SOLICITATION NOTICE
J -- US-797 Recertification of the IV hoods, pharmacy department
- Notice Date
- 6/29/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 561210
— Facilities Support Services
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Center San Diego, Bldg 1, 34800 Bob Wilson Drive, San Diego, California, 92134-5000, United States
- ZIP Code
- 92134-5000
- Solicitation Number
- N0025917Q0125
- Archive Date
- 8/31/2017
- Point of Contact
- Christopher J. Jennen, Phone: 6195328100
- E-Mail Address
-
christopher.j.jennen.civ@mail.mil
(christopher.j.jennen.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the information in FAR Subpart 12.6, using Simplified Acquisition Procedures for commercial items found at FAR 13, as supplemented with the additional information included in this notice. This announcement constitutes the only solicitation; a written solicitation will not be issued. The Request for Quotation (RFQ) number is N0025917Q0125. The North American Industry Classification System (NAICS) code is 561210 and the Small Business Standard is $38.5M. This is a small business set-aside solicitation. The proposed contract is 100% set aside for small business concerns. The Small Business Office concurs with the set-aside determination. This COMBINED SYNOPSIS/SOLICITATION documents and incorporates provisions and clauses in effect through FAC 2005-95 and DFARS Publication Notice 20161222. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/far/ and http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This combined synopsis/solicitation SHALL be posted on FEDBIZOPPS. The Naval Medical Center San Diego (NMCSD) has a request to purchase services for the recertification of the IV hoods located in the pharmacy department IAW the attached Statement of Work (SOW). The base contract period will be from 21 July 2017 - 20 July 2018, with four (4) one (1) year option periods. NMCSD requests responses from qualified sources capable of providing Semi-annual pharmacy hood, surface, air, US-797 testing IAW the SOW: CLIN Description Qty Unit Price Period of Performance: 21 July 2017 - 20 July 2018 Main Pharmacy/Chemo and Ante Room: 0001: Leak Testing and airflow volumes of ceiling HEPA Filter 16 ea $ 0002: Control Environment Monitoring; includes room pressures. Supply/exhaust airflow volume readings and room air exchange rates 02 ea $ 0003: Non-viable Counting of Buffer Room, Ante Room and Chemo Room per IS07 at 0.5um. Includes Temp/rH 06 ea $ 0004: Certification of Biological Safety Cabinet-Includes Leak testing of HEPA Filers, Airflow Velocity Measurements and Site Assessment Test (Bldg 3 Chemo Lab (SN# 100930869) Bldg 1 Main Pharmacy 04 ea $ 0005: Non-Viable Particle Counting of Biological Safety Cabinet Per ISO5 at 0.5um. Includes temp/rH (SN#25-15-BR-1818) 04 ea $ 0006: Certification of Laminar Flow Hood- includes Leak Testing of HEPA Filter and Airflow Velocity Measurements Bldg 1 Main Pharmacy (SN#156131040913; 156132040913; 156042040313) 06 ea $ 0007: Non-Viable particle Counting of Laminar Flow Hood Per ISO5 at 0.5um. Includes temp/rH (SN#156131040913; 156132040913; 156042040313) 06 ea $ 0008: Testing of Isolator - Includes Leak Testing of HEPA filter, Airflow Velocity Measurements, Pressure Test, and Ingress/Egress Test (Bldg 1-3rd Fl NICU Pharmacy SN#1405721012101), (Bldg 1-4th Fl ICU Pharmacy SN#140573101210), (MOR Bldg 1-4th Fl, SN#156436042413) 06 ea $ 0009: Testing of Isolator includes Leak Testing of HEPA, Pressure Test. (Bldg 1 -Main Pharmacy/Chemo Room SN#0113-EMPA-B45) 02 ea $ 0010: Non-Viable Particle Counting of (4) Isolator Per ISO5 at 0.5um. Inludes temp/rH - (Main Chamber and interchange) 08 ea $ 0011: Airborne Viable Sampling - Includes: 2 samples in each of the Hoods in the Main Pharmacy (4 hoods total) = 8 samples. 