UNITYPOINT HEALTH - MARSHALLTOWN Marshalltown, Iowa PHARMACY POLICY AND PROCEDURE

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1 UNITYPOINT HEALTH - MARSHALLTOWN Marshalltown, Iowa PHARMACY POLICY AND PROCEDURE POLICY #: IAC Subject: Sterile Compounding Practices (Formerly Pharmaceutical Compounding - Sterile Preparations USP797) (Formerly Sterile Products #5.01) Purpose: To prevent harm and death to patients treated with compounded sterile preparations (CSPs) Procedure: 1) Training and Evaluation in Aseptic Manipulation Hand Hygiene and Garbing Cleaning Procedures a) Each pharmacy employee who is authorized to sterile compound must have completed training and initial competencies PRIOR to engaging in compounding b) The pharmacy shall have documentation of training and successfully passing the following for each employee INITIALLY i) See Hand Hygiene, Garbing and Gloving SOPs Training and Evaluation Form ii) See Media-Fill Procedure Training and Evaluation Form iii) See Aseptic Technique, Safety and Quality Assurance SOPs Training and Evaluation Form iv) See Glove Fingertip Sampling Procedure Training and Skills Evaluation Form v) See Cleaning and Disinfecting SOPs Training and Evaluation Form c) Training shall include didactic, audio-video and professional publications d) ONGOING annually for low and medium risk levels i) Hand hygiene is assessed for each compounding employee annually ii) Glove and garbing is assessed for each compounding employee annually iii) Cleaning and disinfecting procedures are assessed annually iv) Media fill tests are completed for the highest level of compounding performed (medium) v) Media fill tests for low risk and medium risk levels are repeated every year vi) Media fill tests are observed and documented vii) Media fill tests are performed under the most challenging conditions (i.e. end of day/ shift) viii) Glove fingertip sampling is completed annually for low/ medium risk ix) The results of glove fingertip sampling is properly documented by # CFU per person/ per hand x) Action levels for glove fingertip sampling are based on # of CFUs per person (not hand) xi) Evaluations occur in the following order: hand hygiene, garbing, fingertip sampling - discard gloves, hand hygiene, garbing, media fill testing, cleaning and disinfecting 2) Primary Engineering Controls (PEC) a) The PEC will maintain an ISO Class 5 b) ISO Class 5 air sources i) NuAire (BSC) NU-425FM-400 ii) Pharmagard Positive Pressure Recirculating Compounding Aseptic Isolator (CAI) NU-PR c) The PEC will be free of debris and non-essential items for the specific compound d) First air (air direct from filter to product) will not be blocked e) Critical sites (locations that include any component or fluid pathway surface or opening) will be protected by preventing physical contact (touch) and airborne contamination (ISO Class 5 or better air) f) Critical sites are swabbed with individually wrapped/ single use sterile 70% IPA immediately prior to penetration g) Smoke tests are performed to determine airflow and are unidirectional away from product h) The PEC is cleaned and disinfected top to bottom and back to front

2 3) Secondary Engineering Controls (SEC) Clean Room/ BUFFER Area a) Buffer Areas (ISO Class 7 or better) are where the primary engineering controls (BSC and CAI) are physically located b) The SEC is only accessible to personnel who are garbed c) Equipment is limited to necessary non-permeable, non-shedding and cleanable items for compounding d) No sink or floor drain e) No food or drink f) Items and equipment are cleaned and disinfected when first brought into the room g) The SEC maintains an ISO Class 7 or 8 (7 if adjacent to a negative pressure room and 8 if it is not adjacent to a negative pressure room) h) Work surfaces and shelving are smooth, impervious materials that can easily be cleaned (stainless steel/ molded plastic) i) Ceilings, walls, floors, fixtures, shelving, counters and cabinets are smooth, impervious materials and free from cracks and crevices and are non-shedding (ceilings/ wall tiles impregnated with polymer or epoxy-coated gypsum board) j) Junctures are caulked or covered so dirt cannot accumulate k) Lights are mounted flush to ceiling l) Carts are stainless steel wire, nonporous plastic or sheet metal with cleanable canisters m) Activities are limited to necessary movements (decreases shedding/ bioburden) n) Sterile gloves are donned in this area o) Smoke tests are performed (determines airflow; should be unidirectional away from product) p) Pressure differential monitors are used. Pressure gauge or velocity monitor measures airflow between the buffer area and ante area and between the ante area and general compounding area q) Pressure differential monitors continuously monitor pressure and documented on log every work shift (minimum daily) r) SEC provides HEPA filtered air to room with 30 air changes per hour (ACPH). The PEC is not the only source of filtered air s) The air is received from the ceiling and returned on the wall close to the floor t) There is a physical barrier between ISO class areas (ISO class 5 to 7 and ISO class 7 or 8 to general pharmacy area) and there is inches of water column 4) Secondary Engineering Controls (SEC) Clean Room/ ANTE Area a) The Ante Area (ISO Class 8 or better) is where personnel hand hygiene and garbing procedures, staging of components, CSP labeling and other high-particulate generating activities are performed. b) Contains a sink c) Does not have a line of demarcation (physically separated from BUFFER areas by doors) d) No food or drink 5) Cleaning and Disinfecting a) Cleaning occurs from cleanest to dirtiest (ISO Class 5 PEC to BUFFER area to ANTE area to general supply area) b) Cleaning and disinfecting of the PEC occurs at appropriate times (before each compounding shift, before each batch is started, at regular intervals every 30 minutes, when spills occur or are visibly soiled, when contamination is suspected) c) Residue free disinfectant (70% IPA) is allowed to dry before compounding starts d) When heavy soiling has occurred, a pre-cleaning step is completed before disinfecting. For example, water-soluble solid residues are removed with sterile water (for injection or irrigation) and low-shedding wipes. This shall be followed by wiping with a residue-free disinfecting agent such as sterile 70% IPA, which is allowed to dry before compounding begins e) Materials used for cleaning are appropriate (low shedding, synthetic fibers, dedicated for use in specific compounding area) f) Mops may be used in BUFFER and ANTE area in that order g) Items that are reused are identified and based on manufacturers recommendations that ensure effectiveness after repeated use and do not add to bioburden of area being cleaned

