36E77619R0019-008.pdf

Phase 1 – USP 800 Fargo Pharmacy Gap Assessment

Contract #36C26318C0003

Table of Contents

Section 1 Summary Statement and Project Team

Section 2 Pharmacy Site Assessments

A. First Level Outpatient Pharmacy B. Basement Inpatient Pharmacy

Appendix I Facility Internal Gap Assessment

Appendix II Programmatic Cost Estimate

USP800 Gap Assessment Fargo VAMC 4/20/18

Section 1

Phase 1 – USP 800 Pharmacy Assessment – Summary Statement

USP 797/800 describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration and disposal of sterile and nonsterile products and preparations. The standards are rapidly evolving as states move into compliance with FDA and USP mandates.

The consulting team of National Facility Solutions (prime contractor), Stone Group Architects, BWBR and Dunham was engaged to provide a summary review of the hospital pharmacies at the Fargo VA Medical Center. This effort was two-phased; it began with a review of existing plans, details, specifications and relevant testing documentation for the site. This was followed by a site visit to assess current conditions and identify compliance issues and deficiencies with proposed USP 800 regulations that will go into effect on December 1, 2019.

On February 9, 2018 the design team toured both pharmacy locations within the Fargo VA hospital. The site visit included representatives from NFS, Stone Group Architects, VISN 23, AT Analytical, and Fargo VA staff (Engineering, Maintenance, Pharmacy, and Industrial Hygiene & Safety). The visit began with a discussion of the VA’s system wide goals for USP 800 compliance, a review of current hazardous drug protocols, and a walk-through to review current state protocols, conditions and compliance. At each site, non-compliant USP 797/800 issues were identified and discussed with staff, and these are captured in the general pharmacy comments for each respective pharmacy area.

A Gap Analysis produced by the Fargo VA Pharmacy staff is included as Appendix I (attached at the back of this report), and is intended to compliment the Design team’s review, which together comprise the entire Site Report.

The design team has included a cost estimate of anticipated construction costs associated with renovations required to bring these pharmacies in compliance with USP 797/800. This can be found in Appendix II of this document.

General Site Observations:

The Outpatient Pharmacy is located on the first level and is where all drugs are brought into the hospital and stored. The drugs enter the building through the basement and are delivered by the pharmaceutical supplier in totes that are brought directly to the first level pharmacy area. Pharmacy deliveries are identified separately from standard deliveries to the hospital and bypass the main loading dock/receiving area. It was discussed that hazardous drugs (HDs) are going to start being segregated from non-HDs by their pharmaceutical supplier, but this protocol had not yet been implemented at time of this site visit. Since the Loading Dock/Receiving area does not receive Pharmacy deliveries, no provisions for USP 800 will be required in this area.

The pharmacies in this analysis break down into two groups: the larger outpatient pharmacy located on the first level, and the inpatient pharmacy in the basement.

Both pharmacies appear to have been remodeled in the past. Anteroom and hood rooms were renovated in the Inpatient Pharmacy in 2005. In 2007, the Chemo hood room was renovated. Delivery, unpacking and storage areas will need to be designed to comply with USP797/800 requirements.

Outpatient Pharmacy – Level 1

Upon arrival at the Outpatient Pharmacy, HDs are checked in by a pharmacy tech.

Totes containing HDs are brought directly into the pharmacy area and stacked in an open area that is part of the main circulation aisle. This open aisle area is where the initial unpacking of all drugs takes place. There is no separation from general traffic or other pharmacy products, and no designation on the floor for HD vs non-HD, nor is there a counter to unpack contents from the totes. This breakdown space lacks a dedicated handwashing sink. Additionally, an adjacent area for PPE and spill containment kits is not readily available.

As part of the breakout process, the pharmacy tech separates out the class 1 narcotics and delivers these to the vault, which has restricted access. Additionally, investigative drugs (non-HDs), which are typically narcotics, are also secured in the vault by this same narcotics tech.

The entire outpatient pharmacy area, including this breakdown area, is finished with carpet tile flooring. While flooring material is not specifically addressed in USP 800, carpet is incompatible with HD handling best practices, and should be replaced with a material that provides a surface that is easier to clean and will minimize the concern for HD contamination. This finish selection would fit the requirements for durability and cleanability where cleaning agents are likely to be used, and also fits Facility Guidelines Institute (FGI) guidelines, Infection Control Risk Assessment (ICRA) best practices, and other licensing agencies (i.e. CMS, Dept. of Health) guidance for pharmacy design.