4 samples in the Buffer/Chemo, 2 samples in the Ante Room. Total Samples = 15 30 ea $ 0012: Surface Viable Sampling Includes: 2 samples in each of the hoods in the Main Pharmacy (4 hoods total) = 8 samples 4 samples in the Buffer/Chemo, 2 samples in the Ante Room, 1 control sample. Total Samples = 15 30 ea $ 0013: Airborne Viable Sampling includes: (3) Samples total in the Main Chamber & In the pass Thru Chamber on each Isolator SN# 1405721012101, 140573101210) SN# 0113-EMPA-B45 only 2 samples SN#156436042413 11 samples in the Isolators 1 Control sample Total Samples = 12 24 ea $ 0014: Surface Viable Sampling includes: (3) Samples in the Main Chamber & Pass Thru Chamber on each Isolator. SN#1405721012101 SN#140573101210 SN# 0113-EMPA-B45 on (2) samples SN 156436042413 11 samples in the Isolators 01 Control Sample Total Samples = 12 24 ea $ 0015: Technicians x 1 hour (__)hr $ 0016: Formal Report Documentation 02 ea $ Period of Performance: 21 July 2018 - 20 July 2019 Main Pharmacy/Chemo and Ante Room: 1001: Leak Testing and airflow volumes of ceiling HEPA Filter 16 ea $ 1002: Control Environment Monitoring; includes room pressures. Supply/exhaust airflow volume readings and room air exchange rates 02 ea $ 1003: Non-viable Counting of Buffer Room, Ante Room and Chemo Room per IS07 at 0.5um. Includes Temp/rH 06 ea $ 1004: Certification of Biological Safety Cabinet-Includes Leak testing of HEPA Filers, Airflow Velocity Measurements and Site Assessment Test (Bldg 3 Chemo Lab (SN# 100930869) Bldg 1 Main Pharmacy 04 ea $ 1005: Non-Viable Particle Counting of Biological Safety Cabinet Per ISO5 at 0.5um. Includes temp/rH (SN#25-15-BR-1818) 04 ea $ 1006: Certification of Laminar Flow Hood- includes Leak Testing of HEPA Filter and Airflow Velocity Measurements Bldg 1 Main Pharmacy (SN#156131040913; 156132040913; 156042040313) 06 ea $ 1007: Non-Viable particle Counting of Laminar Flow Hood Per ISO5 at 0.5um. Includes temp/rH (SN#156131040913; 156132040913; 156042040313) 06 ea $ 1008: Testing of Isolator - Includes Leak Testing of HEPA filter, Airflow Velocity Measurements, Pressure Test, and Ingress/Egress Test (Bldg 1-3rd Fl NICU Pharmacy SN#1405721012101), (Bldg 1-4th Fl ICU Pharmacy SN#140573101210), (MOR Bldg 1-4th Fl, SN#156436042413) 06 ea $ 1009: Testing of Isolator includes Leak Testing of HEPA, Pressure Test. (Bldg 1 -Main Pharmacy/Chemo Room SN#0113-EMPA-B45) 02 ea $ 1010: Non-Viable Particle Counting of (4) Isolator Per ISO5 at 0.5um. Inludes temp/rH - (Main Chamber and interchange) 08 ea $ 1011: Airborne Viable Sampling - Includes: 2 samples in each of the Hoods in the Main Pharmacy (4 hoods total) = 8 samples. 4 samples in the Buffer/Chemo, 2 samples in the Ante Room. Total Samples = 15 30 ea $ 1012: Surface Viable Sampling Includes: 2 samples in each of the hoods in the Main Pharmacy (4 hoods total) = 8 samples 4 samples in the Buffer/Chemo, 2 samples in the Ante Room, 1 control sample. Total Samples = 15 30 ea $ 1013: Airborne Viable Sampling includes: (3) Samples total in the Main Chamber & In the pass Thru Chamber on each Isolator SN# 1405721012101, 140573101210) SN# 0113-EMPA-B45 only 2 samples SN#156436042413 11 samples in the Isolators 1 Control sample Total Samples = 12 24 ea $ 1014: Surface Viable Sampling includes: (3) Samples in the Main Chamber & Pass Thru Chamber on each Isolator. SN#1405721012101 SN#140573101210 SN# 0113-EMPA-B45 on (2) samples SN 156436042413 11 samples in the Isolators 01 Control Sample Total Samples = 12 24 ea $ 1015: Technicians x 1 hour (__)hr $ 1016: Formal Report Documentation 02 ea $ Period of Performance: 21 July 2019 - 20 July 2020 Main Pharmacy/Chemo and Ante Room: 2001: Leak Testing and airflow volumes of ceiling HEPA Filter 16 ea $ 2002: Control Environment Monitoring; includes room pressures. Supply/exhaust airflow volume readings and room air exchange rates 02 ea $ 2003: Non-viable Counting of Buffer Room, Ante Room and Chemo Room per IS07 at 0.5um. Includes Temp/rH 06 ea $ 2004: Certification of Biological Safety Cabinet-Includes Leak testing of HEPA Filers, Airflow Velocity Measurements and Site Assessment Test (Bldg 3 Chemo Lab (SN# 100930869) Bldg 1 Main Pharmacy 04 ea $ 2005: Non-Viable Particle Counting of Biological Safety Cabinet Per ISO5 at 0.5um. Includes temp/rH (SN#25-15-BR-1818) 04 ea $ 2006: Certification of Laminar Flow Hood- includes Leak Testing of HEPA Filter and Airflow Velocity Measurements Bldg 1 Main Pharmacy (SN#156131040913; 156132040913; 156042040313) 06 ea $ 2007: Non-Viable particle Counting of Laminar Flow Hood Per ISO5 at 0.5um. Includes temp/rH (SN#156131040913; 156132040913; 156042040313) 06 ea $ 2008: Testing of Isolator - Includes Leak Testing of HEPA filter, Airflow Velocity Measurements, Pressure Test, and Ingress/Egress Test (Bldg 1-3rd Fl NICU Pharmacy SN#1405721012101), (Bldg 1-4th Fl ICU Pharmacy SN#140573101210), (MOR Bldg 1-4th Fl, SN#156436042413) 06 ea $ 2009: Testing of Isolator includes Leak Testing of HEPA, Pressure Test. (Bldg 1 -Main Pharmacy/Chemo Room SN#0113-EMPA-B45) 02 ea $ 2010: Non-Viable Particle Counting of (4) Isolator Per ISO5 at 0.5um. Inludes temp/rH - (Main Chamber and interchange) 08 ea $ 2011: Airborne Viable Sampling - Includes: 2 samples in each of the Hoods in the Main Pharmacy (4 hoods total) = 8 samples. 