Attachment A-DRAFT PWS.docx

Performance Work Statement (PWS) and Delivery Schedule National Laboratory Certification Program Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Performance Work Statement below:

A. Background Information Pursuant to Executive Order 12564 and Public Law 100-71 (Section 503), the Department of Health and Human Services (HHS) has been given the responsibility to establish the requirements for collecting and testing specimens and reporting results for the Federal Workplace Drug Testing Program. A key element of this effort has been the development of the scientific and technical requirements for the National Laboratory Certification Program (NLCP) as specified in Mandatory Guidelines for Federal Workplace Drug Testing Program: Final Rule, Federal Register, 82 FR 7920 – 2017 (Mandatory Guidelines), and as revised. The certification of laboratories is essential to ensure the forensic and scientific supportability of test results reported to the Federal agencies. The Department of Health and Human Services is proposing to establish scientific and technical guidelines for the testing of oral fluid and hair specimens; scientific and technical guidelines for using laboratories to test urine and oral fluid at the collection site; added standards for collectors, on-site testers, and medical review officers (MROs).

B. Objectives The purpose of this contract is to provide the Division of Workplace Programs (DWP) with a Contractor that will satisfy all the requirements for the National Laboratory Certification Program (NLCP) as specified in the Mandatory Guidelines, and any subsequent revisions. The Contractor is expected to maintain sufficient scientific, operational, and logistical capacity to support uninterrupted implementation of all NLCP-related activities from the outset of the contract period. This includes, but is not limited to, having the infrastructure, personnel, and technical resources in place to allow immediate continuity of program operations, including access to necessary performance testing materials and the ability to prepare spiked samples consistent with NLCP protocols. The Contractor must also be prepared to support the expansion of the NLCP to include the scientific and technical Guidelines for the testing of oral fluid and hair specimens; the scientific and technical Guidelines for onsite screening tests for urine and oral fluids at the collection site; and the requirements for the certification of laboratories, as well as the ongoing quality assurance and performance of related activities at collection sites, laboratories, and by Medical Review Officers (MROs).

The Contractor shall operate the National Laboratory Certification Program (NLCP) as described in the Mandatory Guidelines for Urine, the Mandatory Guidelines for Oral Fluid, and the Mandatory Guidelines for Hair. The Contractor shall independently furnish the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government to perform the tasks described below. A copy of the Public Law 100-71 (Section 503), Executive Order 12564, the NLCP Laboratory Application Form, the NLCP Laboratory Information Checklist, the NLCP Inspection Checklist, the NLCP Records Audit Checklist, and the NLCP Manual for Laboratories and Inspectors are available for review if necessary, at SAMHSA, 5600 Fishers Lane Rockville, Maryland 20857, in Room 16-N02. The first three (3) references above can also be found on our website at http://www.samhsa.gov/workplace.

The contractor shall continue to operate crucial components of the program in Task Four as: The Drug Intelligence and Analysis Institute for Excellence. The mission of the Drug Intelligence and Analysis Institute for Excellence is to provide comprehensive and cutting-edge analysis of drugs of interest to the federal government by leveraging the latest study and technology to deliver actionable intelligence that informs decision-making and enhances public safety. The vision is to be the leading center of excellence for federal government studies on drugs of interest to the Federal Drug-Free Workplace Program and associated Federal agencies including DOT, NRC and DoD, by partnering with civilian and federal government entities and delivering accurate and timely information that supports the development of effective policy, programs, and interventions.

The objectives of The Drug Intelligence and Analysis Institute for Excellence include identifying and prioritizing the most pressing study questions related to the Mandatory Guidelines for Federal Workplace Drug Testing drugs of interest and their impact on public safety; developing and implementing a robust study program that leverages cutting-edge technology and innovative methodologies; collaborating with civilian and federal government entities to ensure study findings are integrated into policy and practice; conducting ongoing monitoring and evaluation of the Institute's study program to assess its impact and ensure alignment with stakeholder needs; and disseminating study findings and best practices to a wide range of stakeholders, including policymakers, practitioners, and the public, to promote the effective use of study evidence in decision-making.

This component significantly enhances the program by providing actionable intelligence that informs decision-making and enhances public safety. By staying at the forefront of drug analysis and leveraging the latest technologies, the Drug Intelligence and Analysis Institute for Excellence ensures that the program remains adaptive and responsive to emerging drug trends and threats. This proactive approach supports the overall mission of the NLCP by ensuring that Federal Workplace Drug Testing policies and practices are based on the most current and scientifically sound data available. The Drug Intelligence and Analysis Institute for Excellence will contribute data and insights critical for updating and maintaining the Mandatory Guidelines for Workplace Drug Testing, thus reinforcing the integrity and efficacy of federal drug testing programs. Importantly, the Institute for Excellence works within the current framework of tasks in the contract, integrating seamlessly with ongoing activities and providing additional support to enhance the program's effectiveness and reach.

