FY_17_IDIQ_SOW_ATCH_1-_Final.docx

Attachment 1 Scheduling, Specimen Collection, and Test Results

STATEMENT OF WORK

Indefinite Delivery, Indefinite Quantity (ID/IQ) Contract

U.S. Department of the Interior Interior Business Center Human Resources Directorate Security, Drug and Alcohol Testing Division Drug & Alcohol Testing Branch December 20 2017

Indefinite Delivery, Indefinite Quantity (ID/IQ) Contract

3.1.4 COLLECTION SITE SPECIFICATIONS

3.1.5 COLLECTION SITE INSPECTION & REPORTING

3.1.6 ON-SITE COLLECTIONS

3.1.7 COLLECTION SITE DESIGNATION

3.1.8 INTERNATIONAL COLLECTIONS

3.1.9 COLLECTION REQUIREMENTS

3.1.10 COLLECTION CONTROL REQUIREMENTS

3.1.11 TRANSPORTATION REQUIREMENTS

3.1.12 REPORTS AND RECORDS

3.1.16 QUALITY CONTROL REQUIREMENTS

3.1.17 CONTRACTOR TESTIMONY

3.1.18 MEDICAL REVIEW OFFICER (MRO)

3.1.19 RANDOM GENERATOR

Information Technology Security Artifacts Required for Outsourcing IT Services / Systems

3.2.2 NON-DISCLOSURE AGREEMENT

3.2.4 PERSONNEL CHANGES

3.2.6 APPLICABLE STANDARDS

3.2.7 SECURITY CATEGORIZATION

3.2.8 PROPERTY RIGHTS

3.2.9 INDEPENDENT VERIFICATION AND VALIDATION

3.2.10 INTERNET LOGON BANNER

3.2.11 INCIDENT REPORTING

3.2.12 SELF ASSESSMENT

3.2.13 VULNERABILITY ANALYSIS

3.2.14 LOGON BANNER

3.2.15 SECURITY CONTROLS

3.2.16 CONTINGENCY PLAN

3.2.17 SECTION 508 OF THE REHABILITATION ACT OF 1973

3.3.1 DRUG TESTING OF EMPLOYEES

3.3.3 INFORMATION SECURITY

3.3.4 BACKGROUND INVESTIGATIONS

3.3.5 DTS

3.3.6 KEY PERSONNEL

3.3.6.1 KEY PERSONNEL DEFINITION

3.3.6.2 SUBSTITUTION OF KEY PERSONNEL

3.4.2 SUPPLIES

3.4.3 ELECTRONIC COPY OF MONTHLY BILLING STATEMENT

3.5 TRANSITION

3.5.1 TRANSITION IN

3.5.2 TRANSITION OUT

3.5.2.2 TRANSITION EXECUTION

3.7 PLACE OF PERFORMANCE

4.2 GOVERNMENT POINTS OF CONTACT

4.2.1 CONTRACTING OFFICER’S REPRESENTATIVE

4.2.2 DRUG PROGRAM MANAGER (DPM)

4.2.3 CONTRACTING OFFICER (CO)

1 BACKGROUND

On April 27, 1988, Department of the Interior (DOI) established their Drug-Free Workplace Program which created a need for drug testing services; including the analysis of urine specimens to detect the presence of illegal drugs.

After the inception of the program, DOI allowed other federal agencies, organizations, commissions, and/or foundations to utilize its scheduling, collections, and test results contract to accomplish their own Drug-Free Workplace Program objectives. This allowed the majority of the Government’s needs to be consolidated together, resulting in lower prices being secured by the Government and reduced the number of federal acquisition offices being involved in the award and maintenance of the contract. Approximately 70 federal entities herein referred to as participating Agencies or Government, will be obtaining services from this award.

The solicitation is issued by the DOI. The contract resulting from this solicitation may be used by other Federal agencies; DOI and the participating Agencies will be referred to as the Government for the remainder of the statement of work. The participating Agencies shall be identified at the time of contract award. Currently, there are over 70 other Agencies that have a need for these services under the DOI contract. DOI reserves the right to add additional or delete agencies via modification subsequent to contract award.

2 SCOPE

The Government conducts drug and alcohol testing as required and regulated by the Health & Human Services (HHS) and the Department of Transportation (DOT) to detect the presence of marijuana, cocaine, opioids, amphetamines and phencyclidine (PCP) (and other illicit or abused substances) and to deter illegal drug use by their employees. Commonly needed test types include pre-employment, random, reasonable suspicion/cause, post-accident, return to duty, and follow-up (or for other reasons as needed)

This Indefinite Delivery/Indefinite Quantity (ID/IQ) contract may be used by DOI and the Agencies. DOI reserves the right to add additional or remove agencies via modification subsequent to contract award.

The contractor will be strongly linked to DOI’s other contractor that provides Laboratory Analysis services. The two companies shall have daily contact, work closely together, and rely on one another to help DOI and the Agencies accomplish their program needs.

