Source: https://www.federalregister.gov/documents/2000/06/23/00-15889/federal-drug-testing-custody-and-control-form
Timestamp: 2017-09-22 08:31:39
Document Index: 99943013

Matched Legal Cases: ['§\u20093301', '§\u20097301', '§\u20097301', '§\u20093301', '§\u20097301', '§\u20097301']

Federal Register :: Federal Drug Testing Custody and Control Form
A Notice by the Substance Abuse and Mental Health Services Administration on 06/23/2000
65 FR 39155
39155-39169 (15 pages)
00-15889
New Federal CCF
Copy 1—Laboratory Copy
Copy 2—Medical Review Officer Copy
Copy 3—Collector Copy
Copy 4—Employer Copy
Copy 5—Donor Copy
Privacy Act Statement (For Federal Employees Only)
Instructions for Completing the Federal CCF
Instructions for Completing the Federal Drug Testing Custody and Control Form
List of Acceptable Modifications
Availability of Federal CCF
Use of Expired Federal CCF
https://www.federalregister.gov/d/00-15889 https://www.federalregister.gov/d/00-15889
Notice of final form.
The Substance Abuse and Mental Health Services Administration (SAMHSA) has revised the Federal Drug Testing Custody and Control Form (CCF). The current Federal CCF has a July 31, 2000, expiration date. The Office of Management and Budget (OMB) has approved the use of the new Federal CCF until June 30, 2003. OMB approval of the new Federal CCF allows Federal agencies and employers regulated by the Department of Transportation (DOT) to begin using the new Federal CCF on August 1, 2000, for their workplace drug testing programs.
All urine specimens must be collected using chain of custody procedures to document the integrity and security of the specimen from the time of collection until receipt by the laboratory. To ensure uniformity among all Federal agency and federally regulated workplace drug testing programs, the use of an OMB approved Federal CCF is required. Based on the experiences of using the current Federal CCF for the past several years, SAMHSA and DOT initiated a joint effort to develop a new Federal CCF that was easier to use and more accurately reflected both the collection process and how results were reported by the drug testing laboratories. This effort included scheduling two public meetings attended by over 35 industry representatives who recommended most of the changes to the current Federal CCF. As a result of these two meetings, SAMHSA published a proposed revised Federal CCF in a Federal Register notice (64 FR 61916) on November 15, 1999. A sample of the proposed form was included in that notice.
The first major proposed change was to make the revised Federal CCF a six-part form by eliminating the split specimen copy. Since the split specimen copy is used only when the split specimen is tested (i.e., less than approximately 5 percent of split specimens are tested), it would be more efficient to have the split specimen test result reported on the original laboratory copy (Copy 1). When the split specimen is tested, the primary laboratory would need to make a photocopy of Copy 1 of the Federal CCF and send it along with the split specimen to the second laboratory. Although this procedure requires the primary laboratory to make a photocopy, SAMHSA and DOT believe the cost saving associated with not including a separate split specimen copy with each Federal CCF outweighs the cost associated with the few times that Copy 1 will need to be photocopied by the primary laboratory. Additionally, eliminating the split specimen copy will help make any handwritten information appear more legible on the later copies.
The second major proposed change was to move the specimen bottle seal(s)/ label(s) from the right side of the form to the bottom of Copy 1. This change would permit overprinting information on the form using standard width tractor feed printers rather than requiring more expensive wide carriage printers. In addition, the storage and handling requirements would be similar to other documents since the overall size of the new Federal CCF (including the tractor feed strips) is essentially the same as a standard sheet of paper.
The third major proposed change involved simplifying the chain of custody step by requiring the collector to only sign the form once. SAMHSA and DOT believe the current requirement for the collector to sign the Start Printed Page 39156form three times can be replaced with one signature because the certification statement signed by the collector clearly describes that the collector has possession of the specimen from the time the collector receives the specimen from the donor until the collector releases the specimen for shipment to the laboratory.
The fourth major proposed change was to provide a wider choice of terms that a laboratory can use to report specimen test results. The current form uses the term “Test Not Performed” to report any result other than a negative or positive result. In fact, this term does not always reflect the actual handling of the specimen. SAMHSA and DOT believe it is more appropriate to provide a variety of terms on the Federal CCF that accurately reflect the different specimen test results that a laboratory may report, such as, invalid result, adulterated, substituted, or rejected for testing.