Facilities infection control staff may have input on flooring selection to include weighing options of typical flooring materials such as resilient sheet flooring, VCT, LVT, or a MMA type product.

Regarding pressurization conditions, the general area of the pharmacy is currently in neutral to slightly positive pressure. Pharmacies must consider room pressurization when storing HDs1. Storing active pharmaceutical (APIs) of an HD in a negative pressure environment is required. Additionally, they must store any antineoplastic HD requiring manipulation in a negative pressure environment. Storage of other agents and dosage forms may be based on the facility’s AoR. Absent a current AoR, all current HD storage will need to be moved to a segregated HD storage area. The room must have a negative pressure between 0.01 to 0.03” wc, be vented to the outside, and have a least 12 air changes per hour. If determined to be acceptable within the facility’s current or future AoR, then the current HD storage practice may be acceptable within USP800 guidelines.

Inpatient Pharmacy - Basement A procurement tech orders HDs based on the medication orders received from doctors throughout the hospital. HDs that are in the Outpatient pharmacy are packaged into totes and brought from the Outpatient pharmacy into the Inpatient pharmacy area. The HDs are stored in their container in the appropriate room (Strip-packing, IV Hood, or Chemo Hood). There is no separation from general traffic or other pharmacy products and limited designation on the floor for HDs vs non-HDs. There is a counter and handwashing sink as you enter the space for unpackaging. Additionally, an area for PPE and spill containment kits is not directly available.

The inpatient pharmacy area, including this breakdown area, is furnished with vinyl tile.

This finish is compliant with USP800, but may not be the best choice for flooring material due to potential contamination within the tile seams. Flooring replacement should be considered at the facility level as a best practice solution contributing to a safer pharmacy workspace. Flooring materials could include rubber sheet flooring with heat welded seams or a MMA type floor. Floor finishes within the ante room and positive and negative pressure buffer rooms are monolithic with welded seams and provide an integral base with epoxy paint on walls.

Regarding pressurization conditions, like the outpatient pharmacy, the general area of the inpatient pharmacy is currently in neutral to slightly positive pressure. Pharmacies must consider room pressurization when storing HDs1. Storing active pharmaceutical (APIs) of an HD in a negative pressure environment is required. Additionally, they must store any antineoplastic HD requiring manipulation in a negative pressure environment.

Storage of other agents and dosage forms may be based on the facility’s AoR. Absent a current AoR, all current HD storage will need to be moved to a segregated HD storage area. The room must also have a negative pressure between 0.01 to 0.03” wc, be vented to the outside, and have a least 12 air changes per hour. If determined to be acceptable within the facility’s current or future AoR, then the current HD storage practice may be acceptable within USP800 guidelines.

1 Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy. See USP 800 Chapter 5.2

Section 2 Phase 1 – USP 800 Pharmacy Assessment – Pharmacy Site Assessments

The following general comments apply to all or most of the facilities we toured on February 9, 2018.

Site Visited: Fargo VA Health System – Lower Level Inpatient Pharmacy and First Level Outpatient Pharmacy

Pharmacy Assessment Comments / Observations:

• Both Pharmacies currently have limited access control devices at doorways.

• A dedicated space within the receiving area should be created to provide bulk container receiving, and include space for inspection, PPE and spill kit storage, cleaning/disinfection supply storage and disposal unit. This area should also have suitable flooring (“smooth, impervious, free from cracks and crevices, and non-shedding”, i.e. a cleanable monolithic surface) and scrubbable wall surfaces.

A hand wash sink should be in close proximity to this area.

• Storage within compounding rooms should be limited and covered or enclosed for ease of cleaning and to limit dust and contaminants.

• Pharmacy staff will need to establish USP 800 protocols for spills, containment and returns when damaged HDs are received.

• Pharmacy staff will also need to establish USP 800 compliant protocols for delivery, distribution and administering of HDs and subsequent disposal.

• Generally, with all pharmacy groups, it was recognized that system wide standard operating procedures (SOP) will need to be defined and implemented.

• A dedicated donning area for PPE directly inside the ante room with a demarcation line and PPE storage at all pharmacies is suggested as a best practice measure.

• A sink and eyewash are required in all ante rooms that is located at least one meter from the entrance to the HD buffer room2.

• Floor finishes within the ante room, positive and negative pressure buffer rooms should be monolithic with welded seams and provide an integral base.

• Wall finishes should be a durable, epoxy paint system that can withstand wipe downs and scrubbing associated with the facilities cleaning protocols.

• The ceilings within the ante and buffer rooms are hard-lid (gypsum board) and appear to also have an epoxy paint finish. Facility should verify this is a durable, epoxy paint system that can withstand wipe downs and scrubbing associated with the facilities cleaning protocols.

2 A hand-washing sink must be placed in the ante-room at least 1 meter from the entrance to the HD buffer room to avoid contamination migration into the negative pressure HD buffer room. USP 800 Para 5.3.2

Section 2-A

First Level Outpatient Pharmacy – Assessments

First Level – IB-90 Outpatient Pharmacy Existing Layout:

Summary:

• All HDs and non-HDs are unpackaged after delivery here.

• Current room is used to store all drugs in their final dose form.

• Drugs are sent downstairs for compounding and then back to this location in their packaging for outpatient distribution.

• The general area of the pharmacy is in neutral to slightly positive pressure. Floor has vinyl base and carpet floor, wall and ceiling finishes are monolithic, verify paint is appropriate to withstand cleaning agents, ideally epoxy.

• Room does contain spill kits and PPE for staff.

• Room does not have adequate hand sinks or an eye wash station.

First Level – IB-90 Outpatient Pharmacy Proposed Layout:

Architectural Summary:

• Renovation work must be scheduled to minimize down time. Pharmacy may utilize couriers throughout to assist with compounding needs.

• Wall and ceilings should be gypsum board with an epoxy (ideal) finish system that will allow wipe down and scrubbing per the facilities cleaning protocols.

• Receiving of all drugs to be in the basement for increased efficiency.

(New) HD Storage Room

• This room may not be required based on facility AoR and other risk reducing options.

• Create negative pressure storage room (with monitoring) for HDs that are transported from Basement level HD receiving area.

• Provide covered/enclosed storage for HDs to minimize wipe down efforts.

• Provide Donning/Doffing area directly inside or outside room with PPE storage and waste collection.

• Provide handwashing/eyewash sink and flooring with integral base.

Mechanical Summary:

Per the above architectural sketches hazardous drug (HD) storage is being recommended in a newly constructed space within the first-floor outpatient pharmacy 1B-90. Provide a new exhaust fan to be located on the roof with potential to route the new exhaust ductwork in the existing dumbwaiter shaft located near the elevator bank.

The exhaust fan must be located on the roof maintaining a minimum distance of no less than 20ft from adjacent outdoor air intakes. Exhaust fan will need to maintain a negative pressure in the space at a rate of 12 air changes per hour (ACH). Provide optional room pressurization monitor if desired by staff or VA facilities. This HD storage will also be provided with a new wall hung sink with integral eyewash.

It is recommended to have the outpatient pharmacy rebalanced to insure proper pressurization and airflows. This is not required per USP 800, but is recommended as a best practice to insure a slightly positive to neutral air balance with the adjacent spaces.

Electrical Summary:

Reference the above architectural sketches of the first-floor outpatient pharmacy 1B-90 for the proposed revisions to create a hazardous drug (HD) storage room and the mechanical description. Provide emergency power to any new HVAC equipment.

Power to be fed from equipment branch panelboards located in adjacent electrical room 1B-90A-HAC. Modify the existing power layout to provide critical power for any new refrigerator locations. Provide gasketed and lensed LED lighting. The exterior lens surface of lighting shall be smooth, mounted flush and sealed. Provide critical power for any new refrigerator locations.

Section 2-B

Basement Inpatient Pharmacy Phase 1 USP 800 Pharmacy – Assessments

Basement – BB-80 Inpatient Pharmacy Existing Layout:

General Pharmacy:

• Floor has vinyl base and floor, wall and ceiling finishes are monolithic, verify if paint is epoxy (ideal paint given durability and resistance to cleansing agents)

• Cardboard packaging present in BB-80 Inpatient and in BB-75 Pharmacy Storage.

• Room does contain spill kits and PPE for staff.

Ante Room (+)

• Verify room pressure monitoring and recording system.

• Donning/Doffing area (and adjacent PPE) will be added.

IV Hood (Sterile) (++)

• Current room adequate for current function.

• All HDs left in their original packaging unless manipulated or compounded.

Chemo Hood (HD) (-)

• Verify room pressure monitoring and recording system.

• Current room is small and does not provide enough space for donning/doffing area inside room.

• All HDs left in their original packaging.

Strip Packing Area

• Current manipulation of some HDs occurs in this room. Facility assessment for the AoR will be required to determine future capacity of this space.3

Review of Certification Testing

AT Analytical, Inc. performed a full certification of the basement level BB-80 In-patient Pharmacy on December 18, 2017 with the following results:

IV Hood Sterile (Buffer per report) Room Allowable Limit Measured Value Pass/Fail Particle Test (ISO 7) <352,000/ m3 14,656 m3 Pass Air Changes per Hour >30 AC/hr 48 Pass Room Pressurization >+0.02” w.c. +0.049 Pass

• All point-of-use laminar flow HEPA filters failed leakage testing per December certification. Site staff informed NFS that issues have been corrected and the pharmacy is now in compliance.

Hazardous Chemo Hood Allowable Limit Measured Value Pass/Fail Particle Test (ISO 7) <352,000/ m3 118,159 m3 Pass Air Changes per Hour >30 AC/hr 45 Pass Room Pressurization -0.01” to -0.03” w.c. -0.103 Pass

• All point-of-use laminar flow HEPA filters failed leakage testing per December certification. Site staff informed NFS that issues have been corrected and the pharmacy is now in compliance.

Ante Room Allowable Limit Measured Value Pass/Fail Particle Test (ISO 7) <352,000/ m3 16,640 m3 Pass Air Changes per Hour >30 AC/hr 42 Pass Room Pressurization >+0.02” w.c. +0.022 Pass

Chemo Hood Room for hazardous drugs was found to be holding adequate room pressurization of -.103” w.c. It was noted on the AT Analytical, Inc. that the HEPA

3 HDs that do not require any further manipulation, other than counting or repackaging of final dosage forms, may be prepared for dispensing without any further requirements for containment unless required by the manufacturer or if visual indicators of HD exposure hazards are present (e.g., HD dust or leakage).

Counting or repackaging of HDs must be done carefully. Clean equipment should be dedicated for use with HDs and should be decontaminated after every use. Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants.

USP 800 Para 12 laminar flow diffuser located in the Chemo space failed the leakage testing due to filter perimeter leaks found. Per the site this has been corrected and the HEPA unit was sealed, tested, and found to be compliant. There are two hoods located in the chemo room one is used for sterile compounding and one for non-sterile compounding. It is recommended to relocate these fume hoods to meet the requirement of 1 meter of separation between sterile and non-sterile compounding.

The Sterile IV Hood (Buffer) Room was found to be holding adequate room pressurization of +0.049” w.c. It was noted on the AT Analytical, Inc. that the HEPA laminar flow diffuser located in the Buffer space failed the leakage testing due to filter perimeter leaks found and unable to patch. Per the site the HEPA unit has been replaced, tested, and found to be compliant. Recommendation was made to replace the HEPA Filters.

The Ante room between these two spaces was also found at an acceptable level of pressurization at +0.022” w.c. to the outside pharmacy area. Per AT Analytical, Inc. the ante room is the only room whose HEPA laminar flow diffuser passed the leakage test.

While onsite the Ante Room was having airflow issues due to an issue with the HEPA laminar flow diffuser. The site was aware of this issue and had already issued a work order to have the maintenance staff investigate and repair the issue.

All spaces above utilized existing previous generation room pressure monitors that require periodic maintenance to stay within calibration. It is recommended to consider replacing these monitors with new digital touchscreen display models with diaphragm type sensors that are less prone to drifting out of calibration over time.

Electrical Summary:

Chemo and Sterile IV Hood (Buffer) Rooms were found to have the existing hoods connected to emergency power. Existing equipment is fed with emergency power as required. All lighting is flush mounted with gasketed with smooth lens covers for easy cleaning. Entry to the inpatient pharmacy has controlled and restricted access at all doors.

