S02 FINAL Combined Synopsis Solicitation 36C25621Q1745 Glove Gown Sampling USP Testing.pdf

Combined Synopsis/Solicitation Notice

SUBJECT* Glove Gown Sampling, USP (and other related) Testing Gulf Coast Veterans Health Care System, Pharmacy Services 400 Veterans Avenue / 790 Veterans Way Biloxi, MS 39531 / Pensacola, FL 32507

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 39531

SOLICITATION NUMBER* 36C25621Q1745

RESPONSE DATE/TIME/ZONE 09-13-2021 1300 EASTERN TIME, NEW YORK,

USA

ARCHIVE 99 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* H266

NAICS CODE* 541380

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Gulf Coast Veterans Health Care System Network Contracting Office 16 400 Veterans Avenue BLDG T102 Biloxi MS 39531

POINT OF CONTACT*

C. Robert Oravetz / Contract Specialist Department of Veterans Affairs Network Contracting Office 16 Gulf Coast Veterans Health Care System

Biloxi, MS 39531

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Gulf Coast Veterans Health Care System Pharmacy Services 400 Veterans Avenue / 790 Veterans Way

Biloxi, MS 39531 / Pensacola, FL 32507

POSTAL CODE 39531 / 32507

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/

URL DESCRIPTION VA

AGENCY CONTACT’S EMAIL ADDRESS christopher.oravetz@va.gov EMAIL DESCRIPTION CS e-mail address

This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in Federal Acquisition Regulation (FAR 12.6) as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued.

Solicitation number 36C25621Q1745 is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-02.

The Gulf Coast Veterans Health Care System located at 400 Veterans Avenue Biloxi, MS 39531 is seeking a contractor to support the following requirement: Glove Gown Sampling, USP (and other related) Testing.

This requirement is for testing of all the Gulf Coast Veterans Health Care System (GCVHCS) facility’s sterile clean rooms and segregated compounding areas used for preparation of Compounded Sterile Preparations (CSPs) as well as staff competency testing.

The Statement of Work contained within this solicitation is a non-negotiable document. Offers/quotes shall not include edits, revisions, additions, deletions, alterations, or track change comments to the Statement of Work.

The applicable NAICS code for this procurement is 541380-Testing Laboratories. The associated size standard is $16.5 million.

This solicitation is set aside 100 % for Service-Disabled Veteran Owned Small Businesses (100% SDVOSB set aside).

When preparing offers in response to this solicitation offerors shall refer to FAR 52.212-1 (Instructions to Offerors – Commercial Items), FAR 52.212-2 (Evaluation-Commercial Items) and Addendum to FAR 52.212-1. These sections contain specific instructions, guidance, format, and exact requirements for what constitutes a complete and responsive offer/quote. As specified in these sections an incomplete and/or non-responsive offer shall not be considered for a contract award by the contracting officer.

PAGE 3 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. DUNS: DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 81

520-22-1-119-0004

36C25621Q1745 09-02-2021

C. Robert Oravetz 228-523-5454 09-13-2021

1300 EDT

Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16

X 100

X

541380

$16.5 Million

N/A

X

36C256

Department of Veterans Affairs Gulf Coast Veterans Health Care System Pharmacy Services 400 Veterans Avenue Biloxi MS 39531

36C256

Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically

1-877-489-6135 vafsccshd@va.gov

See CONTINUATION Page

Contractor shall provide Glove Gown Sampling, USP (and other related) Testing for the Gulf Coast Veterans Health Care System (Biloxi, MS) and JACC (Pensacola, FL) locations.

Contractor shall refer to the Statement of Work, the Schedule of Services (Price/Cost Schedule), and all other requirements and conditions that are contained within this solicitation that pertain to the execution of services and the completion of tasks/deliverables.

Contractor shall refer to FAR 52.212-1, FAR 52.212-2, and Addendum to 52.212-2 when submitting offers/quotes in response to this solicitation.

IAW applicable policy and regulation this solicitation is set aside 100% for Service-Disabled Veteran Owned Small Businesses (SDVOSB's)-100% Total SDVOSB Set Aside.

Offers/quotes shall only be accepted by eligible contractors in this socioeconomic category.

