36C26321Q0810 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 618-21-4-109-3069 36C618 Department of Veterans Affairs Minneapolis VA Medical Center One Veterans Drive Minneapolis MN 55417 Cameron Rick cameron.rick@va.gov 36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101 To all Offerors/Bidders

36C26321Q0810 08-16-2021

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 12:00, 08/23/2021 618-3610160-109-822400 Pharmacy- 2580 Non-Medical Contract and-010022400 618-21-4-109-3069 X The purpose of this amendment is to provide greater clarity into the testing facility location requirements. Offeror's testing facility is no longer required to be within 50 miles from the MVAHCS. The MVAHCS desires the ability to drop off samples to expedite the turn-around testing time but the location of the testing facility will no longer be a factor to determine technical acceptability. The SOW and Technical Acceptability Evaluation Factors have been updated to reflect these changes.

Pamela Phillips Contracting Officer Statement of Work for Viable Environmental Testing for MVAHCS Cleanrooms (for 2021 requirements) The Minneapolis VA Health Care System, hereinafter referred to as MVAHCS, requires the services of a contractor to provide viable environmental laboratory testing on environmental samples taken by MVAHCS staff. The United States Pharmacopeial Convention Chapter 797 (USP <797>) sets federal regulation regarding conditions & practices for sterile compounding that MVAHCS must adhere to. It includes minimum practice and quality standards for compounded sterile preparations (CSPs); therefore, contractor shall meet at a minimum all standards listed in the USP <797>.

Frequency of testing is based on the type of sterile compounding the facility does. Quantities as listed are estimated yearly requirements. The MVAHCS attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed.

TESTING REQUIREMENTS:

a. Initial fingertip cultures (GFT)

b. Bi-annual (every 6 months) GFT testing of employees working in the sterile compounding area

c. Quarterly (every 3 months) testing of the IV room environment air

d. Monthly testing of select IV area surfaces.

e. The MVAHCS may require additional testing to be added during the life of this contract. Those additional tests shall be added to the current year at the discretion of the CO and COR.

The above types of testing involve utilization of Tryptic Soy Agar (TSA) media plates supplemented with neutralizing additives (e.g. lecithin and polysorbate 80) to identify bacterial and fungal contamination within the compounding area. The plates are supplied by the vendor. Certificates of Analysis (COA’s) from the manufacturer must be provided with all growth media to verify that the media meets the expected growth promotion, pH and sterilization requirements. Sampling will be done by MVAHCS staff on an ongoing basis. Plates will be returned to the contractor at time of sampling for incubation, CFU count and identification when over the action level (or if requested) for microbial growth.

Incubation must follow USP <797> regulations. For gloved fingertip testing (GFT), Environmental testing (surface and air) plates are incubated at a temperature of 30-35 degrees Celsius for 48 to 72 hours then followed by incubation at 20-25 degrees Celsius for 5-7 days. Media will be inverted during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the CFU reading. If microbial growth exceeds action levels per USP <797>, the contractor will utilize a microbiologist to identify and report identification of the organism to the genus level.

SUBMISSIONS/REPORTS/INVOICES:

Plates from each sampling area will be submitted as a group along with contractor provided submission form. Contractor will document date, time and name of individual receiving the samples to ensure chain of custody. An email will be generated by the contractor to select MVAHCS staff whenever a sample is received by the contractor to include submission form with documentation of receipt.

Contractor will create a report that delineates group name of samples submitted and includes information on each individual sample plate. For each sample the report will indicate the number of colonies observed after initial incubation at 30-35 degrees Celsius and number of colonies observed after final incubation at 20-25 degrees Celsius. If microbial growth exceeds action levels per USP <797>, the contractor will utilize a microbiologist to identify and report identification of the organism to the genus level. Reports will specify dates and temperatures of each incubation period. An email will be generated when a final report is available.

Submission forms, reports and invoices will be available online and be accessible via password protected access and be viewable 24 hours per day, 7 days a week. Reports will be retained online and viewable for at least 1 year. Reports must be in a format that is printable and able to be saved to a VA computer file.

MVAHCS desires the ability to drop off samples to expedite the turn around testing time. Drop off location must be within a 50 mile radius from the Minneapolis VA. Testing facility co-located at the drop off location is preferred but not required to assist in turn around testing time.

EMPLOYEE TESTING:

Sampling of GFT will be done by MVAHCS staff. New employees must pass GFTs including 3 plates for each hand with TSA (total of 6 plates). Current employees require bi-annual (every 6 months) GFT. Testing will be completed for approximately 30-60 employees (potentially more). Each current employee must pass GFT testing of 1 plate for each hand with TSA (total of 2 plates). Failures will require additional testing.

SERVICES REQUIRED:

a. Gloved Fingertip Testing: approximately 350 plates

1. TSA plates, incubation and enumeration of colonies

2. Microbial Identification Streak Plate Sub-culturing at no additional charge

3. 3 TSA plates x 2 hands x ~5 new employees per year equals a minimum of 30 plates, 30 technicians plus ~35 pharmacists x 2 hands x bi-annual testing equals a minimum of 260 plates, plus an additional ~60 plates needed for retesting equals a minimum of 350 plates.

4. If microbial growth exceeds action levels per USP <797>, the contractor will identify and report identification of the organism to the genus level.

b. Air Sampling: approximately 104 plates

1. Rodac plates (special sized TSA to fit SAS air sampler model SAS SUPER 100/180), incubation & enumeration of colonies for each plate. Approximately 104 plates per year or more if environmental issues arise. We currently have 7 IV areas with a total of 26 air testing sites multiplied by quarterly testing equals a minimum of 104 plates.

