Performance_Work_Statement_-_Mobile_Biopsy_Services.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

Phoenix AZ 85016 4212 North 16th Street Phoenix Indian Medical CTR

IHSPIMCUNIT CODE 16. ADMINISTERED BYCODE

X

X

621511

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED OR12

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

03/22/2016 1200 LT

03/07/2016

(602) 200-5371BRADLEY PLATERO

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

16-247-SOL-00030

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 3 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

PHOENIX AZ 85016

4212 N. 16TH St, BLDG 9 Phoenix Indian Medical Center

IHSPIMCUNIT

15. DELIVER TO

Phoenix AZ 85016 4212 North 16th Street

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$32.5

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

Phoenix Indian Medical CTR

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The contractor shall provide all supervision, labor, parts, materials, tools, supplies, maintenance, and equipment necessary to provide Mobile Biopsy Services and qualified technical staff to operate the biopsy equipment and assist PIMC Physicians during biopsy procedures. The contractor shall be responsible for assisting PIMC Physicians during biopsy procedures and operating biopsy equipment for PIMC.

Performance shall be according to the Performance (Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

BARBARA V. BONNETTE

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDEND

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Work Statement (PWS) and supporting documents.

Period of Performance: 04/01/2016 to 03/31/2017

1 Base Year : Mobile Biopsy Services for Period of

Performance from 4/1/16 through 3/31/17

2 1st Year Option: Mobile Biopsy Services for

Period of Performance from 4/1/17 through 3/31/18.

(Option Line Item)

02/01/2017

Period of Performance: 04/01/2017 to 03/31/2018

3 2nd Year Option: Mobile Biopsy Services for

Period of Performance from 4/1/18 through 3/31/19.

(Option Line Item)

02/01/2018

Period of Performance: 04/01/2018 to 03/31/2019

4 3rd Year Option: Mobile Biopsy Services for

Period of Performance from 4/1/19 through 3/31/20.

(Option Line Item)

02/01/2019

Period of Performance: 04/01/2019 to 03/31/2020

5 4th Year Option: Mobile Biopsy Services for

Period of Performance from 4/1/20 through 3/31/21.

(Option Line Item)

02/01/2020

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

3 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 3

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

16-247-SOL-00030

Period of Performance: 04/01/2020 to 03/31/2021

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

PERFORMANCE WORK STATEMENT (PWS)

FOR MOBILE BIOPSY SERVICES AT THE

PHOENIX INDIAN MEDICAL CENTER (PIMC)

SECTION I

DESCRIPTION OF SERVICES/GENERAL INFORMATION

1. INTRODUCTION:

The Phoenix Indian Medical Center (PIMC) is seeking qualified vendors who can provide On-site Stereotactic Breast Biopsy Services at the Phoenix Indian Medical Center (PIMC) in Phoenix, Arizona.

Services shall be performed at PIMC, 4212 North 16th Street, Phoenix, Arizona 85016.

2. PURPOSE OF CONTRACT:

The PIMC seeks to award a contract for Mobile Biopsy Services in which the contractor is to provide a mobile biopsy vehicle with equipment for PIMC physicians to perform biopsy procedures for PIMC patients. Resultant contract will be non-personal in nature, as defined by FAR 31.101, and as such, will be provided independent of Government supervision.

3. DESCRIPTION OF SERVICES:

The contractor shall provide all supervision, labor, parts, materials, tools, supplies, maintenance, and equipment necessary to provide Mobile Biopsy Services and qualified technical staff to assist the PIMC Physician during biopsy procedures.

The contractor shall obtain and maintain all required Federal, State, and Local licenses associated with the operation/transportation of the equipment and performance of the services being requested.

Contractor shall maintain all Federal and State licenses required for possession and operation of equipment.

Performance shall be according to the Statement of Work (SOW) and supporting documents and shall also conform with:

Health Insurance Portability and Accountability Act (HIPPA);

Infection Control, National Fire Protection Association (NFPA);

Health Service Inspection (HSI);

Centers for Medicaid and Medicare Services (CMS);

The Joint Commission (TJC);

Indian Health Service (IHS) standards

4. PERIOD OF PERFORMANCE:

Contract performance shall be for a base year and four (4) one (1) year options for renewal commencing from the date of the award of the contract. Option year renewals are not executed unless by written modification to the contract and approved by the Contracting Officer.