3 h) Cleaning agents are appropriate and identified (agents are compatible, effective, non-toxic residues) i) Areas are cleaned according to a schedule using approved agents by trained personnel - see Cleaning and Disinfecting Log j) Floors are mopped with cleaning and disinfecting agent once daily at time when no aseptic operations are in process 6) Personnel Cleansing and Garbing a) Personnel with a rash, sunburn, weeping sore, conjunctivitis or active respiratory infection shall be restricted from ISO Class 5 and 7 areas b) Compounding personnel in ISO class 5 and 7 remove make-up, visible jewelry (including rings) and all outer clothing (bandanas, scarves, vests). Nails are neat and trimmed c) Donning is completed in the following order - see Hand Hygiene, Garbing and Gloving SOPs - Training and Skills Evaluation Form d) Gowns are discarded if removed from the BUFFER area e) Gowns that are reused are discarded after one shift f) Shoe covers, head covers, face shields and gloves are NOT reused g) Sterile gloves are compatible with alcohol disinfection (tested by manufacturer) h) Gloves are inspected for punctures and tears frequently throughout compounding i) If gloves need replaced, hand cleansing and garbing is repeated j) Hand procedures are appropriate and completed after donning shoe covers upon entry to ANTE area - see Hand Hygiene, Garbing and Gloving SOPs - Training and Skills Evaluation Form k) Personnel cleansing and donning procedures are followed for compounding in an isolator UNLESS the manufacturer provides written documentation that any component is not required l) Personnel are garbed while preparing non-sterile hazardous ingredients m) Personnel re-garb prior to entering ISO Class 7 environment 7) Viable and Nonviable Environmental Sampling (ES) Testing a) Pharmacy has a comprehensive viable and nonviable environmental sampling plan b) Certification and testing of primary (BSC, CAI) and secondary engineering controls (buffer and ante areas) shall be performed by a qualified individual no less than every six months and whenever the device or room is relocated, altered, or major service to the facility is performed c) Certification that each ISO classified area (e.g., ISO Class 5, 7 and 8) is within established guidelines shall be performed by qualified operators no less than every 6 months and whenever the primary engineering control is relocated or the physical structure of the buffer room or antearea has been altered. d) Equipment is certified using state-of-the-art electronic equipment e) Records of certification are maintained and reviewed for competency f) Environmental sampling shall occur as part a comprehensive quality management program and shall occur minimally when several conditions exist including: i) part of the commissioning and certification of new facilities and equipment ii) following any servicing of facilities and equipment iii) as part of the re-certification of facilities and equipment (every 6 months) iv) in response to identified problems with end products or staff technique v) in response to issues with CSPs, observed compounding personnel work practices, or patient related infections where the CSP is being considered as a potential source of the infection g) Surface sampling is completed in all ISO areas h) There is a surface sampling plan that calls for the sampling of areas where contamination is likely (doors, counters) i) The surface sampling procedure is appropriate (gently touching the surface with agar and rolling plate across surface) j) Surface sampling includes: -Areas to be tested same each time to show trending, Frequency of testing, Volume tested, Day and time tested - should be done at end of compounding shift, Action levels, Size and type of plate (24-30cm^2) - see SEMI-ANNUAL ENVIRONMENTAL VIABLE SURFACE SAMPLING LOG: k) Areas of sampling are wiped thoroughly with non-shedding wipes soaked in sterile 70% IPA after a sample is taken (residue left by agar) l) Swabs used for irregular surfaces (wheels on carts)

