Critical Point



Definition and Purpose:To outline the procedures utilized to monitor and quantify possible viable (living microorganisms) contaminants on personnel glove fingertip surfaces.Policy:All compounding personnel (compounding technicians as well as all pharmacists regardless of whether they physically perform the duties of compounding or they supervise compounding) must receive training regarding Hand Hygiene and Garbing as well as successfully complete that competency prior to initiating the Gloved Fingertip Sampling (GFS).Gloved Fingertip Sampling occurs at least at the following occasions:Initial GFS is performed to verify that compounding staff are able to don sterile gloves without contaminating themin association with hand hygiene and garbing competencyon three separate but consecutive occasionsOngoing GFS is performedas a direct measure of the aseptic technique of compounders related to frequent disinfection of their hands while compounding in the ISO Class 5 spacein association with media fill testingAll new compounding personnel (compounding technicians as well as all pharmacists regardless of whether they physically perform the duties of compounding or they supervise compounding) must successfully complete 3 (three) separate occasions of Initial Gloved Fingertip sampling prior to compounding CSPs for human use. Growth media used for GFSInitial GFS is performed with a general growth media (tryptic soy agar with or without additives such as polysorbate 80 and lecithin)Ongoing GFS Performed with general growth media to which lecithin and polysorbate 80 have been added which are necessary to prevent false negatives since the additives neutralize any cleaning or disinfectant solutions on the fingertips of gloves or countertops.Though not required by USP <797>, it is recommended that a fungal specific media (e.g., sabouraud dextrose agar or malt extra agar) be used in addition to general growth media to sample gloved fingertips in ongoing GFS.The designated action level for gloved fingertip samples is dependent upon the location of the employee when the sample is taken:When the GFS is taken immediately after performing hand hygiene, garbing and immediately after donning sterile gloves but before sanitizing gloved hands with sterile 70% IPA, the Action Level is 0 CFUs (total both hands).On occasions that GFS are taken either randomly or after preparation of media fill units within the ISO Class 5 PEC but not immediately after hand sanitization with 70% IPA, then the Action Level is > 3 CFUs (both hands).Action Levels designate the number of CFUs on both gloves (total left hand + total right hand = > 0 CFUs in 2.1 and > 3 CFUs in 2.2.Applicable DocumentsHand Hygiene and Garbing (P-404)Personnel Aseptic Media-Fill Testing and Process Verification (P-402)Personnel and Process Sampling Log (F-402.a)Facility and Personnel Environmental Sampling Action Report (F-204.b).General InformationGFS is an integral part of insuring that the employee is aware of the microbiological bioburden on their gloves since touch contamination is believed to be the primary source of CSP contamination. Employee work practices and routine glove disinfection procedures are critical to minimizing or preventing CSP contamination. The results of GFS aid in the determination of the bioburden within critical sites and may provide information as to the species and origin of specific environmental microbial isolates.Ideally, GFS may also occur prior to any media-fill equipment process verification. Equipment and Materials:Incubator (30-35°Celsius) for general growth media which has been calibrated and NIST certified and has a certified monitoring device/thermometer as part of the incubator or has been added.Incubator (26-30°Celsius) if needed for fungal specific growth media which has been calibrated and NIST certified and has a certified monitoring device/thermometer as part of the incubator or has been added.Low linting towelsSterile 70% IPA (sIPA)Pair of sterile glovesPermanent ink “sharpie” penAppropriate agar platesProceduresPreparation of plates for samplingClean the work surface with an appropriate disinfectantRemove 2 plates of each type of media used for each employee to be sampled from the refrigerator about 30 minutes prior to use..Inspect the plates to ascertain they are free from growth or defect before use.Record the manufacturer, lot number and expiration date of the plates to be used on Personnel and Process Sampling Log (F-402.a) that is used to document each employee’s results.Using a low linting towel and sterile IPA, wipe the exterior of the covered plates prior to bringing into the controlled environment.With a “sharpie” pen, label the bottom of each plate withname of employee who will be sampleddateand designate “#1 Left” on one plate and #2 “Right” on the other plate. Place the labeled plates into a bin to transport to the “clean” side of the anteroom where they will be used.Initial gloved fingertip sampling procedure for those compounding in LAFWs or BSCs The employee from whom the sample will be collected completes hand hygiene and garbing following the organizational policy, but will not complete the step to disinfect gloved hands with sIPA.The collector