Metabolic Stone Disease Testing Services
This is a SOURCE SOUGHT NOTICE in support of the VISN 1 Healthcare System with locations throughout New England, for market research purposes only to determine the availability of potential businesses with capabilities to provide the services described below. Potential offerors are invited to provide feedback via e-mail to Julie Lemire at Julie.Lemrie@VA.GOV. Responses will be used to determine the appropriate acquisition strategy for a potential future acquisition. All responses due by 08/20/2019, at 1500.
Potential contractors shall provide, at a minimum, the following information:
1) Company name, address, and point of contact, phone number, e-mail address, and DUNS.
2) Is your firm eligible for participation in one of the following small business programs? If so, please indicate the program. Anticipated North American Industry Classification System (NAICS) code is 621511 Medical Laboratory Testing. The largest a firm can be and still qualify as a small business for Federal Government programs is no larger than $32.5 Million.
[ ] yes [ ] no Small Business (SB)
[ ] yes [ ] no HUBZone
[ ] yes [ ] no Small Business 8(a)
[ ] yes [ ] no Small Disadvantaged Business (SDB)
[ ] yes [ ] no Women-Owned (WO) Small Business
[ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB)
[ ] yes [ ] no Veteran Owned Small Business (VOSB)
[ ] yes [ ] no Other (please specify)
3) What types of information is needed to submit accurate offers?
4) Provide a brief capability statement (Max 2 pages) with enough information to determine if your company can meet the requirement. The Capabilities Statement for this source sought is not expected to be a Request for Quotations, Request for Proposals or Invitation for Bids, nor does it restrict the Government to an ultimate acquisition approach, but rather the Government is requesting a short statement regarding the company s ability to provide the services outlined in the draft SOW below. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. Submission of capabilities statement will assist our office in tailoring the requirement to be consistent with industry standards. The capabilities will be evaluated solely for the purpose of determining to Set-Aside for the Small Business (SB) Community or to conduct as an Unrestricted Procurement. Other than small businesses may respond to this notice in the event the market does not indicate SB interest. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. The Government will not pay for information solicited. Respondents will not be notified of the results of the evaluation.
Note: Do not include Proprietary, classified, confidential, or sensitive information in responses.
Not responding to this Sources Sought does not preclude participation in any future or potential solicitation, or Request for Quotation. It is the intent of the VISN 1 Healthcare System to use the information gathered for market research purposes only. If a formal solicitation is released, it will be posted via the Federal Business Opportunity (http://www.fbo.gov).
DESCRIPTION OF THE REQUIREMENT:
Performance Work Statement (PWS)
General: Services are required to perform off-site metabolic stone disease testing and disease management services for the Department of Veterans Affairs Medical Centers in VISN 1 (herein referred to as VAMC) for determination of urinary stone-forming risk. The services shall be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).
Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to services as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.
Objectives:
Metabolic stone disease testing and disease management services for the determination of urinary stone-forming risk
At home access for collection of samples and diagnostic testing information
Electronic Algorithms to interpret testing for providers
Education and provider consultation
Outcome data feedback
Patient compliance support
All shipping/mailing costs
Scope:
The contractor shall provide all testing as outlined in this PWS (see test panel). For clinical laboratory samples, the VAMC shall provide a contractor provided requisition form containing at a minimum the patient s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider, sample type and date of birth (second identifier). For specialized testing, the VAMC shall provide a brief clinical history when necessary. CPT codes 8000-9000 shall be included as well as generic codes when new tests are implemented. New tests or products not identified may be added with the permission of the Contracting Officer (CO) and Contracting Officer s Representative (COR). Pricing shall be reviewed and determined to be fair and reasonable prior to ordering products or services.
Locations to be included in this contract:
VA West Roxbury 1400 VFW Parkway, West Roxbury, MA 02132;
VA Bedford, 200 Springs Road, Bedford, MA 01730;
VA Connecticut, West Haven Campus, 950 Campbell Ave, West Haven, CT 06516;
VA Newington (consolidated with West Haven) 555 Willard Ave, Newington, CT 06111;
VA Providence, 830 Chalkstone Ave, Providence, RI 02908;
VA Maine, 1 VA Center, Augusta, ME 04330;
VA Manchester, 718 Smyth Road, Manchester, NH 03104;
VA Central Western MA, 421 North Main Street, Leeds, MA 01060;
VA White River Junction, 215 North Main Street, White River Junction, VT 05009
General Information:
The Contractor Laboratory shall:
Perform testing services entirely upon their premises.
Accept the unique facility National Provider Identifier (NPI) number and not require an NPI for each individual ordering practitioner.
Not charge shipping or transportation fees
Perform analytical testing for VAMC patients for the tests defined in the test panel included in this PWS. The Contractor shall bill only for the tests specified in the request sent by the VAMC Laboratory service and that are contained in the test menu found in this PWS.
Provide a reference test manual, and report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations.
Provide VA and VAMC patients with appropriate laboratory supplies (urine collection containers, preservatives, patient instructions for collecting samples and shipping information).
Provide VAMC and VA patients with test protocol and procedures for collecting and transferring samples obtained.
Provide pick up service for urine collection container at the VISN 1 VA patient s home after completion of collection.
Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.
Provide all test result reports/consults immediately by fax to the send-out office of the sending VAMC and provide a secured web portal with capability to download patient reports in .pdf format. Contact information to be provided upon contract award.
