D.1 ATTACHMENT 1 SOP IP-797 Compounded Sterile Products 02052021.pdf

COMPOUNDED STERILE PREPARATIONS

SOP IP-797

VA Loma Linda Healthcare System Loma Linda, California 92357

Signatory Authority:

Chief, Pharmacy Service

Responsible Owner:

Compounded Sterile Preparations Program Manager;

Supervisor, Inpatient Operations

Service Line(s):

Pharmacy Service

Effective Date:

Month Day, 2020

Recertification Date:

Month Day, 2025

1. PURPOSE AND AUTHORITY

a. The purpose of this standard operating procedure (SOP) is to establish procedures on compounded sterile preparations (CSP). This SOP must be followed by Pharmacy Service employees involved with compounded sterile preparations.

b. This SOP sets forth mandatory procedures and processes to ensure compliance with United States Pharmacopeia (USP) <797> Pharmaceutical Compounding – Sterile Preparations, dated 2008; VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounding Sterile Preparations, dated November 5, 2018; and VHA Directive 1108.07 Pharmacy General Requirements, dated March 3, 2017.

2. PROCEDURES

a. Education and Training. All Pharmacy Service employees involved in the preparation or verification of CSP must complete training and be able to demonstrate knowledge of principles and proficiency of skills for performing sterile manipulations and achieving and maintaining appropriate environmental conditions prior to preparing CSPs independently and on an annual basis per USP guidelines. In addition to the education and training requirements in this SOP, employees who compound hazardous drugs must also comply with requirements in IPC-800 Hazardous Drugs Compounded Sterile Preparations.

(1) Personnel Performance. Once trained, the employee must demonstrate competence of aseptic technique for compounded sterile preparations. Personnel performance will be evaluated as required per USP standards. Failure to demonstrate proficiency or competency will result in re-assignment of the staff member from CSP activities. The staff member must be re-tested and demonstrate acceptable proficiency or competency prior to CSP activities. Refer to Appendix X – Quality Assurance Plan for Compounded Sterile Preparation for additional information on media fill testing, gloved fingertip testing, and other quality assurance activities.

Month Day, Year SOP IP-797

b. Environmental Quality and Maintenance. CSP must be compounded in a USP compliant environment where access is limited to staff members involved with sterile compounding. Individuals entering a sterile compounding area must take appropriate steps to minimize microbial contamination of the environment and the CSPs, including hand hygiene, garbing, and consideration of needed materials to be brought into the compounding area.

(1) Security. The entrance to the compounding areas must be locked and secured at all times. Visitors will be allowed access only in the presence of a licensed pharmacist and must sign in to document their presence.

(2) Environmental Quality Failure. In the event of environmental quality or equipment failures that results in non-compliance of USP compounding standards, staff members must follow the contingency plan outlined in Appendix.

c. Equipment Maintenance, Calibration, and Operation. Staff members must be trained on all new equipment before use. All equipment used for CSPs must be maintained and calibrated per USP standards and manufacturer’s guidelines. Types of testing, frequency, and action plan for equipment monitoring will follow procedures outlined in Appendix. All monitoring will be completed by the designated Pharmacy Service staff member using Form A – Daily IV Room Monitoring Log (Non-Hazardous Drugs). For equipment specifically used for hazardous compounding, refer to IPC-800 Hazardous Drugs Compounded Sterile Preparations.

(1) Eye Wash Stations. Monitoring of eye wash stations will be documented using Form A – Daily IV Room Monitoring Log (Non-Hazardous Drugs) at the frequency defined in Appendix. Facility Management Service (FMS) will be contacted if the eye wash station located in the facility not operating properly. For any contracted compounding areas (such as an IV trailer), the contracted company will be contacted for repair. If an eye wash station is not available, eye wash bottles will be placed in the area as a substitute until an eye wash station can be installed or issues remedied. When completing monitoring of eye wash bottles, staff members will document the presence of non-expired eye wash bottles on Form A – Daily IV Room Monitoring Log (Non- Hazardous Drugs).

d. Personnel Cleanliness and Garb. All individuals entering a sterile compounding area must maintain proper personal hygiene and be properly garbed to minimize the risk of contamination to the environment and CSPs. Individuals that may have higher risk of contaminating the CSP and the environment (such as personnel with rashes, recent tattoos, oozing sores, conjunctivitis, or active respiratory infection) must report these conditions to their supervisor. The staff member’s supervisor will make the final determination on whether the staff member may continue compounding. For employees involved in the compounding of hazardous drugs, refer to IPC-800 Hazardous Drugs Compounded Sterile Preparations.

(1) Personal Protective Equipment (PPE). Staff members must wear the appropriate PPE according to USP guidelines. Staff members must follow the procedures outlined in

Appendix A for donning and doffing in sterile compounding areas. Skin must not be exposed inside the primary engineering controls (PEC). Garb must be replaced immediately if it becomes visibly soiled or if its integrity is compromised. The supervisor may permit accommodations if the quality (sterility, accuracy, integrity, microbial/fungal contamination) of the CSP process and sterile environment remains unaffected.

(2) Hand Washing and Hygiene. Staff members must follow the procedures outlined in Appendix A for hand washing procedures. A closed system of soap to minimize the risk of extrinsic contamination must be readily available or near the sink.

e. Compounding Components and Supplies. Handling of hazardous drugs must follow procedures outlined in SOP PBM-030 Handling of Hazardous Drugs and Agents and SOP IPC-800 Hazardous Drugs Compounded Sterile Preparations.

