PWS Mammo Unit.docx

PROFESSIONAL MEDICAL HEALTHCARE SERVICES

RADIOLOGIC TECHNOLOGY/MAMMOGRAPHER

PERFORMANCE BASED WORK STATEMENT (PBWS)

C-1. BACKGROUND

The Aberdeen Area Indian Health Service-Mobile Women’s Health Unit (MWHU) requires contractor support for the recruitment of a Radiology Technologists-Mammographer trained in the provision of digital mammography. Staff will provide services on the mobile unit that provides services throughout South Dakota, North Dakota, Nebraska, and Iowa.

The contract shall be a non personal health care services contract under which the Contractor is an independent contractor and which shall allow the Government to evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of the services rendered, (e.g., professional judgments, diagnosis for specific medical treatment). The Contractor shall indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. The Contractor shall maintain medical liability insurance, in the coverage amount acceptable to the Contracting Officer, which is not less than the amount normally prevailing within the local community for the medical specialty concerned. The staff will receive an orientation and training on appropriate equipment once onsite. The hourly rate must be quoted as an all inclusive rate.

Workflow in previous years has typically ranged from 11 - 32 patients per day. Staff should expect to perform an average of 20 mammograms per day on a typical day. Services are provided 3-10 hr. days per week (Tuesday-Thursday). A digital mammography examination will be followed by the other women’s health services (i.e. bone density, health education).

The broadband satellite telecommunications capability on the mobile unit will transmit digital images to a contracted reading center for immediate interpretation. A distant radiology department equipped with digital mammography review workstations will interpret images and transmit reports back to the mobile clinic.

The unit is equipped with a Hologic Selenia S Digital Mammography Unit approved by FDA for mobile use. Prior mammograms are digitized on the unit & transmitted when requested for comparison. The unit is equipped with Internet, telephone & fax capabilities.

The staff must utilize the existing equipment & the OmniCare Radiology Information System (RIS) software owned by the Government. The contractor shall ensure all FDA requirements for provision of digital mammography are met & participate in all FDA inspections & assist in developing subsequent corrective action plans if necessary.

C-2. SPECIAL CONTRACT REQUIREMENTS

Contractors cannot serve as witnesses in any suit against the Federal Government. Many of the IHS patients receiving services may only speak a native language and/or reside on a Native American Reservation, therefore, the Contractor must demonstrate sensitivity to cross-cultural and language differences. The Privacy Act of 1974 mandates that the Contractor maintain complete confidentiality of all administrative, medical & personnel records, & all other pertinent information that comes to his/her attention or knowledge. The Privacy Act carries both civil & criminal penalties for unlawful disclosure of records. Violation of such confidentiality shall be cause for adverse action. All IHS regulations & policies applicable to these Acts shall be enforced.

C-3. PERFORMANCE-BASED WORK STATEMENT

The Contractor shall implement a recruitment and placement process and systems that will deliver the required services in a manner that will best meet the Indian Health Services performance objectives. Contractor shall furnish Radiology Technologists for assignment to the mobile unit on an ongoing basis. Contractor is paid at an all inclusive rate. Travel and per diem costs are the sole responsibility of the contractor. The Indian Health Service will monitor the Contractor’s performance in accordance with the Quality Assurance Surveillance Plan (See Attachment 1).

Upon the receipt of an IHS service unit task order, the Contractor shall locate, credential, and have available acceptable and sufficient staffing to provide Radiology Technologists specifically for mammography coverage in accordance with the established schedule. Task orders shall be issued at least (21) calendar days in advance of the need, but some task orders may provide the Contractor with a limited time in which to respond.

Upon the receipt of an IHS service unit task order, the Contractor shall locate, and have available acceptable and sufficient staffing to provide mammography coverage on the mobile unit. Task orders shall be issued at least (21) calendar days in advance of the need, but some task orders may provide the Contractor with a limited time in which to respond.

The contractor is expected to begin services by completing the applications training onsite in May/June 2012 (date to be finalized after contract award). Services shall begin as indicated by the attached schedule which is subject to change with little notice. The Contractor will provide Radiology Technologists trained in digital mammography to perform digital mammograms and bone density exams, participate in refining patient flow, serve as lead QA tech onboard, participate in FDA inspections, and development of CAP when necessary. Staff may be asked to participate in orientation activities for scheduled sites. The contract staff will be the point of contact for the Aberdeen Area Office and the local sites. The onboard staff must work together as a team to assure patient flow is seamless and paperwork is submitted to the appropriate person.

Contract staff shall be motivated and capable of functioning independently with minimum oversight to assure both clinical and non-clinical activities are completed. Non-clinical activities may consist of interaction with Service Unit/Clinic staff and Radiologists, documentation on each sites’ Patient Care Component (PCC) form, and various forms of communication with Service Unit staff for follow-up of abnormal tests and interaction with the administrative staff at the Area Office level.

Contractor will ensure staff is informed that the unit is not a clinic nor is it a hospital and light housekeeping duties are a necessity in maintaining a clean environment in a compact unit.

