Attachment_2_-_Task_Order_1_Statement_of_Work.pdf

Attachment 2 Task Order 1 Performance Work Statement

Premarket Tracking Services

1. Background

The mission of FDA, Center for Devices and Radiological Health (CDRH), is to protect and promote the public health. CDRH accomplishes its mission through the evaluation of new devices for marketing, developing and monitoring product quality and performance standards, taking action against firms that violate the law, educating professionals and consumers on the safe use of devices, and performing research on device problems. CDRH develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices.

CDRH receives, reviews, and renders determinations or otherwise acts upon thousands of premarket submissions each year from device manufacturers and others seeking clearance to market or clinically test new or modified devices in the United States. CDRH maintains internal and public databases and records that provide up-to-date information to the Agency, other Federal agencies, and (where appropriate) industry and the public regarding the Center’s recent and historic actions and determinations on pre-market submissions. CDRH also reports to industry, Congress and the public on review timelines and other performance metrics associated with those actions and determinations. Maintenance of these databases and records depends upon accurate and timely processing and tracking of pre-market submissions, and upon appropriate retention and disposal of records.

In support of its mission, CDRH receives, tracks and processes all pre-market submissions for records retention/disposal purposes. Execution of all tracking and archiving functions includes mail receipt, mail processing, mail distribution to and from divisions, operational functions, jacketing and labeling, electronic submission, user fee and eCopy processing, district office mail, and storage. This includes fulfilling all incoming and outgoing processing and quality control (QC) requirements on a same day as received basis (same day or by 9:00am the following business day for late deliveries defined elsewhere). Each submission may have multiple transactions (i.e., cycles of processing and/or tracking).

Section 4 of this task order reflects the approximate number of the submissions (by type) that CDRH receives each year.

2. Scope

The Contractor shall provide all personnel, equipment (exclusive of Government Furnished Equipment), vehicles, materials, supervision, training, facilities and other items necessary to perform the operation, management, tracking and retention/disposal of the CDRH pre-market submissions.

The scope of this project encompasses receipt and processing all of incoming hardcopy and electronic applications, submissions, and mail received at the Contractor’s Fully

Integrated Records Facility (FIRF). Processing records materials includes triaging incoming submissions, document preparation, barcoding and labeling, jacketing files, preparing files for pick-up by off-site scanner contractor and / or other authorized persons such as FDA reviewers and couriers, document distribution, meta data entry, manual data entry into CDRH tracking systems and repositories, uploading digitized images into EDRs, preparing Records Control Schedules (RCSs), tracking records material, storing files, file retention, retirement of files, and disposition of files.

In addition to the processing tasks identified above, the Contractor shall provide the following support services: task order management, physical and network access control, courier services, responding to stakeholder requests, file management, inventory management, quality control, retrieval of files, staging and preparation of documents for special projects, scanning services, shredding services, processing outgoing correspondence, relocation services, and transition activities. The Contractor shall be responsible for tracking all documents to and from their FIRF and the FDA White Oak campus.

The Contractor must be able to provide support in a dynamic and changing environment.

In addition the Contractor shall provide best practice advice on methodologies for improving the receipt and handling of records material regardless of the method of delivery.

3. Task Order Type

The order type for this task order is firm fixed price. The order type for the transition in period is labor hour. The order type for the optional transition out period is labor hour.

4. Tasks

4.1. Task 1: TRANSITION ACTIVITIES (ID/IQ SOW Task Area #6: Transition

Work Activities)

4.1.1. Transition-In Services

The Contractor shall provide “Transition-In” services in order to provide a smooth and orderly transition from the on-site Document Control Center (DCC) incumbent Contractor to the successor of the Off-site Fully Integrated Records Facility (FIRF) with a minimal disruption of services. The transition period shall begin at date of contract award and shall be completed within 90 calendar days. Upon completion of the transition in period, the successor contractor shall assume full operating accountability and responsibility for performance of all tasks.

The Contractor shall provide a detailed Transition-In Plan. At a minimum, the Transition-In Plan shall include the following:

• Inventory of documentation to be turned over (provided by the incumbent);

• Schedule of turnover;

• Personnel resources required;

• Relocation of all documents, infrastructure, supplies, etc.

• A description of parallel operations and recognition of security issues that includes an updated list of contractor personnel and anticipated start dates and responsibilities.

• Participate in Transition-In meetings with incumbent and COR.

• Conduct and coordinate all on-boarding activities with the COR.

• Prepare security paperwork and obtain secure badging for all Contractor personnel performing work on Government locations.

• Familiarize themselves with the business objectives, processes, and requirements as related to the systems being supported.

• Identify, track and discuss with the COR any potential or known problems, risks, or issues associated with the transition.

4.1.2. Transition-Out Services – Note: these services are optional services for the

Government and will be exercised at the Government’s discretion.

A smooth and orderly transition-out between the incumbent Contractor to a successor Contractor is necessary to ensure minimum disruption to vital FDA business. The Contractor shall be required to submit and execute a Transition-Out plan to ensure business continuity for the FDA in the event that a new Contractor is chosen. At a minimum, this Transition-out plan will include the following:

• Transition-Out Plan and Schedule, to be reviewed and agreed upon by COR and successor Contractor.

