SOLICITATION NOTICE
Q -- NOTICE OF INTENT TO MAKE BPA AWARD
- Notice Date
- 9/17/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Western Regional Contracting Office, ATTN: MCAA W BLDG 9902, 9902 Lincoln Street, Tacoma, WA 98431-1110
- ZIP Code
- 98431-1110
- Solicitation Number
- W91YU0-10-T-0228
- Response Due
- 10/16/2010
- Archive Date
- 12/15/2010
- Point of Contact
- Ron Schreck, 253-968-5420
- E-Mail Address
-
Western Regional Contracting Office
(ron.schreck@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Western Region Contracting Office (WRCO), Madigan Army Medical Center, intends to award Blanket Purchase Agreements (BPAs) for a variety of Diagnostic Laboratory tests, for the following categories of products: See list below of required tests. Examples include, but are not limited to, the following: MPZ, MFN2, EGR2, NFL, SMA DNA, ATAXIA COMPLETE PROFILE, etc. This announcement is prepared in accordance with FAR Part 12 Commercial Items & FAR Part 13 Simplified Acquisition Procedures, and as supplemented with additional information included in this notice. This announcement constitutes the only notice of this action. A solicitation will not be issued. WRCO is requesting, pricing and other supplemental information for the various laboratory diagnostic tests from interested, FDA approved Vendors, both Large and Small Businesses. If the vendor is not an original equipment manufacturer (OEM), the vendor must provide evidence of an existing and continuing relationship with the OEM manufacturer(s) that demonstrates the vendors authority to distribute the OEMs products. The Primary NAICS Code is 621511 Medical Laboratories FSC Code is Q301 Medical Laboratory Testing.. To be eligible to receive an agreement with the federal government, interested parties must register in the Central Vendor Registration (CCR) online at www.ccr.gov The following provisions will be included in the established agreements: 52.212-1 Instructions to Offerors-Commercial Items; Addendum to 52.212-1 Instructions to Vendors; 52.212-2 Evaluation-Commercial Items; Addendum to 52.212-2 Evaluation Criteria; 52.212-3 Offerors Representations and Certifications- Commercial Items. Offerors must complete FAR 52.212-3 Offerors Representations and Certifications- Commercial Items or do so on-line at http://orca.bpn.gov. The following clauses apply to this acquisition: 52.204-7 Central Vendor Registration. 52.212-4 Contract Terms and Conditions Commercial Items; 52.212-5 Deviation Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items 52.219-28 Post Award Small Business Program Representation, 52.222-3, Convict Labor, 52.222-19 Child Labor Cooperation With Authorities And Remedies, 52.222-21, Prohibition of Segregated Facilities 52-222-26, Equal Opportunity, 52.222-35 Equal Opportunity for Special Disabled Veterans, 52.222-36, Affirmative Action for Workers with Disabilities, 52.222-37 Employment Reports on Special disabled Veterans, Veterans of the Vietnam Era, and Other eligible Veterans, 52.222-50 Combat Trafficking in Persons, 52.225-3 Buy American ActFree Trade, Agreements, 52.225-13 Restriction on Certain Foreign Purchases, 52.232-18 Availability of Funds, 52.232-33 Payment by Electronic Funds Transfer-Central Vendor Registration or 52.232-36 Payment by Third Party; 52.252-2 Clauses Incorporated by Reference. The following DFARS clauses apply: 252.212-7001 Deviation, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items; 252.225-7001, Buy American Act and Balance of Payments Program, 252.232-7003, Electronic Submission of Payment Requests, 252.247-7023, Transportation of Supplies by Sea 252.247-7023 with Alt III; 252.232-7010 Levies on Contract Payments, 252.211-7003 Item Identification and Valuation. The following Addendum to FAR 52.212-4(c) will also be included in the agreement: UNILATERAL CHANGES 1. The Contracting Officer may unilaterally reduce and/or de-obligate any quantities not supplied/performed at the end of the BPA call period. 2. Unilateral Modifications: The Government may make unilateral modifications considered administrative in nature. These include, but are not limited to, changes in the accounting and appropriation data, payment and issuing office addresses and other corrections that have no effect on the terms and conditions of the contract. Additionally added, (HIPPA) HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996, PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION ARMY ELECTRONIC INVOICING INSTRUCTIONS FOR REQUIRED USE OF WIDE AREA WORK FLOW OR CREDIT CARD PAYMENT INSTRUCTIONS WILL BE INCLUDED WITH EACH BPA CALL. The full text version of FAR provisions and clauses may be accessed electronically at www.arnet.gov/far STATEMENT OF WORK 1. General Specifications NON PERSONAL SERVICES The Contractor shall provide those diagnostic testing services shown on the attached list. The Government will ship via traceable means, those samples required for testing to the Contractor's facility. Sample will be accompanied with a written order specifying the tests to be performed. Contractor shall complete the test(s) ordered and return results within 14 calendar days after receipt of samples. All results shall be sent as a hard copy via the United States Postal Service. Requested and Panic/Critical/Alert results shall be faxed to the Madigan Army Medical Center, Department of Pathology at (253) 968-1105, immediately following analysis. See paragraph 3, below. 