Appendix_A_specimen-collection-handbook-2014.pdf

Department of Health and Human Services Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

Urine Specimen Collection Handbook for

Federal Agency Workplace Drug Testing Programs

EFFECTIVE MAY 31, 2014

Note: This manual applies to federal agency drug testing programs that come under Executive Order 12564 dated September 15, 1986, section 503 of Public Law 100-71, 5 U.S.C. section 7301 note dated July 11, 1987, and the Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (69 FR 19644) dated November 25, 2008 (effective October 1, 2010).

This manual does not apply to specimens submitted for testing under U.S.

Department of Transportation (DOT) Procedures for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR Part 40).

Previous Versions of this Handbook are Obsolete

Table of Contents

Chapter 1. The Collector

Chapter 2. Collector/Collection Site Records

Chapter 3. The Collection Site

Chapter 4. Federal Agency Blind Samples

Chapter 5. The Federal Drug Testing Custody and Control Form (Federal CCF)

A. Use of an Electronic Federal CCF

B. Federal CCF Requirements

C. Federal CCF Instructions for Use

D. Federal CCF Distribution

Chapter 6. Verification of Donor Identity

Chapter 7. Urine Specimen Collection

A. Collection Site Security

B. Collection Supplies

C. Collection Procedure

D. Direct Observed Collection

E. Monitored Collection

F. Insufficient Specimen

Chapter 8. Miscellaneous Collection Issues

A. Donor Conduct

B. Refusal to Test

Chapter 9. Collector Errors

Chapter 1. The Collector

A collector is the person who instructs and assists donors at a collection site and receives the specimen provided by the donor.

The following restrictions apply:

• The immediate supervisor of an employee may not serve as the collector when that employee is tested, unless there is no feasible alternative. A supervisor serving as a collector must be a trained collector.

• The hiring official of an applicant may not serve as the collector when the applicant is tested, unless there is no feasible alternative. A hiring official serving as a collector must be a trained collector.

• A co-worker who is in the same testing pool or who works with an employee on a daily basis must not serve as a collector when that employee is tested.

• An applicant or employee must not serve as the collector by collecting his or her own specimen.

• An individual working for an HHS-certified Instrumented Initial Test Facility (IITF) or laboratory may not serve as a collector if that individual can link the donor with the specimen drug test result or the report from the test facility (IITF or laboratory).

• An individual who has a personal relationship with the employee (e.g., spouse, ex-spouse, relative, close personal friend) must not serve as the collector.

To qualify as a urine specimen collector for a federal agency program, an individual must:

• Be knowledgeable of the collection procedure described in the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines)

• Be knowledgeable of any guidance provided by the federal agency’s Drug-Free

Workplace Program and additional information provided by HHS relating to the collection procedure described in the Mandatory Guidelines

• Receive training from a qualified trainer for urine specimen collectors on the following topics:

o All steps to correctly perform a urine specimen collection o Completion and distribution of the Federal CCF o Problem collections o Fatal and correctable flaws and how to correct problems in collections o Collector responsibilities to maintain the integrity of the collection process, ensuring the privacy of the donor, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.

• Demonstrate proficiency in urine collections by successfully completing five consecutive error-free mock collections that include: two uneventful scenarios, one insufficient specimen scenario, one where the temperature is out of range, and one in which the donor refuses to sign the Federal CCF and refuses to initial the tamper-evident bottle label/seal o The qualified trainer for collectors must monitor and evaluate the individual, in person or by a means that provides real-time observation and interaction between the trainer and the trainee, and the trainer must attest in writing that the mock collections are error-free

• Complete refresher training on the items above at least every five years from the date of initial training

• Have documentation that he or she has completed training as a collector in accordance with the above requirements (i.e., before collecting any specimens for a federal agency)

• Maintain training documentation and provide it to a federal agency upon request

The collector should have identification with his or her name and his or her employer’s name, address, and telephone number. The collector is required to provide his or her identification (employee badge or employee list) if requested by the donor. There is no requirement for the collector to have a photo ID or to provide his or her driver's license with an address.

To qualify as an observer for a direct observed urine specimen collection for a federal agency program, an individual must:

• Be knowledgeable of the direct observed collection procedure as described in the Mandatory Guidelines

• Be knowledgeable of any guidance provided by the federal agency or by HHS relating to the direct observed collection procedure described in the Mandatory Guidelines

• Receive training on the following subjects: :

o The steps necessary to perform a direct observed collection correctly o Maintaining the integrity and security of the specimen throughout the collection process by maintaining visual contact with the collection container o Ensuring the privacy of the donor o Ensuring that the observation is done in a professional manner, to minimize discomfort of the donor o Avoiding conduct that can be interpreted as offensive or inappropriate

• Be the same gender as the donor. There are no exceptions to this requirement.

An observer is not required to be a trained collector.

