1. (1) Designation of Collection Sites. For urine, blood, oral fluid and hair specimen collection, each laboratory, that has a contract or agreement for testing services with an employer, shall provide collection sites under contract and training for collectors, or shall provide a trained collector to collect specimens for the employer at any time designated by the employer in his contract or agreement with the laboratory. The collector shall be responsible to the laboratory for implementing collection procedures and chain of custody procedures as designated in Chapter 59A-24, F.A.C. The laboratory shall provide to the collection site, or collector, specimen collection kits which, as applicable, shall contain chain of custody forms, as required by subsection 59A-24.005(2), F.A.C., mailing boxes or containers, specimen identification labels, laboratory address labels, urine specimen bottles, FDA approved oral fluid collection devices, external temperature strips, tamper-proof plastic sealable bags and forensic tamper-proof tape to seal the specimen container(s). Kits for alcohol testing must have a 7ml blood vial that contains an anticoagulant and a preservative of sodium fluoride. An oral fluid collection device must not be used if the device’s expiration date has passed. Employers who do not use hair testing for their drug-free workplace program shall not be required to maintain collection facilities and personnel as described in Section 112.0455(13)(b)3.a., F.S. Employers that choose to use hair as a specimen for testing shall meet the requirements found in Section 112.0455(13)(b)3.a., F.S.

2. (2) Chain of Custody Form and Procedures. Chain of custody refers to the methodology of documenting the tracking of specified materials or substances for the purpose of maintaining control and accountability from initial collection to final disposition of all such materials or substances and providing for accountability at each stage in handling, testing, storing and reporting of the test results.

   1. (a) A chain of custody form shall be completed for each donor tested.
   2. (b) Each laboratory licensed under these rules shall provide chain-of-custody forms to be used for each donor.
   3. (c) All chain of custody forms shall provide a unique identifier which shall not be used to identify any other Florida Drug Free Workplace specimen. The employer is permitted to assign an employee identification number for use with each donor tested.

   4. (d) The design of the chain of custody forms shall meet the following requirements:

      1. Prominently indicate the name and address of the laboratory performing the drug test(s).

      2. A section to be completed by the collector or employer respresentative that solicits the following information:

      a. Employer name and address;

      b. Medical review officer name and address;

      c. Employee identification number;

      d. Reason for the test(s); and,

      e. Test(s) to be performed.

      3. A section which indicates the temperature of urine specimens taken within 4 minutes of collection. This shall not be required for chain-of-custody forms for blood, oral fluid, or hair specimens.

      4. A section to be completed by the collector that indicates the following:

      a. The collection facility name, address and telephone number;

      b. A designation that a split sample was or was not collected;

      c. A remarks section;

      d. A statement for the collector to sign incorporating the following language: I certify that the specimen identified on this form is the specimen presented to me or collected by me from the donor providing certification on Copy 4 of this form, that it bears the same identification number as set forth above, and that it has been collected, labeled and sealed in accordance with the Florida Drug-Free Workplace as found in Sections 112.0455, 440.102, F.S., and Chapter 59A-24, F.A.C.; and,

      e. A place for the collector to print his name, a place for the collector’s signature and the date and time.

      5. A section to be initiated by the collector and completed as necessary thereafter that documents the transfer of the specimen for the purpose of maintaining control and accountability for the specimen. At a minimum, this section shall indicate:

      a. Date of transfer;

      b. Signature and name of the person releasing the specimen;

      c. Signature and name of the person receiving the specimen; and,

      d. Purpose of the transfer.

      6. A section to be completed by the laboratory which indicates the following:

      a. An indication as to whether the specimen was received with intact specimen seals;

      b. The test results;

      c. Contains the following statement for the certifying scientist to sign: I certify that the specimen identified by the laboratory accession number on this form is the same specimen that bears the specimen identification number set forth above, that the specimen has been examined upon receipt, handled and analyzed in accordance with the Florida Drug-Free Workplace Program requirements as found in Sections 112.0455, 440.102, F.S., and Chapter 59A-24, F.A.C., and that the results set forth are for that specimen; and,

      d. A place for the certifying scientist to print his name, the signature of the certifying scientist and the date.

      7. A section to be completed by the Medical Review Officer including the following:

      a. The statement: I have reviewed the laboratory test(s) for the specimen identified by this form in accordance with the Florida Drug-Free Workplace Program as found in Sections 112.0455, 440.102, F.S., and Chapter 59A-24, F.A.C.;

      b. A space for determination of test results as one of the following:

      I. Negative;

      II. Positive;

      III. Test not performed; and,

      IV. Test canceled.

      c. A place for remarks;

      d. The signature of the Medical Review Officer; and,

      e. The name of the Medical Review Officer and the date.

