Solicitation- Primary Lab w Att. J 693JK422R800003- Forensic Toxicology Drug Testing Laboratory.pdf

P A R T I

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

QUESTIONS: It is crucial that by 12:00 P.M. EST on July 30, 2022, all prospective offerors e-mail all of their questions concerning this Solicitation to both of the following e-mail addresses: Jason.bush@dot.gov and Rochelle.swain.ctr@dot.gov.

FUNDING FOR THIS PROJECT HAS NOT YET BEEN CONFIRMED: DOT’s sponsoring program office has not yet completed a Procurement Request (PR) in support of this Solicitation / project. Therefore, there is currently no formal certification of available funding for this project. The program office hopes, but does not promise, to complete such a PR in the next several weeks.

INCUMBENT CONTRACTOR: The incumbent contractor is eligible to compete under this Solicitation.

SCOPE OF COMPETITION: Subject to the conditions stated in the remainder of this paragraph, this is a full-and-open-competitive procurement. To be eligible to compete in this procurement, each offeror shall be fully HHS-certified as of the closing date of this Solicitation. Further, the awardee of the new primary drug-testing contract resulting from this Solicitation cannot simultaneously hold a secondary drug-testing contract with the U. S. Department of Transportation (DOT). An HHS-certified company that currently holds a secondary drug-testing contract with DOT would be eligible to submit a proposal, under this Solicitation, for the new primary drug-testing contract to be awarded from this Solicitation;

but if such a secondary drug-testing company were to win the competition under this Solicitation, then any secondary drug-testing contract held by the company, with DOT, would have to be terminated (for the convenience of the Government), before the company could be awarded the new primary drug-testing contract from this Solicitation.

SUBMIT FIVE SAMPLE DRUG-TESTING KITS WITH YOUR VOLUME I PROPOSAL: Each offeror shall submit five sample drug-testing kits with its Volume I Proposal.

SMALL BUSINESS SUBCONTRACTING PLAN (if applicable): Each offeror shall include—in its business /pricing proposal-volume (Volume II) submitted in response to this Solicitation—a Small Business Subcontracting Plan. Each offeror’s Small Business Subcontracting Plan shall propose----and shall price out---- the use of one or more Small Business subcontractor(s) who will provide at least 10% of the supplies to be used by the prime contractor in the performance of this project. Each offeror shall include subcontractor costs / prices in the fixed unit prices (i.e., fixed per-job prices) which the offeror proposes for this project. (Regarding proposed fixed per-job prices, see the year-by-year work-estimate-tables given below in this Section B.) Note, however, that there is not any requirement that any small business or small businesses provide any of the labor to be used in the performance of this project. All of the labor for this project could be performed solely by the prime contractor, and the prime contractor need not be a small business. The NAICS Code for this Solicitation is 621511. The small business size-standard associated with that NAICS Code is an average annual gross revenue of less than $35,000,000, as computed over a company’s three most recently completed fiscal years. However, there is no requirement that a prime offeror, under this Solicitation, be a small business. The significance of the $35,000,000 small-business size-standard is that a prime offeror’s proposed Small Business Subcontracting Plan must include one or more proposed subcontractor-businesses whose average annual gross revenue is less than $35,000,000.

SITE VISIT (if applicable): After proposals have been submitted under this Solicitation, but before any contract is awarded from this Solicitation, the Government shall have the right to make a site-visit to any offeror’s actual business-location and actual laboratory-location, for the purpose of DOT’s determining, in DOT’s sole discretion, whether or not the contractor’s facilities are adequate for the performance of this project.

In accordance with the detailed Statement of Work set forth below in this Solicitation, the contractor shall provide— for the U. S. Department of Transportation’s (DOT’s) Substance Abuse Awareness and Testing Office (SAATO), and for other Federal Departments and agencies who may place orders under the contract resulting from this solicitation— mailto:Jason.bush@dot.gov mailto:Rochelle.swain.ctr@dot.gov forensic analysis of urine specimens in support of the Drug Free Workplace Program for Federal Employees.

However, the contract awarded from this Solicitation will not be a requirements contract—that is, DOT, as well as all of the other Federal Departments and agencies who might be eligible to place orders under the resulting contract, do reserve the right to place any order or orders outside of the contract awarded from this Solicitation, and do reserve the right to place any order or orders with a vendor or vendors (contractor- company or companies) other than the company that is awarded the contract resulting from this Solicitation.

The contract resulting from this Solicitation will have one Base Year and four Option Years, and its Period of Performance is currently estimated to begin January 1, 2023.

NOTE: It is crucial that by 12:00 P.M. EST on July 30, 2022 all prospective offerors e-mail all of their questions to both of the following e-mail addresses: Jason.bush@dot.com and Rochelle.swain.ctr@dot.gov.

The year-by-year work-estimate-tables, as set forth below in this Section B, provide, for each particular project- year:

(a) a guaranteed minimum number of jobs, of each particular job-type, but no minimum is guaranteed unless DOT decides to use a particular job-type (Line Item) in a particular project-year; and (b) an estimated maximum number of jobs, of each particular job-type; and (c) a Government-estimated- realistic number of jobs, of each particular job-type.

But those maximum numbers are not guaranteed.

Each offeror shall compile its Cost Proposal, to be submitted to DOT under this Solicitation, by pricing-out the Government-estimated-realistic-numbers of jobs, shown in the right-most column (headed “GOVERNMENT ESTIMATED REALISTIC QUANTITY”) of each of the following work-estimate- tables:

mailto:Jason.bush@dot.com mailto:Rochelle.swain.ctr@dot.gov

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 The following is a summary of the offeror's IDIQ Firm-Fixed Prices for Fiscal Year 2023.

