36C24224Q0571_1.docx

DOCX document 288 KB Posted May 16, 2024

Attached to: H999--Syracuse VAMC Bio-Safety Hood and Room Testing
Solicitation number: 36C24224Q0571
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2

About this file

Written by GovTribe AI · May 16, 2024

This document is a solicitation (Request for Quote) for annual and semi-annual bio-safety hood and room testing services at the Syracuse VA Medical Center.

The key details are:

The Department of Veterans Affairs is seeking a contractor to perform testing and certification of bio-safety cabinets, fume hoods, laminar flow benches, and HEPA filters at the Syracuse VAMC.
The testing must be conducted in accordance with manufacturer specifications and industry standards, including USP 797 and USP 800 for pharmacy-specific equipment.
The contract is set-aside for certified Service-Disabled Veteran-Owned Small Businesses.
Offers are due by June 10, 2024 at 2:00 PM EDT.
The contract will be awarded for a 1-year base period with two 1-year option periods.
Site visits for interested offerors are scheduled for May 21, 2024.
Pricing is required for the services outlined in the detailed Statement of Work.

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36C24224Q0571

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

528-24-2-7893-0393 36C24224Q0571 05-16-2024 Stephanie.Decker2@va.gov 716-862-7461 06-10-2024 14:00

EDT

Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227 X X 541380 $19 Million N/A X Department of Veterans Affairs Syracuse VAMC 800 Irving Ave Syracuse NY 13210 Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/

See CONTINUATION Page Annual and Semi-Annual Bio-Safetey Room and Hood Testing at the Syracuse VA Medical Center, 800 Irving Ave, Syracuse, NY 13210 Please see SOW for specific details.

Interested offerors may attend a site visit planned for 5/21/2024 at 10:00am by sending an email to donald.devito@va.gov. Vendors must email prior to COB 5/20/2024 to be able to attend.

Questions will be not be accepted after 5/28/2024.

See Section E.5 for submission requirements and evaluation factors. Offers are to be submitted via email to stephanie.decker2@va.gov.

See CONTINUATION Page 528-3640162-7893-854100-2543 0100C1C92 X X X Michelle Harsch michelle.harsch@va.gov Table of Contents

SECTION A	1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES	1
SECTION B - CONTINUATION OF SF 1449 BLOCKS	4
B.1 CONTRACT ADMINISTRATION DATA	4
B.2 STATEMENT OF WORK	5
B.3 PRICE/COST SCHEDULE	18
SECTION C - CONTRACT CLAUSES	98
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)	98
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)	103
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)	104
C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)	104
C.5 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023) (DEVIATION)	107
C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)	109
C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)	110
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)	110
C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)	111
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS	120
D.1 WAGE DETERMINATION	120
SECTION E - SOLICITATION PROVISIONS	129
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)	129
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)	133
E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)	136
E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)	137
E.5 52.212-2 EVALUATION – COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES	137
E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)	139

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C242 Michelle Harsch Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]

52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[ ]

52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly	[]
b. Semi-Annually	[]
c. Other	[x] monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

http://www.tungsten-network.com/us/en/veterans-affairs ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO

DATE

36C24224Q0571

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

Biological Safety Cabinet, Fume Hood, Flow Bench, and HEPA certification and testing, Syracuse VAMC The Syracuse, New York VAMC has a requirement for reoccurring testing and certification of facility Pharmacy-specific and non-Pharmacy specific safety cabinets, fume hoods, laminar flow benches, room environments, and HEPA filters. Permanent HEPA filtration units requiring testing are detailed within this Statement of Work. Testing and certification dates contained within this Statement of Work are best documented; Contractor shall be responsible to confirm and/or adjust certification/testing requirements to ensure no lapse in requirements and thus no undesirable effect on the mission of the Syracuse VAMC.

I. All non-Pharmacy Biological Safety Cabinets, Atmos Tech in Line HEPA Filtered exhaust fan (Attachment A), and laboratory fume hoods (Attachment B) shall be tested in accordance with the manufacturer’s specifications, the latest version of NSF/ANSI 49 standards, and in accordance with the latest edition of GP17-A2 Clinical Laboratory Safety Guidelines.

II. All non-Pharmacy Laminar Flow Benches and Dump Station (Attachment A) shall be tested in accordance with the manufacturer’s specifications, the latest version of NSF/ANSI 49 standards, and in accordance with the latest edition of GP17-A2 Clinical Laboratory Safety Guidelines.