Due to statutory chain of custody requirements, the scheduling, specimen collection, and Medical Review Officer (MRO) requirement (Collection & MRO) must be provided under a contract separate from the Laboratory Analysis Services requirement. Therefore, two separate contracts will be solicited and awarded to two different contractors.

The Collection contractor will help the Government schedule, test, and track their drug and alcohol testing. The contractor will also act as the MRO for the drug tests ordered through the contract. The contractor will be able to provide urine and breath collections nationwide and internationally. The contractor will be able to provide on-site collection services. The contractor must be capable of providing MRO services and maintain an internet based application (referred to as the Drug Testing System where customers can track their collections.) The contractor must have the capability for their MRO, collection, or administrative staff to travel and provide testimony when appropriate.

The Government may perform their own drug and alcohol collections in-house (collections performed by Agency personnel). Federal offices shall be able to enter in-house donor collection information on the contractor’s internet based Drug Testing System (DTS) and the data shall match up with its corresponding records imported from the lab and MRO.

The contractor shall provide to the Government for the collection of urine and saliva/oral fluid/oral fluid specimens and breath alcohol collections for all types of drug and alcohol testing under the HHS and DOT programs. Also, the Contractor shall provide to the Government all labor, materials, and equipment except that provided herein as "Government Furnished," necessary for the collection and transportation of the specimens from the collection contractor to the contractor collection sites to the Government Contract Drug Testing Laboratory.

The Contractor shall be required to perform and comply with all applicable provisions of HHS’ Substance Abuse and Mental Health Services Administration (SAMHSA) and DOT’s regulations. The guidelines and procedures may be routinely updated for the purpose of providing additional guidance. The Contractor shall be required to comply with current guidelines and procedures, and updates as furnished by the Contracting Officer's Representative (COR). To the extent that any of the requirements in this contract are inconsistent with any of those specified in the Mandatory Guidelines promulgated by the HHS, DOT procedures, or other pertinent regulations from governing Federal agencies, or any subsequent amendment thereto, such HHS Guidelines and DOT procedures or amendment shall supersede the requirements specified in this contract, but only to the extent of the inconsistency.

3.1.1 REQUIRED SERVICES

For nationwide collections and international collections, the Contractor shall provide collection services for all types of HHS and DOT drug and alcohol testing in the United States and its territories within 20 miles of the Government employee or applicant using an already established network of collection sites. If there is no medical or collection facility within 20 miles of the employee or applicant then, as requested by the Government the contractor shall attempt to establish a new site at the closest facility to the employee or applicant. All collections for donors shall be accomplished in a physician's office, hospital, medical clinic, Government facilities selected by the Federal office, or similar setting. All collection locations must meet HHS and DOT regulations for collection sites.

Collections in public establishments or personal residences are not authorized. An exception to this rule shall be approved by the appropriate Agency before the collection is made.

The collection facility and staff shall be flexible to accommodate employees whose tour of duty is different than normal duty hours, e. g., 2:00 p.m. - 10:00 p.m. or 10:00 p.m. - 6:00 a.m. This may involve rescheduling staff hours earlier or later on specific collection days to provide services at the beginning of the evening shift (2:00 p.m.) or at the end of the night shift (6:00 a.m.).

Other unique requirements may include providing collections for all shifts in a 24 hour period, and on weekends.

The Government will provide the contractor with electronic requests (e.g., names, social security numbers, telephone numbers, and the proposed collection city and state of agency employees and applicants) submitted through DTS in order to schedule drug and alcohol test collections. The Contractor shall be able to receive drug and alcohol test requests electronically via the DTS, manually by facsimile machine, by e-mail and by telephone. The Contractor shall input all requests received by any method.

When an alcohol test is required, it will be administered at the same time and at the same location as the scheduled drug test.

Contractor shall have on hand a federally approved alcohol-testing device as a back-up for all alcohol testing.

Contractor shall ensure the availability of collection services 24 hours a day/7 days a week at testing locations in the event post-accident or reasonable suspicion testing is required at off-site and/or on-site locations.

All emergency testing requests (post-accident and reasonable suspicion) shall be routed through a toll-free emergency request number to be provided by the contractor.

Alcohol testing shall be completed within two (2) hours of notification to the Contractor for post-accident testing, and within two 2) hours of notification to the Contractor for reasonable suspicion testing.

3.1.2 REQUESTS

The Government shall be able to request a drug and alcohol test collection (under the HHS and DOT programs) in any one of four ways listed below.

1) For Contractor to Schedule a Collection for an Applicant or Pre-Employment Test at a Sub Contracted Collection Site

The Government will provide the required donor information to the Contractor. The Contractor will send supplies and confirm their arrival to the closest collection site location. The Contractor will call (phone only) the donor to schedule the drug test or alcohol collection (for applicant and pre- employment testing).

The contractor will attempt to reach the donor/applicant with three attempted telephone calls over a 2 day period, at different times of the day, in order to increase the opportunity for reaching applicants/employees with varying schedules. Any change in call time periods shall be approved in advance by the COR.

