Pharmacogenetic Testing Procedure

Transcription

1 STEP 1: Explain to the patient that the doctor is requesting a pharmacogenetics test sample in order to acquire a genetic metabolism profile for drugs. The metabolic profile results are classified as poor, intermediate, extensive, and ultra-rapid metabolizers. Extensive metabolizers are considered the normal metabolizers. Purpose of Test: Cytochrome P450 (CYP450) Drug Metabolism: This panel is useful in estimating a patient's unique drug metabolism pattern. An individual's unique array of CYPs can indicate how certain drugs will be metabolized by that individual, which is useful in predicting drug interactions and drug effectiveness for that individual. STEP 2: Pre-Authorization Complete attached Preapproval Information Form for Pharmacogenetic Testing and fax it to (818) Attn: Susan Karapetyan or skarapetyan@pactox.com. PacTox will inform the indicated contact person when we receive the approval from patient s health insurance plan. Once you get the approval from PacTox call patient for collecting the sample. STEP 3: Complete the PacTox Requisition Form Physician must complete and sign the PacTox Requisition form. List ALL medications currently being prescribed to the patient by ALL physicians. Please refer to the requisition guide for completing the requisition form. (Attached) STEP 4: Specimen Collection 1. The patient should not eat or drink immediately prior to giving the sample. If food or drink has been recently taken, the patient should brush his/her teeth, (If brushing is not possible, gargle thoroughly with water) and wait about 30 minutes. Do not eat or drink anything other than water during this time. 2. Open the specimen bag; take out the buccal swab and tube. Open the Omni- Swab packaging at the handle end and carefully remove the swab. Do not touch the collection pad of the swab.

2 3. Holding the handle end of the Omni- Swab, scrape the collection pad (see picture below) firmly against the inside of the left and the right cheek 5-6 times (about 10 seconds) each side, being careful not to eject the tip. 4. Please collect two specimens for each patient to ensure adequate amount. 5. After taking the sample, eject the pad into the tube. Make sure that the tube is closed completely. If the tube arrives at the lab opened, it will be considered contaminated and we will reject the sample as sub-optimal 6. Remove the labels on the requisition form and place them around each tube as shown in the picture. 7. Place the paperwork (PacTox Requisition and Demographics) outside of the Bio-Hazard Specimen bag folded in half (1/2) and then place the tubes which contain the swab sample inside the Ziploc portion of the Bio-Hazard Specimen bag. 8. The Bio-Hazard Specimen bag(s) are to be placed inside of the FedEx Clinical Pak, (15) bags or less. 9. Place Bio-Hazard Specimen bag(s) containing the specimen sample and paperwork in a refrigerator stored at 4 C or cooler until you are ready to ship the samples to the lab.

3 STEP 5: Packaging 1. Samples must be sent to lab within 72 hours. 2. Collect all Bio-Hazard specimen bags which contain the specimen donor samples and paperwork. Place inside of a FedEx Clinical Pak (up to max. per bag). 3. Samples MUST be refrigerated after collection. Send samples immediately once removed from the refrigerator. STEP 6: Shipping 1. When ready to ship, place a preprinted FedEx Billing Label on FedEx clinical pack. 2. FedEx Boxes that are ready for delivery can be dropped off at your local FedEx Office store before 5pm. 3. If the office prefers a FedEx pickup, please set up an account with FedEx and contact FedEx at GoFedEx ( ) to schedule a pick up.

4 9348 De Soto Ave, Chatsworth, CA Phone , Fax Preapproval Information Form for Pharmacogenetic Testing Date: Patient First Name: Patient Last Name: DOB: Address: Client #: Requesting Physician: Contact Person Name: In Network Out of Network Insurance Name: Subscriber Id#: Copy of ID card front and back Diagnosis/ICD9 Codes: Please Provide: Progress Notes for Medical Necessity Contact Person to send the approval for collecting DNA sample Name: Phone: Fax: Address:

5 Requisition Guide 1. Client demographics 2. Indicate requesting physician 3. Provide appropriate ICD-9 codes 4. Provide patient demographics 5. Provide date and time of specimen Collection 6. Collector initials here 7. Provide specimen type DNA 8. Ordering physician to sign 9. Select pharmocogenetic tests to be performed 10. Current Prescribed Medications Indicate patient s current prescribed medications 11. No Drugs Prescribed Indicate if patient is not prescribed medications 12. PRN Indicate if patient is prescribed medication As Needed 13. Provide copy of the insurance card 14. Bill To Indicate billing type 15. Patient to sign here 16. Affix labels around the plastic tubes Pacific Toxicology Laboratories 9348 De Soto Avenue PacTox.com Chatsworth, CA TOXIC