Hazardous Drug Control Program WAC 296-62-500 2012 – Gap Analysis WAC 296-62-… 500 Requirement 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. 50005 Would apply to hospital, infusion Scope 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 50010 50015 (1) Document1 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 Drugs Control Program 1. Written program including: Compliance 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 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. 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 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 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 practices 2,5,7,11-23 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. 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(1c vi) No organizational standard regarding pregnant workers. 50015 (2) Document1 See P&Ps listed in 50015 (1) Precautions 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 controls. 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 50020 Document1 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 questions? 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 & administration 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 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 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. 50025 Document1 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 trained v-ix) Equipment removal practices 50030 50035 Document1 (see also 50020 1c) and cleaning procedures. 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 decontamination 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 policies 50030(2) EVS policies use Universal precautions, is this enough? 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 50040 50045 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 i. Bagged in hood ii. Need a policy iii. Yes 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 Document1 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? 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. 50050 50055 No policies found. Training (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 Appendix: Hazardous Drug Policy Inventory Document1 Make part of the initial hire and annual evaluation process. HLC module or onboarding opportunity.