When leaving messages with receptionist or on voicemail, the contractor will not disclose the required drug test. All attempts will be made to preserve the 48 hour notification rule (no applicant can be given more than 48 hours’ notice when required to submit to a drug screen). The Contractor will not make notifications on Fridays or when the collection site is not open on the weekends. The Contractor will give the applicant the necessary information to complete a successful urine or breath collection (i.e. to bring a photo id, to be ready to provide a urine or breath specimen, not to leave the collection site until it is over, to retain the copy of their Custody and Control (CCF)). The contractors will follow-up the phone call with an e-mail to the applicant with all necessary information.

The Contractor shall contact the Agency on the same day if the Contractor is unable to contact the donor after 3 attempts. This contact shall be by telephone; or via e-mail

2) For Agency to Schedule a Collection for an Applicant or Pre-Employment Test at a Sub Contracted Collection Site

By providing the required donor information (including name, SSN) and collection site code to the Contractor and having the Contractor automatically ship the specimen kit, CCF, and/or Breath Alcohol (BA) Testing Form to the collection site (for drug and alcohol tests). Kits and forms shall be shipped on the same day for drug and alcohol test requests received by the contractor before 4:00 p.m. (eastern time). In these cases, the Government will be responsible for notifying the donor of the collection requirements.

3) For Agency to Schedule On-Site Collections at Agency Facility

By providing the required donor information to the Contractor with the notation an on-site specimen collection is needed (for either drug or alcohol testing). In these cases, the Contractor shall contact the Government to schedule the on-site collection within 8 business hours, on average, of receiving the request. The Contractor shall schedule on-site collections within one week, on average of the agency request. On-site collections will be requested by the Agency a minimum of one week prior to the time the collection is needed.

4) For Agency to Perform In-house Collection

By entering the required donor and collection information into DTS when the Government performs the collection and ships the specimen to the laboratory contractor.

3.1.3 COLLECTION PROCESS

The contractor shall provide each donor with a standard explanation concerning the collection process, to include the following information at a minimum: collection site address and basic directions; telephone number; point of contact; bring photo ID; call collection site prior to going in order to ensure the kit and form have been received and clinic schedule can accommodate applicant/employee for test; report for drug or alcohol test collection within 48 hours of receipt of contractor notification; applicant/employee shall obtain permission from Agency in order to change the scheduled collection date; immediately call the contractor at the 1-800 telephone number or Agency if there are any problems; to drink fluids prior to going to collection site. The contractor shall also verify the donor's name, and SSN/identification number prior to completing the CCF.

In order to reduce the chance of errors in completing the CCF, the contractor, at a minimum, shall complete the following steps on the CCF prior to shipping with the specimen kit to the collection site including: Step 1 (A. through F).

The Contractor shall provide written information to collection site personnel in advance of the collection including: instructions/procedures for the accurate completion of the CCF; shipping specimen to proper lab; distribution of CCF (collector, donor, MRO, agency); billing procedures; donor name; donor SSN; HHS or DOT test; which DOT agency/mode (if DOT test); alcohol test; or both drug/alcohol test.

In order to reduce the chance of errors in completing the breath alcohol (BA) form, the contractor, at a minimum, shall complete the following steps on the BA Form prior to shipping to the collection site including: Step 1 (A,C,D). Also, the contractor shall provide written information to collection site personnel in advance of the collection including: instructions/procedures for the accurate completion of the BA Form; distribution of BA Form (collector, donor, agency); billing procedures; donor name; donor SSN.

The DTS shall allow the agency users to print information to assist the donor in completing the collection including: agency name; donor name; donor SSN; clinic name; clinic address; clinic telephone; clinic hours; clinic point of contact; to bring photo identification; to drink fluids for a urine drug test collection; to expect to be told they will not be allowed to bring outer coats or briefcases or purses into the testing room itself; and that they will be asked to show the contents of their pockets to ensure restricted items are not carried into the testing room; report for drug or alcohol test collection within 48 hours of receipt of contractor notification; applicant/employee shall obtain permission from the Government in order to change the scheduled collection date; immediately call the Contractor at the 1-800 telephone number or the Government if there are any problems; etc.

The Contractor shall be responsible for ensuring their collection site personnel are fully knowledgeable and trained concerning the accurate completion of the CCF and BA Form. Highlighting or a cover sheet with boxes over the areas on the CCF and BA Form to be completed by collection site personnel may prove useful. Further, the contractor shall have an internet site listing the appropriate HHS and DOT drug and alcohol collection procedures, and showing examples of properly completed CCF and BA Forms. In addition, the Contractor shall provide to the collection sites preprinted/prepaid overnight express air bills with the Government Contractor Drug Testing Laboratory address, in order to reduce shipping errors. The air bill information should be linked in DTS to the donor’s record.

For emergency requests (e.g., reasonable suspicion, reasonable cause, post-accident & unsafe practice testing, and any other reasons deemed necessary by the Government) the collection shall be completed immediately or in accordance with HHS and DOT regulations. This service shall be available 24 hours per day, 7 days per week, 365 days per year. Such requests may occur at any time or day of the week at any location, and generally will be made via telephone, followed by a written confirmation. The contractor shall provide service and response via an electronic pager system/cellular or smart phone using a 1-800 telephone number. The Contractor shall be immediately available during business hours, after hours, weekends and holidays. The Contractor response time shall not exceed 30 minutes from the time of the page. This information and telephone number shall be posted on the sign in page of the DTS.