(1) Procurement. Procurement of compounding components and supplies for CSPs must follow procedures as outlined in SOP PBM-031 Pharmacy Inventory Management and VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations.

(2) Receiving. All compounding components, supplies, and equipment removed from shipping cartons must be wiped with sterile 70% isopropyl alcohol (IPA) before being introduced into the clean side of the ante-room, pass-throughs, or brought inside the perimeter of the segregated compounding area (SCA) as outlined in USP standards.

Any items introduced into the PEC must be wiped with sterile 70% IPA using low-lint wipes and allowed to dry before use following USP guidelines.

(3) Storage. All medications, supplies, and other items needed for sterile compounding must be stored in a manner that minimizes contamination. Environmental monitoring of medication storage areas must follow the procedures outlined in SOP PBM-010 Environmental Monitoring of Medication Areas and USP standards.

f. Formulation Development and Beyond Use Dating. CSPs will be prepared according to manufacturer’s stability data or guidelines. If manufacturer’s guidelines are not available for the requested medication order, evidence-based literature or USP standards must be used for formulation development or determination of beyond use dating.

(1) BUD Assignment. A “expiration date” sticker with the BUD will be affixed to the product prior to dispensing. BUD assignments must follow manufacturer’s stability data or USP standards expiring at 23:59.

(a) Intravenous controlled substances will be assigned a beyond use date of 48 hours from the time it was prepared.

(b) Patient Controlled Analgesia (PCA) will be assigned a beyond use date of 9 days from the time it was prepared.

(c) Sodium ferric gluconate will be assigned a beyond use date of 4 hours the time it was prepared.

(d) Phenytoin sodium will have an assigned beyond use date of 1 hour from the time it was prepared.

(2) Short BUD Products. CSPs with short stability (such as sodium ferric gluconate, phenytoin) will be prepared immediately prior to use when Nursing personnel is awaiting pick up at the pharmacy window.

g. Order Processing.

(1) All orders for CSPs will be reviewed by a pharmacist for the following:

(a) Appropriateness of dosage

(b) Frequency

(c) Therapeutic duplication

(d) Drug-drug interactions

(e) Duration of therapy

(f) Indications for use

(g) Drug compatibility

(2) Any orders that require clarification from the prescriber will communicated verbally via telephone or text pager with the ordering medical provider. If the prescriber does not respond after three attempts, the pharmacist will contact the attending physician. If the attending physician does not respond after three attempts, the pharmacist will contact the on-call provider. Pharmacists will follow procedures for verbal telephone orders according to HCS 119-07 Medication Management if the provider is outside of the facility or cannot provide order entry.

h. Compounding. Sterile compounding must be completed in a cleanroom suite or segregated compounding area that is compliant with USP standards. Staff members must follow aseptic technique as outlined during training to minimize risk of contamination to the product.

(1) Component Quality Evaluation. Prior to compounding, compounding staff members must evaluate the quality of the components prior to compounding to ensure the product is usable (such as solution cloudiness, phase separations, particulates in solution, and appropriate solution color and volume) and has not expired. All containers must be checked for leaks and integrity. Staff members must also double-check all components and steps for accuracy before, during, and after compounding including, but not limited to, the drug name, strength, weighing/measuring of amount, necessary calculations, and assigned beyond-use date (BUD). Compounded sterile products must be within 10% of their labeled strength based on accuracy and precision of measuring or weighing the components. The compounding staff member must initial the medication label to document that they have prepared and checked the medication.

(2) Compounding Methods. Staff members must follow aseptic technique as outlined during training to minimize risk of contamination to the product. Only items needed to compound a dose or batch will be placed in the primary engineering control to reduce contamination. The graveyard pharmacist will print the manufacturing list, active order list, and intravenous (IV) batch list in anticipation of compounding.

(3) Cleaning while Compounding. Cleaning during compounding activities must follow USP guidelines. The compounding surface must be allowed to dry completely before resuming compounding activities.

(4) Finished Compounded Products. The following items listed below must be completed by the compounding staff member in preparation of the final product verification check by a pharmacist. If the compounding staff member is a pharmacist, only the steps requiring documentation must be followed.

(a) A label must be affixed to the medication with information on the medication name, strength of medication, diluents, and volume of diluents.

(b) The “expiration date” sticker must be affixed to the medication indicating the

BUD.

(c) The compounding staff member must initial the medication label to document that they have prepared and checked the medication.

(d) The amount of additive added to the IV solution or the number of vials used must be written on the IV label.

(e) The plunger of the syringes used in the preparation will be pulled back to the volume of the additive added.

(f) All additives and supplies used during the preparation (including but not limited to empty vials, solutions used for reconstitution, filter needles, and diluents) will be provided along with the final product to a pharmacist for final verification.

(5) Vials and Ampules.

(a) Single-Dose Vials. Single-dose vials (SDV) punctured inside the PEC will have a BUD of 12 hours. Any SDVs punctured outside the cleanroom must be discarded immediately after use and should not be used for more than one patient.

(b) Multi-Dose Vials. Any reconstituted multi-dose vials must have the final concentration will be written on the vial. Multi-dose vials will be stored and labeled with a BUD of 28 days or less following manufacturer guidelines.

(c) Ampules. Opened ampules cannot be stored for any time period and must be discarded immediately after use.

i. Dispensing.

