36C25619Q1435-001.pdf

STATEMENT OF WORK (SOW)

1. General

a) The Michael E. DeBakey VA Medical Center has a requirement for the Semi-Annual Inspection and Certification of Pharmacy Biological Safety Cabinets and clean rooms to include particle counts per the most current USP

797and 800 requirements. Pharmacy sampling requirements require the following: Semi-Annual certification of six (3) cleanroom testing buffer rooms, three (3) cleanroom testing ante rooms, fifteen (15) biological safety cabinets (BSC’s), four (4) horizontal laminar airflow hoods (LAFH’s), five (5) horizontal LAFH’s, twelve (12) bacterial sampling w/I.D., twelve (12), fungal air sampling per location, twelve (12) bacterial and fungal surface sampling, twelve (12) bacterial/fungal air sampling three (3) IV robots, six (6) glove box/isolators, and three (3) smoke visualization studies completed by a CETA certified technician. Alarm calibration shall be required for all equipment. Pharmacy is currently undergoing construction to meet USP 797/800 requirements. All new equipment has been added to the inventory list as “pending” status until installation has been completed.

b) Decontamination/Decommissioning of Chemical Fume Hoods (CFH)/ Biological Safety Cabinets (BSC) shall be included as necessary to support the equipment upgrades. The semi-annual certification of an additional glove box isolator located in the Nuclear Medicine section has been included with this requirement.

c) Semi-Annual testing shall include inspection of all High Efficiency Particulate Air (HEPA filters, inclusive of two (2) in the main pharmacy, two (2) in the cancer center and one (1) in Nuclear Medicine. The Isolators and IV Robots shall require both viable and surface sampling annually, and surface sampling for both the main pharmacy and the cancer center pharmacy. The contractor shall perform a proper HEPA filter leak test of the room air supply HEPA filters. All HEPA filter in the pass thus shall need to be checked every 6 months, or whenever the cleanroom HEPA’s are checked. Surface sampling with be required for the main pharmacy compound and anti-room, the cancer center compounding and anti-room, and the patient administration areas of nursing unit 4B and the Cancer Center.

d) All BSC’s with Ultra Violet lamps shall be tested with a UV meter and replaced as requested. For semi-annual requirements, not more than six (6) months shall elapse between certification/testing visits. All environmental testing shall include pressure monitoring, viable and non-viable particle counts (bacterial and fungal for the viable), surface sampling, temperature, humidity, and HEPA filter testing. Surface and Air sampling of hoods, both bacterial and fungal are required. Sampling of equipment shall be coordinated with the end user, as work processes may need to be adjusted to allow for the appropriate cleaning and testing.

e) Period of performance is to be for one (1) Base Year and four (4) Option Years. Additional fees or travel charges of any kind shall not be paid. Work not covered by this contract shall not be performed without first obtaining permission of the COR and/or the Contracting Officer. Bills resulting from additional work performed without prior approval shall not be honored.

2. Maintenance and Parts Rider

a) This contact shall include maintenance and parts rider per year to provide for normal hours, after hours, or emergency repairs of the BCSs, CAI’s, CACI’s, Clean Rooms, Ante Rooms, Laminar Airflow Hoods, Alarms, IV Robots, and Glove Box Isolator deficiencies discovered during execution of this contract.

a. All repair work shall be pre-approved by the COR or the Contracting Officer.

b. This parts rider is not to be an assumed line item to the awardees contract.

3. Semi-Annual Inspection and Certification:

a) All BSCs, LAFHs, CAIs and CACIs shall be tested to the following regulatory standards: NSF 49 (BSCs), CETA Compounding Isolator Testing, CAG-003-2006, CETA Compounding Facility Guidelines, GAG-003-2006, CETA USP 797 Viable Environmental Sampling and Gowning, GAG-009 and CETA Certification Matrix for Sterile Comp Facilities-008. Specifications and/or manufacturer specifications to include any additional USP 797 and 800 viable and nonviable particle testing. All BSCs shall be tested to National Sanitation Foundation/ American National standards Institute (NSF/ANSI) Standard 49-2009, Annex F. This standard covers the field certification of (laminar flow) Class II Biological Safety Cabinets.

b) Certification documents shall be placed inside of a plastic sleeve and taped to each hood after passing certification. Markers shall be placed on each hood to indicate the sash level at which each hood provides proper protection and dated stickers showing current certification placed on each hood.