The fifth major proposed change was to include a new step on the original laboratory copy (Copy 1) for reporting the result for the split specimen (Bottle B) since the split specimen copy was eliminated. This change ensures that the primary specimen and split specimen laboratory test results are recorded on the same copy that is provided to the Medical Review Officer if the split specimen is tested.
The sixth major proposed change was to place the Medical Review Officer (MRO) steps for both the primary and split specimens on the MRO copy. This change permits the MRO to record the determination for both the primary specimen and the split specimen (if tested) on the same copy and to use this copy to report results to the employer.
Other changes were considered to be minor changes and were discussed as each part of the proposed new form was described in the November 15, 1999, Federal Register notice.
SAMHSA received thirty comments on the proposed changes from laboratories, printing firms, employers, organizations, and individuals. The majority of comments supported the proposed changes. All comments were reviewed and taken into consideration in preparing the new Federal CCF. The substantive comments submitted and SAMHSA's and DOT's response to those comments are discussed below as each step of the new Federal CCF is described.
Appendix A is a sample of the new Federal CCF.
The new Federal CCF has the following 5 copies: Copy 1—Laboratory Copy, Copy 2—Medical Review Officer Copy, Copy 3—Collector Copy, Copy 4—Employer Copy, and Copy 5—Donor Copy. The reverse side of each copy (i.e., Copy 1, Copy 2, Copy 3, Copy 4, and Copy 5) must have the “Paperwork Reduction Act Notice” statement. The reverse side of Copy 5 must also have the “Privacy Act Statement (for Federal employees only)” and the “Instructions for Completing the Federal Drug Testing Custody and Control Form.” The required statements and instructions for completing the Federal CCF are provided below.
The second laboratory copy was eliminated from the proposed six-part form when SAMHSA and DOT agreed to permit a certified laboratory to transmit a negative result to the Medical Review Officer (MRO) electronically (e.g., facsimile, computer). The only time that a hard copy of the Federal CCF must be sent to the MRO is when the laboratory is reporting either a positive for a specific drug, adulterated, substituted, rejected for testing, or invalid result. For these relatively few non-negative results, the laboratory is required to make and send a photocopy of Copy 1 to the MRO even if an electronic report was sent. SAMHSA and DOT believe the additional cost saving associated with not including the second laboratory copy with each Federal CCF outweighs the cost associated with the few times that Copy 1 will need to be photocopied by the primary laboratory.
Each copy of the new Federal CCF will be on white paper. The proposed changes had required using paper with a different color border for the MRO, collector, employer, and donor copies as opposed to using a different color paper for each of these copies as used for the old form. Two comments supported using paper with different color borders while two comments opposed using color borders. SAMHSA and DOT have reevaluated the need to use either different color paper or paper with different color borders and believe that using white paper for each copy is sufficient to ensure that the copies will be distributed as required. Additionally, using white paper for all copies will reduce the cost to assemble the form and will make handwritten information more legible on all copies.
The sequence of the copies for the new Federal CCF was changed to laboratory, MRO, collector, employer, and donor. Three comments suggested changing the sequence of the copies for the proposed revised form because of the concern with the legibility of the information on the latter copies, especially if a latter copy is needed to replace a lost copy. SAMHSA and DOT concur that legibility is a concern and the best copies, beside the laboratory copy, should be the MRO and collector copies. If the employer and donor copies are not entirely legible, the information can be obtained from the MRO or collector copies. In addition, placing the donor copy last, gives the donor the instructions for collecting the urine specimen and completing the Federal CCF. This may be useful if, at a later time, the donor claims that the collector did not follow the collection procedure.
Copy 1 has a one inch space at the top of the page reserved for the following items: the title “Federal Drug Testing Custody and Control Form” must be printed along the top edge, the OMB Number must appear in the right hand corner, name and street address of the certified laboratory that will test the specimen, a unique preprinted specimen identification number, an accession number after the specimen is received by the laboratory, and any other information (e.g., accounting code) the laboratory or user of the form may want to print on the form.
Step 1 is completed by the collector or employer representative. A space is provided for the name, address, and identification number (if applicable) of the employer and the name and address of the MRO. The collector records the donor's social security number or other employee identification number after verifying the donor's identity. The collector marks the appropriate box to indicate the reason for the test and the appropriate box for the drug tests to be performed. The collector records the collection site address and the phone and fax numbers where the collector can be contacted.
