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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 06, 2018 FBO #6008
DOCUMENT

H -- USP 797/800 INSPECTION AND ANALYSIS OF PHARMACY CLEAN ROOM - Attachment

Notice Date

5/4/2018
 

Notice Type

Attachment
 

NAICS

541620 — Environmental Consulting Services
 

Contracting Office

Department of Veterans Affairs;W.J.B. Dorn VA Medical Center;6439 Garners Ferry Road;Columbia SC 29209-1639
 

ZIP Code

29209-1639
 

Solicitation Number

36C24718Q0607
 

Response Due

5/9/2018
 

Archive Date

5/19/2018
 

Point of Contact

MARK WEST @ JEFFREY.WEST3@VA.GOV
 

E-Mail Address

Jeffrey.West3@va.gov
(JEFFREY.WEST3@VA.GOV)
 

Small Business Set-Aside

Total Small Business
 

Description

General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24718Q0607 Posted Date: May 4, 2018 Original Response Date: May 9, 2018 @ 4:30 PM EST Current Response Date: Product or Service Code: B510 Special Studies/Analysis Environmental Assessments Set Aside: Small Business NAICS Code: 541620 Environmental Consulting Services Contracting Office Address William Jennings Bryan Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209 Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; QUOTATIONS are being requested, and a written solicitation document will not be issued. This procurement is set-aside based on an order or priority as established in 38 U.S.C. 8127. This solicitation is being issued as a tiered evaluation for SDVOSB concerns, or in the alternative, a set-aside for VOSB concerns, or in the alternative, a set-aside for other small business concerns with HUBZone small business concerns and 8(a) participants having priority. If award cannot be made, the solicitation will be cancelled and the requirement resolicited. The tiered evaluation will be conducted as follows: Tier 1: SDVOSB concerns Offers, if any will be evaluated. If no offers were submitted by SDVOSB concerns, or if none of the offers would result in award at a fair and reasonable price that offers best value to the United States, the Government will then move to evaluation of Tier 2 offers. Tier 2: VOSB concerns Offers, if any will be evaluated. If no offers were submitted by VOSB concerns, or if none of the offers would result in award at a fair and reasonable price that offers best value to the United States, the Government will then move to evaluation of Tier 3 offers. Tier 3: HUBZone & 8(a) Small Business concerns - Offers, if any will be evaluated. If no offers were submitted by HUBZone & 8(a) concerns, or if none of the offers would result in award at a fair and reasonable price that offers best value to the United States, the Government will then move to evaluation of Tier 4 offers. Tier 4: All other Small Business concerns - Offers, if any will be evaluated. If no offers were submitted by any Small Business concerns, or if none of the offers would result in award at a fair and reasonable price that offers best value to the United States, then the solicitation will be cancelled and the requirement resolicited. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 36C24718Q0607. The associated North American Industrial Classification System (NAICS) code for this procurement is 541620, with a small business size standard of $15 MILLION. The W.J.B. Dorn VA Medical Center is seeking services FOR ONE-TIME USP 797 AND USP 800 Compliant Inspection and Analysis of Pharmacy Clean Rooms in accordance with Statement of Work. All interested companies shall provide Quotations for the following: STATEMENT OF WORK Clean Rooms Inspection and Analysis GENERAL This requirement is to obtain a firm-fixed priced service contract for one-time Clean Room Inspection and Analysis for the William Jennings Bryan (WJB) Dorn VA Medical Center as the facility has an International Standards Organization (ISO) Class 7 Clean Room for compounding sterile preparations. To support the agency mission and regulations of sterile compounding, the Government requires an analysis service for the Clean Rooms. BACKGROUND The WJB Dorn VA Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Sterile preparations are used for, but not limited to, Operating Room, Inpatient, and emergency, compounds. Microbiological sampling and analysis shall be conducted at the WJB Dorn VA Medical Center s Pharmacy Intravenous (IV) Room, as well as the Chemotherapy Pharmacy Room, in compliance with United States Pharmacopeia, Chapter 797 (USP 797), as well as USP 800, standards. PERIOD OF PERFORMANCE Period of performance shall be determined upon award. Services