The Contractor shall establish a toll free 1-800 telephone and 1-800 facsimile number and customer service representatives to facilitate the contacting and scheduling of Government employees and applicants for collections and breath alcohol tests, and to assist the COR, Government and other representatives in resolving questions or problems. Adequate backup personnel shall be available to assist the customer service representatives during busy periods. The customer service representatives shall be available at a minimum during regular business hours from 8:30am to 5:00pm (eastern time), Monday through Friday. The 1-800 telephone number shall ring directly to an actual Government customer service representative. No submenu of choices, no delays, no transfers, no voicemail during regular business hours. Also, the Contractor customer service manager and representatives, and IT Manager and IT staff representative(s), at a minimum, shall have the ability to communicate with the COR, Government, other agency representatives, laboratory contractor, and MRO contractor using an acceptable electronic mail system, as determined solely by the COR. The customer service representatives shall also have telephone voicemail for after-hours.

The Contractor customer service manager and representative(s) shall return telephone calls to the COR, Government, other agency representative, laboratory contractor, and MRO contractor within one hour, on average, from the time the call is made to the Contractor customer service manager and representative(s).

The Contractor customer service manager and representative(s), and/or IT manager or representative(s) shall immediately notify the COR, laboratory contractor and MRO contractor if the Contractor automated DTS is down for any reason (not operational).

The Contractor shall require its collection sites to send a donor signed copy of the CCF to the Contractor by facsimile machine on the same day the specimen is collected. Collection sites without facsimile machines shall send the donor signed CCF to the Contractor by U.S. Mail on the same day the specimen is collected. This requirement shall be noted on the instructional information provided with the collection kit and forms to the collection site. The Contractor shall have a system or method to track and ensure CCFs are being faxed by the clinics.

The Contractor will have the capability to process electronic CCFs (eCCF). The Contractor eCCF solution must be approved by SAMHSA and allow the Government to place an order for eCCF on DTS.

The Contractor shall call the collection sites no later than the morning of the second day after the specimen was shipped via overnight in order to ensure the kit/CCF has been received, and to verify the collection site address, telephone number, and point of contact. The Contractor shall immediately make any corrections of clinic information in DTS. The Contractor shall immediately resend the kits/forms when the collection site has changed and/or the clinic is unable to locate the kit/form, at no additional cost to the Government.

The Contractor shall work to facilitate sending/receiving testing data file information between the labs and clinics in order to expedite the testing process, and cut down on errors with donor testing notifications to clinics.

3.1.4 COLLECTION SITE SPECIFICATIONS

The collection site is the location for Government employees and applicants to present themselves for the purpose of providing their urine, oral fluid, or breath specimens under controlled conditions. The Contractor shall assume primary responsibility for assuring collection site requirements are maintained at all times in accordance with HHS and DOT Guidelines. In this regard the Contractor shall, as a minimum, ensure:

The collection site possess all necessary personnel, materials, equipment, facilities, and supervision to provide collection, security, storage, and transportation of urine specimens to the designated Government Contract Drug Testing Laboratory;

The collection site has collection facilities that meet the federal regulations promulgated by SAMHSA. The collection site possess all necessary personnel, materials, equipment, facilities, and supervision to perform breath alcohol tests; and the COR is immediately notified if a site fails to meet the above requirements.

The Contractor shall continuously monitor the collection sites for errors and problems, and work with the sites to correct the problems as soon as possible. This includes tracking problem collections as noted by the lab, the agency, the donors and on the CCFs.

Note: The cost for specimens cancelled by the laboratory or unable to be tested shall be borne by the Contractor. This includes: specimens improperly collected; specimens lost; specimens with insufficient urine or saliva/oral fluid/oral fluid amounts; specimens crushed; specimens with fatal flaws; specimens shipped to the wrong lab (and/or wrong lab reports to wrong MRO); etc. The cost includes the amount of the initial test collection; and the cost to ship a new kit/CCF/supplies for the second collection (or as many collections that are cancelled). The Contractor shall be responsible for the cost of recollecting any specimens. Any questions concerning a cancelled specimen will be resolved solely by the COR.

The Contractor shall continuously monitor the collection sites for errors and problems, and work with the sites to correct the problems as soon as possible. This includes tracking problem collections as noted by the lab, the agency, the donors and on the CCFs .

3.1.5 COLLECTION SITE INSPECTION & REPORTING

The Contractor shall ensure that collectors and collection sites satisfy all requirements in the Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Mandatory Guidelines effective on October 1, 2017) or any other updated guidelines released during the contract period. The contractor is responsible for inspecting 5 percent (up to a maximum of 50) collection sites each fiscal year, selected randomly from those sites used to collect Government specimens. The Contractor must investigate reported collection site deficiencies and take appropriate action, which may include an onsite inspection or collection site self-evaluation using the Collection Site Checklist for Collection of Urine Specimens for Federal Agency Workplace Drug Testing Programs and the HHS Urine Specimen Collection Handbook.