• Inventory of documentation to be turned over.

• Inventory and return of all Government Furnished Property.

• Schedule of knowledge walkthrough sessions.

• Training of successor Contractor employees on current policies and procedures.

• Classroom training; hands-on training of new Contractor employees.

• Lessons learned session and retraining;

• Submission of knowledge transfer documentation to include current and up-to-date Standard Operating Procedures.

• Availability of key personnel during transition period.

• Transfer of any documents/files on “hold” to the successor Contractor.

• Participate in all transition-in activities with successor Contractor.

• Identify, track and discuss with the COR any potential or known problems, risks or issues associated with the transition; and With the successor Contractor, coordinate relocation of all documents from the incumbent’s FIRF to the successor’s FIRF.

4.2. Task 2: Program and Project (Task) Management (ID/IQ Task Area 1:

Program and Task Order Management Support)

The Contractor shall provide Task Order project management, to ensure that the scope, schedule, and costs are controlled and consistent with the contract. The Contractor shall designate a Project Manager for all work performed under this Task Order. The Project Manager shall act as a single point of contact to the FIRF Project Manager.

4.2.1. Quality Control Plan

The Contractor shall conduct quality control of the CDRH document room processes.

Quality Control activities for this task order includes meeting Service Level Agreements (SLA’s); ensuring proper handling and safeguarding of material; identifying and mitigating risks; resolving issues; and adhering to processes and procedures. The contractor shall develop a Quality Control Plan. The contractor may also be tasked to provide guidance on proper quality assurance methods related to document control, records or information activities. The Contractor shall provide a monthly quality control report identifying the percentage of SLA’s met as well as identifying the SLAs that were not met and provide an explanation regarding the circumstances.

The Contractor shall establish and maintain a complete Quality Control Plan to assure the requirements of the contract are provided as specified.

At a minimum, the Quality Control Plan shall include:

1.1. An inspection system covering all the services identified in the statement of work. It shall specify the areas to be inspected on either a scheduled or unscheduled basis, how often inspections shall be accomplished and the titles of the individuals who shall perform the inspection.

1.2. The methods for identifying and preventing defective occurrences in the quality of service performed before the level of performance becomes unacceptable.

1.3. Off-site records of all inspections conducted by the Contractor and necessary corrective action taken. This documentation shall be made available to the Government.

1.4. The Contractor shall familiarize personnel by reviewing document control/mail functions currently in place. This review shall be accomplished by studying (or preparing) graphic flow diagrams of the current document control/mail distribution activities. The Contractor may, at any time, recommend improvements designed to improve processing to the COR.

1.5. Perform a 100% quality control inspection on all documents prior to the release to CDRH's Program Operations Staff (POS) or review division for review.

1.6. The Contractor shall have authorization to correct certain processing errors as agreed upon with the FIRF Project Manager without notifying the Program Office of the processing discrepancy.

Requirements of the Quality Control Plan:

1.7. The Contractor shall inform the COR and/or the COR designee via email when a correction to an error in data entry cannot be performed. The email shall explain the issue in sufficient detail to convey the pertinent information so that the COR or COR designee can understand the error and ensure that it is corrected.

1.8. Upon completion of the quality control process, the Contractor shall keep a record that the document QC was performed.

1.9. Emphasis shall be placed on timeliness and accuracy for scanning documents that are not subject to eCopy, into the IMAGE system. Quality control would include, for example, ensuring that submission supplements or amendments correctly relate to original documents and pages are scanned legibly.

1.10. Have a plan in place for implementation if performance goals are not being met, regardless of the reason for the lagging performance whether IT, increased workload personnel issues, holidays, weather or other factors are the cause.

4.2.2. Project Management Plan

The Contractor shall submit a Project Management Plan (including a project schedule) containing the following information:

- A detailed description of the Contractor’s approach for completing the tasks outlines in the PWS;

- An organizational chart for the CDRH FIRF. The organizational chart shall provide a list of employee names, job duties, job titles, and hierarchical structure;

- A Work Breakdown Structure (WBS) identifying activities and personnel/labor categories responsible for activities and risk management at activity levels identified;

and

- An approach for mitigating risks pertaining to contractor performance, cost and schedule.

4.3. Task 3: Processing, Tracking, Courier, and Temporary Storage of Premarket

Submissions (ID/IQ Task Area 2: Document Processing, Handling, Correspondence, and Delivery; ID/IQ Task Area 3: Document Scanning, Photocopy, and Conversion Services and ID/IQ Task Area 5: Tracking and Temporary Storage of Government Records)

Documents and records material shall be received at the FIRF. Contractor staff will receive U.S. Mail and deliveries via commercial and private couriers. Specific mail room processes will be identified in ITOs. The Contractor FIRF will be required to staff the FIRF, sort mail, prioritize, triage, scan, bar-code/track, and distribute both U.S. mail and regulatory submissions to the FDA community or coordinate with U.S. mail couriers. The Contractor shall be responsible for tracking all documents to and from their FIRF and the FDA White Oak campus.

