10- 144 C.M.R. ch. 270, § 2 - Collection And Storage Of Specimens

A. For all testing under this rule, the specimen to be collected must be the subject's urine or blood. The collection of any specimen for use in a substance use test must be performed in a manner that is consistent with specimen collection and labeling standards contained in this rule and the professional training of the person collecting the specimen.

1. Specimen collection and labeling

a. Urine samples may be collected only within a law enforcement or healthcare facility. (29-A § 2527(2).) The collection area for urine must be a toilet facility equipped with a toilet and a sink for washing after specimen collection. The facility must be enclosed in such a way as to ensure the subject privacy from observation, except as provided in Section 2(A)(1), paragraph d, below. Except in the case of emergency, no other person, other than a law enforcement officer or law enforcement representative or a healthcare practitioner, is permitted to enter the toilet facility during collection.

b. Urine specimens must be collected in new, clean containers manufactured for the purpose of urine collection. The container must be sealed and labeled immediately after collection and specimen assessment in a manner which will prevent or reveal tampering with the specimen. The specimen container must be clearly and indelibly labeled with the date and time of collection and the name or other identifier associated with the subject from whom the specimen was obtained. A responsible person who performed or witnessed the collection and who assumes responsibility for the chain of custody must initial or sign and mark the time and date for each specimen on the kit collection worksheet.

c. To ensure accurate and reliable testing and to protect the privacy of the person providing the sample, only a law enforcement officer or law enforcement agency employee of the same sex as the person providing the sample, or a health care practitioner, may observe the individual giving the urine sample. Such observation must be conducted in such a manner as to minimize the violation of the subject's privacy.

d. Blood specimens must be collected in HETL-approved collection kits or a collection tube normally used in a laboratory. All samples must be sealed with tamperproof seals upon submission. Blood specimens must be collected by a qualified person, as described in 29-A MRS § 2524(1). Each specimen container must be clearly and indelibly labeled with the date and time of collection and the name or other identifier associated with the person from whom the specimen was obtained. The time and date for each specimen must be initialed or signed by a responsible person who performed or witnessed the collection and who assumes responsibility for the chain of custody.

e. Whenever possible, the Health and Environmental Testing Laboratory (HETL) must reserve a portion of the specimen collected to ensure that enough remains for subsequent re-analysis, if required or requested. At the request and expense of the person charged, the HETL will segregate an available portion of the sample collected for that person's own further testing. Any segregated samples will be released for further testing upon approval from the agency that submitted the sample or the District Attorney's office.

f. The HETL will provide to law enforcement agencies upon request approved specimen collection kits which include acceptable materials for packing and transportation of urine and blood samples.

2. Specimen handling

a. A chain-of-custody form must accompany specimens from the place of collection to the laboratory and be designed for compliance with 29-A MRS § 2431(2)(J). The chain-of-custody form must include: the individual(s) or location(s) transferring and receiving the item(s); the item(s) being transferred; and the chronological order of all transfers, minimally including the date, and may be incorporated in the laboratory request form. HETL, upon receipt of the sample, will document the handling, analysis and storage of the specimen on a separate form.

b. Handling, storage, and transportation of a specimen from one individual or place to another must be completely and accurately documented on the chain-of-custody form.

c. The chain-of-custody form must be completed by personnel with custody of the specimen.

d. Every effort must be made to minimize the number of persons handling a specimen.

e. Individual specimens must be properly sealed during transportation and stored in such a manner as to minimize the possibility of degradation, contamination, tampering and damage in shipment.

f. The condition of the external package, including whether it is sealed or unsealed, must be documented upon receipt at the laboratory, either on the requisition form that accompanies the specimen(s), in the log book, on the external chain-of custody form, or on other documents that constitute normal laboratory records.

g. Acceptable means of transporting specimens to the laboratory include hand-delivery, national postal service, or a private or government courier service, and must comply with all requirements regarding the continuity of custody of physical evidence.

3. Specimen Receipt

a. The means of delivery of specimens must be recorded by the receiving laboratory.

b. Shipping containers must be opened only in a secure area and only by an individual designated to record receipt of specimens. A "secure area" is an area to which unauthorized individuals either do not have access, or have access only when escorted by authorized personnel.

c. A record of receipt of the specimen must be permanently maintained. This record may be computer-generated, typed, or hand-written.

d. Specimens must be logged-in immediately upon receipt, or as soon as is practicable thereafter, and stored in a refrigerator or freezer, depending on sample type, to prevent sample degradation.

e. The integrity of the individual specimen container and the condition of each specimen must be checked to ensure no obvious damage, tampering or leakage has occurred. Any issues with the condition of the specimen or discrepancies between the submitted paperwork and the sample must be recorded.

Notes

10- 144 C.M.R. ch. 270, § 2