      8. The chain of custody form shall be comprised of the following copies for distribution:

      a. Original laboratory copy (Copy 1) which shall be routed to the laboratory with the specimen; the laboratory will retain upon the completion of testing.

      b. Second Original Laboratory copy (Copy 2) which shall be routed to the laboratory with the specimen; as a means of reporting the test result, the laboratory will forward the copy to the Medical Review Officer.

      c. Split specimen copy (Copy 3) which must accompany the split portion to the laboratory. Split sample testing is optional.

      d. Medical Review Officer copy (Copy 4) which shall be routed directly to the MRO by the collection site personnel; this form copy is not to be sent to the laboratory.

      e. Donor copy (Copy 5) which shall be given to the donor by the collector. Do not send to the laboratory.

      f. Collector copy (Copy 6) which shall be retained by the collector. Do not send to the laboratory.

      g. Employer copy (Copy 7) which shall be forwarded to the employer.

   5. (e) The form shall contain no information which can be traceable to the donor except the unique identifier, the employee identification number, if used, and the laboratory’s specimen identification number.
   6. (f) The form shall also contain the following list of over-the-counter and prescription drugs which could alter or affect a test result. Due to the large number of obscure brand names and constant marketing of new products, this list, as follows, is not intended to be all-inclusive.

1. (g) Handling and transportation of a specimen from one authorized individual or place to another shall always be accomplished through the chain of custody form and procedures. The chain of custody form shall be used for maintaining control and accountability of each specimen from the point of collection to final disposition of the specimen at the laboratory. The purpose of the transfer of possession, the name and signature of the person releasing and receiving the specimen, and the date shall be documented on the form each time a specimen is handled or transferred and every individual in the chain shall be identified. Since the specimen and the chain of custody form are sealed in tamper-proof sealable plastic bags that would indicate any tampering during transit to the laboratory, and since couriers, express carriers and postal service personnel do not have access to the chain of custody forms, there is no requirement that such personnel document chain of custody for the shipping container during transit. Nor is there a requirement that there be a chain of custody entry when a specimen which is sealed in such a shipping container is placed in or taken out of secure storage at the collection site prior to pickup by such personnel. A test shall not be canceled because couriers, express carriers, postal service personnel or other persons involved solely with the transportation of a specimen to a laboratory have not documented their participation in the chain of custody or because the chain of custody does not contain entries related to placing the specimen in or removing it from secure temporary storage at the collection site.
2. (h) Once the specimen has arrived at the laboratory, an internal chain of custody form shall be used by the laboratory until the laboratory has finalized the test results.
3. (i) Every effort shall be made to minimize the number of persons handling the specimens.

4. (3) Security Procedures and Specimen Collection. Collection site security and specimen collection security are the responsibility of the collector through contract with the licensed laboratory. Security procedures shall provide for the designated collection site to be secure including the providing of privacy for the donor and the integrity of the specimen.

   1. (a) Access to Authorized Personnel Only. No unauthorized personnel shall be permitted in any part of the designated collection site when specimens are collected or stored.
   2. (b) Privacy. Procedures for collecting urine specimens shall allow individual privacy unless there is reason to believe that a particular individual intends to alter or has altered or substituted the specimen to be provided.

   3. (c) Integrity and Identity of Specimen. The collection site person shall take precautions to ensure that a specimen not be adulterated or diluted during the collection procedure and that information on the collection bottle and on the chain of custody form can identify the individual from whom the specimen was collected. The following minimum precautions shall be taken to ensure that unadulterated specimens are obtained and correctly identified.

      1. To prevent specimen contamination at the collection site:

      a. For urine specimens, toilet bluing agents shall be placed in toilet tanks so the reservoir of water in the toilet bowl always remains blue. There shall be no other source of water in the enclosure or partitioned area where urination occurs. All other sources of water shall be controlled by the collector.

      b. For oral fluid specimens, there shall be no source of water or other fluids in the area where collection occurs. All sources of water shall be controlled by the collector.

      2. When a donor arrives at the collection site, the collection site person shall request the donor to present a photo identification. If the donor does not have the proper photo identification, the collection site person shall contact the employer who can positively identify the donor. If the donor’s identity cannot be established, the collection site person shall not proceed with the collection. The collection site person shall document the reason for not collecting the specimen and provide the donor with a copy of this documentation.

