Hazardous Drug Gap Analysis

Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
WAC 296-62-…
Hazardous Drugs
This chapter provides minimum requirements for
developing a hazardous drugs control program when
occupational exposure to hazardous drugs is
“reasonably anticipated”. It is designed to provide
effective, assessment-based precautions to minimize or
eliminate occupational exposure to
hazardous drugs.
Would apply to hospital, infusion
Applies to employers in health care facilities regardless centers and clinics
of setting where there is occupational exposure to
hazardous drugs.
Hazardous Drug Policy and
Standard Work Inventory
At minimum applies to Pharmacists, Pharmacy
technicians, Physicians, Physician assistants, nurses,
Patient Care Assistants, OR personnel, environmental
services staff (EVS, laundry, housekeeping) and those
that handle procurement
50015 (1)
Chemotherapy glove, closed system drug transfer
device (CSTD), decontamination, engineering controls,
hazardous drug, health care facilities, HEPA filter,
isolators, MSDS, occupational exposure, ventilated
Hazardous Drugs Control Program
1. Written program including:
Effective January 1st, 2014
Hazardous Drug Policy and
Standard Work Inventory
Reference Policy # on Hazardous
Drug Policy and Standard Work
Gap / Recommendations
Occupational exposure to hazardous
drugs is also covered under WAC
296-800-170, Employer chemical
hazard communication -Introduction. In addition the
employer must follow the
requirements in WAC 296-800-160,
personal protective equipment
(PPE) and chapter 296-842 WAC,
Respirators. Whenever there is a
conflict between rule requirements
the most protective requirement will
take precedent.
System wide approach and
Organizational level policy.
Hospital, Clinics, and Infusion
Occupational exposure to hazardous
drugs is “reasonably anticipated”
for all employees working in the
Hospital or Clinics.
Standardize language in policies to
demonstrate compliance.
Create a document/policy that
defines the overall program and
Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
a) Written Inventory of Hazardous Drugs
b) Hazard assessment (see section 50020)
c) Policies and procedures
Engineering controls
Personal Protective Equipment
Safe Handling practices
Cleaning, housekeeping and waste
Spill control
Personnel issues (eg pregnant workers)
1a. 1
1b. (see section 50020)
1ci. Engineering controls 22, 23,
24, 25, 26, 27, 28
1cii. PPE main policies are 5,18,22
but mentioned in nearly every
1ciii. Safe Handling practices
1civ. Cleaning, housekeeping, and
waste handling 11-22
1cv. Spill control 2,5,21,22
i. Personnel issues (eg
pregnant workers)
ii. Training
reference it in the appropriate
medical center level policies.
No current policies refer to the
Hazardous Drug List or the
stratification of the list into 3 levels
of risk: chemo/biotherapy,
hazardous drugs, and low risk/no
PPE grid isn’t stratified for levels of
Hazardous waste handling by
outside contractors (Crothall). Lack
of common SW for (cleaning,
housekeeping, waste, spills). Not
stratified for levels of risk.
50015(1c vi) No organizational
standard regarding pregnant
50015 (2)
See P&Ps listed in 50015 (1)
Institute Universal precautions or tiered precautions
based on exposure risk. Establish a tiered approach that
effectively matches precautions to the nature of
exposure may be used including, but not limited to,
handling, storing, cleaning, preparing and engineering
Unit and area specific training may
exist. No organizational level
training (annual HLC module,
onboarding opportunity).
Precautions are currently universal
for all hazardous drugs
(chemo/biotherapy, hazardous
drugs, low risk/no PPE). Create a
tiered approach based on hazards.
Clarification of what is required for
chemo/biotherapy v hazardous v
Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
low risk/no PPE.
For chemo/bio require chemo
orders, PPE, prescribing
restrictions, CSTD, biosafety
cabinets, spike & prime in Rx,
patient waste handling defined.
For Hazardous drugs require some
PPE, may have prescribing
restrictions, use biosafety cabinets.
Patient waste handling not required.
For low risk/no PPE. No
precautions necessary unless
medications are crushed.
EVS linen policy doesn’t address
hazardous drug soiled linen
(universal precautions?)
50015 (3)
No policies found.
Annual Review
Annual Review of the Hazardous drug control program
50015 (4)
Employee Input
Seek and consider input from employees
No policies found.
Employees were involved in the
selection of CSTD & chemo gloves
Hazard Assessment
1-2. Hazard Assessment elements (see sub section
Establish annual review committee,
policy, and process.
Nominate Oncology RN, Pharmacy
Manager, Regulatory Compliance,
and Environmental team members.
Feedback method for employee
concerns about efficacy of program
& satisfaction with protections.
Culture of Safety survey custom
500201a PPE not stratified for risk
Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
50025- 45 for details)
a) Personal Protective equipment
b) Engineering Controls (CSTD, hoods)
c) Physical Layout of work areas
d) Types of hazardous drugs handled
e) Volume frequency and Handling
f) Equipment maintenance
g) Decontamination and cleaning
h) Potential hazardous exposures
i) Exposures during drug preparation &
j) Spill response
3. Conduct a hazard assessment as part of the
hazardous drugs control program update and
whenever changes that affect occupational exposure
occur, such as introduction of a new hazardous drug
or a change in handling practices.
a. see section 50015(1) 1cii
b. see section 50015(1) 1ci
c. 22,24,25
d. Hazardous Drug List, 1
e. No policy found
f. USP 797, 27
g. USP 797, 12-21
h. 8
i. 8
j. Main policies 5 & 21, referenced
in many
3. P&T and Pharmacy Informatics
processes now include a hazard
assessment for medications added to
the Formulary.