As tasked, the Contractor shall process required and voluntary electronic copies (eCopies) of submissions provided to FDA on an electronic media (e.g., CD) into the official repository.

The FDA creates and receives a variety of non-regulatory Federal records. This includes but is not limited to, program records, office administration records and dockets. The Contractor shall provide user support services to internal and external stakeholders. Some examples of user support services are: responding to inquiries regarding the status of documents being processed, assisting firms with entering data into an electronic system to comply with regulatory requirements and searching for records to respond to FOIA requests.

In addition, but not limited to, the Contractor shall perform the following tasks related to document and records information processing:

4.3.1. Pre-market Submissions

The Contractor shall be responsible for processing the document types listed below:

Document/Submission

Types Total Anticipated

Submissions in a 12 month period

Total Anticipated Transactions as a

Multiplier* IDE Submissions 7,000 2.3 PMA Submissions 5,000 1.3 510(k) Submissions 10,500 3 All other ODE Documents 1,000 2.4

*NOTE: Total Anticipated Transactions is a multiplier which reflects the total number of documents that is processed to include the original document and any subsequent processing requirements.

Standard Operating Procedures (SOPs) associated with these documents are described in Attachments #1 and #2.

The Contractor shall verify that all inventory inspection information was successfully entered into the CDRH tracking program. The Contractor shall perform a quality control inspection on the data to ensure that the quality and accuracy of captured data is acceptable. If the quality and accuracy of captured data are unacceptable, the Contractor shall document the data discrepancies and forward to the Contractor's quality control inspectors for their corrective action.

Document Scanning: The Contractor shall ensure that the electronic image accurately contains the original paper copy received by FDA. The Contractor shall rescan pages discovered not to have been scanned and retain signed QC sheets for all documents scanned into the system.

Electronic Copies and Electronic Submissions: The Contractor shall ensure that required information is captured by the system and correct information as required using available data entry systems. For electronic submissions received on compact disc (CD) the Contractor shall also 1) verify that the submission is complete and properly packaged, authenticate that both the signed cover letter and CD are in the package, confirm the metadata information is correct, and validate that the bar code sheet and cover letter pages are readable.

4.3.2. Document Maintenance and Shredding

The Contractor shall store on their facility the various documents identified above until informed by the FIRF PM to shred the documents. After a valid eCopy is created, documents are identified daily by the FIRF PM. The Contractor shall provide a copy of the “Certificate of Destruction” in their monthly progress report.

4.3.3. Courier Services

The Contractor shall provide daily courier services (twice per day) from the Contractor’s facility to the FDA White Oak Campus for drop-off and pick-up of documents. The Contractor will be responsible for maintaining the security and integrity of all documents while performing courier services.

5. Meetings

5.1. Kick-Off Meeting

The Contractor shall participate in an initial meeting with the COR; FDA FIRF Project Manager; and FIRF stakeholders within 1 week of a receipt of a task order award. The Contractor is responsible for preparing meeting notes and providing a copy of those notes to the Task Order COR 3 days after the meeting. This discussion shall include the following:

• The objectives for the Task Order;

• A high level overview and discussion of the execution plan;

• Introduction of the Federal Contracting Officer (CO) and Contracting

Officer’s Representative (COR); FIRF Project Manager; as well as the key members of the Contractor’s team;

• A high-level overview and discussion of the transition plans.

• A questions and answers regarding the engagement.

Meeting notes shall detail the discussion held at the initial meeting, capture pertinent clarifications to the scope of work, and reflect any areas of disagreement or misunderstanding on the part of either the FDA or the Contractor.

5.2. Weekly Site Visit

The COR, or their designee, shall perform weekly site visits with the Project Manager / Document Control Supervisor. The weekly site visit schedule shall be mutually agreed upon by both parties. If the site visit is cancelled, the cancelling party shall give the other party at least 24 hours’ notice prior to the site visit date. If possible, the site visit shall be rescheduled for an alternate day during that work week.

The COR may perform unannounced site visits in addition to the weekly site visits.

5.3. Monthly Meeting

One (1) meeting shall be held each month between the Contractor’s Program (Contract) Manager; Project Manager / Document Control Supervisor; and the COR and his/her designees at the discretion of the COR, and possibly Contracting Officer, at the FDA, White Oak Campus – New Hampshire Avenue, Silver Spring, MD. The meetings shall be held to discuss general task order progress; current issues/resolutions; staffing changes; status of Government Furnished Equipment; to provide the Contractor with FDA guidance; and any other topics as deemed necessary by any party.

The Contractor shall provide the meeting agenda to the COR one week prior to the meeting date. The Contractor shall provide the meeting minutes two business days after the meeting has been held.

5.4. Program Reviews

FDA/CDRH expects the Contractor to be a partner in this program so premarket tracking and records retention/disposal can be streamlined and made more efficient while maintaining high quality and timely entry of reports. The Contractor shall host two (2) program reviews each year. During the program review, the Contractor shall discuss project status (to include staffing status, data entry backlog if any), project progress, efficiency and cost savings achieved, difficulties and issues encountered, along with possible solutions.

