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National Laboratory Certification Program RFP No. 277-22-0576 Attachment No. 1c
List of Deliverables Based on PWS
| Task |
| Deliverable |
| Qty |
| Delivery |
General Requirements Deliverables – DTM and OC Requirements
| 1 |
| Final Information Technology (IT Plan) |
| II |
| DTM thru COR |
| 60 calendar days after award |
| 2 |
| Privacy Threshold Analysis (PTA) |
| IV.C.4 |
| Privacy and Chief Information Security Officer (CISO) thru COR |
| 30 calendar days after award |
| 3 |
| Draft system’s Privacy Impact Assessments (PIAs) if full PIAs is needed |
| IV. C. 5 |
| Privacy Officer thru COR |
| No later than 45 calendar days after contract effective date (CED) |
| 4 |
| Entity, data type and relationship diagrams |
| IV. C. 8 |
| CISO thru COR |
| No later than 30 calendar days after award |
| 5 |
| Sensitive data type with physical and logical diagrams |
| IV. D.3 |
| CISO thru COR |
| No later than 30 calendar days after CED |
| 6 |
| Initiate security assessment and authorization process |
| IV. E. 3 |
| CISO thru COR |
| No later than 30 calendar days after CED |
| 7 |
| Privacy and security kickoff meeting |
| Work plan |
| COR and CISO |
| Within four (4) weeks of CED |
| 8 |
| System Authorization to Operate (ATO) |
| IV. E. 4 |
| CIO and CISO |
| Before system goes live |
| 9 |
| Information System Security Plan (ISSP) |
| IV. F |
| CISO and security email box infosecurity@samhsa.hhs.gov |
| Part of ATO package, before system goes live |
| 10 |
| IT security awareness training |
| IV. F. 7 |
| CISO and SAMHSA Training Officer |
| Within 30 calendar days after CED |
| 11 |
| Database, application, and operation system vulnerability scan reports |
| IV. G. 4 |
| CISO or SAMHSA Security |
| Every 30 days after ATO is granted |
| 12 |
| Vulnerability “Change Report” |
| IV. G. 5 |
| CISO or SAMHSA Security |
| Every 30 days after ATO is granted |
| 13 |
| Quarterly IT cost reports |
| IV.M |
| DTM thru COR |
| Quarterly |
| 14 |
| Permanent electronic records |
| V. F.7 |
| DTM |
| 60 days prior to period of performance expiration |
| 15 |
| Records management training and provide Contractor Records Management Training Completion Memorandum |
| V. H |
| COR |
Within 30 days of contract award or new contract staff start date and then annually for the life of the contract.
| 16 |
| Electronic Systems Questionnaire |
| V. I |
| CIO during the kickoff meeting and Records Officer |
| Responses within 4 weeks after the CED and 30 days prior to modifications to system |
| 17 |
| Content Development and Management Plan |
| OC requirements V. A |
| OC and DTM thru COR |
Records Officer Within 60 days after CED
| 18 |
| Web Content Approval |
| OC requirements V. C |
| COR |
| No later than 3 weeks prior to the planned initial posting of document |
| 19 |
| Web Content Migration Plan including a demo |
| OC requirements V. D |
| COR and DTM thru COR |
Records Officer Within 60 days after CED; demo within 30 days after CED
| 20 |
| Meeting on IT transition activities related to data, software, web content, and electronic records |
| OC requirements V. E |
| COR, DTM, and OC |
| Within 30 days after CED |
| 21 |
| Quarterly Reports of actual Web-related IT costs |
| OC requirements V.F |
| OC and DTM thru COR |
| Quarterly |
| 22 |
| Transition Task |
| Transition Task |
| COR and DTM |
| Schedule meeting with COR and DTM to discuss transition activities |
| National Laboratory Certification Program |
| RFP No. 277-22-0576 | |
| Attachment No. 1c | |
List of Deliverables Based on DTM and OC General Requirements:
Task 1. Management
| Task 1 a. Contractor Meetings |
| 1. First Meeting |
2. 4 Meetings with agenda for contractor meetings; quarterly
| 4 |
| 1. First meeting one (1) week after contract effective date. |
2. NLT 2 weeks before meeting.
| Task 1 b. Drug Testing Advisory Board |
| Presentations for Drug Testing Advisory Board (DTAB) Meetings |
| 4 |
| NLT 1 week before DTAB. |
| Task 1 c. Foreign Program Activities |
| Participate in meetings with Foreign Program Activities |
| 2 |
| To be scheduled (as determined by the COR no more than 2 events annually). |
| Task 1 d. Work plan |
| Privacy Impact Assessments |
Entity Relationship Diagrams Physical and Logical Diagrams Meeting with Chief Information Security Officer
Task 2. Administration
| Task 2 a. Standard Operating Procedures |
| Standard Operating Procedure (SOP) Manual |
| 1 |
| NLT 3 months after EDOC. |
| Task 2 b. Security System |
| Documentation of a security system in place. |
| 1 |
| NLT 3 months after EDOC. |
| Task 2 c. Distributing Documents |
| Distributing documents |
| 12 |
| To be scheduled (on an as needed basis determined by the COR). |
| Task 2 d. Freedom of Information Act (FOIA) Requests |
| Materials for FOIA requests |
| 2 |
| Within 3 days after request by the COR. |
| Task 2 e. NLCP Documents |
| NLCP documents distributed to labs |
| 6 |
| NLT 6 months after EDOC. |
| Task 2 f. Mandatory Guidelines |
| Assist in revising the Mandatory Guidelines |
| 1 |
| To be scheduled (determined by the COR). |
| Task 2 g. General Administration Support |
| Assist in reviewing, drafting, editing, creating, and presenting presentations, documents, and trainings. |
| 20 |
| To be scheduled (determined by the COR). |
| Task |
| Deliverable |
| Qty |
| Delivery |
Task 3. Training
| Task 3 a. Inspector Training Workshop |
| Conduct workshop to train new inspectors |
| 1 |
| NLT 1 month to the COR for approval. |
| Task 3 b. Inspector Continuing Education/Laboratory Director Workshop |
| Conduct workshop for inspectors and to inform laboratory directors |
| 2 |
| NLT 2 months before scheduled workshop. |
| Task 3 c. Contractor Staff Professional Development |
| Contractor Staff Professional Development meeting or training. |
| 20 |
| As approved by the COR. |
Task 4. Special Projects
| Task 4 a. New Technology, Instruments, and Analytes |
| Gather and report on information on new technologies and new instruments being developed to test for drugs and additional Analytes |
| 2 |
| Final report submitted to the COR for review within 2 weeks after COR reviews draft report. |
| Task 4 b. Alternative Specimens/ Specimen Performance Testing (PT) |
| Alternative Specimens/ Specimen Performance Testing (PT) Evaluate other types of specimens (e.g., Oral Fluid and hair) for possible use in workplace drug testing programs. |
| 6 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. |
| Task 4 c. Demographic/Database Analysis |
| Demographic/Database Analysis |
| 1 |
| NLT 1 month after EDOC. |
| Task 4 d. New Adulterants, Synthetic Urine, and Drug Culture Products |
| Identify adulterants, Synthetic Urine, and drug culture products that are sold with the intent of defeating. |
| 3 |
| As discovered or requested by the COR. |
| Task |
| Deliverable |
| Qty |
| Delivery |
| Task 4 e. Collectors |
| Develop a quality assurance program to assess the specimen collection process and the compliance of collectors with NLCP requirements. |
| 1 |
| NLT 1 month after EDOC. |
| Task 4 f. Medical Review Officers |
| Develop a quality assurance program to assess the review of drug test results by medical review officers. |
| 1 |
| NLT 1 month after EDOC. |
| Task 4 g. Bibliography of Scientific Journal Articles |
| Maintain a bibliography and copies of journal articles related to drug testing. |
| 1 |
| NLT 1 month after EDOC. |
| Task 4 h. Major Program Problems |
| Develop a Plan, Do, Act, Check Program to assess the major program problem areas |
| 1 |
| NLT 1 month after EDOC |
Task 5. Specimen Investigations
| Task 5 a. Special Investigations |
| Conduct specimen investigations |
| 25 |
| As requested by COR. The investigation will be completed NLT 1 month from the time the contractor notifies the COR of the specimen investigation. |
Task 6. Special Inspections
Task 6 a. Special Inspections
| Conduct special inspections |
| 2 |
| As requested by COR; conducted within 3 weeks after receiving request from COR. Contractor submits a final inspection report to the COR after a special inspection is completed within 2 weeks. |
Task 7. Reporting and Accounting
| Task 7 a. Laboratory Inspection Schedule List |
| Provide laboratory inspection schedule list. |
| 12 |
| NLT 1 month before month scheduled to begin. |
| Task 7 b. Performance Testing Report |
| Provide quarterly performance testing status report. |
| 4 |
| NLT 1 month after all results are reviewed. |
| Task |
| Deliverable |
| Qty |
| Delivery |
| Task 7 c. Laboratory Event History Report |
| Provide laboratory event history report. |
| 1 |
| NLT 1 month after the 12-month period. |
| Task 7 d. Actual Inspection Cost Report |
| Provide quarterly actual inspection cost report. |
| 4 |
| NLT 1 month after the quarter. |
| Task 7 e. Inspector List |
| Provide quarterly trained inspector list. |
Provide application packets upon request to inspector.
