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Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 1 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: I. SCOPE: This policy applies to __________________________ (“Facility”). II. PURPOSE: The purpose of this policy is to address the proper review, storage and safe administration of Radiographic Contrast Media (“Contrast Media”). III. POLICY: Contrast Media are considered medications and must be provided to patients in a safe manner and in accordance with all pertinent state and federal regulations and applicable accreditation standards. IV. PROCEDURE: A. Physician Orders 1. The administration of oral/rectal Contrast Media without prior pharmacist review has been determined to be a safe standard of practice provided that medical staff-approved protocol is followed. See attached protocol (Attachment A). 2. The administration of Systemic Contrast Media requires that: 3. a. A medical staff-approved protocol is followed. b. Prior pharmacist review occurs with the exception of emergent administration or when the administration of systemic Contrast Media is under the direct supervision of a physician (the physician or a licensed independent practitioner is available for timely intervention in the event of an emergency). c. See attached protocol (Attachment B). Orders for Contrast Media must include the following information: Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 2 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: B. a. Contrast to be used b. Radiographic test to be performed c. Administration instructions d. See attached guidelines and procedures (Attachment D) 4. Appropriate consent must be obtained per hospital consent policy. [Hospital to include P&P as reference.] 5. The patient will be advised regarding appropriate use of Contrast Media and potential side effects that if they occur, must be communicated with the patient’s physician. 6. In summary, the process for safe administration of Contrast Media begins prior to administration and will include: a. presence of risk factors identified and addressed b. indication for use present or known c. verification of correct agent, dosage and route present d. verification of correct patient Procurement 1. All Contrast Media will be obtained by the Pharmacy Department. 2. Once Contrast Media are received and checked in by Pharmacy, they will be distributed as floor stock to those areas identified as requiring a radiographic contrast agent inventory (PAR) level. a. An appropriate inventory level will be maintained at all times as determined by the department that stocks the Contrast Media. Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 3 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: b. C. Only trained, designated licensed individuals (Radiology Technologist, Physician or RN) may retrieve Contrast Media from a limited set of secured radiographic medications. Storage 1. Contrast Media must be stored in accordance with manufacturer, state and federal regulatory guidelines. 2. When applicable, if warmers are used, temperature logs shall be maintained. a. Any deviation from the recommended temperature shall be acted on appropriately to correct the problem. b. The pharmacy department must be notified of temperature deviations and will determine if action regarding contrast media is needed. 3. Radiographic material will be secured. 4. Pharmacy will verify correct storage conditions on a routine basis (e.g. monthly floor reports). 5. Retrieval of the Contrast Media from the secured storage area shall be as needed per patient need. 6. In the event that there is a problem with the product, or a product is being recalled, the pharmacy will be notified and will initiate the recall process to ensure removal from inventory. Documentation of recall actions will be maintained in the pharmacy department. 7. Only formulary Contrast Media are to be routinely stocked and stored. All contrast media shall be evaluated and approved through the formulary process as determined by the Pharmacy & Therapeutics (P&T) Committee. Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 4 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: D. Medication Reconciliation Completion of medication reconciliation will be per hospital policy. [Hospital to include P&P as reference.] E. Screening 1. When appropriate, a recent (within the last 30 days) serum creatinine (SCr) shall be obtained and reviewed for potential contraindications in use of contrast. In the event a recent SCr is not available, an order to obtain an SCr prior to the scheduled procedure will be obtained. 