Hazardous Drug Control Program
WAC 296-62-500
2012 – Gap Analysis
WAC 296-62-… / Requirement / Compliance / Gap / Recommendations500 / Hazardous Drugs
This chapter provides minimum requirements for developing a hazardous drugs controlprogram when occupational exposure to hazardous drugs is “reasonablyanticipated”. It is designed to provide effective, assessment-basedprecautions to minimize or eliminate occupational exposure to
hazardous drugs. / Effective January 1st, 2014 / 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.
50005 / Scope
Applies to employers in health care facilities regardless of setting where there is occupational exposure to hazardous drugs.
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 / Would apply to hospital, infusion centers and clinics
Hazardous Drug Policy and Standard Work Inventory / System wide approach and program.
Organizational level policy. Hospital, Clinics, and Infusion Centers.
Occupational exposure to hazardous drugs is “reasonably anticipated” for all employees working in the Hospital or Clinics.
50010 / Definitions
Chemotherapy glove, closed system drug transfer device (CSTD), decontamination, engineering controls, hazardous drug, health care facilities, HEPA filter, isolators, MSDS, occupational exposure, ventilated cabinet / Hazardous Drug Policy and Standard Work Inventory / Standardize language in policies to demonstrate compliance.
50015 (1) / Hazardous Drugs Control Program
- Written program including:
b)Hazard assessment (see section 50020)
c)Policies and procedures
i)Engineering controls
ii)Personal Protective Equipment
iii)Safe Handling practices
iv)Cleaning, housekeeping and waste handling
v)Spill control
vi)Personnel issues (eg pregnant workers)
vii)Training / Reference Policy # on Hazardous Drug Policy and Standard Work Inventory
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 policy
1ciii. Safe Handling practices2,5,7,11-23
1civ. Cleaning, housekeeping, and waste handling 11-22
1cv. Spill control2,5,21,22
- Personnel issues (eg pregnant workers)
- Training
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.
PPE grid isn’t stratified for levels of risk.
Hazardous waste handling by outside contractors (Crothall). Lack of common SW for (cleaning, housekeeping, waste, spills). Not stratified for levels of risk.
50015(1cvi) No organizational standard regarding pregnant workers.
Unit and area specific training may exist. No organizational level training (annual HLC module, onboarding opportunity).
50015 (2) / Precautions
Institute Universal precautions or tiered precautions based on exposure risk. Establish a tieredapproach that effectively matches precautions to the nature ofexposure may be used including, but not limited to, handling,storing, cleaning, preparing and engineering controls. / See P&Ps listed in 50015 (1) / 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 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) / Annual Review
Annual Review of the Hazardous drug control program / No policies found. / Establish annual review committee, policy, and process.
Nominate Oncology RN, Pharmacy Manager, Regulatory Compliance, and Environmental team members.
50015 (4) / Employee Input
Seek and consider input from employees / No policies found.
Employees were involved in the selection of CSTD & chemo gloves / Feedback method for employee concerns about efficacy of programsatisfaction with protections.
Culture of Safety survey custom questions?
50020 / Hazard Assessment
1-2. Hazard Assessment elements (see sub section 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 & administration
j)Spill response
3. Conduct a hazard assessment as part of the hazardous drugscontrol program update and whenever changes that affectoccupational exposure occur, such as introduction of a newhazardous drug or a change in handling practices.
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. / 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. / 500201a PPE not stratified for risk
500201b CSTD not referenced in VNet policies
500201c segregated RN workspace for hazardous drugs?
500201e area specific plans? No coordinated audit of hazardous drug utilization.
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
50025 / 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
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 trained
v-ix) Equipment removal practices / 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 (see also 50020 1c) and cleaning procedures.
2aii. Chemotherapy may be prepared in low volumes with similar precautions.
2ix. Chemotherapy filter exchange process revision
50030 / Personal Protective Equipment
1)PPE assessment
2)PPE use with body fluids and laundry
3)Gloves – chemo gloves, latex free available, 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 (iepentamidine), IV bag disconnects
7)PPE disposal – immediate disposal or decontamination / see section 50015(1) 1cii
PPE main policies are 5,18,22 but mentioned in nearly every policy / Must also evaluate PPE per WAC 296-800-160 & Respirators per WAC 296-842
50030(1) stratification missing from policies
50030(2) EVS policies use Universal precautions, is this enough?
50030(7) Clinics process variable
50035 / Safe Handling practices
1)Receiving & storage
a)Label containers
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
- Sealed bag
- Waste containers seal & wipe
- Remove outer gloves in hood
a)Pharmaceutical waste disposal
4)Personal hygiene
- No eating or drinking.
- Wash hands with soap and water before and after.
1b. double bagging, storage on low shelves, separate from other drugs
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
- Yes
4a. 24,
4b. 5, no Rx policy / 50035(1) not referenced in policies
50035(2a) Do RNs have separate hazardous drug workspace?
50035(2c-e) CSTD that resolve these issues not mentioned in policies.
50035(3a) not standardized for hospital and clinics
50035(4b) policies do not address, area specific SW?
50040 / Cleaning and housekeeping
1)Procedures for cleaning and decontamination
2)Cleaning area ventilation
3)Clean work spaces (after each activity/shift) / 1. 22, 13-22
2. no policies found
3. Rx policies / Clinics v Hospital
50045 / 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
Note: See chapter 296-824 WAC, Emergency response for requirements regarding response to spills that create significant
safety and health risks, and WAC 296-800-150, first-aid summary for emergency washing requirements. / See 50020(j) / Clinics v Hospital
50050 / Training
(1) Provide hazardous drugs
training to all employees with occupational exposure at the time oftheir initial job assignment and on a regularly scheduled basisthereafter.
(2) Include the training elements listed in WAC 296-800-17030,inform and train your employees about hazardous chemicals in yourworkplace. / No policies found. / Make part of the initial hire and annual evaluation process.
HLC module or onboarding opportunity.
50055 / 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
Appendix:
Hazardous Drug Policy Inventory
G:\Dept\RX\Admin\Chemobiotherapy and Hazardous Drugs\Hazardous Drugs Gap Analysis 2012.docx