are to be performed during normal business hours; Monday through Friday, 8:00 a.m. 4:00 p.m. Excluding weekends and holidays. No overtime is allowed at this time. The Contractor shall conduct a one-time Inspection/Analysis on a date and time determined by the Pharmacy Point of Contact. Inspection/Analysis. PLACE OF PERFORMANCE: WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209 PERFORMANCE REQUIREMENTS This requirement is for a one-time professional consultation to inspect the Pharmacy Department Clean Rooms for United States Pharmacopeia (USP) 797 and 800 compliance, and to provide a written report with shortcomings and recommendations that will bring these clean rooms into compliance with USP 797 and USP 800. All work under this contract shall be monitored by the Pharmacy Point of Contact. Final Inspection and acceptance of all work performed, reports and other deliverables shall be performed at the place of delivery by the Pharmacy Point of Contact. The Pharmacy Point of Contact, with the assistance of the other affected Project Managers, is responsible for: All coordination for scheduling and site visit with the Contractor. Scheduling of work performance shall be arranged through the designated Pharmacy Point of Contact assigned. The Contractor shall provide the following service demonstrating experience and meeting the following requirements: Knowledge and understanding of USP 797/800; American Industrial Hygiene Association (AIHA); and American Conference of Government Industrial Hygiene (ACGIH). Knowledge of the Clean Room designs and workflows in relation to USP 797/800 Full UPS 797/800 compliance assessment and quotes, on any recommended work to meet UPS 797/800 compliance per the July 2018 waiver standards, as well as, the South Carolina State Board of Pharmacy, and provide written report of all findings. Inspection and Analysis shall be conducted in the following rooms: IV Room 1A113A, Main Pharmacy, 1st Floor Chemo IV Room 5A132, Chemotherapy Pharmacy, 5th Floor PROJECT MANAGEMENT: The Contractor shall provide a qualified person, with expertise and knowledge of USP 797 and USP 800, to perform an Inspection of the Intravenous (IV) Clean Room as well as the Chemotherapy Pharmacy Clean Room. Inspection shall be performed on both clean rooms, to determine if each, are UPS 797 and UPS 800 compliant. If they are found to not be in compliance, the Inspector shall provide recommendations that may be required, in order to bring these Clean Rooms up to standard for USP 797 and USP 800. The following shall be completed: Perform GAP Analysis of Pharmacy Clean Rooms in helping to establish the requirements for USP 797/800 compliance, as well as, the South Carolina State Board of Pharmacy. Detailed analysis of existing conditions Detailed list of items needed to meet UPS 797/800 requirements Address any questions/comments from WJB Dorn VAMC personnel Recommended cut sheets of proposed products for renovation Drawing depicting the acceptable layout for compliance DOCUMENTATION: The Contractor shall develop a system to issue a report after completing the site visit Inspection and analysis. Written report is to be given within five (5) calendar days and shall include at a minimum: Date Time Name of the Analysist A report shall be issued, via electronic copy. Report shall be delivered via e-mail, to the: Pharmacy Point of Contact and Chief of Pharmacy (or designee), within five (5) business days after the site visit. DELIVERABLES AND DELIVERY SCHEDULE Coordination of Site Visit Pharmacy Point of Contact shall coordinate with the Contractor on the date of the site visit. This coordination shall take place within five (5) business days following the award of the contract. Scheduled date of site visit a date for the site visit will be established and said date shall not exceed ten (10) business days after contract award. GAP Analysis Report shall be submitted within five (5) business days of the completion of the site visit DELIVERY SCHEDULE Coordination with Pharmacy Point of Contact, to schedule Site Visit Five (5) business days, after contract award Date for Site Visit Within ten (10) business days, after contract award GAP Analysis Report Five (5) business days after completion of the site visit NOTICE REGARDING LATE DELIVERY The Contractor shall notify the Pharmacy Point of Contact, as soon as it becomes apparent to the Contractor, that a scheduled delivery may be late. The Contractor shall include in the notification the rationale for late delivery, the expected date for the delivery and