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Quality Plan, Version 5.0
Hematopoietic Cell Therapy Laboratory Operating Manual
Policy Number: 0111
Replaces: Quality Plan, Version 4.0
Effective: April 2007
Authorized: QA Supervisor
Approved: Medical Director
Description
The HCT Laboratory strives to ensure that all processing and testing of patient products and samples is done
in a safe and effective manner. This manual describes the policies and procedures that comprise the HCT lab
quality plan.
Table of Contents
I.
Organizational structure
II.
Agreements
III.
Process development and review
IV.
Personnel qualification, training, and competency
V.
Outcome analysis
VI.
Audits
VII.
Positive sterility cultures of cellular therapy products
VIII.
Errors, accidents, and adverse events
IX.
Record review
X.
Document Control
XI.
Validation
XII.
Qualification
XIII.
Inventory control
XIV.
Product tracking
XV.
Process control
XVI.
Assessments
XVII.
Laboratory Safety
XVIII.
Appendices
i. Agreements list
ii. Audits
iii. Occurrences
iv. Adverse reactions
v. Validation projects
vi. Assessments
vii. Engraftment reports
viii. Sterility reports
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SECTION I – ORGANIZATIONAL STRUCTURE
Updated 8/7/09
Transplant Program
Program Director
NAME
Transplant Teams
Adult
Pediatric
Medical Director:
NAME
Medical Director:
NAME
Physicians
LIST NAMES
Physicians
LIST NAMES
Pharmacy
NAME
Social
NAME
Hematopoietic Cell
Therapy Laboratory
BMT Services
Apheresis
Collection
Bone Marrow
Collection
Medical Director:
NAME
BMT
Administration
NAME
Medical Director:
Open
Medical Director:
NAME
Laboratory Coordinator:
NAME
Data Manager:
NAME
Chief Technologist:
NAME
Primary Harvest
Physician
NAME
Technologist:
NAME
Apheresis Nursing
Staff
Pharmacy
NAME
Social
NAME
Patient Treatment
Coordination
Adult Services
Pediatric Services
Nurse Practitioners:
NAME
Nurse Coordinators:
Adult BMT
NAME
Pediatric Hematology Oncology
Nursing
NAME
Inpatient Nursing – Location
NAME
Adult and Pediatric BMT
NAME
Outpatient Nursing
NAME
Assistant: NAME
Financial: NAME
Hematopoietic Cell Therapy Laboratory
Director Clinical Laboratories
NAME
Medical Director
Manager, Clinical Pathology
NAME
NAME
Assistant Manager
NAME
QM/Compliance Coordinators
HCTL Coordinator
NAME
Technologists
NAME
Page 2 of 14
NAME
The HCTL works within two organizational structures to provide services to the bone marrow transplant
patients. The operation of the laboratory is the responsibility of The FACILITY NAME Department of Pathology
and Laboratory Medicine. The HCTL provides services to patients under the care of The NAME Bone Marrow
Transplant Program and participates in the coordination of care within the program.
Bone Marrow Transplant Program
Section
Sections are Responsible for
Program Director
Medical, operational and administrative oversight for the program
including the adult and pediatric BMT programs.
Overall responsibility for the BMT quality program through the BMT
Quality Management Committee.
Transplant Teams, Adult and
Pediatric
Responsible for the medical care of adult and pediatric patients at
the PSHMC.
Hematopoietic Cell Therapy Lab
Responsible for the processing and storage of the hematopoietic
progenitor cell products collected at the PSHMC.
Participates in the BMT Quality Management Committee.
BMT Services
Administrative oversight for the PSHMC BMT Program.
Nurse coordinators guide patients through the transplant process.
Social workers and financial services provide additional support to the
patients and family members.
Participates in the BMT Quality Management Committee.
Peripheral Blood Progenitor Cell
Collection / Blood Bank
Responsible for the collection of peripheral blood progenitor cell
products.
Responsible for the blood bank testing and blood products for the BMT
patients. Participates in the BMT Quality Management Committee.
Bone Marrow Collection
Medical Director oversees collections. Another Physician specializes in
collection. Collection facility is the main Operating Room suite. O.R. staff
maintain equipment/supplies and provide anesthesia and patient care
support. Participates in the BMT Quality Management Committee.
Adult Services
Nurse practitioners, inpatient and outpatient nursing that provide care to
the Adult BMT patients.
Participates in the BMT Quality Management Committee.
Pediatric Services
Nurse practitioners, inpatient and outpatient nursing that provide care to
the Pediatric BMT patients. Participates in the BMT Quality Management
Committee.
Department of Pathology and Laboratory Medicine
Title
Responsibility
Director, Pathology and
Operational and administrative oversight of the PSHMC
Laboratory Medicine
Laboratories including the HCTL.
Overall responsibility for the Medical Laboratories quality program.
HCTL Medical Director
Responsible for all medical and technical policies and procedures that
relate to the care and safety of patients and donors.
Overall responsibility for the HCTL quality program.
Manager, Clinical Laboratory
Administrative oversight of the PSHMC Laboratories including the HCTL.
QM/Compliance Coordinator
Quality Management/Compliance
Responsible for the Department of Pathology and Laboratory Medicine’s
Quality Management and regulatory Compliance. Provides quality
oversight to the HCTL including: FDA occurrence reporting, outcome
analysis, occurrences, adverse reaction and validation reports review.
Coordinator
Responsible for the daily operation of the HCTL.
Page 3 of 14
Ensures that the laboratory complies with facility policies and procedures
as well as applicable regulations and standards.
Responsible for all HCTL quality assurance with consultation of the
Department of Pathology and Laboratory Medicine Quality
Management/Compliance Coordinator.
Technologist
Performs processing and quality control associated with cellular therapy