c) Pharmacy final sampling reports shall be separated per the following:

a. 2A-290a cleanroom report

b. LAFW report 1

c. LAFW report 2

d. LAFW re-test report

e. 4C-321 report

f. 4C-321 report re-test

g. The Nuclear Medicine report shall be separate from Pharmacy

4. Work Summary

a) The Contractor shall do an inspection and certification of the clean rooms, Biological Safety Cabinets (BSCs), Chemical Fume Hoods (CFHs), grossing stations and Laminar Air Flow Hoods (LAFHs) to determine the extent of the work involved in the semi-annual and annual certifications of the clean rooms, BSCs, and CFHs and service work if required. A parts and labor rider shall be included in this requirement when repairs are necessary to prevent work stoppage. Recertification of the equipment shall be required after the completion of all maintenance and repairs, inclusive of decontamination as necessary. The Contractor is required prior to issuance of the contract to present any issues which would preclude completion of required work. For any unit that fails to pass required certification tests, the COR shall be notified immediately. The contractor shall mark each failing unit or room with professional signage that states the unit is out of service until further notice.

Contractor shall provide an electronic report quarterly of all work completed. Prior to the end of 12 months/first year, the contractor shall send a complete report to the COR, of all equipment serviced under this contract.

b) Particle counts conducted in the two pharmacy clean room locations that contain Pharmacy Biological Safety

Cabinets shall be tested in compliance with the most current United States Pharmacopeias Chapters 797 and

800. The two Pharmacy Department Clean Rooms, Biological Safety Cabinets and Glove Box/Isolators require semi-annual certifications due to the nature of the work conducted in the BSCs and Clean Rooms.

NOTE: The contractor shall be able to respond on station within 24 hours of receiving notification from the COR that services within the scope of this contract are required.

c) The contractor’s field personnel shall have training and be certified in fundamental practices and precautions listed in USP 797/USP 800 and operation of ISO 5 clean rooms. (e.g. gowning, gloving, and hand washing procedures).

d) The contractor shall have a current National Environmental Balancing Bureau (NEBB) certification and shall provide CETA certified technicians for all work completed for the pharmacy.

e) The contractor shall have its own laboratory contractor for growth and testing micro-bacterial samples. The laboratory shall perform batch sampling of all shipments of growing media plates; to confirm that the plates are sterile from the manufacturer.

f) The contractors Fume Hood/ Biological Safety Cabinet testing personnel shall have current certifications showing knowledge on NSF/ANSI-49. Evidence of all necessary certifications, training and any other special skills needed to comprehensively perform the duties as listed within this solicitation.

g) All testing personnel shall have at least five (5) years of experience, inclusive of work conducted at a federal medical facility on the equipment specifically listed. Contractor shall provide at least three (3) references or evidence of performing work of a similar scope to the specific equipment described within the last calendar year for all key personnel involved in servicing any/all VA equipment listed. The contractor shall have the ability to maintain test results and reports for at least 12 months for the government to access and download as necessary.

h) The contractor shall issue a certification certificate (PDF) to show that tested pharmacy equipment has passed a specific test with respect to the requirements of USP 797 and USP 800. The Certificate shall show the test date and the expiration date and be signed by the company’s Industrial Hygienist, with the appropriate training/education to make such a declaration. Chemical Fume Hoods and Biological Safety Cabinets shall have a certification sticker applied directly to the equipment in addition to the 8.5 x 11” PDF performance certificate.

Certification reports shall include the building number and room number of the equipment tested. The MEDVAMC also requests that each piece of equipment tested has its own separate report (along with microbials), and separate reports for the clean rooms.

5. Air Changes Per Hour

The contractor shall calculate the total room volume for each buffer and ante room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The contractor shall calculate “air changes per hour” (ACPH) for each buffer and ante room and include their findings in the report. In the event that a room does not meet USP<797> requirements for ACPH the COR and end user shall be informed immediately.

6. Pressure Requirements

The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797>.

The contractor shall report all pressures to an accuracy of 0.0001.

7. Viable Environmental Sampling

The contractor shall perform viable environmental sampling semiannually (e.g. every 6 months) for fungi and bacteria using high volume sampling pumps capable of achieving and maintaining the required flow rate of 28 liters per minute and impaction samplers to conduct the sampling. A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) contact plates for sampling of fungi.

8. Nonviable Particle Testing

a) The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO/DIS 14644-1.2 standard. Testing shall be performed by qualified operators using state-of-the-art electronic equipment. The equipment shall have current calibration labels and capable of providing the following results:

- ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any LAFW, BSC, CAI and CACI.

- ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area

- ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any ante area.

9. NSF 49 Field Testing Requirements for Biological Safety Cabinets

a) The contractor shall certify all Class II biosafety cabinets to NSF/ANSI 49, Annex F specifications. All equipment used to certify biological safety cabinets shall have NIST traceable or comparable calibration certification. Any unit that fails to meet NSF 49 specifications shall be clearly marked with a sign that shall notify technicians that the unit is out of order until further notice.

b) The contractor shall perform a proper HEPA filter leak test of the room air supply HEPA filters. An aerosol photometer with linear or expanded logarithmic scale shall be used. The instrument shall be capable of indicating 100% upstream concentration with a minimum aerosol concentration of 10µg/L of polyalphaolefin

(PAO) particles, or an equivalent fluid that provides the same particle size distribution. It shall also be capable of detecting an aerosol concentration in the downstream equal to 10-5 of the upstream concentration of the same particles. The sampling rate of air shall be 1 ft3/min. Probe area shall have a maximum open area of 1.7 in2 and a minimum dimension of 0.50 in.

c) An aerosol generator of the Laskin Nozzle type shall be used to create an aerosol by flowing air through liquid DOP or equivalent substitute. When a Laskin Nozzle generator is used, the compressed air supplied to the generator should be adjusted to a minimum of 20 psi.

d) The contractor shall calculate the upstream concentration and locate a point to introduce aerosol that shall allow for adequate mixing.

10. Chemical Fume Hood Testing and Certification

The contractor shall test and certify each fume hood to manufacturer’s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an air flow monitor or controller the contractor shall confirm the unit is calibrated. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, pass/fail grade for the airflow smoke pattern test and low flow alarm test. Any failures shall be reported directly to the COR and the end user. Retesting of failed equipment is required after necessary repairs have been completed.

11. Contractors Responsibility

The Contractor shall perform all work required to give a complete and satisfactory job as required by this Statement of

Work. The Contractor shall be responsible for performing the scope of the work in Accordance with VA Medical Center safety requirements and all Federal, State, and Local regulations. The Contractor shall be responsible for proper containment and disposal of all debris generated under this contract at the job site and during transportation of contaminated materials to an approved disposal site. Disposal documents are to be included in the final report. The contractor shall be required to move or work around existing furniture, fixtures, and finishes during performance of this contract. The site visit shall be scheduled by the Michael E. DeBakey VA Medical Center (MEDVAMC) for interested BSC and CFH Contractors to identify specific work area requirements. The Contractor shall come to the site assessment with appropriate equipment to conduct a thorough assessment of the project area. Contractor shall not allow his/her employees to open desk drawers, cabinets, or to use office equipment, including the use of the non-pay telephones for any purpose other than a local emergency call. Contractor shall provide invoices for payment at the completion of each service visit. Total payment shall be denied for failure to comply with any of the contract requirements.

12. Property Damage

The Contractor shall take all precautions to avoid damage to MEDVAMC property or equipment. Any damage to

MEDVAMC property or equipment by the Contractor shall be repaired by the Contractor to its original sate or better condition at no additional expense to the MEDVAMC. Working Conditions: Buildings 100, 109 and 110 shall be occupied and operations shall continue a normal, temporary or restricted basis for the duration of the project. The Contractor shall take all precautions that their operations are conducted in a manner that does not interfere with normal operations of the surrounding facility and the safety and health of the occupants or the environment. Procedures conducted in the clean rooms, BSCs, and CFHs by VA staff shall require the certifications to be conducted prior to or after the normal dayshift hours of staff in those areas. The entire area shall be left clean and acceptable to the

MEDVAMC.

13. Certifications

Contractors shall provide documentation that employees conducting certifications and repairs are trained and accredited through industry standards as required; National Sanitation Foundation (NSF) the governing body for standards used In the manufacturing and certification of Biological Safety Cabinets, The Controlled Environment Testing

Association (CETA), the International Air Filtrations Certifiers Association (IAFCA) accreditation program for all High

Efficiency Particulate Air (HEPA) filtered devices, and Fume Hoods or other industry recognized training or accreditation programs.

14. Temporary Facilities and Staging Area

The electrical energy and the water consumed shall be provided by the MEDVAMC at no cost to the Contractor from existing lines and sources in the building or from services adjacent to the work areas. Contractor’s use of utilities shall be coordinated with MEDVAMC.