5.5. Emergency Meetings

For emergency processing matters/performance issues, the Program (Contract Manager) or alternate shall be available during normal duty hours upon request (within two hours) by the COR or FIRF PM to meet (either at the Contractor’s facility or FDA White Oak Campus) with government personnel (designated by the COR) to discuss problem areas. After normal duty hours, the manager or alternate shall be available upon request at a time mutually agreed to the next business day.

The following are representative of the meeting types that the Contractor can be expected to perform:

Meeting Activity Typical Location(s)

Estimated Occurrences

Kick-Off Meeting

Meet with COR, FIRF PM, and CO, and Key Personnel to review and finalize schedules.

FDA White Oak Campus

Within seven calendar days from date of task order award.

Transition Meeting Meeting with incumbent Contractor, COR, FIRF PM, CO and Key Personnel

FDA White Oak Campus

Within 7 calendar days from kick-off meeting.

Weekly Site-Visit Meet with COR, FIRF PM, Project Manager /

Contractor’s Facility

The weekly site visit schedule shall be mutually agreed upon

Document Control Supervisor and Program (Contract Manager) by both parties.

Monthly Meeting Meeting with COR, FIRF PM, and Program Staff

FDA White Oak Campus

Weekly for the first 3-months. After first 3-months, meeting will become monthly with

COR.

Program Reviews Meeting with COR and FIRF PM

FDA White Oak Campus

Bi-annually, as agreed upon between COR, FIRF PM and Contractor Program Manager.

Emergency Meetings Meeting with COR and FIRF PM

FDA White Oak or Contractor’s Facility

As agreed upon between COR, FIRF PM and Contractor Program Manager.

6. Deliverables

6.1. Standard Operating Procedures (SOPs)

The Contractor shall maintain a detailed, written, and updated manual of SOPs that are accessible to FDA at all times. The attached SOPs (Attachment #1 and #2) include a step-by-step explanation of the current processes which are currently being practiced at the CDRH on-site DCC facility. The Contractor shall present the FDA FIRF Project Manager and COR with revisions and additions to the SOPs for review and comment. The Contractor shall incorporate Government comments in the revised SOPs and implement the changes. These SOPs are included to illustrate the many steps involved with record tracking and records retention/disposal. However, these SOPs are not intended to act as exact protocols for the Contractor to follow. Additional SOPs for other document types and processing are available upon request.

6.2. Manuals, Logs, and/or Checklists

The Contractor shall maintain manuals, logs, and/or daily checklists that identify letters mailed and documents received by the Contractor. The COR will request an original and a copy of these manuals and checklists on an as needed basis.

6.3. Monthly Progress Reporting

The Contractor shall provide an original and electronic copy of the monthly progress report to the COR by the 10th of each month, for the previous month’s actions. The report shall include the following:

• Number of regulated documents received, processed, entered, etc.

• Document type status.

• Summary of added, modified, or deleted SOP procedures as directed by the COR

• The cumulative hours per labor category and the cumulative amount billed for the period of performance.

• Deliverables for the month

• An overview of work completed, in progress, and planned for each task.

• Identification of problem areas with recommended remedial actions.

• Identification of risks and mitigation plans

• Challenges and issues

• Staffing Plan updates

• Any necessary revisions to the Quality Control Plan

6.4. Daily Report

The Contractor shall prepare and provide daily report to the COR and FIRF PM for review and comment. The Contractor shall maintain a reference file of these reports.

For each day, the daily report shall include:

• Total number of submissions received;

• Total number of submissions processed;

• Total number of submissions partially processed and supporting rationale;

• Total number of failed submissions and supporting rationale;

• Total pending submissions/rejected submissions from previous day(s) and supporting rationale;

• Total submissions received for the current work week;

• Total submissions received for the current work month;

• Total of rejection notifications sent out;

• If IT related issues; provide a percentage of IT down time per daily processing and per contractor staff;

• Provide details of any equipment issues.

6.5. Deliverable Schedule

All deliverables shall be 508 compliant. All electronic and information technology (EIT) must met the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at:

http://www.access-board.gov/sec508/standards.htm.

Pursuant to the HHSAR clause 352.270-19, the Section 508 standards applicable to the prospective award are:

• § 1194.41 Information, documentation, and support http://www.access-board.gov/sec508/standards.htm

• § 1194.21 Software applications and operating systems

• § 1194.22 Web-based intranet and internet information and applications

Deliverable Title Quantity / Frequency

Due Date(s)

Quality Control Plan Original and electronic copy

Draft Plan submitted with Technical Proposal; COR will provide comments to contractor with 10 calendar days from award; Contractor shall provide the Final Plan with 5 calendar days from receipt of COR’s comments.

Quality Control Monthly Report

Original and electronic

Submit to the COR

Quality Assurance Surveillance Plan (QASP)

Original and electronic copy

Draft QASP submitted with Technical Proposal; COR will provide comments to contractor with 10 calendar days from award; Contractor shall provide the Final QASP with 5 calendar days from receipt of COR’s comments.