All costs associated with Tasks 1 through 9, and Task 14 through 22, are reimbursed by the Government. All costs associated with Tasks 10 through 13 are recovered as fees charged to the laboratories participating in the NLCP, unless specifically noted as an exception or by direction of the Contracting Officer Representative or Alternate Contracting Officer Representative (COR / Alt COR). All recovered fees in excess of actual cost are to be distributed back to the laboratories.

The Contractor awarded the contract shall propose a fee schedule that will be reviewed and approved by the Government at the time of contract award. The proposed fee schedule must describe all the different fees that laboratories will pay to participate in the NLCP.

The Contractor shall arrange the least expensive travel and accommodations in accordance with Government travel regulations and HHS Policy on Use of Appropriated Funds for Conferences and Meeting Space and receive conference approvals before obligating any government funds. Upon approval of a conference request by the COR, SAMHSA’s Division of Contract Management (DCM) will provide authorization to the Contractor on the approved funding level for the conference being supported. After receiving this authorization, the Contractor can then begin making all travel arrangements for non-Federal employees attending the meeting.

Specific Requirements Year 1 Task 1. Management

a. Contractor Meetings

i. The Contractor and Government COR / Alt COR will meet on a quarterly (maximum four (4) meetings) basis to discuss all tasks contained in the contract (including financial updates). This may be accomplished by either a site visit or webcast capability. Each meeting will be at least a two (2) day meeting to be held at the Contractor’s site or by a webcast from the Contractor’s site. The first meeting will be held within one (1) week of the contract effective date.

ii. The Contractor shall submit an agenda including updates on each task and sub-task and the financials dedicated to each to the COR / Alt COR listing the items to be discussed during the meeting. No later than (NLT) two (2) weeks before meeting.

b. DTAB

i. The Contractor shall send a maximum of four (4) individuals to attend each meeting of the SAMHSA Drug Testing Advisory Board (DTAB). DTAB meetings are held in the Washington, D.C., area. The Contractor will assist the COR in developing the agenda for each DTAB meeting and will prepare materials for presentation as requested by the COR. For budgeting purposes the contractor should consider each meeting to have two (2) nights of hotel, per diem, round trip air fare, and ground transportation.

ii. The Contractor shall submit all materials being presented at the DTAB meeting NLT one (1) week before the meeting to the COR for review and approval.

c. Foreign Program Activities

i. The Contractor shall participate in meetings and/or international conferences, and webinar/teleconferencing, (subject to approval by the COR, and are limited to two (2) events per year), that are developing drug testing programs or relating to the Mandatory Guidelines. These meetings could be under a trade agreement (i.e. North American Free Trade Act NAFTA) or of a program interest in development of international or global standards.

ii. The Contractor shall develop, maintain, and advertise a international certification cost certification program

d. Work plan

i. Within four (4) weeks after the CED, the Contractor shall create and submit draft system’s Privacy Impact Assessments, Entity Relationship Diagrams, Physical and Logical diagrams, information types along with data types and related relationship diagrams for the data that is being stored, processed and transmitted within the system.

ii. Within four (4) weeks after the CED, the Contractor shall meet with the COR and Chief Information Security Officer at a Privacy and Security Kick Off meeting to plan an implementation schedule that attains an ATO prior to system entering the production stage. (This meeting can be held virtually.)

iii. The contractor is responsible for submitting all required materials 30 days prior to the ATO anniversary date for review by the SAMHSA Security team, and contractor must follow SAMHSA continuous monitoring schedule.

Data Classification Note: Based upon preliminary review of the SOW the data residing within this system should be categorized as a “Moderate” and must obtain Authorization to Operate (ATO) before system gets deployed into the production environment. Please see Security and Privacy Requirements section ‘E’ for example deliverables for the ATO.

Task 2. Administration

a. Standard Operating Procedure (SOP) Manual

i. The Contractor shall maintain a standard operating procedure (SOP) manual that describes in detail how the Contractor will carry out all aspects of the NLCP. The SOP manual must be kept current as program requirements change. The manual shall be delivered NLT three (3) months after Effective Date of Contract (EDOC).

b. Security System

i. The Contractor shall have procedures to maintain the security of the workplace and the security of all current and archived NLCP records. NLT there (3) months after EDOC.

c. Distributing Documents

i. The Contractor shall prepare cover letters and make copies of program documents that will be sent electronically or mailed to inspectors and laboratories after receiving the request from the COR. The final letters and documents must be approved by the COR before they are distributed. No more than twelve (12) cover letters and copies of program documents are anticipated per year of the contract.

d. Freedom of Information Act (FOIA) Requests

i. The Contractor shall assist the COR to prepare and assemble materials in response to Freedom of Information Act (FOIA) requests for disclosure of NLCP records. A list of the documents and copies of the documents must be provided to the COR within three (3) days after receiving the request. No more than two (2) FOIA requests are anticipated per year for contract.