See CONTINUATION Page

520-3620160-119-822400-2660 0100224P8

X X

X 1

Paul. Filhiol Contracting Officer

36C25621Q1745

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE & ITEM INFORMATION JB=JOB EA=EACH

B.3 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.5 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF

COMMERCIAL ITEMS (APR 2020)

C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE

(JUL 2018)

C.8 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES

OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

Solicitation Questions Request Form USP 797 (2019) Highlight VA Directive 1108.12 CETA Highlight

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.6-A ADDENDUM TO 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS

(FEB 2021) (JUL 2020) (DEVIATION)

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: To Be Determined

b. GOVERNMENT: Contracting Officer 36C256 Paul Filhiol

Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16 400 Veterans Avenue BLDG T102 Biloxi MS 39531

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 following successful completion of services

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.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

http://www.fsc.va.gov/fsc/einvoice.asp

B.2 PRICE/COST SCHEDULE & ITEM INFORMATION JB=JOB EA=EACH

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 JB __________________ __________________

Contractor to provide personnel and equipment to perform the services listed below:

PROJECT LOCATION 1: Gulf Coast Veterans Health Care System (Biloxi, MS) PROJECT LOCATION 2: JAAC (Pensacola, FL)

TERMS AND CONDITIONS:

In Accordance With (IAW)

• Veterans Affairs, VHA Directive 1108.12, dated November 5, 2018:

Management and Monitoring of Pharmaceutical Compounded Sterile Preparations.

• USP General Chapter <797>, Pharmaceutical Compounding- Sterile Preparations, Reprinted from USP 42-NF 37

• Statement of Work (SOW)

1. Certification procedures defined in CETA CAG-009-00 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every month.

2. The contractor shall complete viable sampling according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-009-00).

3. All CSP Facilities must be tested according to CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019).

4. Viable particle counts samples will be collected in accordance with applicable CETA guides. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

5. Report Requirements: Results of the certification process will be documented in accordance with CETA guides. All of the following information will be included in the report. Pass/Fail notifications should be included on a per-test basis where applicable.

6. Report Requirements: Comments indicating when dynamic operating conditions were used

7. Report Distribution: A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

8. Staff competency testing: All testing must be in accordance with USP

<797> (and <800> after December 1, 2019) and CETA CAG-009-00 requirements.

9. Staff competency testing: All employees will complete a Media Fill Test (MFT) using soybean-casein digest media initially upon hiring at least every 6 months. Additional testing may be required as needed to address possible failures. Manipulation of MFT must be done in a manner that simulates the most difficult compounding completed by each employee.

10. Glove Tip Sampling (bacterial and fungal) for re-evaluation of employees must occur for each hand immediately following the completion of MFT, but prior to performing any hand hygiene. Testing must be completed at least every 6 months. Additional testing may be required as needed to address possible failures.

11. Qualifications/References: All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

SEMI-ANNUAL VISITS ARE (2) VISITS -PER CONTRACTED YEAR,

MONTHLY VISITS (1) VISIT PER MONTH

Contract Period: Base POP Begin: 10-01-2021 POP End: 09-30-2022

190.00 EA __________________ __________________

USP TESTING - GOWNING GLOVE TIP SAMPLING - BACTERIA -

SEMI ANNUAL TESTING

SAMPLING IN ACCORDANCE TO CETA CAG-009 SECTION 24

(CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees are (48) samples. This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

(1) TSA sample per hand, per person after successful gowning. Total for 12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Base POP Begin: 10-01-2021

Contractor will provide personnel and equipment to perform the services listed below:

USP TESTING - GOWNING GLOVE TIP SAMPLING - FUNGAL - SEMI

ANNUAL TESTING SAMPLING IN ACCORDANCE TO CETA CAG-009

SECTION 24 (CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees is (48) samples.

This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

(1) TSA sample per hand, per person after successful gowning. Total for 12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Base POP Begin: 10-01-2021

168.00 EA __________________ __________________

listed below:

USP TESTING - VIABLE AIR SAMPLING - BACTERIA - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR BACTERIA IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

Contract Period: Base POP Begin: 10-01-2021 listed below:

USP TESTING -VIABLE AIR SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR FUNGAL IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood Positive and Negative Control Samples

Contract Period: Base

144.00 EA __________________ __________________

listed below:

USP TESTING -VIABLE SURFACE SAMPLING - BACTERIA -

MONTHLY TESTING: VIABLE SURFACE SAMPLING FOR BACTERIA

IN ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Base POP Begin: 10-01-2021 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE SURFACE SAMPLING FOR FUNGAL IN

ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Base

1.00 EA __________________ __________________

TRAVEL - BILOXI, MS

TRAVEL/LODGING/MEALS CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from the nearest CNBT Accredited Technician.