All Contract staff will be held to the same Standards of Conduct as federal employees (See Attached – “Standards of Conduct”, Violence in the Workplace memorandum; Courtesy and Respect in the Workplace Policy. Violations of these policies my lead to contract termination.

Any negligent behavior or any behavior jeopardizing patient safety will not be tolerated. Professional Review Action may be taken if an activity, demeanor or conduct of the member is detrimental to patient care, disruptive to mobile unit operations. Each incident will be evaluated and documented. Documentation will be submitted to the contractor. These incidents may be grounds for immediate removal. The final decision is at the discretion of the Contracting Officer’s Representative (COR) and the Chief Contracting Officer.

The contractor’s conformance with the technical requirements of this contract will be monitored for the period of performance. This assessment will include observations of the work system, methods and execution. Examples of monitoring methods include, but are not limited to: compliance with the FDA/MQSA requirements, appropriateness of candidate placement (e.g. number of removals, number of early termination of assignments due to personality conflict, poor work habits, inadequate skills for the assignment, unprofessional or discourteous behavior). An assessment spreadsheet with these methods will be monitored by the COR.

The Contractor shall provide all personnel, supervision, and other services necessary to perform the work. The Contractor shall perform to the standards in the Quality Assurance Surveillance Plan (See Attachment 1). A tentative schedule for the period of performance will be established and provided to the Contractor. Contractor will be notified in advance when possible of any changes to the schedule (See Attachment 2).

The Contractor's work and responsibility shall include, but not be limited to the recruitment and placement of Radiology Technologist-Mammographer staff trained in digital mammography. Contractor shall ensure all staff are qualified and have appropriate certifications (CPR, National, ARRT, etc.) and meet FDA-MQSA requirements.

The Contractor shall provide Radiology Technologists-Mammographer trained in the digital modality. Staff shall be knowledgeable of the Mammography Quality Standards Act (MQSA) requirements, performance standards, and capable of providing required services in a mobile environment.

Contract staff shall:

1. Ensure the Health History form is complete and sent to the Radiologist along with the images.

2. Documents patient teaching on all PCCs.

3. Routinely correspond with the Area Office MWHU Coordinator and be point of contact for the local Service Units/Clinics while the unit is onsite.

4. Team approach shall be initiated to resolve problems with patient flow.

5. Complete bone density exams on patients when requested and document appropriately on the PCC.

6. Follow up on abnormal results with Service Unit/Clinic and Radiologist.

7. Use and cleaning of equipment in accordance to manufacturer’s instructions.

8. Comply with all MQSA/FDA requirements & be knowledgeable of those specific requirements.

9. Appropriate forms and tracking are completed in accordance with FDA and MQSA requirements.

10. Communicate with the Radiologist and Service Unit/Clinic if abnormal results.

Upon presentation of a candidate, the contractor shall furnish the following:

1. Full name

2. Date of birth

3. Social security number

4. Copies of licenses (ARRT), certifications (CPR, HIPAA), and CV

5. Signed and dated Section I – (Personnel) Radiology Technologist required by FDA - MQSA requirements

Contractor shall establish procedures and processes for resolution of and dealing with non-performing contract employees. This plan shall be submitted to the AAIHS within 30 days of award of this contract.

C-5. APPLICABLE STANDARDS

Listed below are some Applicable Standards, but are not limited to:

1. Health Insurance and Accountability Act (HIPAA) Website: http://www.hhs.gov/ocr/privacy

2. Privacy Act of 1974 (45 CFR 5b) Website: http://www.justice.gov/opcl/privstat.htm

3.

Indian Health Service Information Technology and Records Policies.

Website: http://www.ihs.gov/index.cfm?module=InfoTech

4. FDA Mammography Quality Standards Act (MQSA) April 28, 1999 Website: http://www.acr.org

C-6. QUALITY ASSURANCE SURVEILLANCE PLAN

Performance surveillance monitors will be established to comply with regulatory guidelines and to monitor contract performance. The performance surveillance plan has been developed to describe the Indian Health Service’s general plan in providing effective and systematic surveillance and reporting of all aspects of contract performance. This plan recognizes the responsibility of the contractor to carry out its own quality control obligations in the performance of this contract.

Surveillance will be accomplished via insight into the contractor’s performance against requirements listed in the work statement and performance standards listed in this plan. Performance-based incentives are consistent with the intent and purpose of the contract and are outlined on the following grid:

In order to monitor contract performance and provide benchmarking data to participating service units or communities, a standardized report is requested on a monthly basis. This report shall include the logs for services provided on the mobile unit (mammogram, bone density, no-shows) and recommendations for improvements. Reports shall be submitted to the COR.

A final report shall be submitted electronically to the COR with cumulative totals of services provided on the mobile unit no later than 30 days after the end of the contract period.

Upon completion of the contract, the Government will complete and keep on record the Contractor’s performance evaluation form, see (Section J).

