MQSA_RFP_2017.docx

Request for Proposal FDA-17-MQSA

4BSECTION B - SUPPLIES OR SERVICES AND PRICE/COST

B-l - Background and Objectives

In performing the work as described in detail in Section C, C-l Scope of Work, the State contractor shall review and consider the following:

A. Background Information

The Mammography Quality Standards Act of 1992, (MQSA) was signed into law on 27 October 1992. The intent of the Act is to ensure that women receive high quality mammography for early breast cancer detection by requiring the establishment of a federal certification and inspection program for mammography facilities. The Act authorizes FDA to obtain State and/or local assistance in enforcing the MQSA requirements including annual inspections of all certified mammography facilities. NOTE: Interim regulations were published on 30 September 1994 and 03 April 1996. On 28 October 1997, the U.S. Food and Drug Administration (FDA) published final MQSA regulations in the Federal Register. These regulations took effect on 28 April 1999.

B. Objective

This project is designed to obtain State and/or local assistance in the inspection of certified non-Federal mammography facilities in order to document and report compliance with mammography quality standards issued under 21 CFR Part 900.

B-2 - Compensation

A. The contract type is Firm Fixed Price.

B. As consideration for full performance of the work stated in Part I, Section C - Scope of Work, the Government shall pay the State contractor a total fixed price of $ for inspections, and not to exceed $ for Continuing Education Units, for a total contract amount of $ . The period of performance will begin from the date of award and will expire twelve (12) calendar months after the date of the award.

C. Payment up to the full amount of this contract shall be contingent upon receipt and acceptance by the Government of inspection reports and proper invoices as required by Part I, Section F, F2- Reports/Deliverables and Section G, G-3 - Invoice Submission, and in accordance with the schedule in part F

D. Continuing Education for MQSA Inspectors

Total expenditures for each certified inspector to acquire fifteen (15) Mammography Continuing Education Units (MEUs) (strictly limited to registration and tuition fees, membership dues to join professional organizations that offer free or reduced price continuing education courses (i.e. American Society of Radiologic Technologists (ASRT)), course materials, and if necessary, appropriate travel expenses) shall not exceed the fixed allotment of $1,500 within any three-year certification period.

The FDA/Center of Devices and Radiological Health (CDRH) and the FDA/Office of Partnerships shall determine and recommend the necessity of appropriate travel expenses for the MQSA inspector. All travel/training must be approved prior to attendance by the Contracting Officer Representative (COR) and the Contracting Officer (CO).

Funds in the amount of $ to be billed separately for inspectors are allotted for MEUs under this contract.

Note: Salary costs are not reimbursable expenditures while receiving Continuing Education.

E. Training and Travel:

For training/travel, the total expenditures for domestic travel (transportation, lodging, meals, and incidental expenses) not to exceed $TBD incurred in direct performance of this contract shall be allowed based on the Federal Travel Regulations and HHS Travel Regulations.

The domestic travel allowance for training under this contract shall be paid on a cost reimbursement basis. The estimated travel and training costs are subject to FAR clause 52.216-7 “Allowable Cost and Payment’ and FAR clause 52.232-20 “Limitation of Cost”. These FAR clauses are included by reference in Section I of the contract.

F. Schedule

G. As consideration for the full performance of the work, stated in Part I, Section C - Scope of

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

C-l - Scope of Work

Independently and not as an agent of the Government, the State contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below:

The State contractor shall inspect non-federal mammography facilities that have been certified by the Food and Drug Administration (FDA) to perform mammography under the Mammography Quality Standards Act of 1992 (MQSA).Important Note: IN ORDER TO ALLOW FDA THE TIME REQUIRED TO OBTAIN RESOURCES TO COMPLETE NON-CONTRACTED WORKLOADS, THE STATE CONTRACTOR SHALL PROVIDE WRITTEN NOTIFICATION TO FDA IF THE STATE CONTRACTOR DECIDES TO NOT RENEW THE MQSA CONTRACTUAL AGREEMENT FOR THE FOLLOWING PERFORMANCE YEAR. FDA MUST RECEIVE THIS WRITTEN NOTIFICATION FROM THE STATE CONTRACTOR NO LESS THAN SIX MONTHS PRIOR TO THE END DATE OF THE PERIOD OF PERFORMANCE.