Contract Period: Base

TRAVEL/LODGING - PENSACOLA, FL TRAVEL/LODGING/MEALS

CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from nearest CNBT Accredited Technician.

Contract Period: Base

12.00 EA __________________ __________________

REPORT GENERATION FEE - BILOXI

ONE FEE PER VISIT PER SITE

Contract Period: Base

REPORT GENERATION FEE - PENSACOLA, FL

ONE FEE PER VISIT PER SITE

Contract Period: Base

24.00 EA __________________ __________________

OVERNIGHT FREIGHT- OVERNIGHT FEE FOR EXTERNAL LAB

ANALYSIS

OVERNIGHT FREIGHT - SHIPPING OF SAMPLES TO LAB FOR

ANALYSIS FOR BOTH BILOXI, MS AND PENSACOLA, FL SITES.

Contract Period: Base

35.00 EA __________________ __________________

MEDIUM BASIC (VIALS ONLY) MEDIA FILL KITS- PENSACOLA, FL

Contract Period: Base

2.00 EA __________________ __________________

USP TESTING -REPORT GENERATION- MEDIA FILL TESTING

REPORT - PENSACOLA, FL

ONE FEE PER VISIT, PER SITE

Contract Period: Base

60.00 EA __________________ __________________

MEDIUM BASIC (VIALS ONLY) MEDIA FILL KITS- BILOXI, MS

Contract Period: Base

REPORT - BILOXI, MS

ONE FEE PER SITE, PER VISIT

Contract Period: Base

SUBTOTAL – BASE YEAR

listed below:

PROJECT LOCATION 1: Gulf Coast Veterans Health Care System (Biloxi, MS) PROJECT LOCATION 2: JAAC (Pensacola, FL)

TERMS AND CONDITIONS:

In Accordance With (IAW)

• Veterans Affairs, VHA Directive 1108.12, dated November 5, 2018:

Management and Monitoring of Pharmaceutical Compounded Sterile Preparations.

• USP General Chapter <797>, Pharmaceutical Compounding- Sterile Preparations, Reprinted from USP 42-NF 37

• Statement of Work (SOW)

1. Certification procedures defined in CETA CAG-009-00 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every month.

2. The contractor shall complete viable sampling according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-009-00).

3. All CSP Facilities must be tested according to CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019).

4. Viable particle counts samples will be collected in accordance with applicable CETA guides. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

5. Report Requirements: Results of the certification process will be documented in accordance with CETA guides. All of the following information will be included in the report. Pass/Fail notifications should be included on a per-test basis where applicable.

6. Report Requirements: Comments indicating when dynamic operating conditions were used

7. Report Distribution: A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

8. Staff competency testing: All testing must be in accordance with USP <797> (and <800> after December 1, 2019) and CETA CAG-009-00 requirements.

9. Staff competency testing: All employees will complete a Media Fill Test (MFT) using soybean-casein digest media initially upon hiring at least every 6 months. Additional testing may be required as needed to address possible failures. Manipulation of MFT must be done in a manner that simulates the most difficult compounding completed by each employee.

10. Glove Tip Sampling (bacterial and fungal) for re-evaluation of employees must occur for each hand immediately following the completion of MFT, but prior to performing any hand hygiene. Testing must be completed at least every 6 months. Additional testing may be required as needed to address possible failures.

11. Qualifications/References: All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

SEMI-ANNUAL VISITS ARE (2) VISITS -PER CONTRACTED YEAR,

MONTHLY VISITS (1) VISIT PER MONTH

Contract Period: Option 1 POP Begin: 10-01-2022 POP End: 09-30-2023

SEMI ANNUAL TESTING

SAMPLING IN ACCORDANCE TO CETA CAG-009 SECTION 24

(CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees are (48) samples. This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

(1) TSA sample per hand, per person after successful gowning. Total for

12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Option 1 POP Begin: 10-01-2022 listed below:

USP TESTING - GOWNING GLOVE TIP SAMPLING - FUNGAL - SEMI

ANNUAL TESTING SAMPLING IN ACCORDANCE TO CETA CAG-009

SECTION 24 (CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees is (48) samples.