      3. Before collecting a specimen, the collection site person shall check to see that the donor has a chain of custody form or has a letter from the employer authorizing the drug test. If a letter is used, the letter shall contain the following information:

      a. The name of the individual to be tested;

      b. The name of the employer and the employer’s address, phone number, and fax number;

      c. The name, address and phone number of the laboratory with which the employer has contracted or established an agreement for testing services;

      d. The name, address, phone number, and secured fax number of the employer’s Medical Review Officer;

      e. The reason for the test (i.e., either job applicant, reasonable suspicion, routine fitness, or follow-up to treatment);

      f. The drugs for which the laboratory will test; and,

      g. The signature of the employer’s representative authorizing the testing.

      4. If a collection time is assigned by the employer or collection site, and the donor fails to arrive at the collection site at the assigned time, the collection site person shall notify the employer of the missed appointment.

      5. The collection site person shall ask the individual to remove any unnecessary outer garments, such as a coat or jacket, and to empty all clothing pockets. The collection site person shall ensure that all personal belongings, such as a purse or briefcase, remain with the outer garments. The individual may retain his or her wallet, provided that the collection site person shall check it for possible contaminants.

      6. For urine specimens, the individual shall be instructed to wash and dry his or her hands prior to urination. After washing hands, the individual shall remain in the presence of the collection site person and shall not have access to any water fountain, faucet, soap dispenser, cleaning agent or any other materials which could be used to adulterate the specimen. The individual may provide his or her urine specimen in a stall or otherwise partitioned enclosure that allows for individual privacy. The collection site personl shall remain in the restroom or area, but outside the stall or partitioned enclosure.

      7. For oral fluid specimens, the individual must remain in the presence of the collector and shall not have access to any water fountain, faucet, or any other materials which could be used to adulterate the specimen.

      a. The collector shall inspect the individual’s oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen (e.g., candy, gum, food, tobacco, abnormally colored saliva) or could be used to adulterate, substitute, or dilute the specimen. If an item is present that appears to have been brought to the collection site with the intent to adulterate, substitute, or dilute the specimen, or if the individual refuses to remove an item, this is considered a refusal to test and the collector must stop the collection and report the refusal to test.

      b. If the individual has abnormally colored saliva or claims to have dry mouth, the collector can give the individual up to 4 ounces of water to rinse the oral cavity with. The collector must wait 10 minutes before collecting the specimen. If the individual refuses to rinse, this is a refusal to test.

      c. If the individual is unable to provide an adequate specimen within 15 minutes of using the collection device, the collector can give the individual up to 8 ounces of water and wait an additional 10 minutes before collecting the specimen.

      d. A period of 1 hour must be provided or until the individual has provided a sufficient oral fluid specimen. If the individual needs more time before attempting to provide an oral fluid specimen, the individual is not required to drink any fluids during the 1 hour wait time. The collector must inform the individual that the individual must remain at the collection site in an area designated by the collector during the wait period.

      8. Upon receiving the specimen from the individual, the collection site person shall determine that:

      a. Urine specimens contain at least 30 milliliters (mL) of urine. The approximate volume of the specimen shall be documented by the collector at the time of collection. If there is less than 30 mL of urine in the container, another urine specimen shall be collected in a separate container. Collected specimens which contain less than 30 mL of urine shall not be submitted to the laboratory for testing. Such specimens shall be discarded in the presence of the donor and such procedure shall be annotated by the collector on the chain of custody form. The collector is permitted to give the donor water to drink for the purpose of providing another urine specimen not to exceed an 8 ounce glass of water every 30 minutes for up to 2 hours. If the donor still fails to provide 30 mL of urine, the collection site person shall reschedule another collection within 24 hours and notify the employer as soon as possible of such rescheduling.

      b. Blood alcohol specimens shall be collected using aseptic venipuncture technique. The venipuncture site for blood alcohol shall be cleansed with a non-alcoholic antiseptic substance prior to collection. Blood specimens shall contain 7 mL of blood which shall be collected in one tube containing an anticoagulant and a preservative of sodium fluoride. Immediately after collection, the collection site person shall rock the tube gently to mix the anticoagulant and preservative substance with the blood.

      c. Oral fluid specimens contain at least 1 milliliter (mL) of undiluted (neat) oral fluid for each specimen.

      d. A quantity of hair shall be collected as described in Section 112.0455(13)(b)3.f.(IV), F.S.

      9. After a urine specimen has been provided and submitted to the collection site person, the individual shall be allowed to wash his or her hands.