e. NLCP Documents

i. The Contractor shall prepare and revise, as needed, the following NLCP documents: Laboratory Inspection Checklist, Records Audit Checklist, Manual for Laboratories and Inspectors, Specimen Collection handbook, Medical Review Officer manual, NLCP application, education and training documents (e.g., professional scientific workshop presentations), and other related NLCP Program Documents. All NLCP documents prepared and revised by the Contractor must be approved by the COR before they are distributed. NLT six (6) months after EDOC. No more than 6 NLCP documents are anticipated per year for contract. Any materials intended for public dissemination and to be branded as SAMHSA and HHS products shall go through the standard SAMHSA/Office of Communications and HHS/Assistant Secretary for Public Affairs clearance process.

f. Mandatory Guidelines

i. The Contractor shall assist the Division of Workplace Programs to develop or periodically revise the Mandatory Guidelines for urine, oral fluid, hair, and sweat, subject to the COR request for assistance. No deliverable timeline scheduled (to be determined by the COR).

g. General Administration Support

The contract shall support the Division of Workplace Programs in its efforts to oversee HHS-certified laboratories that perform forensic drug testing for federal agencies and federally regulated industries. Efforts under this sub-task may include general support on items such as reviewing, drafting, editing, creating, and presenting presentations, documents, and trainings. No more than 20 activities are expected anticipated per contract year.

Task 3. Training

a. Inspector Training Workshop

i. The Contractor shall prepare materials to train individuals as inspectors for the NLCP. This may be a face-to-face workshop to train new inspectors or course material prepared for webcast training over the web. Final training materials must be submitted NLT one (1) month to the COR for approval before the workshop is scheduled or online material is webcast for inspectors. Any materials intended for public dissemination and to be branded as SAMHSA and HHS products shall go through the standard SAMHSA/Office of Communications and HHS/Assistant Secretary for Public Affairs clearance process.

ii. Inspection training materials are needed to train individuals to inspect laboratories testing urine, hair, sweat, and oral fluid specimens. The Contractor shall select the individuals who will be trained as inspectors from those having the appropriate education and experience and interest in becoming NLCP inspectors. The individuals selected for training are subject to approval by the COR. Individuals attending qualified training session will pay their own travel expenses or use their own time when reviewing course material on the web.

b. Inspector Continuing Education/Laboratory Director Workshop

i. The Contractor shall present a workshop for trained inspectors and laboratory directors to ensure that they are kept current with all changes in the NLCP. A workshop is presented annually before, after, or during the annual meeting of the Society of Forensic Toxicologists, Inc. (SOFT). The Contractor shall make arrangements to distribute workshop materials to those inspectors who were unable to attend the workshop. Final presentation materials must be submitted to the COR for approval prior to the workshop. NLT two (2) months before the beginning of the scheduled workshop. Inspectors and laboratory directors attending the workshop will pay their own travel expenses.

ii. With the consent and approval of the COR, the Contractor establishes the requirements for trained inspectors to acquire continuing education credits to remain in an active inspector status (on an annual basis). This requirement may be through continuing education credits online or at the annual training workshop.

c. Contractor Staff Professional Development

i. The Contractor may send each NLCP contract dedicated professional staff member to one professional meeting (such as, the annual meeting of the American Academy of Forensic Sciences or the annual meeting of the Society of Forensic Toxicologists) or to one professional training course per year. The subject material of a professional training course must have relevance to the NLCP. The reimbursement for the attendance of the contractor’s professional staff at a meeting or training course is subject to prior approval by the COR and no more than twenty (20) meetings/conferences are anticipated per year of the contract.

Task 4. The Drug Intelligence and Analysis Institute for Excellence

a. Purpose

i. The contractor shall implement the mission of the Drug Intelligence and Analysis Institute capitalizing ongoing efforts to provide comprehensive and cutting-edge analysis of drugs of interest to the federal government, by leveraging the latest study and technology to deliver actionable intelligence that informs decision-making and enhances public safety. The contractor shall work towards the vision of being the leading center of excellence for federal government studies on drugs of interest, by partnering with civilian and federal government entities, and delivering accurate and timely information that supports the development of effective policy, programs, and interventions.

ii. The contractor shall implement the goals and objectives of The Drug Intelligence and Analysis Institute for Excellence including:

1. Identify and prioritize the most pressing study questions related to drugs of interest and their impact on public safety.

2. Develop and implement a robust study program that leverages cutting-edge technology and innovative methodologies to answer these questions through both human subject studies and non-human studies.

3. Collaborate with civilian and federal government entities to share information, expertise, and resources, and to ensure that study findings are integrated into policy and practice.

4. Conduct ongoing monitoring and evaluation of the Institute's study program to assess its impact, identify areas for improvement, and ensure that study is aligned with the needs of stakeholders.

