PWS Pharmacy Trailer.docx
DOCX document 24 KB Posted
- Attached to
- W065--Pharmacy Mobile Trailer Rental Federal contract opportunity
- Solicitation number
- 36C24123Q0364
About this file
This performance work statement outlines requirements for the rental of a mobile pharmacy cleanroom trailer at the VA Boston Healthcare System. Key details include:
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The mobile cleanroom trailer must meet ISO class 7 and 8 standards for hazardous and non-hazardous compounding with ISO 5 hoods and biological safety cabinets. HEPA filtration and electrical/IT connections are required.
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A certified technician must be available for scheduled remediation and maintenance to ensure environmental compliance. The trailer will be located at the Jamaica Plain campus for 12 months.
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The intent to award sole source was issued on December 14, 2022 with responses due by February 14, 2023 to the contracting officer. The notice stated a determination had been made to procure this as a sole source rental based on current facility needs.
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|---|---|---|
| 36C24123Q0364.docx | DOCX document |
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Text version
SPECIFICATION/Performance Work Statement
RENTAL OF GERMFREE®MOBILE CLEANROOM AT THE VA BOSTON HEALTHCARE SYSTEM
I. Background A. The purpose of this contract is to provide the Jamaica Plain campus within the VA Boston Healthcare System with a USP <797> and USP <800> compliant. This rental ensures the continuation of patient care for both hazardous and non-hazardous compounded sterile products (CSPs). Appropriately competent staff will operate within the mobile unit to maintain an aseptic environment as directed by USP <797> USP <800> and VHA 1108.12. Each day or part-day on which a specific contract supplies the VAMC with the mobile unit is called a ‘client day’.
II. Objectives A. With respect to the mobile cleanroom, this Performance Work Statement (PWS) will include goals that objectify the need to continuously rent a mobile cleanroom unit. These goals include (but are not limited to): safe appropriate administration of CSPs in various patient care services (i.e. oncology, urgent care, inpatient acute care, inpatient intensive care). Currently, Jamaica Plain has a federally compliant trailer from Germfree to safely compound hazardous medications. The continuation of a rental trailer in Jamaica Plain will support continuity of services with no disruption to patient care, with the potential to support other campuses if needed. The minimum day charge applies each day the mobile unit is effectively operating in the designated space in Jamaica Plain campus.
III. Scope, Tasks or Requirements
| A. The general scope of the work the contractor will be performing is to supply the government (specifically the VA Boston Healthcare System) with a federally compliant mobile cleanroom and a certified and credentialed technician to remediate the mobile cleanroom on specific schedule days designated by the VA. The certified technician will bring the requested remediation to the mobile cleanroom in Jamaica Plain campus. It is expected that all mobile cleanrooms meet both federal standards (USP <797> and <800>) and national VA standards (i.e. VHA 1108.12). |
| B. The following features are required by the VA Boston Healthcare System, with regard to the mobile cleanroom: ISO class 7 and 8 cleanrooms for both hazardous and non-hazardous compounding, ISO 7 ante room for hazardous entry and ISO 8 ante room for non-hazardous entry, ISO 5 units (two vertical hoods for non-hazardous cleanrooms and two biological safety cabinets with negative pressure for hazardous compounding), HEPA filtered pass-through cabinets, HEPA filtration in all ISO classified rooms, electrical and IT capable hook-ups for CPRS capable hard drives and low lint CSP labels. |
| C. The mobile cleanroom must be able to maintain ISO classifications 8, 7 and 5 respectively in location to hazardous and non-hazardous compounding. The mobile cleanroom must be able to maintain pressure gradient according to federal standards. The mobile cleanroom must be able to maintain appropriate temperature and humidity for employee comfort and to maintain a low risk microbial growth environment as outlined in the VA Boston pharmacy operating procedure. |
| D. Any work authorized by the CO to ensure compliance is adhered to in accordance with CSPs pursuant to USP <797>, USP <800>, VHA directive 1108.12. The work shall be identified at the time of awarding the Base or any of the following options. |
IV. Selection Criteria A. The standard of acceptable performance that is to be provided by the contractor is to have a certified and/or licensed technician available for acute remediations/service/maintenance requirements for the ongoing health of the mobile trailer. According to federal guidelines, all certifications must be maintained twice a year. In addition, a competent technician must be available for pressure balances, HVAC remediations, temperature balances and routine maintenance to ensure environmental compliance.
