1 safe handling of hazardous drugs karen bowman, mn, rn, cohn-s, ehs, wsna jeff rochon, chief...

32
1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE Presentation on August 30, 2013

Upload: autumn-start

Post on 30-Mar-2015

215 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

1

Safe Handling of Hazardous Drugs

Karen Bowman, MN, RN, COHN-S, EHS, WSNA

Jeff Rochon, Chief Executive Officer, WSPA

Alex Truchot, Sr. HSE Manager, CBRE

Presentation on August 30, 2013

Page 2: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

2

Legislation

SB 5594 Healthcare Settings:

Hazardous Drugs

L&I will adopt rules for the

handling of hazardous drugs

Rulemaking shall consider

stakeholder input

Created WAC 296-62-500 which

was published January, 2012

Page 3: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

Law passed – LNI to develop Haz Drug program consistant with NIOSH Guidelines

Seattle Times Articles about cancer after years of exposure

2 Stakeholder meetings and WSHSC panel of experts presentation.

LNI rewrites rule in last 2 weeks of Dec.

Hazardous Drugs Advisory Committee established

LNI presented at WSHSC – painted picture of things to come

New rule published

Request for 1 year extension granted. Rule starts Jan 1, 2015

2013201220112010

LNI Model Programs published and Algorithm created

Timeline

Page 4: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

4

NIOSH Guidelines

L&I to mandate to create rules consistent with but not exceed provisions adopted by the NIOSH 2004 alert on preventing occupational

exposures

Presents a standard or universal precautions approach to handling drugs safely

Page 5: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

5

Rule Scope

Applies to all employers in health care facilities regardless of setting with employees with occupational exposure to hazardous drugs

Health Care Facility where a health care provider provides health care to patients

All hospitals Clinics Nursing homes Laboratories Offices or similar places

WAC 296-62-5005

Page 6: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

6

Hazardous Drugs

Any drug identified by NIOSH or any drug that meets at least one of the following six criteria:

Carcinogenicity

Teratogenicity or developmental toxicity

Reproductive toxicity in humans

Organ toxicity at low doses in humans or

animals

Genotoxicity

New drugs that mimic existing hazardous drugs in structure or toxicity

Page 7: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

7

Occupational Exposure

Hazardous drug contact as a result of an employee’s duties

Inhalation Skin Ingestion Injection contact

Note: A hazardous drug that is formulated so that exposure will not occur may require less or minimal exposure protection as long as it is not altered (cut, dissolved, crushed, etc.)

Some drugs defined as hazardous may not pose a significant risk of occupational exposure because of their dosage formulation Example: coated tablets or capsules that are administered to patients without modifying the formulation. Note: They may pose a risk if altered if tablets are crushed or dissolved, or if

capsules are pierced or opened

Page 8: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

8

Occupational Exposure Job Classes

Pharmacists and pharmacy technicians

Physicians and physician assistants Nurses (ARNPs, RNs, LPSs)

Patient care assistive personnel Operating room personnel Home health care workers Veterinarians Janitorial Engineering Shipping and Receiving

Page 9: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

9

Rule Structure

Hazardous Drugs Control Program Hazard Assessment Engineering Controls Personal Protective Equipment Safe Handling Practices Housekeeping Spill Control Training Implementation Medical Monitoring and Recordkeeping

removed

Page 10: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

10

Hazardous Drugs Control Program

Written inventory of hazardous drugs in the workplace – NIOSH list is a starting point

Written polices and procedures including Engineering controls Personal protective equipment (PPE) Safe handling practices Cleaning, housekeeping, and waste

handling Spill Control Personnel issues Training

Requires employee involvementWAC 296-62-50015

Page 11: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

11

Hazard Assessment Conduct an initial and annual

assessment New assessments needed when changes

that affect occupational exposure occur New drug New process Different formulation of a drug

Assessment must include PPE Types of HD handled Volume, frequency, packaging and form of

HD Equipment maintenance Decontamination and cleaning Waste handling Potential HD exposure during work

operations Spill response

Page 12: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

12

Approach NIOSH recommends a standard or

universal precautions approach to managing occupational exposure to hazardous drugs

