Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 16, 2015 FBO #4983
DOCUMENT

Q -- OUTPATIENT LABORATORY SERVICES CSP - Attachment

Notice Date

7/14/2015
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Program Contract Organization East(PCOE);1100 1st Street, 7th Floor, Suite 732;Washington DC 20002
 

ZIP Code

20002
 

Solicitation Number

VA26815Q0116
 

Response Due

7/22/2015
 

Archive Date

7/22/2015
 

Point of Contact

Elaine F DiBucci
 

E-Mail Address

2-3432<br
 

Small Business Set-Aside

N/A
 

Description

The Massachusetts Veterans Epidemiology Research and Information Center, Cooperative Studies Program Coordinating Center (MAVERIC CSPCC), a national program under the Department of Veterans Affairs, Cooperative Studies Program (CSP), has a requirement to obtain the services of an outpatient laboratory service (Contractor) that has offices with widespread geographic distribution to collect up to three required blood specimens from a study participant following his/her angiography procedure if the participant is unable or unwilling to return to the VA medical center where the procedure took place. Blood specimens are collected for each participant at 4 (+/- 2) and 90 days following their angiography. The 90 day blood draw may be drawn up to 180 days following their angiography. A small number of participants will require a third blood draw between 90-180 days following their angiography. For further detail on this service please see the attached Statement of Work. This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (large business, small business, 8(a), SDVOSB, etc.), relative to NAICS code 621511 (size standard of $32.5M). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. Based on responses to this synopsis, the Government may issue this RFQ for these services on eBuy or Fed Biz Ops. Estimated Performance Period: Base Period:September 1, 2015 - August 31, 2016 Option 1: September 1, 2016 - August 31, 2017 Type of Contract: Firm Fixed Price This notice is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Wednesday, July 22, 2015, 4:00 PM, EST. Interest/capability statements may be sent to Elaine DiBucci at elaine.dibucci@va.gov and should include company name, address, point of contact, business size, and product information. No telephone responses will be accepted. This notice is to assist the Government in determining sources only. A solicitation is not currently available. If a solicitation is issued, all interested parties must respond to that solicitation announcement separately from the responses to this announcement. ? Statement of Work for Regional Phlebotomy Services VA CSP#578 Prevention of Serious Adverse Events Following Angiography I.Background The Massachusetts Veterans Epidemiology Research and Information Center, Cooperative Studies Program Coordinating Center (MAVERIC CSPCC) is a national program under the Department of Veterans Affairs, Cooperative Studies Program (CSP), that performs administrative, statistical and data management for national and international, multi-center clinical trials. The MAVERIC CSPCC is conducting a randomized, double-blind, multi-center clinical trial, CSP#578, "Prevention of Serious Adverse Events Following Angiography" at approximately 33 Department of Veterans Affairs Medical Centers nationally. The MAVERIC CSPCC is collaborating with The George Institute for Global Health in Australia to conduct the study at an additional 10-12 sites in Australia, New Zealand and Malaysia. CSP#578 will assess the comparative effectiveness of IV bicarbonate vs. IV saline and the benefit of oral N-acetylcysteine (NAC) vs. oral placebo in preventing clinically important, adverse outcomes in high-risk Veterans undergoing cardiac and non-cardiac angiography. In this trial, 6,680 participants in the United States are anticipated to be, scheduled to undergo coronary or non-coronary angiography will be enrolled if, at the time of angiography, they have underlying chronic kidney disease (CKD) with an eGFR <60 ml/min/1.73 m2 and a diagnosis of diabetes mellitus, or an eGFR <45 ml/min/1.73 m2 regardless of whether or not they have diabetes mellitus. An additional 1,000 participants will be recruited in Australia, New Zealand and Malaysia. Using a 2 x 2 factorial design, participants will be randomized to receive: 1) either IV isotonic sodium bicarbonate or IV isotonic saline and 2) either oral NAC or oral placebo. We will administer ?3 ml/kg of study IV fluid over ?1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5 ml/kg per hour during angiography, and ?6 ml/kg of study IV fluid over ?4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. NAC or placebo will be administered at a dose of 1200 mg orally to all participants 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days. We will assess the effectiveness of bicarbonate compared to saline and NAC compared to placebo for the prevention of a composite primary endpoint consisting of clinically significant, adverse events including death or need for acute dialysis within 90 days following the index angiography or a persistent decline in kidney function defined by an increase in serum creatinine (SCr) from the baseline value of at least 50% at 90 days following the index angiographic procedure. As a secondary outcome, we will assess differences in the development of contrast induced