Delaware Health & Social Services Division of PUblic Health Laboratory INSTRUCTIONS FOR COMPLETING THE PREPAREDNESS REQUEST FOR TESTING FORM AND CHAIN OF CUSTODY FORM PLEASE notify the DPHL prior to collecting a sample to discuss specimen/sample type, to confirm testing methods available, and to coordinate transportation. This document is for Preparedness samples. Utilize the latest version of the Specimen Collection Protocol to determine the specimen collection and storage criteria prior to testing. ALL PREPAREDNESS SAMPLES: Chain of Custody: Each person who accepts custody of a legal sample also accepts responsibility for ensuring the security of that sample. A sample is considered under custody if it is in your possession, in your view after being in your possession, or placed in a secure area (i.e., sealed container for shipping or an area accessible by authorized personnel only) after being in your possession. If a legal sample is to be left unattended, it should always be stored in a locked compartment. When possible the sample transport container should also be locked or sealed (i.e. evidence tape or other custody seal) in a manner to detect tampering. 1. The collector initiates the Chain of Custody. a. Include the printed name and signature of personnel collecting samples. b. Note the date and time of sample collection - It is recommended that all time be recorded using 24-hour notation (e.g., 2:00 PM is 1400 hours). c. A separate Chain of Custody for Clinical Preparedness Samples form is necessary for each patient. d. A separate Chain of Custody for Environmental Preparedness Samples form is necessary for each container. 2. Complete the Time of day and calendar date of each transfer or handling procedure. 3. The COC establishes an intact, contiguous record of the physical possession including collected samples, sample aliquots, and sample extracts, or digestates. a. Detail the number of sample containers. (Count each of the 3 vials submitted for a single VOA sample, i.e. 1 sample = 3 containers) b. Bioterrorism clinical isolates do not require a chain of custody as their collection and custody cannot be proven. These specimens do require completion of a Request for Preparedness Testing Form. c. Use a unique identification code (preferably LIMS barcode stickers) for each sample and container. If LIMS barcodes are not available, use the two-digit year followed by the two-digit month then two-digit date followed by an incrementing two-digit number Add an alpha character to differentiate collection sites. (i.e., 071201-3A would be the third sample collected on 01 December 2007 at the first site). d. DPHL staff will assign a unique LIMS identification code upon receipt of the specimen at DPHL. 4. Record the printed name and signatures of all individuals who are actively involved with physically handling the samples on the COC form. Include all receivers and relinquishers (transferors and transferees). a. In order to simplify record keeping, the number of people who physically handle the sample should be minimized. 5. Detail a short statement that describes the activity of the signatory (i.e., transported to DPHL, transferred to DNREC, etc.) to accompany each signature. a. The COC records shall account for all time periods associated with the sample. b. If samples are stored in the field prior to delivery to the laboratory, detail the location, storage conditions (i.e., chemical or thermal preservation), and security condition (i.e., locked or sealed cooler) of those samples on the COC form. c. Detail sample destruction or disposal on the COC form. 6. Seal transport containers with a tamper-proof custody seal and a strapping or sealant tape. a. The custody seal must have space for the signature of the person who affixed the seal along with the date and time. b. Place the seal so that the transport container cannot be opened without breaking the seal. c. Record the time, calendar date, and signatures of responsible personnel affixing and breaking all seals shall on the COC form. d. When sample containers are shipped by a common carrier, include all common carrier and/or shipping documentation. These documents must be completed and retained with the sample file. 7. Shipping bills (i.e., Federal Express, UPS, etc.) will be retained with the COC or field sheet. Local samples are transported to the lab by DNREC personnel or other authorized personnel. The DPHL courier may be utilized to transport clinical specimens. 8. Make all record entries with waterproof ink. Don not obliterate entries by erasures or markings in records. All corrections to record-keeping errors shall be made by one line marked through the error. The individual making the correction must sign (or initial) and date the correction. 9. Utilize a waterproof, sealable bag or zipper bag to maintain all records in a manner that facilitates documentation tracking and allows historical reconstruction of all analytical events and ancillary procedures that produced the resultant sample analytical data. Request for Preparedness Testing: A Request for Preparedness Testing must be completed for each sample batch submitted for testing and must accompany the Chain of Custody Form. This document details the specimen sampling site and address, the requested analyses, any field sample triage testing, storage conditions, etc. Only ONE Request is needed per batch of samples submitted. 1. Detail the number of specimens in each category. Multiple containers and sample types may be submitted with the same form. However, clinical and environmental specimens may not be submitted on the same form. Submit clinical and environmental samples separately. 2. Provide a detailed description of the samples, include container type, number of specimens, the sampling site name, and address. 