To qualify as a trainer for collectors for a federal agency program, an individual must:

• Be qualified as a trained collector and have regularly conducted drug test collections for at least one year, OR have successfully completed a “train the trainer” course given by an organization (e.g., manufacturer, private entity, contractor, or federal agency)

• Undergo refresher training in accordance with collector requirements (see above) at least every five years from the date of the individual’s initial training

• Maintain documentation of his or her training and provide it to a federal agency upon request.

Before an individual is permitted to collect a specimen for a federal agency, the agency must:

• Ensure that the individual meets the collector requirements described in the Mandatory

Guidelines

• Ensure that the individual or a third party (e.g., third party administrator, collector training organization, federal agency that employs its own collectors) has a copy of the individual’s collector training documentation

• Provide the individual with the name and telephone number of the federal agency’s designated representative to contact in the event that any problems or issues arise during a collection

Chapter 2. Collector/Collection Site Records

The collector should maintain his or her original collector training records (i.e., for initial and refresher training) and should provide copies to his or her employer and, as requested, to the federal agency.

Collection site records must be stored for a minimum of two years. This includes the collector copy (Copy 3) of the Federal CCF for each specimen. Both hardcopy and electronic collection records must be stored and disposed of in a manner that ensures donor confidentiality is maintained.

Chapter 3. The Collection Site

A collection site is a permanent or temporary facility where donors present themselves for the purpose of providing a specimen for a drug test. When there is an immediate need to collect a specimen (e.g., a post-accident situation) and there is no agency-designated site available, a monitored collection may be conducted in a public restroom (see Chapter 7, Section E). The site must have all necessary personnel, supplies, equipment, facilities, and supervision to provide for specimen collection, security, and temporary storage until the specimen is transferred to an HHS-certified IITF or laboratory, and must have arrangements for the transfer of the specimens to a certified IITF or laboratory.

A facility used as a collection site must have:

1. Provisions for donor privacy while he/she provides the urine specimen. The following facilities provide adequate privacy for urine collections:

• An enclosed stall in a multi-stall restroom

• A single person restroom

• A partitioned area that allows for individual privacy

• A mobile restroom (e.g., a vehicle with an enclosed toilet stall).

2. A means for washing hands:

• If practical, the water source should be external to the restroom where collection occurs. If a water source is in the enclosure where the collection occurs, the collector must secure it prior to the collection or conduct a monitored collection (see Chapter 7, Sections C and E).

• If a water source is not available, another means (e.g., waterless cleanser, moist towelettes) outside the restroom is an acceptable alternative.

3. A suitable clean surface, inaccessible to the donor, for the collector to use as a work area:

• If practical, the collector work area should be external to the restroom where collection occurs.

• The collector work area may be inside the restroom only if the donor can have privacy while providing the urine specimen.

4. A secure temporary storage area for maintaining specimens until they are transferred to an HHS-certified IITF or laboratory. Note: Specimens should NOT be exposed to high temperatures for an extended time. These conditions may affect the test results of a urine specimen.

5. Procedures or restrictions to prevent:

• Unauthorized access to the site during the collection,

• Unauthorized access to the collection materials/supplies,

• Unauthorized access to collection site records, and

• Donor access to items that could be used to adulterate, substitute, or dilute the specimen (e.g., soap, disinfectants, cleaning agents, water).

Chapter 4. Federal Agency Blind Samples

Each federal agency is required to have blind samples (i.e., negative samples, positive samples, adulterated samples, substituted samples) submitted along with the donor specimens. The blind samples may be purchased by the federal agency and supplied to the collector, or purchased by the collector and submitted to an IITF or laboratory with an agency’s specimens.

The Mandatory Guidelines specify the approximate percentage of each type (i.e., 75% negative, 15% positive for one or more drugs, 10% either adulterated or substituted). At a minimum, each federal agency must submit 3% blind samples with its donor specimens (i.e., based on the projected yearly number of donor specimens), and effort should be made for them to be submitted quarterly. The blind samples should be distributed throughout the donor specimens rather than being submitted as one group.

Each blind sample must meet the following requirements:

• Positive and negative samples must be validated by the supplier using the appropriate initial and confirmatory drug tests,

• The shelf life of each blind sample must be provided by the supplier to ensure that the sample is submitted for testing prior to its expiration date,

• Positive blind samples should contain at least one of the required drugs listed in the

Mandatory Guidelines, and the concentration should be 1.5 to 2 times the initial drug test cutoff concentration;

• Substituted or adulterated blind samples must demonstrate such characteristics (i.e., meeting substitution or adulteration criteria specified in the Mandatory Guidelines) at the time of the validation by the supplier.

Each blind sample is submitted with a Federal CCF completed as for a donor specimen, with the following exceptions:

• Because there is no donor, the collector provides a fictitious employee identification number or Social Security Number in Step 1c of the Federal CCF and writes fictitious donor initials on the A and B specimen bottle labels/seals.

• The collector indicates that the sample is a ‘blind sample’ on the Medical Review Officer

(MRO) copy where the donor would normally provide a signature (Step 5 on Copy 2 of the Federal CCF).

• The collector may either discard Copy 5 of a paper Federal CCF (the donor copy) or maintain it with Copy 3 of the Federal CCF (the collector copy).