Some health care facilities may find it more effective to institute precautions based on exposure risk. For example a tiered approach that matches precautions to the nature of exposure may be used including but not limited to:

Handling Storing Cleaning Preparing Engineering controls

Page 13: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

13

Engineering Controls

Evaluate and implement appropriate engineering controls to eliminate or minimize employee exposure

Ventilated cabinets

Closed system transfer devices

Safer sharps devices

Safety interlocks

Pharmaceutical waste containers

WAC 296-62-50025

Page 14: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

14

Ventilated Cabinets Prepare hazardous drugs inside an

appropriate ventilated cabinet Mix Compound Crush Pour liquid

When sterility is not required, a Class I biosafety cabinet or isolator intended for containment applications may be sufficient

Alternate precautions may be used where hazard assessment indicates a low potential for occupational exposure. These may include, but are not limited to:

Temporarily designating a preparation area Use of appropriate personal protective

equipment Instituting cleaning procedures

Page 15: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

15

Ventilated Cabinets Cont’d Chemotherapy drugs must be

prepared in an appropriate ventilated cabinet with the exception of circumstances where the employer can document evidence of a clinical need. For example:

There is a non routine need to provide chemotherapy treatment

Compounding services aren’t readily available, and it is in the best interest of the patient to provide local care

Use appropriate filtering media as approved by cabinet manufacturer

Maintain properly and display field-certification label on each cabinet

Place fans downstream of the filter so contaminated ducts are maintained under negative pressure

Page 16: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

16

Ventilated Cabinets Cont’d Do not use a ventilated cabinet that re-circulates air or exhausts air back into

the room environment unless the hazardous drug in use will not volatilize while they are being handled or after they are captured by the filter

Field-certify biosafety cabinet performance, in accordance with National Sanitation Foundation/American National Standards Institute Standard 49:

After installation Relocation Maintenance Repairs to internal components HEPA filter replacement Every six months or as recommended

by the manufacturer

Page 17: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

17

Personal Protective Equipment - PPE1. When there is reasonably anticipated exposure

to hazardous drugs each health care facility must conduct a PPE assessment and provide and ensure use of appropriate PPE in accordance with:WAC 296-800-160, personal protective equipment (PPE), and chapter 296-842 WAC, Respirators

2. Gloves Use powder-free chemotherapy gloves when

handling chemotherapy drugs or potential contact with chemotherapy contaminated items or surfaces

Provide latex-free gloves to employees with latex sensitivities

Wear two pairs of gloves when there is a significant risk of breakage or contamination or permeation

Change gloves every thirty to sixty minutes or when torn, punctured, or contaminated

WAC 296-62-50030

Page 18: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

18

Personal Protective Equipment

3. Protective Clothing – Gowns Wear gowns whenever there is a possibility of

a hazardous drug splash or spill

Wear gowns made of polyethylene-coated polypropylene or other nonabsorbent, non linting protective material as determined by the PPE hazard assessment. Make sure the gown has a closed front, long sleeves, and elastic or knit cuffs

Remove and dispose of gowns: At the end of hazardous drug handling activities When leaving the hazardous drug handling area As possible when damaged or contaminated

If no permeation information is available, change gowns every two to three hours or when contaminated after a splash or spill.

Page 19: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

19

4. Face Protection Wear a full-face shield or a mask and eye protection

as appropriate when splashes to the eyes, nose, or mouth may occur.Examples include:

Cleaning a spill Performing a procedure such as bladder instillation

5. Respiratory Protection Use N95 or equivalent respiratory protection during

spill clean up & whenever there is a significant risk of inhalation exposure to hazardous drug particulates

Use appropriate chemical cartridge-type respirator for events such as large spills of volatile hazardous drugs

6. Disposable PPE Must be discarded into appropriate containers

immediately after use or soon after contamination. Reusable PPE must be properly cleaned & decontaminated after use or contamination

Personal Protective Equipment

Page 20: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

20

Receiving and storage Preparation and administration Waste Handling Personal Hygiene