This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

(1) TSA sample per hand, per person after successful gowning. Total for 12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Option 1 POP Begin: 10-01-2022 listed below:

USP TESTING - VIABLE AIR SAMPLING - BACTERIA - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR BACTERIA IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

Contract Period: Option 1 POP Begin: 10-01-2022 listed below:

USP TESTING -VIABLE AIR SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR FUNGAL IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood Positive and Negative Control Samples

Contract Period: Option 1 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - BACTERIA -

MONTHLY TESTING: VIABLE SURFACE SAMPLING FOR BACTERIA

IN ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Option 1 POP Begin: 10-01-2022 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE SURFACE SAMPLING FOR FUNGAL IN

ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Option 1

TRAVEL/LODGING/MEALS CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from the nearest CNBT Accredited Technician.

Contract Period: Option 1

CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from nearest CNBT Accredited Technician.

Contract Period: Option 1

ONE FEE PER VISIT PER SITE

Contract Period: Option 1

ONE FEE PER VISIT PER SITE

Contract Period: Option 1

ANALYSIS

OVERNIGHT FREIGHT - SHIPPING OF SAMPLES TO LAB FOR

ANALYSIS FOR BOTH BILOXI, MS AND PENSACOLA, FL SITES.

Contract Period: Option 1

REPORT - PENSACOLA, FL

ONE FEE PER VISIT, PER SITE

Contract Period: Option 1

REPORT - BILOXI, MS

ONE FEE PER SITE, PER VISIT

Contract Period: Option 1

SUBTOTAL –OPTION YEAR ONE

listed below:

PROJECT LOCATION 1: Gulf Coast Veterans Health Care System (Biloxi, MS) PROJECT LOCATION 2: JAAC (Pensacola, FL)

TERMS AND CONDITIONS:

In Accordance With (IAW)

• Veterans Affairs, VHA Directive 1108.12, dated November 5, 2018:

Management and Monitoring of Pharmaceutical Compounded Sterile Preparations.

• USP General Chapter <797>, Pharmaceutical Compounding- Sterile Preparations, Reprinted from USP 42-NF 37

• Statement of Work (SOW)

1. Certification procedures defined in CETA CAG-009-00 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every month.

2. The contractor shall complete viable sampling according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-009-00).

3. All CSP Facilities must be tested according to CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019).

4. Viable particle counts samples will be collected in accordance with applicable CETA guides. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

5. Report Requirements: Results of the certification process will be documented in accordance with CETA guides. All of the following information will be included in the report. Pass/Fail notifications should be included on a per-test basis where applicable.

6. Report Requirements: Comments indicating when dynamic operating conditions were used

7. Report Distribution: A formalized written report including all required identified points of contact no more than 14 days from certification evaluation.

8. Staff competency testing: All testing must be in accordance with USP <797> (and <800> after December 1, 2019) and CETA CAG-009-00 requirements.

9. Staff competency testing: All employees will complete a Media Fill Test (MFT) using soybean-casein digest media initially upon hiring at least every 6 months. Additional testing may be required as needed to address possible failures. Manipulation of MFT must be done in a manner that simulates the most difficult compounding completed by each employee.

10. Glove Tip Sampling (bacterial and fungal) for re-evaluation of employees must occur for each hand immediately following the completion of MFT, but prior to performing any hand hygiene. Testing must be completed at least every 6 months. Additional testing may be required as needed to address possible failures.

11. Qualifications/References: All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

SEMI-ANNUAL VISITS ARE (2) VISITS -PER CONTRACTED YEAR,

MONTHLY VISITS (1) VISIT PER MONTH

Contract Period: Option 2 POP Begin: 10-01-2023 POP End: 09-30-2024

SEMI ANNUAL TESTING

SAMPLING IN ACCORDANCE TO CETA CAG-009 SECTION 24

(CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees are (48) samples. This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Option 2 POP Begin: 10-01-2023 listed below:

USP TESTING - GOWNING GLOVE TIP SAMPLING - FUNGAL - SEMI

ANNUAL TESTING SAMPLING IN ACCORDANCE TO CETA CAG-009

SECTION 24 (CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees is (48) samples.

This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

(1) TSA sample per hand, per person after successful gowning. Total for 12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Option 2 POP Begin: 10-01-2023 listed below:

USP TESTING - VIABLE AIR SAMPLING - BACTERIA - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR BACTERIA IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

Contract Period: Option 2 POP Begin: 10-01-2023 listed below:

USP TESTING -VIABLE AIR SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR FUNGAL IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood Positive and Negative Control Samples

Contract Period: Option 2 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - BACTERIA -

MONTHLY TESTING: VIABLE SURFACE SAMPLING FOR BACTERIA

IN ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Option 2 POP Begin: 10-01-2023 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE SURFACE SAMPLING FOR FUNGAL IN

ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Option 2

TRAVEL/LODGING/MEALS CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from the nearest CNBT Accredited Technician.