15. Infection Control

Contractors shall strictly adhere to infection control measures/requirements during all phases of work. These requirements are intended to control the generation/transmission of dust and other infectious disease agents between the work site and other active/occupied building areas. Failure/inability to observe any infection control requirements shall be considered a serious safety issue.

16. Submittal Requirements

The Contractor shall submit the following materials to the MEDVAMC for review and approval prior to starting work:

Material Safety Data Sheets and/or Safety Data Sheets for all chemical products. 30 Hour OSHA Construction Safety

Training for Supervisors and 10 Hour OSHA Construction Safety Training for Workers.

17. Medical Requirements

Contractor shall provide workers with sufficient sets of protective full body clothing. Contractor shall provide additional personnel protective equipment (PPE) as required per applicable OSHA safety standards. Each worker shall, upon entering a job site, put on appropriate protective clothing and PPE, before entering the pharmacy work area. Review of all contract worker Tuberculosis (TB) screening requirements and options (reference VHA Directive 2011-036 Safety and

Health during Abatement). The contractor shall also be notified that anyone failing to meet these requirements is not permitted to work onsite and/or may be removed at any time without notice until these requirements are met.

18. Security Requirements

General Contractor’s employees shall not enter the project site without appropriate VIP badge. Contractor shall obtain

Personal Identity Verification (PIV) badge through the COR and VHA Service Center (VSC) contractor security and onboarding application process. All contractor employees are required to be issued a PIV badge. The determining factor as to the type of badge issued due to the contractor’s employee’s access requirements and the length of the contract period of performance. Contractor is required to follow the Security Requirements outlined. They may also be subject to inspection of their personal effects when entering or leaving the project site.

19. Facility Safety

Any contractor personnel who knowingly and willfully disregards any applicable Federal, State and/or local Occupational

Safety and Health Administration (OSHA) regulations, environmental protection and/or public health statute or its implementing regulations; VA OSH, environmental and/or information security requirement; is subject to immediate removal from the job site and medical center by the VA Police. In addition, the contractor personnel who committed the violation or created/knowingly allowed the violation to occur, shall not be allowed to return to continue performing on the project unless cleared in writing by the Contracting Officer after sufficient rehabilitation (e.g., retraining).

20. Parking Requirements

All contractors are required to park in the contracting parking lot, located behind building 122 near the Holcombe Blvd entrance. Loading/Unloading of equipment ONLY shall be allowed in the tunnel, which is located near the OST entrance.

If personal vehicles are left unattended in the tunnel for more than 2 hours, they are subject to ticketing and towing at the owner’s expense. All contractor vehicles are required to have current plates and insurance. Drivers of said vehicles are required to have current government issued driver’s license.

21. Hours of Operations

a) The Contractor is responsible for conducting business during normal business hours, Monday through Friday from 0700 to 1530, during the times that the COR is available, except for federal holidays or when the government facility is closed due to local or national emergencies, administrative closings, or similar

Government directed facility closings.

b) If a holiday falls on a Sunday, the following Monday shall be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also, included would be any day specifically declared by the President of the United States. Contractor is not required to provide any service(s) on nationally recognized U.S. Government holidays, nor shall the contractor be paid for these holidays.

c) The Contractor shall always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this solicitation when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

d) The healthcare systems operations are 24/7, 365 days a year, therefore on occasions; the Government may process orders for Veterans outside of normal business hours. The Contractor shall be required to provide services under these circumstances.

22. Overtime and Holidays

a) Any overtime and/or holiday pay that may be entitled to the Contractor’s employee(s) shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government. National Holidays:

- Listed below are the ten (10) national holidays:

a. New Year's Day January 1

b. Martin Luther King's Birthday Third Monday in January

c. President's Birthday Third Monday in February

d. Memorial Day Last Monday in May

e. Independence Day July 4

f. Labor Day First Monday in September

g. Columbus Day Second Monday in October

h. Veterans Day November 11

i. Thanksgiving Day Fourth Thursday in November

j. Christmas December 25

b) In addition to the days designated as holidays, the Government observes the following days:

a. Any other day designated by Federal Statute

b. Any other day designated by Executive Order

c. Any other day designated by the President’s Proclamation

c) It is understood and agreed between the Government and the Contractor that observance of such days by

Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation. In the event the Contractor's personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation shall be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

(End of Statement of Work)