Notice Type: Presolicitation Notice

Posted Date: 18-MAR-15

Office Address: Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301

Subject: Q-- VISN 1 Testing Rheumatology, Renal, Pulmonary

Classification Code: Q - Medical services

Solicitation Number: VA24115N0298

Contact: Heather L SimpsonContract Specialist 508-254-2599 mailto:[email protected]

Description: Department of Veterans Affairs

VA Boston Healthcare System

Department of Veterans Affairs Boston Healthcare System

Department of Veterans AffairsVeterans Health Administration

Sources Sought Notice - Rheumatology, Renal and Pulmonary Testing

This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA's understanding of your company's offered services and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought.

This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products in response to the requirement described below. Vendors are being invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought.

The Veterans Health Administration (VHA) is seeking a vendor to provide special Rheumatology, Renal and Pulmonary Testing. Refer to the General Requirements section below for the requested service description. This Sources Sought is to facilitate the Contracting Officer's review of the market base, for acquisition planning, size determination, and procurement strategy.

GENERAL REQUIREMENTS

The contractor shall provide special Rheumatology, Renal and Pulmonary Testing.

Testing to include:

1. Anti Glomerular Basement Membrane (Anti GBM) CPT code 84181

2. Anti Neutrophil Cytoplasmic Antibody (ANCA) test panel to include c-Anca, p-Anca anti-MPO and Anti-PR3activity, CPT code 86021 x 2 and 88347

3. Anti PLA2R testing, CPT code 86021

VA Sites:

1. VA Boston, 1400 VFW Parkway, West Roxbury, MA 02132

2. VA Togus, 1 VA Center, Augusta, ME 04330

The CONTRACTING LABORATORY:

1. Shall perform consultation services entirely upon their premises.

2. Will provide faxed results as well as hard copy.

3. Shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.

4. Provide consultation report that includes the laboratory's name that performed the consultation, laboratory specific accession number, the date and time a specimen was collected, received by the laboratory and completed, and the pathologists signature and technologist initials where appropriate.

5. Shall certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VISN 1 site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

LICENSING AND ACCREDITATION- CONTRACTING LABORATORY

1. Shall have all licenses, permits, accreditation certificates required by law.

2. Shall be accredited by the CLIA or the College of American Pathologists.

3. Medical Director must be licensed Physician with suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards.

4. Must comply with the regulatory requirements of Centers for Medicare and Medicaid Administration.

QUALITY CONTROL:

1. Proficiency testing data will include challenged/failed, a list of tests outside of the +/- 2SD range for the past (2) years. CONTRACTING LABORATORY shall notify VA of any test outside +/- 2 SD range.

2. The VA will maintain an Internal Quality Control Program to monitor the quality of test results received from CONTRACTING LABORATORY.

RESPONSE COMMITMENT

I. NOTES:

A. All questions, comments or concerns should be directed to [email protected]

B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating in a future acquisition does not depend upon a response to this notice.

C. Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit).

II. TIMELINE :

A. This request will close on stated date within the FBO site.

III. Requested information:

Interested parties shall provide the following information in addition to your capability response:

A. Format:

1. MS Word or pdf format (please ensure email is under 5 mb)

2. Page limit - 2-4 pages (please make the response as brief and concise as possible)

3. Company name and Sources Sought number listed on each page

B. Specifics:

1. In your response, please provide the following information based on the requirement.

a. Your company's capability of fulfilling this requirement as it is described.

b. If you are submitting an equal product, please provide detailed information, specs, brochures, etc., for all of your equal items

2. Please also provide name of company, company address, a contact person's name, telephone number, fax number and email address.

3. DUNS number, and indicate if actively registered on System for award management (SAM)

4. Contractual vehicles the company holds, such as NAC or GSA schedules.

5. Socio-economic Status & NAICS Code: State the size of your company [e.g., 8(a) (including graduation date), HUBZone-certified small business, Service-Disabled Veteran-Owned small business, small business, large business, etc.].

Notes:

1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or otherwise, that a procurement action will follow. The Department of Veterans Affairs will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, The Department of Veterans Affairs reserves the right to contact any respondent to this notice for the sole purpose of enhancing The Department of Veteran Affairs understanding of the notice submission.

2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for content marked or designated as business confidential or proprietary which will be fully protected from release outside the government.

The Department of Veteran Affairs Contracting Office POC:

Heather Simpson

Contract Specialist

Email: [email protected]

Link/URL: https://www.fbo.gov/spg/VA/BoVAMC/VAMCCO80220/VA24115N0298/listing.html

...

Abuja — THE newly-launched Cardiac and Renal Centre at the State's University Teaching Hospital Annex in Gbagada is envisaged to reverse the human capital flight from the country's health sector.

Lagos State Governor Babatunde Fashola has officially commissioned the facility.

Ads by Google

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LAWRENCE, Mass., March 19, 2015 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of dialysis products, is proud to celebrate the second annual Home Hemodialysis Day today, March 19, 2015, during National Kidney Month. Observed annually on the third Thursday of March, this initiative is dedicated to raising awareness of home hemodialysis, including nocturnal therapy, with the NxStage® System One? and empowering dialysis patients to choose a therapy that is right for them. This evening in Boston, the city's iconic Zakim Bridge will be lit green in support of NxStage's awareness efforts and to commemorate Home Hemodialysis Day.

