Islamic Republic of Iran
Ministry of Health and Medical Education
Food and Drug Organization
Title: Regulations for plasmapheresis center
Type:
Finalized
√
Draft
No.:
Date of Issue:
Document No.: BP-ST-22-01
Name of Office: Biologic,Deputy for Drug
Chapter 1
1. General Guidelines/Definitions
2. Generalities
3. Quality Assurance System
4. Human Resources
5. Equipment
6. Supplier- and Customer-related Issues
7. Process Control, Final Inspection and Transportation
8. Documents
9. Aberrations, Lack of Conformity
10. Accidents and Severe Adverse Reactions
11. Evaluations
12. Process Improvement through Corrective and Preventive actions
13. Facilities and Safety
14. Traceability
15. Report to the Ministry of Health and Medical Education
Chapter 2- Donor and Healthy Plasma
1. Donor Health Protection Criteria
2. Criteria for Plasma Health Assurance and Recipient Protection
1
15
Table of contents (continued)
Topic
3. Providing Information to Donor
5. Requirements which should be Considered regarding Plasma
6. Storage Devices
7. Consignment and Transportation
8. Reception
9. Expiration
Chapter 3 - Experts Involved in Plasmapheresis
Chapter 4. Laboratory Tests
1. Required Laboratory Testing for Plasma Donors
2. Donor Retested
3. Epidemiological Studies
4. Reporting Test Results to Donor
Chapter 5 - Labeling Process
1. General Requirements
2. Unit Identification
3. Labeling during Collection or Product Preparation
4. Determination of Product Suitability before Labeling
5. Final Label prior to Distribution
6. Pooled Product
Chapter 6 - Documents and Documentations
1. Center Records
2. Record Keeping
2
Donor Care
Chapter 1
General Rules
1. Definitions:
Plasma: Plasma is the aqueous part of blood in which blood cells are suspended.
Plasma products: In this manual, plasma product and plasma harvest are equivalent and are defined as
extracted plasma from blood to be used in refining process.
Fresh frozen plasma (FFP): The plasma collected by apheresis and is frozen and stored for productive
purposes in a limited time and in a specific temperature.
Plasmapheresis: Apheresis consists of collecting one or more elements of blood by machinery processing of
whole blood. At the end of the process or during, the remaining elements of blood are returned back to donor.
If the desired element is plasma, then this method is called plasmapheresis.
Plasmapheresis production center: A center which produces FFP using plasmapheresis method for refining
purposes in pharmaceutical factories to produce plasma-derived pharmaceutical products.
Plasmapheresis of specific immunoglobulins: Plasmapheresis after donor immunization or in donors who are
naturally immunized.
2. Generalities:
2-1. Automated plasmapheresis production center should follow, in addition to the standards mentioned in this
manual, relevant standards of the European Pharmacopoeia, the Europe Union recommendations and the
World Health Organization recommendations with respect to plasma production. Automated plasmapheresis
production center is required to update its information in this field and perform according to the current
international standards at all times in order to preserve the highest level of health for donor and plasma.
2-2. Regarding plasmapheresis of specific immunoglobulin, other standards (which are not mentioned in this
manual) should be observed in addition to current standards.
2-3. The plasma collection process should be based on providing free services to donor, not disclosing donor’s
information, charitable intent of donors, and lack of motive for profit and interest by donor and/or collecting
center.
2-4. Plasma donation in such centers should be voluntary and only gift giving or payment of conventional
amounts of money for the reason of appreciation of the cooperation of donor and compensation for
transportation costs is permitted.
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2-5. The center must have the quality system in a way that this system covers all related activities and quality
and responsibility policies should be determined and completed via applying proper quality assurance
programs, quality control, observance of GMP standards and regulations.
2-6. Due to the use of extracted plasma extracted for therapeutic purposes, it is mandatory to ensure the safety
and quality of plasma to prevent transmission of transmissible diseases via this route.
2-7. In order to protect public health and prevention of dissemination of infectious diseases, it is mandatory to
take all precautionary cares to identify and remove transmissible pathogens via this route using the latest
scientific facilities during the collection, control, and consignment and production processes.
2-8. To ensure participation of blood donation, the donor’s information should be maintained as confidential.
2-9. In reporting abnormal findings to the donor, providing relevant consultations should be considered.
2-10. Plasmapheresis production center should have efficient quality assurance unit.
3. Quality Assurance System:
A. Plasmapheresis production center should have a defined structure and clearly determine and specify
responsible units in preparation of plasma products and contact between responsible persons in key qualitative
activities.
1. Plasmapheresis production center should have a Managing Director who is selected by the board founder.
1-1. Managing Director or Executive Director is in charge of management and coordination of executive
affairs at the center and should assign the qualitative affairs to the officials. Managing Director is responsible
to introduce personnel and technical executives to the Drug Office and supervision on observance of rules,
regulations, guidelines and standards of the Ministry and to provide necessary facilities for observance of
standards and to plan and observe donors’ legal charter. Managing Director is in charge of declaration of
required information by the Ministry and announcement of changes.