4 m) Results reported as CFU per unit of surface area n) Air sampling shall be performed at least semi-annually (i.e. every 6 months), as part of the recertification of facilities and equipment for areas where primary engineering controls are located. o) Air sampling completed in locations that are prone to contamination (zones of air backwash, turbulence, doorways) p) Air sampling completed at all stages including staging, labeling, gowning and cleaning q) Air sampling tests liters at each ISO Class area r) Device used to sample the air is calibrated according to manufacturer s recommendations s) Air sampling results are documented on ES form and periodically evaluated for trends t) All CFUs identified by credited laboratories u) Action levels are followed (see table 4 USP797) v) CFUs above action levels are investigated and re-evaluated for the following: source of contamination identified, source eliminated, affected areas cleaned, re-sampled. Re-evaluation of personnel work practices, cleaning procedures and air filtration efficiency within aseptic compounding locations 8) Storage and Beyond Use Dating a) Expiration Date - chemical and physical stability of manufactured sterile products under certain conditions assigned by the manufacturer b) Beyond Use Date (BUD) - used when chemicals are removed from the manufacturers conditions assigned by compounders c) BUDs are appropriately assigned i) BUDs are based on the information provided by the manufacturer, whenever such information is available. ii) BUDs may be determined by a pharmacist based on drug stability information, stability studies and/or accepted professional principles. The BUD must be safe for patients and determined conservatively. iii) BUDs for Low/Medium/High Risk preparations, in the absence of passing a sterility test, cannot exceed the following time periods (USP797): Immediate Use Low Risk w/ 12- BUD Low Risk Med Risk High Risk Bag and Vial System Room Temp 1 hour 12 hours 48 hours </=30 hours 24 hours According to manufac. Fridge NA 12 hours 14 days 9 days 3 days According to manufac. Frozen NA NA 45 days 45 days 45 days According to manufac. 9) Single and Multidose Containers a) Beyond-use date 28 days, unless specified otherwise by the manufacturer, for closure sealed multiple-dose containers after initial opening or entry. b) Beyond-use time of 6 hours, unless specified otherwise by the manufacturer, for closure sealed single-dose containers in ISO Class 5 or cleaner air after initial opening or entry. c) Beyond-use time of 1 hour for closure sealed single-dose containers after being opened or entered in worse than ISO Class 5 air. d) Storage of opened single-dose ampoules is not permitted. 10) Monitoring Storage Areas a) Temperature is continuously monitored daily including when product is placed in or removed from the area b) Continuous monitoring is verified once daily - see Temperature Monitoring Log 11) Quality Control

5 a) Compounding personnel verify that ingredients for CSPs are of the correct identity and appropriate quality using the following information: vendor labels, labeling, certificates of analysis, direct chemical analysis, and knowledge of compounding facility storage conditions. b) A unit-by-unit physical inspection preparatory to using sterile ingredients and devices is completed by compounding personnel to ensure that the components are sterile, free from defects, and otherwise suitable for their intended use. c) If equipment is used it is calibrated after routine maintenance and is monitored for proper function. Personnel are trained on proper use and documentation is kept on file for the life of the equipment. NA 12) Finished Preparation Release Check a) Compounding personnel review labels and document correct measurements, aseptic manipulations, to confirm correct identity, purity, and strength of ingredients in CSPs. b) CPS shall be visually inspected by compounding personnel and personnel performing a finished preparation release check for abnormal particulate matter and color, and intact containers and seals. c) A pharmacist shall check all CSPs to ensure labels contain correct names and amounts or concentrations of ingredients, total volumes, beyond-use dates, storage conditions, and route(s) of administration. 13) Quality Assurance a) Personnel Training and Evaluation i) See Personnel Training and Competency Evaluation b) Environmental Monitoring i) Air Quality Testing (1) See Semi-annual Certification Reports ii) Surface Sampling (1) See Surface Sampling Log iii) Pressurization Monitoring (1) See Pressurization Monitoring Log iv) Temperatures and Humidity (1) See Temperature Monitoring Log for Back of Pharmacy (2) STAEFA Temperature hourly monitoring per facility management (main pharmacy, refrigerators, freezer) (3) STAEFA Humidity hourly monitoring per facility management (main pharmacy) c) Equipment Calibration and Maintenance - NA 14) Patient Monitoring and Adverse Event Reporting a) Reports of adverse events will be recorded b) Receipt of adverse event reports will go to the Director of Pharmacy or Designee c) The Director of Pharmacy or designee will review and evaluate adverse event reports d) Adverse events claimed to be associated with CSPs will be addressed e) Written standard procedures describe means for patients to ask questions and report concerns and adverse events with CSPs, and for compounding supervisors to correct and prevent future problems. f) Adverse events and defects with CSPs reported to FDA's MedWatch and USP's MEDMARX programs. 15) Other a) Access to the BUFFER area will be restricted to qualified personnel with specific tasks b) Hazardous drugs will be stored at a proper temperature and segregated c) Supplies will be decontaminated by removing them from shipping cartons and wiping or spraying them with a non-residue-generating disinfecting agent while they are transferred to a clean disinfected cart for introduction into the BUFFER area d) Only the furniture, equipment, supplies, and other material required for the compounding activities to be performed shall be brought into the room; their number, design and manner of installation shall promote effective cleaning and disinfection. e) Supplies that are needed frequently can be decontaminated and stored in the ANTE area f) Supplies that are required for back-up or general support of operations may be stored on the designated shelving in the buffer area, but excessive amounts of supplies are to be avoided.