The Estimated Period of Performance is January 1, 2023, through September 30, 2023

LINE

ITEM

SUPPLIES/SERVICES MIN/MAX

QTY

GOVT. EST.

REALISTIC

QTY

FIXED

PRICE

TOTAL

0101 Collection Kits and Forms (Task 1) 8,000/77,800 45,000

0101A Forms Only (Task 1 g-h) 1/9,000 2,250

0101B Kits Only (Task 1 a-f) 1/5,000 1,125

0102 Initial Screening Test (Task 10c) 8,000/75,000 45,000

0103 Confirmation Tests (Task 11) 30/1,650 1,050

0104 Administrative Costs for receiving and processing rejected specimens

(Task 10i)

10/550 50

0105 Specimen Validity Tests (Task 9) 8,000/75,000 45,000

0106 Screening for other Drugs listed in Schedules I & II of the Controlled Substance Act (Task 12)

1/20,000 1,5000

0107 Confirmation Tests for Schedule I & II (Task 12a (3))

1/500 50

0108 Reports (Task 16) 1/26 26 Reports

0109 Aliquots (Task 2g) 1/1650 5

0110 Administrative/Judicial Proceeding Documentation (Task 19 c-d)

1/1000 24 HRS

0110A Administrative/Judicial Proceeding (Task 19 a-b)

1/1,000 HRS 48 HRS

0110B Litigation Packages (Task 16 g) 1/200 PKGS 25 PKGs

0111A Transportation/Shipping Inbound for Items 0101-0110A/B

1 LOT 11,000

(individual and boxes shipments of 24 kits being sent to the lab)

0111B Transportation/Shipping Outbound for Items 0101-0110A/B (Task 2a-

2b and 12 d)

1 LOT 5,000 (50/50

individual/box es of 24 kits)

0112 Travel (for Task 18 and 19) 1 LOT 2 trips to DC for 2 days

0113 Provide Management Briefings (Task 18)

1/200 HRS 20 HRs

0114 Quality Assurance Program, for items 0101-0111B (Task 6)

1 LOT

The FY 2023 Total IDIQ Firm-Fixed Price is TBD

B.2 The following is a summary of the offeror's IDIQ Firm-Fixed Prices for Fiscal Year 2024.

The Estimated Period of Performance is October 1, 2023, through September 30, 2024.

LINE

ITEM

SUPPLIES/SERVICES MIN/MAX

QTY

GOVT. EST.

REALISTIC QTY

FIXED

PRICE

TOTAL

0201 Collection Kits and Forms (Task 1)

8,000/77,800 60,000

0201A Forms Only (Task 1 g-h) 1/9,000 3,000

0201B Kits Only (Task 1 a-f) 1/5,000 1,500

0202 Initial Screening Test (Task 10c) 8,000/75,000 60,000

0203 Confirmation Tests (Task 11) 30/1,650 1,400

0204 Administrative Costs for receiving and processing rejected specimens

(Task 10i)

10/550 100

0205 Specimen Validity Tests (Task 9) 8,000/75,000 60,000

0206 Screening for other Drugs listed in Schedules I & II of the Controlled Substance Act (Task 12)

1/20,000 2,000

0207 Confirmation Tests for Schedule I & II (Task 12 a (3))

1/500 100

0208 Reports (Task 16) 1/26 26 Reports

0209 Aliquots (Task 2g) 1/1650 20

0210 Administrative/Judicial Proceeding Documentation (Task 19 c-d)

1/1000 24 HRS

0210A Administrative/Judicial Proceeding (Task 19 a-b)

1/1,000 HRS 48 HRS

0210B Litigation Packages (Task 16 g) 1/200 PKGS 50 PKGs

0211A Transportation/Shipping Inbound for Items 0101-0110A/B (Task 2c)

1 LOT 15,000 (individual kits and box shipments of 24 kits being sent to the lab)

0211B Transportation/Shipping Outbound for Items 0101-0110A/B (Task 2a-2b and 12d)

1 LOT 7,000 (50/50

individual/boxes of 24 kits)

0212 Travel (for Task 18 and 19) 1 LOT 2 trips to DC for 2 days

0213 Provide Management Briefings (Task 18)

1/200 HRS 20 HRs

0214 Quality Assurance Program, for

The FY 2024 Total IDIQ Firm-Fixed Price is: TBD

B.3 The following is a summary of the offeror’s IDIQ Firm =-Fixed Prices for Fiscal Year 2025.

The Estimated Period of Performance is October 1, 2024, through September 30, 2025.

LINE

ITEM

SUPPLIES/SERVICES MIN/MAX

QTY

GOVT. EST.