acute kidney injury (CIAKI), defined by an increase in SCr of at least 0.5 mg/dL and/or 25% at 96 hours following angiography. Baseline Scr will be measured following participant enrollment and immediately prior to the initiation of study IV fluids and administration of study drug capsules. Serum creatinine will also be measured at 96 hours and 90 days following angiography. Participants experiencing a 50% increase between their baseline and 90 day Scr measurements will have a repeat Scr measurement taken for confirmation. We postulate that the absolute effect of each intervention will be a 2.18% absolute reduction (25% relative reduction) in 90-day events from a baseline event rate of 8.7%. The current study duration is 42 months which includes 30 months of participant recruitment. All participants will be actively followed for 90 days and then passively at 12 months to ascertain the development of end stage renal disease and death. The trial began recruitment in the United States in the 3rd quarter of 2013. As of May 2015, total enrollment is approximately 2100 participants in the United States, Australia,New Zealand and Malaysia. Based on current enrollment rates, we anticipate that enrollment will continue until approximately July 2018. II.General Description of Service The purpose of this agreement is to obtain the services of an outpatient laboratory service (Contractor) that has offices with widespread geographic distribution to collect up to three required blood specimens from a study participant following his/her angiography procedure if the participant is unable or unwilling to return to the VA medical center where the procedure took place. Blood specimens are collected for each participant at 4 (+/- 2) and 90 days following their angiography. The 90 day blood draw may be drawn up to 180 days following their angiography. A small number of participants will require a third blood draw between 90-180 days following their angiography. Approximately thirty-three VA medical centers across the United States will be recruiting patients for this study with anticipated enrollment extending until approximately July 2018 and follow-up visits through October 2018. The purpose of this agreement is to obtain an organization/laboratory service that has vast number of locations around the country that can provide phlebotomy services to participants, at multiple time points, during the life of the study to reduce the travel burden of participants who do not live in proximity to the treating VA medical center. These samples will undergo processing at the laboratory office site at which the blood was collected prior to shipping the sample(s) to the VA medical facility at which the participant received their angiogram. A listing of all available laboratory office sites with phlebotomy services will be provided to the VA with contact information and hours of operation that the study staff at the VA medical centers can use to inform participants where they may go for sample collection. Due to the requirement for samples to be collected at a specified time after the index angiographic procedure, it is preferable that the phlebotomy service have the ability to collect the specimens on weekend days. The samples will need to be collected by certified phlebotomists, processed, packaged and promptly returned to the study staff at the VA Medical Center who made the request. III.Work Requirements a.Development of agreements and requirements Pre-field activities to be completed by the Contractor include meeting (in person or via teleconference) with MAVERIC CSPCC study team staff, attend study meetings (if required), reviewing VA study regulatory and fiscal requirements, and providing details to the CSP#578 Study Team on how specimen collection and processing will be accomplished. The Contractor is required to provide a point of contact for this contract. This person must be identified in advance and any changes to this position must be submitted in writing to the Contracting Officer's Technical Representative (COTR). b. DeliverablesDue: within one month of award The Contractor shall: "Provide the name and contact information for their point of contract (POC) to the MAVERIC CSPCC "Work with the MAVERIC CSPCC, CSP#578 Study Team's to define specific study procedures around blood specimen scheduling, collecting, processing, shipping, and reporting procedures. "Send a representative(s) to study meetings (as required) "Samples must be processed, packaged, and shipped in accordance with agreed shipping procedures. c.. Blood collection procedures 1.Study staff at the participating VA research site will inform the study participant where s/he may go to have blood collected and will provide a laboratory order form with the participant's name, date of birth, the number of 10 ml serum separator tubes to be collected (one or two), the number of 10 ml plasma separator tubes (zero or one) and the VA Medical Center address where the specimen should be sent. All sites will require one serum separator tube for the 90-day collection, but for the 4-day collection some sites will require two 10 ml serum separator tubes, while other sites require one serum separator and one plasma separator tube. 2.The Contractor should provide a means for the study coordinator to identify the blood-draw site(s) closest to the patient's residence that can collect specimens and the hours of availability. Possible methods of communicating this information include a web-based listing or a point-of-contact person(s) at the Contractor's office. 