Project Management Plan Original and electronic copy

Note: The schedule shall be in MS Project format.

Draft Plan submitted with Technical Proposal; COR will provide comments to contractor with 10 calendar days from award; Contractor shall provide the Final Plan with 5 calendar days from receipt of COR’s comments.

Additionally, the Plan will be updated and submitted to the COR as changes occur.

Staffing Plan Original and electronic copy

Draft Plan submitted with Technical Proposal; COR will provide comments to contractor with 10 calendar days from award; Contractor shall provide the Final Plan with 5 calendar days from receipt of COR’s comments. The Staffing Plan must be kept current throughout the life of the task order. The Staffing Plan, and any updates, shall be included in the Monthly Report.

Security Documentation/Paperwork for all employees

Original and electronic copy

Submit documentation to COR within 5 calendar days from kick-off meeting. COR will submit documentation for FDA Security review/approval.

(refer to ID/IQ Clause FDA 1335.

Kick-Off Meeting Notes Original and electronic copy

Submit 3 calendar days after kick-off meeting to COR.

Transition-In Plan (includes schedule)

Original and electronic copy

Draft Plan submitted with Technical Proposal; COR will provide comments to contractor with 10 calendar days from award; Contractor shall provide the Final Plan with 5 calendar days from receipt of COR’s comments

Transition-In Meeting Minutes

Original and electronic copy

Within two business days after conclusion of meeting.

Monthly Progress Report Original and electronic copy

On or before the 10th calendar day of each month. COR by the 10th of each month

Monthly Meeting Agenda Electronic copy to the

COR

One week prior to the meeting date.

Monthly Meeting minutes Electronic copy to the

COR

Within two business days after conclusion of the meeting.

SOP’s (new and revisions) Original and electronic copy (and

CC COR)

New SOP’s shall be submitted to the FIRF PM for review.

The FIRF PM shall return comments within 10 calendar days. The Contractor shall finalize the SOP within 5 calendar days from receipt of FIRF PM comments.

Revised SOP’s shall be submitted to the FIRF PM for review within 1 calendar day from revision. The FIRF PMshall return comments within 5 calendar days. The Contractor shall finalize the revised SOP within 5 calendar days from receipt of FIRF PM comments.

Government Furnished Equipment Inventory

Original and electronic copy

On or before the 10th calendar day of each month. COR by the 10th of each month

Daily Report Electronic Provide by COB each day to the COR and the FIRF PM

Transition-Out Plan (includes schedule)

Original and electronic copy

Initial Plan submitted within 10 calendar days of the Government exercising the Optional Transition-Out Services, via modification executed by the Contracting Officer; COR will provide comments to contractor with 10 calendar days from award;

Contractor shall provide the Final Plan with 5 calendar days from receipt of COR’s comments

Transition-Out Meeting Minutes

Original and electronic copy

Within two business days from transition-out meeting

7. Contractor Personnel

7.1. Key Personnel

The following labor categories are considered Key Personnel under this Task Order:

• Program (Contract) Manager – stipulated in ID/IQ Contract

• Project Manager / Document Control Supervisor

• Supervisors

Should any key personnel need to be replaced, the Contractor shall submit the resumes of potential candidates to the COR for review and input. The final candidate shall be approved by the COR and the CO shall issue a modification to incorporate this change.

7.2. Security

Please refer to Personnel Security Clearance Requirements in the ID/IQ Contract.

All Contractor personnel working under this task order shall be able to attain Public Trust Position (Level 5).

The Contractor shall not employ persons for work on this contract if such person is identified to the Contractor by the COR as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population. Contractor personnel shall present a neat appearance and be easily recognized as Contractor employees. FDA will furnish an identifying badge, which will include at a minimum the employee’s name and photograph. Each employee shall wear the badge on the outer garments at all times.

The Contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. The Contractor shall be required to provide preliminary security background checks for all proposed staff. Additionally, all Contractor staff must pass a preliminary FDA security background check prior to being assigned to the contract. Contract staff shall complete a SF-85 form within 5 workdays upon assignment to contract. All personnel will have a Security Clearance before they are permitted access to the databases inside the FDA firewall. Each employee will receive computer security awareness training annually thereafter (provided by FDA).

7.3. Staffing Plan

The Contractor shall develop and maintain a staffing plan that guarantees the availability of personnel resources to meet all workload requirements from the first day of project operations throughout the life of the contract.

The FIRF, like many document control and regulatory processing centers, is likely to experience significant workload fluctuations. These workload fluctuations may be relatively small or may be large or longer-term fluctuations that result from a change in FDA and CDRH policy or submission procedures. Whatever the case, the Contractor’s staff shall be prepared to handle workload fluctuations to make certain that all work is completed within acceptable timeframes. The Staffing Plan for managing workload fluctuations shall include:

- Giving the Program Manager the authority to add personnel and make changes in staffing assignments, where and when they are needed;

- Hiring project staff who have multiple skills and can overlap more than one assignment;

- Cross-training staff to maximize staff utilization across multiple areas;

- Assigning full-time staff to work overtime hours; and

- Using the services of temporary staffing for short-term assignment.