Contract Period: Option 2

CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from nearest CNBT Accredited Technician.

Contract Period: Option 2

ONE FEE PER VISIT PER SITE

Contract Period: Option 2

ONE FEE PER VISIT PER SITE

Contract Period: Option 2

ANALYSIS

OVERNIGHT FREIGHT - SHIPPING OF SAMPLES TO LAB FOR

ANALYSIS FOR BOTH BILOXI, MS AND PENSACOLA, FL SITES.

Contract Period: Option 2

Contract Period: Option 2

REPORT - PENSACOLA, FL

ONE FEE PER VISIT, PER SITE

Contract Period: Option 2

Contract Period: Option 2

REPORT - BILOXI, MS

ONE FEE PER SITE, PER VISIT

Contract Period: Option 2

SUBTOTAL – OPTION YEAR TWO

listed below:

PROJECT LOCATION 1: Gulf Coast Veterans Health Care System (Biloxi, MS) PROJECT LOCATION 2: JAAC (Pensacola, FL)

TERMS AND CONDITIONS:

In Accordance With (IAW)

• Veterans Affairs, VHA Directive 1108.12, dated November 5, 2018:

Management and Monitoring of Pharmaceutical Compounded Sterile Preparations.

• USP General Chapter <797>, Pharmaceutical Compounding- Sterile Preparations, Reprinted from USP 42-NF 37

• Statement of Work (SOW)

1. Certification procedures defined in CETA CAG-009-00 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every month.

2. The contractor shall complete viable sampling according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-009-00).

3. All CSP Facilities must be tested according to CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019).

4. Viable particle counts samples will be collected in accordance with applicable CETA guides. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

5. Report Requirements: Results of the certification process will be documented in accordance with CETA guides. All of the following information will be included in the report. Pass/Fail notifications should be included on a per-test basis where applicable.

6. Report Requirements: Comments indicating when dynamic operating conditions were used

7. Report Distribution: A formalized written report including all required identified points of contact no more than 14 days from certification evaluation.

8. Staff competency testing: All testing must be in accordance with USP <797> (and <800> after December 1, 2019) and CETA CAG-009-00 requirements.

9. Staff competency testing: All employees will complete a Media Fill Test (MFT) using soybean-casein digest media initially upon hiring at least every 6 months. Additional testing may be required as needed to address possible failures. Manipulation of MFT must be done in a manner that simulates the most difficult compounding completed by each employee.

10. Glove Tip Sampling (bacterial and fungal) for re-evaluation of employees must occur for each hand immediately following the completion of MFT, but prior to performing any hand hygiene. Testing must be completed at least every 6 months. Additional testing may be required as needed to address possible failures.

11. Qualifications/References: All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

SEMI-ANNUAL VISITS ARE (2) VISITS -PER CONTRACTED YEAR,

MONTHLY VISITS (1) VISIT PER MONTH

Contract Period: Option 3 POP Begin: 10-01-2024 POP End: 09-30-2025

SEMI ANNUAL TESTING

SAMPLING IN ACCORDANCE TO CETA CAG-009 SECTION 24

(CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees are (48) samples. This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Option 3 POP Begin: 10-01-2024 listed below:

USP TESTING - GOWNING GLOVE TIP SAMPLING - FUNGAL - SEMI

ANNUAL TESTING SAMPLING IN ACCORDANCE TO CETA CAG-009

SECTION 24 (CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees is (48) samples.

This is for initial testing.

(1) TSA sample per hand, per person after successful gowning. Total for 25 employees to be completed twice per year (at least every 6 months) is

(50) samples per visit (100) samples annually.

(2) Positive/Negative Control samples required per employee group tested. (152)

PENSACOLA LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total for 6 new employees is (36) samples.

(1) TSA sample per hand, per person after successful gowning. Total for 12 employees to be completed twice per year (at least every 6 months) is

(24) samples per visit (48) samples annually.

(2) Positive/Negative Control required per employee group tested.

