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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 12, 2017 FBO #5560
DOCUMENT

Q -- Referral Laboratory Services for Meidcal Genetic Testing - Attachment

Notice Date

2/10/2017
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Brockton Campus;940 Belmont St;Brockton, MA 02301
 

ZIP Code

02301
 

Solicitation Number

VA24117N0187
 

Response Due

2/17/2017
 

Archive Date

5/18/2017
 

Point of Contact

Gina Petrino
 

E-Mail Address

etrino@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

Department of Veterans Affairs Veterans Health Administration Sources Sought Notice Obtain Next Generation Sequencing/Genetic testing for VISN 1 VAMC Labs 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 Notice. 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 to obtain services to perform off-site Next Generation Sequencing/Genetic testing for the Department of Veterans Affairs Medical Center, VA VISN 1 Laboratories (herein referred to as VAMC). 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 the Performance Work Statement (PWS). Contactor 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 the PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Objectives: Obtain Next Generation Sequencing/Genetic testing as described in Gene Panels 1 through 7, below. Scope: The contractor shall provide testing as outlined in this performance work statement (see test menu). For clinical laboratory samples, the VAMC will provide either an electronic generated patient worklist or 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 will provide a brief clinical history when necessary. CPT codes 8000-9000 shall be included as well as generic codes when new tests are implemented. Locations: VA West Roxbury 1400 VFW Parkway, West Roxbury, MA 02132; General Information: Amyotrophic Lateral Sclerosis 27 Gene Panel must include: ALS2 (606352), ANG (105850), ATXN2 (601517), C9orf72 (614260), CHCHD10 (615903), CHMP2B (609512), DCTN1 (601143), ERBB4 (600543), FIG4 (609390), FUS (137070), HNRNPA1 (164017), MAPT (157140), MATR3 (164015), NEFH (162230), OPTN (602432), PARK7 (602533), PFN1 (176610), PRPH (170710), PSEN1 (104311), SETX (608465), SIGMAR1 (601978), SOD1 (147450), SQSTM1 (601530), TARDBP (605078), UBQLN2 (300264), VAPB (605704), VCP (601023). Spinal Muscular Atrophy 16 Gene Panel must include: AR (313700), ASAH1 (613468), ATP7A (300011), DNAJB2 (604139), HSPB1 (602195), HSPB3 (604624), HSPB8 (608014), IGHMBP2 (600502), PLEKHG5 (611101), SLC52A2 (607882), SLC5A7 (608761), SMN1 (600354), SMN2 (601627), UBA1 (314370), VAPB (605704), VRK1 (602168). Comprehensive Muscular Dystrophy/Myopathy NextGen DNA Screening Panel (183 Genes) must include: AARS2 (612035), ACADS (606885), ACADVL (609575), ACTA1 (102610), ADCK3 (606980), AFG3L2 (604581), AGK (610345), AGL (610860), AGRN (103320), AIFM1 (300169), ALDOA (103850), AMPD1 (102770), ANO5 (608662), ATP2A1 (601003), B3GALNT2 (610194), B3GNT1 (605517), BAG3 (603883), BIN1 (601248), C10ORF2 (606075), C12orf65 (613541), CACNA1S (114208), CAPN3 (114240), CAV3 (601253), CCDC78 (614666), CFL2 (601443), CHAT (118490), CHCHD10 (615903), CHKB (612395), CHRNA1 (100690), CHRNB1 (100710), CHRND (100720), CHRNE (100725), CLCN1 (118425), CNBP (116955), CNTN1 (600016), COA5 (613920), COL4A1 (120130), COL6A1 (120220), COL6A2 (120240), COL6A3 (120250), COLQ (603033), COQ2 (609825), COQ6 (614647), COQ9 (612837), COX10 (602125), COX14 (614478), COX6B1 (124089), CPT2 (600650), CRYAB (123590), DES (125660), DMD (300377), DMPK (605377), DNA2 (601810), DNAJB6 (611332), DNM2 (602378), DOK7 (610285), DUX4 (606009), DYSF (603009), EARS2 (612799), EMD (300384), ENO3 (131370), FARS2 (611592), FASTKD2 (612322), FHL1 (300163), FKRP (606596), FKTN (607440), FLNC (102565), FOXRED1 (613622), GAA (606800), GBE1 (607839), GFER (600924), GFM1 (606639), GFPT1 (138292), GMPPB (615320), GNE (603824), GTDC2 (614828), GYG1 (603942), GYS1 (138570), HADHA (600890), HADHB (143450), HCCS (300056), HINT1 (601314), HNRNPA1 (164017), HNRNPA2B1 (600124), HRAS (190020), HSPG2 (142461), ISCU (611911), ISPD (614631), ITGA7 (600536), KBTBD13 (613727), KIF21A (608283), LAMA2 (156225), LAMP2 (309060), LARGE (603590), LDB3 (605906), LMNA (150330), LPIN1 (605518), MATR3 (164015), MEGF10 (612453), MGME1 (615076), MPV17 (137960), MRPL3 (607118), MRPS16 (609204), MRPS22 (605810), MTFMT (611766), MTM1 (300415), MTMR14 (611089), MTO1 (614667), MUSK (601296), MYF6 (159991), MYH14 (608568), MYH2 (160740), MYH7 (160760), MYH7B (609928), MYL2 (160781), MYOT (604103), NEB (161650), OPA1 (605290), PABPN1 (602279), PDSS1 (607429), PDSS2 (610564), PFKM (610681), PGAM2 (612931), PGK1 (311800), PHKA1 (311870), PLEC (601282), PNPLA2 (609059), PNPT1 (610316), POLG (174763), POLG2 (604983), POMGNT1 (606822), POMT1 (607423), POMT2 (607439), PRKAG2 (602743), PRKAG3 (604976), PTRF (603198), PUS1 (608109), PYGM (608455), RAPSN (601592), RBCK1 (610924), RMND1 (614917), RRM2B (604712), RYR1 (180901), SARS2 (612804), SCN4A (603967), SCO1 (603644), SCO2 (604272), SDHAF1 (612848), SEPN1 (606210), SEPT9 (604061), SGCA (600119), SGCB (600900), SGCD (601411), SGCG (608896), SGK196 (615247), SIL1 (608005), SLC22A5 (603377), SLC25A4 (103220), SLC37A4 (602671), SLC52A1 (607883), SLC52A2 (607882), SMCHD1 (614982), STIM1 (605921), SUCLG1 (611224), SURF1 (185620), SYNE1 (608441), SYNE2 (608442), TAZ (300394), TCAP (604488), TK2 (188250), TNNT1 (605355), TNPO3 (610032), TPM2 (190990), TPM3 (191030), TRIM32 (602290), TRMU (610230), TSFM (604723), TTN (188840), TUBB3 (602661), TUFM (602389), TYMP (131222), VCP (601023), YARS2 (610957). Charcot Marie Tooth Disease NextGen DNA Sequencing Panel (50 genes + mtDNA) must include: AARS (601065), AIFM1 (300169), ARHGEF10 (608236), BAG3 (603883), BSCL2 (606158), C12orf65 (613541), COX6A1 (602072), CTDP1 (604927), DHTKD1 (614984), DNM2 (602378), EGR2 (129010), FBLN5 (604580), FGD4 (611104), FIG4 (609390), GAN (605379), GARS (600287), GDAP1 (606598), GJB1 (304040), GNB4 (610863), HINT1 (601314), HK1 (142600), HSPB1 (602195), HSPB8 (608014), INF2 (610982), KARS (601421), LITAF (603795), LMNA (150330), LRSAM1 (610933), MED25 (610197), MFN2 (608507), MPZ (159440), MTMR2 (603557), NDRG1 (605262), NEFL (162280), PDK3 (602526), PLEKHG5 (611101), PMP22 (601097), PRPS1 (311850), PRX (605725), RAB7A (602298), SBF1 (603560), SBF2 (607697), SEPT9 (604061), SH3TC2 (608206), SLC12A6 (604878), TFG (602498), TRIM2 (614141), TRPV4 (605427), VCP (601023), YARS (603623). Whole mtDNA sequencing is also included and is reported separately. Hereditary Sensory and Autonomic Neuropathy and Hereditary Pain Syndromes NextGen DNA Sequencing Panel (20 genes) must include: ATL1 (606439), ATL3 (609369), CCT5 (610150), DHH (605423), DNMT1 (126375), DST (113810), FAM134B (613114), GLA (300644), IKBKAP (603722), KIF1A (601255), NGF (162030), NTRK1 (191315), SCN10A (604427), SCN11A (604385), SCN9A (603415), SPTLC1 (162400), SPTLC2 (605713), TRPA1 (604775), TTR (176300), WNK1 (605232). Parkinson disease/Parkinsonism NextGen DNA Screening Panel (89 genes) must include: ACMSD (608889), ADH1C (103730), AFG3L2 (604581), APOE (107741), APP (104760), ATP13A2 (610513), ATP1A3 (182350), ATXN2 (601517), BST1 (600387), C10ORF2 (606075), C19orf12 (614298), C9orf72 (614260), CCDC62 (613481), CHCHD10 (615903), CLN3 (607042), CP (117700), CSF1R (164770), CYP2D6 (124030), CYP2E1 (124040), DCAF17 (612515), DCTN1 (601143), DDC (107930), DNAJC5 (611203), DNAJC6 (608375), EIF4G1 (600495), FAM47E (HGNC34343), FBXO32 (606604), FBXO7 (605648), FMR1 (309550), FOXO1 (136533), FTL (134790), GAK (602052), GBA (606463), GBA2 (609471), GCH1 (600225), GIGYF2 (612003), GLIS1 (610378), GPNMB (604368), GRN (138945), HIP1R (605613), HLA-DRB5 (604766), HTRA2 (606441), KIF5A (602821), LAMP3 (605883), LRRK2 (609007), LYST (606897), MAPT (157140), MCCC1 (609010), MECP2 (300005), MED13 (603808), MPV17 (137960), MUL1 (612037), NPC1 (607623), PARK2 (602544), PARK7 (602533), PDGFB (190040), PDGFRB (173410), PINK1 (608309), PITX3 (602669), PLA2G6 (603604), PM20D1 (613164), POLG (174763), PRKRA (603424), PRNP (176640), PSEN1 (104311), PTEN (601728), PTS (612719), QDPR (612676), RAB7L1 (603949), SETD1A (611052), SLC20A2 (158378), SLC6A3 (126455), SMPD1 (607608), SNCA (163890), SNCB (602569), SPG11 (610844), SPR (182125), STBD1 (607406), STK39 (607648), STX1B (601485), SYNJ1 (604297), SYT11 (608741), TAF1 (313650), TARDBP (605078), TBP (600075), TH (191290), UCHL1 (191342), VPS35 (601501), WDR45 (300526). DEMYELINATING Charcot Marie Tooth Disease NextGen DNA Sequencing Panel (50 genes + mtDNA) must include: AARS (601065), AIFM1 (300169), ARHGEF10 (608236), BAG3 (603883), BSCL2 (606158), C12orf65 (613541), COX6A1 (602072), CTDP1 (604927), DHTKD1 (614984), DNM2 (602378), EGR2 (129010), FBLN5 (604580), FGD4 (611104), FIG4 (609390), GAN (605379), GARS (600287), GDAP1 (606598), GJB1 (304040), GNB4 (610863), HINT1 (601314), HK1 (142600), HSPB1 (602195), HSPB8 (608014), INF2 (610982), KARS (601421), LITAF (603795), LMNA (150330), LRSAM1 (610933), MED25 (610197), MFN2 (608507), MPZ (159440), MTMR2 (603557), NDRG1 (605262), NEFL (162280), PDK3 (602526), PLEKHG5 (611101), PMP22 (601097), PRPS1 (311850), PRX (605725), RAB7A (602298), SBF1 (603560), SBF2 (607697), SEPT9 (604061), SH3TC2 (608206), SLC12A6 (604878), TFG (602498), TRIM2 (614141), TRPV4 (605427), VCP (601023), YARS (603623). Whole mtDNA sequencing is also included and is reported separately. The Contractor Laboratory shall: Perform testing services entirely upon their premises. Accept VA generated manifests for patient test requisitions. Accept the unique facility National Provider Identifier (NPI) number and not require an NPI for each individual ordering practitioner. Perform analytical testing for VAMC patients for the tests defined in the test menu included in the 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 the PWS. Provide a reference test manual and report of analytical test results, upon award, describing the full scope of its laboratory operations. Provide VAMC with laboratory supplies (collection tubes, sample transport packaging, etc.) not customarily utilized by the VAMC. These supplies are to be used by the VAMC only in connection with specimens being sent for testing to the contractor. Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. Provide test result reports/consults immediately by fax to the send-out office of the sending VA. Contact information to be provided upon contract award. Provide a consultation/laboratory result report and at a minimum will contain 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 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 Testing laboratory name Consult with VAMC on test results by telephone as needed. Upon award, 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 VA Medical Center 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 VA 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 VA 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 VA 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 headers: patient name, date of service, CPT code, test name/procedure, volume, cost per test, total cost. The data shall be in the rows. These reports shall be forwarded to the sending VA site and NCL within 30 days of the end of the quarter. 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 the 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 the 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 shall operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with thePWS. The quality control program shall 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 VA Medical Center will 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, or monitoring of turn-around-time. 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 the 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 will 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 8:00am 4:30p EST Monday Friday, except for Federal Holidays identified above. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within the PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications shall be kept current with any change of personnel assigned to the 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 will incur a charge of $100.00 and will 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 Contracting Officer, Contracting Officers Representative (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 will apprise the contractor of how the government views the contractor's performance and the contractor will 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. Government Personnel: Will beprovided upon award. 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 Contracting Officer. 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. Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work as outlined in this contract. RESPONSE COMMITMENT I. NOTES: A. All questions, comments or concerns shall be directed to Gina.Petrino@va.gov B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility to participate 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 5 business days after this notice is published on 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. 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 Point of Contact: Gina Petrino Contracting Specialist Email: GinaPetrino@va.gov
 

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Document(s)

Attachment
 

File Name: VA241-17-N-0187 VA241-17-N-0187.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3268855&FileName=VA241-17-N-0187-000.docx)

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Record

SN04398833-W 20170212/170210234215-ac2a22604ff04041bd5b2cff342e52ea (fbodaily.com)
 

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