Download Clinical Translational Research Center  Approved by: Administrative Director and  TraCS Institute  Nursing Director 

Clinical Translational Research Center TraCS Institute SOP Title and #: Guidelines for Urine Pregnancy Testing in the CTRC Effective Date: 4/1/2009 I.
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Approved by: Administrative Director and Nursing Director Revisions: Page 1 of 2
Purpose: This Standard Operating Procedure (SOP) describes the activities and identifies the individuals responsible for urine pregnancy testing at the Clinical and Translational Research Center (CTRC). Scope: This SOP applies to the procedures for urine pregnancy testing and documentation of the findings at the CTRC. Applicability: Female subjects participating in research studies performed on the CTRC are frequently required to have pregnancy testing performed prior to study entry, performance of a study procedure, or medication administration. Urine pregnancy testing performed on the CTRC will help facilitate the start of studies and could decrease a patient’s length of stay on the CTRC. All CTRC nursing staff will be trained on the proper urine testing procedure as outlined in the UNC Hospital policy and procedure manual. The policy and procedure manuals of the McLendon Laboratory may be accessed at http://intranet.unchealthcare.org/policies/mclendon_policies_general Annual competency testing will be provided by the Point‐of‐Care Committee to assure all CTRC nurses can competently and accurately perform urine pregnancy testing. Accurate specimen collection and proper handling of such specimens is imperative for all research studies in order to avoid any errors or protocol deviations that could occur. The CTRC will continue to offer serum beta hCG testing if required by sponsor. Responsible Parties: CTRC nursing staff and dietary staff trained in the procedure of urine pregnancy testing and quality assurance who will be using the hospital provided equipment and follow UNC Health Care policy and procedure guidelines. Procedures: A. Industry sponsored studies providing their own urine pregnancy kits should be performed by the study staff. Only study staff will be allowed to perform urine pregnancy testing using sponsor provided kits. The CTRC staff cannot perform any urine pregnancy testing by kits, which are not approved by McLendon Laboratory. B. If a CTRC staff member is performing a procedure that includes risk to a fetus, women of childbearing potential must have a urine pregnancy test performed by CTRC nursing staff or a pregnancy test performed by UNC Hospitals McClendon Laboratories, with results confirmed as negative, prior to having the a procedure performed. Such procedures include, but are not limited to, DEXA scans and dosing of certain medications. C. CTRC trained staff will only perform urine pregnancy testing using hospital approved equipment (Bayer Clinitek) and supplies (pregnancy test cartridges from central distribution order # 050435) Therefore, study staff must get sponsor permission to use hospital supplied testing materials if CTRC staff are to perform the test. D. The Bayer urine pregnancy equipment will have daily quality control (QC) testing using the hospital provided urine controls for testing. QC findings will be documented in a log book by the nurse or nursing assistant performing the procedure. The night shift CTRC nursing staff will be responsible for daily QC testing and documentation of findings. The expiration date of the test cartridge will be checked prior to performing a urine pregnancy test and at time of QC testing. A member of the Point‐of‐Care committee will routinely monitor to ensure the equipment receives QC testing as outlined in the hospital policy. Clinical Translational Research Center TraCS Institute SOP Title and #: Guidelines for Urine Pregnancy Testing in the CTRC Effective Date: 4/1/2009 Approved by: Administrative Director and Nursing Director Revisions: Page 2 of 2
E. For information regarding the actual performance of a urine pregnancy test, please review the hospital policy regarding such testing. F. A positive urine pregnancy test will be immediately confirmed with a serum beta hCG using the UNC Hospitals Laboratory. The principal investigator will be required to write an order for serum beta hCG testing. The CTRC nursing staff or RN study coordinator may take a verbal order for serum beta hCG testing should the study physician be unavailable. A urine pregnancy test result section has been added to the newly revised outpatient check‐in sheet for documentation of results. G. Results from urine pregnancy testing will be documented by the nurse who performed the test on the outpatient check‐in sheet. A positive result will be communicated to the study staff immediately and all further testing (e.g., DEXA scan, XRAY, etc.) or drug administration will be held. H. Study staff requiring on site (POC) urine pregnancy testing should indicate this by indicating a “C” next to “Urine Pregnancy Testing – per CTRC nursing staff” found under the urine section of the lab order form. No study will be charged for this procedure. However, if a serum pregnancy test is required to confirm results, the investigator must pay for this extra test.