| A. The mobile unit is located on the Jamaica Plain campus and will be for the remainder of the contract and/or lease. |
| B. Usage- during the term of this SOW the VAMC shall utilize the contractor’s mobile cleanroom for all CSPs required by the Jamaica Plain pharmacy department and the Brockton and West Roxbury pharmacy departments as needed. |
VI. Government-Furnished Equipment and Government-Furnished Information
| A. The VAMC certifies that each pharmacy technician and pharmacist designated by the VA to operate within the mobile cleanroom is trained and competent in the production of CSPs pursuant to USP <797>, USP <800>, VHA directive 1108.12 and the operating procedure. The VAMC maintains a facility adequate and suitable for the operation and safe location of the mobile cleanroom. VAMC shall perform or cause to be performed all medical services, supervisor and diagnosis and patient care in accordance with applicable professional standards. Further, each designated pharmacy staff member shall protect the mobile cleanroom from damages occasioned by improper use or handling, carelessness or neglect of the equipment. |
| B. The contractor will have a certified and/or licensed technician available when needed for remediation. Only VAMC employee(s) while in the performance of their official duties (and not the contractor’s employee(s) are covered by the Federal Tort Claims Act, 28 U.S.C § 1346 (b), 2671 through 2680. The contractor acknowledges that the mobile unit is in good working condition and is regularly maintained. The contractor will be liable and indemnify the VAMC for damages should patient injury result due to mobile cleanroom malfunction. The contracted vendor acknowledges that it maintains sufficient insurance coverage. |
VII. Security
| A. The VAMC pharmacy service will ensure that all competencies as required by the pharmacy department standard operating procedure are maintained. |
| B. The contractor is required to enter into a business associate agreement (BAA) with the VA. |
VIII. Place of Performance A. This work will be performed at the Jamaica Plain campus and not at the contractor’s site
IX. Period of Performance A. The performance period will be for 12 months
X. Contractor’s Responsibility
| A. Contractor will hold and submit certificates of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Under no circumstances are contractor’s employee(s) considered VA Boston Healthcare System employee(s). |
| B. Technician(s) must be licensed in the state of Massachusetts and hold valid competencies according to the pharmacy SOP. |
| C. The contractor is responsible for keeping equipment in good working order and shall provide all maintenance, repairs, and upgrades to the equipment as required keeping it in optimal condition. |
| D. Technician(s) are subject to the same quality assurance with ethical, professional and technical standards of the health care industry. |
| E. The contractor will provide services in accordance with ethical, professional and technical standards of the health care industry. |
XI. Services Not Covered
| A. Any work other than as specified in the contract shall be identified as a non-priced task, and if determined by the contracting officer to be within the overall scope of the contract, work shall be added by a modification to the contract. |
| B. Any work requested that is identified as outside the scope of the contract shall be addressed by the facility as a separate procurement. |
XII. Federal Holidays Observed by the VA
| New Year’s Day | Labor Day | ||
| MLK | Columbus Day | ||
| President’s Day | Veterans Day | ||
| Memorial Day | Thanksgiving Day | ||
| Independence Day | Christmas Day |
1. Also included would be any other day specifically declared by the President of the United States to be a national holiday.
2. When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday.
XIII. Identification, Parking, Smoking and VA Regulations:
A. The contractor’s FSEs shall always wear visible identification while on the premises of the VAMC. It is the responsibility of the contractor to obtain and pay for parking. The VAMC will not invalidate or make reimbursement for parking violations or charges for the contractor under and conditions. Smoking is prohibited inside any buildings and on federal property. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States Federal District Court, not a local district, state, or municipal court.