will perform hand hygiene and garb appropriate to the area where sampling is taking place.Immediately after the compounding employee dons sterile gloves, the collector will remove the top from the contact plate and place it on a counter top that has been disinfected with s IPA.Alternatively the plate can also be “offered” to the employee by the person performing the sampling.Note: Instruct the compounding employee to sample the hand that corresponds to the marked plate (#1 = Left and #2 = Right).The compounding employee will gently roll the pad each of four fingers and thumb from one hand onto the contact plate with sufficient force to make slight depressions in the agarNote: Sampling occurs to the largest surface area of the pad of each finger and thumb rather than sampling the “tip” of each fingerfillin "Enter Text"The employee must avoid sliding or rotating the plate or touching anything other than the agar surface of the plate during sampling.Repeat the sampling process for the opposite hand on the second labeled plate.After testing, the collector places the covers back onto each plate.The compounding employee removes gloves that were in place during the gloved fingertip sampling, discards them and performs hand hygiene again prior to donning a fresh pair of sterile gloves. Initial (for new employees) gloved finger sampling procedure for those compounding in isolators (CAI or CACI) The employee from whom the sample will be collected completes hand hygiene and garbing following the organizational policy, but in this case dons sterile gloves inside the isolator.Prior to transferring the plates into the incubator, disinfect the outside of the plates with s IPA.Transfer the plates and 2 pairs of sterile gloves into the isolator per manufacturer’s recommendations.If there are only 2 gauntlets then the compounding employee will place the two plates in an area of the isolator not directly over the area where gloves will be donned but still within reach.The employee will remove the top of ONE plate. The employee will don both sterile gloves on top of the isolator glove/gauntlet assembly.The employee will gently roll the pads of each of four fingers and thumb from one hand onto the contact plate (which has had the cover removed) with sufficient force to make slight depressions in the agar.Using the hand that was just sampled (and being careful not to contaminate the non sampled hand), the employee willReplace the top on the sample just completedRemove the top from the other plate Repeat the same sampling process for the opposite hand onto the second labeled plate.Replace the cover on the second plate.Transfer both plates to the ante chamber of the isolator.If there are 3 or 4 gauntlets, then the collector can assist the employee being sampledThe collector removes and replaces the tops of the plates for the compounding employeeThe collector can also transfer the sampled plates into the exit chamber once the sampling has been completed. The collector removes the covered plates from the anteroom/isolator and immediately tapes the covers to prevent the plates from opening and becoming contaminated. The sampled employee removes the gloves that were in place during sampling, now contaminated with agar and dons a fresh pair of sterile gloves and applies sIPA to gloves.The employee must be aware of placing discarded supplies in an area separated from where critical aseptic manipulations will occur. The isolator deck is cleaned with sterile sIPA and disinfects gloves before compounding can occur.?Ongoing GFS in LAFWs or BSCs (for ongoing employee media-fill verification, random sampling or process verification of equipment)The collector will observe the employee as they prepare to perform media-fill verification within the ISO Class 5 area. Note: The collector must have previously performed hand hygiene and garbing per organizational policy.The collector will present the sampling plates to the compounding employee in the ISO Class 5 engineering.The collector will time this request so as not to coincide with a time immediately after hand sanitization with 70% IPA.After the samples are taken (again paying close attention to sampling the left or right hand as indicated on the labeled plate), the compounding employee will:Remove sampled glovesResanitize hands with alcohol based surgical rub with persistent activitydon new pair of sterile gloves and resanitize the gloves with sIPA prior to continuing media-fill verification procedureOngoing GFS in isolators (CAI or CACI), the compounding employee will:Transfer in 2 plates for the purposes of GFS at the time the media-fill supplies are transferred into the incubator.The collector will tell the compounding employee when to sample their hands and the employee will follow the process outlined in section 6.3.Incubation of SamplesTape the cover of each plate in place in several locations. Record the necessary information on the Personnel and Process Sampling Log (F-402.a) upon completing the collection of the gloved fingertip sampling including the time that the plates are placed in the incubator.Calculate the date and earliest time as well as the latest date and time that the general growth media plates may be removed from incubation (48 to 72 hours from the time they were placed in the incubator). Calculate the earliest and latest date the fungal specific media plates may be removed from incubation (5 to 7 days a in the incubator). Place the labeled and secured plates into the appropriate incubator:General growth media is incubated at 30-35°C for 48 to 72 hours.Fungal specific growth media is incubated at 26-30°C for 5 to 7 days.General growth media is incubated upside down (cover is down) to prevent condensation which forms due to the warm incubation temperature from dropping onto the agar causing a “lawn” effect which makes CFUs impossible to count.Since fungal-specific media is incubated a controlled room temperature (26-30°C), condensation rarely forms so they can be incubated right side up.Consideration may be given to inverting all plates, regardless of type, to reduce the potential for error in the incubation process.Reading Samples at the completion of incubationWhenever possible, the person who reads the plates is a person other than the compounding employee tested.After the total incubation period has elapsed, remove plates from incubator and “read” the sampling plates. Read the plates without opening them.Record the date and time the plates are removed for inspection in the space designated on the Personnel and Process Sampling Log (F-402.a).Record the number of CFUs on each plate in the space designated on the form.Record zero (0) if no CFUs are seen on the plate. Document the total number of CFUs for both hands by adding the results from the left hand (plate #1) and the right hand (plate #2) in the space provided. The person reading the plates must sign their name and indicate the time/date the plates were read.It may be helpful to show the employee their GFS sampling plates before they are discarded.Plates will be discarded in red biohazard containers without opening.Actions to be taken in the event results exceed the action levelAny GFS that exceeds the designated action level triggers a sequence of events designed to identify potential errors in the process, reinstruct the employee and review past data.The person reading the plates will inform the Pharmacy Manager (designee) immediately in the event the results of the GFS exceed the designated action level.Should the employee fail the one of the initial GFS The Hand Hygiene and Garbing Competency (F-410.a.) must be repeated after the employee is given additional instruction and opportunity to pass the elements of hand hygiene and garbing with special attention to the process of donning sterile gloves.Employees must complete and pass the initial Hand Hygiene and Garbing Competency which includes GFS three (3) consecutive times before they can compound sterile preparations.Should the employee fail the ongoing GFSA review of the following must occur with the compounding employee:Hand hygiene and garbingGlove resanitizationSurface decontaminationGeneral aseptic work practices including use of first airThe employee will be resampled the following work day under the same conditionsAn evaluation must be made to verify that the employee performed the procedure correctly and that other issues did not trigger a positive (e.g., a defective media bag or a defective HEPA filter above the GFS location, etc.)). Documentation of all actions taken is accomplished on the Facility and Personnel Environmental Sampling Action Report (F-204.b).Speciation to the Genus LevelRegardless of whether or not the Action Level is triggered, Chapter <797> requires that the results of any environmental sampling be sent for speciation at least to the genus level by an appropriate credentialed laboratory.Certain organisms are highly pathogenic (e.g., gram negative rods, coagulase positive staphylococcus, molds and yeasts) so the identification of these is critical to remediation since they can cause patient harm regardless of the CFU count.Once these genus’s are identified, a microbiologist can assist the pharmacy to understand the source of that type of contamination so that the pharmacy can take action to remediate it. It is possible to work with a credentialed laboratory in conjunction with a microbiologist or industrial hygienist to identify resident organisms that occur in each sterile compounding operation. Take a picture of those recurring organisms and develop a training program for staff in conjunction with the lab to reduce the number of plates that may need to be sent in for speciation.This type of CFU identification program must be developed in conjunction with the laboratory and detailed in written policy and procedure.In instances where the Action Level has been exceeded, speciation beyond the genus level to the specific species is recommended.Policy and Procedure Major Change SummaryDateSectionDescription of ChangeMarch 2012PolicyAdded 6.3 and 6.5 addressing initial and ongoing gloved fingertip sampling in incubators.Switched policy to template with updated headers/footers and changed minor grammar.June 20142.06.0Policy statements entirely revised and new material addedMany procedures essentially rewrittenDeleted need to pre-incubate platesAdded legal statement to footer ................
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