J065--HOOD FUME MAINTENANCE - Base plus 4 (8/1/24 - 7/31/29

D.1 STATEMENT OF WORK

The contractor shall provide all labor, personnel, equipment, transport of materials to certified lab, reporting of results, disposal of hazardous/nonhazardous waste materials, proof of licensing, documentation of required service and permits when required to provide testing, tools, materials, supervision, and other items necessary to provide annual preventive maintenance and corrective repair service on-site for the equipment and systems listed in Section 3 below for the Southern Arizona VA Health Care System (SAVAHCS) and as defined in this Statement of Work (SOW).

1. SERVICE/WORK TO BE PERFORMED:
   • The contractor will perform on-site certification testing on equipment/systems as provided for in the contract agreement. Since there are multiple types of hoods and certification requirements, the standards for each device and room are listed in the equipment table below. Service engineer/technicians must be Controlled Environment Testing Association (CETA) registered cleanroom certification professionals.

• • Travel and labor included.
  • All test equipment requiring calibration is traceable through the National Bureau of Standards.
  • Certification:

1. 1. 1. All primary engineering controls (PEC) and secondary engineering controls (SEC) and passthrough certification are completed no less than every 6 months or whenever changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality.  PEC, SEC and passthroughs will be retested if they fail to meet standards of USP 797 and USP 800.  Certification will occur under dynamic operating conditions. Testing for certification includes:
         1. Airflow testing (PEC and SEC)
         2. HEPA filter integrity testing (PEC and SEC)
         3. Total particle count testing (PEC, SEC and passthroughs)
         4. Dynamic airflow smoke pattern testing (PEC and SEC)
         5. Viable air sampling (PEC, SEC and passthroughs)

1. 1. 1. Viable surface sampling (SS) of all PEC and SEC are performed no less than monthly and after every personnel medial fill (MF) testing.  Compounders and personnel with direct observation of compounding will need to be retested if they fail to meet standards of USP 797.  IV room, anteroom, hazardous drug (HD) room and segregated compounding area (SCA) PEC, all SEC and passthroughs will need to be retested if viable SS testing fails to meet standards of USP 797.

1. 1. 1. Personnel gloved fingertip (GFT) testing shall occur no less than every 6 months for compounders and no less than annually for direct observation of compounding.  Personnel GFT testing is performed after donning of garb and MF testing.  Personnel GFT testing is performed three times after each donning of garb for initial personnel certification and once for recertification.   Compounding and personnel with direct observation of compounding will need to be retested if they fail to meet USP 797 standards.

1. 1. 1. Environmental wipe sampling for hazardous drug residue is performed no less than every 6 months or more frequently as needed to verify containment per the standards of USP 800.  The kits used to complete wipe sampling must be verified prior to use to ensure the sensitivity and validity of the methods and reagents used to recover a specific percentage of known marker drugs. A minimum of 6 surface samples will be completed per certification.  Facilities can elect to expand beyond the minimum number of samples, but coordination with the contractor will be required prior to the certification visit.  Surface sampling should include the following areas:

1. 1. 1. 1. Interior of containment primary engineering control (C-PEC) and any equipment contained inside the C-PEC
         2. Pass-through chambers
         3. Surfaces in staging or work areas near C-PEC
         4. Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
         5. Areas immediately outside the hazardous drug buffer room or C-SCA
         6. Patient administration areas

1. 1. 1. No less than 5 commonly used chemotherapy drugs will be tested at your facility at the time of testing. 

1. EMERGENCY LINE ITEM:

• • Service calls with on-site response within 24 hours (Monday to Friday 8:00 AM to 5:00 PM).  Emergency Designated Response time 24 hours unless otherwise agreed upon by COR or designee: Completed as needed and price added separately.

• • Response: All requests for repair service will be considered requests for emergency service unless a statement to the contrary is made by the COR, POC or designee.  A competent service representative adequately equipped with tools, test instruments, service manuals, and repair parts will arrive at the SAVAHCS within the designated response time. The service representative may contact VA staff by phone before arrival at the SAVAHCS.  Such contacts, however, will not serve to alter the requirements for arrival on-site except when the request for service is withdrawn by designee.