The Contractor will provide the COR with an Excel spreadsheet (or other COR approved document) listing the following: names, locations, dates of inspection, outcome of inspection, and name of inspector by August 31 of each year of the contract.

3.1.6 ON-SITE COLLECTIONS

Government entities requiring pre-scheduled on-site collections will provide the collection site locations and requested hours of operation for the collection a minimum of one week prior to the commencement of each collection. The maximum number of collections to be performed per test day will be approximately 200. On-site collections may take place nationwide. Any individual providing on-site collection services must be a certified collector. Those staff providing on-site collections must arrive at the designated collection site earlier than the scheduled collection start time, with all necessary supplies, and be prepared to stay until all donors have tested.

3.1.7 COLLECTION SITE DESIGNATION

The collection sites shall be located in the United States and its territories within 20 miles of the Government employee or applicant. However, if there is no facility within 20 miles of the employee or applicant then the closest facility to the applicant shall be utilized. In an instance such as this, the 20-mile rule can be waived at the Government's discretion; however, the Contractor shall demonstrate a good faith effort to comply with the rule. The Contractor shall have an existing network of collections sites, at a minimum of 1000 different city locations throughout the United States and its territories. Collections will normally be made in local physicians offices, hospitals and medical clinics. The Contractor may be asked to come on-site to Federal facilities to perform collections (the Government will provide all space and facilities). In these cases, the Government reserves the right to make such requests. There exists the possibility the COR or Government believes additional collection sites may be necessary or an existing site may be unacceptable and therefore a replacement will be necessary.

As part of the technical proposal, offerors shall describe the process and time frame for identifying and replacing additional collection sites. Also, how the Contractor ensures the collection site personnel receive initial and ongoing training and instruction concerning required collection guidelines and regulations. Further, how the Contractor proposes to monitor and address collection site successes and failures.

3.1.8 INTERNATIONAL COLLECTIONS

The Contractor shall also have an existing network of international collection sites, at a minimum of 50 different major city locations throughout the world, on each continent and in both hemispheres. The Contractor shall provide a list of at least 50 addresses in their existing network sorted by city and country as an example. The Contractor may be asked to come on-site to Federal facilities to perform collections (the Government will provide all space and facilities). In these cases, the Government reserves the right to make such requests.

3.1.9 COLLECTION REQUIREMENTS

3.1.9.1 DRUG TESTING

To ensure chain of custody and specimen control are maintained collections performed by the Contractor must be done by trained collectors. The Contractor and those performing collections on behalf of the Contractor shall follow the procedures as specified in:

· The HHS Drug Testing Guidelines and DOT regulations including the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration Center for Substance Abuse Prevention Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs (effective October 1, 2017) https://www.federalregister.gov/documents/2017/01/23/2017-00979/mandatory-guidelines-for-federal-workplace-drug-testing-programs

· The HHS Mandatory Guidelines (most recently updated October 1, 2017 https://www.samhsa.gov/sites/default/files/workplace/urine-specimen-collection-handbook-oct2017_2.pdf

· The DOT’s Office of the Secretary of Transportation Office of Drug & Alcohol Policy Compliance Urine Collection Personnel Requirements, found at http://www.dot.gov/ost/dapc/udsc.html

· The DOT’s Office of the Secretary of Transportation Office of Drug & Alcohol Policy Compliance Breath Alcohol Technician and Screening Test Technician Requirements, found at http://www.dot.gov/ost/dapc/bat_stt.html

· Oral Fluid Mandatory Guidelines (when released)

The Contractor shall send written collection procedures (drugs and breath alcohol) with each kit sent to a clinic or onsite collector. Instructions shall also be posted on the Contractor Internet homepage (with examples of properly completed drug forms and breath alcohol forms).

3.1.9.2 BREATH ALCOHOL TESTING

The Contractor shall follow the procedures as specified in the DOT’s Alcohol Testing Procedures Rule: 49 CODE OF FEDERAL REGULATIONS Part 40 (http://www.dot.gov/ost/dapc/bat_stt.html). These procedures shall be subject to future revision and clarification to assure continued conformance to the DOT procedures and regulations, and to appropriate agency program policy requirements.

3.1.10 COLLECTION CONTROL REQUIREMENTS

Periodically, the Contractor shall be subject to pre and post award quality control inspections and evaluations conducted by the COR on behalf of the Government. These inspections and evaluations may be unannounced. The Contractor shall be able to demonstrate at all times the effectiveness and reliability of its collection process.

The Contractor shall establish procedures to track and resolve specimens requiring an affidavit, specimens with fatal flaws and specimens where either the lab or MRO CCF is missing. The procedures shall include preparing and reviewing a written list on a daily basis with the lab and MRO contractors as necessary.

Once the Contractor has received one piece of the case information, the Contractor shall resolve which of the missing pieces is needed to complete and close the case. If one piece but not all of the necessary pieces have been received, the Contractor shall call to obtain the required missing piece(s). The pieces of the case include: lab has electronically reported receiving the specimen, the lab has electronically reported the result, the lab CCF is received, the MRO CCF is received.

