B273MedicalStoragePharmacyUpgradeSOW.pdf

Europe, Africa and Southwest Asia – NAS Sigonella PWD

B273 Medical Storage and Pharmacy Upgrade 25-Mar-2019 NAS I, Sigonella eProject # 1632986

SCOPE OF WORK

TEXT OF GENERAL PARAGRAPHS

1. GENERAL INTENTION/GENERAL DESCRIPTION:

It is the declared and acknowledged intention and meaning to provide complete and ready for use renovation to existing Pharmacy and Medicine Storage at NAS I Hospital (BUMED), by means of a firm fixed price contract.

Scope of this renovation work is (I) upgrade the Pharmacy drug packaging area in order to comply with the USP 800 hazardous drug packaging guidance, and (II) upgrade the Medical Storage space to comply with NFPA codes.

1.1 GENERAL NOTES:

1.1.1 The following paragraphs are intended to provide amplifying or additional information with respect to specific details of the project and are not intended to subordinate any regulatory or statutory requirements contained in the contract.

1.1.2 In case of conflict, Statement of work takes precedence over the attached images and details.

Images and details are attached for general reference only.

1.1.3 If not otherwise stated in this scope of work, all work shall be performed by the Contractor. The Contractor shall provide labor, materials, tools, equipment and transportation to perform the work described below.

1.1.4 Contractor shall conduct meticulous on-site investigation to obtain existing condition assessment and to identify unforeseen condition prior commencing any demolition and new equipment selection.

1.1.5 All Shop Drawings for any Civil/Structural/Architectural, Mechanical and Electrical work and or system shall be submitted within 90 calendar days from the Contract award.

1.2. CURRENT CONDITION:

The NAS I Hospital is located on south-east corner of the base. The two areas to be upgraded/renewed are located on the west side of the first floor.

1.2.1 The Pharmacy drug packaging area includes one room, with no compliant control of the air contamination.

1.2.2 The Medical Storage area is shared with office spaces, with wooden cabinets and glass doors as confinement, with no fire barriers between the two areas.

1.3. ITEMS OF WORK:

1.3. (I) Medical Storage

1. Provide self-extinguishing temporary barriers and separate working space from other areas of the hospital. Air conditioning supply and return grids shall be sealed, and smoke detectors shall be protected or removed for reinstallation. Secure power feeding the existing outlets, light switches, etc.

in the work site where demolitions will occur. The contractor is advised that work will occur near areas that shall remain operative, and all precautions shall be taken to avoid mission disruption.

2. Temporarily protect the existing fixed cabinets separating the storage area from the administrative area. Use flame retardant/ self-extinguishing barriers.

3. Demolish, remove and dispose of existing mobile and fixed scaffolding inside storage area, to include base rails and platforms.

4. Remove and dispose of existing vinyl flooring, including the baseboard. Demolish part of the floor where scaffolding to be removed is anchored and portion of floor necessary for new industrial floor fabrication.

5. Repair the floor surfaces after vinyl flooring removal (paragraph 3 above). Prepare and apply new industrial type floor surfacing to be used for storage spaces.

6. Fabricate new 1 hour fire rated drywalls (gypsum board on metal frame) to confine the storage room, including new baseboard. Extend the new drywall from the storage room floor through the existing suspended ceiling all the way up to reach the second floor slab above (this task includes the modification of existing suspended ceiling to allow the drywall installation). Run new conduit inside the new drywalls and install new power and phone/data outlets, light switches, etc. recessed on the surface of the new drywalls. One section of wall (south of east corner) shall be equipped with a fixed see-through window, with the same fire rating of the surrounding enclosure wall.

7. Reconfigure the storage spaces lighting system and switches to operate the light fixtures from switches located at any the 3ea storage room entrances.

8. Remove and dispose of existing 1 metal double door (leading south to the corridor) and 2 single glass doors (including doorframes) and a glazed wall section in the south east corner. Provide and install a new metal double door at the corridor wall and 2 new metal single doors on the new drywalls, at the same location of the previously removed doors, complete with panic hardware and key operated locks of the same type and quality as installed elsewhere in the bldg. The new doors and doorframes shall be minimum 1 hour fire rated.

9. Modify the existing fire suppression sprinkler system and HVAC system in accordance with the new storage space layout (in accordance with all current NFPA and Italian codes and regulations).

Modify/relocate grids, hatches and other equipment parts from suspended ceiling where conflicting with new walls. Ensure all utility lines penetrations between different areas are properly sealed, and install fire dampers if air ductworks run across the wall, for fire protection rating continuity.

10. Provide for wall surface preparation, priming and painting of both sides of work area where not obstructed by fixed furniture, including surfaces that have not been modified and ceiling. New wall paint shall be latex, nontoxic, fully washable, water based semi-gloss (color as indicated by the Contracting Officer). New finish paint shall be applied in sufficient coats to cover the existing colors (no transparency permitted).

11. Remove the temporary protection from the existing wood cabinets described in paragraph 2 above.

12. At completion of the HVAC modifications, perform the TAB of the air conditions system in the storage spaces and provide certification by a Fire Protection Engineer (FPE) that NFPA and Italian requirements are fulfilled.

13. At completion of all operations described above, remove and dispose of all plastic barriers and protective measures and provide final cleaning of the premises.

14. At completion of tasks restore previously secured power. Provide test and certification of system.

1.3. (II) Pharmacy

1. Provide self-extinguishing barriers and separate working space from other areas of the hospital. Air conditioning supply and return grids shall be sealed, and smoke detectors shall be protected or removed for reinstallation. Secure power where demolitions will occur. The Contractor is advised that work will occur near areas that shall remain operative, and all precautions shall be taken to avoid mission disruption.

2. Demolish and dispose of existing concrete wall to expand room 1A-54 by adding room 1A-55.

Modify wood cabinetry to create space for new door opening, and demolish portion of wall between room 1A-52 and 1A-54 for installation of a new door (See photo #1). Remove and dispose of existing outlets and other devices installed in the existing walls being removed.

3. Modify existing perimeter walls of room 1A-55 to obtain a 1 hour fire rating, to be extended up through the existing suspended ceiling to reach the above existing concrete slab.

4. Remove and dispose of existing floating floor in room 1A-55. Fill the void in the floor using plastic domes filled with light concrete and welded wire fabric, for floor continuity with room 1A-54. Provide new PVC flooring (approx. 16m2) to match type, color and quality of existing floor in room 1A-54.

5. Block both former door entrances to room 1A-54 and 1A-55, by means of metal structure and gypsum board to obtain 1 hour fire rating. Seal flush all joints. Prepare for painting.

6. Fabricate two new 1 hour fire rated drywalls to divide space into three rooms, to be extended up through the existing suspended ceiling to reach the above existing concrete slab. Provide one door frame on each wall (2 ea) plus one on the new opening between room 1A-52 and 1A-54. See sketches 6 of 6.

7. Provide new 2ea sliding doors, chemical lab type, to separate the 3 spaces and one sliding doors, chemical lab type, between room 1A-52 and 1A-54. See attached sketch 6 of 6.

8. Modify existing water supply and drainage line and sink to fit in new spaces. Provide and install a new eye-wash station in the center room (ante room) including new water supply and drainage line connected to the nearest existing utility lines.

9. Install a new hood (furnished by the Government for contractor installation). Provide and install new external exhaust line (new exhaust line shall go from 1A-54/55 to the outside of the bldg.); provide and install new sink and one eye wash station, complete with feeding and drainage lines.

10. Reconficgure the existing fire suppression sprinkler system in accordance with the new lab space layout (in accordance with all current NFPA and Italian codes and regulations). Modify/relocate grids, hatches and other equipment parts from suspended ceiling where conflicting with new walls. Ensure all utility lines penetrations between different areas are properly sealed, and install fire dampers if air ductworks run across the wall, for fire protection rating continuity.

11. Reconfigure the existing electrical lighting system to serve the new 3 spaces, each with independent dedicated light switches in the room. Reconfigure electrical system and install new 110/220V electrical outlets, fed by the closest electrical panel, in the new 3 spaces (the Contracting Officer will indicate the exact locations of outlets).

12. Reconfigure existing HVAC system to have negative pressure in the new three spaces, all three externally exhausted. New hood in room 1A-55 shall be externally exhausted through a HEPA filter.

Room 1A-55 must be at a negative pressure with regard to the area from which it is entered of 0.01 -

0.03 inches of water. Room 1A-55 needs to have 30 or more air changes per hour (ACPH). Room 1A- 55 floors and walls need to be of uniform color, and completely without texture. Variegated surfaces can conceal stains and spills; even slight texture increases the difficulty of deactivation, cleaning and disinfection. Room 1A-55 flooring to be “coved” up the walls of the C-SEC to simplify cleaning. The ante room, 1A-54b MUST be at a 0.02 or greater inches of water positive pressure to the area from which it is entered. All rooms must be ISO Class 7 air.

13. Provide for TAB and TAB report for negative pressure. The new TAB shall be set in order to obtain not less than 12each air changes per hour. The contractor shall provide HVAC modifications to comply with UPS 800 (see attached UPS 800 instructions).

14. Finish joints between existing walls, floors and ceilings and new rearranged spaces; surfaces shall be flush and even for infection and contamination control. All surfaces should be smooth, impervious surfaces, walls, ceilings, floors, countertops and shelving that is free of cracks and crevices to avoid accumulations of residues, and facilitate their easy cleaning.

15. All modifications performed through this statement of work shall comply with USP 800 - Handling Hazardous Drugs (attached).

16. At completion of all operations described above, remove and dispose of all the plastic barriers and protective measures described above.

17. Clean the area free from debris. Haul and dispose to authorized dump site off-base.

18. At completion of tasks restore previously secured power.

Notes:

(1) All work shall be coordinated with the customer and with the Contracting Officer (and/or his designated representatives). No work shall start prior to obtaining all approvals from the Contracting Officer (2)Materials used shall be installed as per their manufacturers printed directions.

(3) The facility where work is being performed will remain in normal operations during the work performance period. Therefore, the contractor shall provide phasing of work plan to reduce to the minimum any interference with the facility activities.

(4) All work shall be conducted in compliance with EM385-1-1 Safety manual and Italian Safety Norms.

(5) Safety equipment and Personal Protection Equipment (PPE) shall be used at all times during the work.

(6) Electrical work shall comply with current applicable NEC and CEI codes.

(7) Contractor shall provide “As Built drawings” (single line diagrams with technical information of each component installed), declaration of conformity in compliance with Italian Norms and Regulations (DM 37/2008, D.P.R. 462/01 and related) of modified electrical systems and electrical certifications of any modified electric panels involved in this project in compliance with CEI EN 61439 Italian Norm and related.

(8) Fire protection system must adhere and be certified as per DM 16 February 1882 and UFC 3-600-01.

New provided fire rated doors and fire rated walls shall be labeled appropriately with certification (provided to the Contracting Officer).

(9) Debris resulting from work performance shall be removed and disposed of off the station per current Environmental protection rules and regulations.

(10) Work locations shall be left clean of debris at the end of each day of work.

2. WORK LOCATION: Bldg. 273. See attached sketches (6 ea) for details.

3. PERIOD OF PERFORMANCE AND CATEGORY OF WORK:

a. The work shall be executed within 270 days of award.

b. CQOP SOA categories and class for this project: General OG1, Class I.

c. Working Hours: Regular working hours are from 7:30 to 16:00, Monday through Friday; excluding US Federal Holidays and Italian Holidays. Work outside of regular working hours is subject to the provisions of the paragraph titled, “Work Outside of Regular Working Hours.”

4. SPECIAL SCHEDULING:

a. The Contractor shall coordinate the work with the Contracting Officer, Bldg. Mangers, and other Government Representatives designated by the Contracting Officer.

b. Work shall begin once all the materials to start and complete the work have been received and have been approved for use.

c. The replacement of drying beds shall be performed one piece at a time coordinating work with the Facility Management.

d. The Contractor shall conduct his operations so as to cause the least possible interference with the normal operations of the station. The work under this contract requires special attention to scheduling interruptions of utilities operations.

e. Outages: Permission to interrupt utility service shall be requested in writing a minimum of 15 calendar days prior to the desired date of interruption. Make utility cutovers and interruptions after normal working hours or on weekends or Government holidays. Interruption to water, sanitary sewer, storm sewer, telephone service, electric service, air conditioning, heating, fire alarm, compressed air, and gas shall be subject to the restrictions above.

5. CONTRACT SKETCHES AND DRAWINGS:

Sketch 1 of 6, Base Map with Work Location Sketch 2 of 6, Building 273 Key Plan with Work Locations Sketch 3 of 6, Work Site I Existing Sketch 4 of 6, Work Site I New Sketch 5 of 6, Work Site II Existing Sketch 6 of 6, Work Site II New Attachment 1 – Wall Types Table Attachment 2 – Ceiling Access Panel Detail Photo – View of wall between room IA-52 and IA-54

Instructions:

- First Supplement to USP 39–NF 34 Physical Tests / (800) Hazardous Drugs—Handling in

Healthcare Settings

- First Supplement to USP 39-NF 34 (1035) Biological Indicators for Sterilization / General

Information

6. SUBMITTALS:

The Contractor shall submit at least one original copy of manufacturer’s literature with each submittal, including an English translation.

Unless specified otherwise, the contractor shall provide three of all required submittal data, shop drawings, catalogue data and other information to the Contracting Officer.

Matter submitted for approval shall be accompanied by complete information concerning the material, articles, and/or design proposed for use in sufficient detail to show compliance with the specifications and shall be approved before incorporation into the work.

Approval thereof will not be construed as relieving the contractor of compliance with the specification even if such approval is made in writing, unless the attention of the Contracting Office is called to the non-complying features by letter accompanying the submitted matter.

Partial submittals of less than the whole of any system made up on interdependent components will not be considered.

Approval of drawings, cuts, and samples by the Contracting Officer shall not be construed as a complete check or approval of the detailed dimensions, weights, gauges and similar details of the proposed articles.

The conformance of such details with the contract requirement, together with the necessary coordination of dimensions and details between the various elements of the work and between the various subcontractors and suppliers shall be solely the responsibility of the contractor, approval of submitted matter notwithstanding. As soon as practicable and before installation, the Contractor shall submit the following literature:

a. Vinyl floor and Industrial Floor.

b. Drywall structure and Gypsum boards.

c. Doors and door hardware.

d. Heating, ventilation and air conditioning equipment and conduits.

e. Electrical and illumination cabling, accessories and equipment.

f. Fire Protection piping and accessories.

7. APPROVAL OF SAMPLES, CUTS AND DRAWINGS:

For this project, all submittals of an administrative nature shall be submitted to the FEAD Office. Technical submittals shall be addressed via the Contracting Officer to the Public Works Department to the attention of Eng. G. Furnari, 095-866887.

8. TESTING:

Contractor shall test in the presence of Government Inspector:

a. HVAC system (TAB)

b. Fire Protection System

c. Electrical and grounding system.

9. TRAINING: N/A

Prepared by:

Dott. Ing. Giuseppe Furnari Civil Engineer - P.E.

Public Works Department, FEAD Division, Engineering Branch Naval Air Station Sigonella, Sicily, Italy Comm: (+39) 095-86-6887

DSN: 624-6887

Photo ‐ View of wall between room IA‐52 and IA‐54

Door and Frame are to be removed. Resulting wall opening is to be blocked. Wood cabinetry on the right of photo is to be removed / modified for new door opening. Electrical outlets/lines interfering with the are to be relocated. Wall is to be extended up to the structure slab ceiling and made 1 hr fire resistant.

Add the following:

á800ñ HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS

(Chapter to become official July 1, 2018.)

1. INTRODUCTION AND SCOPE

This chapter 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, dis-pensing, administration, and disposal of sterile and nonsterile products and preparations.

This chapter applies to all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice fa-cilities, or veterinarians' offices). Personnel who may potentially be exposed to HDs include, but are not limited to: pharma-cists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.

Entities that handle HDs must incorporate the standards in this chapter into their occupational safety plan. The entity's health and safety management system must, at a minimum, include:

• A list of HDs

• Facility and engineering controls

• Competent personnel

• Safe work practices

• Proper use of appropriate Personal Protective Equipment (PPE)

• Policies for HD waste segregation and disposal

The chapter is organized into the following main sections:

1. Introduction and Scope

2. List of Hazardous Drugs

3. Types of Exposure

4. Responsibilities of Personnel Handling Hazardous Drugs

5. Facilities and Engineering Controls

6. Environmental Quality and Control

7. Personal Protective Equipment

8. Hazard Communication Program

9. Personnel Training

10. Receiving

11. Labeling, Packaging, Transport, and Disposal

12. Dispensing Final Dosage Forms

13. Compounding

14. Administering

15. Deactivating, Decontaminating, Cleaning, and Disinfecting

16. Spill Control

17. Documentation and Standard Operating Procedures

18. Medical Surveillance

Glossary Appendices

Appendix 1: Acronyms Appendix 2: Examples of Designs for Hazardous Drug Compounding Areas Appendix 3: Types of Biological Safety Cabinets

References

2. LIST OF HAZARDOUS DRUGS

The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare. An entity must maintain a list of HDs, which must include any items on the current NIOSH list that the entity han-dles. The entity's list must be reviewed at least every 12 months. Whenever a new agent or dosage form is used, it should be reviewed against the entity's list.

The NIOSH list of antineoplastic and other HDs provides the criteria used to identify HDs. These criteria must be used to identify HDs that enter the market after the most recent version of the NIOSH list, or that the entity handles as an investiga-

First Supplement to USP 39–NF 34 Physical Tests / á800ñ Hazardous Drugs—Handling in Healthcare Settings 7721

Official from December 1, 2016 Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 10.6.1.1 by psnf3tcmp on Mon Aug 15 18:39:35 EDT 2016 tional drug. If the information available on a drug is deemed insufficient to make an informed decision, consider the drug haz-ardous until more information is available.

Box 1: Containment Requirements

• Drugs on the NIOSH list that must follow the requirements in this chapter include:

— Any HD API

— Any antineoplastic requiring HD manipulation

• Drugs on the NIOSH list that do not have to follow all the containment requirements of this chapter if an assessment of risk is performed and implemented include:

— Final dosage forms of compounded HD preparations and conventionally manufactured HD products, including antineoplastic dosage forms that do not require any further manipulation other than counting or repackaging (unless required by the manufacturer)

• For dosage forms of other HDs on the NIOSH list, the entity may perform an assessment of risk to determine alternative containment strategies and/work practices

Some dosage forms of drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (e.g., tablets or capsules—solid, intact medications that are administered to patients without modify-ing the formulation). However, dust from tablets and capsules may present a risk of exposure by skin contact and/or inhala-tion. An assessment of risk may be performed for these dosage forms to determine alternative containment strategies and/or work practices. If an assessment of risk is not performed, all HDs must be handled with all containment strategies defined in this chapter.

The assessment of risk must, at a minimum, consider the following:

• Type of HD (e.g., antineoplastic, non-antineoplastic, reproductive risk only)

• Dosage form

• Risk of exposure

• Packaging

• Manipulation

If an assessment of risk approach is taken, the entity must document what alternative containment strategies and/or work practices are being employed for specific dosage forms to minimize occupational exposure. If used, the assessment of risk must be reviewed at least every 12 months and the review documented.

3. TYPES OF EXPOSURE

Routes of unintentional entry of HDs into the body include dermal and mucosal absorption, inhalation, injection, and inges-tion (e.g., contaminated foodstuffs, spills, or mouth contact with contaminated hands). Containers of HDs have been shown to be contaminated upon receipt. Both clinical and nonclinical personnel may be exposed to HDs when they handle HDs or touch contaminated surfaces. Table 1 lists examples of potential routes of exposure based on activity.

Table 1. Examples of Potential Opportunities of Exposure Based on Activity

Activity Potential Opportunity of Exposure

Receipt

• Contacting HD residues present on drug containers, individual dosage units, outer containers, work surfaces, or floors

Dispensing • Counting or repackaging tablets and capsules

Compounding and other manipulations

• Crushing or splitting tablets or opening capsules

• Pouring oral or topical liquids from one container to another

• Weighing or mixing components

• Constituting or reconstituting powdered or lyophilized HDs

• Withdrawing or diluting injectable HDs from parenteral containers

• Expelling air or HDs from syringes

• Contacting HD residue present on PPE or other garments

• Deactivating, decontaminating, cleaning, and disinfecting areas contaminated with or suspected to be contaminated with HDs

• Maintenance activities for potentially contaminated equipment and devices

Administration

• Generating aerosols during administration of HDs by various routes (e.g., injection, irrigation, oral, inhalation, or topical application)

• Performing certain specialized procedures (e.g., intraoperative intraperitoneal injection or bladder instillation)

• Priming an IV administration set

Patient-care activities

• Handling body fluids (e.g., urine, feces, sweat, or vomit) or body-fluid-contaminated clothing, dressings, linens, and other materials

Spills • Spill generation, management, and disposal

Transport • Moving HDs within a healthcare setting

Waste • Collection and disposal of hazardous waste and trace contaminated waste

7722 á800ñ Hazardous Drugs—Handling in Healthcare Settings / Physical Tests First Supplement to USP 39–NF 34

Official from December 1, 2016

4. RESPONSIBILITIES OF PERSONNEL HANDLING HAZARDOUS DRUGS

Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards;

ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. The designa-ted person must thoroughly understand the rationale for risk-prevention policies, risks to themselves and others, risks of non-compliance that may compromise safety, and the responsibility to report potentially hazardous situations to the management team. The designated person must also be responsible for the oversight of monitoring the facility and maintaining reports of testing/sampling performed in facilities, and acting on the results.

All personnel who handle HDs are responsible for understanding the fundamental practices and precautions and for continu-ally evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.

5. FACILITIES AND ENGINEERING CONTROLS

HDs must be handled under conditions that promote patient safety, worker safety, and environmental protection. Signs des-ignating the hazard must be prominently displayed before the entrance to the HD handling areas. Access to areas where HDs are handled must be restricted to authorized personnel to protect persons not involved in HD handling. HD handling areas must be located away from breakrooms and refreshment areas for personnel, patients, or visitors to reduce risk of exposure.

Designated areas must be available for:

• Receipt and unpacking

• Storage of HDs

• Nonsterile HD compounding (if performed by the entity)

• Sterile HD compounding (if performed by the entity)

Certain areas are required to have negative pressure from surrounding areas to contain HDs and minimize risk of exposure.

Consideration should be given to uninterrupted power sources (UPS) for the ventilation systems to maintain negative pressure in the event of power loss.

5.1 Receipt

Antineoplastic HDs and all HD APIs must be unpacked (i.e., removal from external shipping containers) in an area that is neutral/normal or negative pressure relative to the surrounding areas. HDs must not be unpacked from their external shipping containers in sterile compounding areas or in positive pressure areas.

5.2 Storage

HDs must be stored in a manner that prevents spillage or breakage if the container falls. Do not store HDs on the floor. In areas prone to specific types of natural disasters (e.g., earthquakes) the manner of storage must meet applicable safety precau-tions, such as secure shelves with raised front lips.

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. These HDs must be stor-ed in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-antineoplastic, repro-ductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity poli-cy.

Sterile and nonsterile HDs may be stored together, but HDs used for nonsterile compounding should not be stored in areas designated for sterile compounding to minimize traffic into the sterile compounding area.

Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH [e.g., storage room, buffer room, or containment segregated compounding area (C-SCA)]. If a refrigerator is placed in a nega-tive pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator should be considered.

5.3 Compounding

Engineering controls are required to protect the preparation from cross-contamination and microbial contamination (if prep-aration is intended to be sterile) during all phases of the compounding process. Engineering controls for containment are divi-ded into three categories representing primary, secondary, and supplementary levels of control. A containment primary engi-neering control (C-PEC) is a ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs. The containment secondary engineering control (C-SEC) is the room in which the C-PEC is placed. Supplemen-tal engineering controls [e.g., closed-system drug-transfer device (CSTD)] are adjunct controls to offer additional levels of pro-tection. Appendix 2 provides examples for designs of HD compounding areas.

First Supplement to USP 39–NF 34 Physical Tests / á800ñ Hazardous Drugs—Handling in Healthcare Settings 7723

Official from December 1, 2016

Sterile and nonsterile HDs must be compounded within a C-PEC located in a C-SEC. The C-SEC used for sterile and nonster-ile compounding must:

• Be externally vented through high-efficiency particulate air (HEPA) filtration

• Be physically separated (i.e., a different room from other preparation areas)

• Have an appropriate air exchange (e.g., ACPH)

• Have a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas

The C-PEC must operate continuously if it supplies some or all of the negative pressure in the C-SEC or if it is used for sterile compounding. If there is any loss of power to the C-PEC, or if repair or moving occurs, all activities occurring in the C-PEC must be suspended immediately. If necessary, protect the unit by covering it appropriately per the manufacturer's recommen-dations. Once the C-PEC can be powered on, decontaminate, clean, and disinfect (if used for sterile compounding) all surfaces and wait the manufacturer-specified recovery time before resuming compounding.

A sink must be available for hand washing. An eyewash station and/or other emergency or safety precautions that meet ap-plicable laws and regulations must be readily available. Care must be taken to locate water sources and drains in areas where their presence will not interfere with required ISO classifications. Water sources and drains must be located at least 1 meter away from the C-PEC.

For entities that compound both nonsterile and sterile HDs, the respective C-PECs must be placed in separate rooms, unless those C-PECs used for nonsterile compounding are sufficiently effective that the room can continuously maintain ISO 7 classifi-cation throughout the nonsterile compounding activity. If the C-PECs used for sterile and nonsterile compounding are placed in the same room, they must be placed at least 1 meter apart and particle-generating activity must not be performed when sterile compounding is in process.

5.3.1 NONSTERILE COMPOUNDING

In addition to this chapter, nonsterile compounding must follow standards in Pharmaceutical Compounding—Nonsterile Prep-arations á795ñ. A C-PEC is not required if manipulations are limited to handling of final dosage forms (e.g., counting or repack-aging of tablets and capsules) that do not produce particles, aerosols, or gasses.

The C-PECs used for manipulation of nonsterile HDs must be either externally vented (preferred) or have redundant–HEPA filters in series. Nonsterile HD compounding must be performed in a C-PEC that provides personnel and environmental protec-tion, such as a Class I Biological Safety Cabinet (BSC) or Containment Ventilated Enclosure (CVE). A Class II BSC or a com-pounding aseptic containment isolator (CACI) may also be used. For occasional nonsterile HD compounding, a C-PEC used for sterile compounding (e.g., Class II BSC or CACI) may be used but must be decontaminated, cleaned, and disinfected before resuming sterile compounding in that C-PEC. A C-PEC used only for nonsterile compounding does not require unidirectional airflow because the critical environment does not need to be ISO classified.

The C-PEC must be placed in a C-SEC that has at least 12 ACPH. Table 2 summarizes the engineering controls required for nonsterile HD compounding.

Due to the difficulty of cleaning HD contamination, surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabi-nets in the nonsterile compounding area must be smooth, impervious, free from cracks and crevices, and non-shedding.

Table 2. Engineering Controls for Nonsterile HD Compounding

C-PEC C-SEC Requirements

• Externally vented (preferred) or redundant–HEPA filtered in series

• Examples: CVE, Class I or II BSC, CACI

• Externally vented

• 12 ACPH

• Negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas

5.3.2 STERILE COMPOUNDING

In addition to this chapter, sterile compounding must follow standards in á797ñ.

All C-PECs used for manipulation of sterile HDs must be externally vented. Sterile HD compounding must be performed in a

C-PEC that provides an ISO Class 5 or better air quality, such as a Class II or III BSC or CACI. Class II BSC types A2, B1, or B2 are acceptable. For most known HDs, type A2 cabinets offer a simple and reliable integration with the ventilation and pressuri-zation requirements of the C-SEC. Class II type B2 BSCs are typically reserved for use with volatile components. Appendix 3 describes the different types of BSCs.

A laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI) must not be used for the compounding of an antineoplastic HD. A BSC or CACI used for the preparation of HDs must not be used for the preparation of a non-HD unless the non-HD preparation is placed into a protective outer wrapper during removal from the C-PEC and is labeled to require PPE handling precautions.

The C-PEC must be located in a C-SEC, which may either be an ISO Class 7 buffer room with an ISO Class 7 ante-room (preferred) or an unclassified containment segregated compounding area (C-SCA). If the C-PEC is placed in a C-SCA, the be-yond-use date (BUD) of all compounded sterile preparations (CSPs) prepared must be limited as described in á797ñ for CSPs prepared in a segregated compounding area. Table 3 summarizes the engineering controls required for sterile HD compound-ing.

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Table 3. Engineering Controls for Sterile HD Compounding

Configuration C-PEC C-SEC Maximum BUD

ISO Class 7 buffer room with an ISO Class 7 ante-room

• Externally vented

• Examples: Class II BSC or

CACI

• Externally vented

• 30 ACPH

• Negative pressure between

0.01 and 0.03 inches of water column relative to adjacent areas As described in á797ñ

Unclassified C-SCA

• Externally vented

• Examples: Class II BSC or

CACI

• Externally vented

• 12 ACPH

• Negative pressure between

0.01 and 0.03 inches of water column relative to adjacent areas

As described in á797ñ for CSPs prepared in a segregated compounding area

ISO Class 7 buffer room with an ISO class 7 ante-room: The C-PEC is placed in an ISO Class 7 buffer room that has fixed walls, HEPA-filtered supply air, a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas and a minimum of 30 ACPH.

The buffer room must be externally vented. Because the room through which entry into the HD buffer room (e.g., ante-room or non-HD buffer room) plays an important role in terms of total contamination control, the following is required:

• Minimum of 30 ACPH of HEPA-filtered supply air

• Maintain a positive pressure of at least 0.02 inches of water column relative to all adjacent unclassified areas

• Maintain an air quality of ISO Class 7 or better

An ISO Class 7 ante-room with fixed walls is necessary to provide inward air migration of equal cleanliness classified air into the negative pressure buffer room to contain any airborne HD. 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.

Although not a recommended facility design, if the negative-pressure HD buffer room is entered though the positive-pres-sure non-HD buffer room, the following is also required:

• A line of demarcation must be defined within the negative-pressure buffer room for donning and doffing PPE

• A method to transport HDs, HD CSPs, and HD waste into and out of the negative pressure buffer room to minimize the spread of HD contamination. This may be accomplished by use of a pass-through chamber between the negative-pres-sure buffer area and adjacent space. The pass-through chamber must be included in the facility's certification to ensure that particles are not compromising the air quality of the negative-pressure buffer room. A refrigerator pass-through must not be used. Other methods of containment (such as sealed containers) may be used.

HD CSPs prepared in an ISO Class 7 buffer room with an ISO Class 7 ante-room may use the BUDs described in á797ñ, based on the categories of CSP, sterility testing, and storage temperature.

Containment segregated compounding area (C-SCA): The C-PEC is placed in an unclassified C-SCA that has fixed walls, a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas, and a minimum of 12 ACPH.

The C-SCA must be externally vented. A hand-washing sink must be placed at least 1 meter from C-PEC and may be either inside the C-SCA or directly outside the C-SCA.

Only low- and medium-risk HD CSPs may be prepared in a C-SCA. HD CSPs prepared in the C-SCA must not exceed the BUDs described in á797ñ for CSPs prepared in a segregated compounding area.

5.4 Containment Supplemental Engineering Controls

Containment supplemental engineering controls, such as CSTDs, provide adjunct controls to offer an additional level of pro-tection during compounding or administration. Some CSTDs have been shown to limit the potential of generating aerosols during compounding. However, there is no certainty that all CSTDs will perform adequately. Until a published universal per-formance standard for evaluation of CSTD containment is available, users should carefully evaluate the performance claims as-sociated with available CSTDs based on independent, peer-reviewed studies and demonstrated containment reduction.

A CSTD must not be used as a substitute for a C-PEC when compounding. CSTDs should be used when compounding HDs when the dosage form allows. CSTDs must be used when administering antineoplastic HDs when the dosage form allows.

CSTDs known to be physically or chemically incompatible with a specific HD must not be used for that HD.

6. ENVIRONMENTAL QUALITY AND CONTROL

Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment). Surface wipe sampling should include:

• Interior of the C-PEC and equipment contained in it

• Pass-through chambers

• Surfaces in staging or work areas near the C-PEC

• Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)

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• Areas immediately outside the HD buffer room or the C-SCA

• Patient administration areas

There are currently no studies demonstrating the effectiveness of a specific number or size of wipe samples in determining levels of HD contamination. Wipe sampling kits should be verified before use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from various surface types found in the sampled area.

There are currently no certifying agencies for vendors of wipe sample kits.

There is currently no standard for acceptable limits for HD surface contamination. Common marker HDs that can be assayed include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. An example of measurable contamination would be cyclophosphamide levels >1.00 ng/cm2, which were shown in some studies to result in uptake of the drug in exposed workers. If any measurable contamination is found, the designated person must identify, document, and con-tain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thor-ough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.

7. PERSONAL PROTECTIVE EQUIPMENT

Personal Protective Equipment (PPE) provides worker protection to reduce exposure to HD aerosols and residues. Additional PPE may be required to handle the HDs outside of a C-PEC, such as treating a patient or cleaning a spill. The NIOSH list of antineoplastic and other HDs provides general guidance on PPE for possible scenarios that may be encountered in healthcare settings. Disposable PPE must not be re-used. Reusable PPE must be decontaminated and cleaned after use.

Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and nonsterile HDs. Two pairs of chemotherapy gloves are required for administering antineoplastic HDs. Gowns shown to resist permeability by HDs are required when administering injectable antineoplastic HDs. For all other activities, the entity's SOP must describe the appropriate PPE to be worn based on its occupational safety plan and assessment of risk (if used). The entity must develop SOPs for PPE based on the risk of exposure (see Types of Exposure) and activities performed.

Appropriate PPE must be worn when handling HDs including during:

• Receipt

• Storage

• Transport

• Compounding (sterile and nonsterile)

• Administration

• Deactivation/decontamination, cleaning, and disinfecting

• Spill control

• Waste disposal

7.1 Gloves

When chemotherapy gloves are required, they must meet American Society for Testing and Materials (ASTM) standard D6978 (or its successor). Chemotherapy gloves should be worn for handling all HDs including non-antineoplastics and for re-productive risk only HDs. Chemotherapy gloves must be powder-free because powder can contaminate the work area and can adsorb and retain HDs. Gloves must be inspected for physical defects before use. Do not use gloves with pin holes or weak spots.

When used for sterile compounding, the outer chemotherapy gloves must be sterile. Chemotherapy gloves should be changed every 30 minutes unless otherwise recommended by the manufacturer's documentation and must be changed when torn, punctured, or contaminated. Hands must be washed with soap and water after removing gloves.

7.2 Gowns

When gowns are required, they must be disposable and shown to resist permeability by HDs. Gowns must be selected based on the HDs handled. Disposable gowns made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of uncoated materials. Gowns must close in the back (i.e., no open front), be long sleeved, and have closed cuffs that are elastic or knit. Gowns must not have seams or closures that could allow HDs to pass through.

Cloth laboratory coats, surgical scrubs, isolation gowns, or other absorbent materials are not appropriate protective outer-wear when handling HDs because they permit the permeation of HDs and can hold spilled drugs against the skin, thereby increasing exposure. Clothing may also retain HD residue from contact, and may transfer to other healthcare workers or vari-ous surfaces. Washing of non-disposable clothing contaminated with HD residue should only be done according to facility pol-icy as drug residue may be transferred to other clothing. Potentially contaminated clothing must not be taken home under any circumstances.

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Gowns must be changed per the manufacturer's information for permeation of the gown. If no permeation information is available for the gowns used, change them every 2–3 hours or immediately after a spill or splash. Gowns worn in HD handling areas must not be worn to other areas in order to avoid spreading HD contamination and exposing other healthcare workers.

7.3 Head, Hair, Shoe, and Sleeve Covers

Head and hair covers (including beard and moustache, if applicable), shoe covers, and sleeve covers provide protection from contact with HD residue. When compounding HDs, a second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC. Shoe covers worn in HD handling areas must not be worn to other areas to avoid spread-ing HD contamination and exposing other healthcare workers.

Disposable sleeve covers may be used to protect areas of the arm that may come in contact with HDs. Disposable sleeve covers made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of un-coated materials.

7.4 Eye and Face Protection

Many HDs are irritating to the eyes and mucous membranes. Appropriate eye and face protection must be worn when there is a risk for spills or splashes of HDs or HD waste materials when working outside of a C-PEC (e.g., administration in the surgi-cal suite, working at or above eye level, or cleaning a spill). A full-facepiece respirator provides eye and face protection. Gog-gles must be used when eye protection is needed. Eye glasses alone or safety glasses with side shields do not protect the eyes adequately from splashes. Face shields in combination with goggles provide a full range of protection against splashes to the face and eyes. Face shields alone do not provide full eye and face protection.

7.5 Respiratory Protection

Personnel who are unpacking HDs that are not contained in plastic should wear an elastomeric half-mask with a multi-gas cartridge and P100-filter until assessment of the packaging integrity can be made to ensure no breakage or spillage occurred during transport. If the type of drug can be better defined, a more targeted cartridge can be used.

Surgical masks do not provide respiratory protection from drug exposure and must not be used when respiratory protection from HD exposure is required. A surgical N95 respirator provides the respiratory protection of an N95 respirator, and like a surgical mask, provides a barrier to splashes, droplets, and sprays around the nose and mouth.

For most activities requiring respiratory protection, a fit-tested NIOSH-certified N95 or more protective respirator is sufficient to protect against airborne particles. However, N95 respirators offer no protection against gases and vapors and little protec-tion against direct liquid splashes (see the Centers for Disease Control and Prevention's (CDC's) Respirator Trusted-Source In-formation).

Fit test the respirator and train workers to use respiratory protection. Follow all requirements in the Occupational Safety and Health Administration (OSHA) respiratory protection standard (29 CFR 1910.134). An appropriate full-facepiece, chemical car-tridge-type respirator or powered air-purifying respirator (PAPR) should be worn when there is a risk of respiratory exposure to HDs, including when:

• Attending to HD spills larger than what can be contained with a spill kit

• Deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC

• There is a known or suspected airborne exposure to powders or vapors

7.6 Disposal of Used Personal Protective Equipment

Consider all PPE worn when handling HDs to be contaminated with, at minimum, trace quantities of HDs. PPE must be placed in an appropriate waste container and further disposed of per local, state, and federal regulations. PPE worn during compounding should be disposed of in the proper waste container before leaving the C-SEC. Chemotherapy gloves and sleeve covers (if used) worn during compounding must be carefully removed and discarded immediately into a waste container ap-proved for trace contaminated waste inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC.

8. HAZARD COMMUNICATION PROGRAM

Entities are required to establish policies and procedures that ensure worker safety during all aspects of HD handling.