6515--Pharmaceutical Aseptic and Environmental Testing and Analysis

DEPARTMENT OF VETERANS AFFAIRS Network Contracting Office 6 (NCO 6) Sources Sought 36C24622Q0760 In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, the Government reserves the right to revise the Performance Work Statement and other contract requirements, before the release of any associated solicitation. This notice is not a Request for Proposals (RFP). Information provided in this notice is subject to change prior to release of a solicitation. OVERVIEW The Department of Veterans Affairs, Network Contracting Office 6 is conducting market research to identify potential sources for Pharmaceutical Aseptic and Environmental Testing and Analysis for W. G. Hefner Medical Center in Salisbury, North Carolina. See attached draft Performance Work Statement and below scope of work. Forward all questions to the Contract Specialist identified below. SCOPE OF WORK 1.1 Under the authority of United States Pharmacopeia (USP) <797> and Veterans Affairs Acquisition Regulation (VAAR) 873, the Salisbury VA Health Care System (VAHCS) located at 1601 Brenner Avenue, Salisbury, NC, requires services of a medical laboratory scientist to perform incubation and analysis of gloved fingertip and media fill testing for all designated personnel and surface sampling of pharmacy IV hoods and spaces used in sterile compounding. 1.2. Medical laboratory scientists (also referred to as, and covered by the services in the scope of work, a clinical laboratory scientist or medical technologist) shall provide documentation of certification as a Medical Laboratory Scientist, (or equivalent) by the American Society for Clinical Pathology (ASCP). The contractor shall be licensed and insured to provide services in the geographic area covered in the scope of work. Documentation of the aforementioned personnel qualifications must be submitted with offer and upon request of the Salisbury VAHCS. 2. SCOPE: The Contractor agrees to provide all materials, tools, specialized equipment, labor, supervision, and technical expertise for services covered in the scope of work. Salisbury VAHCS Pharmacy will serve as the focal point and the point of contact for this contract. Personnel can be reached at +1 (555) 000-0000 ext. 14362 during normal business hours. The government requests a base + four (4) Option Year contract. 2.1 Glove-fingertip Testing: Glove fingertip (GFT) sampling shall be used to evaluate the competency of personnel in performing hand hygiene, garbing procedures, and aseptic technique, in addition to educating compounding personnel on proper work practices. a. Salisbury VAHCS staff will collect the samples using appropriate agar plates or paddles containing trypticase soy agar (TSA) with lecithin and polysorbate 80. Salisbury VAHCS staff will label and ship the testing plates via overnight delivery to contractor location for incubation and reading of results. b. GFT agar plates or paddles, shall be incubated by the contractor at contractor s location in an incubator at a temperature of 30 to 35 degrees Celsius for 48 to 72 hours, then at 20 to 25 degrees Celsius for no less than 120 additional hours and not more than 168 hours, followed by examination for growth. c. GFT agar plates or paddles, once incubated for the defined time, shall be read to determine if there are any colony forming units (CFUs). An analysis report for each sample shall be submitted to the Salisbury VAHCS Pharmacy via email within 5 calendar days of the reading. GFT analysis report shall include, at a minimum, the following: 1. Sample name or number (assigned by Salisbury VAHCS Pharmacy) 2. Dates and times for each interval of incubation 3. Starting temperature for each interval of incubation 4. Date and time GFT sample was evaluated 5. Number of CFUs in the sample (if any) 6. Name and signature of the person who read and documented results of the sample. 2.2. Media-fill Testing: Media-fill testing (MFT) is used to assess the quality of the aseptic skill of compounding personnel. a. A commercially available sterile fluid media consisting of Soybean-Casein Digest Medium will be used to assess aseptic skill. The Salisbury VAHCS Pharmacy will collect the samples then label and ship via overnight delivery to the contractor where they shall be incubated for 7 days at 20 to 25 degrees Celsius followed by 7 days at 30 to 35 degrees Celsius. b. Once the incubation period for MFT samples is completed, the samples shall be analyzed using visual examination. Failure is indicated by visible turbidity or other visual manifestations of growth in any MFT sample on or before 14 days from the time incubation was initiated. An analysis report for each sample shall be submitted to the Salisbury VAHCS Pharmacy via email within 5 calendar days of the analysis. MFT