The Contractor shall contact the collector scheduled to perform on-site collections on the day before the on-site collection is to be performed, in order to remind the collector.

3.1.11 TRANSPORTATION REQUIREMENTS

After collection of the specimens, the Contractor shall arrange to ship the specimens to the Government Contract Drug Testing Laboratory on the same day the collection is performed, wherever possible. The specimen shall be placed in appropriate containers (cardboard shipping boxes or containers) and securely sealed to eliminate the possibility of tampering. Specimens shall be shipped to the Government Contract Drug Testing Laboratory by overnight express, wherever available. When not available, the U.S. Postal Service overnight express mail shall be used.

Specimens shall, in all cases, be shipped to the Government Contract Drug Testing Laboratory within 24 hours of collection.

3.1.12 REPORTS AND RECORDS

The Contractor shall provide each Government or COR with statistical reports on all collections and MRO results containing specific details on employees and applicants tested in accordance with HHS Guidelines and DOT regulations. The reports shall include specimen number, type of test, drug and/or alcohol test, on-site collections, no shows, QC's, last and first name, social security number, collection date, collection city and state, clinic number, HHS or DOT test, and cost. The information shall be sorted numerically by specimen number. The statistical reports will be available on the DTS or via email. Each agency shall also be provided the data for their own agency.

The Contractor shall establish and maintain a properly secured filing system for all data and records performed under this contract. Records relating to this contract shall be kept by the Contractor according to the latest version of HHS guidelines, DOT regulations, or records retention schedule promulgated by the National Archives(currently the NARA General Records Schedule 1, item 36 “Federal Workplace Drug Testing Program Files”). The Contractor shall have the ability to sort and provide CCF by agency, upon request.

Records resulting from the testing of Government employees or applicants for employment are covered by Privacy Act Systems of Records Notices OPM/GOVT-10 and OPM/GOVT-5 respectively. Destruction of records shall follow regulations issued by the Archivist of the United States (44 U.S.C. 3302). Records shall be destroyed in accordance with 36 CFR 1228.58. Electronic records shall be destroyed in accordance with Federal regulations, as approved in advance by the COR.

Filing System (Records). All records the Contractor maintains in the Secure Filing System and all other records (including financial records) that disclose the identity of any participating Government employee shall be treated in a MEDICALLY CONFIDENTIAL MANNER. The Contractor shall protect all such records from disclosure except in accordance with the paragraph on "Availability (Records)."

All records, hard copy and electronic, are subject to the Privacy Act, 5 UNITED STATES CODE 552a, and other applicable laws and regulations, and shall be maintained and used with the highest regard for employee privacy.

Availability (Records). The Contractor shall not release any records or information relating to participating Agency programs or employees without the advance written approval of the agency COR.

The Contractor shall agree to make available its staff members to discuss the collection of a specimen, breath alcohol test, or MRO result with the Government. Disclosure of records and discussions with staff members under this paragraph shall be on an "unrestricted communications" basis. The Government agrees to provide any necessary consent in accordance with the Privacy Act.

Inspection and Examination. The Contractor shall maintain for inspection and examination by the COR all records associated with the collection and MRO results during performance of the contract.. At the conclusion of the contract, the Contractor shall release all records to the Government or its designated representative within 30 days after completion of the contract. This shall include a hard copy and electronic copy (e-mail, pdf, excel, or DTS).

The Contractor shall receive and store prior collection and MRO records. Security and storage shall be in a manner similar to that for records under this contract.

Records Custodian Designation. The Contractor shall designate in writing a custodian of the records of all collections conducted and MRO results under this contract. A copy of the written designation shall be provided to the Contracting Officer and respective agency COR.

3.1.13 MATERIALS

The Contractor shall provide HHS and DOT mandated CCFs/eCCFs that displays a currently valid Office of Management and Budget (OMB) control number. The Contractor shall use the OMB approved Federal Drug Testing CCF. The bar code labels/numbers shall be mutually agreed upon by the collection and laboratory contract service providers in order to avoid duplicate numbers. The COR shall resolve any disputes.

The Contractor shall as requested, provide all labor, materials, and equipment, except that provided as Government Furnished, necessary to perform the collection of specimens and breath alcohol tests. The specimen kits will meet all HHS and DOT mandated guidelines. The Contractor shall provide OMB approved U.S. Department of Transportation (DOT) Breath Alcohol Testing Forms as necessary.

The Contractor shall ensure their collection sites have all necessary supplies for all types of collections (urine, breath, oral) and that all devices meet HHS and DOT guidelines.

The Contractor shall provide all other material, including the bluing agent, necessary for the on- site collection and transportation of the specimens to the point of conveyance to the designated Government Contract Drug Testing Laboratory.

3.1.14 SCANNING

The Contractor shall have an automated system to scan and track bar code labels. The automated system shall be able to read the barcodes on the CCF. The Contractor shall have an automated system that scans and tracks the donor signed copy of the CCF, and make them available for viewing and printing in the DTS.

