H236--Test and Certify Government Owned Labs in Green Bay VA HCC Contract

STATEMENT OF WORK

GENERAL: Provide all labor, materials, equipment, tools and reports required to test and certify the Government owned laboratory hoods, biosafety cabinets and HEPA bank filters listed below, located at the Green Bay Health Care Center (HCC), 2851 University Ave Green Bay WI 5431 and the John H. Bradley Appleton VA Clinic Building 1, 10 Tri-Park Way Appleton WI 54914.

SCOPE: Provide two-hour telephone response time for equipment related telephone inquiries and 24-hour on-site response time for emergency/issue verification.

Testing of the biological safety cabinets shall follow current standards set by National Sanitation Foundation (NSF)/ America National Standard (ANS)/( NSF/ANSI-49), the NSF Certification policies for biosafety Cabinetry, and manufacturer specification.

All biosafety cabinets shall be certified every 6 months or semi-annually. The operational integrity of the cabinet must be validated before being put into service or after being repaired, relocated or having filters replaced.

Testing of all the hoods for Pharmacy Service shall include a semi-annual air quality evaluation (particle count) as outlined in the most recent edition of the United States Pharmacopeia 797 (USP) indicating the ISO classification for the environment within the hood. The testing of these hoods shall also include a semi-annual high-efficiency particulate air (HEPA) filter integrity/leakage test.

The rooms in Pharmacy Service used for sterile preparations shall be tested for compliance as outlined in the most recent edition of USP 797. This shall include measurement of air changes per hour as well as a semi-annual air quality evaluation (particle count) as outlined in the most recent edition of USP 797 indicating the International Organization for Standardization (ISO) classification for the environment in the buffer and anteroom zones.

Testing of all hoods/units in Pharmacy service, as well as associated rooms, shall include semi-annual microbial testing as outlined in the most recent edition of USP 797.

The sterile preparation rooms in Pharmacy Service shall have an annual room pressurization test, in accordance with ANIS/ the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)/ American Society of Heating and Air-Conditioning Engineers (ASHAE); ANSI/ASHRAE/ASHAE Standard 170-2008 or latest version - Ventilation of Health Care Facilities.

The isolation rooms in Specialty Clinic and Primary Care Clinic 2 shall have an annual room pressurization test, in accordance with ANSI/ASHRAE/ASHAE Standard 170-2008 or latest version - Ventilation of Health Care Facilities.

The rooms in Sterile Processing shall have an annual room pressurization test, in accordance with ANSI/ASHRAE/ASHE Standard 170-2008 or latest version - Ventilation of Health Care Facilities.

The OR suites including Cystology shall have an annual room pressurization test, in accordance with ANSI/ASHRAE/ASHE Standard 170-2008 or latest version - Ventilation of Health Care Facilities.

The biosafety cabinetry in Pharmacy Service shall include a semi-annual containment leakage test. This is the hood cabinetry used for preparation of cytotoxic or hazardous drugs.

The contractor shall document all certifications performed by placing a certification sticker on the certified equipment immediately after certification.

The contractor shall document all certifications by providing reports detailing each certification or test performed within 30 days.

The contractor shall not be required to go on the roof of the building.

The contractor is responsible for providing all contract employees with required personal protective equipment, respiratory protection and an occupational health program to ensure a safe work environment consistent with current Occupational Safety and Health Administration (OSHA) regulations.

SERVICE: Service shall consist of one annual or two semi-annual inspections (see Attachment A) for frequency and month(s) required and certifications that the equipment is functioning properly according to manufacturer s specifications. The contractor shall provide all labor, materials, travel, supervision, tools and facilities required for testing and certification of all equipment listed in this contract

(See Attachment A) located at the Medical Center. Contractor shall ensure that the equipment functions in conformance with the latest published edition of applicable standards, such as: NFPA 99, UL, NSF/ANSI 49, ASHRAE 110, SAFA, ANSI, OSHA, VA, IEST, ISO, USP, CDRH, etc.

Scheduled Work: Scheduled work is required in the performance of this contact shall be performed during the facility regular hours of 8:00 a.m. and 4:30 p.m., excluding federal holidays. The contractor shall notify the COR at least 7 days prior to the normal testing/inspection cycle visit and 8 hours prior to any emergency activities.

Federal Holidays observed by the VAMC(s) are:

New Years Day Independence Day Thanksgiving Day Presidents Day

Martin Luther King Day Labor Day Christmas Day Columbus Day

Memorial Day Veterans Day

REPORTING REQUIREMENTS: The contractor shall be required to report to the Contracting Officer Representative: Room - 1J009, to check in and verify identification is present and worn by contractor(s).

REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR of the existence of the development of any defects or repairs outside of the terms and conditions of this contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs within 7 working days.

DOCUMENTATION/REPORTS: Certification reports shall include full documentation of service performed. Each report shall include a unique identification of equipment and all readings and measurements found. In addition, each report shall contain a written comment on the visual condition and use of each cabinet and hood. An identifying certification sticker shall be placed on each unit at the time of inspection indicating status of unit. All completed written reports are due within 30 days of final on-site inspection.

All preventative maintenance and other repairs shall be done according to the manufacturer s recommendations.