The following shall be accomplished: A. Inspections Inspections shall be performed at certified non-federal facilities performing mammography. The State Facility Listing Report is available on-line. Questions concerning access to the report should be directed to FDA/Division of Mammography Quality Standards (DMQS), Computer Support at (301)796-6633 or via email to cdrhmqrp@cdrh.fda.gov An inspection means the completion of the procedures in the documents entitled “Mammography Quality Standard Act (MQSA) - Facility Inspection Procedures”(a copy provided to all State Program Directors and MQSA Inspectors via email whenever updated) and “FDA Compliance Program 7385.014, Mammography Facility Inspections”, and any subsequent revisions.

The types of inspections that shall be conducted include the following:

- Annual Inspection - this is a routine inspection conducted annually. To assure compliance with MQSA, the inspection shall be conducted no sooner than ten (10) months, and no later than fourteen (14) months from the last routine annual inspection at a facility. For newly certified facilities with no prior inspection date, the inspection shall be conducted no sooner than ten (10) months, and no later than fourteen (14) months from the provisional certification date.

- Follow-up inspection - conducted to determine whether the facility has complied with the terms of their corrective action plan, based upon the deficiencies found during a previous inspection. These inspections shall typically be conducted by FDA.

- Joint Audit Inspection - an inspection conducted by a certified inspector under the observation of an FDA auditor to assure that inspections are conducted properly. Audits shall typically be conducted during an annual inspection and are required for each inspector once during the course of the federal fiscal year (01 October through 30 September). The State Contractor should contact the Regional Radiological Health Representative (RRHR) to discuss in advance the scheduling of audits for returning inactive MQSA certified inspectors or MQSA certified inspectors planning extended leave (i.e. medical leave, maternity leave, etc.).

B. Facilities

All of the inspections conducted by the State Contractor shall be of non-federal facilities that are certified by the FDA. Below is a listing of the various types of facility certification.

Fully Certified Facilities - A fully certified facility is one that had initially applied for and met accreditation standards under a six-month provisional certification status from an FDA-approved Accreditation Body or has successfully completed the re-accreditation process, and subsequently became fully certified for three years. Issuance of the FDA three-year Mammography Facility Certificate means that the FDA: Acknowledges the facility's accreditation by an FDA-approved Accreditation Body; certifies a facility as a mammography facility that can lawfully provide mammography services; will make the facility name and address available to members of the public as a facility certified under MQSA; and shall perform an annual MQSA inspection of the facility.

Provisionally Certified Facilities - A provisionally certified facility is one that has been issued a six-month provisional certificate based on information received by FDA from an approved accreditation body indicating that the facility's application is still in process, but sufficiently complete to allow initial certification. A provisional certificate allows a facility to legally perform mammography services for up to six months while completing the accreditation process. Once FDA is notified of the full accreditation of a facility, FDA issues a certificate fully certifying the facility for three (3) years.

Inspection of facilities in a provisionally certified status should be avoided unless there is a compelling reason to do so. In these cases, the State contractor shall consult with and obtain the concurrence of the Regional Radiological Health Representative (RRHR) before scheduling an inspection of one of these facilities.

Provisionally Reinstated Facilities - A provisionally reinstated facility is one that is currently undergoing accreditation body review for re-accreditation after it had been denied accreditation. This means that the facility is certified by the FDA to lawfully provide mammography services for up to six months while completing the re-accreditation process. Once the FDA is notified of the full reinstatement of the facility, FDA shall issue a three-year certificate to the facility. Provisionally reinstated facilities are subject to inspection and may, in cases of a history of problems preventing accreditation, be considered as a higher priority for inspection than fully certified facilities. States should consult Section 2.1.2, Routine Annual Facility Inspections, “When Should a Facility Be Inspected?” of the MQSA inspection procedures to determine when facilities should be scheduled for their annual inspection.

Facility Notification - The State Contractor shall provide the facility sufficient time to prepare for the inspection. Unless authorized by the RRHR or DMQS to inspect the facility without prior notice, it is recommended that notification be no less than five (5) working days prior to the inspection. Notification shall be provided to the facility in writing (preferably by facsimile or e-mail) unless the facility waives the need for a written notice.

Facility Status Changes - The State Contractor shall advise the FDA of changes in facility status in its Progress Report (e.g., closure, change in name or address, or if a facility is discovered to be performing mammography without a certificate provided by the FDA or by a State approved as a certification body by the FDA). Upon notification of a change in facility status, the State Contractor shall direct the facility to their respective Accreditation Body to effect the official change.