2. Medical technical executive is a physician who should have, in addition to legal licenses, must have
competency approval for medical responsibilities in plasmapheresis production centers from Iran Blood
Transfusion Organization.
2-1. Medical technical executive is responsible for physical examination, interview with donors and
confirmation of their competency for blood donation and performing plasmapheresis appropriately and
preservation the health of the donor and produced plasma in all steps.
3. Production technical executive is a pharmacist who should have, in addition to legal licenses, responsibility
license from the Drug Office.
3-1. Production technical executive is responsible for final confirmation of the produced plasma. Production
technical executive is responsible for evaluation of documents of all step and finally confirmation of plasma
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(release) for shipment to refinery.
4. Laboratory technical executive should have legal licenses and obtain necessary permits for establishment of
laboratory.
4-1. Laboratory technical executive is responsible for correct sampling, appropriate testing, validation of the
devices and methods used and finally confirmation of the correctness of the responses.
B. Plasmapheresis production center must define, establish, document, implement and maintain a quality
system. All employees should receive necessary trainings for its performance.
1. Quality Control System must include at least the following essentials:
• Organization
• Personnel
• Equipment
• Supplier issues
• Process control, final inspection, and transportation
• Documents and records
• Aberrations, lack of conformity
• Internal and external inspections
• Process improvement
• Facilities and safety
• Complications
• Documentations
2. The management service should evaluate the effectiveness of quality system by timed directorial revisions.
3. Plasmapheresis production center must prepare and implement quality system, policies, processes, and
methods to meet requirements for these standards. All these policies, processes and methods must be written
or recorded electronically.
4. Medical Director should verify all policies, processes and medical and technical executive procedures.
5. Each exception in policies, processes and procedures which are confirmed due to clinical situation
necessitates approval and former confirmation by the medical manager.
4. Human Resources:
Plasmapheresis Production center must have policies, processes and procedures to ensure provision of
adequate resources in order to perform, recognize and manage all activities of the center including human
resources.
4-1. Plasmapheresis production center must have a process to ensure employment of sufficient number of
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qualified people (who have gained necessary qualification through education, training, and/or work
experience). Current job description should be defined and maintained by suitable description for any position.
4-2. Plasmapheresis center should have a process for identifying practical training needs and provide amenities
for training of all staff that have effective activities regarding quality of system. The staff that has
responsibility for important tasks should be qualified based on education and appropriate training or work
experience.
4-3. Continued competency assessment should be conducted at certain intervals.
4-4. Training records for each employee must be kept. For revision of important and critical steps of the
process, documents related to names, signatures, initials or identification codes and code and date and time of
the employment must be maintained.
5. Equipment:
Plasmapheresis production center should determine instruments, equipment, and measuring devices which are
necessary for production of plasma products. Plasmapheresis center should have a process to ensure
calibration, maintenance and accreditation of instruments, equipment and measuring devices in accordance
with the applicable standards, terms, and other requirements.
5-1. Plasmapheresis center must have a process for definition of equipment selection criteria.
5-2. All equipment must be qualified to be considered for use.
5-3. All accurate and important instruments and equipment must be verified by Iran Blood Transfusion
Organization.
5-4. Precise instruments and equipment must have unique identification card.
5-5. Plasmapheresis center must have a process for timed monitoring of all accurate and important equipment.
5-6. Monitoring of important and accurate equipment should include the following elements:
Accurate and important equipment should be calibrated and set before using or after activities which may
affect calibration and in regular intervals using instruments and equipment which have enough precision and
correctness.
Calibration process should include a complete description of the type of equipment, unique identification card,
location, inspection frequency, inspection methods, measures taken when the results are not satisfactory, the
method to ensure that equipment used are calibrated and if necessary using protective devices to prevent
setting that may make it out of calibration.
For assessment of conformity of plasma products when it is clarified that the machine has been out of
calibration, the center should act according to aberrations and lack of conformity standards.
Instrument malfunction, faults and defects and adverse incidents should be studied and, if necessary, they
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should be reported to manufacturer.
6. Supplier and customer-related issues
Plasmapheresis production center must have policies, processes and administrative procedures to be able to
evaluate the ability of providing facilities and critical by suppliers according to necessities.
6-1. Eligible Supplier:
Plasmapheresis production center must, if applicable, before acceptance of any contract select the supplier and
evaluate its performance.
6-1-1. When the supplier can not adapt to the required necessities, this matter should be reported to the
management (which has authority to regulate and set a contract).
6-1-2. Laboratory tests and services which are considered necessary in these standards should be valuated by
Iran Blood Transfusion
6-2. Contract:
Plasmapheresis production center should have a process to ensure agreements or contracts or changes in them
for receiving or producing plasma products and critical goods in a way that meet the demands of the customer
and supplier in accordance to the agreement or contract.