Any authorized repairs/maintenance activities mandate only new standard parts by the original equipment manufacture (OEM) to be furnished by the contractor. All parts shall be of current manufacture and shall have full compatibility with the equipment being repaired.

PERFORMANCE STANDARDS: All work must be performed by competent technicians, experienced and qualified to work on the listed equipment. Service Technicians conducting inspection, testing and certification of equipment, must be currently certified as a Technical Certifier by the National Sanitation Foundation (NSF). All work must be performed in accordance with commercial practices. Documentation indicating qualifications (CV, certificates, etc.) must be submitted to the COR, prior to initiation of any work on station.

APPROVAL OF CONTRACTOR PERSONNEL: The VA reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor employee who, by reason of previous unsatisfactory performance at the VA or for any other circumstance, is considered by the Contracting Officer s Representative and Contracting Officer to be objectionable.

TEST EQUIPMENT: Prior to commencement of work on this contract, the contractor shall make available to the COR a copy of the current calibration certification of all test equipment which is to be used by the contractor on the Milo C. Huempfner VA Medical Center and the John H. Bradley Appleton VA Clinic (GB HCC) s equipment. This certification shall also be provided on a periodic basis when requested by the COR. Test equipment calibration shall be traceable to a national standard. All testing and certification equipment must undergo annual calibration by a recognized testing entity (See Attachment A).

PROCEDURES: When a deficiency per the requirements of the SOW exists, it shall be brought to the attention of the COR. The COR shall confirm the deficiency by inspection and record results, noting the date and time of inspection of the deficiencies for correction.

IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's employees shall wear visible identification at all times while on the premises of the VA facilities. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police. The facility will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited on VA 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.

ATTACHMENT A

Annual Services to be done in January

Annual

Hepa Bank #

Hepa filter location

Type

Model

ID

Name (Room)

HFB 1

2C246

OR 3

HFB 2

2C249

OR 2

HFB 3

2C243

OR 4

HFB 4

2C221

OR 1

HFB 5

2C239

OR 5

HFB 6

2C225

Cysto

HFB 7

2C245

Clean Corridor

HFB 8

2C233

Clean Core

HFB 9

2C237

Clean Corridor

HFB 10

1S020

Hood in IV prep

HFB 11

1S020

EF-IL

Hood in Chemo prep

HFB 12

1E024

VAV

IV Prep

HFB 13

1E024

VAV

Chemo Prep

HFB 14

1E021

VAV

Ante room

HFB 15

1D113

Lab

HFB 16

1C233

Isolation room

HFB 17

2C229

Clean Corridor

HFB 18

2C224.1

Clean vestibule

HFB 19

1B029

Isolation room

Bio Hood

1D113

Nuaire

NU-477-400

EE# 77646

Lab

Bio Hood

153E Appleton

Lab

Positive pressure rooms

1G008

Positive pressure

SPS

1G011

Positive Pressure

SPS

2C225

Positive Pressure

Cysto

2C221

Positive Pressure

OR #1

2C249

Positive Pressure

OR # 2

2C246

Positive Pressure

OR # 3

2C242

Positive Pressure

OR # 4

2C239

Positive Pressure

OR # 5

2C132

Positive Pressure

PACU/Recovery

Negative Pressure rooms

1B029 Specialty Clinic

Neg. Pressure room(Isolation)

Neg Pressure room (Isolation)

Primary Care Clinic 2 1C233

Neg. Pressure room (Isolation)

Neg. Pressure Room (Isolation)

SPS 1G025

Neg Pressure (Decon cart washer)

SPS Decon cart washer 1G025

SPS 1G020

Neg Pressure

SPS Decon scope area 1G020

SPS 1G010

Neg. Pressure

SPS Sterilizer Equipment 1G010

SPS 1G023

Neg Pressure

SPS Decon

SPS 1G006

Neg Pressure

SPS Men s Toilet

SPS 1G004

Neg Pressure

SPS Women s Toilet

SPS 1G019

Neg Pressure

SPS Women s Toilet

SPS 1G017

Neg Pressure

SPS Men s Toilet

Semi-Annual Services to be done in July

Semi Annual

Hoods

Room

Make

Model

ID

Name (Room)

IV Prep 1E023

Particle Count

Room

IV Prep

IV Prep 1E021

Particle Count

Ante Room

Ante Room

IV Prep

Laminar

Baker

SG-400

IV Prep

IV Prep

Particle Count

Baker

SG-400

IV Prep

IV Prep

Microbial

Air Plates

12 each

IV Prep

IV Prep

Microbial

Surface Plates

8 each

IV Prep

Oncology Hood

Biohood

Baker

NCB-D4

Oncology Prep

Particle Count

Baker

1E022

Oncology Prep

Particle Count

Room

1E022

Oncology Prep

Microbial

Air Plates

12 each

1E022

Oncology Prep

Microbial

Surface Plates

8 each

1E022

Bio Hood

1D113

Nuaire

NU-477-400

EE#77646

Lab

Bio Hood

153E Appleton

Lab

Clean Storage room

150 Appleton

ACH and Gradient

Clean Storage

HFB 12

1E024

VAV

IV Prep

HFB 13

1E024

VAV

Chemo Prep

HFB 14

1E031

VAV

Ante room