REALISTIC QTY

FIXED

PRICE

TOTAL

0401 Collection Kits and Forms (Task 1)

8,000/77,800 60,000

0401A Forms Only (Task 1 g-h) 1/9,000 3,000

0401B Kits Only (Task 1 a-f) 1/5,000 1,500

0402 Initial Screening Test (Task 10c) 8,000/75,000 60,000

0403 Confirmation Tests (Task 11) 30/1,650 1,400

0404 Administrative Costs for receiving and processing rejected specimens

(Task 10i)

10/550 100

0405 Specimen Validity Tests (Task 9) 8,000/75,000 60,000

0406 Screening for other Drugs listed in Schedules I & II of the Controlled Substance Act (Task 12)

1/20,000 2,000

0407 Confirmation Tests for Schedule I & II (Task 12 a (3))

1/500 100

0408 Reports (Task 16) 1/26 26 Reports

0409 Aliquots (Task 2g) 1/1650 20

0410 Administrative/Judicial Proceeding Documentation (Task 19 c-d)

1/1000 24 HRS

0410A Administrative/Judicial Proceeding (Task 19 a-b)

1/1,000 HRS 48 HRS

0410B Litigation Packages (Task 16 g) 1/200 PKGS 50 PKGs

0411A Transportation/Shipping Inbound for Items 0101-0110A/B (Task 2c)

1 LOT 15,000 (individual kits and box shipments of 24 kits being sent to the lab)

0411B Transportation/Shipping Outbound and 12d)

1 LOT 7,000(50/50

individual/boxes of

24 kits)

0412 Travel (for Task 18 and 19) 1 LOT 2 trips to DC for 2 days

0413 Provide Management Briefings

1/200 HRS 20 HRs

0414 Quality Assurance Program, for

The FY 2025 Total IDIQ Firm-Fixed Price is: TBD B.4 The following is a summary of the offeror’s IDIQ Firm-Fixed Prices for Fiscal Year

2026. The Estimated Period of Performance is October 1, 2025, through September 30, 2026.

LINE

ITEM

SUPPLIES/SERVICES MIN/MAX

QTY

GOVT. EST.

REALISTIC QTY

FIXED

PRICE

TOTAL

0501 Collection Kits and Forms (Task 1)

8,000/77,800 60,000

0501A Forms Only (Task 1 g-h) 1/9,000 3,000

0501B Kits Only (Task 1 a-f) 1/5,000 1,500

0502 Initial Screening Test (Task 10c) 8,000/75,000 60,000

0503 Confirmation Tests (Task 11) 30/1,650 1,400

0504 Administrative Costs for receiving and processing rejected specimens

(Task 10i)

10/550 100

0505 Specimen Validity Tests (Task 9) 8,000/75,000 60,000

0506 Screening for other Drugs listed in Schedules I & II of the Controlled Substance Act (Task 12)

1/20,000 2,000

0507 Confirmation Tests for Schedule I & II (Task 12 a (3))

1/500 100

0508 Reports (Task 16) 1/26 26 Reports

0509 Aliquots (Task 2g) 1/1650 20

0510 Administrative/Judicial Proceeding Documentation (Task 19 c-d)

1/1000 24 HRS

0510A Administrative/Judicial Proceeding (Task 19 a-b)

1/1,000 HRS 48 HRS

0510B Litigation Packages (Task 16 g) 1/200 PKGS 50 PKGs

0511A Transportation/Shipping Inbound for Items 0101-0110A/B (Task 2c)

1 LOT 15,000 (individual kits and box shipments of 24 kits being sent to the lab)

0511B Transportation/Shipping Outbound and 12d)

1 LOT 7,000(50/50

0512 Travel (for Task 18 and 19) 1 LOT 2 trips to DC for 2

0513 Provide Management Briefings

1/200 HRS 20 HRs

0514 Quality Assurance Program, for

The FY 2026 Total IDIQ Firm-Fixed Price is: TBD

B.5 The following is a summary of the offeror’s IDIQ Firm-Fixed Prices for Fiscal Year 2027.

The Estimated Period of Performance is October 1, 2026, through September 30, 2027.

LINE

ITEM

SUPPLIES/SERVICES MIN/MAX

QTY

GOVT. EST.

REALISTIC QTY

FIXED

PRICE

TOTAL

0601 Collection Kits and Forms (Task 1)

8,000/77,800 60,000

0601A Forms Only (Task 1 g-h) 1/9,000 3,000

0601B Kits Only (Task 1 a-f) 1/5,000 1,500

0602 Initial Screening Test (Task 10c) 8,000/75,000 60,000

0603 Confirmation Tests (Task 11) 30/1,650 1,400

0604 Administrative Costs for receiving and processing rejected specimens

(Task 10i)

10/550 100

0605 Specimen Validity Tests (Task 9) 8,000/75,000 60,000

0606 Screening for other Drugs listed in Schedules I & II of the Controlled Substance Act (Task 12)

1/20,000 2,000

0607 Confirmation Tests for Schedule I & II (Task 12 a (3))

1/500 100

0608 Reports (Task 16) 1/26 26 Reports

0609 Aliquots (Task 2g) 1/1650 20

0610 Administrative/Judicial Proceeding Documentation (Task 19 c-d)

1/1000 24 HRS

0610A Administrative/Judicial Proceeding (Task 19 a-b)

1/1,000 HRS 48 HRS

0610B Litigation Packages (Task 16 g) 1/200 PKGS 50 PKGs

0611A Transportation/Shipping Inbound for Items 0101-0110A/B (Task 2c)

1 LOT 15,000 (individual kits and box shipments of 24 kits being sent to the lab)

0611B Transportation/Shipping Outbound and 12d)

1 LOT 7,000 (50/50

0612 Travel (for Task 18 and 19) 1 LOT 2 trips to DC for 2

0613 Provide Management Briefings

1/200 HRS 20 HRs

0614 Quality Assurance Program, for

The FY 2027 Total IDIQ Firm-Fixed Price is: TBD

B.6 The summaries of the offeror’s grand total of the IDIQ Firm-Fixed Prices for Fiscal Year 2023 through Fiscal Year 2027 are TBD.