4 samples in the Buffer/Chemo, 2 samples in the Ante Room. Total Samples = 15 30 ea $ 2012: Surface Viable Sampling Includes: 2 samples in each of the hoods in the Main Pharmacy (4 hoods total) = 8 samples 4 samples in the Buffer/Chemo, 2 samples in the Ante Room, 1 control sample. Total Samples = 15 30 ea $ 2013: Airborne Viable Sampling includes: (3) Samples total in the Main Chamber & In the pass Thru Chamber on each Isolator SN# 1405721012101, 140573101210) SN# 0113-EMPA-B45 only 2 samples SN#156436042413 11 samples in the Isolators 1 Control sample Total Samples = 12 24 ea $ 2014: Surface Viable Sampling includes: (3) Samples in the Main Chamber & Pass Thru Chamber on each Isolator. SN#1405721012101 SN#140573101210 SN# 0113-EMPA-B45 on (2) samples SN 156436042413 11 samples in the Isolators 01 Control Sample Total Samples = 12 24 ea $ 2015: Technicians x 1 hour (__)hr $ 2016: Formal Report Documentation 02 ea $ Total Price $ Delivery must be from 01 February 2017 - 30 September 2017; Delivery Location is 34800 Bob Wilson Drive San Diego, CA 92134. Responsibility and Inspection: unless otherwise specified in the order, the supplier is responsible for the performance of all inspection requirements and quality control. The following FAR provisions and clauses are applicable to this procurement: 52.204-7 System for Award Management 52.204-13 System for Award Management Maintenance 52.204-16 Commercial and Government Entity Code Reporting 52.204-17 Ownership or Control of Offeror 52.204-18 Commercial and Government Entity Code Maintenance 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law 52.211-6 BRAND NAME OR EQUAL 52.212-1 Instructions to Offerors - Commercial Items 52.212-3 and its ALT I, Offeror Representations and Certifications - Commercial Items; 52.212-4 Contract Terms and Conditions - Commercial Items 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial 52.233-3 Protest After Award (Aug 1996) (31 U.S.C. 3553) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) (Pub.L. 108-77, 108-78 (19 U.S.C. 3805 note)) 52.204-10 Sub Contracting 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, S Suspended, or Proposed for Debarment 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations 52.219-28 Post Award Small Business Program Representation 52-222-3 Convict Labor 52.222-19 Child Labor 52.222-21 Prohibition of Segregated Facilities 52.222-26 Equal Opportunity 52.222-36 Affirmative Action for Workers with Disabilities 52.222.50 Human trafficking 52.223-18 Contractor Policy to Ban Text Messaging While Driving 52.225-13 Restrictions on Certain Foreign Purchases 52.232-33 Payment by Electronic Funds Transfer 52.217-5 Evaluation of Options 52.217-8 Option to Extend Services 52.217-9 Option to Extend the Term of the Contract 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation 52.232-18 Availability of Funds 52.247-34 F.O.B. DESTINATION 52.252-1, Solicitation Provisions Incorporated by Reference Quoters are reminded to include a completed copy of 52.212-3 and it's ALT I with quotes. All clauses shall be incorporated by reference in the order. Additional contract terms and conditions applicable to this procurement are: 252.203-7000 Requirements Relating To Compensation of Former DoD Officials 252.203-7001 Prohibition on Persons Convicted of Fraud or Other Defense-Contract-Related Felonies DEC 2008 252.203-7002 Requirements to Inform Employees of Whistleblower Rights 252.203-7005 Representation Relating To Compensation of Former DoD Officials 252.204-7000 Disclosure of Information 252.204-7003 Control of Government Personnel Work Product 252.204-7008 Compliance with Safeguarding Covered Defense Information Controls 252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Information 252.204.7011 Alternative Line Item Structure 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. 