the project impact of the late delivery. The Pharmacy Point of Contact shall review the new schedule and provide guidance to the Contractor. CONTRACTOR QUALIFICATIONS/CERTIFICATION The Contractor shall be responsible for providing personnel with the necessary level of expertise to support the task activities and service requirements. The Contractor shall provide a single point of contact that shall serve as the Project Manager for the life of the Contract. GENERAL ACCEPTANCE General quality measures as set forth below shall be applied to each work product received from the Contractor. Accuracy - Work Products shall be accurate in presentation, technical content, and adherence to accepted elements of style. Clarity - Work Products shall be clear and concise. Any/All diagrams shall be easy to understand and be relevant to the supporting narrative. Consistency to Requirements - All work products shall satisfy the requirements of this service. File Editing - All text and diagrammatic files shall be editable by the Government. Format - Work Products shall be submitted in hard copy and in media mutually agreed upon prior to submission. Timeliness - Work Products shall be submitted on or before the due date specified, as described in assigned tasks or submitted in accordance with a later scheduled date determined by or approved by the POC. QUALITY ASSURANCE The POC shall review, for completeness, preliminary or draft documentation that the Contractor submits, and may return it to the Contractor for correction. Absence of any comments by the POC shall not relieve the Contractor of the responsibility for complying with the requirements. Final approval and acceptance of documentation required herein shall be by letter of approval and acceptance by POC. The Contractor shall not construe any letter of acknowledgment of receipt material as a waiver of review, or as an acknowledgment that the material is in conformance. Any approval given during preparation of the documentation, or approval for shipment shall not guarantee the final acceptance of the completed documentation. Smoking is not permitted within the facilities at any time. All smoking will be conducted in designated smoking areas only. Item Number Unit Qty Description Price 0001 JOB 1 USP 797 AND 800 COMPLIANT CLEAN ROOM INSPECTION AND ANALYSIS Basis of Award Project: PHARMACY CLEAN ROOM INSPECTION & ANALYSIS BASIS FOR AWARD. Award will be made to the lowest priced, technically acceptable responsible offeror, whose offer conforms to all stated terms, conditions, representations, certifications, and any other information required by this solicitation. Offers will be ranked in Tiers by price first then evaluated for technically acceptable. If, the low priced offer is found to be technically acceptable the evaluation process stops no other offer will be evaluated. If necessary this process will be performed until there is a low priced technically acceptable offer. If no offer is technically acceptable the Government will make a determination to re-solicit. Technical tradeoff will not be made and no additional credit will be given for exceeding the minimum requirements. In the event an offeror s proposal is determined to be unacceptable in any of these factors, the entire proposal will be considered unacceptable and the offeror will be ineligible for award. **ALL factors must be rated ACCEPTABLE to be considered for award. B. EVALUATION METHODOLOGY. The award decision will be based on the following: Registered in www.sam.gov to receive Government contracts. Registered in www.vip.vetbiz.gov as a Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (If submitting quote under Tier 1 OR 2 SDVOSB/VOSB) Must be a Small Business in accordance with NAICS 541620. Price. All line items in the Price Schedule must include a price. The total evaluated price will consist of the offeror s total proposed price. The Government may determine that an offer is unacceptable if the prices are significantly unbalanced. Price realism may be performed by the Contracting Officer. Technical. Must provide proof of the following certifications: National Environmental Balancing Bureau (NEBB) CPT : Cleanroom Performance Testing Certificate NSF Certification Past Performance. Must provide a minimum of two (2) past performance experiences in clean room Inspection and analysis as specified in this requirement. Specifically, knowledge of USP 797/800, clean room designs and workflows in relation to USP 797/800. The past performance experience must include the client s POC with email and phone