8. Government Furnished Equipment / Government Furnished Information /

Contractor Furnished Supplies

8.1. Government Furnished Equipment

In accordance with Section 23 of the ID/IQ Statement of Work, the Contractor shall be furnished the following property for this task order: Laptop computers and/or personnel computers, large document scanners, desktop scanners, printers, copiers, tokens, badges, network access, and access to relevant FDA data systems.

The Contractor shall inform and require staff to comply with Government regulations that prohibit the use of any Government property for personal use. The Contractor shall submit to the Contracting Officer and Contracting Officer’s Representative a monthly electronic report on Access to Government Property and Status of Government Property. The Contractor and all Contractor personnel shall acknowledge and sign “FDA Site Policies and Procedures” customized for the FDA Document Control Room.

8.2. Contractor Provided Equipment/Supplies

The FDA Master Approved Technology (MAT) list contains a list of software applications and equipment approved by the Office of Information Management (OIM). The approved technologies are determined to be compatible with FDA’s Technical environment. The MAT list is posted on FDA’s intranet at http://apex.test.fda.gov/pls/apex/f?p=130:1:3075983010524334 (available after contract award).

All Contractor peripheral equipment connected to FDA computers or laptops must be on the MAT List. If Contractor equipment and software is not on the MAT List (as determined after contract award), it must be approved via the formal FDA technical approval process prior to connection to FDA’s network.

The MAT list will be available to authorized Contractor employees after contract award. In addition, FDA posts a list of technologies not approved by OIM on the intranet.

The Contractor shall supply vehicles for use in pick-up and delivery of documents (applications and submissions) and mail. The Contractor is authorized to utilize the General Services Administration (GSA) Federal Supply Schedules to acquire items needed for the performance of this task order.

8.3. FDA Direct Data Cable

The Government shall be responsible for purchasing, installing and maintaining, a Verizon data cable line that directly connects from the FDA White Oak Campus to the Contractor’s facility.

8.4. Contractor Furnished Supplies

Unless provided by the Government (refer to above), the Contractor shall be responsible for the purchase of all supplies, including those necessary to operate the GFE (other than maintenance/repair supplies).

Currently the documents are jacketed using custom-made shelf binder sets from Creative Filing Systems, Inc., 1350 Holton Lane, Takoma Park, MD 20912; Phone: (301) 439-4466;

Email: creativefiling@aol.com.

The specifications are:

2 piece covers, 11 point tinted stock, 12 1/8 x 9 ¾” back cover, 11 ¾ x 9 ¾” front cover, reinforced shelf tab, ¾” scored binding edge on both with 2 hole punching 8 ½ center to center, covers collated with 500 sets per carton.

The colors are:

http://apex.test.fda.gov/pls/apex/f?p=130:1:3075983010524334 mailto:creativefiling@aol.com

PMA: Dark Orange 510k: Light Blue IDE: Yellow and White CLIA: Grey

9. Period of Performance/Hours of Performance/Place of Performance:

The period of performance of this task order is one year from award. The transition-in period of 90 days is included in this one year period. The optional transition-out period of 90 days is included in this one year period.

All work shall be performed at the Contractor’s facility. The hours of operation are to be determined by the Contractor as long as same day processing is achieved. However, the Contractor staff shall be available during normal FDA business hours from 8:00 am – 5:00 pm Eastern Standard Time, Monday through Friday except on Federal Government Holidays.

Services will not be performed at the Federal site when the Federal Government is closed for reasons such as inclement weather or executive order.

10. Travel

All travel costs shall be included in the Contractor’s firm-fixed-price.

11. FIRF Project Manager (PM)

TBD

12. Contracting Officer Representative (COR)

TBD

13 Performance Standards:

REQUIRED SERVICE

STANDARD ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

DEDUCTION FOR

EXCEEDING THE

AQL

14 Invoice Procedures

All invoices shall be submitted in accordance with the FDA Two Way Matching Clause delineated below.

Acceptable methods of delivery include mail, electronic and hand delivery.

Incoming Document Processing

Same business day processing

90% within same day; 99% within 3 business days

“Incoming Processing” means one of the following actions: (1) going on eCopy hold; (2) going on UF hold; or (3) under review and issued to the review division/POS either electronically and/or physically.

2% of the monthly invoice

Outgoing Document Processing

Same business day processing

“Outgoing Processing” means the following actions: (1) logging out of database; (2) issuing letters to applicants (emails/US mail); (3) checking copy against IMAGE and sending to shredder as appropriate.

2% of the monthly invoice

Management of Old Paper Copies of Documents

30 documents a week

No more than 5 errors to be identified within a calendar month

Comparing the paper copy to IMAGE and sending it to the scanner, as applicable.

Provide weekly updates of old inventory.

2% of the monthly invoice

Shredding Documents Daily Shredding

Provide weekly updates of inventory with delivery dates and shredding dates.

2% of the monthly invoice

Scanning Documents Same business day processing

Scanning Documents no more than 5 errors to be identified within a calendar month as a result of poor quality control

Provide weekly updates of inventory with delivery dates and scanning dates.