analysis report shall include, at a minimum, the following: 1. Sample name or number (assigned by Salisbury VAHCS Pharmacy) 2. Dates and times for each interval of incubation 3. Starting temperature for each interval of incubation 4. Date and time MFT sample was evaluated 5. Results indicating the presence or lack of turbidity or other visual manifestations or growth 6. Name and signature of the person who examined and documented results of the sample 2.3. Surface Sampling: Surface sampling is an important component of the maintenance of a suitable microbial controlled environment for compounding sterile products, especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs. a. Surface sampling shall be performed in all ISO classified areas, pass-through chambers connecting to classified areas, and on worksurfaces and frequently touched surfaces near primary engineering controls monthly and shall be initiated by the Salisbury VAHCS Pharmacy. Surface samples will be conducted on appropriate agar plates or paddles containing trypticase soy agar (TSA) with lecithin and polysorbate 80. All growth media used in sampling must have an associated certificate of analysis. Samples will be labeled and shipped to contractor via overnight delivery. b. Surface samples shall be incubated by the contractor at contractor s location in an incubator at a temperature of 30 to 35 degrees Celsius for 48 to 72 hours, then examined and any CFUs recorded. The same samples shall then be incubated at 20 to 25 degrees Celsius for no less than 120 additional hours and not more than 168 hours, followed by examination for growth. c. Once incubated for required period, surface samples shall be read to determine if any CFU is visible. An analysis report for each sample shall be submitted to the Salisbury VAHCS Pharmacy via email within 5 calendar days of the reading and shall include, at a minimum, the following: 1. Sample number (assigned by Salisbury VAHCS Pharmacy) 2. Dates and times for each interval of incubation 3. Starting temperature for each interval of incubation 4. Date and time surface sample was evaluated 5. Number of CFUs in the sample (if any) 6. Name and signature of the staff member who read the sample. d. If CFU levels of a sample exceed the levels as specified in the action levels table below, the sample shall have microbial evaluation performed by the contractor to identify which organism(s) were grown on the respective surface sample. A microbial evaluation report identifying each organism to the genus level shall be provided to the Salisbury VAHCS Pharmacy via email within 10 calendar days. Action Levels for Surface Sampling ISO class of space where sample taken CFU levels triggering microbial identification 5 >3 CFU 7 >5 CFU 8 >50 CFU No ISO class >50 CFU 3. CONTRACTOR S QUALIFICATIONS: The contractor must be regularly established in the business called for, financially responsible, and have the necessary equipment and personnel to furnish service in the volume required for all items under this requirement. The successful Contractor shall meet all Federal, State and Local codes and requirements for the operation of this service and equipment provided. Medical laboratory scientists authorized by the Contractor to perform services under this specification and any resulting contract, shall be certified by the American Society for Clinical Pathology. Qualified personnel must be American citizens (or offer evidence of a green card). Contractor s employee(s) shall be technically proficient in the skills necessary to fulfill the Government's requirements, to include the ability to speak, understand, read & write English fluently. The qualifications of employees authorized to complete services under this specification, shall also be subject to review by the Chief, Pharmacy Service, Chief of Staff, and/or the Medical Center Director of the Salisbury VAHCS. The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; including knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this requirement; and listing of relevant continuing education for the last two (2) years. The Contractor shall provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the Salisbury VAHCS COR or Pharmacy management designee; or upon request, for each Contractor employee working on the contract. 4. CONTRACT REQUIREMENTS: a. All work shall commence within twenty-four (24) hours after receipt of sample and will proceed progressively without undue delay. All work shall be performed by competent personnel, experienced and qualified to work on the specific equipment. b. Hours of Operation: The normal duty hours for these services will be Monday through Friday from 8:00am until 4:30pm (Eastern Standard Time). No operations will be required to perform on federal holidays or after the normal duty hours. 