F107--Pharmacy Environmental Monitoring

Combined Synopsis Solicitation White River Junction VAMC Pharmacy Environmental Monitoring (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 36C24121Q0207-1 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 2021-02. (iv) This requirement is being issued as an open market, small business set-aside. The associated NAICS code is 541380 for Testing Laboratories and small business size standard is $16.5 million. (v) The Government intends to award a firm-fixed price award for Pharmacy Environmental Monitoring 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 Introduction The White River Junction VA Medical Center (WRJ VAMC) prepares and compounds necessary intravenous medications, chemotherapeutic agents, and other sterile products to assigned patients. As a VAMC facility, the pharmacy is required to provide compounded products according to all relevant USP compounding guidelines including USP 797/800. To meet compounding compliance, a multidisciplinary approach has been adopted to provide safe compounded medications. Included in this multidisciplinary approach is the requirement for environmental monitoring. 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 shall 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. All services shall be performed in accordance with the terms and conditions specified in this solicitation and in compliance with the statement of work. The contract will cover a minimum of twelve (12) months from start date. The Contractor shall 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) shall be financially responsible, show evidence of their reliability, ability and experience performing in sterile compounding environments and USP 797/800 environmental monitoring. The contractor and personnel directly employed or supervised by them shall render prompt, detailed service in accordance with the applicable directives referenced in this document. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required. Contractor personnel shall be trained appropriately and deemed competent for performance of work under this contract. 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 shall furnish a copy of state certification to perform contracted service. The company shall 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 shall 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 at WRJ VAMC Pharmacy, Building 39, Room 236 (rooms C, D, E, F, G and H) Cleanroom Cleaning Services shall comply with industry standards and USP Chapter 797/800. Environmental sampling will be performed in Pharmacy compounding spaces as follows: Total number of rooms to be sampled 6 rooms, all 6 rooms require environmental sampling: Anteroom (Room # 236 E), Chemo anteroom (Room # 236 G) Chemo hood room (Room # 236 H) IV compounding room (Room # 236 F). Compounding aseptic isolator (Room # 236 C) Compounding aseptic containment isolator (Room # 236 D) Total square footage of the surfaces to be environmentally sampled. See below, for chart diagram. Width is 12 9 and length is 24 6 x 12 walls Approximately 3,764 square feet (total). The required sampling is to be performed once per month during normal business hours, Monday through Friday (excluding Federal Holidays). Sampling will typically be performed between 1:00 pm and 4:30 pm (after morning compounding is complete). Contractor shall log in when reporting into pharmacy to perform service and log out after service is conducted. All personal servicing VAMC White River Junction shall complete appropriate clearance through the VAMC security process. Vendor workers shall be on VACT access roster prior to entering Pharmacy Compounding space. The environmental testing services will include the following: Monthly during normal business hours. Includes Ante Rooms, IV Prep & Chemo Rooms: Contractor will provide on-site monthly clean room Environmental Monitoring services for USP clean room areas detailed above (Building 39 Room 236 C-H). The environmental surface testing shall be completed by an independent biology lab. The contractor shall collect the samples from each individual campus and deliver the samples to be evaluated to the laboratory that same day before close of business, on the day of sample. There will be no shipping of samples via air/train/mail system outside of the New England area. Plates will be stored in accordance with the manufacturers guidelines before and after use. The Contractor shall utilize a laboratory that is FDA registered and/or accredited by the American Industrial Hygiene Association (AIHA) or the American Association for Laboratory Accreditation(A2LA) for analysis and reporting of the samples collected. The reports are then to be provided to the Chief of Pharmacy Service. The environmental monitoring report should identify the following: Media used/lot numbers of medias and corresponding expiration dating Location of samples taken (with corresponding map) Equipment used (calibration date) Surface testing (tests shall include medias used to identify mold, yeast, gram positive and gram-negative bacteria) Viable and non-viable air testing The identifiable bacteria including genus and species Samples to include: 6 surface samples /per location (total: = 3 rooms with 5 surface samples per room, 8 samples for anteroom (236E)) and 1 sample from each primary engineering control. 1 sample for each of 2 pass-through windows. Total = 31 viable surface samples. 