36C25624Q0328 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) 00586 Department of Veterans Affairs Gulf Coast Veterans Healthcare System 400 Veterans Ave Biloxi

MS

39531 10N16 Department of Veterans Affairs Gulf Coast Veterans Healthcare System 400 Veterans Ave Biloxi

MS

39531 To all Offerors/Bidders

36C25624Q0328

X X X

See CONTINUATION Page The purpose of this modification is to answer the questions asked regarding Solicitation 36C25624Q0328.

All responses are due by 12pm central time Monday, January 15, 2024, by email to me: angela.kennedy2@va.gov

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

A.2 DELIVERY SCHEDULE

End of Document

1. Item 0001 Gowning and Garbing Evaluation- in the RFP it states that we should use the facility’s SOP as guidance for their evaluation. Do you have a copy of this SOP? (Attached). Usually the employee will gown and then the glove/finger tip testing will be performed. The results of the glove fingertip usually denotes if they have garbed correctly or not. Yes, this is correct, see attached SOP.

2. Item 0004 Airflow testing in each classified area quantity 4- can you confirm that the quantity is per room? As it does not match the quantity of HEPAs (10).

There are two classified areas (each consisting of a buffer and storage room) for non-hazardous (IV) and hazardous drugs compounding . There are a total of 5 hoods (2 CACIs, 1 CAI, and 2 LAFW (with HEPAs).

3. Item 0006 Total particle count testing- is this per room? If so I would think it matched the airflow of 4 above? Is it ok to denote in the RFP what the quantity is…ie per room vs each? Yes, the total particle count testing should mirror the airflow testing as described above.

4. Item 0009 Primary engineering control certification- it give a quantity of 10, however it does not list the different types, for instance I know that you guys have both isolators and laminar flow clean benches. Each one has a different price point as they testing of them is very different. Not sure how to indicate this on the RFP? See the response to question number 2.

5. If the text of the RFP it mentions that monthly surface sampling needs to be done, but there is not a line item for pricing? Correct, monthly surface sampling should be done and there should be a line item for pricing. Also, one of the standard tests for cleanrooms under USP 797 is room air exchange rate (RAER). I don’t see this item listed? It is listed in PWS 4.1.4.1.

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

G.V. (SONNY) MONTGOMERY VA MEDICAL CENTER

Section Name: Training Conduct and Competency of Compounding Personnel

SOP and Version # 422.1 SOP Name: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding

Date of Initial: 3/30/22

Last Revision/Review: 10/11/23

1. Definition and Purpose

0. The purpose of this standard operating procedure (SOP) is to standardize the process by which authorized personnel prepare to enter the compounding areas and perform hand hygiene and garbing as one aspect of contamination control aimed at reducing the introduction of sources of viable and nonviable contamination.

0. Contamination Control is a program of required activities that reduces the amount of viable and nonviable particles that are introduced into compounding environments. There are three (3) basic elements of any program of Contamination Control which include: 1) hand hygiene and garbing 2) material handling and 3) conduct inside controlled compounding environments.

0. This SOP is limited to hand hygiene and garbing in preparation for sterile-to-sterile compounding.

0. Since the greatest potential source of contamination to compounded sterile preparations (CSPs) stems directly from compounding personnel, vigorous hand hygiene and meticulous personnel garbing practices contribute significantly to the reduction in particles, thereby reducing the risk of CSP contamination. Those particles are laden with viable contaminants. Shed rates increase with the use of make-up as well as with conditions such as rashes, fevers, and infection.

0. Personnel must also be thoroughly competent and highly motivated to perform flawless hand hygiene and garbing as well as conduct themselves properly in the controlled environments to facilitate contamination control.

1. Policy

0. This SOP applies when working in Restricted Access Barrier Systems (RABS) which are Compounding Aseptic Isolators (CAIs) as well as LAFWs.

0. Personnel who must enter controlled compounding environments to perform their job duties must report to their supervisor any illnesses that may adversely affect the safety or integrity of CSPs by causing either increased particle shedding or introduction of other infectious material such as but not limited to the following:

1. Fever

1. Moderate to severe sunburn

1. Eczema or other severe skin rash

1. A cough, runny nose, or active respiratory infection

1. Conjunctivitis

1. Recent tattoos (new within 2 to 3 weeks and evidence healing is not yet completed)

1. Open wounds or weeping sores

0. If one of the above conditions is present, the affected person reports such to the Inpatient Supervisor and is excluded from working in the controlled compounding environment until the condition is remedied.

