as required.

1. Contractor must be ISO 17025:2005 accredited by an accreditation body that is signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA).

2. Pipette repair and calibration services for all laboratories must be coordinated through DHHS/DHS Logistical Management POC and laboratory requesting the service.

3. Information and status updates regarding calibration, repair, or replacement services for all laboratories must be communicated to DHHS and requesting lab as requested and when contractor has updates to services.

4. Contractor shall provide calibration services for each of approximately 1100 single-channel and 500 multi-channel pipettes (actual numbers may vary) in the system every six months (twice a year).

5. Calibration standards:

a. Calibration services must be performed twice a year for each pipette, approximately every 6 months

b. Calibrations shall provide pre- and post- calibration condition associated with each calibration according to manufacturer’s specifications unless otherwise approved by DHHS.

c. Preventative maintenance minimum: pipette inspection, replace worn seals, shafts and pistons, cleaning and greasing, pressurized leak test, minor repairs

d. Multichannel pipettes: each channel will be calibrated as individual channels.

e. Calibration label must be affixed to pipette with calibration date and next calibration due date.

f. Pipettes that fail calibration and are unrepairable must be clearly marked as such.

6. Repairs standards (repairs not included in preventative maintenance):

a. Repairs can be requested by laboratories any time during the contract

b. Repairs must be preapproved by DHHS

c. Quotes for repairs must be submitted to DHHS via electronically to recipients and designated contacts as instructed within 48 hrs of receiving pipettes.

d. Repaired pipettes must be calibrated as defined in Calibration Standards.

e. DHHS reserves the right to refuse repair.

7. Calibration certificate:

a. Calibration service and documentation must be ISO 17025 compliant.

b. For all calibration services, “as found” (pre-calibration) and “as left” (post-calibration) measurements must be included in the calibration certificate.

c. For all calibration services, pre- and post- conditions must be included in the calibration certificate.

d. Issue of service report and calibration certificate must be provided, electronically to recipient laboratories and listed contacts and as a hard copy with the return shipment, at each calibration service.

e. Contractor must maintain records of all certificates issued under this contract, preferably through electronic access with print capability.

8. Shipping

a. Shipment of the pipettes must be coordinated with the laboratories to avoid interruptions in daily operations.

b. Contractor must provide shipping to and from the laboratory facilities for pipettes submitted for calibration/repair services.

c. Contract shall use 3-day shipping, unless otherwise requested by DHHS.

d. Contractor must perform calibration and preventative maintenance on pipettes and shipped to requesting laboratory within 5 business days.

e. A pipette that requires repairs and calibration must be completed and shipped back to laboratory within 10 days of approval.

f. Contractor must provide service scheduling and tracking of service requests, preferably online.

g. Contractor shall provide notification by email or phone call if necessary (preferably as soon as an issue is identified) to DHHS, designated partners, and the affected Labs when schedules will not be met.

h. The contractor shall report any incidents or damage to pipettes sustained during shipment via email to the DHHS, requesting laboratory, and other points of contacts as identified by DHHS.

i. Contractor will coordinate with DHHS to develop a yearly schedule of pipette calibrations.

3.2 Surveillance Plan

1. A list of serial numbers for pipettes to be serviced under this contract will be generated by the laboratory requesting service and included in the shipment of pipettes to the contractor.

2. A complete inventory of all pipettes covered by this contract will be maintained by DHHS.

3. Only pipettes on this list are authorized for service under this agreement. If the contractor receives a request for service for a pipette not included on the most recent version of the list, the contractor shall provide notification as instructed and wait for approval from DHHS. If approval is not granted by DHHS, service is not authorized under this contract.

4. The contractor shall report any incidents or damage to pipettes sustained during shipment as instructed.

3.2 Performance Requirements and Surveillance Plan

Table 1. Performance Requirements and Surveillance Plan

Monthly inspection of service records

Monthly or as needed inspection of schedule and ability to adhere to schedule

4. DELIVERABLES

4.1. Documentation

1. Contractor will provide service and documentation as outlined in 3. PERFORMANCE AND SURVEILLANCE PLAN REQUIREMENTS.

2. A monthly status report to reflect work accomplished must be provided no later than the 5th of each month to DHHS and designated points of contact.

3. A monthly invoice report to reflect work accomplished and costs must be provided no later than the 5th of each month to DHHS Financial Management POC.

a. Shipping costs must be captured separately in invoice.

b. Repairs performed, with associated quote reference numbers, must be captured separately in invoice.

Table 2. In Appendix A outlines the Deliverables

5. CONTRACT AND PERIOD OF PERFORMANCE

5.1 Contract type

1. IDIQ

5.2 Period of Performance

1. The term of this contract shall be 1 year from date of award with 4 option years. A monthly status report to reflect work accomplished and cost information shall be provided no later than the 5th of each month to the designated financial points of contact using the format requested.

APPENDIX A

Invoicing: The contractor shall furnish an invoice monthly in accordance with instructions provided.

Table 2. Deliverables

Method of Delivery Due Date

DHHS Financial POC

Electronic delivery to recipients as instructed Availability of service begins immediately upon award

Laboratories located across the United States

Return of calibrated pipettes within no more than 5 business days of receipt for calibration.

Availability of service begins immediately upon award

Laboratories located across the United States

Laboratories located across the United States

Applies only when diagnosis deems repair is appropriate relative to replacement cost.

Shipping or delivery during normal business hours.

3-day shipping or equivalent in speed and cost

Availability of service begins immediately upon award

Laboratories located across the United States

Electronic copy (minimum) provided to DHHS

Availability of service begins immediately upon award

Laboratories located across the United States

Status updates