36C26126Q0754.docx

SUBJECT*

PHARMACY USP 797 800 CERTIFICATION TESTING

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 21

POINT OF CONTACT*

Contracting Officer Cynthia Diezel cynthia.diezel@va.gov 916-923-4567

PLACE OF PERFORMANCE

2615 E Clinton Ave

Fresno, CA 93703

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

Performance Work Statement (PWS) Pharmacy USP 797 & 800 Certification Testing VA Central California Health Care System

1. BACKGROUND: The VA Central California Healthcare System (VACCHCS), Fresno VA Medical Center requires semi-annual certification testing to be performed by a Controlled Environment Testing Association (CETA) certified technician in compliance with United States Pharmacopeia USP<795>, USP<797>, USP<800>, International Organization for Standardization (ISO), and VHA Directive for sterile compounding clean rooms.

The VA Central California Healthcare System is requesting a base year contract with up to four (4) option years to be included for this service.

2. SCOPE OF WORK: The awarded vendor must provide CETA certified technician(s) to complete the facility’s clean room testing semi-annually, not to exceed 180 days between test dates. Currently, the active compounding suites are tested in August and February.

2.1. The vendor shall adhere to the most current version of the reference codes as applicable to the clean suite being certified.

2.1.1. USP<795>

2.1.2. USP<797>

2.1.3. USP<800>

2.1.4. International Organization for Standardization (ISO): ISO 14644

2.1.5. The Joint Commission for Healthcare Accreditation

2.1.6. VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations

2.1.7. VHA Directive 1108.06 Inpatient Pharmacy

2.2. <USP>797 & 800 compliance testing of the facility Sterile Compounding Suites shall be performed.

2.2.1. Building 1: The suite consists of four rooms: a Hazardous Drug Room, which contains a biological safety cabinet, a Non-Hazardous Drug Room which contains two laminar flow clean benches, and one Ante Room, and an adjacent Hazardous Storage Room. The Hazardous Drug Room is out of service and is not to be included in the testing requirements.

2.2.2. Building 24: The suite consists of 5 rooms: a Hazardous Drug Room, which contains two biological safety cabinets, a Non-Hazardous Drug Room which contains two laminar flow clean benches, one Ante Room, one Entry Room and one Hazardous Storage Room.

2.3. Comprehensive testing in accordance with <USP797>, <USP800>, and CETA Application Guides (CAGs) shall be implemented for all rooms, equipment and appetences therein. The following are minimum requirements, however CETA Application Guides (CAGs) shall govern the testing if more restrictive or comprehensive than the elements described below.

2.3.1. Airflow volume and velocity measurements of ceiling High-Efficiency Particulate Air (HEPA) Terminal Air Filters (TAFs) to ensure both unidirectional and non-unidirectional flow areas are properly balanced, and unidirectional zones are maintaining proper air patterns.

2.3.2. HEPA filter integrity leak testing of HEPA TAFs.

2.3.3. Certification testing of (2) Biological Safety Cabinets. To include nonviable particle counts.

2.3.4. Airflow visualization studies to determine the path(s) of the air flowing in and around the biological safety cabinets and the Laminar Flow Clean Benches. A video log must be provided to the agency to have smoke studies on record.

2.3.5. Certification testing of (4) Laminar Flow Units (Clean Benches). To include nonviable particle counts.

2.3.6. Particulate counting of cleanroom(s): Non-HD Rooms, HD Room, and Ante Rooms.

2.3.7. Differential pressure measurements for all rooms.

2.3.8. Determine the room air exchange rate (ACH), to confirm a proper ventilation rate is achieved.

2.3.9. Testing of Pass-through boxes (Single Pass Boxes).

2.3.10. Viable particle sampling: airborne and surface. To include count and identification to the genus level. TSA media dual incubated for bacterial and fungal growth detection, colony identification on samples that show growth.

2.4. Note: This facility is not subject to local or State requirements. Vendor will assure compliance with Federal requirements only.

2.5. Stickers indicating the condition, at the time of the testing, and indicating a pass or fail determination, shall be applied to all rooms and equipment prior to the technician departing the Fresno VA facility on the day of field testing. A preliminary report of findings should be provided digitally, via e-mail, to the contracting officer’s representative within 24-hours of the completion of the semi-annual service visit. An official/final report will be required to be provided to the contracting officer’s representative (COR) within 30 days of completed service. The official/final report shall be sent digitally.

2.6. Modifications to room configurations or equipment configurations or failed tests may prompt the need for out- of-cycle certification testing. Supplemental testing may be incorporated through contract modification issued by the Contracting Officer when required by the government.

3. CONTRACTOR QUALIFICATIONS:

3.1. Contractor technicians assigned to certification testing at the Fresno VA must be CETA Certified. There must be a minimum of 3 CETA certified staff members on staff.