(1) A pharmacist must inspect and verify accuracy of the product for the following items:

(a) Patient name

(b) Medication name

(c) Dose and drug concentration

(d) Frequency

(e) Clarity of the solution

(f) Color of the solution

(g) Absence of foreign particulate matter

(h) Correct solution

(i) Diluents and solution volume

(j) Calculations of quantities

(k) Selection of ingredients

(l) Measurement of ingredients

(m) Label accuracy and completeness

(n) BUD assignment

(o) Auxiliary labels indicating appropriate packaging and storage requirements

(p) Light protective bag, if needed. Only light-sensitive CSPs will be placed in a light protective bag. Only the CSP inside the bag will be labeled with the product and patient name.

(q) Presence of compounding staff member’s initials

(2) Pharmacists must ensure that compounded sterile products are within 10% of their labeled strength based on accuracy and precision of measuring or weighing the components. Pharmacists must initial the label to document their verification of the above items. A double check system by two pharmacists must be utilized for all high-risk medications and formulations that require calculations to ensure accuracy of the calculation. Both pharmacists must initial the IV label. Any discrepancies must be resolved and verified again prior to dispensing.

(3) Dispensing Controlled Substance CSP.

(a) Two pharmacist signatures are required upon removal of controlled substances CSPs from the vault refrigerator.

(b) The barcode on the top portion of the VistA IV generated label for a specific controlled substance CSP is separated. Only the patient information and medication name, strength, and other information will be attached to the medication. The strength of the medication will be highlighted in color.

(c) A color-coded sticker specific to the controlled substance medication will be used.

(d) During the graveyard shift, both the pharmacist and technician will double check each other. In the absence of a technician, the pharmacist will double check by annotated two signatures or initials on the label prior to dispensing.

(e) The original beyond use date of 9 days will be covered with a black marker and a new “expiration date” sticker will be affixed onto the product with the new beyond use date of 48 hours from the time it was removed from the refrigerator.

(f) Pharmacy Technicians will ensure the correct expiration dates are entered when loading the medications into the automated dispensing cabinets.

(4) Unused CSP labels will be cancelled under the “Returned and Destroyed” menu in VistA.

j. Storage and Handling. Storage and handling of all components and supplies used for sterile compounding and compounded sterile products will be in a way that minimizes contamination and must follow USP and manufacturer’s guidelines. For any contracted compounding areas (such as an IV trailer), items may be stored in the buffer room if space is limited in the other areas. Environmental monitoring of all medications must follow PBM-010 Environmental Monitoring of Medication Areas. For storage and handling in hazardous compounding areas, refer to SOP IPC-800 Hazardous Drugs Compounded Sterile Products and PBM-030 Handling of Hazardous Drugs and Agents.

(1) Final Compounded Preparations. CSPs made in batches in preparation of orders must be stored in the designated area.

(2) Transportation. A cart will be used to transport CSPs within the main facility or between other buildings on the main campus. A covered bin will be placed on the cart.

Non-hazardous CSPs will be placed in a plastic bag for transportation. Multiple CSPs may be placed in one bag.

k. Disposal.

(1) The designated pharmacy technician will check and retrieve CSPs that have been discontinued, expired or unused from the medication refrigerators and other patient care areas.

(a) Pharmacy Technicians will check the expiration date of all loaded controlled substance CSPs in the automated dispensing cabinets and remove expired products at 23:00 on Sundays.

(b) After returning from the nursing units, the Pharmacy Technician will generate a fill report to refill the controlled

(2) Upon return to the pharmacy, the pharmacy technician will remove any patient information from the products and discard any CSPs that are expiring in 48 hours or less or opened. Any CSPs returned without the tamper seal affixed on the additive port will be discarded and wasted. All returned CSPs will be scanned under the “Returned and Destroyed” menu in VistA for credit purposes to the patient. The pharmacy technician will immediately place the remaining refrigerated CSPs in the designated bin for returned CSPs inside of the medication stock refrigerator. Non-refrigerated CSPs will be placed in the designated bin in room temperature.

(3) These CSPs can be re-used for a new patient as long as patient information has been removed, the product is unused, the product is not expired, there are no signs of tampering, and there is no present of foreign particulates. Prior to being dispensed to a new patient, the technician and pharmacist must ensure that the correct product is selected and is not expiring prior to the anticipated administration time.

(4) Disposal of medication waste, supplies, and personal protective equipment must be disposed of following all facility, State, and Federal regulations. All trash containers, waste receptacles, and sharps containers no more than ¾ full will be removed prior to cleaning. Staff members will contact Environmental Management Services (EMS) for assistance with waste receptacles.

l. Cleaning of Sterile Compounding Areas. All cleaning procedures must be performed by trained and appropriately garbed personnel using facility-approved agents and the procedures outlined in Appendix B. All cleaning procedures must be performed in the direction of clean to dirty areas of the containment primary engineering controls (c-PECs, IV hoods) and the containment secondary engineering controls (c-SECs, buffer/ante-room, cleanroom suites). The buffer room must be cleaned first, followed by the ante-room. All cleaning must be documented.

(1) Cleaning Supplies and Equipment. The VA Loma Linda (VALL) Compounded Sterile Preparations (CSP)/Hazardous Drugs (HD) Advisory Subcommittee must approve all new cleaning supplies and equipment before use. Reusable cleaning tools must be made of cleanable material. All reusable cleaning tools must be cleaned and disinfected before and after each use. Reusable cleaning tools must be dedicated for use in the compounding areas and cannot be removed from these areas except for disposal.