3.The Contractor must ensure that phlebotomy sites are adequately supplied with blood collection, processing and shipping materials that will meet study requirements for the visit. These materials would include blood collections supplies, centrifuge for sample processing and International Air Transportation Association (lATA) and and Department of Transportation (DOT) compliant shipping supplies for biological samples, including gel filled freezer packs. 4.The Contractor's staff will: a.Verify the study participant's full name and date of birth b.Draw the required blood specimen c.Label the tube(s) with the participant name, date of birth, date, and time drawn d.Centrifuge the tubes e.Package the tubes for shipping with the chilled freezer packs f.Ship samples back to the designated contact(s) from the study team at the VA Medical Center that had originally made the request. Blood specimens must be shipped according to International Air Transportation Association (lATA) requirements and Department of Transportation (DOT) biological shipment requirements. i.Specimens collected Monday through Thursday should be shipped to arrive next day. ii.Specimens collected Friday, Saturday or Sunday should be centrifuged and stored in a refrigerator (2-8 degrees C) until they can be shipped on Monday. The contractor will be responsible for providing refrigerated storage for those specimens. iii.Shipping charges from the blood-draw site to the VA Medical Center will be covered by the Contractor. g.Notify the designated contact(s) from the study team that the blood draw has been completed and that the specimen has been shipped including the name of the shipper and the tracking number for the shipment. 5. Once the Contractor's staff has shipped the package and confirmed it was delivered to the VA site in person, he/she will destroy any participant contact information IV.Proposal Requirements The proposal should be limited to a paragraph for discussion and description of each of the required items listed below: "Contractor's staff performing phlebotomy shall be licensed healthcare providers with qualifications (e.g.., RN, LPN) to perform phlebotomy or shall have a phlebotomy certification through an organization that is accredited or approved by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), uses materials and examinations that reflect CLSI standards, and qualifies graduates for an examination through an external certification agency. Training must include how to handle adverse effects of blood draws such as discomfort, bruising, pain, and loss of consciousness. "Contractor must use materials and examinations that reflect Clinical Laboratory and Standards Institute(CLSI) standards. "Contractor must have current knowledge of federal privacy, data security, and risk management procedures and practices. "Contractor must include in their proposal a staffing plan for this project to include a project manager to oversee this project. The staffing plan will demonstrate a knowledge of effective organizational structure, management, and how best to utilize personnel. "Contractor must be able to provide broad geographical coverage at sites a substantial distance from the study sites listed below. The study sites are tertiary medical centers to which patients are referred and study participants will preferentially use the contractor's phelobotomy service in their local community rather than returning to the study site for blood collection. As a condition of this offering the contractor shall provide a listing of all available laboratory office sites with phlebotomy services as well as a geospatial map of the sites. ? " STATESites ARLittle Rock AZTucson CAPalo Alto CASan Francisco CALos Angeles FLBay Pines FLGainesville GAAtlanta GAAugusta ILChicago INIndianapolis MABoston MIAnn Arbor MNMinneapolis MOKansas City MOSt. Louis NCDurham NMAlbuquerque NYNew York NYBuffalo OHCincinnati OHCleveland OHDayton OKOklahoma City ORPortland PAPittsburgh SCCharleston TNMemphis TXDallas TXHouston UTSalt Lake City VARichmond VASalem WASeattle o Contractor must provide a contact number that is available for participating VA Medical Centers to use (at a minimum) Monday through Friday 8:00am- 6:00pm for the purpose of identifying phlebotomy sites. A secure web-based process for identifying phlebotomy sites and placing orders is preferred but not required. o Although not a requirement, the capability to collect specimens on weekends and holidays is desirable. o The contractor shall submit in their proposal their plan for specimen storage for specimens collected on Friday, Saturday or Sunday which cannot be shipped until Monday. o Contractor must be able to centrifuge specimens prior to shipping. o Contractor must have procedures in place for documenting deviations from the procedures outlined in their proposal and the statement of work. The submitted proposals will be reviewed by a subcommittee made up of members of the MAVERIC CSPCC and the CSP#578 Executive Committee having experience in blood collection, processing and shipping procedures. The award will be based on the responding laboratory's experience, response to the proposal requirements and