5. POINT OF CONTACT:

The contractor will provide a Point of Contact (POC) who will be available via the telephone Monday through Friday, 0800 to 1700, excluding Federal holidays and scheduled down days. The POC shall be responsible for the performance of the work.

The POC shall have full authority to act for the contractor on all matters relating to daily operations.

The contractor shall designate this individual, in writing, to the Contracting Officer (CO) before the contract start date.

An alternate may be designated, but the contractor shall identify those times when the alternate will be the primary point of contact.

6 . CONFLICT OF INTEREST:

The contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest.

7. SCHEDULING:

The Government shall provide scheduling for patient biopsy procedures.

8. ENGLISH LANGUAGE REQUIREMENT:

The health care workers(s) shall read, understand, speak, and write English fluently.

9. GOVERNMENT-FURNISHED PROPERTY AND SERVICES:

1. The PIMC shall:

A. Provide copies of current medical licensure for physicians performing biopsy procedures at no cost to the contractor.

B. Provide a suitable secure site for the mobile system.

C. Schedule a minimum of three (3) to twenty (20) stereotactic biopsies per mobile site visit or pay the minimum charge.

D. Provide accredited physicians to perform the procedure, interpret the clinical results, and such support staff as may be necessary.

E. Provide all necessary biopsy supplies including the disposable Mammotome ST Probe, Vacuum tubing set, Tissue marker(s), Vacuum canister and Probe Guide. PIMC will also supply sterile and non-sterile gloves, formalin containers and specimen bags, icepacks, ace wraps, linens, sharps disposal containers and infectious waste bags. PIMC will dispose of sharps and infectious waste.

Additional supplies such as the disposable biopsy trays will be provided by the contractor.

Control the billing and collection for the service components and will subsequently retain all revenue for these services.

F. Provide Nursing and other health maintenance personnel necessary to insure patient stability, whenever such services are needed.

10. CLIENT BACKGROUND:

Many of the IHS patients receiving services under this contract may only speak a native language and/or reside on a Native American reservation. The Contractor shall demonstrate sensitivity to cross-cultural and language difference and to work through interpreters as necessary for non-English speaking patients.

11. CONTRACTOR FURNISHED EQUIPMENT:

Mobile Biopsy Vehicle shall include a ramp and/or a lifting device for non-walking patients. Services shall include equipment maintenance, (scheduled and unscheduled) and required supplies necessary to perform services detailed herein. Contractor shall also be responsible for the control of waste management and proper disposal of all waste materials.

Equipment shall include, but not be limited to, a fully equipped Biopsy Procedure Unit (see Section III for location specific specifications). Contractor shall submit an equipment specification list of all equipment by location with contractor’s signed quote. Contractor shall provide all equipment service records upon request.

Include name of manufacturer, model number, manufacturer’s brochures cut sheets, equipment specifications and all pertinent data with offer.

A. The contract shall require the Contractor to supply a mobile vehicle with equipment as follows and/or equivalent:

1. Provide stereotactic breast biopsy equipment in a mobile configuration. Stereotactic breast biopsy is an x-ray guided method to localize and percutaneously obtain tissue for the diagnosis of mammographic abnormalities. Stereotactic biopsy equipment obtains stereo mammogram images of a mammographic lesion within the breast and then uses computerized triangulation of the targeted lesion to calculate the location and biopsy the targeted area. The following equipment will be provided by the contractor:

a. Dedicated prone stereotactic biopsy table, digital imaging, vacuum assisted breast biopsy system (Mammotome system), capability to print images obtained or transmit images to PIMC Vista Imaging, and any other necessary components including but not limited to patient positioning aids.

b. Disposal biopsy tray to include: syringes and needles for injection, local anesthetic, scalpel, sterile gauze.

c. Post procedure dressing kit to include: steri-strips or equivalent product and cover dressing.

12. EQUIPMENT MAINTENANCE:

Contractor shall perform Preventative Maintenance (PM) as recommended by the original equipment manufacturer (OEM) and repairs for the Mobile Biopsy Unit. The Mobile Unit includes, but is not limited to, dedicated prone stereotactic biopsy table, and digital imaging, vacuum assisted breast biopsy system (Mammotome system).

Contractor shall provide a service contact and phone number for hospital/clinic employees to call in the event of equipment failures.

Contractor shall have phone response within 1 hour and onsite service within 24 hours for the stereotactic breast biopsy equipment and 24 hours for Mobile Unit.

13. HEALTH REQUIRMENTS:

Immunizations: Maintain all immunizations required of practicing medical professionals, and work in a professional manner at all times. Before start of work, health care workers shall provide proof of immunization from the following diseases according to CDC guidelines: Hepatitis B, measles, mumps, rubella, varicella, and influenza. The health care worker shall also provide proof of a negative TB skin test within 12 months (if positive, proof of negative chest X-ray within 12 months) prior to start of work.

Grooming and Hygiene: Contractor personnel shall present a clean, neat appearance and be easily recognized as contractor employees. Contractor personnel will not be allowed to wear fake nails due to infection control guidelines.

14. STAFFING:

Provider shall be solely responsible for all driver-staffing issues related to set-up and operation of the systems. Provider shall perform arrival, set-up, take-down, and departure of mobile systems in a manner that causes limited or no disruption to normal operations at PIMC.

Provider shall perform arrival and departure such that the Biopsy unit operates full days on days scheduled. Appropriate arrival and departure schedules shall be developed such that the Biopsy unit is fairly accommodated regarding its operation.

Provider shall be solely responsible for all technologist-staffing issues related to operation of the mobile systems.

Provider is responsible for cleaning of mobile units and for disposal of trash in a responsible manner.

Contractor’s to provide a Certified Radiologic Technician/Technologist who is proficient in stereotactic biopsy procedures.

Contractor to provide a Medical Assistant. Medical assistants can have postsecondary education such as a certificate or have a high school diploma and have experience through on-the-job training.

Radiologic Technician/Technologist and Medical Support Assistant are required to attend Government orientation before providing direct patient care. Contractor will be solely responsible for all technologist-staffing responsibilities, except patient scheduling related to operation of the mobile systems.

Contractor personnel shall be not be considered Government employees for any purposes. The contractor is required to check the Health and Human Services-Office of Inspector General (HHS/OIG), list of Excluded Individuals/Entities on the OIG website: www.hhs.gov/oig for each person providing services under this contract to ensure that individuals providing services under the contract have not engaged in fraud or abuse of Section 1128/A of the Social Security Act regarding Federal health care programs.

Contractor shall certify that persons listed in Contractor’s proposal have been checked against the HHS/OIG list and are not on the list. During the performance of this contract the contractor shall not use any individual or business listed on the list of Excluded Individuals/Entities.

Contractor is required to maintain applicable insurance policies commensurate with normal business practices and as required by Federal/State/Local laws.

15. VALIDATION OF QUALIFICATIONS, LICENSURE, and CERTIFICATIONS (as applicable):

Contractor shall provide written verification/documentation of medical assistant and radiologic technologist’s credentials/certification with offer.

Education Training Experience Licensure Continuing Medical Education (CME) Requirements. Health care workers, licensed, registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current.

CME shall be obtained at no additional cost to the Government and shall be reported to the COR/PM annually on the first normal duty day in January for the previous calendar year.

16. QUALITY CONTROL PROGRAM (QCP):

The contractor shall develop and maintain an effective QCP to ensure services are performed in accordance with this SOW. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s QCP is the means by which it assures that work will be in compliance with the contract requirements. This QCP is part of the evaluation of proposals.

17. QUALITY ASSURANCE (QA):

The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor performs in accordance with the contract performance standards.

The QASP defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

http://www.hhs.gov/oig

18. FEDERAL HOLIDAYS:

The Phoenix Indian Medical Center normal business hours are 8:00 a.m. to 5:00 p.m., Monday through Friday, excluding federal holidays. There are ten (10) federal holidays each year. When a holiday falls on a Saturday, it is observed on Friday. When a holiday falls on a Sunday, it is observed on Monday.

Federal holidays:

New Year’s Day (observed 1 January);

Martin Luther King, Jr’s Birthday (observed the third Monday in January);

President’s Day (observed the third Monday in February);

Memorial Day (observed the fourth Monday in May);

Independence Day (observed 4 July);

Labor Day (observed the first Monday in September);

Columbus Day (observed the second Monday in October);

Veterans Day (observed 11 November);

Thanksgiving Day (observed the fourth Thursday in November);

Christmas Day (observed 25 December)

19. PERSONNEL SECURITY REQUIREMENTS:

Contractor personnel performing work under this contract must be fingerprinted, background checked, and cleared before performing on-site direct patient care.

20. PHYSICAL SECURITY:

The contractor shall be responsible for safeguarding all Government equipment, information, and property provided for contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

A. KEY CONTROL: The Contractor shall establish and implement methods of ensuring all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized person (note: all references to keys includes key cards).

1) No keys issued to the Contractor by the Government shall be duplicated.

2) The Contractor shall develop procedures covering key control that shall be included in the QCP.

Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas.

3) The Contractor shall immediately report any occurrences of lost or duplicate keys to the Government COR/Project Manager (PM), and Contracting Officer (CO).

4) In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor.

5) In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

6) The Contractor shall prohibit the use of Government issued keys by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor’s employees to permit entrance of persons other than Contractor’s employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

7) Lock Combinations: The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the Contractor’s QCP.

21. CONFIDENTIALITY OF INFORMATION:

Unless otherwise specified, all financial, statistical, personnel, and/or technical data which is furnished, produced or otherwise available to the contractor or health care worker during the performance of this contract are considered Government confidential business information and shall not be used for purposes other than performance of work under this contract. The contractor and/or the health care worker shall not release any of the above information without prior written consent of the Contracting Officer. All medical records, scans, and reports remain the property of the Government.

B. PATIENT LISTS:

No matter how developed, patient lists shall be treated as confidential information in accordance with the Privacy Act and the Health Insurance Portability and Accountability Act (HIPAA). Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the PAIHS, except through PAIHS specified processes.

C. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) of 1996:

All individuals performing services are required to complete initial and annual refresher HIPAA Privacy and Security training and will be held accountable for complying with health information privacy and security policies and procedures.

Contractor is required to maintain the confidentiality of patient records IAW the Privacy Act, Title 5, U.S.C. 552a, Title 38 U.S.C. 5701, 5705, and 7362.

22. HOUSEKEEPING:

Contractor shall be responsible for the overall housekeeping inside of the unit including, but not limited to, removal and proper disposal of all debris on a daily basis or as often as necessary to maintain a sanitized and neat environment. Contractor will dispose of waste in appropriate Hospital receptacles.

23. REPORTING REQUIREMENTS:

Report

Description # of Copies

Recipient Due Date

1 Quality Control 1 COR Quarterly 2 Equipment Maintenance Log 1 COR Quarterly 3 Personnel Licensure 1 COR 10 days prior to start of contract or new employee start date.

4 Required Accreditations 1 COR Annually 5 Liability Insurance 1 COR Annually

24. REFERENCES/PAST PERFORMANCE:

Contractor shall provide a minimum of three references for Breast Biopsy services performed within the last five (5) years at government facilities with offer. Must provide brief description of work performed, location of work performed, and name, title, phone number, and email address of references.

25. PRICING:

Pricing shall be for an all-inclusive monthly rate. Detailed pricing schedule shall be included with offer for the Base period and 4 option years. Offerors are required to use the pricing schedule located in Section V.

26. BREAST BIOPSY INTERPRETATION:

The PIMC will be responsible for reading/interpreting all Breast Biopsy studies and dictation of all required study reports.

27. BIOPSY DATA OWNERSHIP:

The PIMC will own solely the data of the studies performed on the mobile biopsy unit under the contract

28. INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE:

The Contractor shall provide and maintain adequate liability coverage consistent with the risks associated with the performance of all services required by this RFP. A certificate of insurance evidencing the required coverage shall be provided to the Contracting Officer prior to the commencement of services under this contract. Minimum liability insurance will be one million per occurrence, three million aggregate.

