/ CHHS16/244

Canberra Hospital and Health Services

ClinicalProcedure

Albumex® 4 – Storage and Documentation in thePerioperative Unit

Contents

Contents

Purpose

Alerts

Scope

Section 1 – Storage of Albumex® 4 in the Perioperative Unit

Section 2 – Procedure for obtaining Albumex® 4 for use in the Peri-operative Unit (excluding Cardiac Theatre)

Section 3 – Procedure for obtaining Albumex® 4 for use in the Cardiac Theatre

Section 4 – Checking the Albumex Register

Section 5 – Replacement of Albumex® 4 in the Perioperative Unit

Section 6 – Record keeping

Implementation

Related Policies, Procedures, Guidelines and Legislation

References

Bibliography

Definition of Terms

Search Terms

Purpose

This procedureinforms staff working in the Canberra Hospital and health Services (CHHS) Perioperative Unit:

  • how to correctlystore 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

Scope

Alerts

  • Albumex® 4is 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® 4will 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 shouldstill be treated as potentially infectious.
  • Limit all unnecessary personal contact.
  • Personal protection equipment (PPE) should be worn when handling Albumex® 4
  • Always wash hands with soap and water after handlingAlbumex® 4.
  • Albumex® 4 is not permitted to be dispensed for “just in case” scenarios.

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Scope

This procedure applies to staff thatrequire Albumex® 4for patient use from the Perioperative Unit’sAlbumex® 4storage cupboard.

This document applies to the following Canberra Hospital Health Services (CHHS) staff working within their scope of practice:

  • Surgical and Anaesthetic medical staff
  • Perfusionists
  • Registered Nurses (RN)
  • Enrolled Nurses (EN)
  • Nursing students under direct supervision.

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Section 1 –Storage of Albumex® 4 in the Perioperative Unit

Albumex® 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® 4is supplied from the Transfusion Laboratoryin 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® 4must1,5-
  • 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 Bottles5

A 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.

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Section 2 – Procedure for obtaining Albumex® 4 for use in the Peri-operative Unit (excluding Cardiac Theatre)

To obtainAlbumex® 4:

  1. Confirm with the Anaesthetist the number of Albumex® 4 bottles required.
  2. Obtain a patientlabel 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.
  3. Obtain access to the locked Albumex® 4cupboard.

A Registered Nurse (RN) will hold the key to the Albumex® 4 cupboard.The RNholding the key will escort any staff member who is not an RN to the cupboard for the dispensing of Albumex® 4.

  1. Remove the orange slip from inside the Albumex® 4 box and place the patient’sID label in the designated area and document ‘Date Given’ on the orange slip (SeeFigure 2).Leave Albumex® 4 in its box until required.
  2. Document the date, patient’s name, DOB orURN 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.

  1. The completed orange slip must be left in the clear plastic sleeve located on the inside of the door of the Albumex® 4 cupboard.
  2. 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),
  3. The RN will lock the cupboard and return the keys to the RNwho is responsible for holding the key.
  4. 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® 4is no longer required:

  1. Ensure that the bottle is still intact with the red cap firmly in place and remains in its original box.
  2. Return the unused Albumex® 4to the cupboard (see step 3).
  3. Locate and remove the orange slip with the related patients label from the designated location inside the Albumex® 4cupboard.
  4. Cross out the patients’ details on the orange slip.
  5. Place the orange slip into the unused Albumex® 4 box and return the box to the cupboard.
  6. Amend the Albumex® 4 register to reflect the correct balance.

Figure 2:Correctly completed Orange Albumex® 4 Slip.

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Section 3 – Procedure for obtaining Albumex® 4 for use in the Cardiac Theatre

There are four bottles of Albumex® 4 located in OR 12. The orange slips are located in the Albumex® 4boxes and must be completed as perSection 2.

To replace Albumex® 4 in the Cardiac Operating Theatre:-

  1. 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.
  2. The Anaesthetic nurse will take the completed orange slip to the Albumex® 4 cupboard and follow the procedure outlined in section 2.
  3. 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.

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Section 4 – Checking the Albumex Register

  1. The Albumex® 4 stock level will be checked against the Albumex Register by the Anaesthetic TL or a designated RNallocated to the duty at the beginning of every morning shift.
  2. This RNwill document on the Albumex register that the balance has been checked and is correct.
  3. If the Albumex® 4 register is not correct, theAnaesthetic TLmust 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.
  4. If the error is unable to be correcteda 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.

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Section 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 NurseTeam Leader on each shift to ensure that Pathology is notified for product replacement.

To replace Albumex® 4 stock used:-

  1. Record onthe Albumex register ‘10 slips to pathology’ and record the remaining number of used slips in the ‘used slips’ section.
  2. Temporarily change the total balance on the Albumex register from 20 to 10 to accurately reflect the total of slips and bottles remaining.
  3. Place the 10 used orange slips in a specimen bag, seal and put them in aChute Canister prior to being sent to Pathology via the Lamson Tube System (Chute) located opposite the Ward Clerks Office.
  4. 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.
  5. 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.
  6. This RNwill document that the balance has been checked and is correct and has returned to a balance of 20 (total of slips and bottles).

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Section 6 – Record keeping

  1. The Anaesthetic TL will review daily the accuracy of all documentation in the Albumex register.
  2. Incorrect documentation made in the Albumex register must be recorded as a ‘RiskMan’ and reported to the Anaesthetic CNC for action.
  3. 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] TerritoryRecords Act 20026.

  1. In the event of a product recall this information can be electronically sent to the Pathology Department.
  2. After being scanned thepaper copy of the Albumex Register may be destroyed in Confidential Waste

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Implementation

  • 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.

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Related Policies, Procedures, Guidelines and Legislation

Policies

  • Patient Identification and Procedure Matching Policy CHHS 14/051
  • Clinical Records Management Policy DGD-048
  • Clinical Record Forms Design and Approval Policy DGD11-078
  • Administrative Records Management Policy DGD14-022
  • Risk Management Policy DGD15-012
  • Incident Management Policy DGD 12-047
  • Records Disposal Schedule for ACT Health Clinical Records DGD14-005

Procedures

  • Patient Identification-Surgical Safety Checklist SOP CED 011-28
  • Clinical Record Documentation SOP DGD 12-048
  • Incident Management SOP (Procedure) DGD 12/047
  • Fresh Blood Products Administration SOP (Clinical Procedure) CHHS 15/082
  • Healthcare Associated Infections SOP (Clinical Procedure) CHHS 15/072

Standards- 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 Safety
  • Standard 5- Patient Identification and Procedure Matching
  • Standard 7- Blood and Blood product

Guidelines

  • Risk Management Guidelines (ACT Health) DGD 16-016
  • Australian Health Practitioner Regulation Agency Professional Scope of Practice
  • Guidelines For Transfusion and Immunohaematology Laboratory Practice, Australian & New Zealand Society of Blood Transfusion Ltd 1st edition [Internet]. Anzsbt.org.au. 2016. Available from:
  • Guidelines 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, transfusion.com.au [Internet]. Transfusion.com.au. 2014. Available from:

Legislation

  • Health 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)

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References

  1. ALBUMEX® 4 [Internet]. Csl.com.au. 2016. Available from:
  2. ACT Pathology Handbook. ACT Health [Internet]. 2016. p.72. Available from:
  3. ALBUMEX® 4 Safety Data Sheet [Internet]. Csl.com.au. 2014. Available from:
  4. Creutzfeldt-Jakob Disease Fact Sheet [Internet]. Ninds.nih.gov. 2016. Available from:
  5. Australian Red Cross blood service, I need to know about albumin: Transfusion resources [Internet]. Resources.transfusion.com.au. 2016. Available from:
  6. ACT legislation register - Territory Records Act 2002 - main page [Internet]. Legislation.act.gov.au. 2016. Available from:

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Bibliography

  1. Australian Public Assessment Report for Albumin (human) [Internet]. 2011. Available from:
  2. Australian and New Zealand Society of Blood Australian and New Zealand Society of Blood Transfusion 2016 ‘Guidelines for Transfusion and Immunohaematology Laboratory Practice” 1st edition.
  3. Australian & 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:
  4. Australian Red Cross blood service, transfusion.com.au [Internet]. Transfusion.com.au. 2016. Available from:
  5. Australian Red Cross Blood Service- Albumin [Internet]. Transfusion.com.au. 2014. Available from:
  6. Australian Red Cross Service, transfusion.com.au [Internet]. Transfusion.com.au. 2014. Available from:
  7. Australian Red Cross Service, I need to know about plasma fractionation: Transfusion resources [Internet]. Resources.transfusion.com.au. 2016. Available from:
  8. National Safety and Quality Health Service Standards [Internet]. Safety and Quality. 2012. Available from:
  9. Plasma and Recombinant Products [Internet]. National Blood Authority Australia. 2016. Available from:

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Definition 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 Albuminmanufactured from human plasma (the liquid component of blood) collected by the Australian Red Cross Blood Service1,3.

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Search Terms

Perioperative Unit, Cardiac, Albumex, Albumin, Blood product, Documentation

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Disclaimer: 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 Amended / Section Amended / Approved By
Eg: 17 August 2014 / Section 1 / ED/CHHSPC Chair
Doc Number / Version / Issued / Review Date / Area Responsible / Page
CHHS16/244 / 1 / 15/12/2016 / 01/12/2019 / SOH / 1 of 10
Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register