If the collector purchases the samples for the federal agency’s blind program, the collector must send the supplier’s information (e.g., the content and concentration of the blind samples) to the

MRO, to enable the MRO to interpret the results and report them to the agency. The MRO will contact the supplier and/or collector as needed when investigating discrepant results.

Chapter 5. The Federal Drug Testing Custody and Control Form (Federal CCF)

Federal agencies are required to use the Office of Management and Budget (OMB)-approved Federal CCF when collecting specimens for their workplace drug testing programs. Federal CCFs are available from a number of different sources (e.g., IITFs, laboratories, collectors, third party administrators, MROs).

2014 Federal CCF OMB extended the use of the Federal CCF as of May 31, 2014. The 2014 Federal CCF may be used as a paper (hardcopy) or electronic (digital) form, or in a combination paper and electronic format.

A proof of the 2014 Federal CCF and guidance for its use are on the SAMHSA website. The website (currently under construction) is available at: http://beta.samhsa.gov/workplace.

2010 Federal CCF The form content of the 2010 Federal CCF (published in the Federal Register on July 16, 2010) is the same as the 2013 Federal CCF; only minor changes were made to the required statements and instructions to allow its use as an electronic document.

Therefore, SAMHSA is allowing service providers to continue to use preprinted paper 2010 Federal CCFs until supplies are depleted.

Employers are prohibited from using the Federal CCF for:

• Private-sector employee drug testing programs, other than testing conducted under the Department of Transportation (DOT) regulations

• State workplace drug testing programs

• Department of Justice drug testing programs

The use of an incorrect form for a federal agency specimen does not, in and of itself, constitute a reason for the test facility to reject the specimen for testing or for the MRO to cancel the test.

For example, in rare cases, a collector may use a non-federal form or incorrect Federal CCF for a federal agency collection by mistake or as the only means to conduct a collection under unusual circumstances (e.g., post-accident test with insufficient time to obtain a Federal CCF).

In such cases, the test facility processes and tests the specimen, but holds the report pending receipt of a memorandum for the record (MFR) from the collector stating the reason why the correct Federal CCF was not used for the federal agency collection. The form used and the collector MFR should provide all information required on the Federal CCF.

• If the collector realizes an incorrect form was used, he or she must send an MFR with the specimen.

• If an IITF or laboratory discovers the use of a non-federal or incorrect federal form, the collector is notified to provide an MFR with the reason for using the incorrect form. If the http://beta.samhsa.gov/workplace collector does not provide an MFR after five business days, the IITF or laboratory will report a rejected for testing result to the MRO who will cancel the test.

• If an MRO discovers the use of a non-federal or incorrect federal form, the collector is notified to provide an MFR with the reason for using the incorrect form. If the collector does not provide an MFR after five business days, the MRO will cancel the test.

A. Use of an Electronic Federal CCF

A federal agency may use the Federal CCF as an electronic document in its federal workplace drug testing program. An electronic Federal CCF must be the functional equivalent of a paper Federal CCF with respect to integrity, accuracy, and accessibility.

“Personally identifiable information” (PII) is information that can be used to distinguish or trace an individual’s identity alone or when combined with other personal identifying information which is linked or linkable to a specific individual. PII that may be on the Federal CCF includes the donor’s Social Security Number (SSN), name, date of birth, telephone numbers, and employment status. All federally regulated employers and drug testing service providers (e.g., collectors, test facilities, MROs, third party electronic CCF providers) must implement procedures and administrative, technical, and physical controls to ensure donor privacy by restricting access to PII and to drug test results on hardcopy and electronic Federal CCFs, and entered into a computer system or database. Access to donor PII and drug test results must be limited to those individuals requiring access to fulfill job duties. Such individuals must receive training to make them aware of their responsibilities for protecting the information. The confidentiality must be maintained from the time the donor PII is obtained through transmission/transport of the Federal CCF, specimen testing, and records handling (i.e., storage, retrieval, and final destruction).

Federally regulated employers and drug testing service providers (e.g., collectors, test facilities, MROs) who use electronic or combination electronic and paper Federal CCFs must implement procedures and administrative, technical, and physical controls to ensure the authenticity, integrity, and confidentiality of electronic records, and to ensure that electronic signatures are the legally binding equivalent of traditional handwritten signatures. These procedures and controls include, but are not limited to:

• System validation

• The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying upon request of authorized parties (e.g., the MRO, federal agency, or SAMHSA)

• Protection of records to enable accurate and ready retrieval throughout the records retention period

• Limiting system access to authorized individuals (e.g., trained collectors). Procedures must be in place for managing the user authentication system (e.g., assignment, review, revocation).

• Secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete records from the time of initiation of the Federal CCF (changes should be evident when reviewing the original record, and any electronic or paper copy of the original record)

• Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

Before implementing an electronic Federal CCF, HHS-certified IITFs and laboratories must provide a detailed plan and proposed standard operating procedures (SOPs) which include the above items for SAMHSA review and approval (i.e., through SAMHSA’s National Laboratory Certification Program, NLCP), and must undergo an onsite inspection. The review of validation records, specimen records, SOPs, staff training records, and practices associated with the electronic Federal CCF will be part of the NLCP inspection process.