29. EMERGENCIES ON MOBILE BIOPSY UNIT:

A crash cart shall be located within the Mobile Biopsy Vehicle. The mobile provider will provide written emergency plans addressing emergencies such as patient coded, personal injury, fire, and disruptive behavior.

30. DISRUPTION OF BIOPSY SERVICES:

The Biopsy mobile provider will communicate to the Contracting Officer Representative (COR) / Project Manager (PM) any possible and actual disruptions of Biopsy services. Upon becoming aware of possible or actual disruption of Biopsy service, the provider will communicate such service-disruption information to the COR/PM as soon as possible (ASAP). Provider will inform the COR/PM in a timely manner so the patient and service schedule can be appropriately modified with as little inconvenience as possible to patients and services. Contractor will reimburse the Government for downtime per month at the PIMC location prorated based on scheduled clinic hours divided by actual clinic hours’ equals percent of performance.

31. PRE-OPERATION PROVIDER/PAIHS TEST OF BIOPSY OPERATION:

Provider and Government personnel will conduct a test of the Biopsy system and the links to PIMC Vista Imaging. The test will be performed to insure that the system is working properly and to insure that it is functioning to provide services as, when, and how required per the PWS and supporting documents.

32. MAJOR DUTIES AND RESPONSIBILITIES:

2. The Contractor shall:

B. The Contractor shall make an estimated 24 site visits per year at no cost to the Government.

C. The Contractor shall assist the PIMC Physician in performing an estimated 150 biopsy procedures per year.

D. The clinic itself runs from 0800- 1700 on scheduled days. There is set up and break down periods at the beginning and end of the days. If needed, Mobile Biopsy Vehicle shall come, park, and sets up the evening prior to the clinic to be ready for the first patient. If arrival is on the same day the Contractor shall arrive 60-90 minutes before the first patient is scheduled. There is usually a 60 minute period at the end of the clinic for wrapping up the day’s work.

E. Stereotactic breast biopsies use mammographic X-rays to locate and target the area of concern and to help guide the biopsy needle to a precise location. This technique helps ensure that the area that is biopsied is the exact area where the abnormality was seen on the mammogram. It is called stereotactic because it utilizes two images taken from slightly different angles of the same location. The contractor Radiologic technician reviews the planned procedure with the patient and makes sure all of the patient’s questions are answered, and confirms all required paperwork has been completed. The patient then disrobes and changes into a gown. The contractor Radiologic Technician positions the patient on a prone stereotactic biopsy table that is dedicated to this use. The targeted area is localized. The vacuum assisted mammotome biopsy needle is positioned. The PIMC Physician takes the biopsy samples. Usually a marker is placed in the biopsy location. After the procedure additional images are taken to confirm marker placement.

The contractor medical assistant helps the patient back into a supine position, holds pressure on the biopsy site, and applies a bandage. The contractor radiologic technician or the medical assistant will go over post biopsy instructions with the patient.

F. Provide hard copy documentation of each stereotactic biopsy performed. Biopsies performed shall be on an as needed basis. This documentation will include patient name and medical record number, number of biopsies or attempted biopsies performed, and site of biopsy or attempted biopsy.

G. Provide mobile stereotactic biopsy services on an as needed basis for twenty days per month.

Mobile service will include digital stereotactic breast biopsy services delivered to PIMC including support staff as detailed below.

H. Provide stereotactic biopsy services on a pre-arranged mutually acceptable schedule.

I. The Contractor shall provide maintenance, service, and repair on biopsy vehicle and all equipment in the vehicle in order to keep in perfect operating condition at all times.

3. PIMC and the contractor agree that PIMC may cancel a schedule site visit at no cost upon sufficient notice. Sufficient notice, for purposes of this contract, shall be no less than forty-eight hours (48) hours prior to the scheduled appointment time. The contractor will attempt to not cancel scheduled visits to PIMC without sufficient notice.