Provide evaluation of submitted inspector applications.
NLT 2 weeks after the end of each quarter.
| Task 7 f. Special Project Cost Report |
| Provide a quarterly copy of the trained inspector list. |
| 4 |
| NLT 2 weeks after the 3-month period ends. |
Task 8. Appeals
| Task 8 a. Appeals |
| Assist the COR with appeals. |
| 2 |
| As requested by the COR. Contractor provide a list and copy of the documents supporting the adverse action to the COR 2 weeks after the request is received from the COR. |
Task 9. Request for NLCP Applications
| Task 9 a. Request for NLCP Applications |
| Request for NLCP Applications |
| 10 |
| The Contractor determines, with COR approval, the program documents that are included to with the OMB-approved application, as required. |
| Task 9 b. Provide NLCP Application Packages |
| Provide NLCP application packages |
| 10 |
| As requested by laboratories. |
Task 10. Evaluations of Applications (cost recovery)
| Task 10 a. Evaluate Application Packages |
| Evaluate application packages submitted by applicant laboratories |
| 10 |
| As submitted by laboratories NLT 1 week after the Contractor receives the application. |
| Task 10 b. Prepare Laboratory Certification Letters |
| Prepare laboratory certification letters |
| 10 |
| As necessary NLT 1 week after the Contractor recommendation. |
| Task |
| Deliverable |
| Qty |
| Delivery |
Task 11. Responsible Person Qualifications (cost recovery)
| Task 11 a. Review and Approve Responsible Person Qualifications |
| Review and approve Responsible Person qualifications |
| 15 |
| As necessary (New or remedial responsible person will be interviewed during the next schedule routine laboratory inspection NLT 1 week). |
| Task 11 b. Completion of Evaluation: Decision Letter Sent to Laboratory |
| Completion of evaluation: Decision letter sent to laboratory |
| 1 |
| NLT 1 week after completing the evaluation. |
Task 12. Inspection Program (cost recovery)
| Task 12 a. Pre-Inspection Activities |
| Pre-Inspection Activities |
| 2 |
| NLT 1 month after 12 month period ends. As required (There will be 2 mandatory scheduled inspection annually). |
| Task 12 b. Special Inspections |
| Conduct special laboratory inspections |
| 6 |
| A requested by the COR. |
| Task 12 c. Inspector Reimbursement/Consultants |
| Inspector Reimbursement/ Consultants |
| 180 |
As required.