3.2. Contractor must be located with- 250-mile geographical radius of the Fresno VA and be able to dispatch a certified technician to arrive at the Fresno VA within the same business day.

3.3. Contractor personnel performing service on this contract shall have all required certifications and/or licenses per requirements. The Contractor shall maintain certifications, training records of each employee and/or laboratory testing agencies performing services under this contract. The Contractor shall make all updates to certification or records for individuals and/or laboratory testing agencies available for review by the VA. The contractor shall provide a copy of the certification records and photocopy of the employee’s identification when requested by the VA.

3.4. It is the contractor’s responsibility to ensure that only properly trained and competent persons perform testing at the Fresno VA. Evidence of training shall be supplied to the VA prior to the start of work and if/when new individuals are added by the contractor to perform on this contract.

4. PLACE OF PERFORMANCE: Fresno VA Medical Center - 2615 E. Clinton Ave. Fresno, CA 93703

5. PERIOD OF PERFORMANCE: The period of Performance is for (1) year with (4) one-year options.

5.1. Base Period: August 6, 2026 to August 5, 2027

5.2. Option Year 1: August 6, 2027 to August 5, 2028

5.3. Option Year 2: August 6, 2028 to August 5, 2029

5.4. Option Year 3: August 6, 2029 to August 5, 2030

5.5. Option Year 4: August 6, 2030 to August 5, 2031

6. HOLIDAYS:

6.1. Legal holidays recognized by the Federal Government in accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 or any other by the President of the United States to be a national holiday, the following national holidays are observed and for the purpose of this contract is defined as “Legal Federal, official holidays” as follows:

6.1.1. Recognized Holidays

6.1.2. Hours of Operation. The hospital operates 24 hours a day, however business hours will be defined as 7:00 am to 5:00 pm from Monday through Friday except for federal holidays or when the Government facility is closed due to local or national emergencies administrative closing.

7. GENERAL REQUIREMENTS:

7.1. Contractor shall be responsible for the protection of all building floors, floor coverings, walls, wall coverings, ceilings, furniture, light fixtures and equipment in that may be subjected to damage while performing this contract. Contractor shall replace all damaged items with exact matching item or a like item at the VACCHCS discretion.

7.2. Work site shall be left free and clean of all debris after completion of work. Contractor shall be responsible for the safety of all VACCHCS employees, patients and visitors while performing contracted work, including slipping and tripping hazards.

8. GENERAL INFORMATION:

8.1. Contract Manager. The contractor shall provide a contract manager who shall be responsible for the work. The name of this person, and an alternate(s) who shall act for the contractor when the manager is absent, shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all matters relating to this contract.

8.2. The contractor shall keep its employees trained and always certified during contract period. The contractor shall ensure all employee certifications are submitted to CO and COR for proper recording of training. VA has the right to inspect and request verification of licenses and certificates of during the contract period. Contractor shall update list of any changes with personnel or certificates/license and submit to COR and CO.

8.3. Removal of Contractor’s Employees. The contractor shall utilize only experienced, responsible, and capable employees in the performance of this contract. The CO may require that the contractor remove from the Government job any employee that endangers persons, property, environment, EEO policy, Hostile work environment, or federal workplace policy or violates the standards noted in this PWS.

8.4. Government Furnish Equipment. This PWS does not have any government furnish equipment. Contractor shall not use any government own equipment, material, supplies, or tools. Contractor shall furnish all requirements.

9. RECORDS: The contractor shall be responsible for creating, maintaining government required records that are specifically cited in this PWS or required by the Federal, State, and Local law and authorities. The contractor shall provide the original records or a reproducible copy of any such record upon request from the government at no additional cost. The cost of reproductions and delivery shall be the contractor’s responsibility. Only VACCHCS engineering department, COR, or CO shall have the authority to approve request and receive records. Contractor shall safeguard all information. Contractor shall inform CO and COR of any request made, which CO or COR will authorize or disapprove. Additionally, the following standard items relate to records generated in executing the contract:

9.1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

9.2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

9.3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records

9.4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act

9.5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

9.6. The Government Agency owns the rights to all data/records produced as part of this contract.

9.7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

9.8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9.9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

9.10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (Subcontractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any Subcontractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

10. SITE INVESTIGATION AND CONDITIONS AFFECTING THE WORK:

10.1. The Contractor acknowledges that it has taken steps reasonably necessary to ascertain the nature and location of the work, and that it has investigated and satisfied itself as to the general and local conditions which can affect the work or its cost, including but not limited to (1) conditions bearing upon transportation, disposal, handling, and storage of materials; (2) the availability of labor, water, electric power, and roads; (3) uncertainties of weather, or similar physical conditions at the site; (4) the conformation and condition of the ground; and (5) the character of equipment and facilities needed preliminary to and during work performance. The Contractor also acknowledges that it has satisfied itself as to the character, quality, and quantity of materials or obstacles to be encountered insofar as this information is reasonably ascertainable from an inspection of the site, as well as from any documents made a part of this contract. Any failure of the Contractor to take the actions described and acknowledged in this paragraph will not relive the Contractor from responsibility for estimating properly the difficulty and cost of successfully performing the work, or for proceeding to successfully perform the work without additional expense to the Government.

