HPS APJ Customer Intake Form

Please complete this form to help prepare for your upcoming HPS validation. If there is a question you do not have the answer to, simply leave it blank. We appreciate you filling out the information as completely and accurately as possible.


There is a section at the end for questions/comments to include any relevant details about your project that have not been addressed in this form. After completing the form, the HPS team will prepare a custom Experimental Design. We will follow up with a virtual meeting to discuss any additional details or questions.


Questions or comments about this form can be directed to Samatha.Chernoguz@thermofisher.com.

Please ensure this is the full, correct lab name to be used on HPS documents.

Please tell us the name of the person filling out this form.

Please share an e-mail address we can contact for any follow up.

What is the lab's physical address?

Different Shipping*

Is the shipping address different than the lab's physical address?

What is the shipping address for your organization?

Please provide the name of an individual to include in the shipping address. We strongly recommend using a different person then who normally receives shipments. We will be sending a large number of packages and using a different name can be very helpful in keeping the validation materials separate from your regular inventory.


When our shipments arrive, we ask that you unpack them as soon as possible but keep the manufacturer's packaging intact. Store all reagents at the appropriate temperature. Keep our materials separate from your regular inventory and clearly marked as "HPS" or "Validation".

Please provide the name and e-mail of ONE individual at your organization who will need regular updates about the validation progress and will be responsible for accepting the project results and understanding any troubleshooting efforts that may occur. It is important that this individual be on-site throughout the entire validation and available to make decisions as needed.

Please provide the name and e-mail (if different than above) for the individual responsible signing documents related to acknowledging project milestone completion.

Please provide the name and e-mail address for any individuals in addition to those listed above who you would like to have access to the HPS reports and project dashboard.

Would you like your report and other deliverables to be in a language other then English? If so, please indicate your desired language and we will do our best to accommodate your request. Translations are not guaranteed and based on availability.

Validation Workflow and Scope

Please be as accurate and detailed as possible with the answers on this form. If there are any issues that need to be addressed the HPS team will assist whenever possible. If the laboratory and instruments are not ready prior to our arrival, this may result in a delay of your project and possible additional costs.

Select all workflows that are being validated.

Select all lab supplies listed below that are available for the project. If any of the supplies are missing, we will do our best to assist you.

When were your pipettes last calibrated?

Does your laboratory use any of the following non-default parameters for the kits and instruments being used in this validation? Please reference the user manuals for additional details.

Please describe the workflow parameters selected in the previous question. For example: the lab uses half-volume amp reaction for GF kit.

Which amp kit(s) will you be validating?

Direct Amplification

Which TWO cycle numbers would you like to test? Suggested ranges are:

    GF 24-26          GFE 25-28                              

    VFP 25-28        VFE 25-28                           

    YFP 26-29

        

How are the direct samples prepared?

Direct Puncher

Is the puncher instrument new to the lab?

New Puncher Set-Up

Has the new puncher been installed at the laboratory, and has its operation been verified?


Note: The robots must be completely ready before validation can begin. If additional pre-testing or script verification is needed, this should be scheduled separately from the wetwork and may incur additional costs.


Thermomixer

Is there a functioning Thermomixer available to use in the lab?

Which extraction chemistry is being validated?

The lab is asked to provide the items listed below, which are needed for the extraction buffers. Check the box next to the reagents that are available in your lab or that you will purchase prior to wetwork. If any of the items are not available we will do our best to help obtain them.


Which instrument(s) will be validated?

What is the serial number(s) of the extraction instrument(s) being validated?


NOTE: If it is a new instrument that has not been installed yet, please answer "New".

Extraction Robot

Is the extraction robot new to the lab?

New Extraction Robot Set-Up

Is installation and any applicable training for the robot complete?


Note: The robots must be completely ready before validation can begin. If additional pre-testing or script verification is needed, this should be scheduled separately from the wetwork and may incur additional costs.