| Task 12 d. Inspection Contractor Staff |
| Inspection Contractor Staff |
| 25 |
| The Contract staff shall participate as inspectors for laboratory inspection during the regular scheduled annual inspection of the laboratories in the MG program (spread annually and at the discretion of the Contractor). |
| Task 12 e. Post-Inspection Activities |
| Post-Inspection Activities |
| 100 |
| NLT 2 weeks after receiving inspector reports. |
| Task 12 f. Prepare Contractor Cover Letters for Final Inspection Reports |
| Prepare contractor cover letters for final inspection reports |
| 100 |
| NLT 2 week after completing inspector reports. |
| Task 12 g. Prepare Inspection Remedial Action Letters |
| Prepare inspection remedial action letters |
| 50 |
| NLT 2 weeks after receiving information from the laboratory. |
| Task |
| Deliverable |
| Qty |
| Delivery |
Task 13. Performance Testing (PT) Program (cost recovery)
| Task 13 a. PT Samples |
| Prepare sets of PT samples with a list of samples included |
| 200 |
| To be scheduled every 3 months or quarterly. List to be received NLT 2 months from the time of the new lot of PT samples for the upcoming year. |
| Task 13 b. PT Report |
| Prepare quarterly PT reports |
| 4 |
| To be scheduled quarterly. |
| Task 13 c. Prepare PT Remedial Action Letters |
| Prepare PT remedial action letters |
| 60 |
| To be scheduled as needed; NLT 1 week before the PT error notice is sent to the laboratories. |
| Task 13 d. Identify Reference Laboratories to be Used |
| Identify reference laboratories to be used |
| 3 |
| NLT 1 month after EDOC. |
Task 14. Transition/Transfer Activity
| Task 14 a. Transition Planning |
| Comprehensive 90 day transition plan |
(applies only to last Option Year)
| 1 |
| NLT 6 months before the contract expires. |
| Task 14 b. Transfer Planning |
| Transfer Planning The Government will furnish the following property: |
1. Widmer N-3 Automatic Numbering Machine (1)
2. Leica model 10400A TS meter refractometer (2)
3. Data Mate MC 1000 Microfiche reader/printer (1)
| 3 |
| Post new contract award. |
| Task 14 c. IT Requirements |
| Contractor meeting with SAMHSA IT |
| 1 |
| NLT 120 days before contract expires. |
Task 15. Special Contract Requirements
| Task 15 a. Financial Interest |
| Complete financial disclosure forms. |
| 20 |
| To be completed annually. |
| Task |
| Deliverable |
| Qty |
| Delivery |
Optional Tasks
| Task 16. (Optional) (Task 4 a. Multiple Times) Additional Special Project New Technology, Instruments, and Analytes |
| Optional Task |
Conduct Special Projects: New technologies, instruments, and analytes (Task 4 a.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. At the discretion of the COR and based on the availability of funding and programmatic needs. |
| Task 17. (Optional) (Task 4 b. Multiple Times) Additional Special Project Alternative Specimens / Specimen Performance Testing (PT) |
| Optional Task |
Conduct Special Projects: Evaluate alternative specimens (Task 4 b.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. At the discretion of the COR and based on the availability of funding and programmatic needs. |
| Task 18. (Optional) (Task 4 c. Multiple Times) Additional Special Project. Demographic/Database Analysis |
| Optional Task |
Conduct Special Projects: Demographic/Database Analysis(Task 4 c.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. At the discretion of the COR and based on the availability of funding and programmatic needs. |
| Task 19. (Optional) (Task 4 d. Multiple Times) Additional Special Project New Adulterants, Synthetic Urine, and Drug Culture Products |
| Optional Task |
Conduct Special Projects: New Adulterants, Synthetic Urine, and Drug Culture Products (Task 4 d.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. At the discretion of the COR and based on the availability of funding and programmatic needs. |
| Task 20. (Optional) (Task 4 e. Multiple Times) Additional Special Project Collectors |
| Optional Task |
Conduct Special Projects: Collectors (Task 4 e.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. At the discretion of the COR and based on the availability of funding and programmatic needs. |
| Task |
| Deliverable |
| Qty |
| Delivery |
| Task 21. (Optional) (Task 4 f. Multiple Times) Additional Special Project Medical Review Officers |
| Optional Task |
Conduct Special Projects: Medical Review Officers (Task 4f.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report. At the discretion of the COR and based on the availability of funding and programmatic needs. |
| Task 22. (Optional) (Task 4 g. Multiple Times) Additional Special Project Bibliography of Scientific Journal Articles |
| Optional Task |
Conduct Special Projects: Bibliography of Scientific Journal Articles (Task 4 g.)
Final report/Progress report
| 10 |
| Final report submitted to the COR for review within 2 weeks after COR, reviews draft report At the discretion of the COR and based on the availability of funding and programmatic needs. |
Task 23.
(Optional) (Task 4 a., Task 4b., Task 4d., Task 4f., and Task 4g.
Multiple Times) Partnership with DoD Additional Special Projects Contractor conducts special projects as requested by the COR.
Final report submitted to the COR for review within 2 weeks after COR, reviews draft report At the discretion of the COR and based on the availability of funding and programmatic needs.