10.2. The Government assumes no responsibility for any conclusions or interpretations made by the Contractor based on the information made available by the Government. Nor does the Government assume responsibility for any understanding reached or representation made concerning conditions which can affect the work by any of its officers or agents before the execution of this contract, unless that understanding or representation is expressly stated in this contract.

11. QUALITY CONTROL PROGRAM: The Contractor shall coordinate, report, and ensure the timely completion of the work specified in this PWS. This encompasses the planning, coordination, technical direction, and surveillance of all activities necessary to execute all work. The contractor shall submit their Quality Control plan digitally in PDF within 10 days of contract award date. The COR will review the document and note any needed clarifications and return to the Contractor for revisions, if necessary. A VA approved QAQC Plan shall be in place within 30 days of the contract start date.

11.1. The contractor shall provide the overall management effort required to integrate technical and programmatic functions.

11.2. The contractor shall ensure the technical excellence, cost effectiveness, and timeliness of all required work deliverable products.

11.3. The contractor shall develop and maintain an effective quality control program to ensure service is performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which he/she assures that his/her work complies with the requirements of the contract. The overall goal of the program should be to identify and correct any problems that may exist before they are identified by or reported to the COR. The Government has the right to review and ask for corrections, additional items, and updates during the contract period.

12. QUALITY ASSURANCE SURVEYLANCE PLAN:

The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan and PWS. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. Failure to meet the standards of this performance work statement my result in repeated certification testing at no cost to the government. Failure to provide services in accordance with this contract could also result in termination of the contract for cause and/or adversely impact the Contractor’s ability to be selected for future contracts as documented. Government verification inspections of services shall not constitute acceptance nor replace the contractor inspection or in any way relieve the contractor of any responsibility to take all actions necessary to assure highest quality of service rendered. The Quality Assurance Surveillance Plan (QASP) is included in Attachment 1.

13. CONTRACTING OFFICER REPRESENTATIVE:

13.1. The Contracting Officer Representative (COR) will be appointed by the Contracting Officer who will provide technical guidance and clarifications to the Contractor. It shall be noted that interpretation of contractual terms and/or financial matters is the responsibility of the Contracting Officer.

13.2. The COR will monitor the Contractors’ performance to ensure that services and the standards of performance are met in accordance with this Performance Work Statement and the QAQC Plan. In accordance with FAR 52.212-4 (a) “Inspection/Acceptance” the Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of non-conforming supplies or re-work of non-conforming services at no additional cost to the Government

14. STANDARD OF CONDUT: Contractor, subcontractors, and contractor’s personnel must adhere to the contract and shall conduct themselves according to VA conduct standards.

14.1. Neglect of Duties. Contractor, subcontractors, and personnel neglect of duties shall not be condoned. This shall include but not limited to sleeping on duty, unreasonable delay or failures to carry out assigned tasks, conducting personal affairs during duty hours, and refusing to render assistance or cooperate in upholding the integrity of the work site security. This can result in the termination of the contract or removal of the employee(s), which will be the decision the VA. The CO shall inform the contractor in writing of actions.

14.2. Disorderly Conduct. The use of abusive or offensive language, quarreling, intimidation by works, actions, or fighting shall not be condoned. Also included is participation in disruptive activates which interfere with normal and efficient of government operations. This can result in the termination of the contract or removal of the employee(s), which will be the decision the VA. The CO shall inform the contractor in writing of actions.

14.3. Driving. Contractor and Contractor’s employees shall obey all speed limits and traffic signs. Disobeying traffic regulation could result in court citations, which include monetary fines. Continued violations could result in being restricted from driving on VA facilities.

14.4. Parking. Contractor vehicles will be parked only in lots or areas designated by the COR, if available. The Government will not be liable for any lost, stolen, or damage vehicles or items. Contractor shall obey all distances from critical areas which are deemed by the VA or code. Continued violations could result in being restricted from driving on VA facilities.

14.5. Smoking. Smoking is prohibited on VA property. Smoking on VA property could result in citations, which include monetary fines. Continued violations could result in removal from VA facilities.

14.6. Intoxicants. The Contractor shall not allow any employee to possess, sell, consume, or be under the influence of intoxicants, drugs, or substances that produce similar effects. The use of illegal drugs is prohibited on Federal property. Violators will be prosecuted.