252.204-7013, Limitations on the Use or Disclosure of Information by Litigation Support Offerors 252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support 252.211-7003 ITEM UNIQUE IDENTIFICATION AND VALUATION 252.223-7008 Prohibition of Hexavalent Chromium 252.225-7001 Buy American And Balance Of Payments Program-- Basic 252.225-7002 Qualifying Country Sources As Subcontractors 252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports 252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS 252.232-7010 Levies on Contract Payments 252.237-7024 Notice of Continuation of Essential Contractor Services 252.239-7018 Supply Chain Risk 252.244-7000 Subcontracts for Commercial Items 252.203-7994 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements-Representation. 252.203-7995 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements. This announcement will close at 0600am PST on 20 January 2017. Contact Christopher J. Jennen who can be reached at 619-532-8100 or email Christopher.j.jennen.civ@navy.mil. Oral communications are not acceptable in response to this notice. All responsible sources may submit a quote which shall be considered by the agency. Offerors must be registered in the System for Award Management (SAM) database to be considered for award. Registration is free and can be completed on-line at http://www.sam.gov/. All quotes shall include price(s), FOB point, a point of contact, name and phone number, GSA contract number if applicable, business size, and payment terms. Quotes will not be accepted by facsimile. Each response must clearly indicate the capability of the Offeror to meet all specifications and requirements. ******* End of Combined Synopsis/Solicitation ******** STATEMENT OF WORK WITH NO LOANER OPTION NO LOANER OPTION - MEDICAL EQUIPMENT GENERAL REQUIREMENTS: The effort required hereunder shall be performed in accordance with this Statement of Work and in accordance with all other terms and conditions set forth herein. The contractor shall provide all services, materials and equipment necessary for the recertification of the IV hoods located at Naval Medical Center San Diego, San Diego, California, to ensure equipment is functioning at an acceptable level as required by USP797 Surface, Air Viable Sampling and Hood Testing. The scope of work performed under these specifications includes the furnishing of all labor, equipment, and materials to perform the recertification on all Pharmacy IV hoods to assure continued operation at their designed efficiency. Semi-Annual testing shall be conducted in the months of January and July and will commence at 11:00 hours unless Inpatient DIVO requests an alternate time. THE CONTRACTOR SHALL PERFORM THE FOLLOWING FUNCTIONS: *Perform recertification tests IAW CLIN's 0001 - 0015 *Ensure that only FULLY QUALIFIED FIELD ENGINEERS & TECHNICIANS who have gone through original equipment manufacturer (OEM) or comparable third party service schools for the above mentioned equipment shall be employed in the performance of any and all work performed under this contract. Upon request, the Medical Repair Branch will provide the certificates or notarized copies for verification. All recertification services will be provided twice annually, every July and every January. The recertification is required every six months. For TSA media NMCSD Pharmacy requesting one laboratory control sample per media type and lab analysis. The sample will be dual-incubated to determine both bacterial and fungal colony forming units (CFUs). Collect two viable air and surface samples in the Main Chamber and one in the Anti Chamber of each of the Isolators to comply with USP- 797 requirements. NMCSD requests a formal report upon completion of the testing and receipt of laboratory results. The highest standard of professional capability and electrical/mechanical workmanship is to be maintained throughout the life of this contract. Equipment improvements/modifications will be conducted only after acquiring the approval from the Contracting Officer. Ensure that original design and functional capabilities will not be changed, modified, or altered unless the medical Repair Branch authorizes such changes. Provide suitable modern recommended equipment/tools required for the satisfactory execution of all tests required. Furnish manufacturer OEM approved lubricants and lubricate wear points if required within the equipment. Leak Testing of Ceiling HEPA Filter - Main Pharmacy / Chemo and Anti Room, Qty 16. Controlled Environmental Monitoring; includes room pressures, supply / exhaust airflow volume readings and room air exchange rates in Main Pharmacy/Chemo and Ante Room. Qty 2 Non-Viable Particle Counting of Buffer, Ante and Chemo Room per ISO7 at 0.5um. Includes Temp/rH. Qty 6 Certification