2. If microbial growth exceeds action levels per USP <797>, the contractor will identify and report identification of the organism to the genus level.

c. Surface Sampling: approximately 528 plates

1. Rodac plates (TSA), incubation and enumeration of colonies for multiple sites in each room (varies depending on # of hoods, counters, etc. in each room).

2. Surface sampling is conducted monthly; 7 IV areas with a total of 44 surface areas to be tested multiplied by 12 months equals a minimum of 528 plates per year. Additional testing may be required resulting in an approximate maximum of plates to 660.

3. If microbial growth exceeds action levels per USP <797>, the contractor will identify and report identification of the organism to the genus level.

d. Forms for submission to be provided by the contractor.

e. TSA plates for sampling to be provided by contractor, including cost of shipping plates to VA. (VA will cover cost of shipping plates back to vendor for incubation.)

f. Final reports to be provided by the contractor.

g. Contractor must maintain an AIHA-Environmental Microbiological Laboratory Accreditation Program (EMLAP) certification or equivalent. Provide a copy of the certificate at time of the solicitation.

PERIOD OF PERFORMANCE:

The MVAHCS shall award a firm, fixed-price commercial services contract for all items listed in the Schedule of Items. The effective period of the contract shall be from date of award through twelve (12) months with the option to extend the contract for additional 12- month periods, at the discretion of the VA, for up to four (4) additional years.

CONTRACTOR QUALITY CONTROL:

The Contractor Quality Control (QC) Plan, with which the contractor proposes to implement the requirements of FAR Clause 52.246-4, entitled “Inspection of Services-Fixed-Price”, shall identify personnel, procedures, instructions, records, and forms to be used. After contract award, and prior to commencement of work, the contractor’s Quality Control Plan shall be received, reviewed, and formally accepted in writing by the Contracting Officer Representative. In general, the contractor’s quality control plan must address how they intend to assure compliance with the requirements of the contract.

Coordination Meeting: Prior to the beginning of the contract, the contractor shall meet with the Contracting Officer or designated representative and discuss the contractor’s quality control system. During the meeting, a mutual understanding of the system details shall be developed, including the forms for recording the CQC operations, control activities, testing, and the interrelationship of contractor’s inspection and control with the Government’s Quality Assurance. Minutes of the meeting shall be prepared by the contractor and signed by both the contractor and the Contracting Officer. The minutes shall become a part of the contract file. There may also be occasions when subsequent conferences will be called to reconfirm mutual understandings.

a. The Quality Control Plan shall include as a minimum, the following:

1. A description of the quality control organization, including chart showing lines of authority and acknowledgement that the CQC staff shall report to the project manager or someone higher in the contractor’s organization.

2. The qualifications, duties, responsibilities, and authorities of each person assigned a quality control function.

3. Control testing procedures for each specific test performed will be submitted and approved prior to the start of the test.

4. Reporting procedures, including proposed reporting formats and distribution of the documents. Report covers both conforming and defective work.

5. Procedures to correct deficiencies to ensure that they do not recur.

The Government reserves the right to require the contractor to make changes in his CQC Plan and operations as necessary to obtain the quality specified. These changes must be submitted to and approved by the Contracting Officer. Notification of Changes: The contractor shall notify the Contracting Officer in writing of any proposed changes. Proposed changes are subject to acceptance by the Contracting Officer.

b. QC System Manager: The contractor shall identify an individual, within his organization, who shall be responsible for overall management of QC and have authority to act in all CQC matters for the contractor.

Quality Assurance Plan:

The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the Technical Representatives and reported to the Contracting Officer. Acceptable performance on these measures, along with other factors, will be the primary indices of contractor performance and a key consideration in contract renewal decisions.

Performance will be monitored using the following criteria:

Reports will specify dates and temperatures of each incubation period for each plate.

Government Roles and Responsibilities The MVAHCS shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Susan Jacobson, Program Manager/USP797 Compounding Sterile Products and Lynn Peterka, Administrative Officer and Pharmacy Contract COR will be designated as the representatives to coordinate these services. The contact information is listed below.

Technical Representative(s) Susan R. Jacobson and Mara Satter Pharmacy Program Managers/USP797 Compounding Sterile Products Minneapolis VA Health Care System One Veterans Drive, Pharmacy (119) Minneapolis, MN 55417

(612) 467-2040 Susan.jacboson1@va.gov Mara.Satter@va.gov

Lynn Peterka Administrative Officer/Contracting Officer Representative (COR) Minneapolis VA Health Care System One Veterans Drive, Pharmacy (119) Minneapolis, MN 55417 (612)-629-7929 Lynn.peterka@va.gov

A.1 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Evaluation of this requirement will be LPTA basis in accordance with the procedures in FAR Part 13.106-2. (Lowest Price Technically Acceptable)

(1) Price (Base Year + 4 Option Years)

(2) Technical Acceptability (proposed ability and methods to meet the PWS specifics). The Offeror shall demonstrate understanding of the solicitation requirements and produce a proposal that will meet those objectives. Technical acceptability will utilize the points listed here. Each of these points will be assessed individually using a YES/NO rating to derive the Offeror’s Technical Acceptability rating of the following:

A. Contractor must be able to provide all services requested in the PWS in the appropriate timeframes stated.

B. Contractor must maintain an AIHA-Environmental Microbiological Laboratory Accreditation Program (EMLAP) certification or equivalent. Provide a copy of the certificate at time of the solicitation. Contractor must provide a narrative addressing the ability to perform the work and specialized laboratory testing required by USP 797.

C. To ensure accurate testing, contractor’s Turn Around Testing Time equals to or under 7-10 days.

D. Contractor has an acceptable quality control plan.

(3) Past Performance (3 Years demonstrated with references to include Name, E-mail, and Physical Address/Telephone Number)

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)