5. CONTRACTOR S FURNISHED EQUIPMENT: a. Incubators used for GFT, MFT, and surface sample testing must meet the following minimum requirements: 1. Designed for incubating general growth media at a consistent temperature of 30 to 35 degrees Celsius and 20 to 25 degrees Celsius; 2. Equipped with a continuous temperature monitor; 3. Not located in an area where drugs are stored, handled, prepared, or where clinical microbiology samples are cultured, or where they would pose a threat to patient and employee health; and 4. Connected to an emergency power supply or have an internal battery emergency power supply. b. Any equipment or materials used to detect, analyze, or identify microorganisms as deemed acceptable per industry standards. 6. SUPPLIES: Contractor shall be solely responsible for the procurement, receipt, and safekeeping, of all supplies required in the performance of the services defined herein and authorized by the COR/ACOR. Additionally, the Contractor shall be responsible for providing the Salisbury VAHCS with necessary supplies to complete work of services defined herein, including but not limited to, sampling plates or paddles. Contractor shall also be responsible for the waste management, removal and proper disposal of all samples provided for testing by the Salisbury VAHCS. The cost for proper disposal of materials furnished under this contract shall be part of any line item pricing listed in the Schedule of Supplies/Services and should not be separately priced for this requirement. 7. DOCUMENTATION/REPORTS: The Contractor shall provide all documentation and analysis reports to the Chief, Pharmacy Service of the Salisbury VAHCS during the duration of the contract. All documentation and reports shall be submitted as defined herein via e-mail to: contact@example.gov. All analysis reports shall be read by a certified Medical Laboratory Scientist. Documentation required by the successful Contractor prior to the commencement of services: a. Certificate of Insurance not limited to but, includes: Professional Liability, Worker s Compensation, liability and property insurance of Contractor s furnished equipment which shall be submitted to the Contracting Officer within ten (10) calendar days of receipt of notification of award. It is agreed upon and understood that the VISN 6 shall not be held responsible for any damage or vandalism, which may be caused to the Contractor s equipment while on Salisbury VAHCS premises. b. Required Federal, State and local licenses. c. Employee(s) Certifications/Registrations, Competency Check List and Training Certificates. 8. BILLING AND PAYMENT: a. The contractor shall submit payment requests in electronic form via VA s Electronic Presentment and Payment System: http://www.fsc.va.gov/einvoice.asp. b. Invoices shall be submitted monthly for services rendered. The following information must be included all submitted invoices. Invoices submitted without the following information may be rejected for payment. Invoices shall include, at a minimum: 1. Date services performed 2. Contract number 3. Sample Number 4. Contractor's charge per sample 5. Valid purchase order number c. Contractor shall provide scheduled services throughout the contract period. Other necessary personnel for the operation of the services contracted for services for the VA will be provided by the Contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming. d. No charge services: The Contractor shall not charge the Salisbury VAHCS if the quality of the testing performed is unacceptable as determined by Salisbury VAHCS personnel. Contractor shall be notified if the above should occur and monthly billing shall be adjusted accordingly. Non conforming products or services will be rejected. Unless otherwise agreed by the parties, deficiencies shall be corrected within seven (7) days of the rejection notice. If the deficiencies cannot be corrected within seven (7) days, the Contractor shall immediately notify the COR and the Contracting Officer of the reason for the delay and provide a proposed corrective action plan within seven (7) working days. 9. CONTRACT ADMINISTRATION: Notwithstanding the Contractor s responsibility for total management during the performance of this contract, the administration of the contact will require maximum coordination between the Government and the Contractor. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contacting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity, or quality of this contract. The COR shall the responsible for the overall technical administration of this contract as outlined in the COR Delegation Authority. The Government reserves the right to refuse acceptance of Contractor, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. The Contracting Officer and Contracting Officer's Technical Representative shall deal with issues raised concerning contract personnel's conduct. The final arbiter on questions of acceptability is the Contracting Officer. If the Contractor is involved and named in a validated patient complaint the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse. Contractor rendering services is subject to professional or technical direction from the COR. The Salisbury VAHCS shall provide the Contractor the name, title, and telephone number of the COR at the time of contract award. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract. The services to be performed by the contractor will be under the direction of the Chief, Pharmacy Service or his/her designee. 10. CONTRACT QUALITY MONITORS: a. The following monitors will be implemented at the contract inception and be maintained indefinitely until it expires. b. To ensure The Contractor remains compliant with the terms of this contract, Salisbury VAHCS Pharmacy will: 1. Review random samples at least quarterly to confirm that samples are incubated in timely manner in compliance with USP <797> standards and for completion of all required documentation related to sample receipt, storage, handling, and microbial evaluation. 2. Follow up on all complaints regarding issues with timeliness in processing and analysis submission. 3. Review overall pass/fail rate of all personnel and environmental samples submitted. SMALL BUSINESS REQUIREMENTS For market research purposes, all responses to this notice will be reviewed, regardless of small business/socioeconomic category, including those firms that are identified as large businesses. Review of responses to this notice will support later determination of set-aside requirements, if a solicitation becomes available, where the rule of two is met regarding a set-aside, including set-asides under 38 U.S.C. 8127 and 8128 for Service Disabled Veteran Owned Small Businesses (SDVOSB) and/or Veteran Owned Small Businesses (VOSB) firms registered in the Vendor Information Pages (VIP) database, in accordance with priorities set by regulation. NAICS CODE: 238210 Electrical Contractors and Other Wiring Installation Contractors (SBA Size Standard: $16.5 million annual revenue) PRODUCT OR SERVICE CODE (PSC): J061 Maintenance, Repair, and Rebuilding of Equipment Electric Wire and Power Distribution Equipment. INSTRUCTIONS FOR RESPONDING: Interested companies can respond, via email, to contact@example.gov, with the following information: (1.) Company Point of Contact, including name, title, phone number and email address. (2.) Company name, DUNS number, small business/socioeconomic status of the company, and address of the applicable office. (3.) Documentation evidencing certification/licensure to provide ambulance services in the State of North Carolina. (4.) Accord Certification of Insurance Additional information may be requested by the Contract Specialist at a later time. POINT OF CONTACT: Serina Black Contract Specialist Services Team 3 Network Contracting Office (NCO) 6 Regional Procurement Office (RPO) East Veterans Health Administration U.S. Department of Veterans Affairs contact@example.gov DUE DATE FOR RESPONSES: This notice will close on Friday, December 16th, 2022, at 15:30 PM Eastern Time. CONTRACTOR RESPONSIBILITY A potential source, for the purposes of this notice, is considered to be any company meeting the following requirements. Some of the below requirements may be modified prior to release of any solicitation. 1. The potential source is registered in the System for Award Management (SAM) database at https://www.sam.gov, as whichever entity/office that would receive award in the event of a solicitation. 2. The potential source is registered in the Vendor Information Pages (VIP) database at http://www.va.gov/osdbu, if applicable. (This is only applicable to firms meeting Small Business Administration (SBA) and VA requirements for Service-Disabled Veteran-Owned Small Business (SDVOSB) or Veteran-Owned Small Business (VOSB) programs.) 3. The potential source has completed submission of the current cycle, for calendar year 2017, VETS-4212 Report at http://www.dol.gov/vets/programs/fcp/main.htm (Only applicable where the potential source has held federal contracts in the amount of $150,000.00 or more, performed during the current cycle). 4. The potential source has favorable (satisfactory) past performance information for federal contracts, as documented in Government databases, including the Federal Awardee Performance and Integrity Information System (FAPIIS) and Past Performance Information Retrieval System (PPIRS), where applicable. Where performance ratings less than satisfactory have been identified, the circumstances of those ratings may be requested during discussions, or the offeror may be eliminated from the competition.