SOLICITATION NOTICE
H -- Lab Certification Service Contract
- Notice Date
- 4/25/2022 12:28:30 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24122Q0496
- Response Due
- 4/28/2022 7:00:00 AM
- Archive Date
- 05/28/2022
- Point of Contact
- Carlton Lunsford, Contract Specialist, Phone: 203-932-5711
- E-Mail Address
-
carlton.lunsford@va.gov
(carlton.lunsford@va.gov)
- Small Business Set-Aside
- SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
- Awardee
- null
- Description
- Combined Synopsis Solicitation White River Junction VAMC Cleanroom Testing (i) 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. (ii) The solicitation number is 36C24122Q0496 and the solicitation is issued as a request for quotation (RFQ). (iii) A statement that the solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-05. (iv) This requirement is being issued as an open market, small business set-aside. The associated NAICS code is 541990 for All Other Professional, Scentific, and Technical Services and small business size standard is $16.5 million. (v) The Government intends to award a firm-fixed price award for Cleanroom Testing Services at the White River Junction VAMC as indicated in the Performance Work Statement (PWS) or Statement of Work (SOW). Please see the attached PWS/SOW for full requirement details. Please complete the Price Schedule below and submit with the quote submission. Performance Work Statement (Monthly Sampling of Clean Rooms/Compounding Cabinets and Semiannual Certification of Clean Rooms/Compounding Cabinets) Introduction The White River Junction VA Medical Center (WRJ VAMC) prepares and compounds intravenous medications, chemotherapeutic agents, hazardous agents and other sterile/non-sterile products to patients. As a VAMC facility, the pharmacy is required to provide products according to all relevant USP compounding guidelines including USP 797/800. Environmental monitoring (on site sampling, laboratory analysis and reporting, and staff competency testing) services are required for the WRJ VAMC pharmacy. Compounding of IV fluids, nutritional parenteral compounds, and IV-administered chemotherapeutic agents must be accomplished according to Industry Standards, VHA Directives, standard operating procedures (SOP), and applicable USP guidelines. Scope The Contractor shall provide all necessary personnel, supervision, labor, equipment, materials (including gowning materials/sterilized jumpsuits and environmental monitoring tools) and disposal necessary to successfully support the WRJ VAMC pharmacy 797/800 compounding area environmental monitoring requirement. The contract will cover a minimum of twelve (12) months from start date and (4) option years. The Contractor must be able to provide primary services as outlined in this statement of work by WRJ VAMC pharmacy. The contractor (per evaluation by the Contracting Officer) must be financially responsible, show evidence of their reliability, ability and experience performing in sterile compounding environments and USP 797/800 environmental monitoring. The contractor must render prompt, detailed service in accordance with the applicable directives referenced in this document. All Vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with Controlled Environment Testing Association (CETA). All persons who perform work, but meet CETA guidelines/USP 797/800 and VHA Directive 1108.12: Management and Monitoring of Pharmaceutical Compounded Sterile Preparations. Each service person designated by the Contractor to perform work under this contract shall be cleared for access through restricted areas of customer s facilities. The Contractor shall conform to all Federal, State, VA and local regulations governing Environmental Monitoring in USP environments. This includes the use of any related chemicals and equipment. The company must furnish a copy of state certification to perform contracted service. The company must provide this documentation to the Contracting Officer prior to performing any work under the contract. All chemical (MSDS) or control substance used to perform service must be submitted and filed with the Contracting Officer s Representative (COR). All company service persons shall have their name and their company s name indicated on their uniform or a name badge while at the facility so they are easily recognizable as a contractor employee. Description of Services: Environmental Monitoring (on-site sampling, laboratory analysis/reporting, testing) to be performed monthly, and Recertification of compounding areas to be performed semi-annually at WRJ VAMC Pharmacy, Building 39, Room 236, Services must comply with industry standards and USP General Chapter 797/800. Vendor must to respond to facility emergencies within 24 business hours to perform contingency testing and sampling, as needed. Environmental sampling will be performed in Pharmacy compounding spaces monthly and Recertification in the same areas will occur semi-annually: This will include the following: Two Anterooms (Room # 236 E and Chemo anteroom (Room # 236G) Two buffer rooms iso class 7 (Chemo hood Room # 236H and IV compounding Room# 236F) One laminar airflow workstation (LAFW Room # 236F) One biosafety cabinet (BSC Room # 236H) Two compounding isolators (CAI and CACI) (Room #236 segregated compounding areas) One non-sterile hazardous isolator Room 236H (requires certification only) Specific sampling for areas for monthly sampling (Total Samples 48): Air Samples (bacteria + fungi): Total: 10 locations (20 samples) Anteroom HD Airlock HD Buffer HD BSC NH Buffer NH LAFW NH CAI Main Chamber NH CAI Passthrough HD CACI Main Chamber HD CACI Passthrough Surface Samples (bacteria + fungi): Total: 12 locations (24 samples) Anteroom-NH Buffer Passthrough Anteroom Work Table NH Buffer Door Handle HD Airlock Door Handle HD Buffer Door Handle HD Passthrough surface HD BSC Work Surface NH LAFW Work Surface NH CAI Main Chamber Work Surface NH CAI Passthrough Chamber Surface HD CACI Main Chamber Work Surface HD CACI Passthrough Chamber Surface QC (bacteria + fungi): Total: 2 locations (4 samples) Positive control Negative control Room sampling (See chart