Provide a consultation/laboratory result report containing the following information:
Patient s full name
Patient s date of birth
Patient s full social security number or unique hospital identification number
Ordering Physician s name
Date/time of specimen collection, when available
Date/time test completed
Test(s) ordered
Test result(s)
Flagged abnormal results - if applicable
Type of specimen/source
Any additional comments related to test provided by ordering physician, if applicable
Unsatisfactory specimen shall be reported with regard to its unsuitability for testing
VAMC Lab accession number, if supplied
VAMC submitting facility name
Patient location- if supplied
Date/time specimen receipt
Abnormal intervals/Toxic & therapeutic ranges - if applicable
Any other information the laboratory has that may indicate a questionable validity of test results.
VAMC facility account number
Contractor accession number
Contractor address
Contractor CLIA number
Reference intervals- if applicable
Testing laboratory name
Test results with interpretation and pertinent comments
Outcome data complete with cost savings and patient health status improvement information using outcome database for kidney stone formers
Supersaturation (index) calculations that have been documented and correlated with stone type
Sequential test reporting
Clinical history
Patient compliance reporting
Consult with VAMC on test results by telephone as needed.
Provide a printed or electronic Laboratory Manual containing the following information:
Testing methodology for a test must be defined in the laboratory user s manual
Department hours of operation
Accreditation
Technical Staff
Service Departments (Method of contacting, phone numbers, hours of availability)
Quality Assurance Information
Billing Procedures & fee schedules for services provided
Procedures and criteria for phoning reports and other important information
Report forms
Provide telephone number(s) and contact person(s) to be used by the VAMC to make specimen problem inquiries and problem solving on weekdays. *NOTE: Also include names and telephone number(s) of Technical Directors and Pathologists available for consultation.
Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VAMC upon adverse action by a regulatory agency.
Assign a specific local account representative.
Advise VAMC facility of any planned changes in methodology, procedure or reference ranges at least 14 days prior to changes. In the event that two-week notification is not possible due to emergency, contractor shall notify VAMC as soon as possible.
Not release patient s records that include test results to any person other than the ordering healthcare provider or VAMC Pathology and Laboratory Medicine staff member. All member records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient s records. This provision shall survive termination of the resulting contract award.
Certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).
Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the sending VAMC site laboratory administration and to the VISN1 Network Consolidated Laboratory office (NCL). The reports shall be in Microsoft excel format and include at a minimum the following column header: patient name, date of service, CPT code, test name/procedure, volume, cost per test, total cost. These reports shall be forwarded to the sending VAMC site and NCL within 30 days of the end of the quarter.
Exclusions:
No patient history, medication history, X-rays and other test results and information shall be transferred from VAMC to Contractor.
No patient questionnaire shall be distributed, collected or disseminated on behalf of Contractor.
The VAMC is solely responsible for providing medical interpretation and treatment to its patients. Reports and information provided by the contractor are intended for the sole use of VAMC.
Test Panel - Diagnostic testing and kidney stone disease management program panel
Total Estimated Annual Volume = 138 Full Panel Tests done on 24-hour urine samples.
Ca 82340
Oxalate 83945
Uric acid 84560
Citrate 82507
Na (sodium) 84300
Mg (magnesium) 83735
Creatinine 82570
Phosphorous 84105
Cl (chloride) 82436
K (potassium) 84133
pH 83986
Sulfate 84392
Ammonia 82140
Cystine 82615
Urea Nitrogen 84540
Supersaturation Calculation
Written report with comments
Consultation
Outcome (Cost savings and patient health status improvement)
Sequential Test Reporting
Patient Compliance Reporting
Licensing and accreditation Contractor Laboratory:
1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law.
2. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory s Laboratory Director(s) and/or Medical Director(s).
3. Medical Director(s) shall have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards.
4. Personnel assigned to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.
5. Shall comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS).
6. Shall notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.
7. Shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.
Contract Performance Monitoring:
Quality Control: The contractor must operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with this PWS. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract.
The VAMC shall maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VA Medical Center and may include, but is not limited to , unidentified split specimens sent periodically to the contractor for testing, split specimen sent to another reference laboratory for comparison, licensing and clinical information return.
The contractor s facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the VAMC during the life of the contract.
Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required for performing the type of services described herein. 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 has performed in accordance with the performance standards. It defines how the performance standards shall be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).
Federal Holidays: (The contractor does not have to perform on these holidays)
New Year s Day Labor Day
Martin Luther King Jr. s Birthday Columbus Day
President s Day Veteran s Day
Memorial Day Thanksgiving Day
Independence Day Christmas Day
Hours of Operation: The contractor is responsible for providing services 8:00 am-4:30p, EST Monday Friday. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract.
Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contractor laboratory. Each specimen that is lost by the contractor laboratory shall incur a charge of $100.00 and shall be credited to the Government on the monthly invoice.
Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend a post award conference convened by the contracting activity in accordance with Federal Acquisition Regulation Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the Contracting Officer shall apprise the contractor of how the government views the contractor's performance and the contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.
Contractor Program Manager: The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons
Identification of Contractor Employees: All contract personnel attending meetings and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.
Continuing Education: Contractor may provide either online educational sessions (webinar, webcast etc.) or in person at a central location designated by the Program Manager of the Network Consolidated Laboratory (NCL) at a mutually agreeable date/time. These educational sessions shall include educational/scientific updates related to Laboratory Medicine or other appropriate topics and shall be customized to meet the needs of the VA Pathology and Laboratory Medicine Service and Clinical Staff. Presentations shall be provided to the NCL Program Office at least two days prior to session commencement. No proprietary or promotional materials shall be included in the educational presentations
Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work as outlined in this contract.
Julie Lemire
Contracting Officer
603-629-3293
Julie.Lemire@va.gov
Contracting Officers Email address