3.1.15 ON-SITE COLLECTION NATIONWIDE (On-Site)

Onsites will be billed according to the number of donors; 1-10, 11-29 donors, and 30 or more. Each tier may have a minimum amount the contractor will charge in the instances where the Government does not provide the promised amount of donors. The start time for charging will begin at the time the Contractor is scheduled to arrive (and does arrive) at the on-site location check in point (ie; front lobby; entrance to installation screening checkpoint; etc). Arrival and departure times shall be directed and set by the Government at the time the on-site tests are being scheduled with the Contractor.

Any arrival and departure time changes shall be approved in advance by the Government. The Government shall ensure they schedule an adequate amount of time to complete the targeted number of collections. If more time is needed to complete the collections than was originally scheduled by the agency (ie; due to insufficient specimens; employees arriving late to on-site collection; agency scheduling changes; etc), then the Contractor shall decide whether they (the Contractor) will be able to stay at the on-site collection for a time period longer than the time the agency originally scheduled.

Agencies will provide the collection site locations and times a minimum of one week prior to the commencement of each collection. The maximum number of collections to be performed per test day will be approximately 200. On-site collections may take place nationwide. Any individual providing on-site collection services must be a certified collector. Those staff providing on-site collections must arrive at the designated collection site earlier than the scheduled collection start time, with all necessary supplies, and be prepared to stay until all donors have tested.

3.1.16 QUALITY CONTROL REQUIREMENTS

The contractor will submit at least 3 percent blind samples along with its donor specimens based on the projected total number of donor specimens collected per year (up to a maximum of 400 blind samples). Every effort should be made to ensure that blind samples are submitted quarterly. Approximately 75 percent of the blind samples submitted each year must be negative, 15 percent must be positive for one or more drugs, and 10 percent must either be adulterated or substituted. All other requirements for blind specimens that the contractor must meet are located in HHS’ Mandatory Guidelines. The contractor will provide the results of blind specimen testing in an Excel workbook or have the results available on the DTS

3.1.17 CONTRACTOR TESTIMONY

The Contractor shall make contract personnel available, whenever requested in writing by the Government, to provide testimony and documentation as required in support of any administrative and/or court action. Travel and per diem costs are above and beyond the testimony rate. Travel and per diem rates will be based on Government regulations and schedules.

3.1.18 MEDICAL REVIEW OFFICER (MRO)

The Contractor shall be able to provide and perform all of the MRO requirements provided in the MRO Manual for Federal Agency Workplace Drug Testing Programs as created by SAMHSA (found at https://www.samhsa.gov/sites/default/files/workplace/mro-guidance-manual-oct2017_2.pdf. The contractor will also adhere to the MRO requirements contained in the Mandatory Guidelines for Federal Workplace Drug Testing Programs that were published in the Federal Register. The MRO(s) will be certified by one of the organizations approved by SAMHSA (found at http://www.workplace.samhsa.gov/DrugTesting/pdf/apprvd_mro_training_cert_entities.pdf).

Additionally, the contractor shall be able to provide and perform all of the MRO requirements provided by DOT’s 49 CFR Part 40 Subpart G.

3.1.19 RANDOM GENERATOR

The DTS shall have a feature to randomly generate and select names and duty stations for drug/alcohol testing under the HHS and DOT programs. The random generator must be available as a selection option from the main menu screen. The Government must be able to randomly select names from a pool of testing positions (HHS and DOT) by exporting the information from their payroll/personnel data files, and automatically import the records in the DTS system or the Government must be able to send the random draw file to the contractor to post in the DTS (must be posted within one business day of receipt). Or the Government would provide the file of employees eligible to be selected and the contractor would make the random draw. The contractor shall post the random file selections to the DTS within one business day of receiving the data file.

The number of data files may vary from small to large in size (ie., 100 to 50k plus records). Also required is a written explanation of the methodology used for the random number generator (ie., dbase4 generates random numbers in a selected range; the algorithm then adds the number 1 to each random number; etc.).

The random generator must have the capability to perform daily to yearly random drug/alcohol test draws, based on either a percentage or number of tests desired, for any date range selected. Also, the random generator must provide the ability to do random selections by one or more locations (duty stations).

Once the agency data records are randomly selected, the record information to schedule and track a drug/alcohol test will be uploaded in DTS.

The Government must be able to designate whether all or some of the DTS users in their organization are able to select, schedule, and view all or some of the drug/alcohol test types and results.

Also, the Government must be able to generate a report and file for a specific date range that will send all data record information to a printable file (in pdf, excel, and txt format). In addition, an audit trail record (for 2 years) must be provided in the DTS to track the random selections, percentages or numbers selected, and cancellations.

The random generator must provide a feature in DTS to allow the Government to print an acknowledgement of selection form for each random drug test (for both HHS and DOT program). Training must be provided via the HELP menu in the current DTS system.

The DTS shall have screens and functionality to allow users to review random selections, review open randoms, and view random statistical reports.