products and associated samples. Assists with quality assurance efforts.
SECTION II: Agreements
Outside processing or testing laboratories may be employed to provide cell processing or testing services that
are not or cannot be performed by the HCTL. The HCTL and /or the Department of Pathology and Laboratory
Medicine will establish a written agreement that details services that the outside laboratory will provide. The
following process will be followed when outside laboratories services are required:
1. The HCTL Medical Director will review the request for the processing technique or test.
2. If approved, the Coordinator or designee will develop a description of the services that are
needed and laboratories that are capable of providing them. The list shall include:
a. Laboratory Name, contact information and name and qualifications of its Director.
b. SOPs or descriptions of SOPs provided by the laboratory.
c. Turn-around-time for results or completing of processing.
d. Documentation of relevant licensure or accreditation by the appropriate agency or
organization such as FDA, CLIA, FACT, JCAHO, CAP, State agency, and others.
e. Price list and schedule for potential pricing adjustments.
f. Comments from current customer who have been contacted as references.
3. The Medical Director will review the list and select a potential laboratory to provide the service.
4. The laboratory should be contacted to provide a written agreement or document describing their
service and billing policies.
5. The contract specialist in the Purchasing Department will then be enlisted to review the
agreement or documents provided by the laboratory. They can also write or edit an agreement.
NOTE: The purchasing contract specialist is the PSHMC representative authorized to sign the
agreement.
6. The contract specialist will provide an analysis of the agreement.
7. The Medical Director will review the analysis. If approved, the contract specialist will sign the
agreement. If rejected this process will be repeated until an acceptable laboratory/agreement is
implemented.
8. Current agreements are listed in the appendix section of this Quality Plan
Page 4 of 14
SECTION III: PROCESS DEVELOPMENT AND REVIEW
The HCTL provides testing and cell processing services to support cellular therapies. Specific therapies are
developed and organized as a process. The details of developing, performing and documenting processes are
described in this section.
Process Development
Processes are developed to address a patient’s need for a test result or cellular therapy product. New
processes are researched and validated for safety and effectiveness through testing and approved by the
Scientific/Medical Director prior to use in patient care. Each process is illustrated in a flow chart. Discrete tests
and processing techniques are described in standard operating procedures. Documentation of completion of
the process is recorded on processing worksheets and results forms. These worksheets may be in an
electronic format or a paper form. Failures in the performance of a process or procedure are documented as
an occurrence.
Process Review
Processing worksheets are used to document and track the processing techniques and tests performed on a
sample or cellular therapy. The process is reviewed as it is being recorded and after completion.
1. Upon completion of a discrete step in the processing the Technologist is expected to review the
data and the results of any calculations then sign the form by entering their initials. The
Technologist is to also review and sign all supporting documents produced during processing. If
an error or discrepancy is found that may result in not meeting expected endpoints the
technologist is to contact the Coordinator and/or Medical Director and initiate an occurrence
form.
2. Upon completion of processing the worksheet is printed the Technologist is expected to review
the entire worksheet and supporting documentation for accuracy and completeness then sign
their initials next to each step that they completed. If an error or discrepancy is found that may
result in not meeting expected endpoints the technologist is to contact the Coordinator and/or
Medical Director and initiate an occurrence form.
3. Another Technologist will review the worksheet and supporting documentation for accuracy and
completeness then initial and date the worksheet. If an error or discrepancy is found that may
result in not meeting expected endpoints the technologist is to contact the Coordinator and/or
Medical Director and initiate an occurrence form.
4. The Medical Director will perform a final review of the worksheet and supporting documentation
for accuracy and completeness.
Page 5 of 14
SECTION IV: Personnel qualification, training, and competency
Reference: Division of Laboratory Medicine Personnel Policy #3
New Employee Hiring The HCTL follows all equal opportunity hiring practices as outlined in Human
Resources Department policies which state:
FACILITY NAME is an equal opportunity employer. It is the policy of FACILTY NAME not to discriminate
against any person with respect to hiring, wages, hours, fringe benefits, working conditions, placement or
promotion because of race, color, religion, sex, national origin, age, disability, handicap, or status as a
Vietnam-era or special disabled veteran in accordance with applicable federal laws.
Employee’s qualifications are based on their demonstrated ability to perform laboratory analysis in a complex
laboratory environment. The preferred candidates possess a Medical Technology certification or a Bachelors
of Science degree or higher in a relevant scientific field. Preference is given to current FACILITY NAME
Laboratory Medicine employees who have successfully demonstrated the necessary skills and abilities.

Job descriptions are stored in the HCTL employee-training manual.

Candidates must complete an application including a detailed description of their relevant experience.
The application will be used to screen out applicants that do not meet minimum qualifications. A
candidate may be contacted to clarify qualifications

Candidates will then be required to undergo an interview which will involve answering behavior based
questions and may also include a written test.
Training
New HCTL employees are required to complete a training period before they can perform testing or
processing of patient products. The employee is trained by other fully trained employees or an equipment or
supply vendor. The training period will vary depending on the complexity of processing being performed at
that time as well as the duties assigned to the particular employee.
The steps in training a new employee include:

New employee reads the SOP and other relevant material.

The procedure is observed to gain familiarity with the techniques.

The new employee performs the procedure under supervision.

Most training is documented on a training form. The form is signed by the trainer and new employee to
indicate competence in performing the procedure. Training may also be documented on a
reagent/equipment manufacturers training form or as part of an electronic program.

The training documentation is stored in the HCTL employee-training manual.

This process is repeated when new SOP’s are implemented.
Competency
Reference: Division of Laboratory Medicine Personnel Policy #5
Each employee is evaluated on a yearly basis on their ability to perform laboratory procedures. Competency is
assessed by visual or written evaluation and the performance of proficiency testing. The competence
evaluation is documented on the Competency Evaluation form. The completed forms are stored in the HCTL
employee-training manual. Technologists are expected to participate in proficiency testing surveys that are
available for assays performed in the lab. The assays are performed following manufacturers instructions
using normal laboratory procedures for handling and testing. A list of HCTL proficiency test surveys is found in
the following table. Results of the surveys can be found in the Proficiency testing Manual(s). On a rotating
basis one technologist will perform the required assays.
Proficiency Testing Reference: Division of Laboratory Medicine Personnel Policy #1
ACTIVE PROFICIENCY TESTING TABLE
ASSAY
PROVIDER
Stem Cell
Processing
CD34 (FL-4)
WBC Differential
FREQUENCY
CAP
Biannually
DATE
STARTED
Spring /04
CAP
Hematology Lab
Biannually
Biannually
1999
1997
DATE
STOPPED
N/A
N/A
N/A
COMMENTS
Became graded
survey as of 2007
None
Inhouse
Continuing Education
All HCTL employees are required to participate in continuing education (CE). Each employee is required to
document his or her CE credits on the Continuing Education Record form. The type and amount of CE an
employee receives is evaluated during the employee’s annual performance review.
Reference: Division of Laboratory Medicine Personnel Policy #2
Page 6 of 14
SECTION V: OUTCOME ANALYSIS
Patient outcomes are monitored to determine if the processes performed by the HCTL has a negative impact
on patients. The outcomes that are measured are listed in the following table. The data is monitored on an ongoing basis and discussed at weekly adult and pediatric BMT patient care meetings. The data is compiled on
for a quarter report to be reviewed at the BMT Quality Management Committee
OUTCOME SUMMARY PROJECT TABLE
Outcome Study Name and brief Start
description
Date
Product Sterility – See Sterility
10/96
Tracking Manual.
Ongoing
Reporting
Frequency
Quarterly
Duration
Report To
BMT QM Committee,
Infection Control
Committee
End
Date
N/A
Engraftment – Speed of
Hematopoietic recovery.
10/99
Ongoing
Quarterly
BMT QM Committee
N/A
Engraftment – Chimerism data for
non-ablative transplants
1/07
Ongoing
Quarterly
BMT QM Committee
N/A
Apheresis collection volume
5/04
Ongoing
BMT QM Committee
N/A
Apheresis RBC contamination
5/04
Ongoing
Quarterly by
Apheresis
Dept
Quarterly by
Apheresis
Dept
BMT QM Committee
N/A
SECTION VI: AUDITS
Audits are performed to ensure that policies and SOP’s are being followed. The internal audits system is
authorized and reviewed by the Department of Pathology’s Compliance/QI Coordinator. Trained personnel
who have not done the work being audited perform the internal audits following the Internal HCTL Audits SOP.
Problems identified by an audit are investigated and corrected. Systematic problems will result in a process
change. Audits results are reported to the BMT Quality Management Committee.
Recent audits results are listed in the appendix section of this Quality Plan
SECTION VII: POSITIVE STERILITY CULTURES OF CELLULAR THERAPY PRODUCTS
REFERENCE: Sterility Cultures, SOP Number 88
Maintaining the sterility of cellular therapy products intended for infusion is critical to patient safety. At a
minimum the HCTL samples each product for sterility prior to release or cryopreservation. Products requiring
multiple manipulations are tested before and after those manipulations are made. Samples for sterility culture
are inoculated into blood culture bottles that are compatible with the PSHMC Microbiology Laboratories blood
culture system which through an in-house study was validated for HCTL samples. The samples are cultured
and the results are reported back to the HCTL.
Positive cultures – In the event of a positive sterility culture the following actions are taken:

Microbiology will immediately notify the HCTL.

The culture results will be recorded on the patient’s worksheet.

The product(s), if available, label will be modified to indicate the positive culture.

The product(s), if stored, will be quarantined in the Misys system.

The HCTL will then notify the recipients/donors Physician.

The Physician in consultation with the HCTL Medical Director will decide if additional
cultures, antibiotic sensitivities or product collections are necessary.

If the cells are to be infused the potential recipient will be asked to provide informed consent
to proceed.

If infused, the HCTL Medical Director will determine if additional antibiotics are needed and
blood cultures will be performed.

An investigation will be initiated to determine a cause for the contamination.

If required the appropriate regulatory agency will be notified.
Page 7 of 14
Sterility culture results are reported on a quarterly basis to the BMT QM Committee.
SECTION VIII: ERRORS, ACCIDENTS, AND ADVERSE EVENTS
Errors and Accidents (Occurrences)
The HCTL strives is to ensure that patients and their cellular products are handled in a safe and efficient
manner. Occurrences defined as laboratory errors, accidents, or deviations from SOPs can endanger patients
and co-workers or can add additional cost to the services that we provide. All occurrences are documented
and investigated. Results of the investigation will be used to identify and improve HCT laboratory training,
procedures, or policies. Each occurrence is documented on an Error / Accident / Occurrence Report form. A
log of occurrences is maintained. When applicable, the event is reported to the transplant program, the
collection facility, the appropriate regulatory agency and the hospitals risk management department.
Recent occurrence results are filed in the appendix section of this Quality Plan
Planned Deviations
Routine cell processing should not cause a deviation from SOPs. In unusual situations a need to deviate from
SOPs may arise. These “planned deviations” are only acceptable with the approval of the HCTL Medical
Director and recorded on the processing worksheet. If the planned deviation is a result of a corrective action to
address a problem the deviation will be considered an occurrence.
Adverse Reactions
The infusion of hematopoietic cell products can produce mild reactions in some patients. In cases where a
patient exhibits an unusual or severe reaction an investigation of the cause will be undertaken immediately by
the HCTL. At the time of the reaction the HCTL Medical Director will be notified to provide consultation with
the patients physician. The HCTL Medical Director will review each reaction and make the appropriate
changes to ensure the safety of the patients. A log of adverse reactions is maintained. When applicable, the
event is reported to the transplant program, the collection facility, the appropriate regulatory agency and the
hospitals risk management department. A report of adverse reactions is presented quarterly to the BMT QM
Committee.
Recent adverse reaction results are filed in the appendix section of this Quality Plan
Complaints
Complaints involving the HCTL are documented then investigated and corrective action is taken as needed.
Complaints are handled following the procedure General Laboratory Policy #2, Lab Interact/Client Call Interact
Policy
SECTION IX: RECORD REVIEW
Critical records such as requisitions, processing worksheets and instrument printout are reviewed for accuracy
and completeness upon receipt or completion. The patient processing documents are stored in a patient file.
Specific record review is described below.
Processing Request Form, Form – 0012 – The Processing Request Form is completed by the BMT
Coordinators and signed by the patients BMT Physician to request cell processing services as well as provide
patient demographic information and donor eligibility information. The form is reviewed by HCTL personnel
upon receipt for acceptability, initialed and dated.
Processing Worksheets – Cell processing worksheets are reviewed upon completion of processing by the
processing Technologist then reviewed by another Technologist. The Medical Director performs the following
review.
Instrument Printouts – Printouts from the hematology cell counter, flow cytometer and controlled rate freezer
are reviewed by a Technologist for accuracy and completeness.
Final Distribution Labels – Prior to distribution product labels are reviewed by two trained personnel. The
review is documented on the infusion form.
Page 8 of 14
SECTION X: DOCUMENT CONTROL
Documents created by the HCTL include policies, procedures, worksheets, and forms. Documents that are
considered critical to the operation of the HCTL are controlled by the following steps:
1. New SOPs and forms are assigned a tracking number which is recorded on a log sheet. The log is
then used to record the effective date, any modifications to the document and retirement date.
2. When new SOPs or forms are implemented the staff is informed of the change and trained in their
use.
3. Electronic versions of the documents are stored on the PSHMC server which is password protected
and backed up by the PSHMC Information Technology Department.
4. Paper copies of the active critical documents are stored in the SOP manuals.
5. Active HCTL SOPs are stored for use in the HCTL. Critical documents may leave the lab for a single
use and must not be stored for use in another location.
6. Obsolete documents are retired to archive files and any additional copies are destroyed.
7. The duration of storage for critical documents is listed in the following table.
Patient files
A patient file is created and stored in the HCTL to compile data describing all processing and tests performed.
Products that are processed in the HCTL follow several discrete SOP’s to achieve the desired outcome. The
HCTL uses flowcharts and worksheets to describe what procedures and tests are to be performed for a
specific protocol. There forms are assigned a form number and recorded in a form tracking spreadsheet. Upon
completion of processing the worksheet is reviewed for accuracy and completeness. Deviations or errors
found during processing or review are documented on the Error / Accident / Occurrence Form and reported to
the HCTL Medical Director. The HCTL Medical Director reviews the patients processing worksheets.
Misys Laboratory Information System (LIS)
The Misys (formerly Sunquest) LIS provides an electronic means of recording processing data. The LIS is
validated, backed up, and maintained by the Department of Pathology and Laboratory Medicines LIS Team.
The HCTL uses the LIS for several functions including:

Routine cellular product tracking

Recording the time a product is received

Recording of Sysmex XS-1000i blind duplicate testing

Recording of Blood Bank testing performed on a unit

Record the component preparation steps performed

Quarantine of products

Issuing of products and printing of a transfusion tag

Final product inspection prior to issue

Reporting of final processing results

Product shipping

Billing

Maintenance results
Document and Record Storage
Documents and records are stored following minimum requirements of accrediting agencies and guidelines
stated in the Division of Laboratory Medicine General Lab Policy #6.
Table of documents and the times stored
DOCUMENT
STORED
STORAGE PERIOD
SOP’s – Current
SOP Manuals
N/A
SOP’s – Retired
Retired SOP/Worksheet Manual
Indefinitely
or files
Instrument Validation
Instrument Binder
Longer of instrument use period or 10
years.
Maintenance Records
See QC Schema
Longer of instrument use period or 10
years.
Instrument printouts
Patient Files
10 years
QC Records
See QC Schema
10 years
Proficiency Testing
PT Binder
10 years
Patient Results
Patient Files
Indefinitely
Personnel Training
Training Manual
10 years
Signature File
QCP Manual
Indefinitely
Quality Improvement
Quality Plan
10 years
Product Discard Forms
Product Discard File
Indefinitely
Page 9 of 14
Standard Operating Procedures Development
The HCTL strives to ensure that cell-processing procedures are performed in a safe and effective manner.
Standard Operating Procedures
The following steps are used to implement or revise Standard Operating Procedures (SOP’s).
1. The SOP is developed using published reports and manufacturers instructions.
2. The SOP is written in the standard format described in the SOP for SOP’s. This SOP is a “draft” version
until successful validation is completed and a final version is approved by the HCTL Medical Director.
3. A validation plan is written. The SOP may be validated using waste blood products or samples and
performing the necessary cell enumeration. Testing can include cell counts, microbiology assays or other
relevant assays to assure that expected outcomes are met.
4. The validation plan is executed and the results are reviewed.

Unsuccessful plans are revised and the plan retested.

Upon successfully completing the validation plan the validation plan and SOP are submitted
to the HCTL Medical Director for review. A copy of the validation plan is also submitted to
the Compliance Coordinator for review.
5. Upon receiving approval of the SOP/validation plan by the HCTL Medical Director and validation plan by
the Compliance Coordinator staff training is initiated. Upon the completion of training the SOP is
implemented for routine use.
6. The SOP will be assigned an SOP number which is recorded on the SOP Tracking Log. The Tracking
Log is used to record any changes that have been made to the SOP.
7. Modifying SOP’s
Minor modification – The modification does not change the methodology or intent of a procedure. A
minor change does not require the retiring of the SOP. The modification is recorded in the SOP
Tracking Log. The author and the Medical Director must sign the SOP which is stored in the SOP
manuals. Staff is notified of the change.
Examples include:
1. Correction of a spelling error
2. Clarification of a ambiguous step
3. Re-arrangement to reflect actual workflow
4. Replacement of a common laboratory reagent or item.
Major modification – The modification changes the methods performed, major supply item or
work/process flow. A major modification requires the retiring of the SOP by placing it in the Retired
SOP file, moving the electronic version to the archive folder and changing the SOP number. The new
SOP is implemented by following the steps described above including staff training. The modification
is recorded in the SOP Tracking Log. The author and the Medical Director must sign the SOP which
is stored in the SOP manuals.
8. All SOPs is reviewed annually for accuracy and relevancy.
Research Study Procedures
Procedures written for a Food and Drug Administration Investigational New Drug or industry drug study are
the responsibility of the local Primary Investigator (PI) and its sponsors. If the study involves patient care it
must also be approved by the PSHMC Investigational Review Board (IRB). The HCTL Medical Director or
designee is responsible for overseeing the study implementation. These procedures and associated forms are
stored in study binders or files and may not be modified without the authorization of the PI. These SOPs may
deviate from routine HCTL practice however they must be followed as written.
Reference:
Procedure for Performing Validations, SOP 114
Standard Operating Procedures (SOP), SOP 1
SECTION XI: VALIDATION
Prior to implementation of new procedures or equipment in the Hematopoietic Cell Therapy Laboratory, a
Validation Protocol is written to establish documented evidence that provides a high degree of assurance that
the specific process will consistently produce a product meeting its pre-determined specifications and quality
attributes. Manufacturer’s instructions, published reports, and information obtained from other cell processing
laboratories are used to develop a written validation plan. The plan will outline
Reference: Procedure for Performing Validations, SOP 114
Page 10 of 14
SECTION XII: QUALIFICATION
To ensure that the facility, equipment and reagents used by the HCTL perform properly, a program of
qualification is employed. The program includes validation of new equipment, performance of routine
maintenance and testing procedures. Quality control procedures and result forms are maintained in the HCTL.
Equipment or reagent failure – If equipment or a reagent fails to perform as expected the failure is
documented on the Error / Accident / Occurrence Form. The form is also used for trending of failures as well
as providing troubleshooting information. A log of Error / Accident / Occurrence failures is maintained.
HCTL Facility
The laboratory is equipped with a class 100,000-air filtration system and positive pressure airflow. A qualified
testing company certifies the filtration system annually. Temperature is controlled by a thermostat located in
the laboratory and is monitored with alarms by the remote alarm system. Sampling and processing of patient
products is performed within type II biological safety cabinets that are certified annually. Products that are to
be stored for a short term are stored in a monitored refrigerator. Cryopreserved non-infectious products are
stored in the vapor phase of liquid nitrogen. Cryopreserved products that must be quarantined are stored in
the -80C monitored mechanical freezer. The remote monitoring system is located in the Blood Bank. The
monitoring system tracks the equipment environment and will alarm when the established ranges are
exceeded. The monitoring system is compared daily (Monday through Friday) to readings on the equipment.
Reagents
Reagents are to be FDA approved for human use. If a non-FDA approved reagent must be used it must meet
the following criteria:

Scientific literature supports its safety and utility.

It must be of Pharmaceutical grade or obtained from the source that provides the highest
possible quality.

The manufacturer provides a Certificate of Analysis listing the results of safety and potency
testing performed on the lot of reagent.

Criteria are established to qualify each shipment.
Supplies
Supplies are to be FDA approved for human use. If a non-FDA approved supply must be used it must meet
the following criteria:




Scientific literature supports its safety and utility.
It must be obtained from the source that provides the highest possible quality.
The manufacturer provides a Certificate of Analysis listing the results of relevant safety and
potency testing performed on item.
Criteria is established to inspect each shipment.
Equipment
New equipment is tested to assure that the manufacturer specifications are met and the desired outcome will
be achieved when the equipment is put into use. The testing may be performed by the vendor and must be
reviewed by the HCTL staff. Testing must also be done when major repairs have been done or if the
equipment is relocated.
Routine maintenance – This maintenance is performed at intervals recommended by the manufacturer.
Quality Control testing – Is performed following regulatory agency requirements and manufacturer
recommendations.
Equipment correlation studies – Performed when the same test is performed with different methodologies or
instruments or at different sites. The HCTL performs the assays listed below and compares the results to the
results obtained from the same samples assayed on another instrument. The assays are done to monitor
instrument performance, ensure correlation to the backup instrument and monitor Technologist competency.
Equipment Correlation Studies Table
ASSAY
PROVIDER
FREQUENCY
STARTED STOPPED COMMENTS
Hematocrit
Hematology – Blind duplicate
Weekly
4/05
ongoing
Same CLIA certificate
Platelet count
Hematology – Blind duplicate
Weekly
4/97
ongoing
Same CLIA certificate
White Blood Cell
Hematology – Blind duplicate
Weekly
4/97
ongoing
Same CLIA certificate
count
Page 11 of 14
SECTION XIII: INVENTORY CONTROL
Inventory control encompasses the selection of providers as well as the tracking of the products to the patient
in which it was used. The selection of suppliers and inventory control system is described below.
Suppliers
Vendors and suppliers are chosen based on the following criteria:
1. Only FDA approved supplies, reagents and blood products are used. If a non-FDA approved product
must be used it will be validated through scientific literature review and HCTL testing. The Institutional
Review Board must review and approve research protocols that include new reagents, supplies or testing
prior to their use in patient care.
2. Test results from outside laboratories are only accepted if the laboratory posses a current CLIA certificate.
3. Similar items from different vendors are compared for quality and best pricing.
4. The Purchasing department is consulted to determine vendor reputation and information on obtaining the
best possible pricing.
5. Certificates of analysis are required for reagents or products that come in contact with cellular products
and could adversely affect its safety or potency.
Inventory
The HCTL has developed a system of inventory control to record information on orders status and lot number
tracking. Lot number date range is used to track which lots were used for patient processing.
The system includes:

All products received in the HCTL are inspected and logged into the Order Log spreadsheet. Product
inserts are reviewed for changes.

Lot Information recorded is number, expiration date, date started and date stopped.

Supplies that are stocked in the HCTL but not of the lot currently in use are labeled with a New Lot label.

Extra supplies are stored in the Clinical Laboratory storeroom located on Ground South.

Products are stocked so that the oldest date is used first.

Inventory is to be stored in an organized fashion to prevent cross-contamination and mix-ups.

Chemicals are stored as low to the floor as possible.

Acids and bases are stored separately.

An inventory of laboratory supplies is performed on a weekly basis to maintain adequate stock.

Expired products are not used for patient processing. An expired product may be saved for research.
These products are labeled “For Research Use Only”.
Recalls and Alerts
Product recalls and field action alerts require immediate attention to prevent potential further failures or
adverse reactions. The PSHMC Support Services Department subscribes to the ECRI alert service which
provides notice of recalls and field action reports. A recall or field action alert notification involves the following
items:

The ECRI Service notifies a designated PSHMC Team, Laboratory Safety Coordinator, every Friday
of all notices of recalls or alerts involving healthcare supplies or equipment.

The Team reviews the ECRI list to determine if the notices impact PSHMC.

The Laboratory Safety Coordinator notifies the HCTL Coordinator of any notices that may impact the
lab.

The HCTL Coordinator or designee will determine if the HCTL uses the item.

If the HCTL uses the item it will be immediately removed from use then quarantined.

If the product has been used an investigation is initiated to determine if there was potential impact on
a cell product or patient.

If the item had no adverse impact on patient care the Laboratory Safety Coordinator will be notified
and documented in the ECRI system.

If the item did potentially adversely affect patient care the Medical Director and Risk management
Department will be notified to initiate a notification process.
Product Failures
If a product or equipment is suspected to be defective the item is to be removed from use and quarantined.
The manufacturer is then contacted who should provide information or initiate an investigation. The Laboratory
Safety Coordinator is also to be contacted to submit an alert to ECRI. The ECRI system can also be used to
search for previous alerts involving a product.
Page 12 of 14
SECTION XIV: PRODUCT TRACKING
Cellular therapy products used in patient care must be traceable from the source to the recipient. The HCTL
utilizes unit numbers, the laboratory information system and worksheets to track a products history. The
process includes:

An alphanumeric product number is assigned to the product at the time of collection.

If a product was collected elsewhere the collection centers product number is used unless it
is not readable by the laboratory information system. If not, the collection center unit number
is recorded and a HCTL product number is added to the product.

The product is entered into the laboratory information system including donor identity.

The unit number is recorded on a processing worksheet including donor identity.

Blood Bank testing and any component preparation techniques performed by the HCTL are
recorded in the laboratory information system.

Details of the component preparation (processing) is recorded on the worksheet.

Frozen product numbers are recorded in the storage log.

At the time of distribution the product number is recorded on the infusion or transport form.

All paper documents associated with this product are stored in the recipients file.
SECTION XV: PROCESS CONTROL
The HCTL employs several process controls to maintain a safe and efficient processing environment. The
process controls are listed below:
Request for Processing – In order to initiate processing the HCTL must receive a written request from the
recipients Physician. The request must include recipient and donor identifiers, a description of the type of
processing requested, and the anticipated date of processing. Additional requirements are described in SOP
2, Cell Processing and Testing Requests.
Reference:
Donor Eligibility – SOP 94, Specimen and Product Acceptability Criteria.
HCTL Facility
The HCTL is located in the FACILITY NAME room number H5511. The laboratory is staffed Monday through
Friday from 08:00 – 17:00 and as needed on evenings and weekends. The laboratory access is limited to
HCTL staff and locked when unoccupied. In the event of an equipment alarm situation the Blood Bank
personnel have limited access to the laboratory.
Transport
The HCTL staff is responsible for transport of products within the FACILITY NAME. Couriers that have
experience in medical specimen transport and can guarantee prompt delivery transport products that are
shipped outside. Dedicated couriers are used to transport products for patients that have been myeloablated.
SECTION IV - ASSESSMENTS
The HCTL assesses performance by participating in inspections conducted by accrediting agencies,
performing internal audits and participation in proficiency test surveys. The inspections provide an external
scrutiny of compliance with current regulations and standards. Trained employees perform internal audits to
determine if specific SOP’s are being followed. The HCTL also participates in proficiency testing surveys to
determine the accuracy of test results.
Page 13 of 14
SECTION V – LABORATORY SAFETY
The HCTL actively participates in the listed safety programs. Each safety program provides a manual that is
kept in the HCTL lab.
1. Health and Safety Program
The Department of Safety offers the following services to HMC employees. Details on taking advantage
of these services can be found in specific related areas of the Safety Program Manual, Safety Web Page
or by calling the department at ext. 7297.
• Safety Management of the JCAHO Environment of Care Functions
• Training
• Monitoring (indoor air quality, chemical, ergonomic)
• Hazard Surveillance
• Communication of Safety Issues
• Inspections (buildings, labs, fire extinguishers, eye washes, etc.)
• Hazardous Chemical Waste Pick-Up
2.
FACILITY NAME Safety Program
The Division of Pathology and Laboratory Medicine have a safety program that oversees the safety
issues within the clinical laboratories. The Lab program coordinates its efforts with the Department of
Safety Department to offer a comprehensive safety policy. The Laboratory Medicine Safety Manual
includes the following objectives:
1. Departments MSDS Sheets
7. Safety equipment
2. General Safety
8. Safety meeting information
3. Infection Control
9. Accident Report Forms and Information
4. Fire safety
10. Safety orientation checklist
5. Chemical safety
11. Electrical safety
6. HCTL Supplementary Universal Body Substance Precautions
3.
Facilities Infection Control Program
The HCTL employees are required to participate in the annual biohazard safety program offered by the
Infection Control Department.
4.
Disaster Planning
In the event of a disaster the HCTL maintains a section specific disaster plan found with the Department
of Pathology and Laboratory Medicine disaster plan. These plans are stored with the PSHMC disaster
plan.
Reviewed: - Annually
Revised: - When needed
Hematopoietic Cell Therapy Laboratory Operating Manual
Internal HCTL Audits
Page 14 of 14
Policy Number: 118
Effective: April 2007