5. Disseminate study findings and best practices to a wide range of stakeholders, including policymakers, practitioners, and the public, to promote the effective use of study evidence in decision-making. The Institute will also maintain a plan to outline all study questions already answered, current study questions, and future study questions, as well as implications from all studies already completed. This plan will be updated regularly to reflect the latest study findings and developments in the field.

b. Applied Studies Agenda Tracking Tool

i. The contractor shall maintain the Applied Studies Agenda Tracking Tool. This will be a custom reporting tool that will serve as the foundation of the Center for Excellence and be developed to store and report information on special projects that are conducted under the NLCP Contract. Attributes of various applied studies from project approval to close will be entered and tracked in a tool that will allow RTI to provide SAMHSA with custom reports detailing how studies impact and guide policy within the Drug Free Workplace Program. The application will be able to connect studies by topic and aide in highlighting areas of work that need to be further funded and explored. Ad Hoc Reports will be available at the request of the COR within two (2) days. All standard reports will be in a print and report ready format that requires no further manipulation by DWP. NLT one (1) month after EDOC. A quarterly standard report will be submitted NLT 3 weeks after the EOQD.

c. New Technology, Instruments, and Analytes

i. The Contractor shall gather information on new technologies and new instruments being developed to test for drugs and additional analytes (e.g., designer drugs or newly developed illicit drugs) that may or could be included in the drug testing programs. For technologies and instruments, the task includes evaluating the technologies and instruments and providing an assessment/validation of their potential applicability to workplace drug testing programs. Final report submitted to the COR for review within two (2) weeks after COR reviews draft report. No more than two (2) final reports are anticipated per year of the contract.

d. Alternative Specimens / Specimen Performance Testing (PT)

i. The Contractor shall evaluate other types of specimens (e.g., Oral Fluid and Hair) for possible use in workplace drug testing programs. For alternative specimens and other analytes, the task may include establishing cutoff concentrations, estimating detection windows, and ability to develop and include performance testing samples in the NLCP performance testing (PT) program. Final report submitted to the COR for review within two (2) weeks after COR, reviews draft report. No more than six (6) evaluations are anticipated per year of the contract.

e. Adulterants, Synthetic Urine, and Drug Culture Products

i. As discovered or requested by the COR, the Contractor shall purchase and identify adulterants and drug culture products that are sold with the intent of defeating a drug test. The effectiveness of the products to defeat a drug test shall be evaluated. No more than ten (10) products are anticipated to purchased per year of the contract.

f. Human Applied Studies

i. The Contractor shall assess the impacts of drug use on human results for potential application in the Mandatory Guidelines for Federal Workplace Drug Testing Programs, combining as necessary the evaluation of alternative biological specimens (e.g., Urine, Oral Fluid and hair) with comprehensive human applied studies. This integrated approach involves developing and implementing rigorous study protocols to investigate health and behavioral effects of drug use, establishing baseline health indicators, estimating the duration of drug effects, and ensuring the ethical treatment of human subjects. A final report detailing the study findings and their implications for the Guidelines will be submitted to the Contracting Officer's Representative (COR) within two weeks after draft review, with an expectation of no more than six (6) in-depth evaluations per year, aligning the study outputs with the operational cadence of the Federal Workplace Drug Testing Programs.

g. Study and Analysis

i. The Contractor shall assess the impacts of drugs using in vitro methods in the laboratory for potential application in the Mandatory Guidelines for Federal Workplace Drug Testing Programs, combining as necessary the evaluation of alternative biological specimens (e.g., Urine, Oral Fluid and Hair) with comprehensive human applied studies. This integrated approach involves developing and implementing rigorous study protocols to investigate health and behavioral effects of drug use, establishing baseline health indicators, estimating the duration of drug effects, and ensuring the ethical treatment of human subjects. A final report detailing the study findings and their implications for the Guidelines will be submitted to the Contracting Officer's Representative (COR) within two weeks after draft review, with an expectation of no more than six (6) in-depth evaluations per year, aligning the study outputs with the operational cadence of the Federal Workplace Drug Testing Programs.

h. Drug System Monitoring

i. Pulse Testing

1. The contractor shall partner with HHS certified laboratories to perform pulse testing (i.e., prevalence) studies for drugs of interest to the program. The contractor will present all studies to the DTAB and publish relevant study results as approved by the COR. Final report submitted to the COR for review within two (2) weeks after COR, reviews draft report. No more than six (6) pulse testing studies are anticipated per year of the contract.

ii. Dark Web Surveillance

1. The contractor shall collaborate with the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System Web Monitoring Program to complete web monitoring to examine internet chat regarding confounding drug tests. Final report submitted to the COR for review within two (2) weeks after COR, reviews draft report. No more than six (3) Dark Web Surveillance project per contract.

