2-P09-25-000021 SOW.pdf

Pipette Calibration Statement of Work

Background The National Institutes of Health, Clinical Center, Department of Laboratory Medicine (DLM) provides clinical laboratory testing for patients. Pipette calibration is required to meet accreditation requirements of the College of American Pathologists and the Joint Commission in accordance with the Clinical and Laboratory Standards Institute. The contractor must meet the laboratory’s needs in terms of reliability, accuracy, precision, and documentation for inspections. Pipettes are used throughout the day and need to be accessible for emergency use.

Purpose/Justification Per the College of American Pathologists (CAP), the accrediting body for the Department of Laboratory Medicine, all equipment must have function checks that are designed to detect drift, instability, or malfunction, before the problem is allowed to affect test results (COM.30600). Per DLM policy, pipette calibrations are performed once or twice annually, as needed, to detect the above referenced problems.

Scope of Work Pipette calibrations will be performed twice per year, six months apart (June and December) for five years.

The five (5) major testing services in Department of Laboratory Medicine are Chemistry, Hematology, Immunology, Microbiology, and Sterility that use approximately 550-570 single-channel pipettes and nearly 71 multi-channel pipettes.

Pipettes that are not used on a daily basis may only require once per-year calibration while others which operate at very small volumes (<50uL) or are used on a daily basis (any volume) require twice per year calibration.

Some pipettes need to be calibrated against ISO8655 specifications and some pipettes need to be serviced in accordance with ISO17025:2017 approved procedures as needed to ensure accurate and precise pipette performance. Pipettes will be inspected, cleaned, worn or damaged internal parts replaced, pm service performed, and repairs as necessary. 3 volumes x 10 readings is required for ISO 17025.

Deliverables:

The contractor shall provide documentation of successful calibration traceable to each pipette (certificates of each pipette via email and pipette labels affixed to each pipette at the time of each service).

The Contractor shall provide certificates of analysis for all pipettes calibrated in accordance with contractor accreditation to ISO17025 and ISO08655 specifications. A written report will be supplied no later than five (5) business days following the service, detailing the nature of the work performed; any parts replaced and operational test results to ensure performance within the original equipment manufacturer (OEM) guidelines and specifications; any upgrades or modifications; and other pertinent information concerning the condition of the equipment to the Technical Point of Contact.

Pipette labels must show the date of calibration, due date of calibration in next six months, Tech ID who performed the calibration, and ID number.

ISO17025 Pipette calibration certificates shall include certificate Identification number, device details, customer, contact at location, address, environmental factors, calibration date, calibration type, status, next due date, calibration interval, measurement standards, type of maintenance performed, summary statistics of as calibrated and as found, mean, standard deviation, uncertainty measurement, k=2 confidence level, any adjustments performed, test standards used with pass/fail results, sample volumes used, statement of traceability, signatures and date. Single channel pipettes certificates shall include 10 As Found and 10 As Calibrated samples at low, mid and high. Repeaters certificates shall include 10 As Found samples only at low, mid and high. Certificates of Calibration for Multi Channels that pass as found inspection shall include 10 As Found samples only at low, mid and high and no additional samples will be noted per channel. Certificates of Calibration for Multi Channels that Fail as Found shall include 10 As Found samples at low, mid & high, a comment noting what adjustments were performed, and 10 As Calibrated samples at low, mid and high per channel.

ISO08655 specification pipettes calibration certificates shall include Tech ID, customer name, pipette manufacturer, serial number, calibration date, calibration interval, calibration range, calibration due date, balance type used, balance serial number, water temperature, density of water, statistical summary of as found and as calibrated data, ISO08655 specifications, volume used, upper and lower range, accuracy percent, CV percent and Tech signatures. Each single channel pipette calibration certificate shall include four (4) samples at low, mid and high volume both As Found and As Calibrated. Each multi-channel pipette calibration certificate shall include one sample for each channel, low, mid and high volume. Multi Channels that Fail as Found shall include As Found samples, a comment noting what adjustments were performed, and As Calibrated samples. A copy of balance calibration certificate shall be provided to the customer at the time of service.

Service to be performed on-site at NIH to include - calibration maintenance service, repairs, and parts replacement for pipettes manufactured by Eppendorf, Rainin, ThermoFisher, Gilson, Hamilton, to name a few.

The contractor must furnish all personnel, equipment, materials, supplies, services, and shipping costs required to achieve the performance requirements of the statement of work.

The Contractor shall be a pipette calibration service provider with accreditation to ISO17025 and perform pipette calibrations based on ISO08655 specifications. Contractor personnel must be trained and certified to work on equipment. The Contractor shall submit a copy of ISO17025 certification submit two references of similar scope and complexity with quotation.

Over and Above Services:

For services or repairs outside the scope of the work, the contractor shall provide the Technical Point of Contact with a quote. The Contracting Officer will issue a modification providing formal funding, prior to the work being performed.

Only the Contracting Officer (CO) is authorized to approve contract modifications.

Government Furnished Services:

The government will provide electricity and water will be available in order to perform troubleshooting/performance testing.

Additionally, during calibration, it may be determined that some pipettes need repairs or parts. The contractor shall also provide any necessary repairs and/or parts that are required to place the pipette into working order. Quote or included as part of the service. Services outside the calibration the contractor is not responsible for replacing pipettes that cannot be made to work or are beyond their working lifespan.

The Contractor shall replace/repair any damage done to Government property as a result of work performed by the Contractor. The contractor shall not be liable for any loss, damage, or delay due to any cause beyond his/her reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief, or acts of God.

The contractor shall guarantee the pipette calibration for six (6) months and recalibrate or if feasible, repair pipettes that fail within six (6) months of calibration date at no additional charge when they are sent to the contractor.

Place of Performance and Hours:

The contractor shall perform the pipettes calibration and maintenance services on site at the National Institutes of Health, Clinical Center, Department of Laboratory Medicine, 10 Center Drive Building 10 Room 2C324, Bethesda, MD 20892 Monday – Friday, during the normal business hours between 9:30am to 5:30pm.

Services are not performed on a government holiday, weekends or after hours, unless approved by the Program Point of Contact or Contracting Officer. The list of federal holidays is shown below and available at OPM Federal Holidays https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) June (Juneteenth) July (Independence Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving Day) December (Christmas Day)

Point of Contact The technical point of contact for this project is TBD, DLM Quality Manager.

Name: TBD Email Address: First.Last@nih.gov

T-(301) TBD

Period of Performance

Estimated Period of performance is as follows:

Base Year: 11/01/2024 to 10/31/2025 Option 1: 11/01/2025 to 10/31/2026 Option 2: 11/01/2026 to 10/31/2027 Option 3: 11/01/2027 to 10/31/2028 Option 4: 11/01/2028 to 10/31/2029