14.7. Posted Signs: The Contractor shall comply will all posted signs on VA property.

14.8. Criminal Actions. Contractor, subcontractor, or contractor’s employees may be sanction for criminal actions, but not limited to the following:

14.8.1. Falsification or unlawful concealment, removal, mutilation, or destruction of any official documents or records or concealment of material facts by willful omission from official documents or records.

14.8.2. Unauthorized use of Government property, theft, vandalism, or immoral conduct.

14.8.3. Unethical or improper use of official authority or credentials.

14.9. Removal of Personnel. The Government reserves the right to direct the Contractor to remove any employee from the work site for failure to comply with the standards of conduct or for safety/security violations.

15. SECURITY:

15.1. Security Badge: Contractor and contractor’s employees shall obtain the necessary identification badge through the VA’s badging process. The contractor may obtain a temporary badge from dispatch, VA police on arrival to any campus while application for permanent identification badge is in progress. The VA Issued Security badge shall be worn on the upper torso and be visible at all times.

15.2. Contractor’s Badge: Contractor, Subcontractors, employees, and representatives shall have a company badge visible at all time. Contractor’s badge shall be visible at all times.

15.3. Physical Security: The contractor shall be responsible for safeguarding their equipment while on government property government. Additionally, the contractor shall be responsible for any government equipment, information and property provided for contractor use. Contractor will NOT be provided a staging area for storage of tools, equipment, material, supplies, and other items. The Government will not be responsible for damage or loss of contractor’s property. Contractor is responsible to safeguard its property.

15.4. OI&T Security: Office of Information and Technology (OI&T) certification and accreditation requirements do not apply for this service contract and therefore a Security Accreditation Package is not required. At no time will the vendor be in contact or have access to VA sensitive information, OI&T systems, or the VA OI&T network.

16. SAFETY:

16.1. In performance of this contract, the Contractor shall take such safety precautions as the Contractor Officer or his/her designee may determine to be reasonably necessary to protect both the lives and health of the occupants of the building and property. The Contractor Officer or his/her designee will notify the Contractor of any non-compliance. The Contractor shall, after receipt of such notice, immediately correct the condition to which attention has been directed.

16.2. The Contractor shall provide all necessary Personal protective Equipment (PPE) and attire to personnel and require employees to use it during the performance of their duties as necessary. Employees shall be trained on the use and proper maintenance of PPE. The contractor shall conform to all regulations, federal and local OSHA standards.

16.3. Contractor shall comply with the Federal and State OSHA Blood Borne Pathogens Standard(s) and Airborne Infection Precautions. The Contractor shall ensure:

16.3.1. Methods are in place by which all employees are educated as to the risks associated with Blood Borne Pathogens and Infectious Airborne Diseases in Health Care facilities

16.3.2. Have policies and procedures in place which reduce the risk of employee exposure to Blood Borne Pathogens and Infectious Airborne Diseases

16.3.3. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens and Infectious Airborne Diseases.

16.3.4. Provide employees with appropriate personal protective equipment (PPE) and/or clothing such as gloves, caps, gowns, masks, and protective eyewear throughout the performance of this contract.

16.4. Uniforms. The contractor shall require all his employees, including supervisor, to wear distinctive uniform clothing for ready identification. The uniform shall have the Contractor’s name, easily identifiable.

16.5. Supervision. The contractor shall arrange for satisfactory supervision of the contract work. The Contractor or his designee shall always be available, when the contract work is in progress, to receive notices, reports or requires from the Contracting Officer or his representative.

17. INVOICING: Contractor shall invoice in monthly increments or as established by the Contracting Officer in arears for work performed. Invoices will not be paid until all required deliverables have been received during the billing period. Invoices shall be submitted to the COR for review and approval prior to submission to Tungsten.

17.1. All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

17.2. VA’s Electronic Invoice Presentment and Payment System- The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submissions. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

17.3. More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

17.4. Vendor e-Invoice Set-Up Information:

17.5. Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e- invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

17.5.1. Tungsten e-Invoice Setup Information: 1-877-489-6135

17.5.2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

17.5.3. FSC e-Invoice Contact Information: 1-877-353-9791

17.5.4. FSC e-invoice email: vafsccshd@va.gov

18. ATTACHMENTS:

18.1. Attachment 1: Quality Assurance Surveillance Plan (QASP)

ATTACHEMENT 1

Quality Assurance Surveillance Plan (QASP)

The following Performance Requirement Services Summary identifies the performance objective and performance thresholds for critical tasks associated with providing support services for this requirement. The performance threshold describes the minimum acceptable levels of service required for each requirement. The Performance Requirements Summary shall not take the place of the PWS. These thresholds are critical to mission success. Failure to meet the standard will result in termination for default.

1. Inspection Service frequency/ interval

to ensure that PWS requirement is achieved

100 % of the time. No discrepancies are allowed.

100% inspection to ensure that PWS requirement is achieved

to ensure that PWS requirement is achieved

Sources Sought for Pharmacy Certification Testing