2. In the event the screening process determines that the patient is at-risk for an adverse event due to administration of radiographic contrast media, the technologist/nurse is required to contact the physician or LIP for next step orders. At-risk patients can include, but are not limited to, those patients that: 3. a. are diabetic b. are taking a metformin-containing medication c. have reduced renal function, renal disease or a solitary kidney d. are pregnant or nursing e. have had a previous history of allergy or reaction to contrast media f. have had a clinically significant drug-contrast interaction g. have significant respiratory or cardiovascular disease h. are elderly See attached screening tool(s) (Attachment C) Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 5 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: 4. F. Administration 1. G. If hypersensitivity/allergy is noted to a radiographic contrast media, the physician or licensed independent practitioner will be notified prior to procedure for subsequent orders. A Radiologist, a Registered Nurse or an authorized Radiology Technologist may inject intravenous contrast agents for the purpose of the radiological procedure. a. administration must be within the individual’s scope of practice b. competency must be established for management of types of IV lines (e.g., peripheral vs. central line management) 2. Non-contrast medications used during the radiographic process may be administered by those individuals authorized by licensure, scope of practice, or organization policy to do so. 3. A physician shall be readily available to the patient before and during IV contrast administration in the event an adverse contrast event were to occur. 4. A pharmacist will be available if consultation is needed. 5. Prior to administration, the five rights of right patient, right medication (contrast), right dose, right route, and right time shall be performed. 6. Prior to administration, appropriate labeling will occur unless contrast is for immediate use. Labeling will include name of contrast, strength of contrast, amount of contrast, and expiration date/time when expiration occurs in less than 24 hours. The same labeling process is required when auto injectors are used. Monitoring Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 6 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: H. 1. All Radiographic Contrast Material are monitored for adverse drug reactions by the technologist/nurse/licensed independent practitioner. 2. If an adverse event/reaction was to occur, the physician/licensed independent practitioner will be notified immediately. Treatment will be rendered per physician order or emergent protocol. 3. Documentation of adverse events/reactions will be entered into the medical record. 4. In addition, adverse events/reactions will be entered into eSRM, the electronic safety and risk management incident reporting system. 5. In the event of an emergency situation, age-specific crash carts shall be readily available for use. 6. Pharmacy shall ensure that a retrospective medication review occurs periodically to determine that the screening system in place is being used and is effective in identifying potential adverse events and to maximize patient safety. Enforcement All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate disciplinary action pursuant to all applicable policies and procedures, up to and including termination. Such disciplinary action may also include modification of compensation, including any merit or discretionary compensation awards. V. REFERENCES: - Prescription drug information for consumers and Professionals (www.drugs.com) - The comprehensive resource for physicians, drug and illness information (www.rxmed.com) Clinical Quality Policies and Procedures No. CQ-3.006 Page: [INSERT HOSPITAL LOGO] RADIOGRAPHIC CONTRAST MEDIA 7 of 7 Origination Date: 10-16-09 Effective Date: 10-16-09 Retires Policy Dated: Previous Versions Dated: Hospital Governing Board Approval Date: - Contrast Medium Reactions, Recognition and Treatment (www.emedicine.com) Maddox TG, Am Fam Physician 2002; 66: 1229-34, Adverse reactions to Contrast Material: Recognition, Prevention and Treatment, 66 (7); 1229-1234; 2002) D.Kirchin MA, Contrast Agents for Magnetic Resonance Imaging, Top Magn Reson Imaging, 14(5); 426-435; 2003. - Rosovsky, MA, High-Dose Administration of Nonionic Contrast Media: a Retrospective Review; Radiology, 200: 119-12; 1996. - Medication Management and Contrast Media Discussion Guide, 2008. H. Cohen - ACR Practice Guidelines for Use of Intravascular Contrast Media (2006) http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/dx/iv_contrast.aspx - Overview of Contrast Media: Critical Knowledge for Health-Systems Pharmacists – 43rd ASHP Midyear Clinical Meeting and Exhibition. VI. ATTACHMENTS: - Attachment A: Oral/Rectal Radiographic Contrast Media Protocol [Hospital will use its established protocol] - Attachment B: Systemic Contrast Media Protocol [Hospital will use its established protocol] - Attachment C: Screening Tools [Hospital will use its established screening tools] - Attachment D: Radiology Guidelines and Procedure [Hospital will use its established formulary and guidelines or can create using examples included below.] Radiology Procedure Radiology Guidelines Protocols.doc and Procedure.doc Doc8.doc Doc9.doc