C-7 Notice to contractor of certain drug detention procedures:

(a) Pursuant to the agency’s policy applicable to government and contractor personnel, measures will be taken to prevent the introduction and utilization of illegal drugs and related paraphernalia into Government work areas.

(b) In furtherance of the Agency’s control program unannounced inspections may be conducted by authorities:

(c) Where there is probable cause to believe that a Contractor Physician has been engaged in use, possession, or trafficking of drugs, the authorities may detain said Contractor Physician until the Contractor or employees can be removed from the installation, or can be released to local authorities having jurisdiction.

(d) Trafficking in illegal drug and drug paraphernalia by the contractor may lead to cancellation of services.

(e) The Contractor is responsible for conduct of employees performing work under this contract and is, therefore, responsible to assure that employees are notified of these provisions prior to assignment.

(f) The removal of contractor personnel from a Government facility as a result of the drug offense shall not be cause for an excusable delay, nor shall such action be deemed a basis for an equitable adjustment to price, delivery, or other provisions of this contract.

ATTACHMENT 1 – SURVEILLANCE ACTIVITIES AND CONTRACTOR INCENTIVES

Performance surveillance monitors will be established to comply with regulatory guidelines and to monitor contract performance. Performance-based incentives are consistent with the intent and purpose of the contract and are outlined on the following grid:

PERFORMANCE

OBJECTIVES

PERFORMANCE

MEASURE

PERFORMANCE

STANDARD

SURVEILLANCE

PLAN

CONTRACTOR

INCENTIVE

PHASE 1

PERFORMANCE OBJECTIVE 1

RECRUITMENT AND PLACEMENT OF RADIOLOGY TECHNICIAN TRAINED IN DIGITAL MAMMOGRAPHY

CONTINUOUS SERVICE ON A MONTHLY BASIS.

ALL STAFF MUST BE LICENSED

STAFF MUST BE EXPERIENCED IN WOMEN’S HEALTH SERVICES AND PRACTICED WITHIN THE LAST YEAR

DEMONSTRATES A CLEAR UNDERSTANDING OF THE PWS REQUIREMENTS AND POSSESS THE CAPABILITIES TO COMPLETE TASK ORDER PERFORMANCE

RAD.TECH MUST BE FAMILIAR WITH FDA/MQS REQS.

CONTRACTOR SHALL PROVIDE COPIES OF STAFF CERTIFICATION AND LICENSURE, AND DOCUMENTED PRIOR EXPERIENCE PERFORMING DIGITAL MAMMOGRAPHY.

DEMONSTRATE

A CLEAR UNDERSTANDING OF MQSA REQUIREMENTS FOR MOBILE SITES.

STAFF SHALL:

1. <2% LABELING ERROR (POSITION, VIEW, NAME, ETC) ON MAMMOGRAMS SENT TO RADIOLOGIST

2. 100% OF MAMMOGRAMS RECORDED IN THE RIS

THE COR WILL REVIEW CONTRACTOR STAFF QUALIFICATIONS

APPROVAL FOR PERFORMANCE AND STAFFING PLAN WILL BE PROVIDED BY THE COTR

COMPLETE SECTION I FOR STAFF AND SUBMIT TO COR PRIOR TO STAFF ARRIVAL.

MONTHLY REPORTS TO INCLUDE COPIES OF THE LOGS WILL BE PROVIDED TO AND APPROVED BY THE COTR

AAIHS WILL PROVIDE A POSITIVE PERFORMANCE REPORT ON CLINICAL STAFFING CAPABILITIES

PERFORMANCE OBJECTIVE 2

SUCCESSFUL FDA ACCREDITATION.

ONGOING ADHERENCE TO FDA-MQSA REQUIREMENTS

CONTINUOUS SERVICE ON A MONTHLY BASIS.

DEMONSTRATES A CLEAR UNDERSTANDING OF THE REQUIREMENTS AND RESPONSIBILITIES

STAFF SHALL:

1. ASSIST WITH FDA RENEWAL APPLICATION.

2. 100% OF TOTAL MAMMOGRAMS RECORDED IN THE RIS

3. COMPLY WITH FDA/MQSA REQS.

4. PARTICIPATE IN FDA INSPECTIONS AND ASSIST IN CORRECTIVE ACTION PLAN DEVELOPMENT.

MONTHLY REPORTS ON THE NUMBER OF QA ISSUES DUE TO IMAGING ERRORS IDENTIFIED BY THE RADIOLOGIST.

ANNUAL REPORT ON STATUS OF CAP ACTIONS/STATUS.

AAIHS WILL PROVIDE A POSITIVE PERFORMANCE REPORT ON CLINICAL STAFFING CAPABILITIES

Mobile Women’s Health Unit FY2012 Schedule (tentative) (June to Mid-September)

(7 Total Sites)

June 2012

July 2012

17– 19 23 – 27 31 – August 2 Kyle, SD (CST) Trenton, ND (CST) Wanblee, SD (CST)

August 2012

September 2012