Added: Apr 24, 2008 9:53 am
Breast Imaging and Interventional ServicesVA New York Harbor Healthcare System
Statement of Work
1. Introduction and Scope of Work
Females over age 40 represent a small percentage of total patients in the VA New York Harbor Healthcare System. The mammography volume is not sufficient to enable us to provide comprehensive breast imaging services meeting quality and regulatory requirements at each of our facilities. The VA New York Harbor Healthcare System is therefore seeking breast imaging, screening and diagnostic services, and breast interventional services for veterans cared for at our medical centers and community outpatient clinics in the New York metropolitan area.
Services requested include all breast imaging and other diagnostic and surgical procedures for detection, diagnosis and treatment of breast disease in men and women. Inability to provide all services listed will not preclude a Contractor from submitting a proposal.
All services shall comply with all Mammography Quality Standards Act (MQSA) statutes and regulations as well as pertinent regulations of: the Health Insurance Portability and Accountability Act (HIPAA), Privacy Act, Freedom of Information Act (FOIA) and Occupational Safety and Health Administration (OSHA). The contractor shall also comply with any applicable Joint Commission Ambulatory Standards of Care for imaging services. In addition, services will be performed in a manner consistent with the regulations for registered radiologists in the State of New York and consistent with accepted medical practice.
2. Requirements
a. Work to be performed
i. Services to be performed include:
" Screening mammography, bilateral
" Unilateral diagnostic mammography
" Bilateral diagnostic mammography
" Screening mammography, digital, bilateral
" Diagnostic mammography, digital, bilateral
" Diagnostic mammography, digital, unilateral
" CAD for diagnostic mammography
" CAD for screening mammography
" Mammary ductogram or galactogram, single duct
" Mammary ductogram or galactogram, multiple ducts
" Breast MR, Unilateral
" Breast MR, Bilateral
" Stereotactic localization
" Mammographic guidance for needle placement
" Computer analysis of full-field digital mammogram
" Fine needle aspiration with imaging guidance
" Puncture aspiration of cyst of breast
" Biopsy of breast, percutaneous, needle core, using imaging guidance
" Biopsy of breast, percutaneous, automated vacuum or rotating biopsy device, using imaging guidance
" Pre-operative placement of needle localization wire, breast, first lesion
" Pre-operative placement of needle localization wire, breast, each additional lesion
" Image-guided placement, metallic localization clip, percutaneous, during breast biopsy
" Scintimammography
" Breast Ultrasound
" Breast surgery
ii. When clinically indicated, a screening mammogram may be converted to a diagnostic mammogram to expedite final diagnosis. In such instances, the Contractor will be reimbursed only for the diagnostic mammogram.
iii. When clinically indicated to aid in the diagnosis of the patient, additional imaging studies (such as breast sonography or breast MR) may be added. In such cases, the additional imaging should be performed on the same day as the mammogram, if at all possible.
iv. If biopsy is performed, the Contractor shall be responsible for ensuring safe delivery and transportation of the specimen to the laboratory identified in the contract and for reporting results to the VA as noted in "Reporting Requirements."
v. If the Contractor identifies the need for services outside the scope of this contract for an individual veteran, Contractor must contact the VA for preauthorization prior to performing such service.
b. Certification Accreditation and Regulatory Requirements
i. The Contractor shall be certified by the FDA and accredited by the American College of Radiology. The Contractor is authorized to provide services only as long as its accreditation and certification are maintained in good standing. Loss of accreditation must be communicated to the Contracting Officer's Technical Representative (COTR), in writing, immediately.
ii. Contractors providing stereotactic needle localization and biopsy must be accredited by the American College of Radiology / American College of Surgeons Stereotactic Breast Biopsy Accreditation program for the respective procedure(s).
iii. The Contractor shall comply with all Mammography Quality Standards Act (MQSA) statutes and regulations as well as pertinent regulations of: the Health Insurance Portability and Accountability Act (HIPAA), Privacy Act, Freedom of Information Act (FOIA) and Occupational Safety and Health Administration (OSHA).
iv. The Contractor shall provide copies of current accreditation and certification documentation, and renewal documentation, when applicable. Copies of such documentation shall be sent to the Contracting Officer's Technical Representative (COTR) and the Radiology Department of the VA New York Harbor Healthcare System.
v. The Contractor shall provide to the Contracting Officer or COTR a copy of the annual MQSA inspection report, and a copy of any corrective action plan(s) to resolve annual inspection observations (deficiencies).
vi. The Contractor shall make certain and provide documentation to VA New York Harbor Healthcare System upon request that the following requirements are met for individual providing services under this contract:
Physicians:
" Have a current NY State Medical License
" Are board certified by the American College of Radiology (ACR)
" Meet all qualifications required by the FDA and Mammography Quality Standards Act (MQSA).
" performing follow-up exams (ultrasound, breast aspirations, biopsies, etc.) are proficient in performing these exams, board certified by the ACR and meet all qualifications required by MQSA.
Radiologic Technologists:
" Have current NY State License
" Are registered by the American Registry of Radiologic Technologists (ARRT) for Mammography.
" Meet the requirements of the ACR and MQSA.
Medical Physicists:
" Meet all FDA and MQSA qualifications
" Must inspect the mammographic equipment and perform appropriate quality checks at least once per year.
c. Timeliness requirements
i. The vendor shall provide services under this agreement during their regular business hours.
ii. Patients shall be contacted for scheduling within 7 days of the Contractor receiving the referral from the VA New York Harbor Healthcare System.
iii. Procedures shall be performed within 7 days of the desired date noted on the referral form unless the patient specifically requests a later date. Contractor will notify referring provider of all requested appointments beyond 7 days of the desired date.
iv. If the Contractor is unable to contact the veteran within 7 days of receiving the referral, or if the veteran fails to keep a scheduled appointment, the Contractor shall notify the Mammography Coordinator within 3 days of the failed contact or missed appointment.
v. In the rare event that emergency breast imaging services are required, these will be scheduled and performed within 3 days of receipt of the request from the VA.
vi. The vendor shall ask all patients for a photo ID when they present for their exams/procedures, with a copy of their authorization letter/release of information.
vii. The vendor shall provide the VA New York Harbor Healthcare System with a monthly report of the status of VA patients.
viii. See "Reporting Requirements" for timeliness of reporting.
d. Reporting requirements
Reports to VA New York Harbor Healthcare System
i. Mammography reports shall include both the numerical ACR BIRADS code and the full textual description that goes along with it. All reports must be clearly identified with the name and location of the vendor, date of exam, patient name, unique patient number as assigned by the Contractor, patient's Social Security number, view and laterality, and name and address of the requesting facility.
ii. Final, signed reports shall be faxed to the referring physician and the original mailed to the Mammography Coordinator within 48 hours of completion of the examination or procedure.
iii. Results of exams interpreted as "Suspicious", "Highly Suggestive of Malignancy" or "Known Biopsy Proven Malignancy" (BIRADS categories 4, 5
or 6) or those interpreted as "Incomplete, Need Additional Imaging Evaluation" (BIRADS category 0), must also be called to the referring physician and the phone call documented in the Contractor's records. Documentation must include the name of the physician who was given the verbal report, the time of the communication, and confirmation that the VA New York Harbor Healthcare System read/repeat back policy was followed.
iv. Biopsy slides and reports will be forwarded to VA New York Harbor Healthcare System Pathology Department within 48 hours. Address: VA NYHHS, 800 Poly Place, Brooklyn, NY 11209 ATTN: Pathology.
Reports to patients
i. The Contractor shall provide a summary of the results of the mammography examination/procedure written in lay terms:
" Within 10 days of completion of the examination or procedure for normal exams.
" Within 5 days of completion of the examination or procedure for exams interpreted as "Suspicious", "Highly Suggestive of Malignancy" or "Known Biopsy Proven Malignancy" (BIRADS categories 4, 5 or 6).
" Within 7 working days of completion of the examination or procedure for exams interpreted as "Incomplete, Need Additional Imaging Evaluation," (BIRADS category 0), in order to avoid delays in patient work-up.
Follow-up
The Contractor shall be responsible for contacting the Mammography Coordinator concerning any follow-up, and contacting the patient to schedule the follow-up appointment, as authorized by the VA, within the reporting time frames specified above for BIRADS categories 0 and 4, 5 or 6.
Image Labeling and Retention
The Contractor shall make certain of the following:
" All images must be clearly identified with the name of the Contractor and location, date of exam, patient name, unique patient number (as assigned by the Contractor), patient's Social Security number, view and laterality.
" Mammography / Breast Sonogram images - Unless otherwise requested, all images shall be retained for no less than 5 years. (10 years if a first time mammogram.)
" 1 (one) copy of all images shall be provided to the VA, in digital format if available.
" Upon request by, or on behalf of the patient, the Contractor shall release the original mammogram images either to the VA New York Harbor Healthcare System or the patient directly. In accordance with NY State law, no fee for copies will be passed onto the patient or the VA. If the Contractor elects to retain copies, it is at their own expense.
e. Documentation requirements
i. All reports must be provided in MQSA format using BI-RADS nomenclature
ii. Documentation of reports and services provided must:
" Be acceptable for purposes of proper chart entry for patient care.
" Meet third party billing requirements, as governed by guidelines that are defined by VA New York Harbor Healthcare System or third party insurers.
f. Workload data
Below are the numbers of breast imaging procedures and diagnostic procedures performed during Fiscal Year 2007 for patients of the VA New York Harbor Healthcare System. No significant increase or decrease in workload is anticipated.
Facility Screening Mammo Diagnostic Mammo Needle Loc Breast U/S Mastectomy
VA NYHHS 530 285 4 66 4
g. Facility data
All staff, equipment and supplies necessary for the performance of the contracted procedures will be provided by the Contractor. The mammography equipment and mammography program must meet all MQSA compliance requirements at all times. Specifically:
" Equipment must be specifically designed for Mammography, having AEC, grids, magnification capabilities, appropriate compression devices and with large and small focal spots.
" Radiographic film and intensifying screens must be specifically manufactured for mammography.
" Standard Ultrasound equipment with appropriate transducers for breast sonography.
g.
h. Place of performance
All contracted procedures will be performed in Contractor-owned/operated facilities. Should the Contractor have more than one location, the procedures shall be performed only at the location stated in the contract.
i. Procedure for referral and scheduling
i. The VA will provide the Contractor with the following information:
" Referring provider name and contact/alternate contact information: e.g. name, phone number, fax number, pager, etc.
" Patient contact information, including name, phone number, address, etc., to allow Contractor to make contact with the patient.
" Patient demographics and pertinent patient history.
" Request form authorizing procedures to be performed including referral date and purchase order number (PO#); (as noted above, if the results of a screening exam are abnormal, Contractor is authorized to perform necessary diagnostic studies to determine final BIRADS classification).
" Any available prior mammography films and other studies for comparison. Any images of prior studies supplied to the vendor by the VA must be returned to the VA within 7 days of the study date.
ii. See "Timeliness" section for requirements as to when appointments shall be scheduled.
i. Transfer of Patients
In general, VA does not anticipate a need for patient transfer for emergency care. In the unlikely event transfer is necessary, the Contractor will contact the referring physician to arrange for emergency transfer to the VA. In the very unlikely event that the patient's condition is so unstable as to preclude travel to a VA and emergency care is needed, the Contractor will transfer the patient to the nearest medical facility capability of treating the patient, and will notify the VA within 1 hour of such transfer.
j. Patient Safety
The Contractor will adhere to all VA patient safety requirements as well as to OSHA and applicable Joint Commission Ambulatory Standards of Care for imaging services.
k. Exchange of Data
See section d(ii) above
l. Billing
i. The following information must be submitted for reimbursement:
" patient name
" patient Social Security number
" date of service
" CPT code(s) and procedure name(s)
ii. Payment will be authorized only if completed and signed report has been submitted.
m. Payments
i. All reimbursement will be at Medicare rates. A list of common CPT codes follows:
76082 - CAD for diagnostic mammography
76083 - CAD for screening mammography
76086 - Mammary ductogram or galactogram, single duct
76088 - Mammary ductogram or galactogram, multiple ducts
76090 - Unilateral mammogram
76091 - Bilateral mammogram
76092 - Screening mammography, bilateral
76093 - Breast MR, Unilateral
76094 - Breast MR
76095 - Stereotactic localization
76096 - Mammographic guidance for needle placement
G0202 - Screening mammography, digital, bilateral
G0204 - Diagnostic mammography, digital, bilateral
G0206 - Diagnostic mammography, digital, unilateral
S8075 - Computer analysis of full-field digital mammogram
10022 - Fine needle aspiration with imaging guidance
19000 - Puncture aspiration of cyst of breast
19102 - Biopsy of breast, percutaneous, needle core, using imaging guidance
19103 - Biopsy of breast, percutaneous, automated vacuum or rotating biopsy device, using imaging guidance
19290 - Pre-operative placement of needle localization wire, breast, first lesion
19291 - Pre-operative placement of needle localization wire, breast, each additional lesion
19295 - Image-guided placement, metallic localization clip, percutaneous, during breast biopsy
19300-19307 - Mastectomy
S8080 - Bilateral; Scintimammography
ii. VA reimbursement will be considered payment in full and the Contractor will not bill the patient for any services performed under the terms of the agreement.
n. Penalty for non-performance
Studies not performed within the agreed-upon timeframes, or reports not received by the VA within agreed-upon timeframes shall not be billable to the VA.
o. Educational and research activities
No research activities are permitted under the terms of this contact. Contacts may be established with teaching institutions; however such teaching activities will not be reimbursed. Further, all breast studies done under the terms of this contract must be physically read by an attending physician meeting the requirements in section 2(b)(vi) above and documented as such.
3. References
VA New York Harbor Healthcare System Chief of Staff Memorandum No.: 06-03, Subject: Reporting Critical and Unexpected Findings on Imaging Studies.
4. Progress and Compliance
a. The reports required by the VA New York Harbor Healthcare System from the Contractor include, but are not limited to, timely signed reports faxed to the Mammography Coordinator within 48 hours and "suspicious" or positive findings faxed to the Mammography Coordinator within 24 hours. All original signed reports mailed within 48 hours.
b. Contractor quality monitoring - The Contractor shall have a quality monitoring program, and shall agree to comply with the requirements for meeting the Joint Commission program, if applicable as outlined in the VA New York Harbor Healthcare System Joint Commission program. The Contractor shall have in place an internal quality monitoring program which consists of systematic activities to monitor and evaluate the care delivered according to predetermined objective standards and to effect improvement as needed. Quality assurance requirements are as follows:
a. Maintain an established quality assurance program for Mammography in compliance with the daily, weekly, monthly, semi-annual and annual FDA and MQSA requirements.
b. Maintain documentation of all quality assurance testing and corrective actions.
c. With 2 weeks advance notice provide the VA New York Harbor Healthcare System access to review documents.
3. VA monitoring - Compliance with other contract requirements shall be monitored through the facility's performance improvement programs and by committees with responsibility for monitoring clinical care, e.g. Operative and Other Procedures (OOPS) and Medical Records Committees which report to the Clinical Executive Board (CEB) and ultimately to the Executive Council and Facility Director.
4. The performance of the Contractor shall be monitored by the Contracting Officer's Technical Representative (COTR) or designee to make certain that all VA requirements are being met. The COTR or designee will monitor the billing on a monthly basis for accuracy as well as the number of reports being referred each month.
5. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be reported immediately to the COTR.