6 g) Supplies for use in the direct compounding areas shall be decontaminated prior to introduction into aseptic area. They are arranged to decrease clutter and not block first air h) After use supplies are removed with the least amount of movement i) Carts can t be removed from the BUFFER area unless cleaned and disinfected before returning j) Non-essential shedding items shall not be brought into the BUFFER area including pencils, cardboard, paper towels, cotton items (gauze pads) k) Essential paper items shall be put into protective plastic and wiped down prior to being brought into the BUFFER area l) Traffic flow in and out of the BUFFER area shall be minimized m) Personnel must remove all outer garments, cosmetics, visible jewelry n) Personnel entering into the ANTE area must don attire then perform hand washing o) No food, gum or drinks are allowed in the BUFFER or ANTE areas p) Cleaning and disinfecting must be completed at the beginning of the compounding shift, when spills occur with purified water and then disinfected with a non-residue-generating agent using non-shedding wipes q) PECs shall be operated continuously. If turned off it must be turned on 30 minutes prior to cleaning and disinfecting before compounding can begin r) Traffic in the designated compounding area shall be minimized and controlled s) Gloves are disinfected frequently with sterile 70% IPA and allowed to dry t) Rubber stoppers and necks of vials are disinfected with sterile 70% IPA and allowed to dry (10 sec) before they are used to prepare CSPs u) Labels contain correct names and amounts or concentrations of ingredients, total volume, BUD, route of administration, storage conditions, date prepared and any other information for safe use v) Verification = correct identities, purities, and amounts of ingredients by comparing the original order with the compounding record i) Record Requirements (13.8) A production record shall be prepared and kept for each drug product compounded for an individual patient. A production record is not required when mixing or reconstituting a drug according to the product s labeling or the manufacturer s directions. The record shall include the following information: (1) Production date (2) List of ingredients and quantity of each ingredient used (3) Initials or unique identification of each person involved in each of the compounding steps (4) Initials or unique identification of each pharmacist verifying each of the compounding steps (5) Internal control or prescription number (6) See Compounding Log Book w) Compliance with policy and procedure for all aspects of compounding, storage, handling and transport x) Education and Training - (Halogen per education department) y) CSPs may be re-dispensed when sterility, and acceptable purity, strength, and quality can be ensured. z) Packaging will maintain physical integrity, sterility, stability, and purity of CSPs. aa) Modes of transport will maintain appropriate temperatures and prevent damage to CSPs. 16) Immediate Use CSPs a) The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile non-hazardous products or diagnostic radiopharmaceutical products from the manufacturer s original containers and not more than two entries into any one container or package (e.g. bay, vial) of sterile infusion solution or administration container/ device. b) Unless required for the preparation, the compounding procedure is a continuous process not to exceed 1 hour c) During preparation, aseptic technique is followed and, if not immediately administered, the finished CSP is under continuous supervision to minimize the potential for contact with nonsterile surfaces introduction of particulate matter or biological fluids, mix-ups with other CSPs, and direct contact of outside surfaces d) Administration begins not later than 1 hour following the start of the preparation of the CSP

7 e) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1 hour BUD and time f) If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly and safely discarded 17) CSP Microbial Contamination Risk Levels a) Low-Risk Level CSPs i) Aseptic manipulations within an ISO Class 5 environment using three or fewer sterile products and using two or fewer entries into any container. ii) In absence of passing sterility test, store not more than 48 hours at controlled room temperature, 14 days at cold temperature, and 45 days in solid frozen state at 25 to 10 or colder. iii) Media-fill test at least annually by authorized compounding personnel. Media fill is completed under the most challenging or stressful working conditions (not interrupted) iv) Quality assurance includes: (1) Routine disinfection (2) Routine air quality testing of direct compounding environment (3) Visual confirmation that personnel are properly donning and wearing appropriate protective garments including eye protection and face masks (4) Review of all orders and packages of ingredients for accuracy (5) Visual verification of final CSP to ensure the absence of particulate matter b) Medium-Risk Level CSPs i) Aseptic manipulations within an ISO Class 5 environment using prolonged and complex mixing and transfer, more than three sterile products and entries into any container, and pooling ingredients from multiple sterile products to prepare multiple CSPs. ii) In absence of passing sterility test, store not more than 30 hours at controlled room temperature, 9 days at cold temperature, and 45 days in solid frozen state at 25 to 10 or colder. iii) Media-fill test at least annually by authorized compounding personnel. Media fill is completed under the most challenging or stressful working conditions (not interrupted) iv) Quality assurance includes same as Low-Risk Level CSPs 18) Hazardous Drugs as CSPs (see Policy Hazardous Drugs and Chemicals IAC (10)) a) Appropriate personnel protective equipment i) double gloves, gown, eye protection, respiratory protection, ventilated engineering control b) Appropriate primary engineering controls are used for concurrent personnel protection and exposure of critical sites. i) NuAire BSC NU-425FM-400 c) Hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. i) All Antineoplastic and Other Safety/Health Hazardous Drugs are identified by a Hazardous Drug sticker, placed by pharmacy (NIOSH) d) Hazardous drugs shall be handled with caution at all times using appropriate chemotherapy gloves during receiving, distribution, stocking, inventorying, preparing for administration, and disposal. e) Hazardous drugs shall be prepared in an ISO Class 5 environment with protective engineering controls in place, and following aseptic practices specified for the appropriate contamination risk levels. f) Access to drug preparation areas shall be limited to authorized personnel who are garbed i) RX Only ii) As approved by Director of Pharmacy (facilities, certification personnel, etc.) g) A pressure indicator shall be installed that can readily monitor room pressurization, which is documented daily. i) Daily Pressurization Log h) Annual documentation of full training of personnel regarding storage, handling, and disposal of hazardous drugs.

