Draft_Department_of_Transportation_Solicitation_for_Urine_Collection_and_Drug__Alcohol_Testing__11-14-14.pdf

TABLE OF CONTENT

DEPARTMENT OF TRANSPORTATION

COLLECTION AND DRUG TESTING

SOLICITATION NUMBER DTOS59-15-R-000302

CONTRACT

SECTION

DESCRIPTION PAGE

NUMBER

PART I –THE SCHEDULES

(CONTRACT SECTIONS A – H)

A SOLICITATION CONTRACT FORM

STANDARD FORM 33 (Rev 9/1997)

FAR 53. 214(c)

TABLE OF CONTENT

B SUPPLIES or SERVICES and PRICE/COST

Schedule of Pricing for Base Period, Option Period One

(1) thru Option Period Four (4) and Total Contract

Estimated Contract Price

3 -10

C DESCRIPTION/SPECIFICATION/

STATEMENT OF WORK

PERFORMANCE WORK STATEMENT 10 - 42

Task 1 -

Task 2 -

Task 3 -

Task 4 -

Task 5 -

D PACKAGING and MARKING 42 - 43

E INSPECTION and ACCEPTANCE 43 - 45

F DELIVERIES or PERFORMANCE 45 - 46

G CONTRACT ADMINISTRATION DATA 46 - 60

H SPECIAL CONTRACT REQUIREMENT 60 - 73

PART II - CONTRACT CLAUSES

(CONTRACT SECTION I)

I CONTRACT CLAUSES

Contract Clauses Incorporated by Reference 73 - 76

Contract Clauses Incorporated in Full Text 76 - 82

PART III—LIST OF DOCUMENTS, EXHIBITS,

and OTHER ATTACHMENTS

(CONTRACT SECTION J)

J LIST of ATTACHMENTS 82 - 154

PART IV—REPRESENTATIONS and

INSTRUCTIONS

(CONTRACT SECTIONS K – M)

K REPRESENTATIONS, CERTIFICATIONS, and

OTHER STATEMENTS of OFFERORS or

RESPONDENTS

154 - 172

L INSTRUCTIONS, CONDITIONS, and NOTICES

TO OFFERORS or RESPONDENTS

172 -173

M EVALUATION FACTORS for AWARD 173 – 177

SECTION B – SUPPLIES OR SERVICES AND PRICE/COST

B.1 Base Period: XXX – XXX

CLIN Description of Supplies and Services Unit Estimated Quantity

Unit Price

Extended Estimated Total Price/Cost

URINE COLLECTION

0001 Collection - Government Facility Each 15,000

0002 Collection - Contractor Site Each 7,000

0003 Emergency Urine Collection Each 300

BREATH ALCOHOL TESTING (BAT)

0004 BAT - Government Facility Each 6,500

0005 BAT - Contractor Site Each 5,000

0006 Emergency BAT Testing Each 300

BREATH ALCOHOL TESTING FORMS (BATF)

0007 BATF - Preparing Each 30,000

URING COLLECTION/BAT COMBINED

0008 Collection/BAT - Government Facility Each 25,000

0009 Collection/BAT – Contractor Site Each 9,000

0011 Collection/BAT - Emergency Each 300

QUALITY ASSURANCE

0012 Quality Assurance (QA) Services Hour 2,080

SCHEDULING

0013 Scheduling Services Hour

PROGRAM MANAGEMENT

0014 Program Manager Hour 2,080

PROFESSIONAL SERVICES

0015 Professional/Technical – 3 Positions on Gov. Site Hour 6,240

CONTRACTOR TESTIMONY

0016 Contractor Testimony Hour 100

TRANSPORTATION/SHIPPING

0017 Transportation/Shipping Lot

TRAVEL

0018 Travel Related Expenses -Mileage, hotel and rental space for collections

Lot $400,000

0019 Collectors/Breath Alcohol Technicians – Site Time/Travel time

Hour 30,000

MEDICAL REVIEW SERVICES

0020 Medical Review Services – Medical Review Each 30,000

0021 MRO Testimony Hour 100

0022 MRO Litigation Package Package 100

QUALITY CONTROL TESTING

0023 Quality Control Specimen for Laboratory Testing Each 500

AD HOC REPORTS

0024 Remote Location Report Yearly 1

0025 Weekly Scheduling Report Each 52

0025 Off Hour Testing Report Each 52

TOTAL ESTIMATED AMOUNT – BASE PERIOD

B.2 Option Period One: XXX – XXX

Unit Price

Extended Estimated Total Price/Cost

URINE COLLECTION

1001 Collection - Government Facility Each 15,000

1002 Collection - Contractor Site Each 7,000

1003 Emergency Urine Collection Each 300

BREATH ALCOHOL TESTING (BAT)

1004 BAT - Government Facility Each 6,500

1005 BAT - Contractor Site Each 5,000

1006 Emergency BAT Testing Each 300

BREATH ALCOHOL TESTING FORMS (BATF)

1007 BATF - Preparing Each 30,000

URING COLLECTION/BAT COMBINED

1008 Collection/BAT - Government Facility Each 25,000

1009 Collection/BAT – Contractor Site Each 9,000

1011 Collection/BAT - Emergency Each 300

QUALITY ASSURANCE

1012 Quality Assurance (QA) Services Hour 2,080

SCHEDULING

1013 Scheduling Services Hour

PROGRAM MANAGEMENT

1014 Program Manager Hour 2,080

PROFESSIONAL SERVICES

1015 Professional/Technical – 3 Positions on Gov. Site Hour 6,240

CONTRACTOR TESTIMONY

1016 Contractor Testimony Hour 100

TRANSPORTATION/SHIPPING

0017 Transportation/Shipping Lot

TRAVEL

1018 Travel Related Expenses -Mileage, hotel and rental space for collections

Lot $400,000

1019 Collectors/Breath Alcohol Technicians – Site Time/Travel time

Hour 30,000

MEDICAL REVIEW SERVICES

1020 Medical Review Services – Medical Review Each 30,000

1021 MRO Testimony Hour 100

1022 MRO Litigation Package Package 100

QUALITY CONTROL TESTING

1023 Quality Control Specimen for Laboratory Testing Each 500

AD HOC REPORTS

1024 Remote Location Report Yearly 1

1025 Weekly Scheduling Report Each 52

1025 Off Hour Testing Report Each 52

B.3 Option Period Two: XXX – XXX

Unit Price

Extended Estimated Total Price/Cost

URINE COLLECTION

2001 Collection - Government Facility Each 15,000

2002 Collection - Contractor Site Each 7,000

2003 Emergency Urine Collection Each 300

BREATH ALCOHOL TESTING (BAT)