3. Detail the types of testing requested. Each specimen may have different testing performed, however, this must be detailed specifically on the form. Detail any preservatives used or field triage performed. 4. Include the submitters contact information: name, organization, address, office phone, cellular phone, email address, and any other pertinent site collection information. Sample Transport: Transport all documentation and specimens together. 1. The completed Chain of Custody form, the appropriate Request for Preparedness Testing (Clinical ot Environmental), and any other supporting documentation, should be sealed tightly in its own plastic zip-lock bag and attached to the exterior of the secondary container of the sample transport container. 2. The submitter is responsible for ensuring sample security as long as the specimen is in their custody. 3. When the custody of the sample is transferred, each receiver will document sample receipt and release. 4. Copies of the chain of custody form may be provided to submitters, the original remains with the sample. 5. Samples may be delivered to the laboratory using any of the following methods: a. Delivery by the Submitter: Contact DPHL at 302.223.1520 prior to transport/delivery. b. DPHL courier: Call 302.223.1520 to arrange pickup. Please keep in mind that using the DPHL courier may increase transport time. c. Professional Carrier: FedEx, DHL, or UPS. Specify rush delivery. Use the appropriate Packing Instruction. Sample Packaging: Correctly preserving and preparing samples for transport is critical to ensuring the integrity of the sample and the safety of those handling these samples. Steps for preparing samples for transport are as follows . 1. The submitter should contact the Delaware Public Health Laboratory (DPHL) at 302.223.1520 to answer any questions related to any aspect of sample collection, preservation, packaging, and/or transport. 2. Samples must be labeled and tightly sealed in a container (blood tube, specimen cup, etc). 3. Prepare specimens for air transport. Place clinical specimens in a rated secondary container (such as a rigid transport container). 4. Place in a transport container, preferably a cardboard box made for shipment (Class 6.2 infectious substances for clinical samples). 5. Fill container with bubble wrap, Styrofoam peanuts, etc. to prevent breakage of sample. 6. If ice or ice packs are necessary for transport, contain the ice so that leakage into specimen or out of the transport box is avoided. 7. Transport containers should be secured with evidence tape or a custody seal. The signature of the person sealing the evidence with the date must be written across the seal in indelible ink. 8. Mark on the outside of the transport container: Send to: Delaware Public Health Laboratory Attn: Preparedness Laboratory 30 Sunnyside Road Smyrna, Delaware 19977 9. Complete any additional required paperwork. Attach chain of custody, request for testing, and any additional forms to the box according to the instructions above. Biological Preparedness Samples: Contact DPHL Microbiology Section at 302.223.1520. Additional Sample Packaging requirements: 1. Refer to DPHL Specimen Collection Guidelines for Bioterrorism Samples. Chemical Preparedness Samples: Contact DPHL Chemical Preparedness Section at 302.223.1520. Additional Sample Packaging requirements: 1. Refer to DPHL Specimen Collection Guidelines for Chemical Exposure Samples. 2. Clinical chemical exposure sample collection must follow CDC’s “Chemical Exposure Event Specimen Collection”. 3. Follow packaging guidelines for clinical samples provided in the CDC document “Shipping Instructions for Specimens Collected from People Potentially Exposed to Chemical Agents”. 4. Samples must be labeled and tightly sealed in a container (rated jar, blood tube, specimen cup, etc.). a. Follow Packing Instruction 650 (Biological Substance Category B) for clinical samples. b. Environmental samples must minimally be double bagged with the exterior decontaminated. Utilize drinking water sampling bottles for large volume samples. 5. The initials of the person sealing the evidence and the date must be across the seal of all containers and bags in indelible ink. 6. At each step of packaging, all closure points (tube or cup, bags, boxes, containers, etc.) must be sealed with evidence tape with the collector’s initials written half on and half off the tape. a. Place in a transport container, preferably a cardboard box made for shipment (clinical specimens must comply with Packing Instruction 650). b. Fill container with enough sorbent to prevent breakage of sample. Contain ice packs or dry ice so that leakage into specimen or out of the transport box is avoided. c. Urine samples must be frozen or freeze in shipment, dry ice is recommended. d. Blood tubes must NOT freeze, but be chilled, ice packs are recommended. e. Blood and urine must be packaged and shipped separately. 7. Follow Packing Instruction 904 if using dry ice. 8. If directed to ship clinical samples to CDC: a. Contact DPHL for further directions and shipping address. b. Follow guidelines provided in the CDC document “Shipping Instructions for Specimens Collected from People Potentially Exposed to Chemical Terrorism Agents”. 9. If directed to ship environmental samples to a network or affiliate laboratory: a. Contact DPHL for further directions and shipping address. b. Follow guidelines provided in IATA’s Dangerous Goods Regulations, Section 3.11 “Transporting Samples for Further Testing” and US DOT 49 CFR 173.156 “Exceptions for ORM Materials”. Revised 07/01/08 F:\SHARED\PreparednessProtocols\DPHL Instructions for Completing the Preparedness Request for Testing Form and Chain of Custody Form r070108 Delaware Public Health Laboratory . 30 Sunnyside Road . Smyrna, DE 19977 . (302) 223-1520 [p] · (302) 653-2877 [f] DPHL Instructions For Completing The Preparedness Request For Testing Form And Chain Of Custody Form Updated 07/01/08