Contract Period: Option 3 POP Begin: 10-01-2024 listed below:

USP TESTING - VIABLE AIR SAMPLING - BACTERIA - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR BACTERIA IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

Contract Period: Option 3 POP Begin: 10-01-2024 listed below:

USP TESTING -VIABLE AIR SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE AIR SAMPLING FOR FUNGAL IN ACCORDANCE

WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

(2) Positive and Negative Control Samples

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood Positive and Negative Control Samples

Contract Period: Option 3 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - BACTERIA -

MONTHLY TESTING: VIABLE SURFACE SAMPLING FOR BACTERIA

IN ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Option 3 POP Begin: 10-01-2024 listed below:

USP TESTING -VIABLE SURFACE SAMPLING - FUNGAL - MONTHLY

TESTING: VIABLE SURFACE SAMPLING FOR FUNGAL IN

ACCORDANCE WITH CETA CAG-009 (CURRENT VERSION)

BILOXI LOCATION:

Sampling locations per trip:

(1) In IV Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

PENSACOLA LOCATION:

Sampling locations per trip:

(1) In Ante Room

(1) In IV Room

(1) In IV Room Hood

(1) In Chemo Ante Room

(1) In Chemo Room

(1) In Chemo Room Hood

Contract Period: Option 3

TRAVEL/LODGING/MEALS CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from the nearest CNBT Accredited Technician.

Contract Period: Option 3

CNBT TECHNICIAN

Travel Rate: The Travel Rate will be calculated at a specified dollar amount per hour round trip from nearest CNBT Accredited Technician.

Contract Period: Option 3

ONE FEE PER VISIT PER SITE

Contract Period: Option 3

ONE FEE PER VISIT PER SITE

Contract Period: Option 3

ANALYSIS

OVERNIGHT FREIGHT - SHIPPING OF SAMPLES TO LAB FOR

ANALYSIS FOR BOTH BILOXI, MS AND PENSACOLA, FL SITES.

Contract Period: Option 3

REPORT - PENSACOLA, FL

ONE FEE PER VISIT, PER SITE

Contract Period: Option 3

REPORT - BILOXI, MS

ONE FEE PER SITE, PER VISIT

Contract Period: Option 3

SUBTOTAL – OPTION YEAR THREE

listed below:

PROJECT LOCATION 1: Gulf Coast Veterans Health Care System (Biloxi, MS) PROJECT LOCATION 2: JAAC (Pensacola, FL)

TERMS AND CONDITIONS:

In Accordance With (IAW)

• Veterans Affairs, VHA Directive 1108.12, dated November 5, 2018:

Management and Monitoring of Pharmaceutical Compounded Sterile Preparations.

• USP General Chapter <797>, Pharmaceutical Compounding- Sterile Preparations, Reprinted from USP 42-NF 37

• Statement of Work (SOW)

1. Certification procedures defined in CETA CAG-009-00 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every month.

2. The contractor shall complete viable sampling according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-009-00).

3. All CSP Facilities must be tested according to CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019).

4. Viable particle counts samples will be collected in accordance with applicable CETA guides. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

5. Report Requirements: Results of the certification process will be documented in accordance with CETA guides. All of the following information will be included in the report. Pass/Fail notifications should be included on a per-test basis where applicable.

6. Report Requirements: Comments indicating when dynamic operating conditions were used

7. Report Distribution: A formalized written report including all required identified points of contact no more than 14 days from certification evaluation.

8. Staff competency testing: All testing must be in accordance with USP <797> (and <800> after December 1, 2019) and CETA CAG-009-00 requirements.

9. Staff competency testing: All employees will complete a Media Fill Test (MFT) using soybean-casein digest media initially upon hiring at least every 6 months. Additional testing may be required as needed to address possible failures. Manipulation of MFT must be done in a manner that simulates the most difficult compounding completed by each employee.

10. Glove Tip Sampling (bacterial and fungal) for re-evaluation of employees must occur for each hand immediately following the completion of MFT, but prior to performing any hand hygiene. Testing must be completed at least every 6 months. Additional testing may be required as needed to address possible failures.

11. Qualifications/References: All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

SEMI-ANNUAL VISITS ARE (2) VISITS -PER CONTRACTED YEAR,

MONTHLY VISITS (1) VISIT PER MONTH

Contract Period: Option 4 POP Begin: 10-01-2025 POP End: 09-30-2026

SEMI ANNUAL TESTING

SAMPLING IN ACCORDANCE TO CETA CAG-009 SECTION 24

(CURRENT VERSION)

Sampling MUST BE COMPLETED AT LEAST EVERY 6 MONTHS, includes total counts and identification of genus of organism.

BILOXI LOCATION:

(1) TSA sample per hand, per person after successful gowning. Repeat two additional times for a total of (3) complete gowning reviews and (6) samples per person. Total Samples for 8 new employees are (48) samples. This is for initial testing.

(1) TSA sample per hand, per person after successful gowning.