2004 BAT - Government Facility Each 6,500

2005 BAT - Contractor Site Each 5,000

2006 Emergency BAT Testing Each 300

BREATH ALCOHOL TESTING FORMS (BATF)

2007 BATF - Preparing Each 30,000

URING COLLECTION/BAT COMBINED

2008 Collection/BAT - Government Facility Each 25,000

2009 Collection/BAT – Contractor Site Each 9,000

2011 Collection/BAT - Emergency Each 300

QUALITY ASSURANCE

2012 Quality Assurance (QA) Services Hour 2,080

SCHEDULING

2013 Scheduling Services Hour

PROGRAM MANAGEMENT

2014 Program Manager Hour 2,080

PROFESSIONAL SERVICES

2015 Professional/Technical – 3 Positions on Gov. Site Hour 6,240

CONTRACTOR TESTIMONY

2016 Contractor Testimony Hour 100

TRANSPORTATION/SHIPPING

2017 Transportation/Shipping Lot

TRAVEL

2018 Travel Related Expenses -Mileage, hotel and rental space for collections

Lot $400,000

2019 Collectors/Breath Alcohol Technicians – Site Time/Travel time

Hour 30,000

MEDICAL REVIEW SERVICES

2020 Medical Review Services – Medical Review Each 30,000

2021 MRO Testimony Hour 100

2022 MRO Litigation Package Package 100

QUALITY CONTROL TESTING

2023 Quality Control Specimen for Laboratory Testing Each 500

AD HOC REPORTS

2024 Remote Location Report Yearly 1

2025 Weekly Scheduling Report Each 52

2025 Off Hour Testing Report Each 52

B.4 Option Period Three: XXX – XXX

Unit Price

Extended Estimated Total Price/Cost

URINE COLLECTION

3001 Collection - Government Facility Each 15,000

3002 Collection - Contractor Site Each 7,000

3003 Emergency Urine Collection Each 300

BREATH ALCOHOL TESTING (BAT)

3004 BAT - Government Facility Each 6,500

3005 BAT - Contractor Site Each 5,000

3006 Emergency BAT Testing Each 300

BREATH ALCOHOL TESTING FORMS (BATF)

3007 BATF - Preparing Each 30,000

URING COLLECTION/BAT COMBINED

3008 Collection/BAT - Government Facility Each 25,000

3009 Collection/BAT – Contractor Site Each 9,000

3011 Collection/BAT - Emergency Each 300

QUALITY ASSURANCE

3012 Quality Assurance (QA) Services Hour 2,080

SCHEDULING

3013 Scheduling Services Hour

PROGRAM MANAGEMENT

3014 Program Manager Hour 2,080

PROFESSIONAL SERVICES

3015 Professional/Technical – 3 Positions on Gov. Site Hour 6,240

CONTRACTOR TESTIMONY

3016 Contractor Testimony Hour 100

TRANSPORTATION/SHIPPING

3017 Transportation/Shipping Lot

TRAVEL

3018 Travel Related Expenses -Mileage, hotel and rental space for collections

Lot $400,000

3019 Collectors/Breath Alcohol Technicians – Site Time/Travel time

Hour 30,000

MEDICAL REVIEW SERVICES

3020 Medical Review Services – Medical Review Each 30,000

3021 MRO Testimony Hour 100

3022 MRO Litigation Package Package 100

QUALITY CONTROL TESTING

3023 Quality Control Specimen for Laboratory Testing Each 500

AD HOC REPORTS

3024 Remote Location Report Yearly 1

3025 Weekly Scheduling Report Each 52

3025 Off Hour Testing Report Each 52

B.5 Option Period Four: XXX – XXX

Unit Price

Extended Estimated Total Price/Cost

URINE COLLECTION

4001 Collection - Government Facility Each 15,000

4002 Collection - Contractor Site Each 7,000

4003 Emergency Urine Collection Each 300

BREATH ALCOHOL TESTING (BAT)

4004 BAT - Government Facility Each 6,500

4005 BAT - Contractor Site Each 5,000

4006 Emergency BAT Testing Each 300

BREATH ALCOHOL TESTING FORMS (BATF)

4007 BATF - Preparing Each 30,000

URING COLLECTION/BAT COMBINED

4008 Collection/BAT - Government Facility Each 25,000

4009 Collection/BAT – Contractor Site Each 9,000

4011 Collection/BAT - Emergency Each 300

QUALITY ASSURANCE

4012 Quality Assurance (QA) Services Hour 2,080

SCHEDULING

4013 Scheduling Services Hour

PROGRAM MANAGEMENT

4014 Program Manager Hour 2,080

PROFESSIONAL SERVICES

4015 Professional/Technical – 3 Positions on Gov. Site Hour 6,240

CONTRACTOR TESTIMONY

4016 Contractor Testimony Hour 100

TRANSPORTATION/SHIPPING

4017 Transportation/Shipping Lot

TRAVEL

4018 Travel Related Expenses -Mileage, hotel and rental space for collections

Lot $400,000

4019 Collectors/Breath Alcohol Technicians – Site Time/Travel time

Hour 30,000

MEDICAL REVIEW SERVICES

4020 Medical Review Services – Medical Review Each 30,000

4021 MRO Testimony Hour 100

4022 MRO Litigation Package Package 100

QUALITY CONTROL TESTING

4023 Quality Control Specimen for Laboratory Testing Each 500

AD HOC REPORTS

4024 Remote Location Report Yearly 1

4025 Weekly Scheduling Report Each 52

4025 Off Hour Testing Report Each 52

B.6 Contractor Proposed CLINs

B.6.1 The contractor may propose other CLINs to meet the requirements. Contractor proposed CLINs shall describe the work and services proposed quantity and estimated cost for each performance period. The Government is not required to accept Contractor proposed

CLINs unless determined in the best interest of the Government to fulfill the requirements requested.