III. All Pharmacy-specific equipment will obtain CETA (Controlled Environment Testing Association) certification every six calendar months from the date of last certification/testing of bio-safety cabinets, Compounding Aseptic Isolator (Attachment C), laminar flow hoods (Attachment D), ceiling mounted HEPA filters (Attachment E), and room spaces/environments (Attachment F) in accordance with VHA Directive 1108.12, VHA Guidance on Compounding Sterile Preparations Recommendations –USP 797 and USP 800. Pharmacy-specific spaces and equipment are broken down as follows:

1. Pharmacy Contingency space off set by (3) months from Main mixing rooms (currently room D407 and subject to relocation): one (1) bio-safety cabinet, one (1) Laminar Flow Work bench, four (4) ceiling mount HEPA filters shall be certified and tested in staggered frequency against primary Pharmacy spaces and equipment to ensure available redundancy in the event of primary space or equipment process interruptions. Contingency space shall be certified semi-annually for non-viable particle counts.

2. Pharmacy Primary Spaces (B133, B134, B135, B135A, B135B): two (2) bio-safety cabinets, two

(2) Laminar Flow Workbenches, and twelve (12) ceiling mount HEPA filters. Quantity five (5) areas shall be certified semi-annually in February and August for non-viable particle counts; contractor shall increase viable count testing to monthly upon implementation of USP 800 guidelines and notification from the contract COR. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Syracuse VA Hospital through consolidation of equipment/area due dates. Certification and testing shall conform to USP and OSHA standards.

(a) General Requirements:

(1) The Contractor shall comply with Federal, State, and Local Laws, plus any Federal Regulations as applicable to the performance of this contract; to include USP 797 and USP 800.

(2) The individual performing the testing shall be CETA certified to perform this work, in accordance with USP 797 and USP 800. The contractor shall provide a copy of the individual’s CETA credentials prior to start of work.

(3) Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO 7 & 8 rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months.

(4) Surface sampling of all four (4) classified areas and three (3) pass-through chambers connected to classified areas for microbial contamination must be conducted at least every six months based on USP 797 standards. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected.

(5) Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions per USP 797 and USP 800.

(b) Scope:

(1) The contractor shall:

· Perform semi-annual certification of Pharmacy-specific equipment contained within Attachment C and Attachment D.

· Perform semi-annual certification of engineering controls consisting of:

· Non-viable particle count testing in a “Dynamic” operating condition

· ISO Class 8 Garb Room B133

· ISO Class 7 Sterile Preparation Ante Room B135

· ISO Class 7 Non-Hazardous Compounding B135A

· ISO Class 7 Hazardous Compounding B135B

· Unclassified Space – Hazardous Drug Storage Room B134

· ISO Class 7/8 - Contingency Space

· Measure and document HEPA air volumes and velocities.

· Measure and document space pressurization in relationship to adjacent room(s):

1. B133 Garb Room

2. B134 Hazardous Drug Storage Room

3. B135 Sterile Preparation Ante Room

4. B135A Non-Hazardous Compounding

5. B135B Hazardous Compounding

6. Contingency Space

· Perform room calculations to determine air changes per hour in each room.

· Measure and document average air temperature and relative humidity in each room.

· Perform semi-annual ceiling HEPA filter leak / challenge testing (See Attachment E)

(1) Perform semi-annually Viable Environmental Sampling for microorganisms (Bacterial/Fungal counts with ID’s as needed). All environmental testing to be performed by accredited laboratory. Each location listed will consist of quantity: one (1) air bacterial, oneair fungal, one (1) surface bacterial, and one (1) surface fungal sampling. See Attachment F.

· Provide written report of all testing and all results, no later than 14 days following completion of all work.

Certification and Testing documentation layout – Pharmacy results only: Contractor shall provide a written report of all testing and certification results, no later than fourteen (14) days following completion of all work. Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance. Designated testing criteria should include room differential pressure, room air change rates, HEPA Filter leak challenge test, non-viable air particulate, room temperature, and relative humidity. Contractor shall use Attachment G as an example of testing and certification results layout.