      10. No longer than 4 minutes following collection, the collection site person shall measure and record the temperature of the urine specimen, as indicated, on the chain of custody form. The temperature measuring device must be placed on the outside of the container to prevent contamination. If the temperature measurement exceeds 4 minutes, the specimen shall be rendered invalid and shall be rejected. A second specimen shall be collected and a new chain of custody form generated.

      11. If the temperature of a urine specimen is outside the range of 90o-100o degrees fahrenheit, there is reason to believe that the donor may have altered or substituted the specimen and another urine specimen shall be collected under direct observation by an observer of the same gender as the donor, as specified in subparagraph 59A-24.005(3)(c)13., F.A.C. The reason for the observed collection and the identity of the direct observer shall be documented on the chain of custody form.

      12. Immediately after a urine specimen is collected, the collection site person shall also inspect the specimen to determine its color and look for any signs of contaminants. Any unusual findings shall be noted on the chain of custody form.

      13. Whenever a collection site person has reason to believe that a particular individual may alter or has altered or substituted a urine specimen, a higher level supervisor at the collection site or at the laboratory shall review the decision and concur in advance with the collection of a second specimen under the direct observation of an observer of the same gender as the donor. Once approved by a higher level supervisor, the collector shall require the individual to provide another specimen under direct observation. If the same gendered observer is not the collector, the observer shall be identified on the chain of custody form. The observer, if different from the collector, shall not handle the specimen and the specimen shall be handed to the collector by the donor in the observer’s presence. The observer shall keep the specimen in sight at all times prior to it being sealed. A new chain of custody form shall be executed to accompany any specimen collected under direct observation. Information regarding a specimen collected under direct observation shall be included on both the new chain of custody form and on the original form in the remarks section. In addition, the new chain of custody specimen identification number shall be annotated on the original form. Both specimens shall be sent to the laboratory to be analyzed.

      14. The individual being tested, the collection site person, and the observer if used for direct observation, shall keep the specimen in view at all times prior to its being sealed and labeled.

      15. The collection site person shall place securely on the specimen bottle, tube, or container an identification label containing the donor’s specimen number, which matches the specimen number on the chain of custody form, and the date.

      16. The employee (donor) and the collector shall initial the identification label on the specimen bottle, tube, or container for the purpose of certifying that it is the specimen collected from the donor.

      17. The collector shall enter on the chain of custody form all required information.

      18. The individual shall be asked to sign a statement on the chain of custody form certifying that the specimen identified as having been collected from him or her is in fact that specimen he or she provided. It shall be noted and signed on the chain of custody form by the collection site person, with a witness’ signature, if the individual refuses to sign this statement.

      19. The collection station is permitted to store unrefrigerated urine specimens up to 72 hours after collection, provided they are sealed for shipment as described in subparagraph 59A-24.005(3)(c)21., F.A.C., and kept in locked, secure temporary storage. Hair specimens shall be stored at all times in unrefrigerated locked, secured storage.

      20. While any part of the above chain of custody procedures is being performed, it is essential that the specimen and the chain of custody form be under the control of the collection site person. If the collection site person leaves his or her work station momentarily, the specimen and the chain of custody form shall be taken with him or her or shall be secured in a locked room, drawer, file cabinet, etc. After the collection site person returns to the work station, the chain of custody process will continue. If the collection site person is leaving for an extended period of time, the specimen shall be packaged for shipment before he or she leaves the site.

      21. The collection site person shall arrange to send the collected specimens by express shipment, courier, or U.S. Mail to the drug testing laboratory which is designated by the employer. The specimens shall be placed in containers designed to minimize the possibility of damage during shipment. Prior to shipping or storage, the collection site person shall ensure that:

      a. The specimen container is sealed with forensic tamper-proof tape;

      b. The forensic tamper-proof tape contains the initials of the donor, the date the specimen was sealed in the specimen container; and,

      c. The completed chain of custody form and specimen container is enclosed and sealed in a tamper-proof sealable plastic bag before packaging for shipment to the drug testing laboratory.

      22. This rule chapter does not prohibit the use of split samples provided that such samples are collected in the same manner as required in the Mandatory Guidelines for Federal Workplace Drug Testing Programs, Mandatory Guidelines using Urine, or Mandatory Guidelines using Oral Fluid as defined in Rule 59A-24.003, F.A.C.

Rulemaking Authority 112.0455(13)(a), 440.102(10) FS. Law Implemented 112.0455, 440.102 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.005, Amended 5-1-96, 3-11-98, 3-29-00, 5-9-18, 4-9-26.