B.7 Overhead, General and Administrative (G&A) and Other Applicable Rates

B.7.1 Contractor’s G&A Rates for Base and Option Periods are estimated as follows:

Base Period G&A Rate %

Option Period One G&A Rate %

Option Period Two G&A Rate %

Option Period Three G&A Rate %

Option Period Four G&A Rate %

B.7.2 The contractor shall obtain written approval from the COR’s for reimbursement of

Other Direct and Travel costs prior to incurring these reimbursable expenses.

B.8 TOTAL EXTENDED LOADED CONTRACT PRICE FOR LABOR, ESTIMATED

TRAVEL and ESTIMATED OTHER DIRECT COST FOR THE BASE PERIOD AND FOUR

OPTION PERIODS:

B.9 RELATED SUPPLIES AND OTHER DIRECT COSTS

B.9.1 Related Supplies

B.9.1.1 The DOT anticipates the procurement of supplies related to contractor services and work performed under the contract and any underlying task orders. Supplies for the purposes of this contract are those items physically and/or logically associated with the contract services being provided. All related supplies provided by the Contractor shall be identified in writing, authorized in advance by the Contracting Officer Representative (COR), and separately identified in billing/invoice statements accompanied with receipts.

B.9.1.2 The Contracting Officer (CO) may authorize a maximum dollar amount in related supplies in a single order. The COR has accountability for all related supplies purchased under the Contract.

B.9.1.3 For related supplies provided under this contract, the Contractor shall bill the Government for the direct cost of the items purchased and include as a separate invoice line, the applicable administrative overhead/handling rate charge. In no case shall there be any additional costs (such as transportation or delivery fees) other than the direct purchase price and the proposed administrative overhead/handling rate charge.

B.10 Other Direct Costs

B.10.1 Other direct costs necessary for the performance of the work under task orders, such as travel and transportation, lodging and subsistence expenses may be authorized by the CO in the task order. Any cost elements included in the fixed hourly rate for labor must not be charged as other direct cost.

B.10.2 The CO determines which other direct costs are allowable, allocable, and fair and reasonable in accordance with the applicable federal cost principles (i.e., FAR Sub-Part 31.2, FAR Sub-Par 31.3 and FAR sub-part 31.7). For other direct costs that the CO authorizes, contractors are allowed to recover applicable indirect costs on these costs, if doing so is part of the contractor’s usual accounting procedures, consistent with the applicable cost principles, and are included in the contractor's Negotiated Indirect Cost Rate Agreement.

B.10.3 No profit or fee will be applied to direct costs, in accordance with FAR Sub-Part 16.601.

B.11 MINIMUM GUARANTEE

B.11.1 The minimum guarantee value for this requirement is $100,000 over the entire term of the contract. The contract term is five (5) years, which includes one (1) base year and four (4) one (1) year option periods.

END OF SECTION B

SECTION C—DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 Objective

C.1.1 The objective of this contract is for DOT to comply with Executive Order 12564

(E.O.) and the Omnibus Transportation Employee Testing Act of 1991 (Pub. L. 102-143, Title V)

("OTETA"), DOT Drug and Alcohol Workplace Order 3910.1D and other applicable laws and regulations.

C.1.2 The E.O. requires drug testing for certain safety- and security-sensitive employees. The OTETA mandates that a program be established to test for use, in violation of law or Federal regulation, of alcohol or a controlled substance. The OTETA covers the employees of the Federal Aviation Administration (FAA) whose duties include responsibility for safety-sensitive functions, and any employee within any Operating Administration (OA) of the

DOT whose position requires a Commercial Driver’s License (CDL). However, should additional workplace testing needs arise of a comparable nature; these may be included under this contract. In addition, this contract may provide services to the Department of Homeland

Security (DHS) including Transportation Security Agency (TSA), Federal Air Marshals (FAM), U.S. Coast Guard (USCG); and other entities. For TSA the requirements of the Aviation and

Transportation Security Act of 2002 (Pub. L. 107-71) will also apply. This may require changes to collector instructions, forms and entail additional administrative work.

C.2 Definitions – Shall be provided with final solicitation

C.3 Background

C.3.1 Pursuant to E.O. 12564, the Omnibus Transportation Employee Testing Act of

1991 (OTETA), the Aviation and Transportation Security Act of 2002, DOT Drug and Alcohol

Workplace Order, DOT Drug and Alcohol Testing Guide a drug testing for certain safety- and security-sensitive employees is required. The OTETA mandates that a program be established to test for use, impacted employees who to determine compliance with law or Federal regulation, for alcohol or a controlled substance abuse. The OTETA covers the employees of the Federal Aviation Administration (FAA) whose duties include responsibility for safety-sensitive functions, and any employee within any Operating Administration (OA) of the DOT whose position requires a Commercial Driver’s License (CDL). When testing needs arise of a comparable nature as described for this requirement, services to other federal entities shall be provided. This currently includes the Department of Homeland Security (DHS) including

Transportation Security Agency (TSA), Federal Air Marshals (FAM), U.S. Coast Guard (USCG) and the US Merchant Marine Academy (USMMA). Additional riders may include Federal

Bureau of Investigation (FBI), U.S. Nuclear Regulatory Commission (NRC) and the US Secret

Service (USSC) For TSA, the requirements of the Aviation and Transportation Security Act of

2002 (Pub. L. 107-71) shall apply. Support provided for this requirement may require changes to collector instructions, forms and entail additional administrative work.

