Standard Operating Procedure for Preparing, Revising and Using Standard Operating Procedures (SOPs)CHAPTER 1
SCOPE AND APPLICATION
Standard operating procedures are essential documents for ensuring smooth, efficient and lawful functioning/operation of any blood bank. These SOPs may be numerous in a particular blood bank defining their functions but there are some SOPs which remain common for all the blood banks, e.g. SOP for collection of blood, grouping and cross-matching of blood and issuing procedures, etc,. These may also include SOP for policies guiding the rational use of blood and blood components, time-frame for availability of whole blood and its components and instructions in case of established transfusion reaction. SOPs are critical sub-elements of the quality system and are essential to ensure that every procedure is undertaken in a standardized way for generation of consistent results. Therefore individual blood bank must develop its own blood bank specific SOPs based on infrastructure available, test procedures to be followed and availability of reagents.
RESPONSIBILITY
It is the responsibility of the Management/Medical Officer/Technical staff working in the blood bank to frame and follow the SOPs to yield the desired quality results.
STAFF
Medical Officer
Key responsibilities
- Supervision of all the functions like donor selection, phlebotomy, grouping and cross-matching, TTI testing, storage, component preparation, labeling, etc.
- Ensure timely indent of reagents, blood bags, gel cards, equipment and other items required in the blood bank.
- Ensure blood safety measures.
- Ensure proper maintenance of records and reports and timely submission of reports.
- Ensure proper licensing of the blood bank.
- Ensure timely preparation and submission of reports.
- As member secretary of Hospital Transfusion Committee (HTC) to conduct the meetings of HTC to monitor the quality of blood and its components.
- Conducting the proficiency tests for the technical staff.
- Preparation and ensuring use of standard operating procedures.
- Ensure proper handling of biomedical waste.
- Preparation of duty rota for the technician.
The following other categories of whole time competent technical staff required is:
Blood Bank Technician(s)
Key responsibilities
- Registration and bleeding of donors.
- Preparing components.
- Maintenance of various statutory records and completion of registers.
- Checking and recording temperature of all refrigerators, deep freezer, platelet agitator and incubator.
- Preparation of pooled cells.
- Performing red cell serology-ABO and Rh test, Antibody screening, antihuman globulin test, compatibility testing and testing in case of adverse reaction of blood transfusion.
- Testing of blood units for HIV, HBsAg, HCV, VDRL and malarial parasites.
- Issuing blood bags as per request received.
- Discarding of pilot tubes and patient samples after 7 days.
- Disposing of TTI positive bags.
- Maintaining of file of all the requisitions received.
- Carrying out all procedures.
- Maintaining mandatory records.
- Recording and maintaining of temperature of different blood bank refrigerators.
- Informing technical supervisor immediately in the event of breakdown of equipment or any discrepancy in results of tests.
- Contact to other blood banks for supply of blood at the time of emergency.
- Any other work assigned from time to time by the management or the medical officer in charge of blood bank.
Registered Nurse(s)
Key responsibilities
- Registration and bleeding of donors.
- Assisting in pre-donation medical check up.
- Post-donation care.
- Monitoring the refreshment for the donors.
- Completion of registers.
- Maintaining stocks of emergency medicines.
- Maintaining of file of all the blood donor registration forms.
- Maintaining mandatory records in the department.
- Segregation of biomedical waste at the time of its generation.
- Informing Blood Bank Officer immediately in the event of breakdown of equipment in the donor room.
- Recording and maintaining of temperature of different blood bank refrigerators.
- Any other work assigned from time to time.
Technical Supervisor (Where Blood Components are Manufactured)
Key responsibilities
- Supervising and coordinating the blood bank activities.
- Registration and bleeding of donors.
- Preparing components.
- Completion of registers.
- Check and record temperature of all refrigerators, deep freezers, platelet agitator and incubator.
- Preparation of pooled cells as per SOP.
- Performing red cell serology-ABO and Rh test, antibody screening, antihuman globulin test, compatibility testing and testing in case of adverse reaction of blood transfusion.
- Issuing blood bags as per request received.
- Discarding pilot tubes and patient samples after 7 days.
- Disposing of TTI positive bags.
- Maintaining of file of all the requisitions received.
- Carrying out all procedures.
- Maintaining mandatory records in the department.
- Segregation of biomedical waste at the time of its generation.
- Informing Blood Bank Officer immediately in the event of breakdown of equipment or any discrepancy in results of tests.
- Contact to other blood banks for supply of blood at the time of emergency.
- Preparation and timely submission of reports.
- Maintaining inventory of blood bank consumables and stationery.
- Any other work assigned from time to time.
CONTENTS OF SOPs
Technical
The technical contents of SOP should include the following:
- Scope and application.
- Responsibility.
- Materials required to perform the procedure.
- Various steps of procedure to be performed.
- Interpretation of results.
- Quality assurance of reagents/chemicals.
- Documentation required to be maintained.
General
The header of SOP should contain
- Title of SOP.
- SOP number for each SOP.
- Date of issue of SOP.
- Date from which it will be effective.
- Page numbering.
- Revision date and number (The SOPs shall be reviewed/Updated at least once a year).
Name & Address of Blood Bank: ………………………… …………………………………. Drug License No: …………. Valid up to ………………….. | SOP No. | |
Version No./Date of issue | ||
Effective Date | ||
Review Date | ||
Page No. | Page–of– |
The footer should contain the signatures of the authorized person(s) who has prepared it and the person from the management who can authorize for the use of SOP.
The specimen of the footer is given below:
Prepared & Issued By | Approved By |
Each of the SOPs needs to be validated. It includes setting up criteria for acceptance of results generated by SOPs, report of a workshop formulating a protocol, undertaking testing using SOPs, comparing the observed results with the predefined criteria and, if matched, declaring that the SOPs have been validated.
USE OF SOPs
- Once prepared and approved for implementation, SOPs become the roadmaps for operationalizing the Blood Bank.
- Every staff member must have access to all SOPs that affect actions and areas of responsibility.
- SOP's should be followed as approved and maintained by a particular blood bank and if any amendment is required, it has to be documented and must be made by authorized persons only after following proper procedure.
- Any deviation from the SOP must be documented and got approved from authorized person.
- All SOPs including the outdated ones are to be retained in the blood bank for the period as per blood bank policy.
- Their use is mandatory by all the staff members of the Blood Bank every time they perform any activity in the blood bank.
- The licensing and accreditation procedures also demand compulsory use of SOPs.
- The SOPs are also used for capacity building in the quality management of blood transfusion services in which emphasis is laid on ensuring consistency in performing various activities so that the safety and quality of blood is guaranteed.