Patient Data - No patient name, addresses, or any other information that can be used to identify an individual, shall be collected from facilities inspected under this contract. If copies of patient records are collected, patient identification shall be removed and a code used to identify the records.

C. Inspection Procedures

Copies of the inspection procedures and compliance program 7385.014 shall be provided to the State Contractor. FDA shall also provide training in the use of these procedures for all personnel performing MQSA inspections. Additionally, inspection guidance is available in the following areas:

- Policy Guidance Help System (accessible via inspector's laptop and MQSA website).

- MQSA Facility Hotline (accessible via email at MQSAversatechnic.com or telephone at 800-838-7715 or fax at 443-285-0689)

- All Hands Inspector E-Mails

- Course I-III Training Materials (provided to inspectors at MQSA Inspector certification training).

D. Inspection Record/Reports

A computer-generated inspection report shall be generated for each inspection, using the latest version of the Field Inspection Support System (FISS) software. The specific inspection data shall be recorded on a portable computer system supplied by the FDA (or a FDA-approved contractor owned system - reference Attachment 1, entitled “Computer Equipment Specifications for MQSA Inspections”), uploaded into FDA's Mammography Program Reporting and Information System (MPRIS) via telecommunication, and submitted within five (5) business days of the facility inspection. Instructions for completing the computer generated inspection report are contained in the MQSA Facility Inspection Procedures.

E. Inspection Observations

The State Contractor shall notify the FDA Regional and District offices within five (5) working days when the inspection results indicate a Level 1 (serious) or Repeat Level 2 observation. The State Contractor shall discuss the inspection results with the FDA RRHR or the designated FDA field office contact by telephone or email within five (5) working days, and prior to the issuance of the report to the facility. A facsimile or electronic copy of any supporting documentation for the Level 1 or Repeat Level 2 observation shall be sent to the FDA RRHR or the designated FDA field office contact as soon as possible.

If there is a disagreement between the inspection observation and the State supervisors, it is recommended that the State contractor contact the RRHR and DMQS (Senior Compliance Officer).

Level 1 Observations and Repeat Level 1 and Repeat Level 2 Observations - When serious observations are made during an inspection, this will warrant a written response from the facility (within fifteen (15) working days) to FDA with a copy to the State Contractor. The FDA shall contact the State contractor if FDA requires any input on the response from the facility.

Level 2 Observations and Repeat Level 3 Observations - When found during an inspection, this will warrant a written response (within thirty (30) working days) from the facility to FDA with a copy to the State Contractor. The FDA shall contact the State contractor if FDA requires any input on the response from the facility.

Documentation for Inspection Observations – Whenever Level 1 or 2 observations are made; inspectors must copy facility records that document the observations. When needed, inspectors also must include remarks in the inspection software to provide further information on inspection observations. See Section 2.8.10, Copying Records during Inspections and Using Remarks in the MQSA inspection procedures for more information.

F. Performance Standards

Inspection Performance Standard: In accordance with contract requirements, the State contractor shall conduct an annual inspection of all designated, non-Federal mammography facilities within the state.

Inspection Performance Measurement: The FDA shall measure compliance with contract inspection requirements by reviewing inspection records, performing phantom image scoring evaluations, and conducting State-Federal Joint Audit inspections. The FDA shall furnish results of all quality assurance reviews to the State contractor. The FDA shall review a sample of inspection records to verify that the required data and information are complete and accurate. During each twelve (12) month period, the FDA Regional or District office shall review a minimum of two inspection reports with each certified inspector. The FDA shall select the inspection reports at random. If review of the related supporting documentation collected during the inspection is required, the FDA Regional or District office shall notify the State Contractor that the related supporting documentation is needed for the audit process. The State Contractor shall provide a facsimile or electronic copy of the supporting documentation to the FDA Regional or District office for review as part of the audit process.

Action: If FDA finds an inspection record to be unacceptable, the State Contractor will be advised and given an opportunity to correct or submit a new inspection record. Each instance whereby the State Contractor fails to submit or correct the required result report shall result in withholding of invoice payment until the State Contractor submits or corrects the required reports.

Compliance Actions under State Authority – MQSA Compliance Actions are not provided for under this contract. However, the State Contractor may wish to pursue any necessary compliance follow-up to observations subject to the State’s jurisdiction. If the State Contractor pursues compliance follow-up under their State's jurisdiction, the following procedures apply:

1. Adverse Action Taken Against a Facility under State Authority

The State Contractor shall report to the RRHR or other designated contact, any adverse action taken against a facility under State authority within ten (10) working days of the event in instances where a significant observation has occurred that would result in FDA taking action under MQSA. An adverse action could include, but is not limited to, the following:

- Facility license suspension (temporary or permanent),

- Facility license revocation, restrictions or similar sanctions, fines and penalties (civil or administrative),

- Cease and desist orders,

- Civil money penalties or fines,

- Orders requiring additional mammography review or patient notification (see 21 CFR 900.12(j) for a description),

- Remedial or corrective action plans required by State authorities for serious violations (examples being State violations equivalent to MQSA Level 1 violations or any violations considered serious by the State that would also be MQSA violations,

- Prosecution and convictions under State laws relating to fraud and abuse, false billings or kickbacks, and Other State action (identify and provide description).

2. Providing Adverse Action Information (See Attachment 9)

The FDA is required, pursuant to MQSA, to compile certain information about mammography facilities, and make it available to physicians and the general public (42 U.S.C. 263b(1)), who should find this information useful in evaluating the performance of mammography facilities. The report, submitted to Congress annually, will include explanatory information necessary to help in the interpretation of the information provided. One such required category of information is a list of mammography facilities against which States have taken adverse actions. In addition, FDA is also seeking information about which States have instituted a patient notification rule applicable to mammography.

State Contractors shall report at least quarterly, in the progress report, both adverse actions and patient notification information taken under State or MQSA authority.

The information for each cited mammography facility should include the following items:

a. Name and address of the mammography facility.

b. MQSA facility identification number if known.

c. Current status of the facility.

d. Summary of the problems that initiated the State action, including dates of inspections, violations cited, and other pertinent information. When applicable, use the “reason for action” codes at the bottom of the adverse actions report form.

e. Description of the State action (include copies of orders or letters to the facility that were used to inform them of the action).

Performance Standard: The State contractor shall report to the RRHR or other designated contact any adverse action taken against a facility under State authority within ten (10) working days of the event in instances where a significant finding has occurred that would result in FDA taking action under MQSA.

Performance Measurement: The FDA shall measure compliance by reviewing the completeness of quarterly reports.

Action: Each instance whereby the State Contractor fails to meet the contract standards for adverse action reporting requirements shall result in withholding of invoice approval until the standards are met. Additional audits on the State Contractor can take place and/or a corrective action letter may be required if the State Contractor fails to perform inspections to FDA/DMQS procedures.

G. Inspector Certification Training

All inspections under this contract shall be conducted by personnel who are fully certified by the FDA to perform inspections under MQSA. The training for inspector certification shall consist of courses taught under the auspices of the FDA and shall require the inspector to pass specific written examinations and practical hands-on demonstrations.

All new inspectors shall meet the educational requirements for new MQSA inspectors outlined in the “MQSA Inspector Initial Training-Qualification Process” document (Attachment 2) and the “MQSA Inspector Training” chart (Attachment 3) before taking the MQSA training courses.

In determining a State’s need for a trained inspector, FDA shall reference the “DMQS’ State Contract Policy for Training MQSA Inspectors and Assigning Inspection Equipment” (Attachment 4).

NOTE 1: Unless notified and agreed upon otherwise, all mentoring shall be completed within ninety (90) days after completion of course III.

NOTE 2: The State contractor shall ensure that newly certified inspectors complete a minimum of twenty-four (24) inspections within twenty-four (24) months.

NOTE 3: The State contractor is responsible to ensure that their inspector trainees put forth due diligence and effort in completing the Inspector Training courses. FDA may exercise the right to withhold Inspector Trainee course payments for failed efforts in completing Course III.

Maintaining Certification of MQSA Inspectors

MQSA Inspector Certification is granted by the FDA. To maintain their certification, MQSA inspectors shall fulfill the following:

1. Mammography Education Units - Inspectors shall participate in continuing education activities. Each certified inspector shall teach or earn a minimum of fifteen (15) mammography education units (MEUs) during a 36-month period in accordance with the “Mammography Continuing Education (MEU) Policy For Mammography Quality Standards Act (MQSA) Certified Inspectors” (Attachment 5).

MEU approval form submission to ORA’s Office of Partnerships from state inspectors are not required. In addition, documentation (i.e., certified copies) of inspectors’ attendance and completion of continuing education courses are not required to be submitted to ORA’s Office of Partnerships.

