LDT Transition Checklist Survey

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* 1. Please enter your full name.

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* 2. Please enter your email address.

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* 3. Please enter your cell phone number.

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* 4. Enter the name of your laboratory or add website link

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* 5. How many LDTs does your laboratory currently offer?
Pls list number total individual LDT tests offered. (estimate).

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* 6. What is your laboratory's 2023 annual test volume for LDTs?

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* 7. Please list the top 3 LDTs your laboratory offers by name, annual volume .

1) Name of LDT/estimated annual volume -

2) Name of LDT/estimated annual volume -

3) Name of LDT/estimated annual volume -

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* 8. What is the estimated cost of goods (labor and reagent) for each LDT?

LDT #1 Unit Cost

LDT #2 Unit Cost

LDT #3 Unit Cost

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* 9. What is the estimated net reimbursement per Top 3 LDT?

LDT #1 Net Price

LDT #2 Net Price

LDT #3 Net Price

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* 10. What is the average denial rate (%) for each LDT #1-5? Directional estimate is fine.

LDT #1- Denial Rate-

LDT #2- Denial Rate-

LDT #3- Denial Rate-

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* 11. Who are your Top 3 payers for your LDT's

Payer #1-

Payer #2-

Payer #3-

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* 12. How is each LDT billed? ie: CPT code stacking, AMA code or NOC code?

LDT #1-

LDT #2-

LDT #3-

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* 13. Does your laboratory have a QMS ISO 13485 in place?

Yes

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* 14. Are any of your LDTs NYS approved?

Yes

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* 15. If yes, pls list NYS approved LDT's

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* 16. Have you completed a Clinical Data FDA Gap Assessment ?

Yes

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* 17. If not, do you need access to specimen banks?

Yes

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* 18. Are you using any "research use only" reagents in any of your LDT's?

Yes

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* 19. Do you have any of the following internal team capabilities?

Quality management competency

FDA clinical validation competency

Regulatory competency

Overall strategy assessment competency /Exit strategy creation

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* 20. Beside yourself, is there anyone else in your organization who would like a copy of this gap assessment? Pls list name and email below.

Momentum Consulting/Goldbug Strategies is happy to discuss your results "live" and develop an LDT transition action plan with one of our subject matter experts. Pls book a zoom call using the link below:
Schedule a Meeting via Calendly

LDT Transition Checklist Survey

Question Title

* 1. Please enter your full name.

Question Title

* 2. Please enter your email address.

Question Title

* 3. Please enter your cell phone number.

Question Title

* 4. Enter the name of your laboratory or add website link

Question Title

* 5. How many LDTs does your laboratory currently offer? Pls list number total individual LDT tests offered. (estimate).

Question Title

* 6. What is your laboratory's 2023 annual test volume for LDTs?

Question Title

* 7. Please list the top 3 LDTs your laboratory offers by name, annual volume .

Question Title

* 8. What is the estimated cost of goods (labor and reagent) for each LDT?

Question Title

* 9. What is the estimated net reimbursement per Top 3 LDT?

Question Title

* 10. What is the average denial rate (%) for each LDT #1-5? Directional estimate is fine.

Question Title

* 11. Who are your Top 3 payers for your LDT's

Question Title

* 12. How is each LDT billed? ie: CPT code stacking, AMA code or NOC code?

Question Title

* 13. Does your laboratory have a QMS ISO 13485 in place?

Question Title

* 14. Are any of your LDTs NYS approved?

Question Title

* 15. If yes, pls list NYS approved LDT's

Question Title

* 16. Have you completed a Clinical Data FDA Gap Assessment ?

Question Title

* 17. If not, do you need access to specimen banks?

Question Title

* 18. Are you using any "research use only" reagents in any of your LDT's?

Question Title

* 19. Do you have any of the following internal team capabilities?

Question Title

* 20. Beside yourself, is there anyone else in your organization who would like a copy of this gap assessment? Pls list name and email below.

* 5. How many LDTs does your laboratory currently offer?
Pls list number total individual LDT tests offered. (estimate).