B. Federal CCF Content Requirements

Test Facility Identification

At the top of the Federal CCF, the test facility must be identified by one of the following:

• A specific IITF or laboratory name and address

• A list of addresses with check boxes to allow the collector to check the box for the IITF or laboratory to which the specimen will be shipped

• A corporate name and telephone number (the collector will annotate the address of the

IITF or laboratory to which the specimen will be shipped, or the test facility that receives the specimen for testing will annotate its address)

Bottle Labels/Seals

The tamper-evident specimen bottle labels/seals may be at the bottom of Copy 1 or may be separate from the form:

• There must be two labels/seals: one marked with the letter “A” to designate the primary specimen and the other marked with the letter “B” to designate the split specimen.

• Each label/seal must have:

o The same specimen identification number that is at the top of the Federal CCF, o A place for the collector to annotate the date of the collection, and o A place for the donor to initial the label/seal after it is placed on the specimen bottle.

Required Statements

Wording of required statements must be identical to that on the OMB-approved Federal CCF.

The statements must be provided as follows:

• Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen Collection o Paper Federal CCF: printed on the back of the donor copy (Copy 5) o Electronic Federal CCF: provided to the donor as a separate page (e.g., hardcopy, onscreen, posted at the collection site).

• Public Burden Statement o Paper Federal CCF: printed on the back of each copy (i.e., Copies 1 through 5) o Electronic Federal CCF: provided to CCF recipients as a separate page (i.e., with the electronically transmitted Federal CCF copies). The Public Burden Statement may be displayed onscreen or posted at the collection site for the donor and collector, and/or provided to the donor as a hardcopy.

• Privacy Act Statement (For Federal Employees Only) o Paper Federal CCF: printed on the back of the donor copy (Copy 5) o Electronic Federal CCF: provided to the donor as a separate page (e.g., hardcopy, onscreen, posted at the collection site).).

C. Federal CCF Instructions for Use

Step 1. To be completed by the collector or federal agency representative prior to the donor providing a specimen:

• The employer and MRO information

• The collection site and collector information

• The testing authority box indicating under which federal agency the specimen is being collected

• The appropriate box indicating the reason for the test

• The appropriate box for the drug tests to be performed. If the test is to be performed for a drug other than those listed on the Federal CCF, the “Other” box is marked and the specific drug is annotated.

• The collector enters the donor’s identification [e.g., social security number (SSN) or employee I.D. number] after the collector verifies the donor’s identity. If the donor refuses to provide his/her SSN or I.D. number, the collector enters a remark in Step 2 on Copy 1.

Step 2. To be completed by the collector after receiving the specimen from the donor and measuring the temperature of the specimen within 4 minutes. This step requires the collector to mark the appropriate boxes to indicate that:

• The temperature of the specimen was or was not within the required temperature range,

• The collection was a split specimen or single specimen collection (note: split specimens are required for all federal agency collections),

• No specimen was collected and why (if applicable), and

• A direct observed collection was performed and why (if applicable). If the collector was not the observer, the collector provides the name of the observer and the reason for an observed collection on the Remarks line in Step 2. Note: If there is insufficient room on the Remarks line, the collector may provide a separate MFR explaining the use of an observed collection. The collector must send the MFR to the test facility.

Step 3. To be performed by the collector after the donor has watched the collector pour the specimen from the collection container into the specimen bottles and cap the bottles. This step instructs the collector to:

• Place the labels/seals on the primary and split specimen bottles as the donor watches,

• Date the labels/seals,

• Have the donor initial the label/seal on each bottle (i.e., after the labels/seals have been placed on the bottles), and

• Have the donor complete Step 5 on Copy 2 (the MRO copy). The collector instructs the donor to:

o Read the certification statement.

o Record the following:

– His or her name,

– Date of collection,

– Daytime and evening telephone numbers, and

– Date of birth.

o Sign the certification statement. If the donor refuses to sign the certification statement, the collector enters a remark in Step 2 on Copy 1.

The collector does not make any entries on Copy 2.

Step 4. To be initiated by the collector and completed at the test facility. The collector is required to:

• Sign the collector certification statement in Step 4 on Copy 1 to certify that the specimen was collected, labeled, sealed, and released for shipment to the IITF or laboratory in accordance with federal requirements.

• Include the collector’s printed name.

• Record the following:

o Date of collection o Time of collection o The specific name of the delivery service to which the specimen is released for shipment to the IITF or laboratory.

The collector does not make entries below the first bold line in Step 4. Copy 1 entries in Step 4 below the first bold line and in the subsequent Steps are made at the HHS-certified IITF or laboratory.

D. Federal CCF Distribution

Paper Federal CCF

• Copy 1 (Test Facility Copy) signed by the collector is shipped with the specimen package to the IITF or laboratory.