number. The past performance must be within the last five (5) years. Each factor will be scored as Acceptable or Unacceptable as defined below. Offers will be evaluated against the SOW and the stated evaluation criteria. All offers are evaluated using the same standards. "Lowest Price, Technically Acceptable" Evaluation Standards Acceptable ALL of the minimum acceptable criteria are clearly met by the offer. The offer meets the minimum performance and technical capability requirements defined in the solicitation. Unacceptable Not all of the minimum acceptable criteria were met by the offer. An unacceptable offer contains one or more deficiencies that does not meet the performance and technical capability requirements defined in the solicitation. The following table will be used for each proposal received to score each LPTA factor as to whether it is Acceptable or Unacceptable. OFFEROR: __________________________________ Non- Cost/Price Factors Technically Acceptable/Unacceptable REGISTERED IN SAM REGISTERED IN VIP AS SDVOSB/VOSB Small Business Concern per NAICS 541620 TECHNICAL PAST PERFORMANCE PRICE (Not Rated) The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items [JAN 2017] FAR 52.212-2, Evaluation Commercial Items [OCT 2014] FAR 52.212-3, Offerors Representations and Certifications Commercial Items [NOV 2017] 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: FAR 52.212-4, Contract Terms and Conditions Commercial Items [JAN 2017] Applies to this acquisition and a statement regarding any addenda are applicable to the acquisition. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders [NOV 2017] Applies to this acquisition and a statement regarding any addenda are applicable to the acquisition. The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards [OCT 2016] 52.209-6, Protecting the Governments Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment [OCT 2015] 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns [OCT 2014] 52.219-28, Post Award Small Business Program Representation [JUL 2013] 52.222-3, Convict Labor [JUN 2003] 52.222-19, Child Labor [OCT 2016] 52.222-21, Prohibition of Segregated Facilities [APR 2015] 52.222-26, Equal Opportunity [SEP 2016] 52.222-35, Equal Opportunity for Veterans [OCT 2015] 52.222-36, Equal Opportunity for Workers with Disabilities [JUL 2014] 52.222.37, Employment Reports on Veterans [FEB 2016] 52.222-5, Combating Trafficking in Persons [MAR 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] 52.232-33, Payment by Electronic Funds Transfer System for Award Management [JUL 2013] Additional Clauses Required: 52.215-22, Limitations on Pass-Through Charges Identification of Subcontract Efforts [OCT 2009] 52.215-23, Limitations on Pass-Through Charges [OCT 2009] 52.237-1, Site Visit [APR 1984] 52.237-2, Protection of Government Buildings, Equipment, and Vegetation [APR 1984] 52.246-20, Warranty of Services [MAY 2001] 852-237-70, Contractor Responsibilities [APR 1984] 852.273-74, Award Without Exchanges [JAN 2003] All bid offerors shall submit the following: One Copy of the Bid Offer for All Items Listed, Technical Capabilities Statement in Reference to the Requirement, and Past Performance. This is an open-market combined synopsis/solicitation for services as defined herein.    The Government intends to award a Firm-Fixed Priced Service 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 bid offers 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:" Bid Offers shall list exception(s) and rationale for the exception(s). Submission shall be received not later than 4:30 PM EST May 9, 2018. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All bid offers shall be emailed to the Contracting Specialist listed below no later than the data and time listed. Any questions or concerns regarding this solicitation including bid offer should be forwarded in writing via e-mail to the Contracting Specialist, jeffrey.west3@va.gov. No phone call shall be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/CSCVAMC/WJBDDVAMC/36C24718Q0607/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24718Q0607 36C24718Q0607.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4281256&FileName=36C24718Q0607-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4281256&FileName=36C24718Q0607-000.docx

 

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

Record

SN04911307-W 20180506/180504230538-10564a9aa092fb441927eb6a4acb3ceb (fbodaily.com)
 

Source

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

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