Hours of Work: Work required in the performance of this contract shall be performed during the hospital's regular administrative working hours, 8:00 a.m. - 4:30 p.m. excluding weekends and Federal holidays. The Contractor shall notify the Contracting Officers Representative (COR) a minimum of five (5) working days prior to visiting the hospital for inspection purposes. This notification is required to ensure that potential hazards of the hoods being inspected will be communicated to the COR prior to beginning inspection. The user will be responsible for communicating the potential hazards to the COR. Pharmacy-specific certification scheduling will be approved in advance by Pharmacy Chief.

Emergency Requirements: In order to provide the most efficient service to our veterans, our Pharmacy service may require emergency/short notice certification in the event of any unforeseen facility failure (mechanical, electrical, etc.) or unplanned disruption that causes Pharmacy service to be interrupted. Contractor shall be available to provide on-site CETA certification within 96-hour notice, if required.

Representatives of Contracting Officer: The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally supervise the work to be performed under this contract. Such designation will be in writing and will define the scope and limitations of the designee's authority. A copy of the designation shall be furnished the Contractor.

Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his designee may determine to be reasonably necessary to protect the lives and health of human and animal occupants of the buildings. The Contracting Officer or his designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of the work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default in accordance with the Default clause of this contract.

Damage to Government Property From Causes Other Than Contractor's Negligence: Nothing in this contract shall be considered to preclude the Government from receiving the benefits of any insurance the Contractor may carry which provides for indemnification for any loss, destruction of, or damages to property in the custody and care of the Contractor, where such loss, destruction of, or damage is to Government property. The Contractor shall do nothing to prejudice the Government's right to recover against third parties for any loss, destruction of, or damage to Government property and upon request of the Contracting Officer, shall, at the Government's expense, furnish to the Government all reasonable assistance and cooperation (including assistance in the prosecution of suit and the execution of instruments of assignment in favor of the Government) in obtaining recovery.

Contractor's Responsibilities: The Contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employee or others, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by him/her or his/her employee's fault or negligence. Before commencing work under this contract, the Contracting Officer may require the Contractor to furnish a certification from his insurance company indicating the coverage as specified

Research Biosafety Cabinets, Fume hoods, and Laminar (horizontal) Flow cabinets

Location

Fan ID

MFG658

Model

S/N

Testing Frequncy

DG01

Dump Station

Allentown

3210000

201205142J

Semi-annual

DG03

Recirculating

Nuaire

NU-425-400

57049

Semi-annual

DG04

Recirculating

Nuaire

NU-425-400

57047

Semi-annual

DG06

Recirculating

Nuaire

NU-540-500

215775090722

Semi-annual

DG08

Recirculating

Baker

SG-400

SL-43403V

Semi-annual

DG08

In-Line HEPA

Atmos Tech

SA-183

Semi-annual

D117

Recirculating

Nuaire

NU-477-400

169117062915

Annual

D205a

D-Wing/49

Nuaire

NU-425-600

57893ABM

Semi-annual

D213c

Recirculating

Nuaire

NU-540-500

220320051123

Annual

D217

Recirculating

Nuaire

NU-540-600

217801011123

Annual

D215

Recirculating

Nuaire

NU-425-500

157316061313

Annual

D305

D-Wing/53

Nuaire

NU-540-500

220318051123

Semi-annual

ATTACHMENT A:

Laboratory Fume Hood

Location

Fan ID

MFG658

Model

S/N

Testing Frequncy

D117

D-wing/42

Duralab

D117-01

Annual

D205

D-wing/49

Duralab

D205-01

Annual

D213

D-wing/48

Duralab

D213-01

Annual

D217

D-wing/46

Duralab

D217-01

Annual

D217A

D-wing/47

Duralab

D217A-01

Annual

D222

D-wing/45

Duralab

D222-01

Annual

Laminar/Horizontal Flow Hoods

Location

Fan ID

MFG658

Model

S/N

Testing Frequncy

D213b

Recirculating

Labconco

3610000

080181456P

Annual

D217a

Recirculating

Nuaire

NU-240-630

219722041223

Annual

Attachment B:

Laminar Flow Benches Labs and Morgue

Location

Fan Type

MFG

Model

Freq

A342

Horizontal

Hamilton

4FT

Annual

C322

Horizontal

1375

Annual

C322

Horizontal The Baker Co.

Annual

C325A

Horizontal

The Baker Co.