0. Personal hygiene can have a negative effect on the health and safety of patients and maintaining good personal hygiene is the responsibility of people who work in the controlled environments. Therefore, employees working in these environments will shower or bathe daily before reporting to work and will wear freshly laundered street clothes or scrubs.

0. Personnel must don the garb and perform hand hygiene in an order that generally proceeds from the dirtiest to cleanest body parts, top to bottom (head, face, feet) and as otherwise delineated in this SOP.

0. All compounding and/or other authorized personnel (persons other than trained compounding personnel), who perform facility cleaning, must receive training on hand hygiene and garbing, as well as successfully complete a competency assessment prior to entering the compounding area to perform cleaning activities.

0. Other individuals who have not successfully completed the Hand Hygiene and Garbing Competency, but who need to enter the compounding area (e.g., certification personnel, an external vendor performing environmental sampling, etc.), can enter the compounding areas only under the following circumstances:

6. May not be wearing any cosmetics

6. Must remove jewelry

6. Must be assisted through the complete hand hygiene and garbing process by a trained and qualified sterile compounding staff member

6. Must be accompanied by a trained and qualified person during hand hygiene and garbing and throughout their stay in the compounding area. Visitors, other than those certifying equipment or performing environmental sampling, are not allowed to place their hands inside of the primary engineering controls (PECs) at any time.

6. Remove earbuds and headphones

6. Individuals will not bring in electronic devices that are not necessary for compounding or other required tasks into the compounding area

6. Nails are clean and neatly trimmed. No nail products may be worn (all nail polish, artificial nails and extenders are not allowed)

6. If eyeglasses are worn, they are cleaned with an eyeglass wipe on the lenses and with a disinfectant wipe on the frames

0. Compounding will be performed with newly donned sterile gloves only. The use of sterile gloves is required to reduce the potential for the introduction of additional bioburden into the direct compounding area. This practice includes donning of sterile gloves over the RABS gloves inside of the main chamber of a compounding isolator.

0. Disposable gowns are required

0. No garb may be worn outside the work room or SCA.

0. Hand hygiene and garbing must be performed every time the worker enters the SCA.

0. USP 797 allows gowns used for nonhazardous sterile compounding to be reused for one shift however this is not preferred.

1. Applicable Documents

3.1 External Documents

3.1.1 United States Pharmacopeial Convention, Inc. USP Chapter 797 Pharmaceutical Compounding—Sterile Preparations.2008 version.

3.1.2 United States Pharmacopeial Convention, Inc. USP Chapter 797 Pharmaceutical Compounding—Sterile Preparations. 2019 version. Published but not official as of 10/28/19.

3.1.3 Media Fill and Gloved-Finger Tip Testing (SOP-422.2)

3.1.4 Conduct of Personnel, Aseptic Technique Overview, and End Product Verification (SOP-322.1)

3.1.5 Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding Sink on Clean Side of Ante-Room (410.a)

3.1.6 Job Aid: Garbing for Nonhazardous Sterile Compounding Sink on Clean Side on Ante-Room (404.a)

4.0 Procedures

0. Good personal hygiene is expected from all persons who enter the compounding area. Personnel are asked to shower or bathe daily, which reduces particulate shed from skin, if they intend to enter the compounding area.

0. Preparation for Hand Hygiene and Garbing

1. Clothing

0. Street clothes may be worn if freshly laundered. Clothing that has been previously worn retains dead skin cells and is likely to shed more particles.

0. Shirts with upright collars are not permitted as they extend above the gown collar. Rounded T-shirt collars or V-necks are permissible.

0. Long-sleeve shirts are not permitted as they interfere with hand hygiene.

0. Scrubs are preferred over street clothes worn from home.

0. If staff complain of being cold, they may wear a synthetic, short-sleeve T-shirt (rounded collar) underneath their clothing or scrubs.

0. In a similar manner to clothing, closed-toe shoes that cover the entire foot (no ballet flats) dedicated to the facility are preferred over shoes worn from home. Facility-dedicated shoes are not worn outside the pharmacy offices.