4. PIMC reserves the right to refuse employment under this contract or require dismissal from this contract work of any employee or subcontractor employee who by reason of previous unsatisfactory performance at PIMC or for any other reasonable reason, is considered by the Contracting Officer to be objectionable, as long as thirty (30) days written notification of unsatisfactory performance has been provided.

33. GUIDELINES/MEDICAL RECORDS:

The Contractor shall follow all available guidelines within DHHS, PHS, IHS, PIMC Medical Staff regulations, policies, procedures, and by-laws. The Contractor's employees/technicians providing services will need to abide by and comply with all JCAHO, CMS, and FDA regulations. All hospital safety procedures and infection control policies are to be adhered to by the Contractor.

Contractor shall adhere to the HIPAA, Privacy Act with regards to IHS CHS patients’ medical records, including records of alcohol and substance abuse programs. The actions of unauthorized disclosure from a patient’s record are protected by the HIPAA, Privacy Act and may be subject to penalty and legal action.

34. INVOICE SUBMISSION:

Invoices shall be prepared with the following information CLEARLY identified on the invoice:

1. Invoice Date and Number

2. Contract Number

3. Charges for service or products identified BY LINE ITEM Number

4. Brief description of products or services rendered

5. Charges should follow Line Item structure on contract to include Quantity, Unit of Issue, Unit

Price, and Total Amount as applicable

6. Dates of Service or Shipment

Invoices shall be prepared and submitted electronically and in accordance with rates and terms as stated in the contract. Invoices should be sent electronically to the following departments and addresses in the same e-mail:

Finance: PHX_PIMCAPInvoice@ihs.gov For purposes of interest accrual and time of official receipt, Finance is designated as the point of receipt for the Government. Invoices shall be submitted electronically to the e-mail address listed above.

Acquisitions: Bradley.Platero@ihs.gov A copy of the invoice should be sent electronically to the contract specialist(s) at the address listed above.

Service Unit Representatives: Laura.Tillman@ihs.gov A copy of the invoice should be sent electronically to the Service Unit Representative(s) at the address listed above.

35. DESIGNATED CONTRACTING OFFICER REPRESENTATIVE:

Dr. Laura Tillman, Director, Inpatient and Specialty Services, (602) 263-1674, Laura.Tillman@ihs.gov, is hereby designated as the COR for, this contract and the designee shall perform the following duties:

1. The Contracting Officer shall designate the COR representing the Government for the purpose of this contract in writing. Such designation will set forth the duties specifically delegated in regard to the performance of this contract. A copy of the designation will be provided to the contractor.

2. The major responsibility of the COR is to ensure Contractor accountability, monitor contract performance, and assist the Contractor in the resolution of program problems encountered during the performance of this contract.

3. The COR shall be responsible for:

a) Monitoring the Contractor’s technical progress, including the surveillance and assignment of performance and recommending to the contracting Officer changes in requirements;

b) Interpreting Statement of Work;

c) Performing technical evaluation as required;

d) Performing technical inspection and acceptance required by the contract;

e) Assisting the contractor in the resolution of technical problems encountered during performance.

mailto:PHX_PIMCAPInvoice@ihs.gov mailto:Bradley.Platero@ihs.gov mailto:Laura.Tillman@ihs.gov mailto:Laura.Tillman@ihs.gov

The COR’s responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder. The COR does not have the authority to change or alter the order amount, terms and conditions.

36. CONTRACTING OFFICER:

The Contracting Officer is the only person with authority to act as the agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the contractor for any costs incurred during the performance of this contract;

or (5) otherwise changes any Terms and Conditions of this contract. The Government may unilaterally change its COR designation.

SECTION II

PERFORMANCE WORK OBJECTIVES/STANDARDS

Performance Requirements Summary: The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

(The Service required -usually a shall statement)

Performance Standard Performance Threshold

(This is the maximum error rate. It could possibly be "Zero deviation from standard")

Method of Surveillance

PRS #1. The contractor shall provide on-site Mobile Biopsy Vehicle and technical support

The contractor provided on site Mobile Biopsy Vehicle and radiologic technologist/medical assistant to assist PIMC Physician with Biopsy Procedures.