i. Study Collaborations

i. The contractor shall collaborate with external partners to identify areas of study need and priority. The contractor shall collaborate with external partners on drug-related study projects conducted internally. The contractor shall collaborate with external partners on drug-related study projects conducted externally. No more than twenty-five (25) collaborations are anticipated per year of the contract.

j. Symposium on New Technology, Instruments, and Analytes

i. i. The Contractor shall organize and conduct an annual symposium focused on the latest developments in new technologies, instruments, and analytes pertinent to drug testing programs. This symposium will serve as a platform for professionals in the field, including laboratory directors, toxicologists, and program administrators, to discuss and evaluate emerging trends and innovations. The symposium will be scheduled to coincide with key industry events, such as the annual meeting of the Society of Forensic Toxicologists, Inc. (SOFT).

ii. The Contractor shall be responsible for coordinating all logistical aspects of the symposium, including venue selection (which can be in conjunction with another conference), speaker arrangements, and distribution of symposium materials to attendees. Additionally, the Contractor will ensure that presentation materials are prepared in advance and submitted to the Contracting Officer’s Representative (COR) for approval no later than two (2) months before the scheduled symposium.

iii. Attendees will be responsible for their own travel expenses, but the Contractor shall make provisions for those unable to attend by offering virtual participation options or by distributing symposium materials post-event. A final report summarizing the symposium’s key findings, discussions, and potential implications for workplace drug testing programs will be submitted to the COR within two (2) weeks following the event.

Task 5. Special Projects

a. Gap Analysis

i. The contractor shall provide a consultant to assist potential applicant laboratories prepare for certification using a gap analysis to inform the laboratory on the effort needed to meet minimum program requirements. The contractor shall maintain not share the report or any laboratory-specific information with SAMHSA or RTI. The contractor will provide a post-consultation survey for the consultant and for the laboratory to provide their feedback on the process. Final report submitted to the COR for review within two (2) weeks after COR reviews draft report. No more than two (4) final reports are anticipated per year of the contract.

b. Drug Testing Work Group (D-TWG) Meetings and Public Engagement

i. The Contractor shall establish and manage a Drug Testing Work Group (D-TWG) to present and discuss topics relevant to workplace drug testing with federal stakeholders and the public. Each quarterly meeting shall include a one-day open session featuring subject matter presentations and a half-day strategy session limited to D-TWG members and technical staff. The open session shall include presentations, public comments, and moderated question-and-answer segments.

ii. The Contractor shall host the meetings virtually using a secure web platform and will manage advance registration through an RTI-hosted website. The Contractor shall distribute meeting notices and agendas via email and post them to the NLCP website no later than two (2) months prior to the meeting date.

iii. The Contractor shall ensure that all materials presented during the public session, including slides and relevant discussion materials, are formatted for public posting and uploaded to the NLCP website no later than one (1) month following the meeting. A full meeting summary, including all public questions and responses, shall be prepared and submitted to DWP in a finalized report-ready format (no further manipulation required by DWP) no later than one (1) month after each meeting concludes.

Topics to be covered may include, but are not limited to:

· Workforce drug use trends

· Positivity rates

· Advances in drug detection technologies

· Medical Review Officer (MRO) and specimen collection issues

· Emerging testing matrices and subversion methods

· Programmatic strategies for drug use deterrence

iv. The Contractor shall finalize and execute agreements with all consultants and subject matter experts supporting the D-TWG no later than one (1) month before the first meeting. No more than four (4) meetings are anticipated per year of the contract.

c. Collectors

i. The Contractor shall develop a quality assurance program to assess the specimen collection process and the compliance of collectors with NLCP requirements. NLT one (1) month after EDOC.

d. Medical Review Officers

i. The Contractor shall develop a quality assurance program to assess the review of drug test results by medical review officers and their compliance with NLCP requirements. NLT one (1) month after EDOC.

e. Bibliography of Scientific Journal Articles

i. The Contractor shall maintain a bibliography and copies of journal articles related to drug testing. NLT one (1) month after EDOC.

f. Major Program Problems

i. The contractor shall develop a Plan, Do, Check, Act Program to assess the major program problem areas, their impact to the current and future state of the program and implement corrective actions as approved by the COR. NLT one (1) month after EDOC.

Task 6. Specimen Investigations

a. Special Investigations

i. Upon request from the COR, the Contractor shall investigate potential problems with regulated specimen test results that have been brought to the attention of the Division of Workplace Programs. An investigation may involve only reviewing documents provided by a laboratory or may include having the specimen tested by a reference laboratory. The investigation will be completed NLT one (1) month from the time the contractor notifies the COR of the specimen investigation. If additional testing by a reference laboratory is necessary to resolve the problem, the time allowed for the Contractor to report its findings to the COR will be appropriately increased. No more than 25 investigations are anticipated per year of the contract.