• Copy 2 (MRO Copy) signed by the donor is sent to the MRO o Original Copy 2 is sent by courier or mail, or o A copy of Copy 2 is sent via fax or provided electronically. The collector maintains the original Copy 2 in the collection site records.

• Copy 3 (Collector Copy) is maintained in the collection site records.

• Copy 4 (Employer Copy) is sent via fax, courier, or mail, or is provided electronically.

• Copy 5 (Donor Copy) is given to the donor.

Note: Copies 2 through 5 are identical. The Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen Collection are printed on the back of Copy 5.

Electronic Federal CCF

• Copy 1 (Test Facility Copy) signed by the collector is electronically provided to the IITF or laboratory.

To facilitate linkage of the specimen package to the electronic Federal CCF sent to the test facility, the collector must either:

o Include a printed copy of the Test Facility copy (i.e., Copy 1) of the Federal CCF with the specimen; or o Apply a label to the outside of the specimen package, with the specimen identification number, test facility name and contact information, and collection site name and contact information.

• Copy 2 signed by the donor is maintained as an electronic file by the collector/collection site and:

o A copy is provided electronically to the MRO o A copy is provided electronically to the Employer o A copy is provided to the donor. This may be a printed copy or a copy that is electronically provided.

Note: The Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen Collection are provided to the donor as a separate page (e.g., hardcopy, onscreen, posted at the collection site).

Employers, collectors, test facilities, and Medical Review Officers (MROs) who use electronic or combination paper and electronic CCFs are responsible for ensuring the security of data transmissions and limiting access to any data transmission, storage, and retrieval systems.

Chapter 6. Verification of Donor Identity

The donor must provide appropriate identification to the collector upon arrival at the collection site.

Acceptable forms of identification are:

• A photo identification (e.g., driver’s license, employee badge issued by the employer, or any other picture identification issued by a Federal, state, or local government agency),

• Identification by the supervisor of the donor or by a federal agency representative, or

• Other identification allowed under a federal agency's workplace drug testing plan.

If the identity of the donor cannot be established, the collector stops the collection.

Unacceptable forms of identification are:

• Identification by a co-worker,

• Identification by another donor,

• Non-photo identification (e.g., social security card, credit card, union or other membership cards, pay vouchers, voter registration card), or

• A faxed copy or photocopy of an identification document.

Chapter 7. Urine Specimen Collection

A. Collection Site Security

The collection site must be secure to prevent unauthorized access to specimens, collection supplies, and collection site records. A permanent site that is used solely for specimen collections must be secured at all times. At facilities that are not dedicated specimen collection sites, the area of the site used for specimen collections must be secured during the time a specimen is collected.

A collector must:

• Prohibit unauthorized personnel from entering the collection site during the collection;

• Perform only one specimen collection at a time;

• Restrict access to collection supplies before and during the collection;

• Ensure that only the collector and the donor are allowed to handle the unsealed specimen;

• Ensure that chain of custody is maintained and documented throughout the collection procedure,

• Ensure that Copy 1 of the Federal CCF is sent to the IITF or laboratory (i.e., paper Copy 1 enclosed with the specimen and sealed for shipment; electronic Copy 1 provided electronically) and

• Ensure that specimens are transported to the test facility in a sealed and secure shipping container to eliminate the possibility of damage during shipment and to prevent undetected tampering.

B. Collection Supplies

The following items must be available at the collection site to conduct proper urine collections:

1. Single-use plastic collection containers. Each collection container must not substantially affect the specimen collected and must be:

• Supplied as an individually sealed item using a tamper-evident system (e.g., in a sealed plastic bag, shrink wrapped, with a peelable or sealed lid, or another easily visible tamper-evident system),

• Large enough to easily catch and hold at least 55 mL of urine, and

• Graduated with volume markings clearly showing the volume (e.g., 45 mL).

2. Single-use plastic specimen bottles. Each specimen bottle with cap must not substantially affect the specimen collected and must be:

• Supplied as individually sealed bottles with a tamper-evident system (e.g., using plastic bag, shrink wrap, with a peelable or sealed lid, or another easily visible tamper-evident system),

• Able to hold at least 35 mL, o The split specimen bottle may be the same size as or smaller than the primary specimen bottle, but must be able to hold at least 20 mL.

• Leak-resistant (i.e., have a screw-on or snap-on cap that prevents leakage),

• Marked clearly to indicate the minimum levels of urine to be poured into each bottle (30 mL for the primary specimen and 15 mL for the split specimen), and

• Designed so that the required tamper-evident bottle label/seal from the Federal CCF is not damaged when the donor initials it and has no overlap that conceals printed information.

3. Temperature strips. The temperature strips must be capable of temperature readings between 90°-100°F (32°-38°C). The temperature strips must accurately measure the temperature of the specimen and not contaminate the specimen. The strips may be affixed to the collection container as supplied or placed on the collection container after the donor gives the collection container with the specimen to the collector.