C.3.2 Collection/testing shall be required in all 50 States, Puerto Rico, the U.S. Virgin

Islands, and certain locations in the Western Pacific area, such as Guam, American Samoa.

C.3.3 The estimated number of DOT employee collections/tests to be performed is approximately 15,000 collections for drug testing and 7,000 alcohol tests a year (this estimate includes all riders). The estimated number of DHS employee collections/tests to be performed is approximately 30,000 collections for drug testing and 27,000 alcohol tests a year.

Approximately, 300 of the annual tests were scheduled during weekends, holidays and off hours. Approximately 200 of these tests are emergency after-hours testing tests that must be completed within 4 hours of notification. The contractor shall participate with DOT in this effort by assisting, in a flexible and responsive manner, in establishing and modifying procedures required and assuring a high quality of performance. The actual number of tests to be performed each year will vary depending upon such factors as random testing rate, volume of testing other than random, and testing required to support other federal entities outside of DOT that may participate in this contract. Specific procedures may differ somewhat from the procedures defined in the various DOT final rules for the drug and alcohol testing of transportation industry employees; i.e., Title 49 of the Code of Federal Regulations (49CFR) Part 40 and other Operating Administration specific regulations. It is the responsibility of the contractor to be familiar with the DOT Federal Employee Workplace Testing Program policies and procedures, DOT Drug and Alcohol Workplace Order, DOT Drug and Alcohol Testing Guide. Also, procedures are, under certain circumstances, subject to negotiation with exclusive bargaining representatives of covered employees of DOT or other participating entities. The contractor, and any subcontractor associated with this contract, will be subject to contract Quality Assurance inspections by DOT.

C.4 Scope

C.4.1 The contractor shall provide all services necessary personnel and materials to conduct a drug and alcohol testing services for covered DOT employees and applicants. The contractor shall provide collection and testing services pursuant to the terms of the resulting contract in all 50 States, Puerto Rico, the U.S. Virgin Islands, and certain locations in the

Western Pacific area, such as Guam, American Samoa. Under the resultant contract, the annual testing goal is predicted to range from 15,000 to 30,000 drug collections and 7,000 to

27,000 alcohol tests. The contractor shall have the ability to support this range of tests.

Approximately 300 of the annual tests scheduled shall be conducted during weekends, holidays and off hours. The contractor shall have the ability to respond during these periods to support the required number of tests. Approximately 200 of annual tests are emergency off-hour tests that shall be completed within 4 hours of notification. The contractor shall fully comply with this completion turn-around response time. The actual number of tests to be performed each year shall vary depending upon such factors as random testing rate, volume of testing other than random, and testing required to support other federal entities outside of DOT, which may participate in this contract. When the rate of positive tests exceeds 1% for any one (1) year period, the contractor testing rate may be increased by the Government. The number of tests required under the other types of testing described in this scope of work shall also vary depending upon such factors as random testing rate, volume of testing other than random, and testing required to support other federal entities outside of DOT, who may participate in this contract. Reasonable suspicion and post-accident tests are expected to be approximately 1% of total tests. Follow-up tests are expected to be approximately 12% of total tests and pre-employment and pre-appointment shall be about 20% of estimated drug tests. Pre-employment alcohol testing is not currently performed within DOT; however, it may be implemented by the Government when needed.

C.4.2 If DHS decides to participate in acquiring services under the resultant contract, the time period of participation is estimated to align with the period of performance for the resulting contract award. Once DHS establishes its own testing policies and procedures, they may also decide to obtain drug and alcohol testing services with other providers. Nonetheless, DHS predicts random testing volume of 30,000 drug tests and 27,000 alcohol tests a year in approximately 550 duty locations, of which 50 of these locations are in addition to the 950 DOT duty locations identified under Section J.9, Geographic Distribution of DOT and Other Entity

Employees. The DHS’ emergency testing requirements are expected to be about the same as

DOT; under 100 events a year. The DHS shall also require return-to-duty and follow-up testing.

The TSA, as part of the DHS has a separate contract for the majority of its pre-employment testing. However, it is anticipated that TSA Headquarter and other DHS organizations as identified under this requirement, shall request pre-employment testing. The estimated amount of pre-employment testing by all of the organizations within DHS is under 1,000 tests per year.

C.4.3 The full impact of other entities participating in this contract requirement cannot be guaranteed at this time; however, the estimated quantities described reflect anticipated requirements. Attachment J.9 lists the duty locations and number of employees at each of those locations to help gauge testing and other services that may be required. Offerors shall provide the requested information on Attachment J.9 to indicate their organization’s ability to provide service coverage.

C.4.4 Contractor provided services shall include work related to substance abuse testing, related awareness, medical review officer functions; expert witness testimony including expertise beyond collection, alcohol testing; MRO; and program design and/or advisory services when it is required.

C. 5 Contract Requirements

C.5.1 The contractor shall provide all qualified personnel and resources to perform the following tasks associated with the scope of work of this contract:

C.5.1.1 Task 1 - Urine Collection and Transportation Requirements

C.5.1.1.1 The contractor, in conjunction with the requirements identified in Section J.1 -

J.7, and J.16 as follow:

SECTION J

ATTACHMENT

NAME OF SECTION J ATTACHMENT

J.1 J-1. Department of Transportation (DOT), Federal Motor Carrier Administration regulation 49 CFR Part 382.*Public Domain http://www.FMCSA.dot.gov/rules-regulations/topics/drug/engtesting.htm

J.2 J-2. Mandatory Guidelines for Federal Workplace Drug Testing Programs, effective September 1, 1994, and published at 59 Federal Register 29,908 (1994), issued by the Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services (HHS). Public Domain http://workplace.samhsa.gov . Select “Federal Programs” and then select “HHS Mandatory Guidelines”

J.3 J-3. Department of Transportation, Office of the Secretary regulation 49 CFR Part 40.