Sterile Guard

Annual

C343

Horizontal

Thermo Scientific

Annual

C349

Horizontal

Fisher Hamilton

54L933

Annual

C375

Horizontal

Thermo Scientific

1321

Annual

C389

Horizontal

Labconco

Premier Protector

Annual

BL-18

Morgue

Horizontal

MorTech

Attachment C:

Sterile Compounding Area/IV Cleanroom suite 2 - locations Main Sterile Compounding Area/IV cleanroom suite

Primary Engineering Controls (PEC):

Type

Class

Model #

Serial #

EE #

Location

BSC-1, Class II B2

ISO 5

NU-430-400

172639021116

248263

B135B

BSC-2, Class II B2

ISO 5

NU-560-400

194119092319

288945

B135B

LFB-1

ISO 5

NU-201-600

151283061212

211056

B135A

LFB-2

ISO 5

NU-201-600

151282061212

211054

B135A

Secondary Engineering Controls (SEC):

ISO level

Garb room

ISO 8

B133

Anteroom

ISO 7

B135

Non-Haz/IV Prep buffer room

ISO 7

B135A

Haz/chemo buffer room

ISO 7

B135B

Hazardous Storage room

Unclassified

B134

Main Sterile Compounding Area/IV cleanroom suite

The following drawing depicts the Pharmacy Primary and Secondary Engineering Controls layout. The drawing is not to scale.

Attachment D:

Contingency space:

Contingency/Alternate Sterile Compounding Area/IV cleanroom suite

Primary Engineering Controls (PEC):

Type

Class

Model #

Serial #

EE #

Location

BSC, Class II A2 with VFC exhaust canopy

ISO 5

NU-543-400

xxxx

C105C

LFB

ISO 5

NU-240-430

xxxx

C105D

Secondary Engineering Controls (SEC):

ISO level

Garb room

ISO 8

C105A

Anteroom

ISO 7

C105B

Non-Haz/IV Prep buffer room

ISO 7

C105D

Haz/chemo buffer room

ISO 7

C105C

Contingency Sterile Compounding Area/IV clean room suite

The following drawing depicts the Pharmacy Primary and Secondary Engineering Controls layout. The drawing is not to scale.

ATTACHMENT E:

Pharmacy-specific HEPA Filters – tested Semi Annually

HEPA location

HEPA size (feet)

Garb Room B133

2 x 2

Garb Room B133

2 x 4

Ante Room B135

2 x 4

Ante Room B135

2 x 4

IV Room B135A

2 x 4

IV Room B135A

2 x 4

IV Room B135A

2 x 4

Hazardous Compounding B135B 2 x 4

Hazardous Compounding B135B 2 x 2

Chemo Storage B134

2 x 4

Contingency C105A

2 x 2

Contingency C105B

2 x 4

Contingency C105C

2 x 2

Contingency C105C

2 x 4

Contingency C105D

2 x 4

Area

Testing Frequency

Garb Room B133

Semi-annually

Ante Room B135

Semi-annually

IV Room B135A

Semi-annually

Hazardous Compounding B135B

Semi-annually

Laminar Flow Benches B135A (2)

Semi-annually

Biologic Safety Cabinets B135B (2)

Semi-annually

Pharmacy Compounding Pass-Through Windows (3)

Semi-annually

Contingency C105A Semi-annually

Contingency C105B Semi-annually

Contingency C105C Semi-annually

Contingency C105D Semi Annually

ATTACHMENT F:

Viable air & surface Environmental Sampling Areas – to be tested Semi-Annually

ATTACHMENT G:

**Example Document of Certification testing Results**

Location/Facility:	Vendor:
Date:	Certifier:

PRESSURE

Higher Pressure

Lower Pressure

Accept Min Pressure

Actual Diff Pressure

Design Pressure

Actual Pressure

Results

Garb Room

Main Pharmacy

0.029

POS

PASS

Anteroom

Garb Room

0.02

0.023

POS

PASS

IV prep room (non-HD)

Anteroom

0.02

0.030

POS

PASS

Haz Compound

Anteroom

0.01 – 0.03

0.022

NEG

PASS

Haz storage

Garb Room

0.01

0.024

NEG

PASS

ROOM

ROOM AREA (FT)

ROOM VOLUME (FT3)

AIR VOLUME

(cfm)