1.  PERFORMANCE:

• • Hours: Normal duty hours are 8:00 a.m. through 4:30 p.m., Monday through Friday, not including federal holidays.  Whenever contact with Operations Supervisor is required outside of normal duty hours, the Utility System Repair Operator (USRO) may be contacted as an alternate.  The hospital operator at extension "0" can contact the USRO via radio.
  • Preventive maintenance will be scheduled with a contact person as assigned by the Contracting Officer’s Representative (COR), Point of Contact (POC) or designee.  This PM work must be completed in the month specified during the request unless another date is agreed upon by COR or designee. The Operations supervisor can be contacted at (520) 792-1450 ext. 15020. All contractor personnel (without exception) must report to the Maintenance & Operations Department, Bldg. 2-room B17, to sign in and receive a contractor identification badge before any work is performed and return to the same location to sign out and turn-in said badge along with the documented service report (as described in section 4, DOCUMENTATION) for the service performed.
  • Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer.
  • Payment: Payment will be made in Tungsten, and upon receipt of a properly prepared invoice which references the period for which payment is due, the contract number and/or assigned purchase order number. The invoice must include the correct payment address.
  • Waste Removal: The contractor is responsible to remove and properly dispose of all waste related to the services provide on-site at SAVAHCS.
  • Failure to carry out the above procedures will be considered as a failure to document the service visit and will constitute a failure to perform.
  • All shipping for parts will be included in the cost of the contract.

1. DOCUMENTATION:

• • Service reports will be provided for all service activities including preventive maintenance, emergency repair, and safety inspections, and must contain the following information:

• 1. Date(s) and time of service.
  2. Complete description of equipment serviced including model number and serial number.
  3. Complete description of equipment services performed including upgrades, updates and software changes made.
  4. Complete list of all materials, parts, or assemblies installed or replaced including serial numbers of parts where applicable.
  5. A statement of the complaint that initiated the service call.
  6. Total standard labor hours, total overtime/premium hours, and total travel hours expended during the repair.
  7. Last calibration date of service equipment.
• For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:
  • Company name and contact information.
  • Unit make, model and serial number.
  • Report number
  • Location (e.g., building, room number)
  • Certification date
  • Recertification date
  • Technician signature

1. REMOVAL OF EQUIPMENT:

1. • Whenever possible, all repairs and preventive maintenance will be performed at the SAVAHCS.  When that is not possible, the COR, POC or designee may give approval for service work to be done at another location. All transportation charges will be borne by the contractor.
   • VA property may not be removed from the SAVAHCS prior to execution, and approval of all documents as required by Logistics Service. Computer hard drives and other storage media items may not leave VA property.
   • Requirements for service reports for designated equipment not at this location are the same as for work done on-site.  Service reports for incoming equipment will be presented for signature at the time of delivery.  If equipment is returned via commercial carrier, the service report may be included with the shipment.
2.  GOVERNMENT REPAIRS:  Government employees will work on contract equipment only with authorization of the contractor or following the failure of the contractor to respond.  The government is not obligated to perform any work on contract equipment.
3.  PRIOR INSPECTION OF EQUIPMENT: Potential contractors may, at their own expense, inspect equipment covered by this solicitation (ref 52.237-1 SITE VISIT).  Arrangements must be made in advance with Operations Supervisor. (see section 3, above).
4.  GUARANTEE:  The contractor will guarantee workmanship and all parts furnished by the contractor for a period of not less than 90 days.

1.  EQUIPMENT:

EE#

LOC.