Public Domain http://www.dot.gov/ost/dapc/NEW_DOCS/part40.html

J.4 J-4. DOT, National Highway Traffic Safety Administration Conforming Products List (CPL).

Public Domain http://www.dot.gov/ost/dapc/testingpubs/20071217_CPL_EBT.pdf

J.5 J-5. DOT, Office of the Secretary, DOT Drug and Alcohol Testing Guide. Public Domain http://dothr.ost.dot.gov/hrprograms/drugandalcohol/Guide2010.pdf. Select “Drug and Alcohol Testing Guide”

J.6 J-6. Confidentiality of Alcohol and Drug Abuse Patient records, 42 CFR Part 2. Public Domain http://www.hipaa.samhsa.gov/Part2ComparisonCleared.htm

J.7 J-7. DOT, Office of the Secretary, DOT Order 3910.1D. Public Domain http://dothr.ost.dot.gov/hrprograms/drugandalcohol/order_3910d.pdf

J.16 J-16 Substance Abuse Awareness and Testing Office (a.k.a. (DDO) BAT Supplemental Training Course Instructor’s Manual shall apply the necessary procedures as specified to fulfill the requirements described in Task 1.

These procedures are subject to further revisions and clarification to ensure compliance with DOT regulations, specific entity requirements, and applicable employee collective bargaining agreements. In some instances, collective bargaining agreements may allow for the presence of an employee union representative during any or all of the collection and testing procedures.

Guidance on when union representatives is required or requested should be obtained and coordinated with the Contracting Officer’s Representative (COR). The COR shall coordinate with the Contracting Officer and Substance Abuse Awareness Testing Office (SAATO), Drug http://www.fmcsa.dot.gov/rules-regulations/topics/drug/engtesting.htm http://www.fmcsa.dot.gov/rules-regulations/topics/drug/engtesting.htm http://workplace.samhsa.gov/ http://www.dot.gov/ost/dapc/NEW_DOCS/part40.html http://www.dot.gov/ost/dapc/testingpubs/20071217_CPL_EBT.pdf http://dothr.ost.dot.gov/hrprograms/drugandalcohol/Guide2010.pdf http://www.hipaa.samhsa.gov/Part2ComparisonCleared.htm http://dothr.ost.dot.gov/hrprograms/drugandalcohol/order_3910d.pdf

Program Coordinator (DPC) and Site Coordinator (SC) to ensure compliance with collective bargaining agreements. References described in Section J.5, DOT, Office of the Secretary, DOT Drug and Alcohol Testing Guide. Public Domain http://dothr.ost.dot.gov/hrprograms/drugandalcohol/Guide2010.pdf. Select “Drug and Alcohol Testing

Guide” of this contract provide the DOT Drug and Alcohol Testing Guide, applicable to this task area.

C.5.1.1.1.1 To ensure that the urine chain-of-custody and specimen control are maintained, the contractor shall follow the procedures as specified below. These procedures are subject to future revisions and clarification to assure compliance with J.2, Department of Health and

Human Services (HHS) Guidelines and DOT program policy requirements J.5 –J.7 and J.15 as follow:

NAME OF SECTION J ATTACHMENT

J.5 J-5. DOT, Office of the Secretary, DOT Drug and Alcohol Testing Guide. Public Domain http://dothr.ost.dot.gov/hrprograms/drugandalcohol/Guide2010.pdf. Select “Drug and Alcohol Testing Guide”

J.15 J-15. Substance Abuse Awareness and Testing Office (a.k.a. (DDO) BAT Supplemental Training Course Instructor’s Manual)

C.5.1.2 Collection Site Designation

C.5.1.2.1 The collection/testing site is the location for specified DOT employees or applicants to present themselves for the purpose of providing a urine specimen. Testing sites shall be designated by the CO, COR or DPCs. Generally, the testing site will be at one of the approximately 950 DOT duty locations throughout the 50 United States, Puerto Rico, U.S. Virgin

Islands, and certain locations in the Western Pacific area. These locations are listed in section

J.10, Sample DOT Drug Test List. In instances when 100-200 testing events a year are required for any given location, the DOT facility will not be the most effective site to conduct collection/testing. In these instances, the DPC will arrange with the contractor for outside offsite testing. This site may be at the contractor’s facility or at a non-DOT government facility. When this is necessary, the offsite location shall be reasonably accessible to federal employees and shall meet the DOT site specifications. Mobile collection/testing units may be acceptable if first approved by the DPC and COR. Collection/testing shall not be performed at an employee’s/applicant’s residence or hospital. In all circumstances, whether onsite or offsite, the

DOT retains final approval authority of the site which collection/testing takes place. Attachment

J-9, Geographic Distribution of DOT and Other Entity Employees, provides information on the duty locations of DOT employees.

C.5.1.2.2 The DPC or designee shall notify the contractor of the name, proposed enter-on-duty date, earliest date for testing, and city and state of applicant/employee to be tested. The contractor shall furnish the DPC or designee with its local point-of-contact name, address, and phone number for the pre-employment test. The contractor shall also inform the DPC, COR or designee of the testing schedule. The testing site shall be in commuting distance for the applicant in all but rare cases. If the contractor is not able to accommodate the testing request, or if the testing would be less expensive and can be arranged at a government facility, then the http://dothr.ost.dot.gov/hrprograms/drugandalcohol/Guide2010.pdf http://dothr.ost.dot.gov/hrprograms/drugandalcohol/Guide2010.pdf

DOT or other entity and the contractor shall work out the best alternative to fit the requesting federal entity's needs. The contractor shall obtain the DOT or other federal entity's prior approval for atypical testing circumstances; e.g., performing testing at a site other than the contractor's office and related travel costs for the collector.