8 i) Hazardous Medications Written Assessment i) When used, a closed system transfer device (CSTD) shall be used in an ISO Class 5 primary engineering control device. j) At least 0.01 inch water column negative pressure is required for compounding of hazardous drugs. i) Certification reports k) Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs. l) Total external exhaust of primary engineering controls. i) Certification reports m) Assay of surface wipe samples every 6 months. i) SEMI-ANNUAL ENVIRONMENTAL VIABLE SURFACE SAMPLING LOG n) Disposal of all hazardous drug wastes shall comply with all applicable federal and state regulations. i) See Policy Hazardous Drugs and Chemicals AC (10) o) Spills of Hazardous Drugs 3.20(8) i) Hazardous Spills Occurring in the BSC (1) Spills should be cleaned up immediately (2) A spill kit should be used if the volume exceeds 150mL or the contents of one drug vial or ampule (3) If there is broken glass, utility gloves should be worn to remove it and place it in a puncture-resistant container (4) The BSC, including the drain spillage trough, should be thoroughly cleaned (5) If the spill is not easily and thoroughly contained, the BSC should be decontaminated after cleanup (6) If the spill contaminates the HEPA filter, use of the BSC should be suspended until the cabinet has been decontaminated and the filter is replaced ii) Hazardous Spills Occurring outside the BSC (1) Contain the spill with paper towels and/or other absorbent material (2) If the spill is small, place a chair or some other type of barricade to isolate the spill and prevent people from walking through the spill (3) If the spill covers a large area, someone must be assigned to the area to prevent people from walking through the spill (4) Personal protective equipment may be essential to contain and isolate the spill (5) After the spill has been contained/ isolated, call ENS for clean-up and advise the following: (a) Exact location of spill, Name of hazardous material, Amount of hazardous material, What has been done to contain and isolate the spill p) Transport i) Transport hazardous drugs in closed containers that minimize the risk of breakage ii) All staff members should wear Personal Protective Equipment when doing stocking, inventory control, selecting drug packages for further handling and transport 19) Preparation Recall (13.6(3)) a) If used preparation(s) are determined to not meet product quality standards, pharmacy will discontinue use of the product(s) and quarantine any unused product(s) until they can be destroyed. b) A variance report will be documented 20) Delivery of Sterile Preparations (13.33) a) Staff will prevent the depression of syringe plungers or dislodging of syringe tips during transport b) Physical shaking and undue exposure to heat or light will be addressed on a preparation-specific basis c) Alternative transport modes or special packaging measures may be used to assure quality of CSPs (coolers, no tube system, light exposure packaging, etc.)

9 d) The use of tamper evident closures and seals on CSP ports will be used to protect product integrity and sterility and add an additional measure of security 21) Master Formulation Records (USP800). A Master Formulation Record must be created for CSPs prepared in a batch for multiple patients or for CSPs prepared from nonsterile ingredients. a) Name, strength and dosage form of the CSP b) Physical description of the final preparation c) Identities and amounts of all ingredients and appropriate container closure systems d) Complete instructions for preparing the CSP, including equipment, supplies and a description of the compounding steps e) BUD and storage requirements f) Quality control procedures (e.g., ph, filter integrity, and visual inspection) g) Sterilization method, if applicable h) Any other information needed to describe the operation and ensure its repeatability (e.g., adjusting ph and tonicity and temperature) 22) Compounding Records. A Compounding Record must be created by the compounder preparing the CSP to document the compounding process. Each Compounding Record must be reviewed and approved before the CSP is released (signature or initials and date). a) Name, strength, and dosage form of the CSP b) Master Formulation Record reference for the preparation, when used c) Date and time of preparation of the CSP d) Assigned internal identification number (e.g., prescription or lot number) e) Signature or initials of individuals involved in each step (e.g. technician or pharmacist) f) Name, vendor or manufacturer, lot number, and expiration date of each ingredient and container closure system g) Weight or measurement of each ingredient h) Documentation of the calculations made to determine and verify quantities and or concentrations of components, if appropriate i) Documentation of quality control procedures in accordance with the SOP (e.g., filter integrity, ph, and visual inspection) j) Any deviations from the Master formulation Record, if used, and any problems or errors experienced during the compounding of the CSP k) Total quantity compounded l) Assigned BUD m) Duplicate container label if prepared in a batch Additional Information: 23) CMS Survey Procedure a) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws (CMS A (b)(1)) i) Ask for one or more examples of situations in which a BUD had to be determined for a compounded sterile medication (CSP) based on the policy. ii) Is there evidence that the BUDs are determined consistent with the hospital s policies and procedures? iii) Review the hospital s procedures for maintaining the quality of CSPs during storage, transport and dispensing. b) Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use (CMS A (b)(3)) i) Review the pharmacy policies and procedures for determining BUDs (for medications compounded in-house as well as from external sources). Can the hospital demonstrate that the policies and procedures are consistent with or more stringent than the applicable USP standards? Can it demonstrate that the pharmacy personnel assigned to determining BUDs when a manufacturer s instructions are not available have the expertise and technical support needed to properly conduct the assessments needed to make such determinations in a manner consistent with standards and hospital policies?

10 ii) Ask for one or more examples of situations in which a BUD had to be determined for a compounded sterile medication (CSP) based on the policy. Interview pharmacy personnel assigned to carry out this function within the hospital and/or to assess how this is done by external source(s) of CSPs. Is there evidence that the BUDs are determined consistent with the hospital s policies and procedures? Closing Banner: Originated by: Pharmacy Department Effective date: 2/10/11 Authorized by: P&T Cmte/ Date: 07/16, 9/16 Authorized by: Jessica Rosenhamer, Pharmacy Director Revision date: 3/16, 07/16 Review date: 9/15, 5/16, 7/17 References: USP797 USP800 CETA Certification Guide for USP797 Iowa Pharmacy Law CMS