The State MQSA Project Director shall track and maintain MEU records for each of their state inspectors. This new MEU tracking process places MEU tracking responsibility on the State MQSA Program Manager and/or state inspector. These individuals shall validate the MEUs earned for the purpose of maintaining inspector certification and their approved MEU contract amount.

The state MQSA Project Directors are responsible for keeping track of their state inspectors’ MEU allotment and spending for each contract year. Beginning fiscal year 2017, each state under a MQSA contract with the FDA shall submit bi-annual MEU spending tracking update reports for each MQSA inspector in their state. The reports shall be submitted to ORA’s Office of Partnerships and FDA/Office of Acquisitions and Grant Services to ensure MEU funds are obligated and expensed appropriately. See Section C1, G –Inspector Certification Training for more information on submitting required bi-annual MEU spending tracking reports.

The bi-annual MEU spending tracking update reports to be submitted for each MQSA inspector shall include the following:

· State

· Name of Inspector

· Inspector ID

· Conference/Course Title and Date

· Accreditation Organization

· MEU’s earned

· Fund spent

In addition, the FDA MQSA Auditor shall review the MEU certification of each state inspector at the time of the annual inspector audit to ensure inspectors are earning the minimum amount of MEUs within the required timeframe.

2. Minimum Inspection Requirements - Inspectors shall perform a minimum of twenty-four (24) inspections within a twenty-four-month period to remain proficient in conducting MQSA inspections and to maintain an “active” certification status as set forth in the “Continuing Experience Policy for Mammography Quality Standards Act (MQSA) Certified Inspectors (9/13/00)” (Attachment 6).

3. Annual Audit - MQSA Inspectors shall receive a satisfactory Audit from a certified MQSA auditor during each federal fiscal year (01 October - 30 September) or satisfactorily complete re-mediation requirements if audit results warrant re-mediation. The Joint Audit shall consist of comparison of the phantom image score between the auditor and inspector for the phantom image taken on the day of the joint audit, examination of the inspector’s evaluation of QA/QC records, personnel and medical records, medical physicist report(s), and the medical audit and analysis. During the Joint Audit, inspectors shall demonstrate proficiency and accuracy in entering inspection data into the Facility Inspection Support System (FISS). Of equal importance will be the auditor observing the inspector's personal interaction with facility personnel and the inspector's ability to present serious and significant observations during the discussion with facility management. Serious and significant observations (if applicable) are those that would impact upon the facility’s ability to accurately diagnose breast cancer. Additional audits (or mentoring) may be performed if serious deficiencies are observed in any area of the inspection process.

4. Review of MQSA Inspection Records - The auditor shall review a sample of the MQSA inspection reports and any related records or images collected during the inspection, and submitted by each certified inspector during each Federal fiscal year. These records will be reviewed as additional indicators of performance problems. If such a review indicates performance problems, additional audits or remedial training may be scheduled to correct the observed deficiencies.

5. Statement of Conduct - Each inspector shall acknowledge and follow the “Statement of Conduct for MQSA Inspectors” (Attachment 7).

6. Review Requirements - MQSA Inspectors shall maintain current knowledge of MQSA policy changes and other important issues related to MQSA inspection procedures by logging on to the MPRIS system on a regular basis, but not less than once per month, to review all inspector e-mail, software upgrades, and other pertinent documents.

NOTE (1): Training on the use of the computers, software, and programs shall be provided through training courses, teleconferences, workshops, the RRHR, DMQS staff and FDA MQSA auditors.

NOTE (2): The State contractor shall notify DMQS when an inspector leaves the MQSA inspection program to coordinate the return of FDA-issued IT equipment, and FDA-issued inspector identification card. The State, through its Progress Report, shall notify DMQS of any changes to an inspector’s status. The State may also give advance notice of the change in the inspector’s status to the RRHR.

7. Inspection Questions/Problems - Any questions or problems resulting from the use of the inspection procedures or testing equipment furnished by FDA shall be reported to the FDA RRHR and DMQS. DMQS may be reached by telephone, facsimile and/or email via the following:

· MQSA Facility Hotline phone line (08:30am-4:30pm EDT): 800-838-7715

· MQSA Facility Hotline fax number: 443-285-0689

· MQSA Facility Hotline e-mail: MQSA hotline@ versatechinc.com

8. Training Performance Standard: The State Contractor shall retain documentation (i.e. certificate copies) of their inspector’s attendance and completion of continuing education. This documentation shall be used to validate the MEUs earned for the purpose of maintaining certification.

