D.2 ATTACHMENT 2 SOP IPC-800 Hazardous Drugs Compounded Sterile Preparations 02052021.pdf

HAZARDOUS DRUG COMPOUNDED STERILE PREPARATIONS

SOP IPC-800

VA Loma Linda Healthcare System Loma Linda, California 92357

Signatory Authority:

Chief, Pharmacy Service

Responsible Owner:

Compounded Sterile Preparations Program Manager; Supervisor, Inpatient Clinical

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 hazardous drug (HD) compounded sterile preparations (CSP) prepared in the hazardous drug sterile compounding area. This SOP must be followed by Pharmacy Service employees who are involved HD CSPs.

b. This SOP sets forth mandatory procedures and processes to ensure compliance with VHA Directive 1108.07 Pharmacy General Requirements, dated March 3, 2017;

VHA Directive 1108.06 Inpatient Pharmacy Services, dated February 8, 2017; VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounding Sterile Preparations, dated November 5, 2018; United States Pharmacopeia (USP) <797> Pharmaceutical Compounding – Sterile Preparations, dated 2008; and USP <800> Hazardous Drugs – Handling in Healthcare Settings, dated 2017.

2. PROCEDURES

a. Education and Training. In addition to the training and competency requirements outlined in SOP PBM-030 Handling of Hazardous Drugs and Agents and SOP IP-797 Compounded Sterile Preparations, all Pharmacy Service employees involved in the preparation or verification of HD CSPs must be trained using a hazardous drugs preparation training program on stringent aseptic and negative pressure techniques necessary for manipulating sterile hazardous drugs per USP guidelines.

b. Environmental Quality and Maintenance. Hazardous drugs must be compounded in a USP compliant environment where access is limited to staff members involved with the compounding of hazardous drugs. 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.

February 10, 2021 SOP IPC-800

(1) Security. The entrance to the compounding area 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 an 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.

c. Equipment Maintenance, Calibration, and Operation. Staff members must be trained on all new equipment before use. All equipment used for HD 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 IP-797 Compounded Sterile Preparations. All monitoring will be completed by the designated Pharmacy Service staff member using Form A – Daily IV Room Monitoring Log (Hazardous Drugs).

(1) Biological Safety Cabinet/Compounding Aseptic Containment Isolator (BSC/CACI). The BSC/CACI must be powered on at all times if possible. The BSC/CACI must be operating for at least 30 minutes prior to initial chemotherapy preparation.

(2) Eye Wash Stations. Monitoring of eye wash stations will be documented using Form A – Daily IV Room Monitoring Log (Hazardous Drugs). Facility Management Service (FMS) will be contacted if the eye wash station is 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 (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.

(1) Personal Protective Equipment (PPE). Staff members must wear the appropriate PPE according to USP <800> Hazardous Drugs – Handling in Healthcare Settings, National Institute for Occupational Safety and Health (NIOSH) guidelines and VALL Assessment of Risks based on the type of activity and potential exposure. 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.

(3) Contamination. If potential exposure occurs during compounding, the staff member must notify the supervisor immediately. Potentially contaminated clothing must not be taken home under any circumstances.

e. Compounding Components and Supplies. Handling of hazardous drugs must follow procedures outlined in SOP PBM-030 Handling of Hazardous Drugs and Agents in addition to those outlined in this policy.

(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 items 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.

f. Formulation Development and Beyond Use Dating. HD CSPs will be prepared according to manufacturer’s 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 stability data expiring at 23:59. In the absence of manufacturer guidelines, USP guidance on BUD will be followed.

g. Transcribing Chemotherapy Orders. This section applies to orders transcribed from a physician’s note.

(1) The first pharmacist will initiate transcription of the chemotherapy order from the physician’s note into Veterans Health Information Systems and Technology Architecture (VistA). The pharmacist is responsible for selecting the right order from the treatment cycle to be given on that date and ensuring that the order is still appropriate for the patient. Any adjustment or changes (i.e., based on labs) require the pharmacist to contact the prescribing provider. Changes or adjustments made by the provider must be reflected in the transcribed order by the initial pharmacist.

(2) A second pharmacist will double check the medication order entered by the first pharmacist with the physician’s treatment note. This double check will be documented by the second pharmacist.

h. 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.

i. Compounding. Compounding of hazardous drugs 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. Compounding staff members must inspect BSC/CACI prior to use to ensure the glove and sleeves are undamaged and intact.

(1) Component Quality Evaluation. Prior to 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, volume/amount, and necessary calculations. 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 main chamber of the BSC/CACI to reduce contamination. A closed system transfer device (CSTD) is used whenever possible for hazardous drug preparation, handling, and administration. Chemotherapy-containing intravenous bags must be attached and primed with a non-drug containing solution before adding the antineoplastic agent. Doses in syringes must be clear of air and not require any further manipulation after dispensing.

(3) Cleaning while Compounding. A chemotherapy preparation spill mat should be placed onto the work surface to contain inadvertent spills. The mat must be replaced and discarded frequently during extended compounding or preparation. 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.

j. 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 high-risk compounded medications such as chemotherapy agents. Both pharmacists must initial the IV label to document this verification. Any discrepancies must be resolved and verified again prior to dispensing.

(3) All hazardous drugs must be in their final ready-to-administer form when dispensed. Any packaging, repacking, labeling, and transporting of hazardous drugs must follow guidelines as outlined in SOP PBM-030 Handling of Hazardous Drug and Agents and USP <800> Hazardous Drugs – Handling in Healthcare Settings, dated 2019.

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

k. 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. Storage and handling of all hazardous drugs must also follow guidelines as outlined in SOP PBM-030 Handling of Hazardous Drug and Agents and USP <800> Hazardous Drugs – Handling in Healthcare Settings, dated 2019. Environmental monitoring of all medications must follow PBM-010 Environmental Monitoring of Medication Areas.

(1) Final Compounded Preparations. CSPs made in batches in preparation of orders (such as pre-medications for chemotherapy patients) must be stored in the designated area.

(2) Transportation. HD CSPs will be placed in a plastic bag then into an outer chemotherapy bag for transportation. Multiple CSPs may be placed in one bag. 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. A spill kit must be available on the cart in the case of spills.

l. 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.

(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.

m. Cleaning of Sterile Compounding Area. 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 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. Spray bottles are strictly prohibited to avoid spreading HD residue. 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) Cleaning Personal Protective Equipment. In addition to the personal protective equipment (PPE) required for HD compounding (see Section 2.d), 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. All staff members must wear gloves tested to ASTM D6978 standards for resistance to chemotherapy to reduce the transfer of HD residue.

(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 HD 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. 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.

n. Quality Assurance. All quality assurance testing and documentation of results must follow procedures outlined in IP-797 Compounded Sterile Preparations. 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.

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

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

(3) 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 high-risk hazardous drug end products prior to dispensing and initialing to document the verification. Two pharmacists must verify the end product prior to dispensing.

c. Pharmacy Service staff members. All Pharmacy Service staff members involved in hazardous drug 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 <800> 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. United States Pharmacopeia (USP) <800> Hazardous Drugs – Handling in Healthcare Settings, dated December 2019.

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

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

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

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

g. SOP PBM-030 Handling of Hazardous Drugs and Agents.

h. SOP PBM-031 Pharmacy Inventory Management.

i. SOP IP-797 Compounded Sterile Preparations.

j. SOP IP-797qa Quality Assurance Plan for 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:

https://dvagov.sharepoint.com/:f:/s/VHALOM/policies_sop/EhDZJJltWyVCnblFVmYiSfY BAsGK5eCBfqShynd9GkJYUg?e=TzIzYN https://dvagov.sharepoint.com/:f:/s/VHALOM/policies_sop/EhDZJJltWyVCnblFVmYiSfYBAsGK5eCBfqShynd9GkJYUg?e=TzIzYN https://dvagov.sharepoint.com/:f:/s/VHALOM/policies_sop/EhDZJJltWyVCnblFVmYiSfYBAsGK5eCBfqShynd9GkJYUg?e=TzIzYN

July 31, 2020 APPENDIX A

SOP IPC-800

A-1

PERSONAL HYGIENE AND GARBING PROCESS

1. BEFORE ENTERING THE ANTE ROOM.

a. Wear closed-toe shoes and attire that covers the entire legs.

b. Remove all the following items:

(1) Personal outer garments (such as bandana, coats, hats, jackets, sweaters, and/or vests)

(2) Cosmetics

(3) Hand, wrists, piercings and other exposed jewelry (cover any jewelry that cannot be removed)

(4) Earbuds or headphones

(5) Electronic devices not necessary for compounding or other required tasks

c. Ensure all nails are clean, neatly trimmed, and free of nail products (no artificial nails, extenders, gels, polish, or nail length greater than 1/4th inch)

d. If applicable, secure long hair with a hair tie and wipe eyeglasses with a low-lint wipe.

e. Enter the ante-room.

2. UPON ENTERING THE ANTE-ROOM

a. Don two (2) shoe covers prior to crossing the line of demarcation.

b. Cross line of demarcation.

c. Don head covers over hard and ear +/- beard cover if facial hair exceeds stubble.

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

e. Remove visible debris from underneath fingernails under warm running water using a disposable nail cleaner and disposable surgical scrub brush.

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

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

A-2

h. If a hands-free sink is not available, use a sterile-lint free wipe to shut off water faucet.

i. Don gown.

j. Ensure any new items brought into the buffer room are wipes with sterile 70& isopropyl alcohol (IPA).

3. UPON ENTERING THE BUFFER ROOM

a. Enter buffer room.

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

c. Don a pair of sterile gloves.

d. Wipe gloves with sterile 70% IPA.

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

f. Don additional sterile gloves as appropriate. Preparation of hazardous agents require double sets of gloves. Gloves must be changed every 30 to 60 minutes during compounding or immediately upon compromise, damage, or contamination.

4. UPON EXITING THE BUFFER AND ANTE-ROOM

a. Remove outer layer of sterile chemotherapy gloves inside the PEC.

b. Exit buffer room.