500201b CSTD not referenced in
VNet policies
500201c segregated RN workspace
for hazardous drugs?
500201e area specific plans? No
coordinated audit of hazardous drug
500201g outside contractors SW
500201i CSTD, Rx spiking &
priming chemo in biosafety cabinet,
RN dry spiking not mentioned in
policies. Rx Dept policies need to
be updated.
3. No policy in place
Note: The likelihood that a worker will experience adverse effects from
exposure to hazardous drugs varies depending upon
the relative toxicity and absorptive properties of a drug, the amount,
duration and frequency of contact, and the lack of
proper work precautions.
Engineering Controls
1) Engineering controls
a) Closed Transfer devices
b) Safe Sharps devices
c) Safety interlocks
2) Ventilated cabinets
a) Prepare drugs within cabinet
i. crushed orals
ii. no cabinet available
b) cabinet has continuous monitoring device
c) HEPA filter
1abc. See section 50015(1) 1ci
2a. 22
2ai. no crushed meds process
b-g. yes, contracted to Technical
Safety Services (TSS)
2ai. CSTD not referenced in
policies. Clarification of when they
are needed. Crushing of oral drugs
is done on nursing units but
discouraged. Need DO NOT
CRUSH warnings added to
labeling/MAR. Hazardous drugs
may be crushed with PPE but
chemo/biotherapy may NOT.
Needs a designated preparation area
Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
d) outside exhaust
e) downstream fans
f) not-recirculating
g) Maintenance & cleaning procedures
i) Field certify performance
ii) Isolators
iii) field certification label displayed
iv) workers doing maintenance are
v-ix) Equipment removal practices
(see also 50020 1c) and cleaning
2aii. Chemotherapy may be
prepared in low volumes with
similar precautions.
2ix. Chemotherapy filter exchange
process revision
see section 50015(1) 1cii
Personal Protective Equipment
1) PPE assessment
2) PPE use with body fluids and laundry
PPE main policies are 5,18,22 but
3) Gloves – chemo gloves, latex free available,
mentioned in nearly every policy
two pair, change every 30-60 minutes, replace
if damaged or contaminated
4) Protective clothing – chemo gowns, change
every 2-3 hours
5) Face protection – spills and bladder instillations
6) Respiratory protection –
a/b. N95 or chemical cartridge respirator
for spills of volatile drugs, inhaled drugs (ie
pentamidine), IV bag disconnects
7) PPE disposal – immediate disposal or
Safe Handling practices
1) Receiving & storage
a) Label containers
1a. WAC 296-800-170
1b. double bagging, storage on low
shelves, separate from other drugs
Must also evaluate PPE per WAC
296-800-160 & Respirators per
WAC 296-842
50030(1) stratification missing from
50030(2) EVS policies use
Universal precautions, is this
50030(7) Clinics process variable
50035(1) not referenced in policies
50035(2a) Do RNs have separate
Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
b) Storage and transport – minimize breakage
and spillage
2) Preparation and administration
a) Designated work areas
b) Coordinated tasks
c) Spike and prime
d) Do not disconnect tubing
e) Prep in a ventilated hood
a. Sealed bag
b. Waste containers seal & wipe
c. Remove outer gloves in hood
3) Waste handling
a) Pharmaceutical waste disposal
4) Personal hygiene
a. No eating or drinking.
b. Wash hands with soap and water before
and after.
Cleaning and housekeeping
1) Procedures for cleaning and decontamination
2) Cleaning area ventilation
3) Clean work spaces (after each activity/shift)
2a. yes for Rx
2b. CSTD, red baskets, double
bagging, yellow buckets in OIC
2c. CSTD, spiking in Rx or dry
spiking by RNs
2d. CSTD, dry connections
2e. yes
Bagged in hood
Need a policy
3a. 12-22
4a. 24,
4b. 5, no Rx policy
Spill control
3) Spill response procedures
a) Authorized responders & circumstances
b) PPE
c) Spill kit locations
d) Area containment and signage
e) Reporting
f) Restricted access
g) Waste disposal
4) Spill kits or clean-up materials near potential
spill locations
See 50020(j)
Note: See chapter 296-824 WAC, Emergency response for requirements
hazardous drug workspace?
50035(2c-e) CSTD that resolve
these issues not mentioned in
50035(3a) not standardized for
hospital and clinics
50035(4b) policies do not address,
area specific SW?
Clinics v Hospital
1. 22, 13-22
2. no policies found
3. Rx policies
Clinics v Hospital
Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
regarding response to spills that create significant
safety and health risks, and WAC 296-800-150, first-aid summary for
emergency washing requirements.
No policies found.
(1) Provide hazardous drugs
training to all employees with occupational exposure at
the time of their initial job assignment and on a
regularly scheduled basisthereafter.
(2) Include the training elements listed in WAC 296800-17030,inform and train your employees about
hazardous chemicals in your workplace.
Implementation Plan
1) Effective Dates
a) Written plan completed by Jan 1, 2014
b) Employee training by July 1 2014
c) Ventilated cabinets in place by Jan 1 2015
2) DOH
a) Advisory Committee
b) Trade Associations
Hazardous Drug Policy Inventory
Make part of the initial hire and
annual evaluation process.
HLC module or onboarding