of Biological Safety Cabinet - Includes Leak Testing of HEPA Filters, Airflow Velocity Measurements and Site Assessment Test. Building 3 Hem/Onc Pharmacy. Building 1 Main Pharmacy IV Room. Qty 4 Non-Viable Particle Counting of Biological Safety Cabinet Per ISO 5 at 0.5um. Includes temp/rH Qty 4 Certification of Laminar Flow Hood - Includes Leak Testing of HEPA Filter and Airflow Velocity Measurements. Building 1 Main Pharmacy IV Room Qty 6. Non-Viable Particle Counting of Biological Safety Cabinet Per ISO 5 at 0.5um. Includes temp/rH Qty 6 *Testing of Isolator - Includes Leak Testing of HEPA, Filter, Airflow Velocity Measurements, Pressure Test and Ingress / Egress test in Building 1, Floor 3, NICU Pharmacy. Building 1, Floor 4, ICU Pharmacy. Building 1, Floor 4, MOR Pharmacy. Qty 6 Testing of Isolator - Includes Leak Testing of HEPA, Pressure Test. Building 1 - HEMOC. Qty 2 Non-Viable Particle Counting of 4 Isolators per ISO 5 at 0.5um. Includes temp/rH-(main chamber and interchange). Qty 8 Airborne Viable Sampling - Includes: 2 samples in each of the hoods in the Main Pharmacy (4 hoods total) = 8 samples. 4 samples in the buffer/chemo. 2 samples in the Ante Room. 1 Control Sample. Total samples = 15. Qty 30 Surface Viable Sampling - Includes: 2 samples in each of the hoods in the Main Pharmacy (4 hoods total) = 8 samples. 4 samples in the buffer / chemo. 2 samples in the Ante Room. 1 control sample. Total samples = 15. Qty 30 Airborne Viable Sampling - Includes: (3) Samples total in the Main Chamber & in the Pass Through Chamber on each Isolator. 11 samples in the Isolators. 1 Control sample. Total Samples = 12. Qty 24 Surface Viable Sampling - Includes: (3) Samples in the Main Chamber & Pass Through Chamber on each Isolator. 11 samples in the Isolators. 1 Control sample. Total Samples = 12. Qty 24 Option Species ID if sample has growth. Qty TBD. Formal Report Documentation. Qty 2 Ensure base access prior to appointment time via Pass & Decal located at NBSD, 3101 E. Harbor Dr. Building #3436, San Diego, CA 92113, 619-556-9249/50 for RAPID GATE access. TITLE TO EQUIPMENT: The contractor shall not assume possession or control of any part of the equipment. The Government retains ownership to title thereof. LIABILITY: The contractor shall not be liable for any loss, damage, or delay due to any cause beyond his reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief of acts of God. UTILITIES: The contractor may use Government utilities, (electrical power, compressed air, and water) that is available and required for any service performed under this contract. The building engineer, to ensure compatibility with the Naval Hospital's electrical wiring and equipment, must approve contractor electrical equipment. ACCESS TO EQUIPMENT: The contractor shall be provided reasonable access to all equipment that is to be tested and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment. Under no circumstances may contractor start services no earlier than 11:00 hours due to in-patient work load. CONTRACTOR CHECK-IN/CHECK-OUT: The contractor or his representative is required to report to the Medical Repair Branch for Visitor Badges during the hours of 0730-1600 hours, Monday through Friday, prior to and upon completion of any service/repair performed. TRAVEL AND RELATED EXPENSES: The contractor is responsible for its related trip expenses including round trip travel, mileage, meals and all other necessary expenses related to travel. Contractor must have DBIDS to obtain access inside Naval Medical Center San Diego Base and the Main Pharmacy. For DBIDS Access information call 32nd Street Pass & Decal at 619-556-1653. GOVERNMENT PERSONNEL: Naval Hospital employees will not perform maintenance or attempt repairs to equipment while such equipment is under the purview of this contract unless agreed to in writing by the contractor. PARTS AVAILABILITY: To ensure minimal downtime to equipment, the contractor shall maintain replacement repair parts and materials necessary to perform each repair or supply said parts and materials within (1) one day. PARTS/SUPPLIES QUALITY: Parts and Supplies provided under this contract shall be guaranteed to be equal in all respects, including performance, interchangeability, durability and quality to the OEM parts when new or as presently recommended by the manufacturer. -End of Statement of Work-
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