Home Hemodialysis Day provides a platform for home dialyzors and their care partners to share their experiences and stories with others to strengthen the home hemodialysis community.  To celebrate the day, NxStage is distributing green ribbons at dialysis centers across the country and highlighting inspiring patient stories at http://ww2.nxstage.com/patient-stories.html.  At the same time, the Company is encouraging patients and care partners to unite, spread the word and capture their support using the hashtag, #HomeHemodialysisDay. 

"With home nocturnal therapy, I get to live life on my own terms," said Robby Richardson of Savannah, GA who performs more frequent nocturnal therapy at home with the System One. "By doing my treatments while I sleep, I feel better and am able to maintain my full-time job teaching special education to high school students. Nocturnal therapy has worked so well for me that I've also gone back to my passion of leading ghost tours around the historic district in Savannah. Nocturnal therapy has allowed me to make dialysis work for my life, and not the other way around."

"We have made huge strides in advancing access to home hemodialysis care over the years, most recently receiving FDA clearance for the System One as the first and only machine approved for nocturnal therapy," said NxStage President, Joe Turk. "Still, only a tiny fraction of patients that could truly benefit have access today.  We are building on the tradition of National Home Hemodialysis Day to empower all of our patients to share their life-changing stories, and help others understand the significant clinical and quality of life benefits that our home hemodialysis therapies can offer."

For more information about the System One, or home nocturnal hemodialysis, please visit www.nxstage.com. To see Robby Richardson's personal account of his experience with home hemodialysis, please visit our YouTube page.

Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.

Additional Risks Associated with Nocturnal Home Hemodialysis Therapy
The NxStage System One may be used at night while the patient and care partner are sleeping. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep. Ancillary anticoagulant infusion pumps and fluid leak detection devices may be used to decrease certain risks for home hemodialysis treatments performed at any time, but NxStage requires the use of fluid leak detectors to identify leaks from the vascular access, Cycler and Cartridge when performing nocturnal therapy with the NxStage System One.

About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. http://www.nxstage.com/.

About NxStage Medical
NxStage Medical Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.

Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2014. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Media contact: 
Kristen K. Sheppard, Esq.
ksheppard@nxstage
Tel: (978) 332-5923

Logo - http://photos.prnewswire.com/prnh/20110503/MM94799LOGO

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nxstage-celebrates-second-annual-national-home-hemodialysis-day-300052789.html

SOURCE NxStage Medical Inc.

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LAVAL, QUEBEC--(Marketwired - March 19, 2015) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") reported today that it has successfully completed its PBI-4050 Phase Ib multi-dose clinical trial in patients with chronic kidney disease. ProMetic's orally active lead drug candidate, PBI-4050, was found to be safe and well tolerated without any serious adverse events reported.

The objectives of this, randomized, double-blind, placebo-controlled, multi-dose study were to demonstrate the safety and tolerability of PBI-4050 and to determine the pharmacokinetic profile of PBI-4050 following multiple oral doses over 10 days in patients with stage 3b or 4 stable renal impairment. The trial was conducted in 8 patients with 6 patients receiving PBI-4050 and 2 patients receiving matching placebo.

"We are pleased to see that the safety and pharmacokinetic profiles of our lead drug candidate remain unaffected by the severely impaired renal function in the patients tested", commented Dr. John Moran, ProMetic's Chief Medical Officer. "Since fibrosis is the pathological pathway leading to organ failure and death in many diseases of differing aetiologies and affecting various organs, we plan to test the efficacy of this drug in several of fibrosis-related conditions"

The Phase II clinical trial in patients suffering from the metabolic syndrome and the resulting Type 2 diabetes is scheduled for patient enrolment to commence in April, 2015 following the recent CTA clearance by Health Canada. PBI-4050 has also received an orphan drug designation status by the FDA for the treatment of Idiopathic Pulmonary Fibrosis ("IPF") and a phase II trial in IPF has been cleared by Health Canada and is scheduled to commence in the coming weeks.

Both phase II trials are 12 weeks, open-label, single-arm, exploratory Phase II studies to evaluate the safety and tolerability of PBI-4050 in 40 patients suffering from IPF and 12 to 36 patients suffering from the metabolic syndrome and the resulting type 2 diabetes. Both Phase II trials will gather data on the effects of PBI-4050 and will monitor each patient's progress against their own respective baseline.

Following the confirmation of PBI-4050's safety profile in both healthy volunteers and patients, the Corporation is expanding its clinical programs in both the US and EU in existing indications and in rare disease indications associated with fibrosis.

More on PBI-4050

PBI-4050 is an orally active lead drug candidate with excellent efficacy and safety profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is gradually replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates' anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases ("CKD"). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end stage renal disease or ESRD) leading to the need for maintenance dialysis or kidney transplant.

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe and Asia.

Forward-Looking Statements

This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic's Annual Information Form for the year ended December 31, 2013, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.

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