Biopsy - SOW.pdf

1. INTRODUCTION:

The Phoenix Indian Medical Center (PIMC) has a need for 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:

Contractor to provide on-site Stereotactic Breast Biopsy Service for PIMC physicians to perform biopsy procedures for PIMC patients. This contract is 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 on-site Stereotactic Breast Biopsy Services and qualified technical staff to assist the PIMC physicians during biopsy procedures.

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

Performance shall be according to the Performance Work Statement (PWS) 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 American College of Radiology (ACR) Food and Drug Administration (FDA)

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) and Contracting Officer Representative (COR) 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.

b. Provide a secure site for the biopsy services.

c. Schedule a minimum of three (3) to twenty (20) stereotactic biopsies per 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 the following biopsy supplies: vacuum assisted breast biopsy system (Mammotome system), 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 (see Contractor Furnished Equipment). PIMC will do all 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.

g. Limited space will be provided to the contractor for the placement of equipment in the Medical Imaging Department, Mammography Room. Space is limited to biopsy table and computer console workstation.

Contractor may leave equipment on government site, however liability of theft or damage will be covered by the Contractor.

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:

Biopsy services shall include equipment and 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. 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.

The contract shall require the Contractor to supply equipment as follows and/or equivalent and supplies as needed:

A. Provide stereotactic breast biopsy equipment. 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:

i. Dedicated prone stereotactic biopsy table, digital imaging, capability to save images obtained to encrypted USB drive (Government will provide encrypted USB drive) and compatible with Vista Imaging DICOM, and any other necessary components including but not limited to patient positioning aids.

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

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

12. INFORMATION TECHNOLOGY REQUIREMENTS ARE AS FOLLOWS:

The breast biopsy system shall be Food and Drug Administration (FDA) approved and capable of saving images to a USB encrypted drive. Images must be compatible with Vista Imaging Approved Digital Imaging and Communications in Medicine (DICOM) Modality Interfaces list dated September 1, 2020 (Attachment A - Vista Imaging DICOM Modality Interfaces 9/1/2020).

In addition the breast biopsy system must meet the minimum below:

a. DICOM – VA Vista Rad and Vista Imaging compatible;

b. Hard copy of the original OEM System manuals on site with machine;

c. Attachment A - Vista Imaging DICOM Modality Interfaces 9/1/2020 or compatible to interface with DICOM – VA Vista Rad and Vista Imaging.

d. UBS port to connect USB Encrypted Drive, FIPS 140-2 compliant.

At no time shall the contractor’s computer or equipment connect to the Governments network. All images will be saved on USB encrypted drive (government will provide the USB encrypted drive).

13. EQUIPMENT MAINTENANCE:

Contractor shall perform Preventative Maintenance (PM) as recommended by the original equipment manufacturer (OEM) and repairs for the Biopsy Unit. The biopsy unit includes, but is not limited to, dedicated prone stereotactic biopsy table, and digital imaging. Contractor will also provide annual physicist inspection to unit.

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 biopsy Unit.

Contractor shall provide PIMC COR copies of all PM, service repairs and annual physicist inspection report.

14. HEALTH REQUIREMENTS:

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.

15. STAFFING:

Provider shall be solely responsible for all staffing issues related to set-up and operation of the systems.

Provider shall perform set-up, take-down, and departure of biopsy 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 system.

Provider is responsible for cleaning of biopsy 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 biopsy 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.

16. 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

• Mammography Quality Standards Act (MQSA) 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 annually on the first normal duty day in January for the previous calendar year.

17. QUALITY CONTROL PROGRAM (QCP):

The contractor shall develop and maintain an effective QCP to ensure services are performed in accordance with this PWS. 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.

18. 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

19. 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.

20. PERSONNEL SECURITY REQUIREMENTS:

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

21. 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.

KEY CONTROL: No keys will be issued to the contractor. Access to the mammography room will be provided by the PIMC Radiologic Technologist on duty.

22. 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.

A. 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.

B. 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.

23. HOUSEKEEPING:

Contractor shall be responsible for the disposal of waste items, 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.

24. REPORTING REQUIREMENTS:

Report

Description # of Copies

Recipient Due Date

1 Quality Control 1 COR Monthly/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, or 10 prior to license expiration.

4 Required Accreditations 1 COR Annually 5 Medical Liability Insurance 1 COR Annually 6 Preventative Maintenance 1 COR Quarterly/Semi-Annually 7 Physicist Report 1 COR Annually

25. 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.

26. PRICING:

Pricing shall be for an all-inclusive rate. Detailed pricing schedule shall be included with offer for the base period and 4 option years.

Pricing schedule will need to be updated for minimum visit rate or by exam.

27. BREAST BIOPSY INTERPRETATION:

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

28. BIOPSY DATA OWNERSHIP:

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

Contractor is required to turn in the hard drive at the end of the contract or replacement of hard drives during the contract.

29. 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.

30. DISRUPTION OF BIOPSY SERVICES:

The Biopsy provider will communicate to the Contracting Officer Representative (COR) 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 as soon as possible. Provider will inform the COR 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 USB image format to PIMC Vista Imaging. The test will be performed to insure that the system DICOM images are compatible 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:

1. The Contractor shall:

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

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

C. 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. Contractor is to set up and be ready before the 1st first patient.

D. 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.

E. 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.

F. Provide stereotactic biopsy services on an as needed basis for twenty days per month. Biopsy service will include digital stereotactic breast biopsy services delivered to PIMC including support staff as detailed below.

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

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

I. 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.

J. 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.

K. Contractor shall wear a PIMC provided dosimeter at all times while at PIMC. Contractor will leave the PIMC dosimeter on PIMC campus at all times.

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.

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

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 mailto:PHX_PIMCAPInvoice@ihs.gov mailto:brian.numkena@ihs.gov

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

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

The Biopsy services 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 1 month time period

*Validated customer complaints from providers and patients.

RPS#3. The contractor shall provide high quality digital image quality

Validated customer complaints

Zero suboptimal image quality.

Each image will be viewed by PIMC Radiologist.

PRS #4. 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 #5. 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.

LOCATION SPECIFIC REQUIREMENTS

1. GENERAL REQUIRMENTS: The contractor will provide the Biopsy Services 24 (twenty-four) days per year as follows: Two (2) regularly scheduled days per month.

2. BIOPSY UNIT POSITIONING: The Biopsy Services unit will 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 REQUIREMENTS:

General Requirements

a. Dedicated prone stereotactic biopsy table, digital imaging, capability save images on encrypted UBS drive, 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.