2. Specifications for Quality Standards 2.1. Accreditation: The Contractor's laboratory shall be currently accredited by the College of American Pathologists (CAP) and maintain accreditation for the duration of this contract. The laboratory shall also certify that it is in full compliance with the requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA 88) as they exist as of the date that the solicitation is issued, and provide a copy of any and all inspection reports involving compliance and certifications with CLIA 88. The Contractor shall also provide evidence of current CDC Interstate Licensure. The Contractor shall provide copies of all current accreditation and certification documents. Contractor shall notify MAMC immediately in the event of loss of any accreditation, certification or licensure. Loss of any accreditation, certification, or licensure may, at Madigan Army medical Centers discretion, be grounds for termination of the contract for cause. 2.2. Personnel: The Laboratory Director shall be a fully licensed MD or PhD who is an active, full time director. The Contractor shall have a full-time staff of in-house professional scientists and consultants at the MD and PhD levels, including a cytogeneticist. Medical doctors should have specialty or subspecialty boards in areas of expertise. 2.3. The Contractor shall, at no additional cost, provide MAMC with consultative service concerning interpretation of tests, value, and limitations of procedures offered and shall provide MAMC readily available access to the stated professionals to assist with interpretation of patient results and to make recommendations for additional tests. 3. Turnaround Times Turnaround times equal to or less than the times specified in the TAT Listing from receipt of specimen by contract laboratory is required. Abnormal results shall be faxed and/or e-mailed to both the Department of Pathology and the Department of the requesting physician immediately following analysis. All results shall be mailed to the Department of Pathology. All results require appropriate normal ranges or interpretive explanations. Each report shall be reviewed and signed by a Board Certified Laboratory Director. Written results reported as lost in the mail shall be re-mailed by the contractor at no additional cost. 4. The Contractor shall provide a catalog of services immediately following award, which lists specimen specifications, quantity of sample, shipping instructions and requisition forms at no additional cost. 5. Health Insurance Portability and Accountability Act (6 May 10) Introduction In accordance with DoD 6025.18-R Department of Defense Health Information Privacy Regulation, January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented. (a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R. Individual has the same meaning as the term individual in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g). Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E. Protected Health Information has the same meaning as the term protected health information in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract. Electronic Protected Health Information has the same meaning as the term electronic protected health information in 45 CFR 160.103. Required by Law has the same meaning as the term required by law in 45 CFR 164.103. Secretary means the Secretary of the Department of Health and Human Services or his/her designee. Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C. Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501. (b) The Contractor shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law. (c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract. (d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract. (e) The Contractor shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tmaprivacy/breach.cfm (f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware. (g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware. (h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information. (i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it. (j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524. (k) The Contractor shall make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government. (l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Governments compliance with the Privacy Rule. (m) The Contractor shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528. (n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528. General Use and Disclosure Provisions Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government. Specific Use and Disclosure Provisions (a) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor. (b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached. (c) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B). (d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1). Obligations of the Government Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions (a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520. (b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractors permitted or required uses and disclosures. (c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522. Permissible Requests by the Government The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause. Termination (a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract. (b) Effect of Termination. (1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below (2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information. (3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information. Miscellaneous (a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required. (b) Survival. The respective rights and obligations of Business Associate under the Effect of Termination provision of this Clause shall survive the termination of this Contract. (c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule. 6. CREDIT CARD PAYMENT INSTRUCTIONS This order will be paid by Government Credit Card. The current Government credit card is Visa. All cost associated with the use of the credit card i.e. transaction fees, must be included in the price for the appropriate CLIN. See FAR 52.232-36. Credit card charges will not be processed until the invoice has been certified and the cardholder has authorized payment. If total amount differs from amount stated within this contract, Logistics Division will submit a copy of the invoice to this office and the contract will be modified accordingly. REQUIRED TEST LIST Ahtena Test #Required Test(s)Est. Annual Req. 102SMA DNA Test2 112Nabferon Antibody Test2 247PMP22 DNA Sequencing2 297Dominant CMT eval4 368NeoComplete Paraneoplastic profile w/ Recombx4 470MuSK antibodies test4 519Mito Myopathy Eval2 520Complete Tuberous Sclerosis Evaluation4 527Complete Hereditary Spastic Paraplegia Eval2 593Spinocerebellar ataxia type 14 (SCA14)6 515Leber's hereditary optic neuropathy (LHON) mtDNA Evaluation2 599Ataxia Complete Profile2 363NeoCerebellar Degeneration Paraneoplastic profile w/ recombx4 105SCA3-Machado-Joseph Disease-DNA test2 126Complete Myotonic Dystrophy Evaluation2 275SensoriMotor Neuropathy Profile Complete2 371Spinocerebellar ataxia type 1 (SCA1)2 372Spinocerebellar ataxia type 2 (SCA2)2 373Spinocerebellar ataxia type 6 (SCA62 384Spinocerebellar ataxia type 8 (SCA8)2 387Spinocerebellar ataxia type 10 (SCA10)4 388Spinocerebellar ataxia type 17 (SCA17)4 405Facioscalpulohumeral muscular dystrophy (FSHD) DNA test4 493Aprataxin- APTX DNA Sequencing Test4 515Leber's hereditary optic neuropathy (LHON) mtDNA Evaluation2 530SPG4 DNA Sequencing test2 580Limb girdle muscular dystrophy evaluation2 626Primary Torsion Dystonia (DYT1) DNA test2 421Complete CADASIL Evaluation2 170ADmark Profilee1 109ADmark ApoE Genotype A & Ie1 172Admark Tau/AB42 CSF A & Ie1 174Admark Asymptomatic/Symptomatic PS-1 A & Ie1 521TSC1e1 522TSC2e1 523TSC Familial Mutatione1 416Progressive Myoclonus Epilepsy Evaluatione1 415Lafora Disease Evaluatione1 411EPM2Ae1 412EPM2Be1 410EPM1e1 535SCN1A DNA Sequencing Teste1 320Connexin 26 DNA Sequencing Teste1 327OtoDx Aminoglycoside Hypersensitivity Teste1 328OtoDx Sensorineural hearing Loss Profilee1 142Rett Syndrome (MECP2) DNA Sequencing Teste1 141ARX DNA Sequencing Teste1 104Fragile X DNA Teste1 706Chromosome Analysis with Fragile X DNAe1 704Chromosome Analysis - Routinee1 630Norrie Disease DNA Teste1 531Atlastin (SPG3A)e1 532NIPA1 (SPG6)e1 117Kennedy's Disease (SBMA) DNA Teste1 620Familial Amytrophic Lateral Scerosis (S0D1) DNA Teste1 595Autosomal Dominant Ataxia Evaluatione1 402Chorea Diferential Evaluatione1 374SCA7e1 594SETXe1 401DRPLAe1 119Friedeich Ataxia DNA Teste1 116Huntington's Disease DNA Teste1 550Parkinsonism Evaluatione1 541Parkin DNA Teste1 542PINK1 DNA Sequencing Teste1 106FXTAS DNA Teste1 101Duchenne/Becker Muscular Dystrophy DNA Deletion Test e1 103Duchenne/Becker Muscular Dystrophy DNA Carrier Test e1 100Dystrophin Teste1 108DM1 DNA Teste1 110DM2 DNA Teste1 561Dysferlin Blood Teste1 562 FKRP DNA Sequencing Teste1 563Calpain 3 DNA Sequencing Teste1 300OPMD DNA Teste1 500Mitochondrial Enzyme Deficiency Myopahty Panele1 501Myoglobinuria Test Panele1 502Glycogen Storage Myopathy 'A' Panele1 503Glycogen Storage Myopathy 'B' Panele1 504Lipid Storage Myopathy Profilee1 517MELAS mtDNA Evaluatione1 518MERFF mtDNA Evaluatione1 516NARP mtDNA Evaluatione1 514KSS/CPEO mtDNA Profilee1 635Neurofibromitosis Type 2 DNA teste1 600Peroxisomal Disorders Teste1 124NeoEncephalitis Paraneoplastic Profile with Recombxe1 478NeoSensory Neuropathy Paraneoplastic Profile with Recombxe1 118CARe1 122MaTae1 123CV2e1 115Rie1 120Hue1 125Yoe1 127Zic4e1 475LEMS Antibody Teste1 263Sensory Neuropathy Profile-xpe1 274Motor Neuropathy Profile Completee1 276Multifocal Neuropathy Evaluatione1 234Small Fiber Painful Axonal Neuropathy Profilee1 270Co-GM1 Triad Antibody Teste1 145MAG Dual Antigen Antibody Teste1 261GALOP Antibody Teste1 210Sulfatide Antibody Teste1 160GQ1b Antibody Teste1 390Complete CMT Evaluatione1 391Partial CMT - Demyelinating Onlye1 392Partial CMT - Axonal Onlye1 294Partial CMT - Recessive Onlye1 243Complete HNPP Evaluatione1 286Complete Dejerine - Sottas Neuropahty Evaluatione1 326Chronic Demyelinative Neuropathy Profilee1 245Congenital Hypomyelination Evaluatione1 296Entrapment Neuropathy Evaluatione1 235Amyloidosis Evaluatione1 133Connexin 32e1 222LITAF/SIMPLEe1 134MPZe1 223MFN2e1 248EGR2e1 221GDAP1e1 239Periaxine1 249NFLe1 131PMP22 Dup/Dele1 90THROMBOGENE V Test (Factor V)e1 98THROMBX Evaluation Profile Ie1 99THROMBX Evaluation Profile IIe1 113Botulinum Toxin Type A Antibody Teste1
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- Place of Performance
- Address: Western Regional Contracting Office ATTN: MCAA W BLDG 9902, 9902 Lincoln Street Tacoma WA
- Zip Code: 98431-1110
- Zip Code: 98431-1110
- Record
- SN02286080-W 20100919/100917234849-08f07337e81312647e854e7273feadda (fbodaily.com)
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