The Mobile Biopsy Vehicle and technologist/medical assistant will be available for services 95% of the time

Monthly stats. % uptime is number of clinical hours performed divided by scheduled Clinical hours in the month.

PRS #2. The contractor shall provide quality customer service

Validated customer complaints

No more than one validated customer complaint per 6 month time period

*Validated customer complaints from providers and patients.

PRS #3. The contractor shall provide quality biopsy equipment and technical assistance to the PIMC Physician during Biopsy Procedures

Biopsy equipment and technical assistance will be high quality

No more than one validated low quality performance per month

**Validated complaint from PIMC Physician.

PRS #4. Shall Adhere to HIPPA requirements

Within acceptable standards

Zero deviation from standard

Subject to contract termination

* Validated Customer Complaint: Complaints must be validated. Complaints are validated if found to be reasonable and true after an administrative investigation.

**Validated complaint from PIMC Physician: Complaints are validated if found to be reasonable and true after an administrative investigation Defective or low quality assistance is performed under the radiologic technologists control such as reviewing the planned procedure with patients and making sure all patient questions are answered, confirming all required paperwork has been completed, properly positing patient on a prone stereotactic biopsy table during a biopsy procedure, and taking images to confirm maker placement and goes over biopsy instructions with the patient.. The medical assistant helps the patient back into a supine position, holds pressure on the biopsy site, and applies bandage, and goes over biopsy instructions with the patient. Complaints are validated if found to be reasonable and true after an administrative investigation.

SECTION III

LOCATION SPECIFIC REQUIREMENTS

1. GENERAL REQUIRMENTS: The contractor will provide the Mobile Biopsy Vehicle unit 24

(twenty-four) days per year as follows: Two (2) regularly scheduled day per month.

2. MOBILE BIOPSY UNIT POSITIONING: The Mobile Biopsy Vehicle unit will be positioned at the Phoenix Indian Medical Center (PIMC), 4212 N. 16th Street, Phoenix, Arizona, 85016.

3. HOURS: Scanning of the first patient is to begin by 0800 and completion of the last patient by

1700, AZ Time. Work shall be performed on weekdays. The certified radiologic technologist and a medical assistant support person, will present to the PIMC Surgery Department, transport the patient to and from the prone stereotactic biopsy table. Most patients will be ambulatory, however, use of a wheelchair might be required.

Scheduling and initial screening of the patient will be performed by the radiologic technologist and medical support assistant with oversight by the PIMC Physician who is performing the biopsy procedures.

4. Minimum Examination Requirements:

Radiologic technologists shall review the planned procedure with patients and making sure all patient questions are answered, confirming all required paperwork has been completed, properly positing patient on a prone stereotactic biopsy table during a biopsy procedure, and taking images to confirm maker placement and goes over biopsy instructions with the patient. The medical assistant helps the patient back into a supine position, holds pressure on the biopsy site, and applies bandage, and goes over biopsy instructions with the patient. Both the radiologic technician and medical support assistant shall assist the PIMC Physician during biopsy procedures.

5. MINIMUM EQUIPMENT REQUIRMENTS:

General Requirements

a. Dedicated prone stereotactic biopsy table, digital imaging, vacuum assisted breast biopsy system (Mammotome system), capability to print images obtained or transmit images to PIMC Vista Imaging, and any other necessary components including but not limited to patient positioning aids.

b. Disposal biopsy tray to include: syringes and needles for injection, local anesthetic, scalpel, sterile gauze.

c. Post procedure dressing kit to include: steri-strips or equivalent product and cover dressing.

SECTION IV

ATTACHMENTS

1. Arizona State Tax Exemption

2. Wage Determination No. 2015-5469

3. RFI Form

4. Business Associate Agreement

SECTION V

FEE/SCHEDULED PRICING

The following shall be the fee schedule for the contract period. The cost shall be all inclusive to include all biopsy procedures performed, associated costs, biopsy vehicle, all biopsy equipment, supplies, and technical support.