CLASS

MIN ACCEPTED ACR

AC/HR

TEST RESULT

GARB ROOM B133
100.0
750.0
212
8
12
17
PASS

ANTE ROOM B135
158.0
1,158
587
7
30
30
PASS

HAZ

COMPOUND B135B

109.0

818.0

1,285

PASS

CHEMO STORAGE B134
150.0
675
140
UN
12
12
PASS

IV ROOM B135A
178.0
1,335
1,050
7
15
47
PASS

IV ROOM W/PECS
178.0
1,335
1,050
7
30
154
PASS

AIR EXCHANGES IN ROOM

UN == unclassified

LOCATION

ROOM TEMP (°C)

USP guidelines

HUMIDITY (%Rh)

USP ?? Guidelines

GARB ROOM B133

21.0

20°C

Less than 60%

ANTEROOM B135

22.0

20°C

Less than 60%

IV PREP ROOM B135A

22.0

20°C

Less than 60%

HAZ COMPOUND B135B

22.0

20°C

Less than 60%

HAZARDOUS STORAGE B134

Not measured

Less than 60%

TEMPERATURE – relative HUMIDITY **Current temperature above 20°C to maintain %Rh less than 60%. Engineering to replace valve to better regulate ?? to be replaced with most current/updated standards of USP

DYNAMIC SMOKE TEST

LAMINAR EQUIPMENT

ISO CLASS

TEST RESULT

VIDEO EVIDENCE

BSC-1

PASS

YES

BSC-2

PASS

YES

LFB-1

PASS

YES

LFB-2

PASS

YES

Staff performing smoke test – Marci

PARTICLES

LOCATION

CLASS

ACCEPT MAX AVERAGE

COUNT

ACTUAL MAX AVERAGE

COUNT

RESULTS

Model #

Serial #

EE#

Report ID

BSC-1
5
3,520
0
PASS
NU-430- 400
159451100913
225052
687616

BSC-2
5
3,520
0
PASS
NU-560- 400
194119092319
288945
687617

LFB- 1 (right)
5
3,520
0
PASS
NU-201- 630
151282061212
211056
687614

LFB-2 (left)

3,520

PASS

NU-201-

151283061212

211054

687615

HAZ COMPOUND

352,000

3940

PASS

ANTEROOM

352,000

3660

PASS

IV PREP (NON- HD)

352,000

2560

PASS

GARB ROOM

3,520,000

312,240

PASS

HAZ STORAGE

HEPA LEAK TEST – Room filters

HEPA ID

Source

Actual Leakage

Design Leakage %

Pass/Fail

HAZ - TAF1

Supply

0.00

<0.01

PASS

HAZ - TAF2

Supply

0.00

<0.01

PASS

HAZ - TAF3

Supply

0.00

<0.01

PASS

HAZ - TAF4

Supply

0.00

<0.01

PASS

ANTE – AF1

Supply

0.00

<0.01

PASS

ANTE – TAF2

Supply

0.00

<0.01

PASS

NONHAZ – TAF1

Supply

0.00

<0.01

PASS

NONHAZ – TAF2

Supply

0.00

<0.01

PASS

NONHAZ – TAF3

Supply

0.00

<0.01

PASS

GARB – TAF1

Supply

0.00

<0.01

PASS

GARB – TAF2

Supply

0.00

<0.01

PASS

CHEMO STORE – TAF1

Supply

0.00

<0.01

PASS

HEPA LEAK TEST - equipment

Source

Model #

Serial #

EE#

Report ID

Design Leakage

Actual Leakage Pass/Fail

BSC-1
Exhaust
NU-430-400
159451100913
225052
687616
<0.01
0.00
PASS

Supply

<0.01

0.00

PASS

BSC-2
Exhaust
NU-560-400
194119092319
288945
687617
<0.01
0.00
PASS

Supply

<0.01

0.00

PASS

LAFW 1 (right)
Supply
NU-201-630
151282061212
211056
687614
<0.01
0.00
PASS

LAFW 2 (left)
Supply
NU-201-630
151283061212
211054
687615
<0.01
0.00
PASS

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

1.00

__________________

Annual Bio-Safety Testing Contract Period: Base POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H999 - Other Quality Control, Testing, and Inspection - Miscellaneous

0001AA

1.00

__________________

(Location: D117) Recirculating Fan, Nuaire, Model: NU-477-400, SN: 169117062915