The Aggregate Grand Total Potential IDIQ Ceiling Price, counted across all five potential project-years, is: $

DOT, in its sole discretion, shall have the right to decide whether or not any particular job- type, or job-types (i.e., Line Item, or Line Items) will or will not be used, at all, in any particular project- year or project-years. In other words, some job-types (Line Items) might not be used, at all, in some project-years.

For each needed trip to be made by the contractor to Washington, D. C. (listed as “1 TRIP TO DC”, in the tables above), it is estimated that only one contractor-staff-member would need to make the trip, and that the meeting would be a two-day meeting, and that the contractor-staff-member would need to stay overnight, in Washington, DC., for two nights (specifically, the night before the meeting-day).

To be entitled to receive the minimum-job-quantities specified in the work-estimate-tables set forth above, both of the following conditions must be satisfied: (a) DOT, in its sole discretion, must decide to use the particular job-type, at all, in the project-year in question; and (b) the contractor must start out with, and must at all times maintain, a performance-level on this project that is at least satisfactory, as determined by the Government, and in addition the contractor must remain in compliance with all of the terms of this contract.

Subject to the conditions stated in the next sentence, the contractor’s performance of any specific needed job or jobs, of any type or types specified in the year-by-year work-estimate tables set forth above in this Section B, may be requested by any program officer employed as a Federal employee in DOT’s Substance Abuse Awareness and Testing Office (SAATO). However, in performing such jobs during any project-year of this contract, the contractor shall never allow the cumulative total of its billed and billable dollar-amounts to exceed the total dollar- amount of the available funding cumulatively obligated to the Task Order applicable to that project-year.

Subject to the conditions stated in the next sentence, Federal Departments and Federal agencies, outside of DOT, may place orders under this contract. However, any order placed under this contract, by a Federal Department or Federal agency outside of DOT, must be billed to, and must be paid by, the Federal Department or Federal Agency which placed that order. DOT will neither accept nor pay invoices for work not ordered by DOT.

Obligated Amount: [To be filled in, in each awarded Task Order document] Accounting Information: [To be filled in, in each awarded Task Order document]

All travel that is eligible for reimbursement shall be reimbursed at cost in accordance with the travel and per diem clause (reference Section G). The loaded cost of travel and per diem shall not exceed

$2,000 per year, unless otherwise approved in writing by the Contracting Officer. Travel costs are included within the total contract value as stated above.

(End of Section B)

SECTION C – STATEMENT OF WORK

BACKGROUND

The U.S. Department of Transportation (DOT) Substance Abuse Awareness and Testing Office (SAATO) requires forensic analysis of urine specimens in support of its Drug-Free Workplace Program for Federal employees. The Program is authorized by Executive Order 12564 and the Omnibus Transportation Employee Testing Act of 1991. This contract covers testing for all operating administrations within the DOT, the Office of the Secretary (OST) and the Office of the Inspector General (OIG). In addition, testing for other Government, State or local agencies may be required under this contract. This may include testing requirements of DOT 49 CFR Part 40.27.

This contract shall be performed in accordance with this Statement of Work, and all other terms and conditions of this contract. The contractor shall be able to perform laboratory functions as outlined in the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Attachment-I) hereinafter referred to as the HHS Guidelines, the "DOT Order 3910.lCseries", Drug and Alcohol-Free Departmental Workplace (Attachment-2) and the DOT Drug and Alcohol Testing Guide (Attachment-3). Website addresses where each of these documents can be obtained are proved in Section J of this Solicitation. Those documents are intended to provide each offeror with background information concerning the DOT Drug and Alcohol Testing Program.

Each offeror must be fully HHS-certified prior to the closing date of this Solicitation.

Other agencies may obtain services under this contract as contract riders, subject to the prior written approval of DOT's COR for this contract. The following guidelines apply:

1. Each participating agency shall directly communicate service requirements with the contractor.

2. The contractor shall deal directly with individual participating agencies on service requirements.

3. The contractor shall invoice the participating agency directly, not through DOT, for services provided.

4. Disagreements related to specific delivery requirements shall be resolved between participating agency and contractor.

5. The participating agency shall pay the contractor directly, not through DOT, for services.

The Contractor shall:

• Provide split specimen collection supplies

• Provide single specimen collection supplies (as needed)

• Provide notice of shipping confirmation for supplies that have been sent out

• Be capable of performing 500 laboratory drug screenings within a 24-hour period

• Be capable of performing 50 confirmations testing of urine specimens within a 24-hour period

• Provide specimen validity

• Provide specimen shipment via overnight courier

• Provide monthly reports

• Perform forensic urinalysis at a single facility. If contractor has more than one location, the servicing location performing the forensic urinalysis will be selected by DOT.

• Provide transportation and shipping of kits and supplies to collection contractor sites.

• Provide transportation and shipping of collected specimens from collection sites to the contractor's facility.

• Provide storage and transportation of an electronic transmission of results via Secured File

Transfer Protocol (SFTP) as described in Attachment J-7 that enables specimen status information and drug test result information to be electronically loaded into DATMIS (DOT customized software system). Refer to Attachment-7, Data Transmission Format. The inability of an offeror to provide drug test results in the required format and by the required method of delivery will eliminate that offeror from further consideration under this Solicitation.

