Parkview Health Laboratories PHLEBOTOMY MANUAL Policy & Procedure Title: Paternity Specimen Collection Source: Phlebotomy Standardization Effective Date: 3-15-11______________________ Origination Date: 09/01/97 Revision Date(s) w/ Initials: 01/05, 07//09 acs, 10/10 acs, 3/11 acs Technical Supervisor: ________________________ I. PRINCIPLE To provide clients with accurate determination of paternity by performing buccal swab and/or blood specimen collection per client request; clinical significance and result interpretation is to be referred to the paternity testing facility. II. SPECIMEN REQUIREMENTS AND COLLECTION METHOD A. Patient Preparation: 1. Individuals who have had a blood transfusion within three (3) months prior to a blood specimen paternity collection may not be tested and will need to reschedule for a date at least three (3) months after the date of the blood transfusion. 2. Individuals who have had a bone marrow transplant are not eligible for a blood specimen paternity collection. 3. Buccal swab paternity collection may be performed on patients listed in II.A.1 and II.A.2 with no restrictions. 4. Patients should be informed during scheduling call that at least one form of identification is required. Acceptable forms of identification are: a. b. c. d. e. f. g. Driver’s license State ID card Passport Military ID Student photo ID Employee photo ID Birth Certificate (for children) 5. Patients should be informed during scheduling call that the procedure will take no less than 30 minutes and up to 1 hour. Policy #3624 Page 1 of 6 Parkview Health Laboratories PHLEBOTOMY MANUAL Policy & Procedure Title: Paternity Specimen Collection B. Specimen Type: DNA Diagnostic buccal swab. Whole blood specimens in any color tube are acceptable. Specimens are stable 30 days refrigerated. Additional acceptable specimens are listed in Appendix B. specimen types may be associated with additional testing fees. C. Other Handling Conditions: Specimens must be mailed to the appropriate testing facility in the prepaid mailer envelope. All specimens must be sealed with tamper-evident tape/stickers. Results will be returned to Central Laboratory within 2-3 weeks and mailed to the address listed on the requisition within 3-4 weeks. III. PROCEDURE A. EQUIPMENT AND MATERIALS 1. Equipment: a. Provided by testing facility in paternity collection kit: (1) Outer cardboard mailer (2) Consent forms (3) Instruction sheet (4) Zip-lock bag (5) Tamper-evident tape/stickers (6) Ink Pad (7) Buccal Swabs (8) Film for Polaroid camera b. Provided by Parkview Health Laboratories (1) Polaroid camera B. PROCEDURE 1. Verify that one of the patients in question (child, mother, or alleged father) is recently deceased or near death. Policy #3624 Page 2 of 6 Parkview Health Laboratories PHLEBOTOMY MANUAL Policy & Procedure Title: Paternity Specimen Collection a. Paternity testing and DNA banking requests from outpatients or outreach patients should be referred to: EMSI Pelz Paramedical 619 Airport North Office Park Fort Wayne, IN 46825 (260)490-8322 2. Notify the patient or patient next-of-kin that the procedure will require payment prior to service. These costs are not covered by insurance. Verify the patient or patient next-of-kin would like to continue. 3. Inform the patient or patient next-of-kin that they will need to go to Central Lab for the following: a. Payment – acceptable forms of payment include cash, money order, or cashier’s check. Credit cards and personal checks will not be accepted b. Documentation – Photo id or birth certificate is required for all living patients being tested. In addition, a custodian consent form will need to be completed by the deceased patient’s next-of-kin. Other paper documentation may need to be completed as determined by the testing laboratory in a specific situation. c. Specimen collection – a blood specimen will be used for the deceased patient’s specimen. A blood specimen or buccal swab will need to be collected from other involved individuals. Per testing laboratory request, mother, child(ren) and alleged father should all be tested. 4. To ensure trained staff are available, request the patient or patient next-of-kin contact Central Lab to set up appointment for specimen collection and payment. Or if the patient prefers, they may provide contact information and Central Lab staff will contact the patient or patient next-ofkin to set up an appointment. 5. Contact Central Lab Sendout Lead. Explain the situation so that needed paper documents can be obtained and proper pricing determined prior to patient presentation. 