Four comments recommended that the we retain the same sequence for the reasons for the test as on the current CCF. SAMHSA and DOT concur with that recommendation and changed the sequence to coincide with that on the current CCF. Three comments were opposed to requiring the collector to indicate the acronym of the Federal agency for which the specimen was being collected because the collector did not always have that information. We agree that that information is not always known by the collector and deleted the acronym from the new Federal CCF.
Step 2 is completed by the collector after receiving the specimen from the donor and measuring the temperature of Start Printed Page 39157the specimen. This step requires the collector to mark the appropriate box to indicate if the temperature of the specimen was within the required temperature range, whether it is a split or single specimen collection, if no specimen was collected, and if it was an observed collection. A “Remarks” line is provided when the collector is required to provide a comment. One comment suggested placing the box for the split specimen collection before the box for the single specimen collection. SAMHSA and DOT agree with the comment because the vast majority of collections are split specimen collections rather than single specimen collections.
Step 3 directs the collector to affix the seal(s)/label(s) to the specimen bottle(s), to date the seal(s) after being placed on the specimen bottle(s), to have the donor initial the seal(s) after being placed on the specimen bottle(s), and to instruct the donor to complete step 5 on the MRO copy (Copy 2). This is essentially the same instruction that appears on the current form.
Step 4 is a revised chain of custody step that is initiated by the collector and completed by the laboratory after the specimen is accessioned by the laboratory. This step requires the collector to only sign the form once to certify that the specimen was collected, labeled, sealed, and released for shipment to the laboratory in accordance with Federal requirements. SAMHSA and DOT believe that one collector signature is sufficient to document chain of custody from this procedure. The collector is also required to note the time of the collection, the date of collection, and the specific name of the delivery service to whom the specimen is released for shipment to the laboratory. This is the same information that is required on the current Federal CCF. Since there is no requirement for delivery service personnel to document chain of custody during transit because they do not have access to the specimen bottle(s) or the Federal CCF, chain of custody annotations resume when the shipping container/package is opened and an individual at the laboratory has access to the specimen bottle(s) and the Federal CCF. We consider this individual to be the accessioner, and he or she is required to document the condition of the primary specimen bottle seal, sign the Federal CCF, print his/her name, the date the specimen was accessioned, and then to whom the specimen was released. The entry for the “Specimen Bottle(s) Released To” may include transfer to temporary storage or transfer to another individual. After this transfer, chain of custody for the specimen bottle(s) is documented by the laboratory using an internal chain of custody form. Two comments suggested deleting the requirement to record the delivery service since it was mentioned in the certification statement signed by the collector and one commenter suggested allowing preprinting a generic term for the delivery service. SAMHSA and DOT believe it is extremely important to document that the collector transferred the shipping container/package to a specific delivery service. It ensures that the collector knows that the specimen must be directly transferred to a specific delivery service rather than to another individual or to temporary storage.
Step 5(a) is completed by a certifying scientist at the laboratory to document the test result for the primary specimen. The certifying scientist is required to provide a signature, print his or her name, and the date. This step has boxes to allow the certifying scientist to easily check whether the result is negative, positive for a specific drug, rejected for testing, adulterated, substituted, invalid result, and/or dilute. One comment suggested adding a box to check when a specimen was dilute rather than requiring a comment to written on the “Remarks” line. SAMHSA and DOT concur with that recommendation and added a box to check when a specimen was dilute.
Step 5(b) is used by a certifying scientist at the second certified laboratory to document the test result for the split specimen, if the split specimen is tested. This step has a space for the name and address of the second laboratory, a certification statement, appropriate boxes for the certifying scientist to report the test result for the split specimen, a signature line, a line to print his or her name, and the date. There were no comments submitted regarding this step.
There must be two tamper-evident specimen bottle seal(s)/label(s) located in the bottom one and three-quarter inch space of Copy 1. One label must have the letter “A” on it to designate its use for sealing and labeling the primary specimen bottle and the other has the letter “B” on it to designate its use for sealing and labeling the split specimen bottle. Each seal/label must have the same specimen identification number (either preprinted or overprinted before use) that appears at the top of the form, a place for the collector to annotate the date of the collection, and a place for the donor to initial each label after it is placed on the specimen bottle. If a single specimen collection procedure is used, the “B” label is discarded by the collector.