C.5.1.3 Collection Site Specifications

In accordance with Health and Human Services Mandatory Guidelines for Federal Workplace programs, as described under J.17, Health and Human Services urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Program. Public Domain http://beta.samhsa.gov/sites/default/files/specimen_collection_handbook_2010_100908.pdf , the contractor shall assume primary responsibility for assuring Government and non-

Government facility testing sites meet mandatory requirements. In this regard, the contractor shall, ensure:

C.5.1.3.1 The collection site has facilities that are clean, well lit, and sufficiently secure to prevent compromise during collection/testing;

C.5.1.3.2 The contractor shall be responsible for arriving on site and preparing the restrooms for collection activities in sufficient time to ensure collections are not delayed;

C.5.1.3.3 The contractor shall assure the portion of the facility being used for collection/testing is secured during collection and no unauthorized personnel are admitted in any part of the collection/testing area. Union representatives, when requested by the employee, may be present when authorized by the COR or designee, SC or DPC.

C.5.1.3.4 The contractor shall notify the DPC immediately if a site fails to meet the above requirements.

C.5.1.3.5 The contractor shall provide all labor, materials including authorized urine collection custody and custody control forms (CCF), urine collection kits, laboratory coats, and identification badges. The contractor shall be responsible for preparation of these forms, obtaining DOT CO/COR approval, printing and distribution. Urine collection kits and forms shall be obtained by the contractor from the DOT contract laboratory in sufficient time to ensure that the collection schedule is not delayed.

C.5.1.3.6 Damage to Government or non-Government facilities resulting from collector’s action shall be the responsibility of the contractor.

C.5.1.4 The Government shall not provide any additional material support for performance of this contract.

C.5.1.5 Urine Collection Requirements

C.5.1.5.1 All DOT employee/applicant urine collections shall be accomplished using split specimen procedures in accordance with the description identified under Attachment J.2, Mandatory Guidelines for Federal Workplace Drug Testing Programs and J.5, DOT, Office of http://beta.samhsa.gov/sites/default/files/specimen_collection_handbook_2010_100908.pdf the Secretary, DOT Drug and Alcohol Testing Guide. A split specimen is the result of a single void of urine into a collection container that is subsequently divided into two specimen bottles for shipping and testing. The contractor is responsible for following the same procedures for ensuring the identity, integrity, and security of the second urine specimen as are required for the first specimen.

C.5.1.5.2 Other federal entities participate in this contract may require that single urine specimens be taken in accordance with J.2 and J.5. The contractor shall clarify which single urine specimen procedures shall be used at the time of the request for collection.

C.5.1.5.3 For DOT random collections, two collectors shall be provided to perform the work, unless otherwise approved by the DOT. Collectors of both genders shall be available, because the gender of the DOT employees providing the sample is not always identified until shortly before the actual collection. For post-accident, reasonable suspicion, pre-employment, or follow-up collections, the gender of the donor is known with certainty before the collection is scheduled, therefore, one same gender collector shall be assigned. In some cases, random collections may involve all male or all female donors. When this occurs and two collectors are required because, the collection goal exceeds ten collections at one site, both collectors may be of the same gender as the donor(s) when the gender of those donors are known in advance.

The CO, COR or designee, or the DPC or designee may waive same gender collector requirements under certain circumstances. The contractor shall obtain a written waiver from the

COR or designee in advance of collection when the proposed collector’s gender is not the same as the donor’s gender.

C.5.1.5.4 The contractor shall adhere strictly to the schedule established by DOT and be prepared to begin collections at the requested times. The collection process is usually scheduled by DOT as close to the start of a work shift as possible. Approximately 40 percent of the work force may be on a work schedule spanning times other than 8:00 a.m. to 5:00 p.m.

Although testing will usually be targeted for the start of a work shift, this will vary. The collector(s) shall arrive at the collection site at least 30 minutes before collections are scheduled to begin, in order to prepare the site to conform to HHS Guidelines (Attachment J.2). The collector(s) shall provide identification to the point-of-contact/SC and provide the SC with the donor list to be worked. Inability to adhere to the schedule shall be reported immediately to the

DPC. During the collection process, the SC will annotate the list and return it to the collector upon completion of the collection(s). This process may vary in DHS random testing.

C.5.1.5.5 The collector shall initiate a CCF, acceptable to HHS, DOT and the contractor laboratory, which serves as an identification document for the urine sample collected.

C.5.1.5.6 Upon donor's arrival at the collection site, the collector shall request the donor to present valid photo identification described below. If the donor does not have proper identification, the collector shall request the SC to make a visual identification of the donor. If the SC cannot make visual identification of the donor, the donor shall be instructed to return to his/her work station for photo identification, immediately return to the collection site, and to not stop along the way to use the restroom. The collector shall note on the CCF and notify the DPC immediately of any failure to provide proper identification. Acceptable forms of identification include:

C.5.1.5.6.1 Employee identification with photo;

C.5.1.5.6.2 Driver's license with photo;

C.5.1.5.6.3 School identification card with photo, or

C.5.1.5.6.4 SC’s or supervisors visual identification of the employee.

C.5.1.5.7 If the donor fails to appear at the assigned time or fails to follow procedures, the collector shall contact the SC. If the SC is not able to explain or resolve the situation, the collector shall immediately contact the DPC to obtain guidance on action to be taken. The collector shall annotate this situation on the CCF in the remarks section.