diagram below: Width is 12 9 and length is 24 6 x 12 walls = Approximately 3,764 square feet total) Microbiological Air and surface Monitoring Requirements: Total airborne particles must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. When conducting sampling of the PEC, care should be taken to avoid disturbing the unidirectional airflow within the PEC. Measurements of total airborne particles in other classified areas, including the buffer room(s) and ante-room(s), should be taken at representative locations that reflect the quality of air in the room(s). Sampling and reporting will meet all requirements in the most recent edition of USP General Chapter 797 Pharmaceutical Compounding- Sterile Preparations and USP General Chapter 800 Hazardous Drugs- Handling in Healthcare Settings. Recertification Requirements: Recertification must be done following procedures in the current Controlled Environment Testing Association (CETA) certification guide for Sterile Compounding Facilities or an equivalent guideline. Re-certification indicates that the compounding area is meeting its design and air quality specifications (see Table). It is important to place special emphasis on certifying the ISO Class 5 areas. Recertification must be performed at least every 6 months and must include: Airflow testing: Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report. HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification. Total particle count testing (Total Airborne Particle Sampling): Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). Re-certification and reporting will meet all requirements in the most recent edition of USP General Chapter 797 Pharmaceutical Compounding- Sterile Preparations and USP General Chapter 800 Hazardous Drugs- Handling in Healthcare Settings. ISO Classification of Particulate Matter in Room Air PRICE/COST SCHEDULE ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 832.00 HR __________________ __________________ Provide Physician Neurology Services Contract Period: Base POP Begin: 05-02-2022 POP End: 04-30-2023 1001 832.00 HR __________________ __________________ Provide Physician Neurology Services Contract Period: Option 1 POP Begin: 05-02-2023 POP End: 04-30-2024 2001 832.00 HR __________________ __________________ Provide Physician Neurology Services Contract Period: Option 2 POP Begin: 05-02-2024 POP End: 04-30-2025 3001 832.00 HR __________________ __________________ Provide Physician Neurology Services Contract Period: Option 3 POP Begin: 05-02-2025 POP End: 04-30-2026 4001 832.00 HR __________________ __________________ Provide Physician Neurology Services Contract Period: Option 4 POP Begin: 05-02-2026 POP End: 04-30-2027 GRAND TOTAL __________________ (vi) The Contractor shall provide all resources necessary to provide Cleanroom Testing IAW the attached PWS/SOW. Please see the attached PWS/SOW for full requirement details. (vii) The Place of Performance is the White River Junction VAMC and/or CBOC locations as outlined in the PWS/SOW. (viii) Provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition in addition to the following addenda s to the provision: The full text of FAR provisions or clauses may be accessed electronically at: http://acquisition.gov/comp/far/index.html. (ix) Provision at 52.212-2, Evaluation -- Commercial Items, applies to this requirement. (x) Submission of Quotes: (1) Quotes: shall be received on or before the date and time specified in Section (xv) of this solicitation. Note: Offers received after the due date and time shall not be considered. (2) Offerors: shall submit their quotes electronically via email to carlton.lunsford@va.gov. (3) Questions: shall be submitted to the Contracting Officer in writing via e-mail. Oral questions are not acceptable due to the possibility of misunderstanding or misinterpretation. The cut-off date and time for receipt of questions is April 26, 2022 at 1:00 PM EST. Questions received after this date and time may not be answered. Questions shall be answered in a formal amendment to the solicitation so all interested parties can see the answers. (4) Quote Format: The submission should be clearly indexed and logically assembled in order of the evaluation criteria below. All pages of the quote shall be appropriately numbered and identified by the complete company name, date and solicitation number in the header and/or footer. (x) FAR 52.212-2 Evaluation Process: Award shall be made to the best value, as determined to be the most beneficial to the Government. Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall be considered non-compliant and your quote could be removed from the evaluation process. Offeror quotes shall be evaluated under FAR Part 13.106-2(b) -- Evaluation of Quotations or Offers. Therefore, the Government is not obligated to determine a competitive range, conduct discussions with all contractors, solicit final revised quotes, and use other techniques associated with FAR Part 15. The contracting techniques associated with FAR Part 15 are not mandatory. The Government shall award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation shall be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 1. Price (Follow these instructions): a. Offeror shall complete the attached Price Schedule, with offerors proposed contract line item prices inserted in appropriate spaces. Offerors must also provide all applicable labor rates for the solicited services so they can be compared to the applicable wage determination for compliance with the Service Contract Labor Standards. b. Ensure your representations and certifications are complete in the System for Award Management (SAM) ( https://www.sam.gov). Otherwise, you will need to fill out solicitation Clause 52.212-3 ""Offeror Representation and Certifications -Commercial Items"" and submit with the quote. Federal Acquisition Regulations require that federal contractors register in the SAM database at http://www.sam.gov and enter all mandatory information into the system. Award cannot be made until the contractor has registered. Offerors are encouraged to ensure that they are registered in SAM prior to submitting their quotation. 