MQSA_RFP_2015.doc

Request for Proposal

FDA-15-MQSA

THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

1 | 39

2.

CONTRACT NUMBER

3.

SOLICITATION NUMBER

FDA-15-MQSA

4.

TYPE OF SOLICITATION

SEALED BID (IFB)

[ X]

NEGOTIATED (RFP)

5.

DATE ISSUED

April 18, 2015

6.REQUISITION/PURCHASE NUMBER

7. ISSUED BY CODE

8.

ADDRESS OFFER TO (If other than Item 7)

Type of Contract: Firm-Fixed Price

DHHS/FDA/OAGS/DASG/State Contracts Branch

5630 Fishers Lane, Room 2024, HFA-500

Rockville, MD 20857 Period of Performance: TBD to TBD

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder"

SOLICITATION

9.

Sealed offers in original and 1 copy for furnishing the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in 5630 Fishers Lane, Rm 2024, Rockville, MD 20857 until 1:00 PM EASTERN local May 20, 2015.

(Hour) (Date)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR NFORMATION CALL:

NAME: Yared Girmai

E-MAIL ADDRESS

yared.girmai@fda.hhs.gov

AREA CODE

NUMBER

402-7581

EXT.

11. TABLE OF CONTENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions in 52.214-16, Minimum Bid Acceptance Period.

12.

In compliance with the above, the undersigned agrees, if this offer is accepted within 90 calendar days from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13.

DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause 52-232-8)

1. ACKNOWLEDGMENT OF

AMENDMENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

15A. NAME AND

CODE

FACILITY

16.

NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER (Type or print)

ADDRESS OF

OFFEROR

CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE

17.

SIGNATURE

18.

OFFER DATE

AWARD (To be completed by Government)

19.

ACCEPTED AS TO ITEMS NUMBERED

20.

AMOUNT

21.

ACCOUNTING AND APPROPRIATION

22.

AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

[ ] 10 U.S.C. 2304(c)( ) [ X ] 41 U.S.C. 253(c)( 5 )

23.

SUBMIT INVOICES TO ADDRESS SHOWN IN

(1 copy unless otherwise specified)

ITEM

G-3

24.

ADMINISTERED BY (If other than item 7)

CODE

25.

PAYMENT WILL BE MADE BY

CODE

Office of Financial Services

10903 New Hampshire Avenue

WO32 Second Floor, MAIL HUB 2145

Silver Spring, MD 20993-0002

26.

NAME OF CONTRACTING OFFICER (Type or print)

27.

UNITED STATES OF AMERICA

(Signature of Contracting Officer) 28.

AWARD DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

4B

SECTION 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 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 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 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, F-1 - 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, 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 will determine and recommend the necessity of appropriate travel expenses for the MQSA inspector.

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 policy.

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

F. As consideration for the full performance of the work (base period and one option year), stated in Part I, Section C - Scope of Work, the Government shall pay the contractor a total fixed price of $______ for inspections, $______ for training, and not to exceed $_________ for Mammography Education Units, for a total contract amount of $_____________.

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

C-l - Scope of Work

Independently and not as an agent of the Government, the 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 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 CONTRACTOR SHALL PROVIDE WRITTEN NOTIFICATION TO FDA IF THE CONTRACTOR DECIDES TO NOT RENEW THE MQSA CONTRACTUAL AGREEMENT FOR THE FOLLOWING PERFORMANCE YEAR. FDA MUST RECEIVE THIS WRITTEN NOTIFICATION FROM THE 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 10 months, and no later than 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 10 months, and no later than 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 will normally 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 will normally 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).

B. Facilities

All of the inspections conducted by the 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 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 will 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 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 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 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 will be provided to the Contractor. FDA will 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 MQSAhotline@HCMSLLC.com or telephone at 800-838-7715 or fax at 410-290-6351)

- All Hands Inspector E-Mails

- Course I-III Training Notebooks (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 Contractor shall notify the FDA Regional and District offices within five (5) working days when the inspection results indicate a level 1 (serious), repeat level 2 observation. A facsimile copy of the MQSA Facility Inspection Report shall be sent to the designated FDA contact as soon as possible. If it is not possible to send a facsimile within five (5) working days, the Contractor shall notify the FDA RRHR field office contact by telephone or email.

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

Level 1 Observations and Repeat Level 1 and 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 Contractor. The FDA will contact the 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 Contractor. The FDA will contact the 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 contractor shall conduct an annual inspection of all designated, non-Federal mammography facilities within the state.

Inspection Performance Measurement: The Government will measure compliance with contract inspection requirements by reviewing inspection records and conducting joint State-Federal inspections (audit inspections). Results of all FDA quality assurance reviews will be furnished to the contractor. A sample of inspection records will be reviewed by FDA to verify that the required data and information are complete and accurate. During each twelve (12) month period, the FDA Regional or District office will request the Contractor to send a minimum of two inspection reports with all inspection films for each certified inspector. The reports will be selected at random by the FDA and all records and films will be returned to the Contractor at the completion of the audit.

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

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

Contractors shall report, 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 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 Government will measure compliance by reviewing the completeness of quarterly reports.

Action: Each instance whereby the Contractor fails to meet the contract standards for adverse action reporting requirements shall result in withholding of invoice approval until the standards are met.

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 will 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 90 days after completion of course III.

NOTE 2: The contractor shall ensure that newly certified inspectors complete a minimum of 24 inspections within 24 months.

NOTE 3: The 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 portions of the course.

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. The current requirement is for each certified inspector to 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).

According to the MEU policy, inspectors shall submit documentation (i.e., certificate copies)of their attendance and completion of continuing education courses to ORA’s Division of Human Resources Development (DHRD) for state inspectors and ORA’s Office of Partnerships (formerly DFSR) for FDA inspectors. This documentation shall be used to validate the MEUs earned for the purpose of maintaining certification.

2. Minimum Inspection Requirements - Inspectors shall perform a minimum of 24 (twenty-four) inspections within a 24-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 them. The audit shall consist of observation of the physical measurements completed on the mammography systems; examination of the inspector’s evaluation of QA, personnel and medical records, medical physicist report(s) and during the audit inspectors, enter 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 films 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 keep up to date on 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 a 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 will be provided through training courses, teleconferences, workshops, the

RRHR, DMQS staff and FDA MQSA auditors.

NOTE (2): The 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, 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 and/or laptop via the following:

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

• MQSA Facility Hotline e-mail: MQSAhotline@HCMSLLC.com

8. Training Performance Standard: The contractor shall submit documentation (i.e., certificate copies) of their inspector’s attendance and completion of continuing education to the DHRD. 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 contractor shall not invoice for these inspections until the deficiencies are resolved.

NOTE: THE FDA RESERVES THE RIGHT TO INACTIVATE 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 for the issuance of inspection test equipment and laptop computers. If the Contractor wishes to use their own equipment (such as laptop computers), the Contractor shall obtain approval by DMQS. In addition, the Contractor shall maintain their own equipment and maintain equipment compatibility with program standards.

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 fax to the facility no later than five (5) working days from the date of the submission of the inspection.

J. Quality Assurance Measurements

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

II. The FDA will also monitor inspector performance. The FDA will provide the 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. A sample of inspection records will be reviewed by FDA to verify that the required data and information is complete and accurate. During each twelve (12) month period, the FDA regional or district office will request the Contractor to send a minimum of two inspection reports with the inspection films for each certified inspector. The reports will be selected at random by FDA and all records and films will be returned to the Contractor at the completion of the audit. If FDA finds an inspection record to be unacceptable, the 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.

(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.

(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.

(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 contract will be from the effective date of award for 12 months plus one option year. The Government may extend the period of performance for one additional option year in accordance with clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000).

F-2 – Reports/ Deliverables The contractor shall submit the following reports:

A. Inspection Reports The Contractor shall complete the computer generated inspection record. Inspection records shall be submitted to the FDA's central computer system via telecommunication using the FDA supplied portable computer (or Contractor supplied computer equipment, with approval by FDA).

The contractor shall maintain, in either electronic or paper form, a copy of the MQSA Facility Inspection Report and the Inspection Detail Report for the duration of the current contract. Both of these reports can be created using the FDA supplied portable computer (or Contractor supplied computer equipment, with approval by FDA) using the FISS software. If maintained in electronic form, these reports must be kept in a location other than on the computer used to conduct the inspection.

The Contractor shall submit to the Government technical reports describing progress of the program electronically via MPRISweb (Mammography Program Reporting & Information System)

The report must be used to include the following information:

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

· Facility name

· Facility identification number

· Date of inspection

· Inspector name and ID

· Date uploaded to DMQS

· Level(s) of observations

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:

· Facility name

· Address

· Identification number

· Date inspected

· Inspector

· Change

4. State Adverse Actions – The 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 contractor shall report both adverse actions and patient notification information in the quarterly progress report. The 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.

In addition to the electronic submission, progress reports shall also be prepared and submitted along with the signed invoices via email (preferably), facsimile or mail within fifteen (15) working days after each quarter to your FDA Contract Officer (your point of contact is listed in the first page of MQSA contract). Progress reports shall be sent by only one method (i.e. if a report is sent via email, there is no need to also send it by fax or hard copy.

FDA Contracts Office Food and Drug Administration

State Contracts and Compliance, HFA-500

Attn: Contracting Officer

5630 Fishers Lane, Room 2024

Rockville, Maryland 20857 e-mail:Yared.Girmai@fda.hhs.gov

POC: Yared Girmai

Phone: 240-402-7581

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 L. 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 Contractor 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 are responsible for monitoring the contractor’s technical progress, including the surveillance and assessment of performance and recommending to the CO changes in the requirement. 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

The Contractor shall submit vouchers or invoices in accordance with the FAR 52.232-25 "Prompt Payment (OCT 2008)," and FAR 52.232-33 “Payments by Electronic Funds Transfer – Central Contractor Registration (Oct. 2003).

A. In accordance with the above clauses, your invoices should include the following:

-Name and address of the Contractor

-Invoice date and Invoice Number

-Contract or Purchase Order Number which authorizes supplies/services

-Shipping and Payment terms

-Name and address of Contractor Official to whom payment is sent

-Bank Name of the financial institution receiving payment, -Routing transit number of the financial institution receiving payment, -Name and phone number of the person to notify in the event of a defective invoice

-Tax Identification Number

-DUNS

All payments will be made by Electronic Funds Transfer (EFT) and the Contractor shall be responsible for providing any changes to the Central Contractor Registration (CCR) database.

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

B. Travel for contract purposes – All travel negotiated and agreed to under this contract for training, contract meetings with FDA field office(s), etc. will be accomplished under state travel authorities and be reimbursed to the 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. An original and one (1) copy of invoices shall be submitted to the attention of the designated Contracting Officer at the following address:

-DHHS/FDA/OAGS

-State Contracts and Compliance

-5630 Fishers Lane, HFA-500

-Rockville, Maryland 20857 D. In addition, one informational copy of all vouchers shall be submitted to the COR designated in Section G.

G-4 - Government Furnished Property – Authorization - Transfer A. The 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 C. The inspection record format will be furnished to the Contractor with the portable computer system. With the approval of the Division of Mammography Quality Standards (DMQS), the 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 Contractor shall obtain written approval from DMQS before loading any state owned software on the FDA computer.

D. 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 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

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

F. Equipment/Laptop Security - Each user of the Mammography Program Reporting and Information System (MPRIS), whether a State inspector or a State supervisor, must 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 must 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.

G. In addition to the applicable Government Property Clause in Part II, Section I, the contractor shall comply with the provisions of DHHS publication, Contactor’s Guide for Control of Government Property, which is incorporated by reference. This Handbook is available on the HHS website:

http://ncioa.cancer.gov/oa-internet/reference/Appendix_Q_HHS_Contracting_Guide-508.pdf The 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 Contractor Performance

a. Contractor Performance Evaluations

Interim and final evaluations of 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 Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through the Contractor Performance Assessment Reporting System (CPARS) web site, which is managed by the Department of Defense (DOD). Details regarding CPARS training and on-line registration can be found at http://www.cpars.gov/.

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the FDA contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H-1 – Confidentiality Definitions

a. Confidential Commercial Information:

Confidential commercial information is valuable data or information which is used in one's business and, if voluntarily submitted by the information's owner to FDA, is of a type customarily not disclosed to the public by the person to whom the information belongs or, if not voluntarily submitted, is information which, if disclosed by FDA would be likely to cause substantial harm to the competitive position of the person to whom the information belongs or impair the agency's ability to obtain similar data in the future. Examples of records that may fall within the definition of confidential commercial information either in part or in their entirety include information in an application to market an unapproved product, or in an Establishment Inspection Report containing the results of an inspection of a regulated company.

b. Disclosure:

Disclosure means releasing, transferring, providing access to, or otherwise divulging to the public nonpublic information by any means of communication--including photographic, written, oral, electronic (including databases), or mechanical.

c. Nonpublic information:

Nonpublic information includes but is not limited to trade secret, confidential commercial, predecisional, or other information, such as personal privacy information about an individual, information provided by a confidential informant, techniques and procedures for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law,…