4. Federal CCFs. An OMB-approved Federal CCF as described in Chapter 5.

5. Tamper-evident labels/seals. Two tamper-evident labels/seals are used to seal the specimen bottles (i.e., primary and split specimens). Occasionally, a tamper-evident label/seal will not properly adhere to the specimen bottle (e.g., due to moisture, temperature, or specimen bottle material). If this occurs, see Chapter 7, Section C, Step 18 for instructions on using another tamper-evident seal.

6. Leak-resistant plastic bags. The plastic bag must have two sealable compartments or pouches (i.e., one large enough to hold two specimen bottles and the other large enough to hold Copy 1 of the Federal CCF).

7. Absorbent material. The absorbent material is placed inside the leak-resistant plastic bag with the specimen bottles in case a specimen bottle leaks during shipment. The U.S. Postal Service and other express carriers require the use of absorbent material when shipping biological materials.

8. Shipping containers. Boxes or bags used to transport specimens to an IITF or laboratory must be securely sealed to prevent the possibility of undetected tampering. It is not necessary to use a shipping container/mailer if a courier hand-delivers the sealed leak-resistant plastic bags containing the specimen bottles directly from the collection site to the IITF or laboratory.

9. Bluing agent. Bluing agent is added to the toilet bowl and water tank to prevent undetected specimen dilution by the donor.

10. Secure temporary location. It is the collector’s responsibility to prevent unauthorized access to the specimen bottles and Federal CCF. Prior to placement in a shipping container, the sealed leak-resistant plastic bag containing the specimen bottles must be kept:

• Within the collector’s line of sight, or

• In a secure temporary location (e.g., locked in a refrigerator or cabinet).

Note: Specimens should NOT be exposed to high temperatures for an extended time.

These conditions may affect the test results of a urine specimen.

11. Disposable gloves. HHS recommends that collectors use single-use disposable gloves while handling specimens. The Occupational Safety and Health Administration has specific standards addressing protection of employees who are exposed to potentially infectious body fluids (29 CFR Part 1910.1030).

12. Paper Federal CCFs. All collection sites, including those using electronic Federal

CCFs, should maintain a supply of paper Federal CCFs.

C. Collection Procedure

1. Prepare the collection site to collect urine specimens:

• Assemble supplies.

• Ensure that there is bluing agent in the toilet. If no bluing agent is available or if there is an automatic flushing system, turn off the water supply and flush the toilet to remove any water in the toilet when possible.

• Turn off the water supply or secure water sources inside the restroom.

o The collector must provide a means for the donor to wash his or her hands before and after the collection. The collector must secure the water source after the donor washes his or her hands and restore the water supply after the collection, or provide another means (e.g., waterless cleanser, moist towelette).

o If a water source inside the restroom cannot be turned off or secured, the collector must perform a monitored collection as described in Chapter 7, Section E.

• Remove any soap, cleanser, disinfectant, or other potential adulterants, and

• Inspect and/or secure areas or items that could be used to conceal adulterants (e.g., false ceilings, ledges, trash cans, towel dispensers).

2. If a donor does not arrive at the collection site at the assigned time for the drug test, contact the federal agency representative to obtain guidance on the appropriate action to be taken.

3. Begin the collection without delay when the donor arrives at the collection site. Do not wait because an authorized employer or federal agency representative is late in arriving or because the donor states that he or she is not ready or is unable to urinate. If the donor states that he or she is unable to provide a urine specimen, continue with the collection procedure through Step 11 below.

4. Verify the donor’s identity (see Chapter 6).

5. Describe the basic collection procedure to the donor and instruct the donor that he or she may read the instructions for completing the Federal CCF (e.g., on the back of the paper Federal CCF).

6. Answer any reasonable and appropriate questions that the donor has about the collection process.

7. Complete the collector’s portion of the Federal CCF (See Chapter 5).

• Ensure that the specimen identification number on the Federal CCF matches the identification number printed on the specimen bottle labels/seals and on the specimen package label (if any).

• Verify any collection demographic information in Step 1 of the Federal CCF.

• If the information is not present, record the information in Step 1 of the Federal CCF to include:

o The employer's name, address, telephone and fax numbers, and employer ID number (if applicable), o The specific MRO name, address, telephone number, and fax number, o Donor identification (SSN or employee ID number), o Specific testing authority for the federal agency drug test (if known), o Reason for test, o Drug test to be performed, o Collection site address, and o Collector telephone and fax numbers.

8. Ask the donor to:

• Remove any unnecessary outer clothing (e.g., coat, jacket, hat, etc.).

o The donor must not be asked to remove other articles of clothing (e.g., shirts, pants, dresses, undergarments) or to remove all clothing and wear a hospital or examination gown.

o It is not necessary for the donor to remove the following items, unless the collector suspects that they are concealing something that may be used to adulterate or substitute a specimen:

– Work boots or cowboy boots, or

– A hat or head covering that the donor refuses to remove based on religious practice.