2% of the monthly invoice

1. One copy to the Contract Specialist. If submitted electronically, contract number/task order number shall be referenced in the subject line.

2. One PDF version to the COR – clearly marked “Courtesy Copy Only”.

Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer

– System for Award Management) and or other applicable FAR clauses contained in this contract, and must contain the following:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, task order number and line item numbers;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract;

(x) Electronic funds transfer (EFT) banking information;

(xi)DUNS number.

An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items, listed in (i) through (xi) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead, must contain no ink changes and be legible for printing.

Direct questions regarding payment to the FDA Payment Office at:

FDA/OC/OA/OFO/OFS

ATTN: DIVISION OF PAYMENT SERVICES

10903 New Hampshire Ave White Oak Bldg 32, Mail Hub 2145

301.827.3742 OR 866.807.3742

OFS/PaymentServices@fda.hhs.gov Silver Spring, MD 20993-0002

14.1 Payment Schedule

Invoices during the period of performance shall be submitted on a monthly basis in an amount of 1/12 of the fixed price portion of the task order value. For example, if the fixed price portion of the task order value is $120,000 then each invoice for the 12 month period of performance would be $10,000.

14.2 Transition-in Period

Invoices for the transition-in period shall be submitted on a monthly basis and in accordance with FAR 52.232-7 “Payment under Time-and-Materials and Labor-Hour Contracts” (AUG 2012).

Invoices shall include a list of tasks performed during the period of performance, broken down by labor categories, and personnel name. Total hour per labor category and rates must be broken out and clearly defined for each task and personnel per invoice.

14.3 Optional Transition-out Period

Invoices during the transition-out period shall be submitted on a monthly basis and in accordance with FAR 52.232-7 “Payment under Time-and-Materials and Labor-Hour Contracts” (AUG 2012).

Invoices shall include a list of tasks performed during the period of performance, broken down by labor categories, and personnel name. Total hour per labor category and rates shall be broken out and clearly defined for each task and personnel per invoice.

Attachment 1 to Task Order 1 – Basic Workflow for all Submission Types

1. Submissions come into mailroom area.

2. Mailroom staff:

a. Opens mail and date stamps submissions.

b. Stratifies mail by each of the 3 program sections: 510(k); PMA; and IDE. Each of these program sections cover multiple submission types.

c. Logs in delivery tracking information.

d. Scans in mail tracking labels.

e. Delivers submissions to each of the program sections.

3. Each of the 510(k), PMA, and IDE program section performs the following incoming functions:

a. Jackets 1 copy of the document unless it is part of the eCopy pilot.

b. Logs document into APPS or CEntry database, depending on the submission type.

Depending on the submission type and purpose of the document, there will be some differences in the database fields.

c. User fee (UF) and eCopy processing of document.

i. Initial UF checks are automatic based on the APPS or CEntry database logic.

ii. eCopy processing requires use of the separate eCopies Loader software program to assess the validity of the eCopy and, if applicable, provide a list of eCopy errors. A document may require multiple rounds of eCopy processing until the applicant provides a valid eCopy.1 An eCopy record is generated for the document.

d. If a document needs to go on eCopy or user fee hold:

i. TIS performs quality check.

ii. Document is put on appropriate hold shelf with eCopy record attached.

iii. eCopy and/or UF hold letter is emailed/faxed and then mailed to the applicant.

e. If processing a response to an eCopy and/or UF hold:

i. Depending on the submission type, UF responses are handled in coordination with POS. UF information and dates are entered into APPS or CEntry.

ii. eCopy replacements are processed like initial eCopies, except that APPS and CEntry have special screens for entry of the receipt date for these eCopy replacements. The actual validation of the eCopy with the separate eCopies Loader software is identical regardless of whether it is the initial eCopy or replacement eCopy.

1 For Turbo 510(k)s, eCopy processing does not apply. Turbo 510(k)s are loaded into IMAGE via separate loading software. Keep this in mind whenever eCopy processing is referenced.

f. If the submission is not subject to eCopy processing, then one paper copy is processed through to the scanning staff for front-end loading into IMAGE.

i. The scanner is expected to follow the priorities and timeframes set by the business project manager. For example, items identified as high priority, may have a 48-hour timeframe for scanning into IMAGE. See item 9 below for more details.

g. Once a document has cleared eCopy and UF processing, as applicable:

i. Emails/faxes and mails letters from APPS or CEntry, if one generated, to applicant. The “DCC Letters” mailbox is cc’d.

ii. If there was an eCopy (including Turbo), the eCopy record is finalized. Each eCopy record includes the eCopy media (CD, DVD, or flash drive), all versions of the company cover letter, and the IMAGE loading sheet from the eCopies Loader software in a plastic sleeve. Each plastic sleeve is then stored in a folder on the DCC shelf. DCC shall not destroy any eCopy records without explicit direction from the eCopy Program Coordinator.

iii. TIS performs quality check.

iv. If a document is part of the eCopy pilot, then the document is stored on the eCopy pilot shelf for at least 16 days, after which it can be shredded after confirmation of its contents in IMAGE.

v. For those documents not part of the eCopy pilot, the routing slip is attached to the front of jacketed copy. All remaining paper copies are bound to the jacketed copy. Package is put in section-specific cart for delivery to POS/Review Divisions.

vi. TIS completes daily log that includes information for all submission processed in.