11 Personnel Training and Competency Evaluation (Initially and Annually for Low and Medium Risk Level Compounding) Training Checklist Training shall be completed and documented before any compounding personnel begin to prepare CSPs. Train on Standard Operating Procedures (SOPs) Hand Hygiene, Garbing and Gloving Aseptic Technique, Safety and Quality Assurance Cleaning and Disinfecting Watch ASHP Video Guide to Chapter 797 (may refer to companion guide) Competency Checklist SOPs Observational Assessment Hand Hygiene, Garbing and Gloving Must complete successfully prior to preparing CSPs Aseptic Technique, Safety and Quality Assurance Cleaning and Disinfecting Complete Compounding Sterile Preparations Written Assessment (Passing Results 100%) Results Read Policy #USP797 Media Fill Test Observational Assessment (Passing results = Negative/ No Turbidity) Sample # Media LOT # Watch Nuaire Videos Working Safely in the Pharmagard 797 (An Interactive Guide) PharmaGard PR-797 Compounding Aseptic Isolator (Operation and Maintenance Manual) Working safely in your NuAire Biological Safety Cabinet NuAire BSC NU-425FM-400 (Operation and Maintenance Manual) U- 543_BioSafety_Cabinet_ p df Gloved Fingertip/ Thumb Observational Assessment INITIALLY - Must complete successfully at least 3x prior to preparing CSPs (Passing Results = CFU both hands = 0) ANNUALLY for low/ medium risk (Passing Results = CFU both hands </=3) Results Results Results Person Trained/ Date Qualified Trainer/ Date

12 Hand Hygiene, Garbing and Gloving SOPs - Training and Skills Evaluation Form The qualified evaluator (pharmacist) will check each space for which the person being assessed has acceptably completed the described activity, prints N/A if the activity is not applicable to the assessment session or N/O if the activity was not observed. HAND HYGIENE, GARBING and GLOVING SOPs TRAINING EVALUATION Presents in a clean appropriate attire and manner. (Personnel with rashes, sunburn, weeping sores, conjunctivitis, or active respiratory infection, shall not prepare CSPs.) Nails are neat and trimmed (no artificial nails) Removes make-up (Hazardous Compounding ONLY), visible jewelry (including rings) and outer garments (bandanas, scarves, vests) Washes hands or disinfects hands with sanitizer Brings (or stores) no food or drinks in the ante-area or buffer areas Walks across sticky mat (optional) Puts on Head cover, Beard cover and Face mask, Eye shield (optional unless working with hazardous drugs or germicidal disinfectants), shoe covers (Hazardous Compounding ONLY) *Order Specific* Uses anti or non-antimicrobial soap. Removes debris from under nails using nail pick under warm water. Washes hands and forearms using soap and warm water (for at least 30 seconds). Dried using lint-free towel Selects the appropriate sized non-shedding gown with sleeves - snug around wrists and enclosed around neck - examining for any holes, tears, or other defects. Puts on gown ensuring full closure. Disinfects hands using a waterless alcohol-based surgical hand scrub with persistent activity and allows hands to dry thoroughly Puts on sterile gloves ensuring that there is a tight fit with no excess glove material at the fingertips. Examines gloves ensuring that there are no defects, holes or tears. Disinfects gloves with sterile 70% IPA. (Hazardous Compounding ONLY) Follows Aseptic Technique and Related SOPs Removes and discards gloves in the ante-area (Hazardous Compounding ONLY) and performs hand hygiene Removes gown in ante-area and discards it, or hangs it on hook if it is to be reused within the same work day Removes and discards mask, head cover, beard cover and shoe covers in ante-area (Hazardous Compounding ONLY) Performs hand hygiene The person assessed on SOPs is immediately Informed of all unacceptable activities (i.e. spaces lacking check marks, N/A, or N/O) and is informed and shown of specific corrections by the qualified evaluator. Re-evaluation of the person being assessed shall occur to ensure correction of practice deficiencies. Person Assessed/ Date Qualified Evaluator/ Date

13 Aseptic Technique, Safety and Quality Assurance SOPs - Training and Evaluation Form The qualified evaluator (pharmacist) will check each space for which the person being assessed has acceptably completed the described activity, prints N/A if the activity is not applicable to the assessment session or N/O if the activity was not observed. ASEPTIC TECHNIQUE, SAFETY AND QUALITY ASSURANCE SOPs TRAINING EVALUATION Follows hand hygiene, garbing and gloving SOPs Disinfects drugs/ supplies/ bins/ equipment with 70% IPA prior to bringing into the ante area Disinfects ISO Class 5 device surfaces with an appropriate agent (70% IPA). Disinfects components/ vials with an appropriate agent (70% IPA) prior to placing into ISO Class 5 work area. Introduces only essential materials in a proper arrangement (to minimize movement) in the ISO Class 5 work area Does not interrupt, impede, or divert flow of first-air to critical sites (never bring hands or objects above, beneath or behind one another) Ensures syringes, needles, and tubing remain in their individual packaging and are only opened in ISO Class 5 work area Performs manipulations only in the appropriate direct compounding area of the ISO Class 5 device (six inch clearance from all walls) Does not expose critical sites to contact contamination or worse than ISO Class 5 air Disinfects stoppers, injection ports, and ampoule necks by wiping with sterile 70% IPA and allows sufficient time to dry Affixes needles to syringes without contact contamination Punctures vial stoppers and spikes infusion ports without contact contamination Disinfects gloves routinely by wiping with sterile 70% IPA during prolonged compounding manipulations After the preparation of every CSP, the contents of the container are thoroughly mixed and inspected for the presence of particulate matter, evidence of incompatibility, or other defects Labels preparation(s) correctly Disposes of sharps and waste according to institutional policy (minimize exit and re-entry into the isolator) The person assessed on SOPs is immediately Informed of all unacceptable activities (i.e. spaces lacking check marks, N/A, or N/O) and is informed and shown of specific corrections by the qualified evaluator. Re-evaluation of the person being assessed shall occur to ensure correction of practice deficiencies. Person Assessed/ Date Qualified Evaluator/ Date