• Leave other personal belongings (e.g., briefcase, purse) with the outer clothing. The donor may retain his or her wallet.

o To safeguard a donor’s belongings, procedures may be established to secure the items during the collection. These may include:

– An itemized receipt for belongings left with the collector,

– Storage in a lockable cabinet (i.e., with access controlled by the donor) or

– An envelope, box, or container secured with tamper-evident tape.

• Empty his or her pockets and display the items to ensure that no items are present that could be used to adulterate the specimen.

o If there are no items that can be used to adulterate a specimen, instruct the donor to return the items to the pockets and continue the collection procedure. Go to Step 9.

o If an item is found that appears to have been brought to the collection site with the intent to adulterate the specimen, use a direct observed collection procedure (see Chapter 7, Section D). Note: Document the item found in an MFR (e.g., photograph, written description). Return the item(s) to the donor at the end of the collection.

o If an item that could be used to adulterate a specimen appears to have been inadvertently brought to the collection site, secure the item and continue with the normal collection procedure. Go to Step 9. Note: Document the item found in an MFR (e.g., photograph, written description). Return the item(s) to the donor at the end of the collection.

o If the donor refuses to display the items in his or her pockets, stop the collection.

This is considered a refusal to test (see Chapter 8, Section B).

9. Instruct the donor to wash and dry his or her hands under your observation.

• Liquid soap is preferred over bar soap, because bar soap gives the donor the opportunity to conceal soap shavings under his or her fingernails in an attempt to adulterate the specimen.

• After washing his or her hands, the donor must remain in the collector’s presence and not be allowed access to any water fountain, faucet, soap dispenser, cleaning agent, or other materials which could be used to adulterate, substitute, or dilute a specimen.

10. Give the donor or allow the donor to select the collection kit or collection container (if it is separate from the kit) from the available supply.

11. Unwrap or break the seal of the kit or collection container. You may allow the donor to perform this step.

• Both the collector and the donor must be present.

• Only the seal on the collection container is broken at this time (i.e., the specimen bottles remain sealed/wrapped).

Note: If the donor has stated that he or she is unable to provide a specimen, at this point in the collection, request that the donor enter the restroom and attempt to provide a specimen. If the donor comes out of the stall with an empty collection container, he or she has demonstrated the inability to provide a specimen. Follow the Insufficient Specimen procedure in Chapter 7, Section F.

12. Direct the donor to:

• Take the collection container into the restroom/stall to be used for the collection,

• Provide a specimen of at least 45 mL,

• Not flush the toilet, and

• Return with the specimen as soon as he or she has finished completing the void.

o You may inform the donor that the temperature of the urine specimen must be read within 4 minutes after the void to be valid. Longer wait periods may cause the temperature to be out of range and necessitate an observed collection.

o A reasonable time limit may be set for completing the void.

Note: Neither the collector nor anyone else may go into the restroom with the donor, except in the case of a direct observed collection (see Chapter 7, Section D) or a monitored collection (see Chapter 7, Section E).

Note: Both the collector and the donor must maintain visual contact with the specimen from the time the specimen is transferred to the collector until specimen bottles have been sealed for shipment to the IITF or laboratory.

Note: After receiving the specimen from the donor, whenever practical, the collector may allow the donor to wash his or her hands and to flush the toilet. (The collector may inspect the toilet for any materials indicative of specimen tampering prior to flushing.)

13. When you receive the specimen from the donor, read the temperature strip affixed to or placed on the outside of the collection container.

• Do this within 4 minutes after the void.

• Mark the appropriate box in Step 2 of the Federal CCF:

o If the temperature is within the acceptable range (32° - 38°C; 90º-100ºF), mark “Yes” and proceed with the collection procedure. Go to Step 14.

o If the temperature is outside the acceptable range, mark “No” and perform a second, directly observed collection:

– Complete the first collection before initiating the second collection, including Step

14 (examining the physical characteristics of the urine, noting any abnormal characteristics in the Remarks line of the Federal CCF), and continuing with the procedure in Step 16.

– Record an appropriate comment on the Remarks line in Step 2 of the Federal

CCF for the first specimen to indicate why two specimens were collected, including a cross reference to the specimen identification number of the second specimen.

– Begin the collection of a second specimen using a direct observed collection procedure (see Chapter 7, Section D) and a new collection kit (i.e., a new collection container and a new Federal CCF).

– Record an appropriate comment on the Remarks line in Step 2 of the Federal

CCF for the second specimen to indicate why two specimens were collected, including a cross reference to the specimen identification number of the first

Note: The first specimen and its Federal CCF are sent to an HHS-certified laboratory regardless of the specimen volume.

Note: Both the first and second specimens must be sent to an HHS-certified laboratory for testing (i.e., not to an IITF).

Note: If the donor refuses to provide a second specimen or leaves the collection site before the collection process is completed, this is considered a refusal to test (see Chapter 8, Section B).

14. Inspect the specimen for adulteration or substitution by examining the physical characteristics of the urine.

• Note any abnormal characteristics such as:

o Unusual color (e.g., specimen is blue), o Presence of foreign objects or material, o Unusual odor (e.g., bleach), or o Signs of adulteration (e.g., excessive foaming when shaken).