Task 7. Special Inspections

a. Special Inspections

i. The Contractor conducts, upon request of the COR, a special laboratory inspection that is needed to investigate potential problems associated with a laboratory that may be withdrawing from the NLCP or for other special circumstances brought to the attention of the Division of Workplace Programs. The Contractor ensures that a special laboratory inspection is conducted within three (3) weeks after receiving the request from the COR. The Contractor submits a final inspection report to the COR after a special inspection is completed within two (2) weeks. Generally, the cost for this type of inspection is reimbursed with government funds. No more than two (2) special inspections are anticipated per year of the contract.

Task 8. Reporting and Accounting

a. Laboratory Inspection Schedule List

The Contractor prepares a list of the laboratories scheduled for inspections in a given month and provides the list to the COR at least one month prior to the month the inspections begin. The list includes, at a minimum, the laboratory name and address, laboratory category, workload, previous inspection performance, and scheduled inspectors. NLT one (1) month before month scheduled to begin. No more than 12 laboratory inspections scheduled lists are anticipated per year of the contract.

b. Performance Testing Report

i. The Contractor provides quarterly Performance Testing Status Reports that summarize the scores for each laboratory in the PT program, for each of the last two cycles, and the cumulative score for the last two cycles. In addition, each report provides a combined overall summary of performance for all laboratories similar to that provided for each laboratory. Additionally, the Contractor provides a summary of performance for alternative matrices that are being evaluated under the Mandatory Guidelines.

ii. The PT status report is submitted to the COR after receiving all the test results from the laboratories for a PT cycle. NLT one (1) month after the results are reviewed.

c. Laboratory Event History Report

i. The Contractor documents all interactions with applicant and certified laboratories and provides the information as an annual report to the COR. Each annual report may contain only the updated information entered since the previous report. History report is delivered NLT one (1) month after the 12 month period.

d. Actual Inspection Cost Report

i. The Contractor provides a quarterly report that summarizes the actual inspection costs associated with each inspection. The report shall include: (1) bar graphs that give the average cost per month for each item (i.e., inspector airfares, hotel costs, meal costs, miscellaneous expenses, car rental costs) - the bar graphs indicate 12 months on a contract year basis, and (2) cost tables that list for each laboratory inspected the inspection date, name of inspectors that conducted the inspection, and for each inspector the airfare, hotel, meal, miscellaneous, and car rental costs. The Inspection Cost Report is delivered NLT one (1) month after the quarter to the COR.

e. Inspector List

i. When an inspector application package is requested, the Contractor sends the requestor approved application. The Contractor determines, with COR approval. A complete application package shall specify all the information that must be submitted by an applicant inspector as part of the application process. No more than ten (10) application package requests are anticipated per year of the contract.

ii. The Contractor evaluates the application packages submitted by applicant inspectors that are interested in participating in the NLCP. NLT one (1) week after the contractor receives the application. No more than ten (10) evaluation application packages are anticipated per year of contract.

iii. The contractor maintains a database for the trained inspectors. The database includes, but is not limited to, the following information for each inspector: name, business address, home address, phone and fax numbers, inspections conducted, and any other information that has been entered in the database that would impact an individual's selection for a particular inspection. A list of trained inspectors is provided to the COR quarterly. NLT two (2) weeks after the three (3) months period ends.

f. Special Project Cost Report

i. The Contractor provides a quarterly report that summarizes the actual special project costs associated with each project. The report shall include: (1) bar graphs that give the average cost per month for each project (i.e., airfares, hotel costs, meal costs, miscellaneous expenses, car rental costs if travel is involved) - the bar graphs indicate twelve (12) months on a contract year basis, and (2) projected cost of upcoming special projects. NLT two (2) weeks after the three (3) month period ends.

Task 9. Appeals

a. Appeals

i. The Contractor assists the COR in preparing documents to support an adverse action (such as, suspension or revocation) taken against a laboratory. An appeal of an adverse action by a laboratory may include scheduling a special inspection of the laboratory. The Contractor must provide a list and copy of the documents supporting the adverse action to the COR two (2) weeks after the request is received from the COR. No more than two (2) appeals are anticipated per year of the contract.

Task 10. Request for NLCP Applications

a. Request for NLCP Applications

i. The Contractor documents all inquiries requesting information regarding the NLCP. No more than ten (10) requests are anticipated per year of the contract.

b. Provide NLCP Application Packages

i. When an application package is requested, the Contractor sends the requestor an Office of Management and Budget (OMB)-approved application and associated program documents. The Contractor determines, with COR approval, the program documents that are included to with the OMB approved application. A complete application package shall specify all the information that must be submitted by an applicant laboratory as part of the application process. No more than ten (10) application package requests are anticipated per year of the contract.