• Provide expert witnesses, as necessary, in connection with administrative and judicial proceedings. Maintain HHS certification

• Maintain confirmed positive specimens (including the split specimen) in long term frozen storage during the entire Period of Performance of the contract, unless otherwise directed by the

COR.

• Test results database

The urine specimens will be collected and forwarded to the laboratory by a separate DOT contractor hereinafter referred to as the collection contractor. Work shall be performed with the contractor personnel and equipment and the contractor will be subject to contract Quality Assurance inspections that are announced and unannounced, by DOT.

SCOPE OF WORK

Forensic Toxicology Drug Testing Laboratory (FTDTL) Analysis Contract -- Delineation of Contractor Tasks

Task 1 - Provide split-specimen urinalysis collection supplies.

a. Plastic specimen collection containers. Each collection container must not substantially affect the specimen collected and must be:

1. Individually sealed 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),

2. Large enough to easily catch and hold at least 60 mL of urine, and

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

b. Temperature strips. The collection container and one shipping bottle shall have affixed to it a temperature strip. The temperature strips must be capable of temperature readings specified in the HHS Guidelines. The temperature strips must be easy to read and interpret, and its shelf life shall be no less than 18 months from the time of delivery to the collection contractor.

c. Plastic specimen bottles. Each specimen bottle with cap must not substantially affect the specimen collected and must be:

1. 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),

2. Able to hold at least 35 mL (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).

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

4. 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

5. 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.

d. 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).

e. Absorbent material. The absorbent material that is placed inside the leak-resistant plastic bag with the specimen bottles in case a specimen bottle leaks during shipment.

f. Shipping containers. Must be a box sealed in plastic or shrink wrap to prevent the possibility of undetected tampering. Each box should be preprinted with a "certified drug-free" label.

Boxes shall have a secure sealing method for shipping collection supplies from the collection site to the contractor.

g. Federal CCFs. The contractor shall provide the OMB-approved Federal CCF Federal Drug Testing

Custody and Control Form, hereinafter referred to as the CCF. The form will be complete with tamper-evident label/seals for use on the split specimen and/or single specimen shipping bottles. The CCF shall be modified to include six boxes at the top for the collector to hand write in the appropriate DOT account code. The account code (Attachment-5) is a requirement, and it also cannot be altered in any way.

h. Tamper-evident seals. The Federal CCF has two tamper-evident labels/seals that are used to seal the specimen bottles (i.e., primary and split specimens).

i. The contractor shall provide a copy of the tracking confirmations of all shipments of collection supplies within 5 working days of shipment of the collection kits. This tracking confirmations at a minimum shall contain the address to where the kits were shipped, date shipped, and umber of kits shipped.

j. Shipping labels for the collection contractor to mail the specimens back to the lab for testing as stated in Task 2 c. The shipping labels should have all the necessary account information for the shipment to be made in an overnight delivery.

Task 2 - Preparation and shipping of collection supplies, specimens and aliquots.

a. The laboratory shall have the ability to supply a minimum of 3,000 split specimen collection supplies on a monthly basis.

b. The contractor shall provide a copy of the tracking confirmations of all shipments of collection supplies within 5 working days of shipment of the collection kits. This tracking confirmation at a minimum shall contain the address to where the kits were shipped, date shipped, and number of kits shipped.

c. The collection contractor will pack the specimen bottles in the shipping containers furnished by the contractor. The contractor shall pay for the transportation of shipping containers from the collection sites to the contractor's facility. There are approximately 950 duty locations throughout the 50 States, Puerto Rico, the U.S. Virgin Islands, and certain locations in the Western Pacific area, such as Guam, American Samoa.

d. If a request has been made by the Medical Review Officer (MRO) to have a split or single specimen analyzed by another HHS certified lab (under contract to the DOT), the split-specimen or single-specimen, bottle and the associated copy of the custody and control form shall be shipped, under proper controls to insure confidentiality, security, and preservation of the chain-of-custody, to the designated laboratory.

e. In accordance with Task 7b of this Statement of Work, provide a secure delivery system which shall protect the specimen chain-of-custody, maintain security, and result in full analysis of the sample and necessary processing (including the reporting of the drug test results) within five working days after receipt of the sample.

f. Upon completion or termination of the contract, any remaining stored specimens shall be shipped to a

HHS laboratory identified by DOT, as requested by the COR or Designated Representative. Any such shipment shall follow strict chain of custody procedures. In addition, packaging will be such as to maintain the specimens in a frozen state.

g. Prepare and send out aliquots, under proper controls to insure confidentiality, security and preservation of the chain-of-custody, aliquots of specific specimens for reanalysis at other laboratories.

h. The contractor is responsible for paying for all transportation and shipping of items identified in this statement of work unless stated otherwise.

Task 3 - Laboratory Requirements

a. The facility of the contractor performing this contract shall participate in and satisfy the requirements for the maintenance proficiency testing program, which included comprehensive performance testing and laboratory inspections as set forth in the HHS Guidelines.

b. All forensic urinalyses will be performed at a single facility of the contractor. If contractor has more than one location, the servicing location performing the forensic urinalysis will be selected by DOT.

c. The facility of the contractor performing this contract shall maintain its HHS certification.

d. Should the contractor lose its HHS certification during the contract period, the DOT may immediately terminate the contract for default in accordance with Federal Acquisition Regulation (FAR) 52-249-8, Default (Fixed Price Supply and Service). The contractor shall be responsible for paying any additional costs of forensic analysis of urine specimens incurred by the Government as a result of the contractor's breach of the contract.