Basement – BB-80 Inpatient Pharmacy Proposed Layout:

General Pharmacy

• Renovation work must be scheduled to minimize down time. Pharmacy may utilize couriers throughout to assist with compounding needs.

• Review storage needs for non-HD medications and supplies to consolidate overall space allocation to create dedicated HD delivery/breakout space and construction of new spaces described below.

• Provide a dedicated area for delivery, inspection and breakout of HDs with PPE and spill containment supplies and hand wash sink directly adjacent.

• Wall and ceilings should be gypsum board with an epoxy (ideal) finish system that will allow wipe down and scrubbing per the facilities cleaning protocols.

• Receiving of all drugs to be in the basement for increased efficiency.

Ante Room (+)

• A thorough review of USP 797 should also be completed when determining ante room procedures and layout as this room serves both HD and non-HD buffer rooms.

• Provide more room for Donning/Doffing area (and adjacent PPE) should be added.

• Verify room pressure monitoring and recording system.

• Move sink for minimum 1-meter separation from HD buffer room entrance. (see footnote 2 on page 4 above)

IV Hood (Sterile) (++)

• Provide new room and relocate equipment.

VHAMINFleckD Line

VHAMINFleckD Line

VHAMINFleckD Line

VHAMINFleckD Line

VHAMINFleckD Line

VHAMINFleckD Callout Door into HD Storage - need a sink/eyewash in this space also

VHAMINFleckD Callout Pass-thru to HD buffer

VHAMINFleckD Callout This HD delivery space can go away.

• Room pressure monitoring and recording system.

Chemo Prep (HD) (-)

• Change existing IV Hood room to negative pressure Chemo Hood room

(New) HD Storage Room (-)

• Expand existing Chemo Hood room for new HD Storage room.

• Create negative pressure storage room (with monitoring) in close proximity to delivery/breakout space to minimize travel distances for transport of HDs.

• Provide space for 1 hood for compounding of non-sterile HDs4.

• Provide covered/enclosed storage for HDs to minimize wipe down efforts.

• Provide Donning/Doffing area directly outside room with PPE storage and waste collection.

• Provide handwashing sink and flooring with integral base.

Per the above architectural sketches hazardous drug (HD) storage is being recommended in a newly constructed space within the basement floor in-pharmacy BB-

80. Provide a new exhaust fan to be located on the roof, with potential to route the new exhaust ductwork in an existing shaft/plumbing chase located above the SPS storage or Soiled Utility. The exhaust fan must be located on the roof maintaining a minimum distance of no less than 20ft from adjacent outdoor air intakes. Exhaust fan will need to maintain a negative pressure in the space at a rate of 12 air changes per hour (ACH).

Provide optional room pressurization monitor if desired by staff or VA facilities. This HD storage will also be provided with a new wall hung sink with integral eyewash.

Provide a new VAV box for dedicated temperature control and diffusers/grilles as required in the new staff lounge. Recommendation to add sink to staff lounge for staff use and to prevent misuse of sink in pharmacy area for none pharmaceutical use.

Electrical Summary:

Reference the above architectural sketches of the first-floor outpatient pharmacy BB-80 for the proposed revisions to create a hazardous drug (HD) storage room and the mechanical description. Provide emergency power to any new HVAC equipment.

Power to be fed from equipment branch panelboards located in adjacent electrical room BB-80B HAC. Modify the existing power layout to provide critical power for any new refrigerator locations. Provide gasketed and lensed LED lighting. The exterior lens surface of lighting shall be smooth, mounted flush and sealed. Provide critical power for any new refrigerator locations.

Provide new lighting and electrical outlets to the newly proposed staff lounge. New power to be fed from panelboards located in adjacent electrical room BB-80B HAC.

Modify existing lighting and power layout to fit new space layout. Any new power to be fed from panelboards located in adjacent electrical room BB-80B HAC.

4 VA staff are currently reviewing the possibility of placing a non-sterile HD compounding hood in the HD storage room. Further discussions will be required prior to completing this assessment.

Appendix I

VA Fargo Pharmacy Staff GAP Analysis

USP 800 Assessment

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