9. Training Performance Measurement: A random sample of the MQSA Inspection Records submitted on a federal fiscal year basis by each certified inspector shall be reviewed. If such a review indicates performance problems, additional audits or remedial training may be scheduled to correct the observed deficiencies.

Action: Serious and significant deficiencies in any area of the inspector certification process (inspection requirements, MEUs, etc.) that would impact upon the facilities ability to accurately diagnose breast cancer could result in that inspector being mentored or receiving remedial training. Consequently, the State contractor shall not invoice for these inspections until the deficiencies are resolved.

NOTE: THE FDA RESERVES THE RIGHT TO INACTIVATE STATE CONTRACTOR PERSONNEL IN PERFORMANCE OF THIS CONTRACT AT ANY TIME.

H. Equipment: FDA shall furnish applicable equipment including laptop computers for use in this contract in accordance with the respective policies. If the State Contractor wishes to use their own equipment (such as laptop computers), the State Contractor shall obtain approval by DMQS. In addition, the State Contractor shall maintain their own equipment and maintain equipment compatibility with program standards.

Internet access is a requirement to conduct MQSA inspections. Inspectors are required to download and upload inspections onto their laptop computers to perform MQSA inspections. If internet access is not allowed utilizing the state’s information technology system, personal wi-fi access should be included as an expense within your proposal. Users shall only access the internet in order to visit sites such as the FDA public website and MPRISweb.

I. Dissemination of Information

The State inspector shall notify the facility of the preliminary inspection results during the discussion with facility management in accordance with FDA Compliance Program

7385.014. A copy of the MQSA Facility Inspection Report shall be sent via mail, e-mail or facsimile to the facility no later than five (5) working days from the date of the submission of the inspection.

J. Quality Assurance Measurements

I. State Contractor performance shall be evaluated by FDA throughout the duration of the contract. This shall be accomplished by various methods including review of inspection records and joint State-Federal inspections (Joint Audit Inspections).

II. The FDA shall also monitor inspector performance. The FDA shall provide the State Contractor with relevant information on the monitoring of inspector performance for the purpose of identification of any area where improvement of such performance is required. Please see attached “Complaint Resolution Process” (Attachment 8).

III. The FDA shall review a sample of inspection records to verify that the required data and information is complete and accurate. During each twelve (12) month period, the FDA regional or district office shall review a minimum of two inspection reports for each certified inspector. The reports shall be selected at random by FDA. If the FDA finds an inspection record to be unacceptable, the State Contractor will be advised and given an opportunity to correct the report or submit a new inspection record.

SECTION D – PACKING AND MARKING

This section is not applicable to this solicitation/contract.

SECTION E – INSPECTION AND ACCEPTANCE

E-1 – Inspection and Acceptance

Pursuant to the appropriate inspection clause as provided below, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer at the Food and Drug Administration, State Contracts and Compliance, HFA-500, 5630 Fishers Lane, Rockville, Maryland 20857.

52.246-4 Inspection of Services – Fixed Price

(a) Definition. “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires. The same requirements are required by all subcontractors that perform any services for the Contractor.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties. If a subcontractor performs inspections, documentation shall be obtained by the Contractor explaining the type of services performed and the required documents needed by the MQSA performance standards and measurements.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or (2) Terminate the contract for default.

SECTION F – DELIVERIES OF PERFORMANCE F-1 – Period of Performance The period of performance is 12 months for the base year with four 12 month option years. The total period of performance inclusive of options is 60 months.

F-2 – Reports/ Deliverables

The State contractor shall submit the following records:

A. Inspection Reports

The State Contractor shall complete the computer generated inspection report for each inspection, using the latest version of the Field Inspection Support System (FISS) software with the FDA supplied portable computer (or Contractor supplied computer equipment, with approval by FDA). Inspection reports shall be uploaded into the FDA's Mammography Program Reporting and Information System (MPRIS) via telecommunication and submitted within five (5) business days of the facility inspection

The State contractor shall maintain, in either electronic or paper form, a copy of the MQSA Facility Inspection Report, the Inspection Detail Report, and any supporting documentation collected during the MQSA inspection for the duration of the current contract. If maintained in electronic form, these reports shall be kept in a location other than on the computer used to conduct the inspection.

The report shall include the following information:

1. Facilities Inspected - A list of the facilities inspected during the reporting period, including:

2. Cumulative Inspections Performed - A cumulative total of the number of inspections performed since the beginning of the contract period of performance.

