Name of FacilityDepartment of Pathology
Address of FacilityTRANSFUSION SERVICE PROCEDURE MANUAL
Procedure Number: QM 130.2
Page 1 of 13
Writing or Revising Standard Operating Procedures
I.PURPOSE:
Transfusion Medicine procedures follow a standard format. The format is consistent with the recommended NCCLS format or Information Mapping format. The Transfusion Medicine Medical Director must approve all standard operating procedures (SOP) prior to implementation and the Transfusion Service staff must review all SOPs that apply to their job responsibilities. A historical record of each SOP will be maintained and SOPs removed from use must be retained for a minimum of 5 years.
II.PROCEDURE:
A.SOP Format
1.0.Basic Set-up:
1.1Page Margins:
1.1.1There should be a one-inch margins on all sides of the page.
1.2Type Set and Size:
1.2.1The type set (Font Face) is "Times New Roman".
1.2.2The type size (Font Size) is a 12-point type for all parameters (i.e., Headers, Page numbers, and Text of SOP)
1.3Page Numbering:
1.3.1Page numbering should be located on the upper right-hand corner of each page of the SOP.
1.3.2Use the "Page __ of __" format. Use the computer-generated option for page numbering.
1.3.3Forms are NOT part of the page numbering process.
1.4Numbers:
1.4.1All single digit numbers should be spelled out, i.e., zero (0) to nine (9).
1.4.2All numbers greater than a single digit can be written using the Arabic numeral.
B.Procedures should have most or all the sections described below.
NOTE: If a procedure is a process, the format may be written in the information mapping style.
1.0Header on the first page of the SOP shall have the following information:
1.1Facility’s name and address on the left hand side.
Facility Name
Address of Facility
1.2Department, SOP number and dates on the right hand side.
Department of Pathology
TRANSFUSION MEDICINE PROCEDURE MANUAL
Procedure Number:
Date Written:
Date Revised:
Page X of Y
1.2.1Each SOP is given a number. The numbers are sequential according to category of SOP.
Transfusion Service Procedure Manual
- 100-199 Administrative Policies and Procedures, Tissue Procedures
- 200-299Routine Serologic Testing
- 300-399Special/Extended Testing
- 400-499Component Preparation
- 500-599Miscellaneous Procedures
- 600-699Quality Control & Preventive Maintenance
- 700-799Computer Procedures
HPC Laboratory Procedure Manual
I. 100-199 Administrative Policies and Procedures
II. 200-299 Hematopoietic Progenitor Cell Processing
III. 300-399 Cryopreservation
IV. 400-499 Storage
V. 500-599 Miscellaneous Procedures
VI. 600-699 Quality Control & Preventive Maintenance
VIII. 700-799 Computer Procedures
IX. 800-899 Transportation
X. 900-999 HPC Collections
BloodDonorCenter Manual
I.Organizational Information
II.Regulatory
III.Donor Collections
IV.Quality Control
V.Laboratory
VIII.Distribution/Imports
IX.Customer Services
Quality Plan Manual
I.Organizational Policies
II.Resources
III.Equipment
IV.Suppliers
V.Process Control
VI.Documents and Records
VII.Deviations, Nonconformances and Complications
VIII.Assessments
IX.Process Improvement
X.Facilities and Safety
1.2.2Similar SOPs may be kept together by using a decimal and numbering the SOPs sequentially. (e.g. 304.1, 304.2, 304.3, etc.)
1.2.3Date Written.
1.2.3.1This is the date the original SOP was written.
1.2.3.2The date must include at least the month and year.
1.4Date Revised.
1.4.1.This date will change with each revision of the SOP.
1.4.2The date must include at least the month and year of the revision.
1.4.3Page number of the page and the total number of pages in the SOP.
2.0Subsequent pages shall have all the above information (date written and date revised are optional.)
3.0Title
3.0.1The title should explain the content of the procedure.
3.0.2Use specific terms.
3.0.3If the specimen or instrumentation is important, include them in the title.
4.0Purpose
4.1This is usually in paragraph form.
4.2Explain the reason, clinical indications, for the test (procedure/policy).
4.3General information should include expiration date storage conditions of blood components.
4.4Include the general principles of the test method.
5.0Materials, Equipment, Supplies
5.1List specific reagents required to perform the test.
5.1.1List the name and chemical formula, when applicable.
5.1.2In a bold statement, list any health or safety hazards.
5.1.3If the reagent must be prepared, give directions on how to prepare the reagent.
5.1.4List specific storage requirements important to the testing procedure including:
5.1.4.1Temperature
5.1.4.2Stability (shelf life)
5.1.4.3Labeling
5.1.5List specific equipment required to perform the procedure.
5.1.6List any special supplies needed to perform the procedure.
5.1.7List any forms used for recording results.
6.0Specimen
6.1Include specimen requirements.
6.1.1Condition of patient preparation.
6.1.2Anticoagulants which are acceptable or unacceptable.
6.1.3Acceptable age of the sample.
2.9.2Labeling requirements
6.2Conditions which interfere with testing.
6.2.1Hemolysis, lipemia, icteric, etc.
6.3Amount of specimen.
7.0Procedure
7.0.1Write detailed instructions in a stepwise manner.
7.0.1.1It should be detailed enough so someone with a basic background could takethe procedure and perform the test.
7.0.1.2Consider the background of a person who would perform the procedure.
7.0.1.3DO NOT write steps in paragraph form. Each step is a separate line.
7.0.2Use the present imperative form (action verbs).
7.0.3Keep instructions free of extraneous matter, such as explanationsjustifications. These go in the NOTES.
7.0.4Include controls when necessary.
7.0.5Indicate hazards and course of action to be taken in handling and disposing of hazardous material.
7.0.6If forms are used, list instructions for completing the form(s).
8.0Procedural Notes
8.1Notes are additional explanation in the procedure.
8.2Explain reasons for special precautions.
8.3List a possible source of error.
8.4Include a helpful hint.
9.0Interpretation – Reporting Results
9.1Explain the interpretation of the test results.
9.2Controls should be included in the interpretation.
9.3Explain steps to take when unexpected results occur.
9.4If calculations are used in the interpretation:
9.4.1Give the calculations (formula).
9.4.2Explain the formula.
9.4.3Give an example of the calculation.
9.5Explain the way in which the results are recorded and reported to the physician.
10.0Computer Entry
10.1When computer steps are included in the procedure, the functions must be referenced in the procedure.
10.2If variations from the routine function procedure are necessary they should be included in the Computer Entry section under the appropriate function.
11.0References
11.1Specific references should be included at the end of each procedure.
11.2Manufacturer’s Operating Manuals or direction circulars may be referenced.
11.3AABB Technical Manual and AABB Standards current edition are referenced when indicated.
11.3.1At the beginning of each manual the specific current edition of each publication willbe listed.
12.0Back Page will contain the following:
12.1The procedure title at the top of the page.
12.2Written by and date.
12.2.1The original author’s name remains permanently on the SOP.
12.2.2Date the original SOP was written.
12.3Revised by and date.
12.3.1The name of the person revising the SOP is listed. This name may change with eachSOP revision.
12.3.2Date the SOP was revised.
12.4Effective date.
12.4.1Date the SOP was put into effect.
12.4.2The date must include the month, day and year.
12.5Approved by and date.
12.5.1The Medical Director signs approval.
12.6Reviewed and date.
12.6.1The Medical Director and Transfusion Service Supervisor sign for annual review.
12.7SOP revised or retired.
12.7.1The appropriate box is marked when the SOP is revised or retired.
12.7.2Date the SOP is revised or retired.
12.7.3Medical Director signs approval.
13.0Staff Annual Review Page.
13.1Responsible staff signs for review.
14.0SOP Historical Record.
15.0SOPs in more than one manual are stamped COPY (blue ink) on the bottom right hand side of each page.
III.INFORMATION MAPPING FORMAT:
A.The basic set-up is the same as in Step I.
B.Title
1.0The title should explain the content of the procedure.
2.0The title is in bold print and left justified.
C.When to use
1.0This is in text format, usually one or two sentences.
D.Materials
1.0List materials needed to perform the process
E.Procedure
1.0Describe the steps and corresponding action in table format
F.Continue as in Step II.B.7.0.
IV.TABLEOF CONTENTS:
A.A Table of Contents is prepared for each volume (series).
B.Update the Table of Contents whenever new SOPs are added or SOPs are deleted.
V.REVISION OF EXISTING SOPs:
A.The Transfusion Service Supervisor must approve all revisions prior to having them typed.
B.Requests for changes are submitted on a “Document Change Control form”.
C.Modify the revision date on the header or footer and the back page of the SOP.
D.Maintain a copy of procedure prior to the revision for a minimum of 5 years. A second copy isstoredas an electronic copy.
1.0The date the SOP was removed from use must be recorded on the SOP and the document control form.
VI.IMPLEMENTATIONOFNEWANDREVISEDPROCEDURES:
A.New procedures.
1.0A training period of 1-3 weeks, dependent on the procedure complexity, will be determined.
2.0Training objectives will be prepared for most procedures.
2.1Training objectives will serve as documentation of employee competency.
B.Revision of existing procedures.
1.0The training period will vary depending upon the extent of the revision.
2.0The usual training period of a SOP revision is 1 week.
C.If the revision is major – new training objectives may be prepared.
D.If the revision is minor, the supervisor will prepare a summary of the revision.
1.0All responsible staff will read the summary and the new SOP.
2.0After reading the SOP the employee signs the summary sheet next to his/her name. See document list – SOP revision.
3.0The summary sheet may also be used for new SOPs or major revisions to existing SOPs with no training objectives. See document list.
4.0The supervisor will file minor revision staff documentation.
VII.PROCEDURE MANUAL ORGANIZATION:
A.Organizational Charts are in the front of the first volume.
B.Standard Reference Material will be in the front of each manual.
1.0Current edition publication information is included for reference material.
C.Table of Contents will be next.
D.All pages are placed in plastic pages.
1.0Procedures are placed in numerical (SOP#) order.
VIII.REFERENCES:
A.American Association of Blood Banks,Technical Manual, current edition.
B.NCCLS, Clinical Laboratory Technical Procedure Manuals, Third Edition 1996.
Writing or Revising Standard Operating Procedures
Written:June 2003By:
Revised:March 2005By:
Effective date:
Approved by:
Medical Director, Transfusion MedicineDate
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SOP Revised
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Medical Director, Transfusion Medicine
Writing or Revising Standard Operating Procedures
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