cost. V.Performance Period The CSP#578 study will be ongoing for 12 base months of which 12 months will entail participant recruitment and one 12 month option period (if funded). Participants will be actively followed for 90 days. The projected period of performance for the phlebotomy service is from the study start date to four months after the last participant is recruited which would be in the second quarter of 2018. VI.Type of Contract Indefinite Delivery Indefinite Quantity (IDIQ) samples, Firm Fixed price (FFP per sample collection. Cost reimbursement (Travel to study meetings when requested.) VII.Travel If required, a representative may be requested to also attend the annual study meetings after the first year to report on procedural issues related to the blood collection. Travel and per diem shall be reimbursed in accordance with Subpart 31.2 of the Federal Acquisition Regulations. Reimbursement of travel costs shall be made when the contractor submits an invoice for travel along with supporting documentation (receipts as required by Federal Travel Regulations). Expenses for subsistence and lodging shall be reimbursed to the contractor only to the extent that overnight stay is necessary and authorized for performance of services under this task order at the per diem rates authorized by the Federal Travel Regulations in effect at that time. VIII.Publications All presentations and publications from this study will be done in accordance with current CSP guidelines. The presentation or publication of any or all data collected by participating investigators on participants entered into the VA Cooperative Study is under the direct control of the study's Executive Committee. This policy is applicable whether the publication or presentation is concerned with the results of the principal undertaking or is associated with the study in some other way. No individual participating investigator has any inherent right to perform analyses or interpretations or to make public presentations or seek publication of any or all of the data other than under the auspices and approval of the Executive Committee. All clinical study reports and journal manuscripts must also be reviewed and approved by the MAVERIC CSPCC Director prior to submission for publication. Any presentation or publication, when formulated by the Executive Committee or its authorized representatives, should be circulated to all investigators participating in manuscript preparation for their review, comments, and suggestions at least four weeks prior to submission of the manuscript to the presenting or publication body. All publications must give proper recognition to the study's funding source, including the Department of Veterans Affairs, and should list all investigators in the study. IX.Ownership of Data and Documents Subject to the publications clause, all documents, protocols, data, know how methods, operations, formulas, confidential information and materials provided to the central laboratory are and shall remain VA property. Copies of any documents referenced herein shall be returned to the VA, CSP upon request within 14 days of such request. X.Termination of CSP#578 XI.Invoicing An invoice will be submitted quarterly in arrears listing the de-identified participant ID# and date of test. The invoice will be reviewed by the MAVERIC CSPCC and any discrepancies will be communicated with the vendor. The MAVERIC CSPCC will be responsible for verifying and certifying all costs prior to payment. Invoices will be sent to: Boston VA Healthcare System MAVERIC (151MAV) CSP 578 COR 150 South Huntington Ave Boston, MA 02130 The prices for the required services as outlined in this statement of work are hereby stated in Table 2: XII.Additional Requirements The responsibilities of the Contracting Officer (CO) are to administer the contract and ensure that the contractor performs in accordance with contract documents. The CO is the only responsible official for the Government in all contractual matters that involve change, direction, work performance, time and money. All correspondence and any questions shall be directed to the CO for advisement. Any technical questions pertaining to this contract should be directed to the Contracting Officer's Representative (COR) as delegated by the CO. (Refer to the Delegation of Authority issued after award). The COR has duties and limited responsibilities as detailed in the Delegation of Authority, which the Contractor is cautioned to read. The Contractor may be held liable if they follow direction for which the COTR has no authority to issue. The administrative business hours for the MAVERIC CSPCC are 9:00-5:00pm, Monday through Friday with federal holidays excluded. FY2015FY2016Total Number of samples Travel to meetings Technical Effort Subtotal Overhead (30%) GRAND TOTAL Detailed Budget for Regional Phlebotomy Service*
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/7a2604d62c616d4c801d85bb504f46b2)
 

Document(s)

Attachment
 

File Name: VA268-15-Q-0116 VA268-15-Q-0116.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2165698&FileName=VA268-15-Q-0116-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2165698&FileName=VA268-15-Q-0116-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03796077-W 20150716/150714235252-7a2604d62c616d4c801d85bb504f46b2 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |