Title of Manual: Specimen Collection Document Number: GPA.SPC.49.0

Transcription

1 Page 1 of 5 I. PURPOSE The packaging and shipping of clinical laboratory specimens to prevent spills during transport is regulated by the U.S. Department of Transportation (DOT), the U.S. Postal Service (USPS) and the International Air Transport Association (IATA). DOT has regulatory authority for hazardous materials transported in, from, and through the country by any mode except the U.S. Mail. This regulatory authority includes establishing training requirements and ensuring compliance through on-site inspections. The hazardous materials regulations (HMR) have a two tiered classification system for infectious substances; Category A and Category B. The purpose is to establish a procedure for phlebotomist to safely and legally transport medical specimens to Greensboro Pathology while maintaining specimen integrity. This applies to all phlebotomist who have been trained to package and/or transport infectious substances and diagnostic specimens. 1. Infectious Substance: OSHA Division 6.2 hazardous substance; substances which are known to contain, or are reasonable expected to contain, pathogens. Pathogens are defined as microscopic organisms (bacteria, viruses, parasites, fungi) and other agents which can cause disease in humans or animals. An infectious substance must be classified as a Category A or Category B. Classification must be based on known medical history, symptons of the source patient, or professional judgment concerning the individual circumstances of the sours human. When samples are shipped commercially, these samples are classified as 6.2 (infectious substances) Category B. 2. Category B: an infectious substance that is not in a form generally capable of causing permanent disability or life threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes category B infectious substances transported for diagnostic or investigational purposes. A category B infectious substance must be described as Biological Substance, category B and assigned identification number UN Culture: An infectious substance containing a pathogen that is intentionally propagated. A culture was derived from a specimen but does not include a human or animal patient specimen. 4. Patient Specimen: Human or animal materials collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, urine, tissue, tissue swabs, body parts, and specimens in transport media (e.g. transwabs, culture media, and blood culture bottles)

2 Page 2 of 5 II. MATERIALS Reagents Supplies Equipment III. PROCEDURE Proper Speciman Transport Bags Cooler to Protect From Weather Cold packs/dried Ice 1. TRAINING a. Employees involved in transportation of dangerous goods (including diagnostic specimens and infectious substances) must be trained in the shipment of dangerous goods. b. Each employee will retrain every two years to meet regulatory requirements. c. Training curriculum consist of : i. The employee s reading of this procedure which represents a general awareness and familiarity with the aspects of transporting dangerous goods and the importance, nature and contents of IATA, USPS, and DOT regulations. Completion of computer based training and quiz as required and supplied by Greensboro Pathology. The employees reading of the Shipping Diagnostic and Infectious i Specimens as provided by Greensboro Pathology. Bloodborne pathogen training is included in both new hire orientation and annual safety training curriculum which is required of every employee. Documentation is stored in the employees personnel file. d. A record of training is available upon request to the appropriate authorities. 2. TRANSPORTATION a. Specimens are separated and stored according to required transport temperature transport before being transported ambient, refrigerated, or frozen. b. Ground carrier must follow DOT regulations, 49 CFR as outlined below. c. Title 49 CFR Basic Requirements. i. Diagnostic specimens must be packaged in a triple packaging, consisting of a primary receptacle, a secondary packaging, and an outer packaging. Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging.

3 Page 3 of 5 i iv. Secondary packaging must be secured in outer packaging with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or the outer packaging. The complete package must be capable of successfully passing the drop test at a drop height of at least 1.2 meters (3.9 feet). The outer packaging must be clearly and durably marked with the words Diagnostic Specimen d. Title 49 CFR Liquid Samples packaging requirements. Liquid diagnostic specimens must be packages in conformance with the following provisions i. The primary receptacle must be leak proof with a volumetric capacity of not more than 500 ml (16.0 ounces) Absorbent material must be placed between the primary receptacle and secondary packaging. If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them. The absorbent material must be of sufficient quantity to absorb the entire contents of the primary receptacles. i The secondary packaging must be leak proof. iv. For shipments by air craft, the primary receptacle or secondary packaging must be capable of withstanding without leakage, an internal pressure producing a pressure differential of not less than 95 kpa (0.95 bar, 14 psi). v. The outer packaging may not exceed 4 L (1 gallon capacity). e. Title 49 CFR Solid Samples packaging requirements. Solid diagnostic specimens must be packaged in a triple packaging, consisting of a primary receptacle, secondary packaging, and outer packaging, conforming to the following provisions. i. The primary receptacle must be sift proof with a capacity of not more than 500 g (1.1 pounds). i iv. If several fragile primary receptacles are placed in a single secondary packaging they must be individually wrapped or separated so as to prevent contact between them. The secondary packaging must be leak proof. The outer packaging may not exceed 4 kg (8.8 pounds) capacity. 3. During transportation, containers must be placed in the back of a vehicle on in a trunk. 4. If a spill occurs, report immediately to the closest Greensboro Pathology collection site and report the spill to management.

4 Page 4 of 5 This procedure is not intended to serve as a comprehensive training program for the Department of Transportation (DOT) training requirements. IV. QUALITY CONTROL V. CALCULATIONS/CALIBRATION VI. INTERPRETATIONS VII. METHOD PERFORMANCE SPECIFICATIONS VIII. REFERENCES 1. Department of Transportation Hazardous materials Regulations (HMR; 49CFR Parts ) 2. The United States Occupational Safety and Health Administration (OSHA) 3. IATA Regulations IX. RELATED DOCUMENTS

5 Page 5 of 5 X. DOCUMENT HISTORY Minor Revision (Laboratory Director s Signature on Original Subsequent Document Attached) Major Revision (Requires Laboratory Director & Department Director Signature - where applicable) Reason for Change 2/10/14 New Document Control Format 6/23/14 Moved to Manual Laboratory Director: Natalie Depcik-Smith, M.D. Department Director: Robert M. Gay, M.D. Designee: