HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 1 of 8
POLICY:
All departments of the Hospital Laboratory System are required to follow an established protocol for
writing, revising, updating, maintaining and implementing laboratory procedures. Each test done within
the confines of the laboratory system must have a written protocol in accordance with a designated
format. Laboratory procedures are to follow guidelines as defined by the Clinical Laboratory
Improvement Act 1988, State regulations, CAP recommendations, and NCCLS GP2-A3.
PROCEDURE:
I. FORMAT
A. Each technical procedure must include the following components as applicable:
1. Principle and/or Purpose of the test (summarized); clinical application and/or usefulness may
be included.
2. Specimen Requirement and collection method, any special patient preparation or restrictions.
List amount required, collection containers, specimen stability and storage conditions, specimen
handling and processing, procedures for submission of specimen to referral laboratory.
3. Criteria for specimen rejection including those characteristics, which can compromise the test
results (e.g. hemolysis, lipemia, drugs, etc.)
4. Special Safety Precautions should be included in procedures when additional safety
requirements- beyond the basic handling of biologic and other hazardous materials- are
necessary. If no special precautions are required, use the statement: "Follow all safety
precautions according to the Hospital Infection Control manual and/or the Laboratory Safety and
Chemical Hygiene manual."
5. Reagents/Supplies/Equipment including name, manufacturer, chemical formula,
concentration, preparation, and storage requirements as appropriate. Provide a highlighted
statement of any extraordinary health or safety information associated with the reagent as well as
the general category or class of the hazard (i.e.; toxic, corrosive, carcinogenic, explosive,
biohazard, etc.). Describe the course of action to take in the event that a test system becomes
inoperable (alternative or backup systems.)
6. Calibration and Calibration Verification, including preparation of standards, calibration
procedure, and remedial action to take when calibration fails to meet criteria for acceptability.
7. Quality Control, including preparation of QC materials, frequency of testing, acceptable
limits, corrective action, documentation and remedial action to take when quality control fails to
meet criteria for acceptability.
8. Instrumentation, including operation verification checks, maintenance, result reporting,
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 2 of 8
trouble-shooting and corrective actions.
9. Procedure including step-by-step directions, trouble-shooting and corrective actions.
10. Microscopic Examinations, including the detection of inadequately prepared slides.
11. Calculations (give an example)
12. Normal Range or Expected values (include age and sex specifics if available)
13. Critical values (if applicable)
14. Linearity or Reportable Range (if applicable)
15. Reporting Results (computer steps, prompts, etc.)
16. Interpretation of results
17. Procedure Notes
18. Limitations of methods including interfering substances, pitfalls, and precautions.
19. References including manufacturer's literature, textbooks (try to use reference less than 5
years old if available), standards publications (NCCLS).
20. Author ("Prepared by ____________" statement)
21. Approval, including committees and responsible managers.
22. Original Date (date original policy was put into effect)
23. Replacement date (list every replacement in chronological order)
24. Review signatures
25. For Intranet policies, include statement: "Original Policy Signed by: (titles)"
26. Take draft copy to system-wide team meetings for review and changes. Policies and
procedures should be written with a system perspective when possible.
27. Make corrections according to comments on all review documents.
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 3 of 8
28. Continue steps 2-4 as necessary.
29. Revisions should be reviewed and approved by the Medical Director, Laboratory Director
and Laboratory Supervisor.
30. Obtain required approval signatures.
31. Assign Effective Date after all signatures are obtained and staff education has occurred.
B. Each non-technical procedure may include:
1. Any of the above technical components as necessary.
2. Any policy statements pertaining to the operation of individual departments.
C. Effective Date:
The Effective Date of the policy should be after the last signature date.
II. INDEX
A. The Laboratory follows Hospital guidelines in the numbering of policies and procedures. The
following numbers are to be used by each department:
105.000 – 105. Assessment of the Patient – Laboratory
180.000 – 180. Lab Administration
180.500 – 180. Laboratory Information Systems
181.000 – 181. Lab Safety/Chemical Hygiene
182.000 – 182. Medical Technology Program
182.400 – 182. Lab Continuing Education
182.700 – 182. Blood Collection Program
182.851 – 182. Cytology Prep Tech Program
183.001 – 183. Phlebotomy / Specimen Collection
183.250 – 183. Specimen Receiving / Processing
183.500 – 183. Courier Services
183.750 – 183. Client Services
184.000 – 184. Chemistry
185.000 – 185. Microbiology
186.000 – 186. Virology
186.400 – 186. Serology
186.700 – 188. Parasitology
187.000 – 187. Hematology
187.500 – 188. Coagulation
188.000 – 188. Flow Cytometry
188.500 – 188. Urinalysis
189.000 – 189. Blood Bank
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 4 of 8
190.000 – 190. Histology/Pathology
191.000 – 191. Tissue Typing
192.000 – 192. Cytology
193.000 – 193. Hospital Cancer Institute – Hemostasis/Thrombosis
193.500 – 193. Hospital Cancer Institute – Molecular Diagnostics
194.000 – 194.999 Surgical Lab
B. Index Composition
1. All policy and procedure manuals will have an alphabetical and numerical index. The index
should list the policy number, the title, and the effective date of the most current copy of the
policy. The “Level” is listed as (1) for hospital wide policies that affect all departments, (2) for
policies that affect two or more departments, or (3) for department specific policies only.
2. A Master Index will be maintained for EACH manual. The master index will contain policies
from ALL campuses and a standardized, organized method of numbering/naming policies will be
maintained.
C. Title Key
1. Global Policy
A Global Policy is a policy used by ALL campuses. This is a standardized Laboratory
procedure/policy that is implemented without modifications at the campuses. It has NO
specific notation or campus designation after the title.
2. If a policy is modified at a campus, add the campus name to the end of the title to indicate
specific procedural instructions exist for that location.
For example:
189 "Blood Bank Equipment Maintenance" becomes 189 "Blood Bank Equipment
Maintenance – Al" for the modified policy at Al campus.
III. WRITING OF PROCEDURES
A. The following people are permitted to write procedures:
1. Supervisors
2. Assistant Supervisors/Instructors
3. Coordinators
4. Senior Technologists
5. Technologists
6. Directors
7. Assistant Directors
8. Administrative Coordinators
9. Pathologists
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 5 of 8
B. The following process should be followed when writing a technical or administrative policy.
1. Write draft of policy, consulting with current and appropriate textbooks, journal articles,
package inserts, department pathologist and other medical staff as needed.
2. Send draft copy to appropriate people for review and comment. These may include:
a) Pathologist
b) Lab Medical Director
c) Lab Administrative Director
d) Lab Assistant Administrative Director
e) Lab Administrative Coordinators
f) Administrative personnel of other affected departments such as Nursing, Safety, or
Security.
g) Supervisors and campus department coordinators
IV. APPROVAL OF POLICIES
A. Committee approval dates should be listed on the signature page (which should be documented in
committee meeting minutes).
B. Procedures are to be approved by the appropriate persons and their signature and date will indicate
approval. This may include the following:
1. Department Supervisor
2. Administrative Coordinator
3. Administrative Director
4. Medical Director
5. Department Pathologist
6. Campus Lab Administrator and Campus Medical Director
7. Vice President over Laboratory
8. Administrative personnel of other affected departments
C. Global policies are used throughout the laboratory system in an effort to standardize procedures.
Signatures and approval for global policies include:
1. The Laboratory Administrative Director
2. The Laboratory Medical Director: the medical directors at individual campus laboratories have
designated a pathologist to sign and review department and global policies and procedures.
3. Department Supervisors have been designated to perform the annual review of all department
policies and procedures.
4. The system Department Teams (i.e.: Blood Bank Team, Hematology Team, etc.) will review
and approve all procedural changes as needed.
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 6 of 8
D. Campus Specific Policies are used at an individual satellite laboratory when unique instructions
must be utilized at only that location. Signatures and approval for campus specific policies include:
1. The Campus Laboratory Administrative Director
2. The Campus Lab Medical Director
3. Campus Department Coordinator has been designated to perform the annual review of all
department policies and procedures at each campus.
E. Upon change of directorship, the new medical director must ensure that all lab procedures are well
documented, reviewed promptly and undergo at least annual review by the supervisor, department
pathologist, and/or medical director.
V. DISTRIBUTION OF POLICIES AND PROCEDURES
A. Copies of policies will be distributed to appropriate departments and campus laboratories.
1. Retain original policy in originating department
2. Intranet Policies: When the policy is available on the intranet, send an email to all affected
department supervisors and campus directors (and others as necessary) to notify them of the
policy's availability/update/etc. so that it can be reprinted for their manual. It can also be copied
from the intranet if modifications are needed at the campus, and subsequently published on the
intranet as a campus specific policy.
3. Non-intranet Policies
a) Include a cover page listing policy additions/deletions/changes, date of distribution.
b) Provide a new dated index (see II. Index above) which includes Effective Dates of
policies
c) Send a hard copy of the signed global policy plus a computer copy (on disk or via
email) for campus modifications if necessary.
VI. POLICY REVIEW
A. Each procedure must be reviewed annually. Each reviewer should look for changes in methodologies,
instrumentation, reagents, etc. The reviewer will determine the status of the procedure relevant to
approval revision or deletion.
B. The Laboratory Medical Director delegates the department technical supervisor, assigned senior
technologist, and/or pathologist to review each policy and procedure.
C. Signature and date document each procedure reviewed.
D. Standardized Global policies: each individual policy will be reviewed at the location where the
original manual is maintained.
E. A logbook shall be maintained in each department that includes Policy and Procedure Changes.
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 7 of 8
Documentation of employee review of new or changed policies is filed in this book. This documentation
should be saved for three years. All department employees must sign/initial the document to indicate
his/her acknowledgement and understanding of the procedural change.
F. Personnel Review of Manuals: Laboratory manuals are to be reviewed by all laboratory personnel
annually.
VII. POLICY REVISION
A. All changes to existing procedures must be approved by the department supervisor, pathologist, the
laboratory administrative director, and/or the laboratory medical director.
1. Minor changes may be added to the original document and all campus copies. The supervisor
must initial and date all changes.
a) Draw a single line through the item to be changed
b) Insert the change above the single line.
c) Supervisor initials and dates after the inserted change
d) Inform all testing personnel of change immediately
e) Revisions are incorporated into a new updated policy within 2 years.
2. Major changes require retyping and reprinting the entire procedure and distributing the revised
edition. If the change involves a major revision of the written procedure, or the introduction of a
new test, procedure, or instrument, a technical demonstration of the new test must be presented
to employees. Employees shall be educated about new or modified policies or procedures with
the appropriate training and/or competency validated before performing new testing.
3. Employees shall be notified of policy changes, new policies, and removal of policies promptly.
Notification and education shall target employees where appropriate. Documentation of
employee review of the new procedure should be maintained in the Policy and Procedure Change
logbook.
VIII. MANUAL LOCATION
1. Policies and procedures must be accessible to employees within the department, at or near the area
where the test is to be performed.
2. Shortened, step-by-step procedures describing the actual performance of the test may be written on
index cards and kept at the location of the testing to be done; however, this does not constitute nor
replace a complete procedure.
IX. DISCONTINUED POLICIES
Obsolete or superseded policies are removed to a retired file for historical review and liability reasons.
Such a retired record file must be kept indefinitely according to Hospital policy.
HOSPITAL
POLICY & PROCEDURE
DEPARTMENT
POLICY
CELLULAR THERAPY LABORATORY
Policy for Preparing, Implementing and Reviewing SOP’s
Effective Date
11/18/2005
Page 8 of 8
REFERENCES:
Clinical Laboratory Improvement Act, 1988
College of American Pathologists, Laboratory Accreditation Program, 2001 Checklist
Joint Commission on Accreditation of Healthcare Organizations, Accreditation Manual
for Pathology and Clinical Laboratory Services, 2003
National Committee for Clinical Laboratory Standards, Document GP2-A4, "Clinical
Laboratory Technical Procedure Manuals-Fourth Edition; Approved Guideline",
April 2002.
State Administrative Code, Chapter 59A-7
Prepared by:
Date of Approval:
_________
Date of Discontinuance:
____/____/____
Original Date: 10/1/1996
Replaces: July 2004 (193.416)
Replaces: Oct. 15, 2004
__________________________
Medical Director
___________________________
Assistant Director