REGULATIONS
Vol. 37 Iss. 26 - August 16, 2021

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Chapter 20
Proposed

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-425, 18VAC110-20-500; adding 18VAC110-20-505).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information:

September 24, 2021 - noon - Department of Health Professions, Conference Center, 2nd Floor, 9960 Mayland Drive, Henrico, VA 23233

Public Comment Deadline: October 15, 2021.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific authority for the board to regulate the dispensing of prescription drugs is found in § 54.1-3307 of the Code of Virginia.

Purpose: The regulation will allow an interested hospital to utilize these newer and proven technologies that facilitate efficiencies in the management and dispensing of drugs without the cost and burden of applying for an innovative pilot program; allow these proven technologies to be used to verify drug accuracy, which decreases risk of human error associated with manual pharmacist verifications; and allow pharmacists more time to focus on patient-centered clinical activities.

The purpose of this regulatory action is to update regulations for utilization of newer technologies in the practice of pharmacy in a hospital system and for facilitating time for pharmacists to be more involved in direct patient care. Technologies such as medication carousels and radio-frequency identification (RFID) components of a robotic pharmacy system have already been approved for use as innovative pilot programs and have been shown to protect the health and safety of the drug supply and patients in hospitals.

Substance: Amendments are proposed for 18VAC110-20-425 on robotic pharmacy systems to allow for medication carousels used in a hospital to store and guide the selection of drugs to be dispensed or removed from the pharmacy. A pharmacist will not be required to manually check the accuracy of a drug removed from the carousel by a pharmacy technician when the technology is used, in compliance with the regulation, to verify accuracy. Because medication carousels rely on the use of barcode scanning to verify drug accuracy, certain safeguards are adopted to include a verification check by a pharmacist for the accuracy of the barcode assignment to an individual drug.

A new section, 18VAC110-20-505, is added to incorporate another technology already approved for innovative pilot programs the use of RFID to verify the accuracy of drugs placed into a kit for licensed emergency medical services personnel or other kits used as floor stock throughout a hospital. The regulation specifies the responsibilities of a pharmacist and the duties of a pharmacy technician in the use of RFID technology.

Issues: The advantage to the public and the hospital systems is the use of new technology that accurately and efficiently prepares medications for dispensing from a pharmacy to patients on the floor or to persons receiving emergency services by emergency management services agencies. There are no disadvantages. There are ample safeguards to ensure the accuracy and integrity of the drugs dispensed through use of medication carousels or RFID technology. There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to amend 18VAC110-20 Regulations Governing the Practice of Pharmacy (regulation) in order to incorporate certain practices that are currently only authorized as part of pilot programs in select hospitals. Specifically, the board seeks to (i) amend section 425 Robotic Pharmacy Systems to add the conditions under which medication carousels may be utilized and (ii) create a new section regarding the use of Radio Frequency Identification (RFID).

Background. In order to facilitate the adoption of new technologies in the practice of pharmacy, the board can authorize select hospital systems to implement new technologies under pilot programs. The Department of Health Professions (DHP) reports that 26 approved pilot programs are currently active, of which nine use medication carousels, three use RFID technology, and the rest address other issues unrelated to this action. DHP also reports that the earliest medication carousel pilot was authorized in 2012, and the earliest RFID pilot was authorized in 2014. Since then, no incidents of error or harm have been reported to the board, as is required of pilot programs. Thus, the board proposes to amend the regulation so that these technologies can be adopted by hospital systems without having to first secure authorization for a pilot program.

Medication carousels. Medication carousels are containers consisting of several long horizontal shelves secured behind glass. Several bins of medication sit on each shelf, and an operator can rotate the shelves until the desired bin and medication are presented. The carousel could be operated by a pharmacist or pharmacy technician, and access to the medications in a carousel can be restricted to the specific authorized staff. In a hospital setting, medications may be removed from the pharmacy carousel on a physician's order for a specific patient, or they may be placed in an automatic drug dispensing system, which is essentially a smaller medication carousel located in an emergency room or an in-patient floor.

Medication carousels are often used in conjunction with a robotic pharmacy system, which automatically dispenses barcoded unit-doses based on information entered into the dispensing software. According to DHP, along with barcode labeling and scanning, the use of medication carousels has reduced medication errors and made inventory management more accurate and efficient. Thus, the board seeks to add language regarding medication carousels to section 425 Robotic Pharmacy Systems rather than create a new section.

The proposed amendments, which largely specify the oversight responsibilities of the pharmacist, are conditioned on the extent to which automation software is already in use. For example, a pharmacist would not be required to verify the accuracy of a patient-specific drug removed from a medication carousel (i) if the order was entered into the dispensing software by a pharmacist and transmitted electronically to the medication carousel and (ii) if the dispensed medication is scanned by both the pharmacy technician retrieving the medication and the nurse or other staff who is authorized to administer the medication. The requirements for medications to be retrieved from the carousel and placed in an automatic drug dispenser are analogous; a pharmacist would not need to check every dose of every medication transferred from the carousel to the dispenser by the pharmacy tech (i) if the pharmacist entered the order in the dispensing system and (ii) if the barcode on the medication was scanned by the pharmacy tech and again by the person administering the drug.

Finally, a pharmacist would be required to verify the accuracy of all drugs that are manually removed by a pharmacy technician without the use of barcode scanning technology. A pharmacist would also be required to perform a daily random check of five percent of drugs that were prepared that day utilizing the medication carousel technology and maintain a record with the date, a description of any discrepancies, and their initials. Such records would need to be maintained for a minimum of two years and be available for inspection or audit within 48 hours of a request by the board.

RFID technology. RFID technology has been used in inventory management for crash carts and kits used by emergency services since about 2011.1 RFID tags (which are similar to barcodes but can be encoded with much more information) are affixed to every medication placed in an emergency kit or on a crash cart tray. Entire kits or trays are placed in a scanner that "reads" all the RFID tags and can indicate which medications need replacement. Prior to the adoption of this technology, pharmacy technicians would have to check each item in each kit or tray, which took much longer and resulted in higher error rates.

The board proposes to create a new section 505, Use of radio-frequency identification, containing the responsibilities of pharmacists and pharmacy technicians using RFID technology. Specifically, a pharmacist would be required to update, develop and maintain the RFID database, issue tags to specific drugs, and develop lists for each kit. Pharmacy technicians would be allowed to place RFID tags on drugs, retrieve tagged drugs from the hospital's inventory to place onto kits, and utilize the scanning device that verifies that the kit contains the drugs it is supposed to as per the list programmed by the pharmacist. A pharmacist would be required to verify that all drugs have been accurately tagged prior to storage in the hospital's inventory and perform a daily random check of five percent of all kits that were prepared that day using the RFID technology. The pharmacist would need to maintain a record of the daily checks, including the date of verification, a description of any discrepancies and their initials and maintain these records for one year. Pharmacies using RFID technology would also be exempt from certain verification requirements contained in other sections of the regulation, since they would now be redundant.2

Estimated Benefits and Costs. Adding language regarding the use of these new technologies to the regulation would directly benefit the hospital systems currently engaged in the pilot programs since they would no longer have to pay the renewal fee of $260 per renewal period (generally two years) or pay for any unannounced inspections. Hospitals wanting to implement these technologies would also benefit by not having to apply for a pilot program or pay the initial application fee of $325. In general, having the requirements in the regulation would also benefit hospitals weighing whether to adopt these new technologies by making the cost of future regulatory compliance more transparent. In addition, hospitals that have implemented the pilot programs as well as those choosing to adopt these technologies in the future would benefit from the cost-savings offered by the technologies directly: more efficient inventory control, less staff time spent verifying medications being dispensed or re-stocking kits. Staff and patients would similarly benefit from lower error rates in medication dispensing or the re-stocking of emergency medical kits. The cost of technology adoption largely falls on the hospitals choosing to do so, although some portion of such costs would likely be passed on to payers. Developers and providers of the technology would also benefit to the extent that the proposed amendments encourage more hospitals to adopt these technologies.

Businesses and Other Entities Affected. The proposed amendments primarily affect hospitals and hospital systems, which are generally not-for-profit. DHP reports that these technologies are more likely to be adopted by large hospital systems as compared to smaller independent hospitals, since they are more easily able to absorb the fixed costs of adopting a new technology and more likely to find it cost-effective. Smaller hospitals will likely adopt the use of the technology as technology-related costs decrease; clear regulation from the board regarding how the technology may be used may also encourage adoption. As mentioned previously, businesses providing these new technologies would also be affected to the extent that the proposed amendments lead to a greater demand for their products and services. Consumers or payers would be affected to the extent that costs of adopting the new technologies are passed on to them.

Small Businesses3 Affected. The proposed amendments are unlikely to adversely affect any small businesses. Any small businesses in Virginia that provide these technologies to hospitals would benefit from the proposed amendments if it increases the demand for their services; the number of such firms is unknown.

Localities4 Affected.5 The proposed amendments do not introduce new costs for local governments and are unlikely to affect any locality in particular.

Projected Impact on Employment. The proposed amendments are unlikely to affect the employment of pharmacists or pharmacy technicians in hospitals. DHP reports that the use of this technology was purported to free time for pharmacists to perform more clinical-related functions.

Effects on the Use and Value of Private Property. To the extent that the proposed amendments increase demand for the new technologies, the value of the providers of the technology may increase. Real estate development costs are not affected.

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1The University of Maryland Medical Center, one of the first to implement the use of RFID technology in emergency kits, reported lower re-stocking times and reduced error rates. See https://www.baltimoresun.com/health/bs-hs-rfid-for-crash-carts-20120727-story.html and https://kitcheck.com/blog/university-maryland-presentation-ashp-fewer-errors-efficiency-kit-check/.

2Specifically, the proposed language indicates that, "Pharmacies engaged in RFID tagging of drugs shall be exempt from the requirements in subsection C of 18VAC110-20-490, subsection A of 18VAC110-20-460, and subsection A of 18VAC110-20-355."

3Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

4"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

5§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The proposed amendments for 18VAC110-20-425 allow any interested hospital to use technology commonly referred to as medication carousels to store and guide the selection of drugs to be dispensed or removed from the pharmacy. A pharmacist will not be required to manually check the accuracy of a drug removed from the carousel by a pharmacy technician when the technology is used in compliance with the regulation to verify accuracy. Because medication carousels rely on the use of barcode scanning to verify drug accuracy, certain safeguards are included in the proposed amendments regarding a verification check by a pharmacist for the accuracy of the barcode assignment to an individual drug.

The proposed amendments also add a new section, 18VAC110-20-505, to incorporate another technology already approved for innovative pilot programs: the use of radio-frequency identification (RFID) to verify the accuracy of drugs placed into a kit for licensed emergency medical services personnel or other kits used as floor stock throughout a hospital. The responsibilities of a pharmacist and the duties of a pharmacy technician in the use of RFID technology are included in the proposed amendments.

18VAC110-20-425. Robotic pharmacy systems.

A. Consistent with 18VAC110-20-420, a pharmacy providing services to a hospital or a long-term care facility and operating a robotic pharmacy system that dispenses drugs in barcoded unit dose or compliance packaging is exempted from 18VAC110-20-270 C, provided the accuracy of the final dispensed prescription product complies with a written quality assurance plan and requirements of this chapter. The following requirements for operation of a robotic pharmacy system shall apply:

1. Pharmacists shall review for accuracy and appropriateness of therapy all data entry of prescription orders into the computer operating the system.

2. The packaging, repackaging, stocking, and restocking of the robotic pharmacy system shall be performed by pharmacy technicians or pharmacists.

3. Pharmacists shall verify and check for the accuracy of all drugs packaged or repackaged for use by the robot by a visual check of both labeling and contents prior to stocking the drugs in the robotic pharmacy system. A repackaging record shall be maintained in accordance with 18VAC110-20-355 A, and the verifying pharmacist shall initial the record. Packaging and labeling, including the appropriate beyond-use date, shall conform to requirements of this chapter and current USP-NF standards.

4. A written policy and procedure must be maintained and complied with and shall include at a minimum procedures for ensuring:

a. Accurate packaging and repackaging of all drugs for use in the robotic pharmacy system, to include properly labeled barcodes, and method for ensuring pharmacist verification of all packaged and repacked drugs compliant with this chapter and assigned barcodes;

b. Accurate stocking and restocking of the robotic pharmacy system;

c. Removing expired drugs;

d. Proper handling of drugs that may be dropped by the robotic pharmacy system;

e. Performing routine maintenance of robotic pharmacy system as indicated by manufacturer's schedules and recommendations;

f. Accurate dispensing of drugs via robotic pharmacy system for cart fills, first doses, and cart fill updates during normal operation and during any scheduled or unscheduled downtime;

g. Accurate recording of any scheduled or unanticipated downtime with an explanation of the problem to include the time span of the downtime and the resolution;

h. Appropriately performing an analysis to investigate, identify, and correct sources of discrepancies or errors associated with the robotic pharmacy system; and

i. Maintaining quality assurance reports.

5. All manual picks shall be checked by pharmacists.

6. If it is identified that the robot selected an incorrect medication, the pharmacy shall identify and correct the source of discrepancy or error in compliance with the pharmacy's policies and procedures prior to resuming full operations of the robot. An investigation of the cause of the event shall be completed, and the outcome of the corrective action plan shall be summarized and documented in a readily retrievable format.

7. Quarterly quality assurance reports demonstrating the accuracy of the robot shall be maintained. At a minimum, these reports shall include a summary indicating the date and description of all discrepancies that include discrepancies involving the packaging, repackaging, and dispensing of drugs via the robotic pharmacy system found during that quarter plus a cumulative summary since initiation of the robotic pharmacy system.