(a) Prohibited Supplies and Equipment. The use of dust mops, dusting wands, and air circulators is strictly prohibited to avoid dust borne contamination. Cleaning equipment with wooden handles are prohibited as the material is not easily cleanable.

(b) Disposal of Supplies and Equipment. Wipers, pads, and mop heads should be disposable. All wipes will be used one-time only from the cleaning area of compounding to the most soiled area, then promptly discarded. Cleaning supplies must be disposed in a manner that minimizes the potential for dispersal of contaminants into the air by placing in a plastic bag or zip lock waste bag prior to trash disposal to minimize organic vapors. All disposable materials must be discarded after use per local, State, and Federal laws and regulations.

(2) Personal Protective Equipment for Cleaning. In addition to the personal protective equipment (PPE) required for compounding, a mask with vapor relief (such as the 3M Particular Respirator 8514, N95, with Nuisance Level Organic Vapor Relief) will be used for respiratory protection to minimize odor or organic vapor exposure during terminal cleaning.

(3) Cleaning Agents. Selected cleaning agents will comply with all relevant USP standards. The VALL CSP/HD Advisory Committee must approve all new cleaning agents before use. The manufacturer’s directions or published data for minimum contact time must be followed for all cleaning agents used. When sterile 70% isopropyl alcohol (IPA) is used, it must be allowed to dry completely.

(4) Cleaning Procedures. Cleaning of the sterile compounding areas will follow procedures as outlined in Appendix B occurring at the minimum frequencies specified in USP guidelines. All cleaning procedures must be performed in the direction of clean to dirty areas of the containment primary engineering controls (c-PECs, IV hoods) and the containment secondary engineering controls (c-SECs, buffer/ante-room, cleanroom suites). The buffer room must be cleaned first, followed by the ante-room. All areas where CSPs are handled (including reusable equipment and devices) must be cleaned according to USP standards. For cleaning of hazardous compounding areas, refer to SOP IPC-800 Hazardous Drugs Compounded Sterile Products. If compounding is not performed daily in the area, it must be completed before initiating compounding.

Cleaning will also occur any time a spill occurs, before and after certification, any time voluntary interruption occurs, before and after quality assurance testing, and if the ventilation tool is moved. Increased cleaning frequency may occur as a result of activation of the contingency plan as outlined in Appendix C.

m. Quality Assurance. All quality assurance testing and documentation of results must follow procedures outlined in Appendix based on USP standards. Any adverse results will be communicated to the VALL CSP/HD Advisory Committee as soon as the results are available. Sterility testing is not conducted at VALL as it is not required for any CSPs assigned a BUD within USP guidelines.

3. ASSIGNMENT OF RESPONSIBILITIES

a. Pharmacy Supervisors. Pharmacy Supervisors or designee are responsible for:

(1) Ensuring staff members are trained and have demonstrated competency prior to being authorized to compound independently.

(2) Training staff members on new equipment before use.

(3) Ensuring all education and training requirements are met for staff members.

(4) Reassigning staff members from compounding duties in the event of failure during quality assurance testing.

(5) Determining whether a staff member may continue compounding after receiving reports of any issues that may increase risk of contamination to the CSP or sterile environment.

b. Pharmacists. Pharmacists are responsible for:

(1) Being present when visitors are entering any sterile compounding areas and ensuring visitors sign in to document their presence.

(2) Verifying all CSP end products prior to dispensing and initialing to document verification.

c. Pharmacy Service staff members. All Pharmacy Service staff members involved in sterile compounding are responsible for:

(1) Maintaining proper personal hygiene and wearing proper PPE prior to entering any sterile compounding areas.

(2) Following aseptic technique and other appropriate procedures as outlined during training to minimize risk of contamination to the CSP or sterile environment.

(3) Following the contingency plan in the event of an environmental or equipment failure that results in non-compliance to USP standards for sterile compounding.

(4) Reporting any conditions that may increase risk of contamination to the CSP or sterile compounding environment.

(5) Following all items outlined in this policy.

4. DEFINITIONS

a. Double check – A procedure in which two staff members separately check (along and apart from each, then compare results) each component as outlined in the policy with the prescriber’s order.

5. REFERENCES

a. United States Pharmacopeia (USP) <797> Pharmaceutical Compounding – Sterile Preparations, dated 2008.

b. VHA Directive 1108.07 Pharmacy General Requirements, dated March 10, 2017.

c. VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated November 5, 2018.

d. VHA Directive 1108.06 Inpatient Pharmacy Services, dated February 8, 2017.

e. SOP PBM-010 Environmental Monitoring of Medication Areas.

f. SOP PBM-031 Pharmacy Inventory Management.

g. SOP IP-797 Compounded Sterile Preparations.

6. REVIEW

This SOP must be reviewed, at a minimum, at recertification, when there are changes to the governing document, and any regulatory requirement for more frequent review.

7. RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of February 2026. In the event of contradiction with national policy, the national policy supersedes and controls.