14 Cleaning and Disinfecting SOPs - Training and Evaluation Form The qualified evaluator (pharmacist) will check each space for which the person being assessed has acceptably completed the described activity, prints N/A if the activity is not applicable to the assessment session or N/O if the activity was not observed. CLEANING AND DISINFECTING SOPs TRAINING EVALUATION Follows hand hygiene, garbing and gloving SOPs Uses appropriately labeled container for the type of surface to be cleaned and labeled cleaning system (see cleaning/ disinfecting log) Cleans and disinfects all ISO Class 5 devices prior to compounding in the following order: walls, IV bar, and work surface. (Wipes from back to front and from top to bottom using overlapping strokes. With each stroke uses a new portion of the wiper. Passthrough is cleaned from the main chamber) Changes ISO Class 5 device sterile gloves. Disinfects gloves with sterile 70% IPA Cleans all counters, easily cleanable work surfaces, sink and stainless steel bins Cleans floors starting at the wall opposite the room entry door; mops floor surface in linear overlapping strokes toward the operator. Moves carts as needed to clean entire floor surface. Changes microfiber mop cover every 100sq feet. Replaces sticky mat. Cleans buffer area and ante-area ceiling followed by walls. (Use linear overlapping strokes from top to bottom changing microfiber mop cover at least every 25 cleaning steps) Cleans all buffer area totes and storage shelves by removing contents. Cleans the inside surfaces of the tote and then the entire exterior surfaces of the tote. Allows totes to dry. Uses new wipe as needed. Cleans all buffer area carts by removing contents and starting with the top working down to wheels. Allows to dry. Uses new wipe as needed. Cleans buffer area chairs by starting with the top working down to wheels. Cleans the interior and exterior of trash bins, and storage bins Cleans all ISO Class 5 device exteriors starting with the top working down Does cleaning from cleanest to dirtiest (ISO Class 5 PEC, Buffer Area, Ante-Area) Uses a disposable cleaning system (Hazardous Buffer Area ONLY) Documents all cleaning activities as to who performed such activities with date and time noted. (see cleaning/ disinfecting log) The person assessed on SOPs is immediately Informed of all unacceptable activities (i.e. spaces lacking check marks, N/A, or N/O) and is informed and shown of specific corrections by the qualified evaluator. Re-evaluation of the person being assessed shall occur to ensure correction of practice deficiencies. Person Assessed/ Date Qualified Evaluator/ Date

15 Compounding Sterile Preparations Written Evaluation 1. USP <797> requirements must be met in healthcare settings that compound sterile preparations. a. hospital b. most c. all d. Joint Commission accredited 2. Proper procedures and aseptic technique the risk of contamination. a. greatly decrease b. somewhat increase c. somewhat decrease d. have no effect on 3. contamination is the principle source of CSP contamination. a. filter b. touch c. water d. air 4. Eating, drinking, and gum-chewing are allowed in the ante area but not inside the buffer area surrounding the laminar air flow workbenches. a. true b. false 5. Generally, aseptic manipulations should be performed at least inches inside the workbench. a. 6 b. 9 c Clean HEPA filters periodically with sterile 70% isopropyl alcohol. a. true b. false 7. If a laminar air flow workbench is turned off between aseptic processing sessions, it must be operated long enough to be free of room air in the critical area for at least. a. 10 minutes b. 30 minutes c. 3 hours d. 30 seconds 8. Which of the following can be reworn if properly stored in the ante area? a. gown b. gloves c. shoe covers d. masks 9. Primary engineering controls need to be cleaned and disinfected: a. at the beginning of each shift b. before each batch c. at least every 30 minutes during compounding d. when surfaces are visibly soiled e. when surface contamination is known or even suspected f. all of the above g. none of the above 10. Immediate-use CSPs are only used when preparation of CSP under low-risk conditions would subject the patient to additional risk due to. a. delay b. aseptic technique c. potency d. contamination Passing Score = 100% Action Level Score <100% The person assessed on compounding sterile preparations written evaluation who receives a score of <100% is immediately Informed of ALL incorrect answers and provided the appropriate answer and rationale by the qualified evaluator (pharmacist) Re-evaluation of the person being assessed shall occur to ensure correction of knowledge deficiencies. Person Assessed/ Date Qualified Evaluator/ Date