Task 4 - Personnel Requirements

a. The personnel performing this contract shall meet or exceed the requirements for laboratory personnel set forth in the HHS Guidelines.

b. At time of award, the contractor shall establish a formal program for training all personnel in the use of equipment. Each person utilizing a piece of equipment shall be formally trained in its operation and given appropriate annual follow-up training.

c. All personnel to perform work under this contract shall be trained to proficiency in the forensic chain- of-custody handling of all specimens tested.

d. The contractor shall maintain training records on all personnel used in support of this contract. These records shall be available to the COR or the Designated Representative upon request.

Task 5 - Equipment Requirements

a. At the latest by the time of contract-award, but, ideally, in each offeror's proposal, a formal maintenance program, consistent with the manufacturer's guidelines, shall be established for all contractor furnished leased or owned equipment used in the performance of this contract.

b. Equipment used in the performance of this contract shall meet the following standards:

(1) Each piece of equipment utilized shall be properly calibrated to the manufacturer's specifications prior to use on each day or shift (if applicable). Calibration by technologists shall be under the supervision of a graduate-level chemist.

(2) All testing and storage equipment shall be maintained at least to manufacturer's standards.

(3) The equipment maintenance program will be subject to Contract Quality Assurance Review.

Task 6 - Quality Control

a. The Quality Assurance and Quality Control program, accessioning areas, testing facilities, storage areas, and record archives of the contractor performing work under this contract shall be subject to Contract Quality Assurance reviews by the COR or Designated Representative. These areas shall be made available for such inspections during the contractor's normal working hours. The Contract Quality Assurance reviews may be announced or unannounced by the Government.

b. The contractor shall maintain an internal quality control program which encompasses all aspects of the testing process including: delivery, unsealing and accessioning, validity, screening, and confirmation testing, chain-of-custody, storage, security, and result reporting. Program procedures shall be designed, implemented, and reviewed to monitor each step of the testing process.

c. The contractor's internal quality control program shall meet or exceed the HHS Guidelines for every sample batch for validity, initial, and confirmation test.

d. The contractor shall generate, implement, and document quality control procedures to assure that quality control sample carry-over and/or carry-over from positive specimens does not contaminate other specimens being tested.

Task 7 - Security Requirements

a. Facilities used for long-term storage (defined as up to five years) of specimens under this contract shall be equipped with security locking systems and doors, walls, ceilings, and floors of a type so as to ensure adequate security. Emergency power equipment shall be available to maintain specimen temperatures in these facilities during prolonged power failures.

b. All portions of the contractor's facility where specimens (primary and split specimens and/or single specimens) will be received, stored or tested under this contract shall be secure. Such buildings and portions of buildings shall be resistant to unauthorized entry, tampering and compromise; keyed locks shall be tamper-proof, and all cipher locks shall be subject to periodic combination changes. The construction and physical security of secure areas shall be capable of preventing and detecting attempted forced or surreptitious entry. Access to these secure areas and access roster will meet the HHS Guidelines. The access roster shall be available for review by the CO, COR, or the Designated Representative.

Task 8 - Maintain the internal contractor chain of custody

a. The maintenance of a strict chain of custody is critical to a forensic testing program. The contractor's obligation begins with shipment of the specimens to the laboratory.

b. Every effort shall be made to minimize the number of people handling a sample. Specimens shall only be handled by authorized personnel and shall not be left unattended, except in a secure area.

c. Logs shall be kept, tracking the primary specimen (Bottle A), the split specimen (Bottle B), and single specimens submitted by DOT or any agencies riding DOT's contract, by code number assigned by the FTDTL at every stage of the process. Under no circumstance shall the donor's name or social security number be used for this purpose. Logs shall list each and every employee handling a primary specimen and the split specimen.

d. The contractor shall designate a records custodian to maintain records on all testing and chain of custody documents and related matters. Records are subject to Contract Quality Assurance by the COR or the Designated Representative.

e. Custody and control forms shall accompany the specimens at every stage. This includes the custody and control form completed by the collection contractor at the time of specimen collection and any intra-laboratory custody and control forms used by the contractor. Intra-laboratory custody and control forms shall identify specimens through the use of information that matches the security/identification label and a separate distinct and non-repeating sequence number assigned to each specimen.

f. Any damage to the specimens or wrappings, and any indication of suspected tampering shall be noted on the chain of custody form and the COR or Designated Representative shall be contacted immediately.

Task 9 - Provide specimen validity testing

a. The contractor shall perform specimen validity testing in accordance with the HHS Guidelines.

b. Adulterated, substituted, or invalid specimens will be retained in long-term frozen storage until the COR or Designated Representative authorizes its destruction.