6. When the patient or patient next-of-kin present at Central Lab, processing staff is to ask the patient what payment method will be used, and fill out a Receipt and a Balance Sheet from the “Balance Sheets” folder at the front desk. Policy #3624 Page 3 of 6 Parkview Health Laboratories PHLEBOTOMY MANUAL Policy & Procedure Title: Paternity Specimen Collection a. Once the forms have been filled out and the money has been collected, the phlebotomist is to call the Billing department at extension 39420 and request that a billing staff member accept the payment for the paternity. The phlebotomist is to ensure that both forms are given to Billing staff along with the payment. b. The processor who will be collecting the test is to accompany all of the parties being tested and any legal guardians into the draw room. None of the parties may leave the draw room until the paternity has been completed to ensure that the chain of custody of specimens is not compromised. c. The processor is to complete a requisition for each patient: (1) The requisition must include the patient’s address, or the address to which the patient would like the results mailed. d. The paternity is to be performed according to the instructions included with all paternity kits. (1) If the collection will utilize a buccal swab, a DNA Diagnostics paternity kit is to be used (these are located in the bottom desk drawer in the draw room). (2) The paternity chain of custody form is to be stamped with the Parkview Health Laboratories address stamp as the location to which the results should be mailed. This stamp is located on the desk in the draw room. (3) The Polaroid of the patients/legal guardians must be signed and dated by all responsible parties appearing in the photograph. e. The patients may leave the draw room when the paternity is completed, and the mailing envelope is sealed. f. The UPS mailing envelope is to be taken to the storeroom clerk for mailing. If UPS has already stopped for the day, the collecting phlebotomist will need to call the 800 number listed on the envelope to schedule a pickup. Any FedEx mailing envelopes should be placed on the counter in the mailroom in Processing. g. The UPS tracking form (usually found inside the UPS mailing envelope on blue paper) is to be stapled to the Paternity Test Order Form and the pink copy of the receipt. These are then to be placed in the Paternity Scheduling folder located in Phlebotomy. Policy #3624 Page 4 of 6 Parkview Health Laboratories PHLEBOTOMY MANUAL Policy & Procedure Title: Paternity Specimen Collection h. The processor should order testing into SOFT using the test code MSOT. The Sendout Lead will keep the SOFT labels as reference for test verification upon receipt of the results from the paternity testing laboratory. i. Results will arrive in triplicate at the Central Laboratory. They are to be routed to the Sendout Lead or designated personnel. The Lead or designee will: (1) Verify each test in SOFT (2) Look up the patient addresses in PaperVision based on the SOFT order number. (3) Mail one copy of the results to each of the addresses provided by the patients on the Parkview requisitions. (a) If the address is the same for both the child and the alleged father, both copies of results must be mailed to that address in separate envelopes. (4) Affix one of each SOFT label to the third copy and file in the Paternity file under the alleged father’s last name. All results should be referenced by the alleged father’s last name. j. A patient may pick up a copy of the results from the Central Laboratory; the patient will be required to present proper photo ID to obtain a copy of the results. k. The results may not be given to any patient representative without a court order for release of such information, or unless said representative is also the legal guardian of a minor who has been tested. IV. Procedure Notes and Limitations of Methods A. Biological relationship determination is available. Contact DNA Diagnostic Center for pricing and additional required paperwork. B. DNA banking is available for paternity testing at a later time. Contact DNA Diagnostic Center for pricing and additional required paperwork. C. Questions regarding specimen requirements, required paperwork, and/or pricing should be referred to DNA Diagnostics Center at 1-800-929-0815. Policy #3624 Page 5 of 6 Parkview Health Laboratories PHLEBOTOMY MANUAL Policy & Procedure Title: Paternity Specimen Collection V. References A. DNA Diagnostics Center. Fairfield, OH 45014. B. Paternity Scheduling and procedure, Phlebotomy Manual, Parkview Health Laboratories, 3rd Rev. 03/1998. Policy #3624 Page 6 of 6