2. Past Performance: Provide (3) references of work, similar in scope and size with the requirement detailed in the PWS/SOW. References must include contact information; brief description of the work completed, and contract # (if relevant). Please utilize Attachment 1 Past Performance Worksheet for your references and please submit as part of your quote submission. References may be checked by the Contracting Officer to ensure your company is capable of performing the PWS/SOW. The Government also reserves the right to obtain information for use in the evaluation of past performance from any and all sources. 3. Technical: The offeror s quote shall be evaluated to determine if the organization has the experience and capabilities to provide the requested services IAW the PWS/SOW in a timely efficient manner. a. Contractor shall demonstrate their corporate experience and approach to meet all requirements stated in the PWS/SOW. b. Contractor shall demonstrate that their technicians meet the qualification standards stated in the PWS/SOW. c. Contractor shall provide a quality control plan, which explains the offerors approach to quality control and methodologies. An example quality assurance surveillance plan is attached, see Attachment 2 QASP and can be utilized as a template. d. Contractor shall provide all current and relevant licenses and/or certifications for the State of Connecticut. e. If you are planning to sub-contract some or all of this work, please provide the name and address(s) of all subcontractor(s) (if applicable) and a description of their planned subcontracting effort. The following solicitation provisions apply to this acquisition: 52.204-7 - System for Award Management (OCT 2018) 52.204-16 - Commercial and Government Entity Code Reporting (JUL 2016) 52.216-1 Type of Contract (APR 1984) 52.217-5 - Evaluation of Options (JUL 1990) 852.233-70 - Protest Content/Alternative Dispute Resolution (OCT 2018) 852.233-71 - Alternate Protest Procedure (OCT 2018) 852.252-70 - Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) 852.270-1 - Representatives of Contracting Officers (JAN 2008) Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: 52.212-4, Contract Terms and Conditions Commercial Items Addendum to FAR 52.212-4 52.252-2, Clauses Incorporated by Reference (FEB 1998) http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR) 52.203-16, Preventing Personal Conflicts of Interest (DEC 2011) 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (APR 2014) 52.204-4, Printed Or Copied Double-Sided On Recycled Paper 52.204-13, System for Award Management Maintenance (OCT 2018) 52.204-18, Commercial and Government Entity Code Maintenance (JUL 2016) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 Days. 52.217-9, Option To Extend The Term Of The Contract (Mar 2000) The Government may extend the term of this contract by written notice to the Contractor within 10 days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at 30 Days before the contract expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract shall be considered to include this option clause. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 Years and 6 months FAR 52.228-5,- Insurance,- Work on a Government Installation. CL-120, SUPPLEMENTAL INSURANCE REQUIREMENTS FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 852.203-70, Commercial Advertising (May 2018) VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION) 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) 852.237-70 CONTRACTOR RESPONSIBILITIES (April 1984) 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders The following subparagraphs of FAR 52.212-5 are applicable: 52.203-6, Restrictions on Subcontractor Sales to the Government (SEPT 2006) 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2018) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note). 52.219-8, Utilization of Small Business Concerns (OCT 2018) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)). 52.222-3, Convict Labor (June 2003) (E.O. 11755). 52.222-21, Prohibition of Segregated Facilities (APR 2015). 52.222 26, Equal Opportunity (SEP 2016) (E.O. 11246). 52.222-35, Equal Opportunity for Veterans (OCT 2015) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). 52.222-37, Employment Reports on Veterans (FEB 2016) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627). 52.222-54, Employment Eligibility Verification (OCT 2015)52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33, Payment by Electronic Funds Transfer System for Award Management (Jul 2013) (31 U.S.C. 3332). 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Requirements (MAY 2014) (41 U.S.C. chapter 67) 52.222-54, Employment Eligibility Verification (OCT 2015). All quotes shall be sent to carlton.lunsford@VA.gov This is a(n) SDVOSB/VOSB Set-aside Full & open-market combined synopsis/solicitation for Cleanroom Testing services as defined herein. The government intends to award a Firm Fixed Price contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes, must include a statement regarding the terms and conditions herein as follows: ""The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."" OR ""The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"" quotes shall list exception(s) and rationale for the exception(s). (xv) Quotes shall be received not later than 4/28/2022 at 10:00am EST. All quotes will be emailed to carlton.lunsford@va.gov with the subject line to include 36C24122Q0496. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the contract specialist Carlton Lunsford @ carlton.lunsford@va.gov No later than 12/14/2020 by 1:00 pm Eastern Time. Point of Contact (xvi) The POC of this solicitation is contract specialist Carlton Lunsford, carlton.lunsford@va.gov.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/80796e424e77422fa0bd8c765df70f00/view)
- Place of Performance
- Address: White River Junction VAMC 215 North Main St, White River Junction 05001-3833
- Zip Code: 05001-3833
- Zip Code: 05001-3833
- Record
- SN06306519-F 20220427/220425230057 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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