• A specimen suspected of not being a valid urine specimen must be sent to an HHS-certified laboratory for testing (i.e., not to an IITF).

• If you observe any abnormal characteristic(s) that appear to be due to adulteration or substitution by the donor, immediately begin a second specimen collection using a direct observed collection procedure (see Chapter 7, Section D) and a new collection kit (i.e., a new collection container and a new Federal CCF).

o Record an appropriate comment on the Remarks line in Step 2 of both Federal CCFs

(i.e., for the first and second specimens) to indicate why two specimens were collected including a cross reference to the associated specimen identification number.

o Complete the first collection by continuing with the procedure in Step 16.

15. Check the specimen volume to ensure that the specimen contains at least 45 mL of urine.

• If the specimen volume is at least 45 mL, complete the specimen collection procedure continuing with Step 16.

• If the specimen volume is less than 45 mL, discard the specimen and immediately begin a second collection using the same procedures and the same Federal CCF. Use a new collection container for the second collection.

Note: If the donor refuses to attempt to provide a second specimen or leaves the collection site before the collection process is completed, this is considered a refusal to test (see Chapter 8, Section B).

• When a second specimen must be collected, follow the Insufficient Volume procedure in

Chapter 7, Section F.

o When the donor hands you the second specimen, continue with the collection procedure, including Step 13 (checking specimen temperature) and Step 14 (examining physical characteristics of the urine).

o If the donor is unable to provide at least 45 mL for the second specimen after a period of three hours, stop the collection procedure and report the failure to provide a sufficient specimen as described in the Insufficient Volume procedure in Chapter 7, Section F.

16. Unwrap the sealed specimen bottles in the donor’s presence.

17. In the donor’s presence, pour the urine from the specimen collection container into the specimen bottles and secure the lid/cap on each bottle.

• Pour at least 30 mL into the “A” Bottle and at least 15 mL into the “B” bottle.

18. Place the appropriate tamper-evident label/seal over the lid/cap of each bottle to ensure that the lid/cap cannot be removed without destroying the label/seal.

• The donor must observe the sealing of the specimen bottles.

• If the tamper-evident label/seal does not adhere properly to the specimen bottle (e.g., due to moisture, temperature, specimen bottle material) or is accidentally broken or damaged during the collection process:

o Apply the unacceptable label/seal (i.e., printed with the same specimen identification number as the Federal CCF) to the bottle, and o Apply a second, separate tamper-evident seal to seal the specimen bottle.

– Place the additional seal perpendicular to the original label/seal, to avoid obscuring information on the original label/seal,

– Initial and date the second seal,

– Ask the donor to initial the second seal, and

– Provide a comment on the Remarks line in Step 2 of the Federal CCF explaining why the second seal was used.

19. Discard any excess urine remaining in the collection container after the bottles have been filled with the appropriate volumes of urine.

• The only exception is when the excess urine is being used to conduct clinical tests in conjunction with a physical examination that is required by the federal agency. No further tests may be conducted on the excess urine.

20. Write the date on the tamper-evident labels/seals.

21. Ask the donor to initial the label/seal on each bottle, using care to avoid damage.

• If the donor fails or refuses to initial the seals, note this on the Remarks line in Step 2 of the Federal CCF and complete the collection process. This is not considered a refusal to test.

22. Inform the donor that it is not necessary for him or her to continue observing the collection procedure after the bottles have been sealed, and that he/she is allowed to wash his or her hands.

23. Assist the donor in completing the donor portion of the Federal CCF:

• Instruct the donor to read the donor certification statement in Step 5 on Copy 2 of the Federal CCF.

• Instruct the donor to complete the donor portion on Copy 2 of the Federal CCF:

o Sign and date the certification statement, o Provide his or her date of birth, o Provide his or her printed name, o Provide day and evening contact telephone numbers.

• If the donor refuses to sign the form or to provide the other information, make a comment on the Remarks line in Step 2 of the Federal CCF to that effect. At a minimum, print the donor’s name where indicated. Note: This does not constitute a refusal to test.

24. Complete the collector chain of custody portion in Step 4 on Copy 1 of the Federal CCF:

• Provide your printed name,

• Sign where indicated,

• Record the date and time of the collection, and

• Record the specific name of the delivery service to which the specimen bottles are being released.

25. Prepare specimen package.

Paper Federal CCF:

• Separate Copy 1 of the Federal CCF from the other four copies. Place Copy 1 and both specimen bottles inside the appropriate pouches of the leak-resistant plastic bag and seal the bag. Note: Attach any collector MFRs for the specimen to Copy 1 prior to sealing in the bag.

Electronic Federal CCF:

• Place both specimen bottles inside the leak-resistant plastic bag and

• Place a copy of Copy 1 inside the appropriate pouch of the leak-resistant plastic bag or place the specimen package label on the outside of the bag, and seal the bag.

26. Give a copy of the Federal CCF to the donor (i.e., Copy 5 of the paper Federal CCF, a copy of Federal CCF Copy 2 of the electronic Federal CCF).