C.5.1.5.8 The collector shall require the donor to remove any unnecessary outer garments

(e.g., coat, jacket) that might conceal items or substances that could be used to tamper with or adulterate his or her urine specimen. Also, all personal belongings (e.g., purse, briefcase, etc.)

must remain with outer garments. The donor may; however, retain his or her wallet. The collector shall direct the donor to empty his or her pockets and display the items to ensure that no items are present that could be used to adulterate the specimen. If nothing is there that could be used to adulterate a specimen, the donor may place the items back into his or her pockets and the collection procedure continues.

C.5.1.5.9 If an item is found that appears to have been brought to the collection site with the intent to adulterate the specimen, the collector will immediately contact the DPC or other authorized official and a collection using direct observation procedures is used. If the item appears to be inadvertently brought to the collection site, the collector shall secure the item and continue with the normal collection procedure. The secured item is returned to the donor at the conclusion of the testing process. If the donor refuses to show the collector the items in his or her pockets, this is considered a “refusal to test”. The DPC shall be notified immediately. The collector shall note any unusual behavior or appearance on the part of the donor on the CCF.

C.5.1.5.10 The donor shall be instructed to wash and dry his or her hands prior to urination.

After washing hands, he or she shall remain in the presence of the collector and not have access to water fountains, faucets, soap dispensers, cleaning agents or any other materials that could be used to adulterate the specimen. If a water source or other dispenser containing possible contaminants is present, the collector, shall prohibit its use and shall tape it up to avoid use.

C.5.1.5.11 At the collection site, toilet-bluing agent shall be placed in the toilet tank, wherever possible, or the bowl so that the reservoir water in the toilet bowl will always remain blue. There should not be any other sources of water (e.g., shower, sink, etc.) in the enclosure where urination occurs.

C.5.1.5.12 The donor may provide his or her specimen in the privacy of a stall, or otherwise partitioned area that allows for donor privacy. A same gender collector must accompany the donor undergoing testing into the restroom. The restroom must be secured during the collection procedure. The collector remains in the restroom, but outside the stall until the specimen is collected. If the restroom is not equipped with stalls or other privacy shields, the collector shall remain outside the door of the restroom while the donor is urinating. All sources of water or other possible contaminants must be taped or otherwise secured during the collection. The donor shall be asked by the collector to void into a disposable specimen container and asked not to flush the toilet until the specimen has been handed over to the collector. The donor may then flush the toilet and should then observe the collector complete the chain-of-custody procedure. The collector shall note any unusual behavior by the donor or unusual specimen characteristics, e.g. color, odor, etc., on the CCF.

C.5.1.5.13 In the event where DOT's designated collection site is not accessible, and where there is a requirement for immediate specimen collection, a public restroom may be used if proper security arrangements can be maintained. The restroom should be closed to the public during the actual collection process.

C.5.1.5.14 Upon receiving the specimen from the donor, the collector shall determine that it contains at least 45 milliliters (1.52163 fluid ounces) of urine. If there is not sufficient urine in the container, the insufficient specimen shall be discarded and another specimen shall be collected. If the donor provides an insufficient amount or is unable to provide a specimen, i.e.

shy bladder, the collector shall inform the SC or DPC. The SC or supervisor shall instruct the donor to drink fluids and tell him/her where to wait until ready to provide another specimen.

Under no circumstance shall the collector combine the results of multiple voids in order to obtain the required amount of urine to complete a urine collection. In some cases as authorized by the DPC or SC, the donor may return to work and drink fluids at the work site.

The donor has up to 3 hours to provide a specimen. In these instances, the collector shall immediately contact the SC/DPC to discuss appropriate action. It will be the responsibility of local DOT management or the SC/DPC to direct an employee to remain at the collection site for any additional time period. Within the allowable 3-hour time-frame, the collector must annotate the CCF under the remarks section with the time of each attempt.

C.5.1.5.15 After the specimen has been provided and submitted to the collector, the donor should be allowed to wash his or her hands.

C.5.1.5.16 Immediately after collection the collector shall, in the presence of the donor, measure the temperature of the specimen, and conduct an inspection to determine the specimen’s color and identify signs of contaminants. Any unusual findings resulting from the inspection shall be included on the CCF. The time from urination to temperature measurement is critical and shall not exceed 4 minutes before obtaining a reading. If the temperature of the specimen is outside the range of 32-38 degrees Celsius or 90-100 degrees Fahrenheit, this gives rise to reasonable suspicion of adulteration/substitution. Another specimen shall be collected and both specimens forwarded to the laboratory. Any specimen suspected to be adulterated shall always be forwarded for testing. The contractor must immediately inform the DPC or COR of any occurrence of this nature and provide specimen identification information.

C.5.1.5.17 Collection under direct observation shall only occur when it has been authorized by the COR or designee or the DPC. Generally, direct observation shall be authorized only when: 1) DOT orders testing for reasonable suspicion and requires direct observation, or 2) the collector has reason to believe that the specimen has been adulterated/substituted/tampered (In these cases, the contractor shall immediately contact the DPC or other authorized official to discuss appropriate action.), or 3) collections are ordered under the return-to-duty and follow-up program.

C.5.1.5.18 The collector shall tell the donor that in order to conduct the direct observation properly, he/she must be able to tell that the urine is excreted directly from the donor's body.

Authorization to observe urination is given in situations where there is reason to believe the donor may attempt to adulterate or substitute the specimen. Adulteration would involve the addition of a substance to the specimen before the specimen is given to the collector.

Substitution occurs when the donor provides a specimen that is not human urine. Donors have been known to tape a plastic or latex container containing "clean" urine to the body prior to collection. This may produce an acceptable temperature. The collector must position him/herself in such a manner that he/she can see the urine pass directly from the donor's body into the collection cup. The contractor's procedure manual and training shall provide specific procedures for direct observation. Under contract section J.5 – J.6 and J.16 are procedures to facilitate direct observation by collector.

C.5.1.5.19 When testing CDLs, the direct observation procedures refer to contract section J.3, Department of Transportation, Office of the Secretary regulation 49 CFR Part 40. Public Domain http://www.dot.gov/ost/dapc/NEW_DOCS/part40.html. Section J.3 shall be used for guidance and compliance of direct observation of CDLs instead of Section J.5 – J.6 and J.16 described above.