8. SIGNATORY AUTHORITY

Samineh Sam, PharmD Chief, Pharmacy Service Date Approved:

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: SOPs are available at:

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A-1

APPENDIX A

PERSONAL HYGIENE AND GARBING PROCESS FOR NON-HAZARDOUS

STERILE COMPOUNDING AREAS

Before Entering the Ante Room

a. Wear attire that covers the entire legs.

b. Wear closed-toe shoes.

c. Remove all the following items:

a. Personal outer garments (such as bandanas, coats, hats, jackets, sweaters, vests)

b. Cosmetics (as it may shed flakes and particles)

c. Hand, wrist, and other exposed jewelry including piercings that could interfere with the effectiveness of garbing (such as the fit of the gloves, cuffs of sleeves, and eye protection) or otherwise increase the risk of contamination of the CSP. Cover any jewelry that cannot be removed.

d. Earbuds or headphones

e. Electronic devices not necessary for compounding or other required tasks

f. Any other items that are not easily cleanable or not necessary for compounding.

d. Ensure all nails are clean, neatly trimmed and free of nail products (no artificial nails, extenders, gels, polish, nail length <1/4 inch).

e. If applicable, secure long hair with a hair tie.

f. If applicable, wipe glasses with low-lint wipe.

g. Enter ante room.

Upon Entering the Ante Room

1. Donning must not occur simultaneously with another employee.

2. Don low-lint disposable shoe covers prior to crossing the line of demarcation.

3. Cross line of demarcation.

4. Don low-lint disposable head cover over hair and ears +/- beard cover if facial hair exceeds stubble.

5. Don face shield and mask (surgical mask or N95 fitted mask).

6. Wash hands.

a. Remove visible debris from underneath fingernails under warm running water using a disposable nail cleaning tool. Brushes or hand dryers must not be used for hand hygiene.

b. Wash hands and forearms up to elbows with soap and water for at least 30 seconds.

c. Dry hands and forearms to the elbows completely with low-lint disposable towels or wipes.

d. Use a sterile-lint free wipe to shut off water faucet, if a hands-free sink is not available.

7. Don low-lint gown with long sleeves that fit snugly around the wrist and enclosed at the neck.

APPENDIX A

A-2

8. Make sure any new items being brought into the buffer room are wiped with sterile 70% isopropyl alcohol (IPA).

Upon Entering the Buffer Room

1. Enter buffer room.

2. Use hand sanitizer on hands and allow to dry.

3. Don a pair of sterile powder-free gloves. All gloves must be inspected for holes, punctures, or tears and must be replaced immediately if such defects are detected.

4. Wipe gloves with sterile 70% IPA.

5. Apply sterile 70% IPA to gloves upon introducing your hands into the primary engineering control (PEC) and whenever nonsterile surfaces (such as vials, counter tops, chairs, or carts) are touched.

Upon Exiting the Buffer Room + Ante Room

1. Exit buffer room.

2. Doffing must not occur simultaneously with another employee.

3. Doff personal protective equipment (PPE) on clean side of line of demarcation.

a. Remove gloves by peeling the gloves inside out.

b. Remove the gown by pulling away from the body, rolling it inside-out, and touching only the inside of the gown.

c. Remove goggles, mask, head/hair cover, and beard cover.

d. Remove shoe covers and step over the line of demarcation to the dirty side of the ante room.

e. Dispose of PPE into waste container.

4. Exit ante room.

5. Apply hand sanitizer to hands and allow to dry completely.

B-1

APPENDIX B

CLEANING OF NON-HAZARDOUS DRUG STERILE COMPOUNDING AREA

Pharmacy staff members must follow the steps below for cleaning the sterile compounding areas for non-hazardous drugs. Cleaning must be documented on the cleaning log. Make sure all appropriate PPE (gown, gloves, shoe covers, hair covers, face mask, goggles) is worn while cleaning. To minimize vapors of the cleaning agent, use the 3M Particulate Respirator 8514, N95, with Nuisance Level Organic Vapor Relief.

IV Hood (DAILY with PREemptRTU® One-Step Disinfectant and Cleaner)

1. Remove all loose items from the IV hood.

2. Remove any visible particles, debris, and/or residue with Sterile Water for Injection or Irrigation using a sterile, low-lint wiper.

3. Saturate a sterile, low-lint wipe with the cleaning agent. For daily cleaning, use

PREemptRTU® One-Step Disinfectant Cleaner.

4. Clean the surface of the hood from clean to dirty by working from back to front, top to bottom utilizing overlapping strokes. Overlap each swipe with at least 25% coverage.

5. For each different wall/surface of the unit, a new sterile, low-lint wipe saturated with the cleaning agent must be used. Dispose of the used wipe after use.

6. Clean the ceiling of the unit first.

7. Clean the IV bar next.

8. Clean the back wall next, going from top to bottom.

9. For the side walls, begin in the top back corner. Wipe down the entire span of wall surface with long, side-to-side motion swiping from top to bottom in overlapping lines.

10. Clean repeater pump, if present (including all connections, pump, crevices, cords).

11. Clean the works surface last, beginning in the back and ending at the front of the unit.

12. After cleaning all surfaces, allow the cleaning agent to sit on the surface for 10 minutes without any contact. The surfaces must be visibly wet for at least 1 minute.

13. Saturate a low-lint wipe with sterile 70% isopropyl alcohol and repeat the entire cleaning process.

14. Allow the surface to dry completely.

APPENDIX B

D-2

IV Hood (Terminal Cleaning MONTHLY with PeridoxRTU® Sporicidal Disinfectant and Cleaner)

1. Remove all loose items from the IV hood.

2. Remove any visible particles, debris, and/or residue with Sterile Water for Injection or Irrigation using a sterile, low-lint wiper.

3. Saturate a sterile, low-lint wipe with the cleaning agent. For monthly, cleaning, use

PeridoxRTU® Sporicidal Disinfectant and Cleaner.