Task 10 - Provide urinalysis in accordance with initial screening protocols specified in the HHS Guidelines

a. The contractor shall be capable of performing at least 500 screening tests of specimens submitted under this contract within any 24 hours, not including Federal holidays or days (such as weekends) when the contractor facility is closed. The figure of 500 specimens per 24-hour period is a minimum. Actual amounts of specimens received per day may fluctuate. The contractor shall immediately notify the COR if the number of specimens received in any one day will prevent the contractor from meeting the requirement to provide test results within five working days from the date any sample was received at the contractor's facility. This includes providing results of any necessary confirmation testing.

b. The contractor will initially examine each specimen and the accompanying documentation for administrative errors, and evidence of damage, tampering, substitution or low volume. Any evidence of damage, tampering, substitution, low volume or test results that might impugn the integrity of the sample shall be immediately reported to the COR or Designated Representative. Such specimens shall not be destroyed, but shall be maintained with full attention to chain-of-custody and security until the COR or Designated Representative authorizes either testing or disposal of the specimen.

c. Initial screening shall follow the HHS Guidelines threshold levels for the "HHS panel. The contractor's screening process will adhere to testing procedures contained in the HHS Guidelines.

d. During processing, specimens shall be secured in short-term refrigerated storage that meets the HHS

Guidelines.

e. All testing shall be performed under secure conditions with strict chain-of-custody procedures followed at all times, as specified in Task 8.

f. The contractor shall provide the MRO test results in accordance with HHS guidelines via fax or electronic means. The MRO may be a contractor or Federal MRO.

g. Test results must be provided to SAATO and the designated representatives in the J-4D and J-7 formats.

h. Unless the contractor receives prior notice from the COR, or the Designated Representative, negative specimens (including the related split specimen) that are not suspected of adulteration, substitution, tampering or dilution may be disposed of in accordance with the HHS Guidelines. Specimens that screened positive at or above the set threshold or sensitivity levels, in accordance with the HHS Guidelines for one or more drugs in the "HHS panel shall undergo confirmation testing in accordance with Task 11 and 12.

i. Administrative cost for receiving and processing specimens that are not subsequently tested will be billed to the government at the rate identified in the pricing.

Task 11- Provide urinalysis tests in accordance with confirmation protocols specified in the HHS Guidelines

a. Confirmation testing of those specimens screening positive at or above the set threshold or sensitivity levels in accordance with the HHS Guidelines shall be conducted. The contractor shall also have the capability of performing 50 confirmation tests within a 24 hour period of a positive screening test result.

The figure of 50 confirmation test results per 24-hour period is a minimum. Actual amounts of specimens received per day may fluctuate. The contractor shall immediately notify the COR if the number of specimens received in any one day will prevent the contractor from meeting the requirement to provide test results within five working days from the date any sample was received at the contractor's facility.

This includes providing results of any necessary confirmation testing.

b. The contractor will adhere to the HHS Guidelines for confirmation testing. Every attempt must be made to identify invalid specimens.

c. During processing, specimens shall be secured in short- term refrigerated storage that meets the HHS

d. All testing shall be performed under secure conditions with strict chain-of-custody procedures followed at all times, as specified in Task 8.

e. The contractor shall provide the MRO test results in accordance with HHS guidelines. The MRO may be a contractor or Federal MRO. Test results may be provided as specified in Task 15 and 16.

f. Test results must be provided to SAATO and the designated representatives in the J-4D and J-7 formats.

g. Unless the contractor receives prior notice from the COR or the Designated Representative, urine specimens, (including the related split specimen as appropriate), that are not confirmed as positive and are not suspected of adulteration, substitution or tampering may be disposed of in accordance with the HHS Guidelines.

h. Following testing, confirmed positive specimens (including the split specimen) shall be retained in long-term frozen storage until the COR or Designated Representative authorizes its destruction.

i. If the split specimen fails to reconfirm the primary specimen, both specimens shall be retained indefinitely for inspection by HHS.

j. The contractor shall make available the services of the individual responsible for day-to-day management of the laboratory or a forensic toxicologist to consult with the MRO to determine whether positive findings may be justified by physical conditions, prescription drugs, or other legal explanation.

h. Upon completion or termination of the contract, any remaining stored specimens shall be shipped to a

HHS certified laboratory identified by DOT, as requested by the COR or Designated Representative. Any such shipment shall follow strict chain of custody procedures. In addition, packaging will be such as to

Task 12 - Perform tests for other drugs listed in Schedules I and II of the Controlled Substances Act

a. Perform tests for other types of drugs listed in Schedules I and II of the Controlled Substances Act.

(1) The contractor shall be informed by the COR of the cutoff value(s) for drug test results to be considered positive.

(2) Specimens shall be handled through normal delivery, security, and chain-of-custody procedures as outlined in this Statement of Work.

(3) Testing shall include a screening test and, if the screen is positive, a confirmation test. The screening test shall be an immunoassay test, if a reliable test for the drug is available, but may be thin layer, high performance liquid and/or gas chromatography test. Confirmation testing shall be accomplished by quantitative gas chromatography/mass spectrometry techniques if such a test can reliably be performed. However, the use of full-scan gas chromatography/mass spectrometry techniques with quantification by an alternate technique may be required. Testing techniques shall be those required or recommended by HHS.

b. Unless the contractor receives prior notice from the COR, specimens that are not confirmed as positive for a Schedule I and II drug, or suspected of adulteration, substitution, or tampering may be disposed of immediately after testing. The contractor must ensure that all recording/procedures have been completed in accordance with the contractor's testing procedures for the specimen, and the terms and conditions of this contract have been met, prior to disposing of the specimen.

c. Confirmed positive specimens shall be secured in long-term frozen and will be retained in long-term frozen storage until the COR or Designated Representative authorizes its destruction.

d. Such positive specimens shall, upon the request of the COR, be released to DOT or the split specimen shipped, to other facilities for further testing.

e. Upon completion or termination of the contract, any remaining stored specimens shall be shipped to a HHS certified laboratory identified by DOT, as requested by the COR or Designated Representative. Any such shipment shall follow strict chain-of-custody procedures. In addition, packaging will be such as to

Task 13 - The contractor shall prepare and ship invoices, monthly reports, semi-annual statistical summary reports and/or litigation packages as required.