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

d. Remove remaining gloves by peeling the gloves inside out.

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

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

g. Remove outer layer shoe covers. Keep inner layer of shoe cover on.

h. Dispose of PPE into the waste container.

i. Wash hands with soap and water.

j. While removing the last layer of shoe covers, step over the line of demarcation to

A-3 the dirty side of the ante-room.

k. Exit the ante-room.

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

July 31, 2020 APPENDIX B

B-1

CLEANING OF HAZARDOUS DRUG STERILE COMPOUNDING AREA

Pharmacy staff members must follow the steps below for cleaning the sterile compounding areas for 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.

IV Hood (DAILY Cleaning 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 PeridoxRTU® Sporicidal Disinfectant and

Cleaner.

4. With PeridoxRTU®, clean each wall/surface of the unit 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. If available, open the front access window.

7. If available, clean the sleeves, glove ports, and airlock passthrough.

8. Wipe the filter diffuser in the top of the work area wiping from back to front, side to side in overlapping strokes.

9. Clean the back wall, beginning at the top to the bottom using overlapping strokes working downward toward the work surface and wipe the rear air return grill. Work sideways from left to right.

10. 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. Be sure to clean the entire airlock door surface that is exposed to the inside of the work area, including handle.

11. If used, clean repeater pump (including all connections, pump, crevices, cords).

12. Lift the work tray and wipe, beginning in the back and ending at the front of the unit.

13. Wipe the glove ports.

14. Wipe the IV hanging bar and hooks.

15. Wipe the front air return grill.

16. Close the front window. Wipe the glove sleeves and gloves and replace on the front window.

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

July 31, 2020 APPENDIX B

C-2

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

19. Allow the surface to dry completely.

Work Surfaces Outside the IV Hood (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 PeridoxRTU® Sporicidal Disinfectant and

Cleaner and clean each surface. Clean each wall/surface of the unit with 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 of 5 minutes before resuming compounding activities.

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

Surface of the hood must be decontaminated with PeridoxRTU® between compounding different HDs, daily when used, any time a spill occurs, before and after certification, any time voluntary interruption occurs, and if the ventilation tool is moved.

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 PeridoxRTU® Sporicidal Disinfectant and

Cleaning.

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. After cleaning the surfaces, allow the cleaning agent to sit on the surface for 3 minutes without any contact.

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

7. Allow the surface to dry completely before compounding.

July 31, 2020 APPENDIX C

C-1

CONTINGENCY PLAN FOR 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 Inpatient (IP) Pharmacy Supervisor.

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.

d. The Chief of Pharmacy or designee will notify Veterans Integrated Service Network (VISN) of the CSP contingency status by issuing a brief record of events.

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 is out of acceptable range per USP standards (for example, 20 – 25C or 70-77F per USP <797> Pharmaceutical Compounding – Sterile Preparations, dated 2008) for less than 24 hours, compounding will continue with no restrictions but the temperature must be monitored cautiously. If room temperature is continuously out of acceptable range for greater than 24 hours, the actions listed below must be followed:

October 31, 2020 APPENDIX C

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

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 lighting in the compounding area, the following actions 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 no greater than 12 hours for CSPs.

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

3. Air Pressure Loss. If differential air pressure loss 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 room air pressure is continuously out of acceptable range for greater than 1 hour, the actions listed below must be followed:

a) Ante-Room Negative or Neutral.

(1) Place work order and contact HVAC for repairs.

(2) Treat compounding area as a segregated compounding area.

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

b) Buffer Room Neutral.

(1) Place work order and contact HVAC for repairs.

(2) Wear N95 face masks while compounding.

(3) Compound as usual with no BUD restrictions.

c) Buffer Room Positive.

(1) Discontinue compounding activity in this location.

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(2) Compound in an alternative functioning room if available.

(3) Place work order and contact HVAC for repairs.

(4) If no functioning compounding areas are available, consider alternative options in Section I below.

D. Primary Engineering Controls (PEC) Failure. If the PEC does not meet ISO Class 5 standards, compounding activities will cease and be moved to an alternative functioning PEC. A work order must be placed and FMS contacted for repair. If an alternative PEC is not available, the actions listed below must be followed:

a) If an alternative functioning PEC is available:

(1) Cease compounding activities and move to the alternative functioning PEC.

(2) Place work order and contact FMS for repair.

(3) Stagger live virus CSP production and HD CSP production to alternate compounding in a single PEC.

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

(1) Place work order and contact FMS for repair.

(2) Perform terminal cleaning of PEC and work surfaces.

(3) Wipe down PEC between each new product.

(4) Assign BUD to CSPs of 1 hour or manufacturer’s recommendation, whichever is less.

(5) Perform audit of administration times through Bar Code Medication Administration (BCMA) to ensure CSPs are being administered to patients within 1 hour.

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:

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(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:

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:

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i. Immediately perform terminal cleaning of affected room.

ii. If using a gloved box, assign BUD to CSPs of 12 hours or manufacturer’s recommendation, whichever is less.

iii. If using a non-gloved box, assign BUED 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 actional 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 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.

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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.

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.

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