4. Mailroom staff:

a. Takes submissions from section carts for delivery to POS/Review Divisions.

b. Delivers submissions a minimum of 3 times a day and on an ad hoc basis. The first delivery is by 9 am for submissions processed the previous night or early that same morning.

c. Picks up submissions completed by Review Divisions to be delivered back to the tracking program section at the same time deliveries are made.

d. Picks up submissions from POS to be delivered to Review Divisions and tracking program section.

e. Picks up submissions from Review Divisions to be delivered to POS.

5. Each of the IDE, PMA, and 510(k) program section performs the following outgoing functions:

a. Over time, we intend to phase in the automation of the logging out processing for submission types so that the program sections may have little to no role. Until then, for submissions types for which there are log-out functions in APPS or CEntry, the following applies:

i. APPS or CEntry is updated.

ii. letter is email/faxed and then mailed to the applicant.

iii. For 510(k) clearances, the SE package is sent to the scanner to load the package into IMAGE.

b. If a final decision, confirms that the contents are in IMAGE. If not, the submission is processed to the scanning staff.

6. Performs ad hoc functions such as misroutes, deletions, corrections, rejacketing, and retrieving lost documents as necessary.

7. Monitors the user fee and eCopy hold shelves and contacts submission applicants for status updates for submissions on hold over 2 weeks. Follows-up every 2 weeks until the holds are lifted or the submissions are deleted.

8. Old documents on the DCC shelves are to be checked against IMAGE. If in IMAGE, then it is shredded. If not in IMAGE, then it is sent to the scanner to be scanned into

IMAGE.

9. Scanning staff:

a. Maintains records of boxes or submissions received for scanning

b. Prepares documents for scanning by numbering each page, removing fastening devices, checking for doubled-sided, color, or other pages that require special processing, and copying oversized documents so they will fit on standard paper

c. Enters indexing information for each document according to established practices and IMAGE system capabilities for that specific document type.

d. Prints and inserts bar-coded cover sheets and separator sheets as required by imaging system

e. Scans documents by selecting appropriate options in the imaging system prompts and loading the document pages into the scanner

f. Performs quality assurance to ensure that the electronic images accurately represent the paper documents received for scanning. This includes:

i. Reviewing each document page for accuracy and readability by comparing the scanned image to the paper, and identifying problem pages.

ii. Reviewing the indexing information to ensure its accuracy.

iii. Rescanning pages and correcting indexing information, as necessary, and confirming successful rescans.

iv. Annotating any changes made during the quality assurance process.

v. Reviewing the documents during a final quality control phase.

g. Transmits the completed electronic version for uploading into the IMAGE system.

h. Returns completed paper documents to their box for retention until shred timeframes are met, and updates work tracking information.

10. Shredding staff:

a. Material placed in designated shred bins will be shredded as per the schedule set.

Adequate bins should be available and shredding should be performed multiple times a week.

SOPs may be developed or updated as needed by either POS or one or more of the IDE, PMA, or 510(k) program sections.

Attachment 2 to Task Order 1 – Scanning Process – Quality Control SOP

All scanned documents will be checked for image quality, indexing readability and correct processing prior to transmission to the Electronic Database for retrieval and storage. The process is separated into two parts – Initial QC and Final QA. The actual document must be viewed and compared with the images scanned into the computer. QC/Verifiers will adhere to the following procedures:

Part 1: Initial QC

I. To begin select the QA Module button on the Image 2000 ODE Documents menu screen – Single Click

II. Select the Run Single Batch option on the Index menu (Example A.1) – Single Click

III. The Show only the batches that are ready to send tasks box should be checked (Example B.1)

IV. Using the arrow-bar, scroll through the listing to select the document to be verified

(Example B.2). Highlight the document number and click the OK button. The documents are listed based on the following structure:

A. The scan operators initials (3) B. The Box Number C. Folder Number D. Date of scan (YYYYMMDD) E. Time of scan (HHMMSS)

V. When the document opens if there are any page numbering discrepancies a message will display “You must fix all page discrepancies before accepting the task.” Click on OK

VI. Each index item that has a numbering error will have the word discrepancy next to the document number for easy identification. These items need to be corrected (see item XI. Corrections)

VII. The 1st page of the coversheet will be displayed with several thumbnail images of the individual document pages (Example C) to the left of the larger image

VIII. Verify Folder Identification Number A. Find the number on the original document (Original submission, Approval

Order, Cover Letter/Sheet, Decision letter, Inventory page or Folder cover) this number will be a minimum of 5 characters and must begin with a predetermined letter or group of letters

B. The Folder Identification Number must match on the Cover Letter , Decision Letter, Route Slip and if written on a Cover Page

IX. Using the Coversheet – Verify the Total Document Pages is correct:

A. Check the last thumbnail page on the screen B. Check the Total Document Pages listed on the Coversheet C.