These direct observation procedures differ from HHS Collection Handbook described at contract section J.16. When direct observation must occur, authorization shall be given from the COR, designee or DPC.

C.5.1.5.20 Both the donor and the collector should keep the specimen in view at all times prior to being sealed and labeled. If the specimen is transferred to a split container, the collector shall require the donor to observe the transfer of the specimen to the specimen bottle(s) and the placement of the tamper proof seal/label(s) over the bottle cap(s) and down the sides of the bottle(s).

C.5.1.5.21 The identification label should contain the date, the donor's specimen number.

The donor shall initial the label after it is placed on the specimen bottle.

C.5.1.5.22 The donor shall be asked to read and sign the CCF that contains a certification statement. The collector must annotate a refusal to sign this statement on the CCF.

C.5.1.5.23 The collector shall complete the appropriate chain of custody portion of the CCF.

If the CCF is not properly annotated there will be penalties assessed. Contract section J.12, Table of Penalties, shall be read by the contractor to understand penalties.

C.5.1.5.24 When the urine sample is ready for shipment to the DOT contractor laboratory, the specimen shall be properly packaged for shipment with the appropriate copies of the CCF documents. Except in rare instances, the specimens shall be shipped at the end of the day's collections. Should the time between collection and shipment exceed 24 hours, the COR must be notified of the circumstances that caused the delay of specimens shipment. The appropriate http://www.dot.gov/ost/dapc/NEW_DOCS/part40.html copies of the CCF shall be sent via overnight courier to the DPC, SAATO and/or the Medical

Review Officer (MRO), immediately after the site is completed.

C.5.1.5.25 The collector shall return the collection site to a condition for general use, e.g.

tape and collection related trash should be removed, restroom closed signs taken down, etc.

Any damage should be reported to the SC.

C.5.1.6 Collection Control Requirements

C.5.1.6.1 In order to ensure that the urine specimens are properly identified and not accidentally confused with any other sample, the collector shall always use strict chain-of-custody procedures when collecting and transferring the specimen. While performing any part of the chain-of-custody procedures, the contractor shall assure the urine specimen and custody documents are always under the total control of the collector. If the collector must leave his or her workstation, the specimens and custody forms shall be taken with him or her, left in another collector’s custody, or must be secured in a locked area or container.

C.5.1.6.2 The collectors shall always have the container or specimen bottle within sight before and after the donor has urinated. The container shall be tightly capped, properly sealed, and labeled.

C.5.1.6.3 The contractor is responsible for storing and securing urine specimens from point of receipt from donor to transfer to the courier.

C.5.1.6.4 The proper CCF shall be utilized for the purpose of maintaining control and accountability from initial collection to final disposition of all specimens. The form and bottle seal/label(s) shall identify the specimen with a unique identification number that matches the form to the seal/label(s).

C.5.1.6.5 The contractor shall be subject to announced and unannounced inspections conducted by DOT. This shall include, at a minimum, on-site observation of contractor personnel by DOT personnel. The contractor shall be able to demonstrate at all times the effectiveness and reliability of its collection process. DOT inspections shall include on-site observation of the performance of contractor personnel.

C.5.1.6.6 In the event that collection/chain-of-custody procedure errors are made by the contractor collection personnel and these errors result in cancellation of the test at the laboratory, the contractor shall be responsible for the costs associated with that collection, as well as any cost paid by DOT for administrative costs of cancellation. In the event the error meets the criteria in J-7 the collector shall complete that training. When collector error training has been conducted, collector training certification shall be submitted to the DOT before the collector resumes collections.

C.5.1.6.7 Under this contract, the collection contractor and/or subcontractors are not permitted to have direct communication with the DOT designated laboratory relating to DOT federal employees and applicants. The contractor shall coordinate with the DOT laboratory

COR to establish a mutually agreeable order and supply process. In general, this communication shall be directly between the contractor, DOT collection COR, and DOT laboratory COR, or designee.

C.5.1.6.8 Collection personnel must be able to answer routine questions about urine collection for drug testing and alcohol testing procedures and equipment operation. The contractor shall maintain records of the training provided (dates, persons trained, time spent, topics covered) for inspection. All training and/or retraining will be at the expense of the contractor. Contractor errors resulting in canceled specimens or tests or causing administrative consequences shall, at the discretion of the CO upon recommendation of the COTR, be the subject of penalties. The contractor shall provide a current Collector/BAT Training Plan explaining how these requirements will be met as part of the proposal.

C.5.1.7 Distribution Requirements.

C.5.1.7.1 The collector shall ship the specimens to the laboratory after completion of the collection process. The specimens shall be placed in appropriate containers (specimen boxes or padded mailers as required for shipment of bodily fluids that are securely sealed to eliminate the possibility of tampering. The collector shall place the appropriate copies of the CCF in the box or padded mailer containing the specimen. An outer mailing wrapper is placed around each sealed container.

C.5.1.7.2 Specimens shall be sent via overnight courier to the laboratory at the conclusion of testing for the day, or, in unusual situations, no later than 24 hours of the completion of collection/site.

C.5.1.7.3 The loss of damage that occurs to improperly packaged specimens while in transit is the responsibility of the contractor. The contractor shall be responsible for all replacement collection costs (material and labor) to the extent that specimens were collected, packaged, and sent to the laboratory for analysis. The contractor is responsible for retaining written evidence of shipments, e.g. courier tracking number and number of specimens in each package, and for placing traces on lost shipments. The contractor shall report all situations requiring tracking, as well as the results of the contractor's inquiry, to the COTR and DPC.

C.5.1.7.4 Specimens or empty specimen bottles received at the laboratory and unable to be tested because of insufficient quantity, whether due to…