It is also the responsibility of the supplier of the seals/labels to ensure that they are tamper-evident. Tamper-evident is defined as a seal/label that cannot be removed from the specimen bottle after 5 minutes contact with the specimen bottle.
Three comments supported locating the seals/labels at the bottom of the form and three comments were opposed and recommended leaving the seals/labels attached to the side of the form. They were concerned that placement of the seals/labels at the bottom of the form would jam the printers because of the thickness of the form. SAMHSA and DOT believe that reducing the number of copies to 5 from 7 and ensuring that a good quality tamper-evident seal/label is properly placed on the form that the seals/labels will not interfere with the printing or overprinting process. There are numerous examples of forms used with labels placed directly onto the forms that do not cause printing problems and we fully expect that to be the case when the new Federal CCF is printed and used.
The Medical Review Officer copy is the same format as Copy 1 except that step 5(a) has been replace with step 5. This step 5 on Copy 2 is completed by the donor after the specimen bottle(s) are sealed, initialed by the donor, and dated. The donor is required to read the certification statement, provide a signature, printed name, date of collection, daytime phone number, evening phone number, and date of birth. This information will be used by the Medical Review Officer to contact the donor for results that require donor contact before making a determination.
Exactly the same as Copy 2.
The following Paperwork Reduction Act Notice must appear on the back of each copy (i.e, Copy 1, Copy 2, Copy 3, Copy 4, and Copy5) of the Federal CCF:
Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 Start Printed Page 39158minutes/laboratory; and 3 minutes/Medical Review Officer. Federal employees may send comments regarding these burden estimates, or any other aspect of this collection of information, including suggestions for reducing the burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.
There were no comments submitted regarding this Paperwork Reduction Act Notice statement.
The following Privacy Act Statement must appear on the back of the donor copy (Copy 5):
Submission of the information on the attached form is voluntary. However, incomplete submission of the information, refusal to provide a urine specimen, or substitution or adulteration of a specimen may result in delay or denial of your application for employment/appointment or may result in your removal from Federal service or other disciplinary action.
The authority for obtaining the urine specimen and identifying information contained herein is Executive Order 12564 (“Drug-Free Federal Workplace”), 5 U.S.C. § 3301 (2), 5 U.S. C. § 7301 and Section 503 of Public Law 100-71, 5 U.S.C. § 7301 note. Under provisions of Executive Order 12564 and U.S.C. 7301, test results may only be disclosed to agency officials on a need-to-know basis. This may include the agency Medical Review Officer, the administrator of the Employee Assistance Program, and a supervisor with authority to take adverse personnel action. This information may also be disclosed to a court where necessary to defend against a challenge to an adverse personnel action.
There were no comments submitted regarding this Privacy Act statement.
The following instructions must appear on the back of the donor copy (Copy 5):
A. Collector ensures that the name and address of the drug testing laboratory appear on the top of the CCF and the Specimen I.D. number on the top of the CCF matches the Specimen I.D. number on the labels/seals.
B. Collector provides the required information in STEP 1 on the CCF. The collector provides a remark in STEP 2 if the donor refuses to provide his/her SSN or Employee I.D. number.
C. Collector gives a collection container to the donor for providing a specimen.
D. After the donor gives the specimen to the collector, the collector checks the temperature of specimen within 4 minutes and marks the appropriate temperature box in STEP 2 on the CCF. The collector provides a remark if the temperature is outside the acceptable range.
E. Collector checks the split or single specimen collection box. If no specimen is collected, that box is checked and a remark is provided. If it is an observed collection, that box is checked and a remark is provided. If no specimen is collected, Copy 1 is discarded and the remaining copies are distributed as required.
F. Donor watches the collector pouring the specimen from the collection container into the specimen bottle(s), placing the cap(s) on the specimen bottle(s), and affixing the label(s)/seal(s) on the specimen bottle(s).
G. Collector dates the specimen bottle label(s) after they are placed on the specimen bottle(s).
H. Donor initials the specimen bottle label(s) after the label(s) have been placed on the specimen bottle(s).
I. Collector turns to Copy 2 (MRO Copy) and instructs the donor to read the certification statement in STEP 5 and to sign, print name, date, provide phone numbers, and date of birth after reading the certification statement. If the donor refuses to sign the certification statement, the collector provides a remark in STEP 2 on Copy 1.
