SOURCES SOUGHT
Q -- Nuclear Medicine Imaging Proficiency Testing Program
- Notice Date
- 8/20/2010
- Notice Type
- Sources Sought
- NAICS
- 621512
— Diagnostic Imaging Centers
- Contracting Office
- Department of Veterans Affairs;Contracting Officer (101);VA Medical Center;325 New Castle Road, Bldg. 19;Butler PA 16001-2480
- ZIP Code
- 16001-2480
- Solicitation Number
- VA24410RI0357
- Response Due
- 8/30/2010
- Archive Date
- 9/29/2010
- Point of Contact
- Carol Callihan
- E-Mail Address
-
ct
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice only. The purpose of the notice is for market research to identify potential qualified contractors capable of providing the services listed herein. This is neither a solicitation announcement nor a request for proposals and does not obligate the Government to award a contract or to pay for any costs associated with a response to this notice. Responses to this notice identifying interest must be submitting in writing by August 30, 2010, 4:00 PM. To meet the requirements of the Clinical Laboratory Improvement Amendments(CLIA) of 1988, and VHA Handbook 1105.2, the Department of Veterans Affairs is seeking interest from qualified contractor who can provide a Nuclear Medicine Imaging Proficiency Testing Program. The imaging proficiency program is employed throughout VA's imaging services and those external medical facilities that provide nuclear imaging services to VA patients through contracts. All VHA and contracted sites must complete the proficiency process. Nuclear Medicine Imaging Proficiency Testing Program must be provided in accordance with Clinical Laboratory Improvement Amendments(CLIA) of 1988, and VHA Handbook 1105.2. In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA'88) as part of the Public Health Services Act (Title 42 United States Code (U.S.C.) 263a). This amendment codified into law requirements for the staffing, management, procedures and oversight of United States (U.S.) laboratories that perform testing used in the diagnosis, treatment and prevention of disease in patients. The Department of Health and Human Services (HHS) then published implementing regulations for CLIA'88, under Title 42, Code of Federal Regulations (CFR) Part 493. In 1992, Congress passed Public Law (Pub. L.) 102-139, Sec. 101(a), which exempted VHA from CLIA'88 and stated that the Secretary of Veterans Affairs would, in consultation with the Secretary of HHS, publish regulations that would " establish standards equal to that applicable to other medical facility laboratories in accordance with the requirements of Section 353(f) of the Public Health Services Act." NOTE: This requires VA laboratories to meet the requirements of CLIA'88, but left the enforcement and oversight of the regulations to VA. The CLIA regulations (42 CFR 493) have been and continue to be modified over time. Rather than revising and publishing VA regulations so that they are equal to 42 CFR 493, this Handbook substitutes 42 CFR 493 for those areas where VA regulations do not provide explicit guidance. All laboratory testing within VA used for the diagnosis, treatment, and prevention of disease in patients must be provided in compliance with the procedures outlined in this Handbook and meet the requirements of 42 CFR 493, CLIA'88. Laboratory testing, where applicable, must also meet the requirements of the following organizations: (a) The Joint Commission; (b) College of American Pathologists (CAP); (c) American Association of Blood Banks (AABB); (d) Food and Drug Administration (FDA); (e) Occupational Safety and Health Administration (OSHA); and (f) Nuclear Regulatory Commission (NRC). All laboratory testing, regardless of location, must undergo an on-site inspection by an approved accrediting agency. For this program, imaging proficiency is assessed by means of an "imaging phantom". A phantom may be defined as a specially designed simulator that is imaged to evaluate and analyze the performance of a nuclear medicine imaging staff and equipment. The phantom used to evaluate proficiency should appear similar to human tissues and organ. The purpose of the program is to evaluate the adequacy of the technologic capability of the devices employed, the skill of the technical staff performing the imaging procedure and the expertise of the physician who interprets the nuclear scan and renders an impression. 1. The vendor will furnish the specific phantom as approved by the Nuclear Medicine Program Office (the vendor may contract out for the fabrication of the phantom). 2. The vendor will complete the following administrative responsibilities: a. Annually, with input from the Nuclear Medicine Program Office, the vendor will develop and produce a nuclear medicine imaging phantom relevant to VA's patient population and imaging capabilities. b. Develop an instruction manual "Results Packet" to accompany the phantom, explaining in detail how the phantom is to be imaged and how the data is to be collected. Concurrence by the Program Director or designee is required prior to finalization of the Results Packet. c. Maintain an updated address list for all VAMCs that provide Nuclear Medicine services. Individual VAMC's will communicate with contractors and provide the phantom for implementation. d. Mail individual phantoms to each VAMC using a tracking system to assure delivery. e. Phantoms must be mailed no later than November 1 of each year, with a return date no less than three (3) weeks and no greater than six (6) weeks from the original send out date. f. The vendor will provide technical support by telephone for subscribers who have questions or difficulties imaging the phantom. g. In the case of defective phantoms, the vendor will send out replacement/s within 2 weeks of notification. h. The vendor will read and interpret the results of phantom images returned. i. The vendor will notify the NM program office of the names of facilities that have not responded within the given time frame. j. The vendor will provide at least 2 hours of continuing medical education (CME) credits to the participating physicians and VOICE credits to the participating technical staff. This exercise will be completed within 3 weeks of the closing date of the phantom exercise. k. The vendor will provide the following reports to the facilities: oWritten results of imaging performance by nuclear medicine laboratory to each participating VAMC, by July 15. oWritten results of physician-specific performance to each participating nuclear physician, by July 15. 3. An overall report "Subscriber Performance Review" providing both detailed facility results and summary information will be sent to National Headquarters, Office of the Program Director, Nuclear Medicine and Radiation Safety Service, Diagnostic Services, Patient Care Services, by August 31. This will include a comparison of the VA's results with the private sector facilities that participated in the particular exercise. Concurrence by the Program Director or designee is required prior to final release of the report.
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