8. All records required by this section shall be maintained at the address of the pharmacy for a minimum of two years. Records may be maintained in offsite storage or as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

B. Intravenous admixture robotics may be utilized to compound drugs in compliance with § 54.1-3410.2 of the Code of Virginia and 18VAC110-20-321; however, a pharmacist shall verify the accuracy of all compounded drugs pursuant to 18VAVC110-20-270 18VAC110-20-270 B.

C. Medication carousels functioning with or without a robotic pharmacy system in a hospital may be utilized to store and guide the selection of drugs to be dispensed or removed from the pharmacy under the following conditions:

1. The entry of drug information into the barcode database for assignment of a barcode to an individual drug shall be performed by a pharmacist who shall verify the accuracy of the barcode assignment.

2. A pharmacist is not required to verify the accuracy of a patient-specific drug removed from a medication carousel if:

a. The entry of the order for a patient-specific drug into the pharmacy's dispensing software is verified by a pharmacist for accuracy and is electronically transmitted to the medication carousel; and

b. The patient-specific drug removed from the medication carousel by a pharmacy technician is verified for accuracy by the pharmacy technician who shall scan each drug unit removed from the medication carousel prior to dispensing, and a nurse or other person authorized to administer the drug scans each drug unit using barcode technology to verify the accuracy of the drug prior to administration of the drug to the patient.

3. A pharmacist is not required to verify the accuracy of the drug removed from the medication carousel by a pharmacy technician if that drug is intended to be placed into an automated drug dispensing system as defined in § 54.1-3401 of the Code of Virginia or distributed to another entity legally authorized to possess the drug if:

a. The list of drugs to be removed from the medication carousel for loading or replenishing an individual automated dispensing system is electronically transmitted to the medication carousel; and

b. The drug removed from the medication carousel is verified for accuracy by the pharmacy technician by scanning each drug unit removed from the medication carousel prior to leaving the pharmacy and delivering the drug to the automated drug dispensing system or distributed to another entity, and a nurse or other person authorized to administer the drug scans each drug unit using barcode technology to verify the accuracy of the drug prior to administration of the drug to the patient. If the drug is placed into an automated drug dispensing system located within a hospital, or the entity receiving the distributed drug, wherein a nurse or other person authorized to administer the drug will not be able to scan each drug unit using barcode technology to verify the accuracy of the drug prior to patient administration, then a second verification for accuracy shall be performed by a pharmacy technician by scanning each drug unit at the time of placing the drugs into the automated dispensing system.

4. A pharmacist shall verify the accuracy of all drugs that are manually removed from the medication carousel by a pharmacy technician without the use of barcode scanning technology to verify the accuracy of the selection of the drug product prior to dispensing those drugs or those drugs leaving the pharmacy.

5. A pharmacist shall perform a daily random check for verification of the accuracy of 5.0% of drugs prepared that day utilizing the medication carousel technology. A manual or electronic record, from which information can be readily retrieved, shall be maintained and shall include:

a. The date of verification;

b. A description of all discrepancies identified, if any; and

c. The initials of the pharmacist verifying the accuracy of the process.

D. All records required by this section shall be maintained at the address of the pharmacy for a minimum of two years. Records may be maintained in offsite storage or as an electronic image that provides an exact image of the document that is clearly legible, provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent of the board.

18VAC110-20-500. Licensed emergency medical services (EMS) agencies program.

A. The pharmacy may prepare a kit for a licensed EMS agency provided:

1. The PIC of the hospital pharmacy shall be responsible for all prescription drugs and Schedule VI controlled devices contained in this kit. A Except as authorized in 18VAC110-20-505, a pharmacist shall check each kit after filling and initial the filling record certifying the accuracy and integrity of the contents of the kit.

2. The kit is sealed, secured, and stored in such a manner that it will deter theft or loss of drugs and devices and aid in detection of theft or loss.

a. The hospital pharmacy shall have a method of sealing the kits such that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.

c. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy may be used.

3. Drugs and devices may be administered by an EMS provider upon an oral or written order or standing protocol of an authorized medical practitioner in accordance with § 54.1-3408 of the Code of Virginia. Oral orders shall be reduced to writing by the EMS provider and shall be signed by a medical practitioner. Written standing protocols shall be signed by the operational medical director for the EMS agency. A current copy of the signed standing protocol shall be maintained by the pharmacy participating in the kit exchange. The EMS provider shall make a record of all drugs and devices administered to a patient.

4. When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year. A pharmacist, pharmacy technician, or nurse shall reconcile the Schedule II, III, IV, or V drugs in the kit at the time the opened kit is returned. A record of the reconciliation, to include any noted discrepancies, shall be maintained by the pharmacy for a period of two years from the time of exchange. The theft or any other unusual loss of any Schedule II, III, IV, or V controlled substance shall be reported in accordance with § 54.1-3404 of the Code of Virginia.

5. Accurate records of the following shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year:

a. The record of filling and verifying the kit to include the drug contents of the kit, the initials of the pharmacist verifying the contents, the date of verification, a record of an identifier if a seal is used, and the assigned expiration date for the kit, which shall be no later than the expiration date associated with the first drug or device scheduled to expire.

b. The record of the exchange of the kit to include the date of exchange and the name of EMS agency and EMS provider receiving the kit.

6. Destruction of partially used Schedules II, III, IV, and V drugs shall be accomplished by two persons, one of whom shall be the EMS provider and the other shall be a pharmacist, nurse, prescriber, pharmacy technician, or a second EMS provider. Documentation shall be maintained in the pharmacy for a period of two years from the date of destruction.

7. The record of the drugs and devices administered shall be maintained as a part of the pharmacy records pursuant to state and federal regulations for a period of not less than two years.

8. Intravenous and irrigation solutions provided by a hospital pharmacy to an emergency medical services agency may be stored separately outside the kit.

9. Any drug or device showing evidence of damage or tampering shall be immediately removed from the kit and replaced.

10. In lieu of exchange by the hospital pharmacy, the PIC of the hospital pharmacy may authorize the exchange of the kit by the emergency department. Exchange of the kit in the emergency department shall only be performed by a pharmacist, nurse, or prescriber if the kit contents include Schedule II, III, IV, or V drugs.

B. A licensed EMS agency may obtain a controlled substances registration pursuant to § 54.1-3423 D of the Code of Virginia for the purpose of performing a one-to-one exchange of Schedule VI drugs or devices.

1. The controlled substances registration may be issued to a single agency or to multiple agencies within a single jurisdiction.

2. The controlled substances registration issued solely for this intended purpose does not authorize the storage of drugs within the agency facility.

3. Pursuant to § 54.1-3434.02 of the Code of Virginia, the EMS provider may directly obtain Schedule VI drugs and devices from an automated drug dispensing device.

4. If such drugs or devices are obtained from a nurse, pharmacist, or prescriber, it shall be in accordance with the procedures established by the pharmacist-in-charge, which shall include a requirement to record the date of exchange, name of licensed person providing drug or device, name of the EMS agency and provider receiving the drug or device, and assigned expiration date. Such record shall be maintained by the pharmacy for one year from the date of exchange.

5. If an EMS agency is performing a one-to-one exchange of Schedule VI drugs or devices, Schedule II, III, IV, or V drugs shall remain in a separate, sealed container and shall only be exchanged in accordance with provisions of subsection A of this section.

18VAC110-20-505. Use of radio-frequency identification.

A hospital pharmacy may use radio-frequency identification (RFID) to verify the accuracy of drugs placed into a kit for licensed emergency medical services pursuant to 18VAC110-20-500 or other kits used as floor stock throughout the hospital under the following conditions:

1. A pharmacist shall be responsible for performing and verifying the accuracy of the following tasks:

a. The addition, modification, or deletion of drug information into the RFID database for assignment of a RFID tag to an individual drug; and

b. The development of the contents of the kit in the RFID database and the associated drug-specific RFID tags.

2. A pharmacy technician may place the RFID tag on the drugs, and a pharmacist shall verify that all drugs have been accurately tagged prior to storing the drugs in the pharmacy's inventory.

3. A pharmacy technician may remove RFID-tagged drugs from the pharmacy's inventory whose RFID tags have been previously verified for accuracy by a pharmacist and place the drugs into the kit's container. A pharmacy technician may then place the container into the pharmacy's device that reads the RFID tags to verify if the correct drugs have been placed into the container as compared to the list of the kit's contents in the RFID database.

4. A pharmacist shall perform a daily random check for verification of the accuracy of 5.0% of all kits prepared that day utilizing the RFID technology. A manual or electronic record from which information can be readily retrieved, shall be maintained that includes:

a. The date of verification;

b. A description of all discrepancies identified, if any; and

c. The initials of pharmacist verifying the accuracy of the process.

5. Pharmacies engaged in RFID tagging of drugs shall be exempt from the requirements in subsection C of 18VAC110-20-490, subsection A of 18VAC110-20-460, and subsection A of 18VAC110-20-355.

6. All records required by this subsection shall be maintained for a period of one year from the date of verification by the pharmacist.

VA.R. Doc. No. R21-6271; Filed July 22, 2021