3. Facility Status changes – A list of the facilities with status or address changes, including:

4. State Adverse Actions – The State contractor shall report any action taken at the state level against mammography facilities. If there was no adverse action taken, the contractor shall check “no”.

The State contractor shall report both adverse actions and patient notification information in the quarterly progress report. The State contractor shall report only those state cases that are comparable to those that could be the subject of adverse actions under MQSA.

The following information for each cited mammography facility shall be captured on the Adverse Actions Report form:

a. Name and address of the mammography facility.

b. MQSA facility identification number if known. c. Current status of the facility.

d. Summary of the problems that initiated the State action, including dates of inspections, violations cited, and other pertinent information.

e. Description of the State action (include copies of orders or letters to the facility that were used to inform them of the action

5. Work to be performed - A brief discussion of the work to be performed during the next month(s).

6. Changes to Inspector Information - Changes in Inspector status, phone numbers, mail addresses, email addresses, and/or names.

7. Current problems – Provide a brief synopsis of problems that are being encountered (or were encountered), proposed corrective action, as well as a point of contact and telephone number.

SECTION G - CONTRACT ADMINISTRATION DATA

G-1 – Administrative/Technical Personnel

A. The Government administrative and technical personnel assigned responsibilities for this contract are as follows:

Contracting Officer Representative (COR): Jocelyn Ramos 510-337-6894 jocelyn.ramos@fda.hhs.gov

Regional Radiological Health Representative (RRHR):

Central Region: Jeffrey Sincek at: jeffrey.sincek@fda.hhs.gov Northeast Region: George Allen, Jr. at: george.allen@fda.hhs.gov Southeast Region: Karen R. Smallwood at: karen.smallwood@fda.hhs.gov Southwest Region: CAPT Scotty L. Hargrave at: scotty.hargrave@fda.hhs.gov Pacific Region: Terri Jones at: terri.jones@fda.hhs.gov

B. The Contracting Officer Representative (COR) and Contracting Officer (CO) are authorized to correspond and hold conferences with the State Contractor and/or subcontractor on matters of a technical nature, conduct inspections and perform evaluations permitted by the contract, approve technical data required by the contract and maintain the official technical file.

The COR and the RRHR shall monitor the State contractor’s technical progress, including the surveillance and assessment of performance and recommending changes in the requirement to the CO. Action taken by the COR to resolve technical problems encountered during performance of the contract shall be documented and a copy of the documentation shall be furnished to the CO. This documentation also includes site visit reports and minutes of all meetings held in connection with this contract.

The COR is not empowered to issue or approve changes, enter into any agreement or contract modifications or any other matter which may affect the cost, period of performance, terms or conditions of the contract.

G-2 -Project Director

The performance of the work required by this contract will be conducted for the State under the direction of:

Name:

Title:

Email Address:

Telephone: ( )

G-3 – Quarterly Invoice Submission

A. The contractor shall submit all invoices to:

1. U.S. FOOD AND DRUG ADMINISTRATION

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail

2. One courtesy copy to the Contracting Officer Representative (COR) US. Food and Drug Administration Office of Partnerships | Contracts and Grants Attn: Jocelyn Ramos Email: Jocelyn.Ramos@fda.hhs.gov and MQSAProgram@fda.hhs.gov

(Required method of delivery is via email)

B. 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 specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(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 (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

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

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

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

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.

All payments will be made by Electronic Funds Transfer (EFT) and the State Contractor shall be responsible for providing any changes to the System for Award Management (SAM) database.

*IMPORTANT NOTE: Quarterly invoices shall not be approved without Inspection Reports. Therefore, timely submission is critical to expedite invoice payment processing.

The electronic submission of Inspection Reports through MPRISweb is now mandatory for all state contracts. The State contractor shall submit the Inspection Reports describing progress of the program electronically via MPRISweb link below:

https://mpris.fda.gov/MPRISWeb/user/login.jsp Questions related to electronic report submission, please contact: CDRH MPRIS Support (mailto:cdrhmqrp@cdrh.fda.gov ) or call: (301) 796 - 6633.