Safe Handling Practices

WAC 296-62-50035

Page 21: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

21

Receiving and Storage Label HD containers as required by Hazard

Communications (Global Harmonization) policy Store and transport in a manner that minimizes

the risk of breakage

Preparation & Administration Provide designated areas and limit access during

preparation Coordinate tasks to minimize occupational exposure. Spike and prime IV tubing and syringes in a manner

to limit occupational exposure Do not remove tubing from IV bags that held HD Seal final product in a bag when prepared in a hood Remove all outer gloves and sleeve covers and bag

them for disposal while inside the cabinet

Receiving and Storage/Preparation & Administration

WAC 296-800-170

Page 22: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

22

Waste Handling Dispose of pharmaceutical waste in

accordance with applicable state and federal regulations

Place disposable items in designated containers

Personal Hygiene Prohibit eating and drinking in areas

where HD are handled Wash hands with soap and water

before donning gloves, immediately after removal, and whenever hands are contaminated

Waste Handling/Personal Hygiene

Page 23: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

23

Establish procedures for cleaning and decontamination of areas and equipment

Do not clean contaminated equipment in unventilated areas

Clean work surfaces before and after each continuous activity and at the end of the work shift

Cleaning and Housekeeping

WAC 296-62-50040

Page 24: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

24

Develop written spill response procedures which include at minimum:

Description of who is authorized to respond and under what circumstances

PPE for various hazardous drugs and spill sizes.

Location and use of spill kits or clean-up materials

Possible spreading of contamination, and area containment and signage

Reporting and evaluating the circumstances surrounding spills and releases

Restricted access to hazardous drug spills Waste disposal

Spill Control

WAC 296-62-50045

Page 25: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

25

Training

WAC 296-62-50050

Provide training

The time of initial job assignment

On a regular basis thereafter

Whenever changes in the workplace

occur that may affect occupational

exposure (Implied).

Page 26: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

26

Schedule

Adoption January, 2012

Effective dates January 1, 2015 - Hazardous Drugs

Control Program Training completed by 7/1/15 Ventilated cabinets installed by 1/1/16

Page 27: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

27

Implementation

The department will work with stakeholders to implement this chapter by doing the following:

Establish a Hazardous Drugs (HD) Advisory Committee

Develop model programs for implementation of these rules in a variety of health care facilities and settings

Provide education, training and consultation services to ensure that these model programs are widely distributed and can be effectively utilized.

Establish a hazardous drugs web page, and post relevant resources, sample programs and forms

Page 28: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

28

HD Advisory Committee Associations nominated Employer representatives:

WSMA WSHA WSPA WSVMA WHCA

Associations and Labor nominated Employee Representatives:

Virginia Mason: Registered Nurse (Oncology) WSNA: Registered Nurse (Occupational Health) Seattle Cancer Care Alliance: RN (Oncology) Nursing Home Facility: RN (Geriatrics) Bartell Drugs (Pharmacy Technician A)

DSHS representatives from Western State and Rainier School

DOH

Page 29: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

29

Establish a Hazardous Drugs Web Page L&I Hazardous Drugs web page http://www.lni.wa.gov/Safety/Topics/Ato

Z/HazardousDrugs/default.asp

Page 30: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

30

Model Programs and Training Develop model programs for

implementation of these rules in a variety of health care facilities and settings

Provide education, training and consultation services to ensure that these model programs are widely distributed and can be effectively utilized

This is subcommittee work

Page 31: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

31

Next Steps Subcommittee work on Model

Programs and Intention of NIOSH’s list

Continue efforts with WSHA, WSMA and other stakeholders

Work with ASHP, APhA, AHA to encourage dialog with NIOSH on their guidelines

Work with L&I on education of inspectors about pharmacies

Legislative fixes?

Page 32: 1 Safe Handling of Hazardous Drugs Karen Bowman, MN, RN, COHN-S, EHS, WSNA Jeff Rochon, Chief Executive Officer, WSPA Alex Truchot, Sr. HSE Manager, CBRE

Thank YOU!

Questions?

32