4. Clean each wall/surface of the IV hood with a new sterile, low-lint wipe twice.

Dispose of the used wipe in a sealable plastic bag.

5. Clean the surface of the hood from clean to dirty by working from back to front, top to bottom utilizing overlapping strokes. Overlap each swipe with at least 25% coverage.

6. Clean the ceiling of the unit first.

7. Clean the IV bar next.

8. Clean the back wall next, going from top to bottom.

9. For the side walls, begin in the top back corner. Wipe down the entire span of wall surface with long, side-to-side motion swiping from top to bottom in overlapping lines.

10. Clean repeater pump (including all connections, pump, crevices, cords).

11. Clean the works surface last, beginning in the back and ending at the front of the unit.

12. After cleaning all surfaces, allow the cleaning agent to sit on the surface for 5 minutes without any contact.

13. Saturate a low-lint wipe with sterile 70% isopropyl alcohol and repeat the cleaning process of the IV hood.

14. Allow the surface to dry completely.

Work Surfaces Outside the IV Hood (DAILY with PREemptRTU®) Including work surfaces, pass-throughs, and sinks

1. Remove all loose items from the work surfaces.

2. Remove any visible particles, debris, and/or residue with Sterile Water for Injection or Irrigation using a sterile, low-lint wipe.

3. Saturate a sterile, low-lint wipe with the cleaning agent and clean the surfaces outside the hood as required.

4. Clean the surfaces by working from clean to dirty, back to front, top to bottom (if necessary), utilizing overlapping unidirectional strokes. Overlap each swipe with at least 25% coverage.

D-3

5. After cleaning all surfaces, allow the cleaning agent to sit on the surface for the allotted contact time of 10 minutes before resuming compounding activities. The surfaces must be visibly wet for at least 1 minute.

6. Saturate a low-lint wipe with sterile 70% isopropyl alcohol and repeat the cleaning process.

Work Surfaces Outside the IV Hood (MONTHLY Terminal Cleaning with PeridoxRTU®) Including work surfaces, pass-throughs, sinks, storage shelving/bins, equipment outside the hood

1. Remove all loose items from the work surfaces.

2. Remove any visible particles, debris, and/or residue with Sterile Water for Injection or Irrigation using a sterile, low-lint wiper.

3. Saturate a sterile, low-lint wipe with the cleaning agent and clean each surface.

Clean each wall/surface of the unit using a new sterile, low-lint wipe. Dispose of the used wipe in a sealable plastic bag.

4. Clean the surfaces by working from clean to dirty, back to front, top to bottom (if necessary), utilizing overlapping unidirectional strokes. Overlap each swipe with at least 25% coverage.

5. After cleaning all surfaces, allow the cleaning agent to sit on the surface for the allotted contact time before resuming compounding activities. For PeridoxRTU®, the contact time is 5 minutes.

6. Saturate a low-lint wipe with sterile 70% isopropyl alcohol and repeat the cleaning process for any stainless-steel surfaces.

In Between Compounding

1. Remove all loose items from the work surface.

2. Remove all visible particles, debris, and/or residue with Sterile Water for Injection or

Irrigation using a sterile, low-lint wiper.

3. Saturate a sterile, low-lint wipe with sterile 70% isopropyl alcohol.

4. Clean the work surface by working from back to front, top to bottom (if necessary), utilizing overlapping unidirectional strokes. Overlap each swipe with at least 25% coverage.

5. Allow the surface to dry completely before compounding.

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Frequency for Cleaning and Disinfecting Surfaces and Applying Sporicidal Agents in Compounding Areas

Site Cleaning Disinfecting Applying Sporicidal

PEC(s) & equipment inside the PEC(s)

Equipment and all interior surfaces of the PEC daily & when surface contamination is known or suspected

• Equipment & all interior surfaces of the PEC daily & when surface contamination is known or suspected

• If compounding process <30 minutes: apply sterile 70% IPA to the horizontal work surface at least every 30 minutes

• If compounding process >30 minutes: compounding must not be disrupted, and the work surface of the PEC must be disinfected immediately after compounding

Monthly

Removable work tray of the PEC

Work surface of the tray Daily Daily Monthly

All surfaces and the area underneath the work tray

Monthly Monthly Monthly

Pass-through(s) Daily Daily Monthly

Work surface(s) outside the PEC Daily Daily Monthly

Floor(s) Daily Daily Monthly

Sink(s) Daily Daily Monthly

Wall(s), door(s), and door frame(s) Monthly Monthly Monthly

Ceiling(s) Monthly Monthly Monthly

Storage shelving and bins Monthly Monthly Monthly

Equipment outside the PEC(s) Monthly Monthly Monthly

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APPENDIX C

CONTINGENCY PLAN FOR NON-HAZARDOUS DRUG

STERILE COMPOUNDING AREAS

A. General

Staff members must refer to the contingency plan outlined in this Appendix for any events expected to affect hazardous drug (HD) compounded sterile product (CSP) production at VA Loma Linda Healthcare System (VALLHCS)

B. Communication of Events

1. For any events that are predicted to affect CSP production and/or negatively affect patient care, staff members must immediately notify the Chief, Associate Chiefs, Inpatient (IP) Pharmacy Supervisor, and CSP Pharmacy Program Manager.

2. For events that are predicted to affect CSP production for greater than 1 hour, the procedures below will be followed:

a. The IP Pharmacy Supervisor or designee must notify the Pharmacy Management team and CSP Facility Program Manager if any conditions require activation of the contingency plan. Any changes of status will also be communicated.

b. The IP Pharmacy Supervisor or designee will notify Nursing Service or Administrator on Duty for any possible delays in patient care, including any restrictions placed on beyond use dating (BUD) for CSPs.

c. The CSP Facility Program Manager must notify the VALLHCS CSP/HD Advisory Committee of any activated contingency plan.

C. Secondary Engineering Controls (SEC) Failure. If the primary engineering controls (PEC) remain functional but the SEC does not meet International Organization for Standardization (ISO) Class 7 conditions, the contingency procedures to be followed will be based on the type of failure and anticipated downtime.

1. Temperature Out-of Range. If room temperature exceeds 25C or 77F for less than 24 hours, compounding will continue with no restrictions but the temperature must be monitored cautiously. If room temperature is continuously exceeds 25C or 77F for greater than 24 hours, the actions listed below must be followed:

a. Place work order and contact Heating Ventilation and Air Conditioning (HVAC) for repair.

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b. Perform terminal cleaning of primary engineering controls (PEC) and work surfaces.

c. Assign BUD to CSPs of 12 hours or manufacturer’s recommendation, whichever is less.

2. Power Outage. If there is sudden or unexpected power outage affecting the compounding area, the actions listed below must be followed:

a. Consult with Facility Management Service (FMS) for arrangement of emergency power and/or lighting.

b. Compounding may continue if compounding areas meet ISO Class conditions, lighting is sufficient for safe preparation of CSPs and lighting provides safe working environment for staff members. If SEC does not meet USP standards for ISO Class conditions, assign BUD to CSP of 12 hours or manufacturer’s recommendation, whichever is less.

c. If lighting is not sufficient, compounding must be relocated to a contingency location.

3. Air Pressure Loss. If differential air pressure is out of acceptable range per USP standards for less than 1 hour, compounding will continue with no restrictions but air pressure must be monitored cautiously. If differential air pressure is continuously out of acceptable range for greater than 1 hour, the actions listed below must be followed:

a. Place work order and contact HVAC for repairs.

b. Assign BUD to CSPs of 12 hours or manufacturer’s recommendation, whichever is less.

D. Primary Engineering Controls (PEC) Failure.

a. If an alternative functioning PEC is available:

i. Cease compounding activities and move to the alternative functioning PEC.

ii. Place work order and contact FMS for repair.

b. If no alternative functioning PEC is available and anticipated downtime is less than 8 hours:

i. Place work order and contact FMS for repair.

ii. Perform terminal cleaning of PEC and work surfaces.

iii. Wipe down PEC between each new product.

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iv. Assign BUD to CSPs of 12 hours or manufacturer’s recommendation, whichever is less.

c. If no alternative functioning PEC is available and anticipated downtime is greater than 8 hours, consider alternative options in Section I below.

E. Environmental Parameter Failure. If viable or non-viable air or surface sampling test results return with positive results for growth, the actions listed below must be followed:

a) PEC Air or Surface Sampling. If results return positive for actionable growth, the actions listed below must be followed:

(1) If an alternative PEC is available in a different SEC: Cease compounding activities in affected PEC and move compounding activities to alternative PEC. Perform terminal cleaning of affected PEC immediately upon notification of results and immediately prior to re-testing date.

(2) If an alternative PEC is available in same SEC:

i. Immediately perform terminal cleaning of the affected PEC.

ii. Consult with CSP/HD Advisory Committee to consider organism result and determine if compounding should continue in same SEC.

iii. If compounding is to continue in same SEC, assign BUD to CSPs of 1 hour or manufacturer’s recommendation, whichever is less. Perform audit of administration times through Bar Code Medication Administration (BCMA) to ensure CSPs are being administered to patients within 1 hour.

(3) If an alternative PEC is not available:

i. Immediately cease all HD compounding activities.

ii. Consult with CSP/HD Advisory Committee to consider organism result and determine if compounding should continue in available areas.

Determine triage area and BUD restrictions if necessary.

iii. If BUD restrictions are limited to 1 hour, perform audit of administration times through BCMA to ensure CSPs are being administered to patients within 1 hour.

b) Ante-Room Air or Surface Sampling. If results return positive for actionable growth, the actions listed below must be followed:

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i. Immediately perform terminal clean of affected room.

ii. Assign BUD to CSPs of 12 hours or manufacturer’s recommendation, whichever is less.

c) Buffer Room Surface Sampling. If results return positive for actionable growth, the actions listed below must be followed:

i. Immediately perform terminal clean of affected room.

ii. Assign BUD to CSPs of 12 hours or manufacturer’s recommendation, whichever is less.

d) Buffer Room Air Sampling. If results return positive for actionable growth, the actions listed below must be followed:

i. Immediately perform terminal cleaning of affected room.

ii. Assign BUD of 1 hour or manufacturer’s recommendation, whichever is less. Perform audit of administration times through BCMA to ensure CSPs are being administered to patients within 1 hour.

e) Repeat positive growth on retesting: If re-testing results return with the same growth, the CSP/HD Advisory Committee must be consulted to determine the course of action which may include exploring long-term actions if necessary. FMS and Infection Prevention will be consulted to develop an action plan to address the conditions.