MPRIS Inspection Reports

Inspection reports uploaded to FDA's Mammography Program Reporting and Information System (MPRIS) central computer system via telecommunication and submitted within five (5) business days of the facility inspection. See MPRISweb link below:

https://mpris.fda.gov/MPRISWeb/user/login.jsp

Copies of MPRIS inspection reports submitted along with invoice to FDAVendorPaymentsTeam@fda.hhs.gov; Jocelyn.Ramos@fda.hhs.gov and MQSAProgram@fda.hhs.gov

Invoices Signed invoices submitted within fifteen (15) working days after each quarter to Department of Payment Services at FDAVendorPaymentsTeam@fda.hhs.gov, and Contracting Officer Representative via email, Jocelyn.Ramos@fda.hhs.gov and MQSAProgram@fda.hhs.gov

B. Travel for contract purposes – All travel negotiated and agreed to under this contract for training, contract meetings with FDA field office(s), etc. shall be accomplished under state travel authorities and be reimbursed to the State Contractor through the contract voucher/invoice.

Invoices with reimbursable travel costs must include a list of expenditures or receipts for associated costs, such as incurred per diem, airfare, ground transportation costs, etc.

Note: Salary costs are not reimbursable expenditures while receiving Continuing Education.

C. In addition to the electronic submission, inspection reports shall also be prepared and submitted along with the signed invoices via MQSA program mailbox MQSAProgram@fda.hhs.gov and COR Jocelyn.Ramos@fda.hhs.gov and to Department of Payment Services via FDAVendorPaymentsTeam@fda.hhs.gov within the timeframe specified in MPRISweb.

G-4 - Government Furnished Property – Authorization - Transfer A. The State Contractor is authorized the retention and use of the equipment listed below. The accountability of this equipment is hereby transferred to this contract from Contract No. _________________ .

Items

1. Laptop

2. Carrying case

B. The inspection record format will be furnished to the State Contractor with the portable computer system. With the approval of the Division of Mammography Quality Standards (DMQS), the State Contractor may use their own computers and software for the recording of inspection data, provided that the inspection data is the same as that produced by FDA supplied equipment and software. The State Contractor shall obtain written approval from DMQS before loading any state owned software on the FDA computer.

C. IT Equipment (laptop and carrying case) Return – - Upon the departure or reassignment of an inspector, ALL FDA provided IT equipment shall be returned to DMQS within thirty (30) days of the departure or reassignment of an inspector to the following address:

U. S. Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health (OIR) Division of Mammography Quality Standards (DMQS) MPRIS Computer Support Food and Drug Administration 10903 New Hampshire Avenue

WO66 - 4525

Silver Spring, MD 20993-0002 Telephone Number: (301) 796-6633

D. Additional Equipment - Unless stated otherwise, no other equipment or supplies are provided under this contract.

E. Equipment/Laptop Security - Each user of the Mammography Program Reporting and Information System (MPRIS), whether a State inspector or a State supervisor, shall read and accept annually the MPRIS Rules of Behavior (RoB) (Attachment 10), which are available to each user after logon to the MPRISweb software application.

The MPRIS RoB, which is required by security regulations for both FDA and the Department of Health and Human Services (HHS), details system responsibilities, policies for system use, and the rules for the use of all MPRIS applications. FDA maintains a record of every user’s acceptance of the RoB.

Section 4 in the MPRIS RoB explains in detail the rules for the use of the FDA-furnished MQSA laptops. In particular, please note:

• Section 4.2, Connection to the Internet, states, “Users can access the Internet only in order to visit sites such as the FDA public web site and MPRISweb.”

• Section 4.5, Use of Government Equipment, states, “The use of MQSA-furnished government equipment is restricted to official FDA business only.”

Additionally, State personnel shall not install software on FDA-issued MQSA laptops by State personnel without first obtaining the written permission of the MPRIS Program Manager, Division of Mammography Quality Standards (DMQS), FDA.

These rules and policies prohibit the configuration and use of FDA-issued MQSA inspector laptops, and the installation of software on them, for any non-MQSA usage, such as connecting to the Internet.

F. In addition to the applicable Government Property Clause in Part II, Section I, the State Contractor shall inventory all accountable Government property and submit a list of that property to the Contracting Officer annually on the anniversary of contract award and within ninety (90) days after completion or termination of the contract. The inventory list, reflecting each item of accountable property as a separate line item, shall contain the following data elements:

1. Barcode/tag number

2. Item name/description

3. Manufacturer’s name

4. Manufacturer’s model number

5. Manufacturer’s serial number

6. Unit cost

7. Date received/inventoried

8. Contract number

9. Remarks (optional)

G-5 – Post Award Evaluation of State Contractor Performance

a. State Contractor Performance Evaluations Interim and final evaluations of State Contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations will be provided to the State Contractor as soon as practicable after completion of the evaluation. The State Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement.