Albumex in the Perioperative Unit



Canberra Hospital and Health ServicesClinical ProcedureAlbumex? 4 – Storage and Documentation in the Perioperative UnitContents TOC \h \z \t "Heading 1,1" Contents PAGEREF _Toc469566015 \h 1Purpose PAGEREF _Toc469566016 \h 2Alerts PAGEREF _Toc469566017 \h 2Scope PAGEREF _Toc469566018 \h 2Section 1 – Storage of Albumex? 4 in the Perioperative Unit PAGEREF _Toc469566019 \h 3Section 2 – Procedure for obtaining Albumex? 4 for use in the Peri-operative Unit (excluding Cardiac Theatre) PAGEREF _Toc469566020 \h 4Section 3 – Procedure for obtaining Albumex? 4 for use in the Cardiac Theatre PAGEREF _Toc469566021 \h 5Section 4 – Checking the Albumex Register PAGEREF _Toc469566022 \h 5Section 5 – Replacement of Albumex? 4 in the Perioperative Unit PAGEREF _Toc469566023 \h 6Section 6 – Record keeping PAGEREF _Toc469566024 \h 6Implementation PAGEREF _Toc469566025 \h 7Related Policies, Procedures, Guidelines and Legislation PAGEREF _Toc469566026 \h 7References PAGEREF _Toc469566027 \h 8Bibliography PAGEREF _Toc469566028 \h 9Definition of Terms PAGEREF _Toc469566029 \h 9Search Terms PAGEREF _Toc469566030 \h 10PurposeThis procedure informs staff working in the Canberra Hospital and health Services (CHHS) Perioperative Unit: how to correctly store Albumex? 4 and of the documentation processes to accurately record the use of Albumex? 4.This Standard Operating Procedure (SOP) describes for staff the process to ScopeAlertsAlbumex? 4 is not classified as hazardous or as a dangerous good according to established criteria3. Albumex? 4 is manufactured from human plasma and as such may contain infectious agents4. The risk that Albumex? 4 will transmit an infectious agent has been reduced by screening plasma donors and through the use of virus inactivation and removal procedures during the manufacturing process. Despite the above measures Albumex? 4 should still be treated as potentially infectious.Limit all unnecessary personal contact.Personal protection equipment (PPE) should be worn when handling Albumex? 4Always wash hands with soap and water after handling Albumex? 4.Albumex? 4 is not permitted to be dispensed for “just in case” scenarios.Back to Table of Contents ScopeThis procedure applies to staff that require Albumex? 4 for patient use from the Perioperative Unit’s Albumex? 4 storage cupboard.This document applies to the following Canberra Hospital Health Services (CHHS) staff working within their scope of practice:Surgical and Anaesthetic medical staffPerfusionistsRegistered Nurses (RN)Enrolled Nurses (EN)Nursing students under direct supervision.Back to Table of ContentsSection 1 – Storage of Albumex? 4 in the Perioperative UnitAlbumex? 4 is a 4% human albumin solution for intravenous administration containing 40g/L of albumin1. It is often required in the Perioperative Unit at the request of the Anaesthetist.Albumex? 4 is supplied from the Transfusion Laboratory in the form of 500ml glass bottles. It arrives pre-packaged in a cardboard storage box (see Figure 1).Albumex? 4 should be stored as per the manufacturer’s guidelines.Albumex? 4 must1,5-Be used immediately after opening.Be stored below 30°C. (Do not freeze)Not be used if the solution has been frozen.Be protected from light, (keep in original packaging until ready for use).Not be used after the expiry date.Be at room temperature before administration. Not be used if turbid (cloudy).Be used for one patient, on one occasion only.Figure 1: Albumex? 4, 500ml Glass Bottles5A maximum of 20 bottles are stored in a locked cupboard located in the Anaesthetic work area of the sterile stock room [“middle room”]. Storage in a locked cupboard is not a legislative requirement but is required for tracking purposes.Note:The key to unlock the Albumex? 4 cupboard in the Anaesthetic work room is located on both the Operating Room (OR) 8 drug keys and the Anaesthetic Team Leader (TL) drug keys.A further four bottles of Albumex? 4 are located in the cardiac specific theatre Operating Room (OR) twelve, for exclusive use during cardiac surgery. Two are located on the Anaesthetic Drug Trolley and two are located on the Perfusion Trolley.Back to Table of Contents Section 2 – Procedure for obtaining Albumex? 4 for use in the Peri-operative Unit (excluding Cardiac Theatre)To obtain Albumex? 4:Confirm with the Anaesthetist the number of Albumex? 4 bottles required.Obtain a patient label from the patient’s notes (one is required for each bottle) and cross check the patient’s full name, date of birth (DOB) and unit record number (URN) on the label with the patient’s identification (ID) band.Obtain access to the locked Albumex? 4 cupboard.A Registered Nurse (RN) will hold the key to the Albumex? 4 cupboard. The RN holding the key will escort any staff member who is not an RN to the cupboard for the dispensing of Albumex? 4.Remove the orange slip from inside the Albumex? 4 box and place the patient’s ID label in the designated area and document ‘Date Given’ on the orange slip (See Figure 2). Leave Albumex? 4 in its box until required.Document the date, patient’s name, DOB or URN and the OR number on the ‘Albumex register’ located in the Albumex? 4 cupboard and sign in the designated area. Note: Accurate documentation of patient ID details in the Albumex register and on the Albumex? 4 orange slip maintains an important link between the patient and the batch of the product. This practice is strongly recommended by the manufacturer1 of Albumex? 4 and is a requirement of the Transfusion Laboratory.The completed orange slip must be left in the clear plastic sleeve located on the inside of the door of the Albumex? 4 cupboard.All the used orange slips and the remaining Albumex? 4 boxes must be counted at the time of dispensing to ensure that all the Albumex? 4 is accounted for (e.g.: used slips + remaining Albumex? 4 = number dispensed from Pathology), The RN will lock the cupboard and return the keys to the RN who is responsible for holding the key.The Anaesthetist or the anaesthetic nurse administrating the Albumex? 4 is responsible for ensuring it is accurately recorded on the Intravenous Fluid and Additive Order Sheet and that the sticker located on the side of the Albumex? 4 bottle is peeled off and adhered to the sheet next to their entry.In the event the Albumex? 4 is no longer required:Ensure that the bottle is still intact with the red cap firmly in place and remains in its original box.Return the unused Albumex? 4 to the cupboard (see step 3).Locate and remove the orange slip with the related patients label from the designated location inside the Albumex? 4 cupboard.Cross out the patients’ details on the orange slip.Place the orange slip into the unused Albumex? 4 box and return the box to the cupboard.Amend the Albumex? 4 register to reflect the correct balance.Figure 2: Correctly completed Orange Albumex? 4 Slip.Back to Table of ContentsSection 3 – Procedure for obtaining Albumex? 4 for use in the Cardiac TheatreThere are four bottles of Albumex? 4 located in OR 12. The orange slips are located in the Albumex? 4 boxes and must be completed as per Section 2.To replace Albumex? 4 in the Cardiac Operating Theatre:-The Perfusionist or Anaesthetist who administers the Albumex? 4 to the patient is responsible for placing the patient ID label on the orange slip as set out in Section 2 and for giving it to the anaesthetic nurse allocated to OR 12 for replacement.The Anaesthetic nurse will take the completed orange slip to the Albumex? 4 cupboard and follow the procedure outlined in section 2.Remove the replacement Albumex? 4 from the cupboard leaving the orange slip inside the box and place the box in its designated location in OR 12.Back to Table of Contents Section 4 – Checking the Albumex RegisterThe Albumex? 4 stock level will be checked against the Albumex Register by the Anaesthetic TL or a designated RN allocated to the duty at the beginning of every morning shift.This RN will document on the Albumex register that the balance has been checked and is correct.If the Albumex? 4 register is not correct, the Anaesthetic TL must be informed and must follow-up on the discrepancy and determine where the error occurred. They must consult with all necessary staff including the Post Anaesthetic Care Unit (PACU) staff and Perfusionist, and review patient notes.If the error is unable to be corrected a Transfusion laboratory senior scientist must be contacted on 62442918 and informed, as well as the Anaesthetic Clinical Nurse Consultant (CNC). Investigative actions must be briefly documented in the Albumex register and a ‘RiskMan’ submitted.Back to Table of ContentsSection 5 – Replacement of Albumex? 4 in the Perioperative Unit Once there are 10 used orange slips in the Albumex? 4 cupboard, it is the responsibility of the Anaesthetic Nurse Team Leader on each shift to ensure that Pathology is notified for product replacement. To replace Albumex? 4 stock used:-Record on the Albumex register ‘10 slips to pathology’ and record the remaining number of used slips in the ‘used slips’ section.Temporarily change the total balance on the Albumex register from 20 to 10 to accurately reflect the total of slips and bottles remaining.Place the 10 used orange slips in a specimen bag, seal and put them in a Chute Canister prior to being sent to Pathology via the Lamson Tube System (Chute) located opposite the Ward Clerks Office.Pathology will dispense and deliver a box containing 10 new Albumex? 4 bottles to the Perioperative Unit which must be secured in the Albumex? 4 cupboard as soon as possible. The new stock must be placed behind the old stock to ensure stock rotation.Record of receipt of the Albumex? 4 stock from Pathology is entered into the Albumex Register by recording ’From pathology’ and ‘10’ in the ‘bottles in’ section.This RN will document that the balance has been checked and is correct and has returned to a balance of 20 (total of slips and bottles).Back to Table of ContentsSection 6 – Record keeping The Anaesthetic TL will review daily the accuracy of all documentation in the Albumex register.Incorrect documentation made in the Albumex register must be recorded as a ‘RiskMan’ and reported to the Anaesthetic CNC for action.The Albumex Register will be scanned by the RN at the end of each month and saved in the following location:Q:\TCH\surgicalservices\Theatres\ANAESTHETIC NURSING 2016\Quality assurance Scanned Document Records\Current ANA Document Record FY 2015 - 2016\ANA Albumex Register (insert current year i.e. FY 16-17) in accordance with the [ACT] Territory Records Act 20026. In the event of a product recall this information can be electronically sent to the Pathology Department.After being scanned the paper copy of the Albumex Register may be destroyed in Confidential WasteBack to Table of ContentsImplementation The information will be communicated to staff through the staff communication books and meetings.This procedure is discussed during orientation to the Perioperative Unit as well as part of ongoing education. A summary of the procedure will also be found in a laminated hard copy format, located in the Albumex? 4 cupboard in the anaesthetic work room.Back to Table of ContentsRelated Policies, Procedures, Guidelines and LegislationPoliciesPatient Identification and Procedure Matching Policy CHHS 14/051Clinical Records Management Policy DGD-048Clinical Record Forms Design and Approval Policy DGD11-078Administrative Records Management Policy DGD14-022Risk Management Policy DGD15-012Incident Management Policy DGD 12-047Records Disposal Schedule for ACT Health Clinical Records DGD14-005Procedures Patient Identification-Surgical Safety Checklist SOP CED 011-28Clinical Record Documentation SOP DGD 12-048Incident Management SOP (Procedure) DGD 12/047Fresh Blood Products Administration SOP (Clinical Procedure) CHHS 15/082Healthcare Associated Infections SOP (Clinical Procedure) CHHS 15/072Standards- National Safety and Quality Health Service Standards (NSQHS)NSQHS Standards influencing this procedure may include but are not limited to:Standard 1- Governance for Safety and Quality in Health Service Standard 4- Medication SafetyStandard 5- Patient Identification and Procedure MatchingStandard 7- Blood and Blood productGuidelines Risk Management Guidelines (ACT Health) DGD 16-016Australian Health Practitioner Regulation Agency Professional Scope of PracticeGuidelines For Transfusion and Immunohaematology Laboratory Practice, Australian & New Zealand Society of Blood Transfusion Ltd 1st edition [Internet]. .au. 2016. Available from: for the Administration of Blood Components, Australian & New Zealand Society of Blood Transfusion Inc., Royal College of Nursing Australia, 2nd edition [Internet]. 2011. Available from: Guidelines for Patient Blood management, Australian Red Cross Blood Service, .au [Internet]. .au. 2014. Available from: Records (Privacy and Access) Act (1997)[ACT] Territory Records Act (2002)Electronic Transactions Act (2011)Information Privacy Act (2014)Therapeutic Goods Act (1989)Medicines, Poisons and Therapeutic Goods Act (2008)Back to Table of ContentsReferencesALBUMEX? 4 [Internet]. .au. 2016. Available from: Pathology Handbook. ACT Health [Internet]. 2016. p.72. Available from: ? 4 Safety Data Sheet [Internet]. .au. 2014. Available from: Disease Fact Sheet [Internet]. Ninds.. 2016. Available from: Red Cross blood service, I need to know about albumin: Transfusion resources [Internet]. Resources..au. 2016. Available from: legislation register - Territory Records Act 2002 - main page [Internet]. Legislation..au. 2016. Available from: to Table of ContentsBibliographyAustralian Public Assessment Report for Albumin (human) [Internet]. .au. 2011. Available from: and New Zealand Society of Blood Australian and New Zealand Society of Blood Transfusion 2016 ‘Guidelines for Transfusion and Immunohaematology Laboratory Practice” 1st edition. & New Zealand Society of Blood Transfusion Ltd., Royal College of Nursing Australia, Guidelines for the Administration of Blood Components, 2nd edition [Internet]. Dec. 2011. Available from: Red Cross blood service, .au [Internet]. .au. 2016. Available from: Red Cross Blood Service- Albumin [Internet]. .au. 2014. Available from: Red Cross Service, .au [Internet]. .au. 2014. Available from: Red Cross Service, I need to know about plasma fractionation: Transfusion resources [Internet]. Resources..au. 2016. Available from: Safety and Quality Health Service Standards [Internet]. Safety and Quality. 2012. Available from: and Recombinant Products [Internet]. National Blood Authority Australia. 2016. Available from: to Table of ContentsDefinition of Terms Albumin: is a protein made by the liver. It is the most abundant protein in blood7.Albumex? 4: is the trade name for Albumin manufactured from human plasma (the liquid component of blood) collected by the Australian Red Cross Blood Service1,3.Back to Table of ContentsSearch Terms Perioperative Unit, Cardiac, Albumex, Albumin, Blood product, DocumentationBack to Table of ContentsDisclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Service specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.Date AmendedSection AmendedApproved ByEg: 17 August 2014Section 1ED/CHHSPC Chair ................
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