F. Unavailable Water Supply. If there is an interruption to the availability of the water supply used for hand washing, the actions listed below must be followed:

a) If water drainage is working properly:

i. Use Sterile Water for Irrigation for hand washing.

ii. Place work order and contact FMS for repairs.

b) If water drainage is not working properly:

i. Place work order and contact FMS for repairs. Request portable hand washing station if possible. The portable hand washing must be cleaned and disinfected prior to being situated in the ante-room.

ii. If portable hand washing station is unavailable, use significant amount of hand sanitizer before compounding. Assign BUD of 1 hour or manufacturer’s recommendation, whichever is less. Perform audit of administration times through BCMA to ensure CSPs are being administered to patients within

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1 hour.

G. Miscellaneous Conditions or Circumstances

1. For any refrigerator or freezer failures, refer to SOP PBM-010 Environmental Monitoring of Medication Storage Areas.

H. Alternative Options when Compounding Must Cease. When it has been determined that CSPs can no longer be compounded, alternative options must be sought in the order listed below following VHA Directive 1108.12 Management and Monitoring CSPs. If purchasing from outside vendor, purchase information should be documented.

a) Use commercially available products when possible.

b) Consider switching to commercially available therapeutic alternative drug temporarily.

c) Prepare CSP at another VA Medical Center (VAMC) within the Veterans Integrated Service Network (VISN) 22.

i. Ensure requirements are met per VHA Directive 1108.12 Management and Monitoring of CSPs prior to moving compounding activities to another

VAMC.

ii. Ensure proper CSP transportation between VAMCs as outlined in SOP IP-001 Inpatient Pharmacy Services. Temperature monitoring devices must be used during transportation to ensure maintenance of appropriate storage conditions. Secure dollies or carts should be utilized to transport CSPs safely.

d) Purchase CSP from a Food and Drug Administration (FDA) registered and regulated outsourcing facility (FDA-OF) according to requirements of VHA Directive 1108.12 Management and Monitoring of CSPs. The vendors listed below have an established contract with VALLHCS as of the signing of this SOP.

i. Avella of Deer Valley, Inc. (503A) – This facility maybe used to obtain hazardous drugs. CSPs must be ordered 24 hours in advance of medication administration.

ii. SCA Pharmaceuticals (503B) – This facility may be used to obtain pre-filled syringes.

e) Purchase CSP from a Pharmacy Compounding Accreditation Board (PCAB)-accredited outsourced compounding pharmacy according to requirements of VHA Directive 1108.12 Management and Monitoring of CSPs.

https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities https://www.achc.org/pcab-accredited-providers.html https://www.achc.org/pcab-accredited-providers.html

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f) Purchase from a Specialized Hospital Pharmacy that is not PCAB-accredited according to requirements of VHA Directive 1108.12 Management and Monitoring of CSPs.

g) Purchase from a non-accredited pharmacy or a non FDA-OF.

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APPENDIX D

QUALITY ASSURANCE PLAN FOR STERILE COMPOUNDING AREAS

A. All Quality Assurance (QA) testing and documentation of results will be completed as outlined in the table below. All results will be communicated to VALLHCS Compounded Sterile Products/Hazardous Drugs Advisory Committee as soon as the results are available.

B. Personnel Performance

1. Written demonstration of proficiency of core competencies and visual demonstration of competency in hand hygiene, garbing, and aseptic technique will occur per the frequencies outlined in USP guidelines.

2. Visual demonstration of competency, media fill testing, gloved fingertip and thumb sampling will be completed according to USP guidelines by a VA Contracted Service if possible.

3. Any failure in personnel performance during written or visual demonstration will results in suspension of employee assignment to CSP activities until corrective action is complete. Re-training of the employee will be completed.

4. Repeat testing will be conducted until acceptable results are achieved prior to reassignment of the employee to CSP activities.

C. Equipment Monitoring

1. Certification of primary engineering controls (PEC) must be completed before a compounding area is used by a VA Contracted Service as outlined in USP guidelines.

a. Certification of PECs by the VA Contracted Service must include airflow testing, HEPA filter integrity testing, total particle count testing, and dynamic airflow smoke pattern testing.

b. Classified areas additional must be recertified if there are any changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality.

c. All sampling sites for total airborne particle sampling (non-viable air sampling) will be selected at the discretion of the VA Contracted Service following USP guidelines.

d. Air pressure of ante-room, buffer room, and PECs will be monitored daily.

2. Temperature monitoring of the medication storage refrigerators and/or freezers in sterile compounding areas will follow procedures outlined in SOP PBM-010 Environmental Monitoring of Medication Areas.

3. Eye wash stations will be monitored at least once weekly by Pharmacy staff members.

D. Environmental Monitoring

1. Microbiological air and surface monitoring must be performed by a VA

Contracted Service as outlined in USP guidelines. Sampling must be performed per the frequencies defined in USP guidelines.

a. Before and after sampling, the sampled area must be thoroughly cleaned and disinfected following proper procedures as outlined in the SOP.

APPENDIX D

D-2

2. Temperature monitoring of sterile compounding areas will follow procedures outlined in Attachment A and SOP PBM-010 Environmental Monitoring of Medication Storage.

E. Sterility Testing

1. Sterility testing will not be conducted at this facility as it is not required for any

CSPs assigned a BUD within the USP 797 guidelines. All CSPs compounded at the facility will be assigned a BUD within USP 797 guidelines.

F. Documentation

1. Monitoring will be documented on the Daily IV Monitoring Log Sheet.

2. QA results and corrective actions must be documented. Records must be maintained in accordance with the requirements in USP guidelines.

3. Regular review of QA data must be performed to detect trends and the results of the review documented.