Task 11. Evaluations of Applications (cost recovery)

a. Evaluate Application Packages

i. The Contractor evaluates the application packages submitted by applicant laboratories that are interested in participating in the NLCP. NLT one (1) week after the contractor receives the application. No more than ten (10) evaluation application packages are anticipated per year of contract.

b. Prepare Laboratory Certification Letters

i. After an applicant laboratory satisfies the initial certification requirements, the Contractor sends a letter to the COR indicating that the applicant laboratory is being recommended for certification, NLT one (1) week after the Contractor recommendation. A certification letter and certificate is then issued by HHS. As necessary NLT one (1) week after the Contractor recommendation. No more than ten (10) certification letters are anticipated per year.

Task 12. Responsible Person Qualifications (cost recovery)

a. Review and Approve Responsible Person Qualifications

i. The Contractor documents the review and recommendations for approval of each individual serving as a Responsible Person, co-Responsible Person, or alternate-Responsible Person. The Contractor shall develop instructions that describe what information is needed for an individual to be considered for these positions based on the Mandatory Guidelines. (New or remedial responsible person will be interviewed during the next schedule routine laboratory inspection NLT one (1) week). No more than fifteen (15) Responsible Person qualification documents are anticipated per year of contract.

b. Completion of Evaluation: Decision Letter Sent to Laboratory

i. Upon completing an evaluation, the Contractor shall send one letter to the laboratory with its acceptance or rejection of the individual for that position and/or actions needed to make the individual acceptable. NLT one (1) week after completing the evaluation.

Task 13. Inspection Program (cost recovery)

a. Pre-Inspection Activities

i. The Contractor maintains a laboratory inspection program that satisfies the requirements described in the Mandatory Guidelines.

ii. The types of regular inspections needed include inspections of applicant laboratories, Electronic Control and Custody Form (EECF) programs, instrumented initial test laboratories and maintenance inspections for all HHS-certified laboratories. Additionally, a laboratory that withdraws from the NLCP may be inspected and charged a separate inspection fee depending on when the last regular inspection was conducted. All laboratory inspections are conducted on a schedule period with the laboratory notification. Per Mandatory Guidelines the laboratories are to have two (2) scheduled inspections over a period of one (1) year.

iii. The Contractor shall establish a fee schedule that charges various size laboratories an appropriate cost recovery fee for each inspection and for other program activities (such as, the PT program activities described under Task N). The fee schedule is subject to approval by the COR. The Contractor shall regularly assess the effectiveness of the inspection and PT programs and recommend changes to ensure the forensic nature of the NLCP and minimize costs to the laboratories. The Contractor shall evaluate fees annually to ensure that the fees are appropriate. The evaluation and recommendation of the laboratory fees will be delivered NLT one (1) month after twelve (12) month period ends.

iv. The pre-inspection activities include selecting the trained inspectors that will be used for each inspection, arranging all the required travel for the inspectors, and requiring laboratories to submit information that will be used by the inspectors and the Contractor to prepare for the inspections.

b. Special Inspections

i. The Contractor schedules special laboratory inspections when requested by the COR. The Contractor proposes how special inspections will be conducted and the fees to be charged to the laboratories with approval by the COR. Generally, a special inspection is conducted when the findings from a regular inspection indicate that a serious problem may exist at the laboratory and corrective action must be verified before the next regular inspection is scheduled. The Contractor may anticipate the need to schedule and conduct six (6) special inspections per year.

c. Inspector Reimbursement/Consultants

i. The Contractor ensures that inspectors receive a consulting fee (to be established by the Government at the time of contract award) and reimbursement for hotel costs, meals, rental car costs, and miscellaneous travel expenses. The Contractor shall establish procedures to minimize and document all travel costs.

ii. The funds collected through laboratory fees that are used to reimburse the inspector costs under this subtask (Task M-1.) are only subject to a Materials Support Expense (MSE) fee and the Contractor fee. The contractor may anticipate no more than 180 inspector reimbursements per year.

d. Inspection Contractor Staff

i. The Contractor staff will participate as inspectors for laboratory inspection during the regular scheduled annual inspection of the laboratories in the MG program. The Contractor may anticipate that Contractor staff will participate in twenty-five (25) inspections per year (spread annually and at the discretion of the Contractor).

ii. The Contractor staff receive regular wages (in lieu of a consulting fee) while inspecting laboratories and these wages are subject to fringe, overhead, General and Administrative, and fee adjustments.

e. Post-Inspection Activities

i. Final Inspection Report

1. The Contractor reviews the reports submitted by the inspectors and prepares and sends a final inspection report to the laboratory. The final report may be sent electronically or mailed to the laboratory. A copy of the final report is sent to each of the inspectors who participated in the inspection. Final inspection reports are due NLT two (2) weeks after receiving inspector reports. The contractor may anticipate the need to review the reports from 100 inspections per contract year.

f. Prepare Contractor Cover Letters for Final Inspection Reports

The Contractor prepares a cover letter to accompany the final inspection report to the laboratory that provides an outcome of the inspection and comments on any deficiencies that need to be corrected. The final report and related materials may be sent electronically or mailed to the COR when there is an unacceptable or failed inspection outcome. Final inspection reports are due NLT two (2) week after completing inspector reports. It is anticipated that there could be approximately one hundred (100) cover letters per year of contract.

g. Prepare Inspection Remedial Action Letters

i. The Contractor reviews information submitted by a laboratory in response to the final inspection report. After reviewing this additional information, the Contractor prepares a response that is sent electronically or mailed to the laboratory with its evaluation of the information and returns the information to the laboratory. Remedial action letters are due NLT two (2) weeks after receiving laboratory inspection response. It is anticipated that there could be approximately fifty (50) remedial action letter per year of contract.