1 viable air sample per location (one sample per room x 4 rooms), 1 sample per laminar airflow workbench (LAFW) and one sample per biological safety cabinet (BSC) =2 (Cabinets). 1 non-viable particle per location (one sample per room x 4 rooms), 1 sample per LAFW and one sample per BSC =2 (Cabinets). 2 surface samples from the compounding aseptic isolator (CAI) and 2 surface samples from the compounding aseptic containment isolator (CACI). For each isolator, 1 surface sample taken from the interchange chamber and 1 surface sample taken from the main chamber where compounding is performed. 2 viable air samples from the CAI and 2 viable air samples from the CACI. For each isolator, 1 viable air sample taken from the interchange chamber and 1 viable air sample taken from the main chamber. 2 non-viable air samples from the CAI and 2 non-viable air samples from the CACI. For each isolator, 1 non-viable air sample taken from the interchange chamber and 1 non-viable air sample taken from the main chamber. The contractor will provide environmental monitoring on a monthly basis without interruption. If the contractor cannot meet a monthly requirement, it is up to the contractor to provide a contingency date to fulfill the work order/contract details. The contractor shall use current USP standards and the VHA Directive when evaluating bacterial/fungal growth within the ante room and buffer areas. If the colony counts exceed the parameters defined in the USP standards, the contractor will notify the pharmacy service. The contractor will also identify high risk organisms (yeast, mold, gram negative bacteria and coagulase positive Staph) within the monthly surface and viable air sampling. If a high-risk organism is found within hazardous or non-hazardous rooms, the contractor will notify the pharmacy department in a timely manner (as quickly as possible once results are available). The pharmacy department will implement an action plan as follows: 1. Identify the source of the high-risk organism 2. Initiate a cleaning process (top-down clean the area three times, i.e. triple clean ) to eliminate the bacterial growth 3. Re-test the affected area 4. Shorten beyond use dating until environmental monitoring reports are clear Provision of Media-fill and Glove-tip testing per USP 797 Recommendations. Types of Media Used to Test Viable Sampling A general microbiological medium such as Trypticase Soy Agar (TSA) or Soybean-Casein Digest Medium should be used to support the growth of bacteria. For fungi, Malt Extract Agar (MEA) or some other media that supports the fungal growth shall be used. Media used for surface sampling shall be supplemented with additives to neutralize the effects of disinfecting agents (e.g., TSA with lecithin and polysorbate 80). Sampling Viable Particulates to Meet USP 797 Compliance Gloved Finger Sampling: TSA plates should be used to sample gloved fingertips after compounding CSPs prior to exiting the ISO Class 5 environment. Glove fingertip sampling shall occur inside of the ISO Class 5 environment. Do not disinfect gloves with Isopropyl alcohol immediately prior to sampling. Personnel should "touch" the agar with the fingertips of both hands in a manner to create a slight impression in the agar. Media-Fill Testing: Aseptic media-fill testing is used to quantify aseptic technique of compounding personnel or processes and to ensure that the processes used produce a sterile product without microbiological contamination. The microbiologic growth medium is substituted for the drug product to simulate admixture compounding. The growth media is then incubated and checked for turbidity and presence of microbiological contaminates. USP 797 Levels of Viable Colony Counts Considered Elevated The following table lists the action levels adapted from the Pharmaceutical Compounding - Sterile Preparations <797>, that when exceeded shall initiate further investigation. ISO Class Active Airborne (cfu*/m3) Glove Fingertip (cfu/contact plate) Inanimate Surfaces** (cfu/contact plate) 5 > 1 > 3 > 3 7 > 10 not required > 5 8 > 100 not required > 50 * cfu = colony forming units ** Contact plate areas vary from 24 to 30 cm2. When swabbing is used in sampling, the area covered should be at least 24 cm2 but no larger than 30 cm2. Regardless of the cfu counts, corrective actions shall be dictated by identifying the microorganisms recovered. If pathogenic microorganisms are found, you shall immediately remedy the situation. Contractor should provide availability of kits and processing for gloved-finger sampling and media-fill tests. All results need to be reported back to the facility in an expeditious manner. Note: If it is determined that additional cleaning and follow up Environmental Testing is needed due to results of Environmental Monitoring, notify the COR and Chief of Pharmacy Service, provide an estimate for the additional scope and do not proceed without Contracting Officer approval. Contractor Personnel Security Requirements: Contractor employees who have access to the WRJ VAMC shall be the subject of a background investigation and shall receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. The requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start of the contract, the Contractor will be responsible for the actions of the individuals who perform on the contract. Position Sensitivity - The position sensitivity has been designated as low risk. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Agency Responsibilities: The Contracting Officer will initiate the Background Investigation request into the Security and Investigations Center (SIC). Vendor Responsibilities: The Contractor has two key responsibilities: getting all employees who will work in a VA facility electronically fingerprinted at a local VA hospital or police station and having those same employees fill out the E-QIP questionnaire that will be emailed to them once the contracting officer initiates the investigation. When the request is submitted the Contractor Request Database will generate an "initial" email with the website link and instructions to all email addresses listed on the request worksheet. This email will indicate what level of investigation was requested and how to complete the process. This is not considered an initiated investigation at this point. A case is not initiated until we have received a complete security package from the contract employee and can forward that security package to OPM. Time Frames: Below is a breakdown by level of each investigation handled by the SIC. Time frames may vary due to OPM. Low Risk (NACI) The case is only open for 30 days except in rare occasions when something in the person's background requires an extension. This investigation is done by mail and that is why we shall be so stringent with the paperwork. The average turn around on these cases is 45 days. Cleanroom Training for WRJ VAMC Staff Contractor will perform employee training and certification for gowning procedures (garments provided by the contractor). The contractor shall be well versed in maintaining aseptic technique and educate the pharmacy department for proper disposal of items which are used by the contractor. This training will need to include the entire clean room team at all locations (Total of 55 personnel combined). Contractor will be available for additional training services for new employees. Once annual VA employee testing is completed (gowning technique, fingertip testing for regular garbing and glove box technique) the contractor will provide certification to the pharmacy department. All proficiency tests will be scheduled in advance to allow the pharmacy department adequate central coverage. Contractor Quality Control and Assurance Requirements: The Contractor will be required to provide their Quality Control and Assurance program. This program shall detail all steps required to maintain and continuously provide a clean room environment in accordance with published criteria for USP 797/800 Sterile Compounding areas. <> ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 12.00 MO __________________ __________________ On-site Environmental Monitoring as outlined per PWS 1001 12.00 MO __________________ __________________ On-site Environmental Monitoring as outlined per PWS Contract Period: Option 1 POP Begin: POP End: 2001 12.00 MO __________________ __________________ On-site Environmental Monitoring as outlined per PWS Contract Period: Option 2 POP Begin: POP End: 3001 12.00 MO __________________ __________________ On-site Environmental Monitoring as outlined per PWS Contract Period: Option 3 POP Begin: POP End: 4001 12.00 MO __________________ __________________ On-site Environmental Monitoring as outlined per PWS Contract Period: Option 4 POP Begin: POP End: GRAND TOTAL __________________ (vi) The Contractor shall provide all resources necessary to provide Pharmacy Environmental Monitoring 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 addendums 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 not later than 4/7/2021 at 10:00am EST. All quotes will be emailed to contact@example.gov with the subject line to include the solicitation number. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). (2) Offerors: shall submit their quotes electronically via email to contact@example.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 5, 2020 at 10:00 AM 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. (xi) 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 13. The contracting techniques associated with FAR Part 13 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.beta.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 Vermont. 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. (xii) 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 (AUG 2020) 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) (xiii) 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. (xiv) 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) 52.204-18- Commercial and Government Entity Code Maintenance (AUG 2020) 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 30 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 0 months FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 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: 52.204-10, 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). 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)). 52.222-21, Prohibition of Segregated Facilities (APR 2015). 52.222 26, Equal Opportunity (SEP 2016) (E.O. 11246). 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627). 52.232-33, Payment by Electronic Funds Transfer System for Award Management (Jul 2013) (31 U.S.C. 3332). (xvi) All quotes shall be sent to contact@example.gov This is an VOSB Set-aside open-market combined synopsis/solicitation for Fresenius Dialysis Equipment 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). (xvii) Wage Determination SCLA: 2015-4139 (Rev 14) 201221 VT Windsor (xviii) Point of Contact The POC of this solicitation is Carlton Lunsford, contact@example.gov.