16 Media Fill Procedure - Training and Evaluation Form The qualified evaluator (pharmacist) will check each space for which the person being assessed has acceptably completed the described activity, prints N/A if the activity is not applicable to the assessment session or N/O if the activity was not observed. Media Fill Procedure - Personal Aseptic Technique Test (PATT) For Low and Medium Risk Levels - Catalog #GM7020 QI Medical Inc TRAINING EVALUATION Sanitize work area using standard procedures. Swab vial and bag ports according to the pharmacy s standard operating procedures Select 1 GroMed partially filled minibag, and 1 GroMed 20mL vial, each containing sterile Trypticase Soy Broth growth medium. Wipe the injection ports of the bag and vial with a wipe dampened with IPA. If using a laminar airflow hood, place the containers at least 6 inches within the work area so as to protect the injection ports and not interrupt the clean air flow Select 20 sterile 18G x1 needles (or smaller size as appropropriate) and one sterile 3, 5, or 6c disposable syringe. Remove the syringe from the pouch and place the syringe in the work space Aseptically attach a needle to the syringe Withdraw 1mL of TSB fromt eh GroMed vial and inject the TSB into the bag of sterile TSB. Change the needle.l The frequent needle changes make the complexity of the procedure approach a worst case situation. Repeat procedure (#6) 19 more times, using 19 different needles but he same syringe and receiving bag of TSB. At the end of the transfers there will be approximately 120mL in the minibag. Immediately inspect the final container contents for particulates, corings, and fibers. These particles should not be recorded as microbial growth. Repeat procedure (#6) 19 more times, using 19 different needles but the same syringe and receiving bag of TSB. At the end of the transfers there will be approximately 120mL in the minibag. Immediately inspect the final container contents for particulates, corings, and fibers. These particles should not be recorded as microbial growth. Label the final container of TSB. Incubate at 20-25C or 30-35C for 14 days. (LAB) Passing Result = Negative/ No Turbidity Action Level Result = Positive/ Turbidity Compounding personnel whose media-fill vials result in gross microbial colonization (positive/ turbidity) shall be immediately Re-instructed by expert compounding personnel Re-evaluated by expert compounding personnel to ensure correction of all practice deficiencies. Person Assessed/ Date Qualified Evaluator/ Date

17 Glove Fingertip Sampling Procedure - Training and Skills Evaluation Form The qualified evaluator (pharmacist) will check each space for which the person being assessed has acceptably completed the described activity, prints N/A if the activity is not applicable to the assessment session or N/O if the activity was not observed. Glove Fingertip Sampling Procedure TRAINING EVALUATION Follows hand hygiene, garbing and gloving SOPs INITIALLY - test performed 3x immediately after garbing (assessment #1) ANNUALLY - test performed immediately after media-fill completed (assessment #2) Immediately prior to sampling, gloves shall NOT be disinfected with sterile 70% IPA Collects a gloved fingertip and thumb sample from both hands in separate plates Use of appropriate sterile plates filled with nutrient agar with neutralizing agents such as lecithin and polysorbate 80 Lightly press all fingertips and thumb into the agar creating a slight impression Immediately discard the sampled gloves and perform proper hand hygiene Cover plates securely and invert Incubate at degrees for hours Passing INITIAL Results = CFU both hands <0 for all three tests Action Level INITIAL Results = CFU both hands >0 for ANY of three tests Passing ANNUAL Result = CFU both hands <3 Action Level ANNUAL Result = CFU both hands >3 Compounding personnel whose gloved fingertip sample results exceed action levels (INITIAL CFU both hands >0 and ANNUAL CFU both hands >3) shall be immediately Re-instructed by expert compounding personnel Re-evaluated by expert compounding personnel to ensure correction of all practice deficiencies Person Assessed/ Date Qualified Evaluator/ Date

18 SEMI-ANNUAL ENVIRONMENTAL VIABLE SURFACE SAMPLING LOG: SURFACE SAMPLING PROCESS LOCATION PLAN Areas to be tested same each time to show trending Surface sampling shall be done at the conclusion of compounding NuAire Isolator main chamber (work surface) NuAire Isolator Interchange (work surface) The surface to be sampled shall not be disinfected prior to sampling. NuAire Chemo BSC (work surface) Contact Plates - Carefully remove the lid and take the sample by rolling the convex agar surface in one direction across the surface of the site. Immediately replace the lid on the plate. Contact plate is filled with general solid agar growth medium and neutralizing agents. Size and type of plate 24-30cm^2 Swabs - Carefully remove the swab from its container. Allow excess media to drain before removing completely from container. Scrub the area with the swab using a twisting. Sample the entire area if less than 2 inch by 2 inches otherwise sample a 2 x2 area. Document the size of the sample area. Place swab in appropriate diluent; an aliquot is planted on or in the specified nutrient agar Apply a brief spray of 70% IPA to the site and follow with a wipe or use a wipe presaturated with IPA to remove nutrients. Positive Cleanroom (door handle) Negative Cleanroom (door handle) Samples shall be given to lab personnel for incubation once completed Ante Room (shelving work surface) Passing Results ISO Class 5 = CFU per plate </=3 ISO Class 7 = CFU per plate </=5 ISO Class 8 or worse = CFU per plate </=100 Action Level Results ISO Class 5 = CFU per plate >3 ISO Class 7 = CFU per plate >5 ISO Class 8 or worse = CFU per plate >100 Results reported as CFU per unit of surface area. Any cfu count that exceeds its respective action level are Investigated and re-evaluated for the following: source of contamination identified, source eliminated, affected areas cleaned and re-sampled. Re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location. Person Assessed/ Date Qualified Evaluator/ Date

19 PRESSURIZATION MONITORING LOG (RX Tech) Month: DAILY 0700: ante-area & neg pressure CHEMO (>/=-0.01), ante-area & pos pressure (>/=0.02), and ante-area & pharm (>/=0.02) *Notify Director of Pharmacy immediately if pressures are not within normal limits TEMPERATURE MONITORING LOG (RX Tech) DAILY 0700: 59-77F (15-25C) *Notify Director of Pharmacy immediately if temperatures are not within normal limits