XIV. Orientation for Contractor Employees
| A contractor will attend an orientation meeting as arranged by the contracting officer’s representative (COR). The VA will schedule this meeting and it will include discussion of the following topics: (VA will provide information to the contractor regarding these topics and will document the meeting): |
| 1. Fire and safety |
| 2. Infection Control |
| 3. Disaster procedures |
| 4. Other |
B. The contractor will be responsible to ensure contractor employee(s) providing work on this contract are fully trained and completely competent to perform the required work.
XV. Contractor Personnel Security Requirements:
All contractor employee(s) who require access to the Department of Veterans Affairs’ contractor’s computer systems or have access to sensitive information shall be the subject of a background investigation. The contractor is encouraged to have its employee immediately download the background investigation packet from: http://www.osp.va.gov/security_and_investigations_center_FF.asp upon notification of contract award.
A contractor’s employee shall not commence working at VA under contract until the contracting officer receives notification from the VA Office of Security and Law Enforcement that the contract employee’s application was received and complete. A favorable adjudication from the VA Office of Security and Law Enforcement must be received in order for a contractor employee to continue contract performance. This requirement is applicable to all subcontractor personnel.
| A. Position Sensitivity- the position sensitivity has been designated as low risk. | |
| B. Background Investigation- The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquires (NACI). | |
| C. Contractor Responsibilities: | |
| i. The contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractor’s 1st month’s invoice(s) for services rendered. | |
| ii. It is imperative for the contractor to provide, at the request of the VA a listing of contractor personnel performing services under the contract in order for the background investigation process to commence. This list will include names (first, middle, last) social security number, date of birth, city, state and country of birth. | |
| iii. The contractor or their employee(s) shall submit a complete background investigation packet. Additional guidance and information in completing the required forms and examples of the forms can be found at: http://www1.va.gov/vABackground_Investigation/page.cfm?pg=2. |
The following required forms must be submitted to the VA Office of Security and Law Enforcement before contract performance begins: (Standard Form 85 Questionnaire for Non-Sensitive Positions, optional Form 306 Declaration for Federal Employment, Standard Form 86A (EG) Continuation Sheet for Questionnaire, electronic fingerprint form)
Fingerprinting is required with the background investigation. Fingerprinting can be done at the local VA facility. The electronic fingerprint verification form must be submitted with the above required forms.
| D. The contractor shall inform the contract employee that when filling out Standard Form 85, that there should be no gaps in employment history. Any gaps in employment history on Standard Form 85 may result in OPM rejecting the documentation for instigation and delay contract performance. |
| E. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract and at all request of the VA submit another employee for consideration. |
| F. The contractor may utilize a private investigating agency if such agency possesses an OPM and Defense Security Service certification. A cage code number must be provided to the VA Office of Security and Law Enforcement. VA Office of Security and Law Enforcement will verify the information and advise the contracting officer whether contractor’s access to the computer systems can be authorized. |
| G. All contractor employee(s) and subcontractors are required to complete the VA’s privacy training annually. All contactor employee(s) and subcontractors requiring access to VA computer network are required to complete Cyber Security training courses annually either on-line or hard copy. Documented proof must be provided to the contracting officer. |
| H. The contractor will notify the COR immediately when their employee(s) no longer require access to the VA computer systems. |
XVI. Government Responsibilities
| A. The contracting officer will request the contractor employee’s background investigation by the Office of Security and Law Enforcement. |
| B. The Office of Security and Law Enforcement will notify the contractor with instructions for the contractor’s employees(s), coordinate the background investigations and notify the contracting office and contractor of the results of the investigation. |
| C. The VA facility will pay for requested investigations in advance. A bill for collection will be sent to the contractor to reimburse the VA facility. The contractor will reimburse the VA facility within 30 days. If timely payment is not made within 30 days from date of bill for collection, then the VA shall deduct the cost incurred from the contractors 1st month’s invoices rendered. |
| D. The current fees associated with background investigations are $210.00 each for low level investigation and $850.00 each for medium level investigation, and $2,900.00 each for high level investigation. |
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