The review random selections function shall allow users to review all random selections; and have fields allowing selection by user level; SSN; date range; tested for (ie; drug; alcohol; both); test mode (ie; HHS; DOT); retrieve (ie; online; printed; download versions); and whether to include notification letter. Once criteria is provided and data is retrieved; DTS shall display fields for SSN; name; userid; test mode; tested for; status; date selected; misc info. Clicking on field heading names must sort data by alpha or numeric.

The review open randoms selection function shall allow users to review all open randoms (cases not collected); and have fields allowing selection by user level; SSN; date range; tested for (ie; drug; alcohol; both); test mode (ie; HHS; DOT); case open (ie; excused; unexcused); display and download data. Once criteria is provided and data is retrieved; DTS shall display fields for SSN; name; userid; test mode; tested for; status; date selected; status; reason (ie; tdy; furlough; etc). Clicking on field heading names must sort data by alpha or numeric. Clicking on reason field will allow user to edit record with reason for not testing. DTS will allow user to click on record from this screen and data (ie; SSN; name; userid; etc) will automatically populate an open test request (for either agency or contractor schedules collection; onsite; inhouse).

The random statistics function shall allow users to run statistical reports by date range; tested for; test mode; userid; etc.

Please provide an overall cost estimate, implementation schedule, and solution for agencies to obtain their testing information beyond the life of the current contract. Additional requirement details and specifications, and examples for the random generator are provided below. The COR shall be the sole decision maker concerning whether or not the random generator meets the requirements.

3.2 DRUG TESTING SYSTEM (DTS)

The Contractor shall be able to provide and perform all of the automated DTS requirements provided in this Statement of Work at the task order level.

The Contractor is required to comply with the security and privacy requirements summarized in this section and identified in the IT Security and Privacy Checklist, NIST standards and the DOI Security Control Standards established using the NIST SP 800-53. All applicable security and privacy controls identified herein, and in the DOI Security Control Standards, shall be assessed in accordance with the NIST SP 800-53 (current revision)., Guide for Assessing the Security Controls in Federal Information Systems and Organizations; Building Effective Assessment Plans.

The level of compliance with the required minimum baseline security and privacy controls are determined by the Government to ensure a level of trust with the service provider and that the risk from using external services is at an acceptable level to the DOI authorizing official.

The Contractor shall be required to work with the Government to ensure requirements of the DTS are met within one year of contract award. DOI will require preliminary testing to ensure data transfers are safe and operations can begin. Preliminary testing shall be conducted during the Transition In period. Upon successful completion of preliminary testing, a Temporary Authority to Operate will be issued to the contractor. All costs associated with meeting the Government’s IT requirements, including updating, monitoring, installing, maintaining, purchasing, programming, hiring, travelling, moving, shipping, configuring, and any other work/actions/labor that is performed by the contractor, shall be incurred by the contractor.

Information Systems processing Government data must be assessed prior to going into production and annually thereafter and reaccredited every three years or whenever there is a major change that affects security. The contractor must follow the most current releases of the following: National Institute of Standards and Technology Special Publication 800-37, 800-18, Rev.1, 800-30, 800-60 vol. 1 and vol. 2, 800-53, 800-53a Federal Information Processing Standard 199 and Federal Information Processing Standard 200, the associated DOI guides/templates, and the DOI Privacy Impact Assessment. The government will reserve the right to conduct the Security Assessment, using either government personnel or an independent contractor. The contractor shall take appropriate and timely action to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. The Authorizing Official (AO) for the system will be the official identified in DOI Secretarial Order No. 3255.

Information Technology Security Artifacts Required for Outsourcing IT Services / Systems The following artifacts are to be provided in order to determine the contractor’s readiness to complete the DOI security evaluation and testing process in support of an accreditation.

1. Information System / Network Identification Elements

a. Overall System / Network Description

b. Architectural Diagrams of Network and/or Information Technology Components

c. Architectural Diagram of System Specific Components

d. List of all network perimeter devices (i.e. firewalls, intrusion detection system etc.)

e. List of components associated with DOI information system (servers, applications, version numbers).

f. List of any system interconnections / interfaces with other systems.

g. List of Data elements to be processed, stored and/or transmitted by information system.

h. List of facility physical security mechanisms, to include physical security surrounding area where DOI information system will be housed.

2. Contingency Planning Capabilities

a. Description of current contingency plans in place (i.e. alternate sites, locations, agreements, etc.)

b. Provide disaster recovery procedures in place for facility, network or components of network.

c. Provide backup and recovery procedures that in place for information system or network.

3. IT Change / Configuration Management Capabilities

a. List / Describe processes in place for Information Technology system changes.

b. List / Describe processes in place for patch management, hotfixes etc.

c. Describe processes in place for network / system configuration baseline management.

4. Other Agency Assessments

a. Provide any supporting documentation from other agency assessment and/or accreditations.

5. Any Applicable Federal or Government Agency Requirements

a. Provide a list of any federal or government agency requirements that are applicable to this company.

3.2.1 PERSONNEL SECURITY REQUIREMENTS

The Contractor shall keep all information in the strictest of confidence and take measures to protect it from unauthorized modification or destruction,…