MAKE

MDL

SN

Certification Standards

EQU. TYPE

AREA

92627

BA080-57

Baker

Edgegard VF401

128826

Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1

Positive Isolator

Pharm

93003

BA080-57

Baker

Edgegard VF601

130072

Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1

Positive Isolator

Pharm

88030

BA080-57

Baker

SG-304

126553

Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1

Negative Isolator

Pharm

98084

BA080-57

Baker

CS-500

125183

Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1

Negative Isolator

Pharm

92626

BA080-57

Baker

Edgegard VF401

128825

Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1

Positive Isolator

Pharm

114338

BA086

Baker

BCG 401

143302

Per USP 797/800

BSC Biochemgard

Pharm

Do not have yet

BA084

Baker

BCG 401

Do Not Have yet

Per USP 797/800

BCG Biochemgard

Pharm

57903

0B138A-57

BSL III Hood Room

Filters

HEPA

Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing

BSL III

Lab

55366

0B139-57

Ante Room

Filters

HEPA

Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing

BSL III

Lab

0B140-57

BSL III Lab Room

Filters

HEPA

Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing

BSL III

Lab

57903

0BA015-57

Extraction

Filters

HEPA

Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing

BSL III

Lab

76270

107-10

NUAIRE

NU-437-400

163682061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

76272

107-10

NUAIRE

NU-437-400

163684061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

53702

110-10

BAKER

SG403A

94853

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

76256

110-10

NUAIRE

NU-437-500

163685061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

76269

110-10

NUAIRE

NU-430-600

163698061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II B Direct Inflow Method

Research

76261

112-78

NUAIRE

NU-437-600

163690061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

76263

113-10

NUAIRE

NU-435-400

163692061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II B Direct Inflow Method

Research

76259

113-78

NUAIRE

NU-437-500

163688061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

76260

114A-78

NUAIRE

NU-437-500

163689061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

76262

115-78

NUAIRE

NU-437-600

163691061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Research

53149

116-78

Fisher Scientific

115V

80383682

Smoke Containment/Face Velocity

Fume Hood

Research

76264

116-78

NUAIRE

NU-435-400

163693061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II B Direct Inflow Method

Research

56724

138A-78

Thermo Electron

C8004055

68013

AIHA/ANSI Lab Ventilation Requirements

Downdraft Table

Research

30029

111-78

LABCONCO

6900000

255087

Ductless-Smoke Containment/Face Velocity

Fume Hood

Research

86409

138-78

SAFETY LAB

112537002

171150096

Walk-In

Walk-in

Research

81099

107-10

LABCONCO

3955200

160728749B

Smoke Containment/Face Velocity

Fume Hood

Research

76271

111-78

NUAIRE

NU-3437-400

163683061014

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II, Type A2 Biological Safety Cabinet

Research

76658

0B146-57

MOPEC

BF100

BF100H14006

Per Manufacturer's Specifications; Directional Smoke/Face Velocity

Fume Hood

Lab

86323

0B147-57

NUAIRE

NU-435-400

176331092816

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II B Direct Inflow Method

Lab

34107

0B138-57

NUAIRE

NU-427-400

77388AFR

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II B Direct Inflow Method

Lab

61599

0B133-57

NUAIRE

NU-425-600

140865102610

BSL III

Lab

34546

0B138-57

NUAIRE

NU-427-400

82675AGR

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II B Direct Inflow Method

Lab

96063

B146-57

MOPEC

MB1060R

MB1060R0135661001

Smoke Containment/Face Velocity

Fume Hood

Lab

96064

B146-57

MOPEC

MB1060R

MB1060R0135661002

Smoke Containment/Face Velocity

Fume Hood

Lab

62974

0B146-57

Air Science

P5-36

P66066

Ductless-Smoke Containment/Face Velocity

Fume Hood

Lab

73235

0BA028A-38

Labconco

3440001

130171290C

Per Manufacturer's Specifications; Per NSF Standard No. 49

Class II A Direct Inflow Method

Lab

102996

0B133-57

Thermofisher Scientific

1300

300429464

Per Manufacturer's Specifications; Per IES-RP-CC-001

Class I Biological Safety Cabinet

Lab

103551

0BA045-57

Thermofisher Scientific

1100-2-C

210514

Fume Hood

Lab

39668

0BA028B-38

Air Clean Sys

AC648LFUVC

AC648LFUVC2356

Per Manufacturer's Specifications; Per IES-RP-CC-001

Class I Biological Safety Cabinet

Lab

104536

181U-57

PCI

G18-E

121-0019

Smoke Containment/Face Velocity

Fume Hood

SPS

55283

181U-57

PCI

G14KA

29590

Smoke Containment/Face Velocity

Fume Hood

SPS

75491

2756-80

Air Science

P30

P70084

Chemical Fume

Fume Hood

Derm

76657

227-57

Mopec

BF100

BF100H14005

Per Manufacturer's Specifications; Directional Smoke/Face Velocity

Fume Hood

OR

66199

A109-38

Comecer

FHR1 50 LAR

40C1C\0111\V11246

Chemical Fume

Fume Hood

Radiology