Item Per Biopsy Procedure

Unit Rate Per Biopsy Procedure

Total Annual Cost

Base Year: Mobile Biopsy Services

150 EA $ $

1st Year Option:

Mobile Biopsy Services

150 EA $ $

2nd Year Option:

Mobile Biopsy Services

150 EA $ $

3rd Year Option:

Mobile Biopsy Services

150 EA $ $

4th Year Option:

Mobile Biopsy Services

150 EA $ $

6 Month Extension

75 EA $ $

GRAND TOTAL $

PROVISIONS

52.252-1 -- Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

_http://acquisition.gov/far/index.html

52.212-1 – Instructions to Offerors—Commercial Items (Oct 2015)

52.212-3 -- Offeror Representations and Certifications -- Commercial Items (Feb 2016)

52.237-1 -- Site Visit (Apr 1984)

52.209-5 -- Certification Regarding Responsibility Matters (Oct 2015)

(a)

(1) The Offeror certifies, to the best of its knowledge and belief, that --

(i) The Offeror and/or any of its Principals --

(A) Are [_] are not [_] presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(B) Have [_] have not [_], within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks “have”, the offeror shall also see 52.209-7, if included in this solicitation); and

(C) Are [_] are not [_] presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision; and

(D) Have [_], have not [_], within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains unsatisfied.

(1) Federal taxes are considered delinquent if both of the following criteria apply:

(i) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(ii) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(2) Examples.

(i) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(ii) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(iii) The taxpayer has entered into an installment agreement pursuant to I.R.C. §6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(iv) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code).

(ii) The Offeror has [[_] has not [_], within a three-year period preceding this offer, had one or more contracts terminated for default by any Federal agency.

(2) “Principal,” for the purposes of this certification, means an officer; director; owner; partner;

or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

This Certification Concerns a Matter Within the Jurisdiction of an Agency of the United States and the Making of a False, Fictitious, or Fraudulent Certification May Render the Maker Subject to Prosecution Under Section 1001, Title 18, United States Code.

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

(c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the certification will be considered in connection with a determination of the Offeror’s responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror nonresponsible.

(d) Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a) of this provision. The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation for default.

(End of Provision)

52.212-2 -- Evaluation -- Commercial Items (Oct 2014)

(a) The Government intends to award a contract resulting from this solicitation to the responsible, responsive offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1) Technical Acceptability:

2) Past Performance:

i. Recency: In order for past performance to be considered recent, performance must be ongoing or must have been performed within the last five (5) years from date of issuance of this solicitation. Past performance information that fails this condition will not be evaluated.

ii. Relevancy: Relevant performance information will be based on performance involving the service and/or support, and complexity as this solicitation requires.

iii. In the case of an offeror without a record of relevant past performance, or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305 (a)(2)(iv)).

Therefore, the offeror shall be determined to have unknown past performance. In the context of acceptability/unacceptability, “unknown” shall be considered “acceptable.”

3) Price:

i. Options. The Government will evaluate offers for award purposes by adding the total price for all options IAW FAR 52.217-9 "Option to Extend the Term of the Contract" to the total price for the basic requirement. The 6 month option period IAW FAR 52.217-8 "Option to Extend Services" will also be evaluated as part of the total price. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

4) Technical and past performance, when combined, are significantly more important than cost or price. Past performance will be rated on an “acceptable” or unacceptable” basis.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

52.216-1 -- Type of Contract (Apr 1984)

The Government contemplates award of a firm fixed price contract resulting from this solicitation.

(End of Provision)

52.233-2 -- Service of Protest (Sep 2006)

(a) (a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from

Barbara Bonnette, Indian Health Service Acquisition Management 40 N Central Ave, Suite 507 Phoenix, AZ 85004

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

CLAUSES

52.252-2 -- Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

_http://acquisition.gov/far/index.html

(End of Clause)

52.212-4 -- Contract Terms and Conditions -- Commercial Items (May 2015)

52.232-18 -- Availability of Funds (Apr 1984)

52.237-2 -- Protection of Government Buildings, Equipment, and Vegetation (Apr 1984)

52.246-4 -- Inspection of Services -- Fixed-Price (Aug 1996)

352.222-70 –Contractor Cooperation in Equal Opportunity…