Task 14. Performance Testing (PT) Program (cost recovery)

a. PT Samples

i. The Contractor maintains a PT program that satisfies the requirements described in the Mandatory Guidelines for each specimen type. This includes preparing sets of initial PT samples to be sent to applicant laboratories and maintenance PT samples to be sent to certified laboratories. The laboratories will receive the PT samples on a scheduled delivery every three (3) months or quarterly annually.

ii. The number and composition of PT samples used to prepare each year’s sets of samples must be submitted to the COR for review and approval annually. The list of the new PT samples must be received by the COR NLT two (2) months from the time of the new lot of PT samples for the upcoming year (typically twelve (12) months from the last review). It is anticipated that there could be approximately two-hundred (200) PT samples per contract year.

b. PT Report

i. The Contractor electronically sends or mails a quarterly PT report to each laboratory. Each report shall include, at a minimum, the following: laboratory name and identification number, screening score, confirmation score, quantitation score (percent of results within +20 percent or +2 SD of mean and the number of drug challenges exceeding +50 percent of the expected value), reporting score, and number of false positives. These scores shall be provided for the current PT cycle and cumulative scores for the last two cycles.

ii. A similar PT report shall be sent to laboratories that are in the initial certification process.

c. Prepare PT Remedial Action Letters

i. The Contractor notifies a laboratory when it has not satisfied all the requirements associated with the PT program and directs the laboratory to submit additional information and/or to take corrective action.

ii. The Contractor reviews the information submitted by a laboratory in response to a remedial action request and prepares correspondence that provides an assessment of the corrective action or further action the laboratory must take to be in compliance with PT program requirements. After reviewing the information submitted by the laboratory, the Contractor shall return the information to the laboratory. It is anticipated that there could be approximately sixty (60) remedial actions per year.

iii. The Contractor prepares a final PT error notice report assessing the major and minor errors when laboratories have not satisfied all of the requirements of the PT program. The final PT error notice and related materials including assessed fees will be sent electronically or mailed to the COR. NLT one (1) week before the PT error notice is sent to the laboratories.

d. Identify Reference Laboratories to be Used

i. The Contractor shall use several reference laboratories to verify and determine the mean concentrations of the PT samples before they are sent to the laboratories as either initial or maintenance samples. Contractor shall identify reference laboratories to participate in this service NLT 1 month after EDOC. No more than three (3) reference laboratory testing are anticipated per year.

ii. The Contractor shall recall a PT sample from a laboratory if there is any concern that the Contractor may have sent an incorrect PT sample to the laboratory. The recall procedure shall include using a reference laboratory to retest the PT sample in question.

Task 15. Transition/Transfer Activity

a. Transition Planning

i. Six (6) months prior to the end of the contract, the Contractor provides a comprehensive ninety (90) day plan that would detail the transfer of all relevant administrative and operational information associated with the NLCP to the incoming new contractor when the contract ends. The information to be transferred would include all computer maintained items, but is not limited to, the following essential functions: applications, certifications, proficiency testing performance data, inspection materials, inspection data/reports, program actions, administrative/ operational program devices, training materials, and trained inspector data base.

b. The contractor shall follow the requirements of Contract Closeout and schedule a meeting with the COR and DTM to discuss the execution of information technology transition activities related to data, software, web content, and electronic records. Use the Chain of Custody Form when records are transferred from Vendor to COR at end of contract and for providing authorization to destroy any records (requests need to be made from the vendor to the COR and COR provides approval).

c. The contractor shall be notified 120 days during the period of performance (year 1, 2, 3, 4, or 5) to transition/transfer all technical assistance training and collaboration materials to the SAMHSA Extranet. The contractor shall maintain and develop new materials in the extranet environment provided by SAMHSA. All links to these materials will be placed on new and existing technical assistance websites.

d. Transfer Planning the Government will furnish the following property:

i. Widmer N-3 Automatic Numbering Machine (1)

ii. Leica model 10400A TS meter refractometer (2)

iii. Data Mate MC 1000 Microfiche reader/printer (1)

iv. These items will be transferred from the current Contractor to the new Contractor after award of the contract, if necessary. The cost for this task is reimbursed by the Government. Any transfer activity is due NLT three (3) months before contract expires.

e. IT Requirements

i. The contractor shall schedule a meeting with the COR and DTM to discuss the…