The contractor is responsible for transportation of all documentation including monthly invoices, monthly reports, semi-annual summary reports, litigations and other documentation requested by DOT.

a. The contractor is responsible for all transportation and shipping of items identified in this statement of work unless stated otherwise.

Task 14 - Maintain Records

a. The contractor shall maintain the following documentation and/or records in accordance with the HHS Guidelines. (All records are subject to Contract Quality Control Review):

(1) Technical information/documentation to support the accuracy and shelf life of the temperature-sensing device required by HHS Guidelines.

(2) Technical information/documentation to substantiate the drug free certification required by HHS

Guidelines

(3) Documentation/records of the contractor's participation in one or more of the proficiency testing programs required by HHS Guidelines.

(4) Documentation/records of the contractor's accreditation required by HHS Guidelines

(5) Files on all contractor personnel shall conform to HHS guidelines.

(6) The procedures, which establish the formal equipment maintenance program, required by HHS

Guidelines

(7) Records of equipment maintenance and calibration required by HHS Guidelines. These records shall include and list dates of all breakdowns, maintenance, calibrations, and repairs.

(8) The procedures/documentation that establish and maintain the internal quality control program required by HHS Guidelines

(9) Records to support the performance of the contractor's quality control program and the results of the blind testing required by HHS Guidelines

(10) The access roster and security documents required by HHS Guidelines

(11) Records to substantiate the contractor's compliance with the chain-of-custody requirements of HHS

Guidelines. These records include the written chain-of-custody procedures developed by the contractor, the chain-of-custody logs, the document designating a records custodian, a listing of the personnel trained in the contractor's chain-of-custody procedures and the dates of the training, and the chain-of-custody records for each sample tested under this contract.

(12) Individual chain-of-custody records shall include the date, the technologist performing the analysis and the substances found.

(13) Documentation on all aspects of the testing process, including chain-of-custody documents for all specimens, shall be maintained, and all records on individual urine specimens testing positive, including initial test records and chromatographic tracings, shall be retained in such a manner as to permit retrieval by social security number or specimen number, i.e., if only the individual social security number is known, the foregoing information shall be retrievable; likewise, if only the specimen number is known, the foregoing information shall be retrievable.

Task 15 -Daily Data File Transmission (Electronically)

Shall be provided (electronically) within 24 hours of the completed test result. The report shall report the results of tests performed under Tasks 9, 10, 11 and 12. Results shall be reported according to the HHS Guidelines through an electronic transmission via Secure File Transfer Protocol (SFTP) as described in Attachment J-7 that enables specimen status information and drug test result records to be electronically loaded into DATMIS (DOT customized software system). The inability of an offeror to provide SFTP data file transmission in the required format and by the required method of delivery will eliminate that offeror from further consideration under this Solicitation.

a. One test record shall be generated for each specimen tested. Each report shall list the control form number, the employee's agency, the employee's social security number or employee number (if used), the collection date, the date the sample was received by the contractor, the date the drug test results were reported to the DOT, the reason for test, any other information the contract requires to track the sample within its lab or to be able to report the actual values of, and normal ranges for, each test, as well as the test result - positive or negative. Positive test results shall state the drug(s) and/or metabolite(s) found, but not the level of the drug(s) or metabolite(s) in the sample.

b. Test results shall include the actual values of the specific gravity, pH, and creatinine, along with the normal ranges for each test, respectively.

c. Upon the written request of the COR or the DOT MRO, the contractor shall provide additional reports. Each of these reports shall include the information required by paragraph (a) above plus the level of the drug(s) or metabolite(s) in the sample.

d. All test records shall be transmitted electronically to the Substance Abuse Awareness and Testing

Office (SAATO). Applicable OA Headquarters offices shall only receive OA test records, and OA regional offices shall only receive applicable test records. DOT account codes are identified at Section J, Attachment J-5. The test results shall be transmitted in the format found in Section J, Attachment-J-7.

Task 16 - The contractor shall provide data, reports, and notifications

The following shall be submitted for review by the COR or Designated Representative:

a. A MONTHLY INVOICE REPORT, Shall be provided within 14 calendar days after the month being reported.

At a minimum, this report shall include the following information for each DOT Operating administration (OA), agencies riding the DOT contract and DOT Special account code. This report will be provided as support documentation for the contractor's monthly invoice which should only have information about what was utilized in the month.

(1) billing period

(2) account codes

(3) invoice number (i.e., summary and detail information by account number provided as separate documents)

(4) total specimens

(5) total screen cost

(6) total specimens confirmed

(7) total specimen confirmed cost

(8) total canceled specimens

(9) total canceled specimen costs

(10) total specimen validity test

(11) total specimen validity test cost

(12) total litigation packages

(13) total litigation package cost

(14) total kits and forms

(15) total kits and forms cost by account code

(16) total cost of shipping kits and forms out with supporting documentation by account codes

(17) total cost of shipping specimens from the collection site to the laboratory and supporting documentation by account codes

(18) total costs

b. A MONTHLY REPORT BY ACCOUNTING CODES, shall be provided within 14 calendar days after the month being reported. This report will be provided as support documentation for the contractor's monthly invoice. The report shall be sorted by account code using the date collected to report data, and at a minimum, shall include the following information.

(1) account code

(2) date period (should be based on the specimen collected date)

(3) total specimens tested by test type (should be based on the specimen collected date)

(4) total positives specimens with the type of drug

(5) total rejected…