J. Collector completes STEP 4 (i.e., provides signature, printed name, date, time of collection, and name of delivery service), immediately places the sealed specimen bottle(s) and Copy 1 of the CCF in a leak-proof plastic bag, releases specimen package to the delivery service, and distributes the other copies as required.
SAMHSA recognizes that different hardware and software are used to prepare and print forms and this will create minor differences in the appearance between forms. The following is a list of acceptable differences and modifications when printing the Federal CCF:
(1) The OMB number may appear either vertically or horizontally in the upper right hand corner of the form.
(2) The name and address of the testing laboratory and the unique specimen identification number at the top of the form and on the specimen bottle seal(s)/label(s) may be printed during the original printing and form assembly process or added by “overprinting” after the form is assembled.
(3) Preprinting and/or overprinting the employer name and address, MRO name and address, and collection site information is permitted.
(4) The spaces for the employer name and address, MRO name and address, and the collection site address may have lines.
(5) The unique specimen identification number at the top of the form and on the tamper-evident seal(s)/label(s) may be either a bar code with an associated human readable number or only a human readable number.
(6) A laboratory does not need to assign and record a separate laboratory accession number in the one inch space at the top of the form if it uses the unique specimen identification number to track the specimen after receipt. When this is the case, the form may be printed without the words “LAB ACCESSION NO.” appearing on the top of the form.
(7) The size of each “check” box may vary slightly.
(8) The font size and style used for letters may vary to enhance readability.
(9) The “exact” location for each item on the printed form may vary slightly from the location indicated on the sample form provided in Appendix A.
(10) The data entry/information fields may be highlighted using different colors to show where the collector, donor, and laboratory would be providing information. The colors used to highlight the fields may be different for different fields, but must not prevent making clear facsimiles and photocopies of the information that is printed or handwritten in these fields.
(11) The space for the donor's SSN or Employee I.D. No. may have combs, boxes, or a single line.
(12) The legend at the bottom of copies 2 through 5 may be printed using different colors or a different color stripe may be printed at the bottom of copies 2 through 5. To ensure consistency and correct distribution of the copies, if different color stripes or legends are used at the bottom of each copy, the following colors must be used: MRO copy—pink, Collector copy—yellow, Employer copy—blue, Donor copy—green.
(13) A reference mark(s) may be used to position the form in a printer to overprint information in the correct Start Printed Page 39159location or to optically scan the information in the various fields.
(14) The size of the two tamper-evident seals/labels may vary, but must be placed within the space provided at the bottom of Copy 1.
(15) The color of the preprinted information on the “A” specimen bottle tamper-evident seal/label may be different than the color of the preprinted information on the “B” specimen bottle tamper-evident seal/label.
The new Federal CCF is available on the SAMHSA website (www.health.org/​workpl.htm) as an electronic “.pdf” file that can be opened, saved, and printed.
SAMHSA and DOT recognize that there may be a large supply of old forms at collection sites after the August 1, 2000, implementation date for the new Federal CCF. To avoid discarding these forms, OMB is permitting the use of the old Federal CCF until supplies are exhausted, but not to be used beyond July 31, 2001. After that date, remaining copies of the old Federal CCF should be destroyed.
End Signature Start Printed Page 39160 Appendix A
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Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Federal employees may send comments regarding these burden estimates, or any other aspect of this collection of information, including suggestions for reducing the burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.
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The authority for obtaining the urine specimen and identifying information contained herein is Executive Order 12564 (“Drug-Free Federal Workplace”), 5 U.S.C. § 3301 (2), 5 U.S.C. § 7301, and Section 503 of Public Law 100-71, 5 U.S.C. § 7301 note. Under provisions of Executive Order 12564 and 5 U.S.C. 7301, test results may only be disclosed to agency officials on a need-to-know basis. This may include the agency Medical Review Officer, the administrator of the Employee Assistance Program, and a supervisor with authority to take adverse personnel action. This information may also be disclosed to a court where necessary to defend against a challenge to an adverse personnel action.
[FR Doc. 00-15889 Filed 6-22-00; 8:45 am]