When was the last PM on the instrument?


Please explain any reported/known issues regarding the instruments (reported by analysts to TL, the lab to TF, or from the FSE).

Is the instrument currently being used? If not, when was the last time it was successfully run?

Which quant kit(s) are being used for the validation?

Automation Enhancer

Does your protocol use automation enhancer in the quant setup?

Which quant instrument will be used for the validation?

What is the serial number(s) of the quant instrument(s) being used in the validation?


NOTE: If it is a new instrument that has not been installed yet, please answer "New".

Quant Instrument

Is the quant instrument new to the lab?

New Quant Set-Up

Is installation and applicable training for the QS5 complete? This includes calibration of the instrument.

Quant Calibration

Has a spectral calibration been run within the last year?

When was the last PM on the instrument?


Please explain any reported/known issues regarding the instruments (reported by analysts to TL, the lab to TF, or from the FSE).

Is the instrument currently being used? If not, when was the last time it was successfully run?

Which amp kit(s) are being used for the validation?

What thermal cycler is being used for the project?

Note: ProFlex 2x96 instruments are not compatible with HID chemistry.

What is the serial number(s) of the thermal cycler(s) being used in the validation?


NOTE: If it is a new instrument that has not been installed yet, please answer "New".

Thermal Cycler

Is the thermal cycler(s) new to the lab?

New TC Set-Up

Has the thermal cycler been installed and amplification programs installed?

Thermal Cycler Program

Have the amplification parameters been programmed on the Thermal Cycler being used for this project?

Is the instrument currently being used? If not, when was the last time it was successfully run?

Which CE is being used in the validation?

What is the serial number(s) of the CE instrument(s) being used in the validation?


NOTE: If it is a new instrument that has not been installed yet, please answer "New".

CE Instrument

Is the CE instrument new to the lab?

New CE Set-Up

Has installation, calibrations, and applicable training been completed? This includes spectral and spatial calibrations as well as dye installation.

When was the last PM on the instrument?


Please explain any reported/known issues regarding the instruments (reported by analysts to TL, the lab to TF, or from the FSE).

CE Spectral Calibration

Has a spectral calibration been successfully completed within the last 6 months?

CE Spatial Calibration

Has a spatial calibration been successfully completed within the last 6 months?

CE Dye Set

Has the appropriate dye set been installed on the instrument?

Is the instrument currently being run? If not, has it been properly shut down or maintained (daily/weekly maintenance)?

Are there temperature fluctuations or humidity issues in the lab? If yes, please explain.

What is the lab protocol for the heat/chill DNA denature process prior to CE?

GeneMapper Version

Which version of GeneMapper ID-X is being used for this project?

Would you like to use any of the following new features in GMID-X v1.7 for sample analysis? Select all that apply.


Refer to User Bulletin for additional information.

Liquid Handler

Will a liquid handling robot be used for any portions of the workflow being tested?

Which processes will the liquid handler be used for?

Liquid Handler Set-Up

Is the robot(s) completely ready for validation to begin?


This includes any installation and/or programming. If additional pre-testing or script verification is needed, this should be scheduled separately from the wetwork and may incur additional costs.

Rapid

Rapid Instrument

Has the instrument been installed?

What is the serial number(s) of the RHID instrument(s) being validated?

Entitlement Training

Had your laboratory received training for Rapid?

Instrument Connections

Do you plan to connect the instrument to Rapid Link?

Lab Partner

Do you plan to have a laboratory partner for reach-back?

Database

Do you plan to use a database?

If you will not be using a database, what is the plan for profiles obtained from Rapid analysis?

Please explain any IT issues that you are aware of. For example a database needs to be set-up or stand alone instruments need to be connected to Rapid Link.

Power Source

What will be used for the instrument's power source?

Please describe the other power source being used for the Rapid Instrument.

Questions/Comments

Please include any questions or comments about the upcoming project.

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