0. Shoes with pointy toes or heels are not be worn since those surfaces will tear the shoe covers.

1. At all times, the skin of the legs and feet below the hem of the gown are completely covered.

1. Nylon stockings or tights are acceptable in the event a dress or skirt is worn or shoes that do not completely cover the foot.

1. Shorts or skirts worn without stockings are not acceptable.

1. Socks must cover ankle so that when personnel are seated, skin on the leg is not exposed.

1. Before entering the compounding area, personnel must remove the following which are prohibited while working in the compounding area:

2. Personal outer garments (e.g., bandannas, coats, hats, jackets, scarves, sweaters, vests)

2. All cosmetics since they shed flakes and particles, all hand, wrist, neck, and head jewelry

2. Nail polish and artificial nails (and tips)

2. Personal electronic devices or earbuds:

3. Cell phones must be left outside compounding areas (not carried in the pocket)

3. Music players and/or earbuds may not be worn

2. Hanging eyeglass lanyards are not acceptable; if glasses are worn for eyesight correction, suggest the use of an elasticized eyeglass strap to keep glasses in place and prevent the need to touch glasses to reposition them on the nose.

1. Nails are short and neatly trimmed. Nails are short enough if when viewing fingertips from palm side of hands, nails cannot be seen above fingertips.

1. Discard gum, hard candy, or cough drops.

1. After smoking a cigarette or vaping, employees wait 5 minutes before performing garbing activities. Smokers generate 10 to 20 thousand additional particles up to 10 minutes after smoking (Invernizzi, G et al. Residual tobacco smoke: measurement of its washout time in the lung and its contribution to environmental tobacco smoke. Tob. Control. 2007. 16(1):29-33.).

1. Before proceeding to the compounding area, employees visit the restroom to prevent additional trips in and out of the cleanroom suite and SCA.

1. Tie back any long hair with a band.

0. General Garb Considerations

2. Garb Storage

0. Garb is stored in a manner that protects it from contamination.

0. Garb is stored away from the danger of splashing water from the sink.

2. Immediately outside of the compounding areas, wipe the frames of personal glasses with an EPA-registered one-step bactericidal disinfectant cleaner and the lenses with specialty lens cleaners that will not destroy special coatings present on many eyeglasses.

2. Head covers, facemasks, and facial hair covers (if applicable) may be donned in any order.

2. Facemasks

3. Facemasks are donned before the head cover if they are the loop type but are donned after the head cover if they are the tie type.

3. Facemasks are donned so that the folds face down on the outside (forming pockets on the inside that facilitate the collection of exhaled spittle).

3. The metal bar of the facemask is bent so that it conforms closely to the bridge of the nose and cheeks.

3. While holding the facemask by the bridge of the nose, the bottom of the facemask is pulled so that the pleats open and it extends below the chin.

3. Facemasks are never reused and are changed immediately when wet with inhaled moisture. Wet facemasks have demonstrated an increased resistance to airflow, are less efficient at filtering particles and result in increased venting out the sides of the mask.

2. Beard and Head Covers

4. Headcovers are worn whether the staff has hair or not. Skin from the head sheds, therefore, headcovers are worn even for those who are bald or have shaved heads.

4. Headcovers entirely capture all hair and must maintain the capture of all hair.

4. Bouffant caps are usually enough for most individuals.

4. Those with goatee-type beards don a standard beard cover over the facemask.

4. In addition to facemasks and bouffant caps, the following personnel wear hoods:

4. Those who have excessive facial hair or full beards which extend along the jawline to the ear wear a full hood instead of a bouffant cap. Beard covers do not maintain coverage of full beards which present increased risk because they shed more particles than skin and will be close to the direct compounding area (DCA).

4. Those whose hair is not entirely captured by a bouffant cap or whose hair migrates out of the bouffant cap.

4. Those who wear a religious headdress (Hijab, Sheila, etc.) don a hood over the freshly laundered religious headdress. The hood must completely cover all aspects of the headdress; then, the headdress and the hood are tucked into the gown.

2. Shoe Covers

5. Garbing is not a test of balance, so a stool or bench is provided to ensure proper garbing.

5. Shoe covers are donned one foot at a time while stepping over the line of demarcation (LOD) in the work room; blue covers are for IV SCA use only, white shoe covers are donned over blue covers for HD SCA use.

2. Gowning

6. Gowns are low lint, are back closing all the way to the neck, have elastic sleeves and do not have pockets.

6. Take care when donning gowns to stand far enough away from personnel who are actively performing hand hygiene that spray of water does not contaminate the gown.

6. Gowns retain significant particles. If gowns are reused, they must be hung up on the clean side of the work room but far enough away from the sink, so they are not exposed to splashing water.

0. Other Considerations

3. Line of Demarcation (LOD)

0. A physical line of demarcation is outlined in the work room. The LOD designates the line beyond which:

0. Street shoes are not worn without a shoe cover

0. Dirty carts (carts used to bring components and supplies from the supply area to the work room (line of demarcation) may not pass.

0. Performing hand hygiene

4. Hands and arms to elbows are wetted and soap added and lathered slightly.

4. After hands are wetted and soap is applied, a disposable nail pick is used to clean each nail every time that hand hygiene is performed whether debris is visible underneath the fingernails.

4. Brushes are not used since they cause micro-abrasions of the skin.

4. During hand hygiene, lather must be produced using either antibacterial or non-antibacterial soap.

4. After the nails have been cleaned with the nail pick, apply additional soap if needed and begin the lathering process. Fingertips to elbows are lathered with soap for at least 30 seconds which is measured by a digital or manual clock.

4. After rinsing arms and hands, dry both thoroughly with low-lint wipes which work to remove additional microbes from the hands to the disposable wipe.

0. Considerations about gloves

5. Sterile gloves are best donned in the buffer room or inside the perimeter of the segregated compounding area in nonhazardous sterile compounding situations.

0. Activity occurring in the buffer room

0. Though it’s acceptable to enter the buffer room without gloves on the first activity once entering must be to don gloves.

0. Once gloves are donned, if stocking the buffer room or performing other activities aside from compounding, doff those gloves and don a fresh pair of sterile gloves prior to starting compounding.

5. Application of an alcohol-based hand rub

1. The hand rub must be applied following manufacturer’s instructions.

1. The hand rub is applied with an emphasis to the subungual areas of the nails, all surfaces of the hands as well as the surfaces of the wrists.

1. Hands must be allowed to dry completely prior to donning sterile gloves.

5. Sterile gloves are always the last item donned before compounding begins.

5. All compounding personnel wear sterile gloves when compounding.

5. Note that if compounding occurs in a RABS, the operator will:

4. Perform hand hygiene immediately before entering RABS.

4. Place hands in gloves attached to the sleeves of the RABS.

4. Don the sterile gloves over the RABS gloves.

5. Additional considerations for RABS gloves

5. The gloves attached to the sleeves are changed daily and more often if needed.

5. The gloves attached to the RABS sleeves are sanitized with sterile IPA and allowed to dry completely before donning sterile gloves over them.

5. Check sterile gloves for damage to packaging, expiration date and for damage to gloves before and after donning the gloves as well as intermittently during compounding activity.

5. Gloves may become punctured or torn. If tearing or a puncture occurs, the compounder must perform hand hygiene again and re-glove.

5. Sterile IPA is applied to all surfaces of gloved hands and wrists then allowed to dry at the following times:

8. Before entering the Class 5 space (for instance to put materials into the PEC).

8. At the start of each batch or patient prep before performing aseptic manipulations and after touching any nonsterile items.

8. Any time the compounder’s hand re-enter the ISO Class 5 area.

8. Periodically during prolonged periods of compounding within the Class 5 area but no less than every 30 minutes.

5. If sterile IPA is applied by spraying gloved hands, this must occur in a manner that does not result in aerosol contacting the HEPA filter. Whether spraying or using a sterile low-linting wipe presaturated with sterile IPA, all surfaces of gloved hands must be contacted by sterile IPA and then allowed to dry before resuming activity.

0. Exiting the SCA

6. Walk into the doffing box or beyond the buffer room, remove and discard all garb in waste receptacle.

6. If reusing the gown for one shift, discard the gloves and hang the gown on the clean side of the work room (at least 3 feet away from the sink).

6. At no time may any hazardous drug garb be reused; refer to the HD Compounding SOP; 322.1 for more information.

1. Specific Garbing Procedures and Sequences

1. Refer to the HD Compounding SOP; 322.1 for sequence procedures in doffing garb for specific best practice order in the HD SCA.

IV Room Certification