6-3. Agreement or contract revision:
Plasmapheresis production center should have a process to ensure that agreements or contracts or any change
in them will be revised and, if necessary, become as part of the agreement or contract.
6-4. Reception, inspection, and testing materials received:
Plasmapheresis production center should posses a process to ensure the reception, inspection, and testing (if
required) sensitive materials before reception and usage.
6-4-1. Any container which is used for collection, preservation and storage, including those for plasma and
blood samples of the products, must be inspected in order to ensure its integrity. Its label must be complete,
stuck onto the container, and legible.
6-4-2. Sensitive materials should be in conformity with the requirements of Iran Blood Transfusion
Organization.
6-4-3. All dishes and solutions used for collecting, maintaining and storing of plasma products and all
laboratory reagents used for tests on blood samples should meet the criteria of the reference center or a valid
interior/exterior center or be in a higher state than the mentioned centers’ criteria.
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6-4-5. If the laboratory reagents are produced by plasmapheresis production center, documents which show
that the reagents are suitable for usage must be prepared and preserved.
7. Process control, final inspection and transportation:
Plasmapheresis production center should have policies, processes, and valid executive methods to guarantee
plasma products quality. Plasmapheresis production center should ensure that the policies, processes, and
executive methods used are under control.
7-1. Process control
7-1-1. Plasmapheresis production center should have a process to ensure validity of its processes.
7-1-2. Plasmapheresis production center should ensure the performance of all its processes and methods.
7-1-3. Plasmapheresis production center should establish quality control program which is so comprehensive
to ensure that reagents, equipment and methods perform as expected. Its documents should be prepared and
kept. The results should be revised and if necessary corrective actions should be made.
7-1-4. Plasmapheresis production center should participate in proficiency testing, if applicable, for ant analyte
which is tested in that center. When the approved reference program is not available, there should be a system
to determine the accuracy and reliability of the results of these experiments. The results should be reviewed
and in cases when necessary items and desired time is not met, corrective action should be made.
7-1-5. Plasmapheresis production center should have a process that ensure all plasma products and sensitive
materials used in their processing as well as laboratory samples and the donor’s and refiner’s documents are
determined and are detectable.
7-1-6. For any important and critical step in the collection and processing, testing and sensing the product,
there should be a mechanism to identify personnel who carry out these processes and the time this action has
been done.
7-2. Plasma products; new or modified:
Plasmapheresis production center should have a process for developing and performing new or modified
processes and methods. This process should include determination of specifications and validation of required
issues of these specifications.
7-2-1. Plasmapheresis production center should ensure that the application of all plasma products and modified
methods are under control.
7-3. Inspection:
Plasmapheresis production center should have a process to ensure that plasma products in a defined step have
been inspected at the center and have been verified regarding expected and necessary specifications.
7-4. Final inspection:
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Plasmapheresis production center should have a process to ensure that plasma products have been inspected
and verified according to expected and necessary specifications in a defined step in that center.
7-5. Relocation, Storage, Distribution and Transportation:
Plasmapheresis production center should have a process to ensure that plasma derivative products, samples,
and sensitive materials are relocated, stored, distributed, and transported in a way that ensure detectability,
prevention of damage, and limitation of lost products.
8. Documents:
Plasmapheresis production center should have policies, processes and procedures to ensure that documents are
identified, reviewed, approved and prepared documents are archived according to document archiving policies.
8-1. Plasmapheresis production center must have a process for controlling the production of documents which
include the following components:
8-1-1. Master list of documents include policies, processes, executive procedures, forms and labels that are
related to the requirements of these standards.
8-1-2. Using a standard format for all policies, processes, and executive methods. Other methods can be added
by giving their references.
8-1-3. Reviewing and approving of new and modified documents before application
8-1-4. Each of the policies, processes and procedures should be revised annually by a person who is
authorized. Annual revised documents should be kept.
8-1-5. Controlling of all documents (policies, processes, methods, labels and forms) related to the
requirements of these standards ensures that only valid and current documents are used and obsolete and
invalid documents are not used.Valid and appropriate documentations must be accessible in each place that
activities carried out in that place needs observance of these standards.
8-1-6. Current and obsolete documents should be determined to be properly archived and protected.
9. Aberrations, lack of conformity:
Plasmapheresis production center must have rules, processes and procedures to ensure keeping and evaluation,
investigation and monitoring of aberrations or inability to meet the specific requirements. The responsibility of
revision and authority for the use or non-use of plasma and sensitive and critical material and non-conforming
services should be defined. The aberrations should be reported according to specific requirements.
9-1. Lack of conformity:
With the discovery and detection of non-compliance in plasma, sensitive materials, and services they should
be assessed and whether they can or can not be used should be evaluated.
Plasmapheresis production center should ensure documentation and keeping, evaluation, investigation and
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observation regarding adverse reactions due to plasma donation.
9-1-1. Non-conforming plasma and plasma products should be quarantined and ultimately should be discarded
according to defined standards and under supervision of the Drug Office.
9-1-2. Plasmapheresis production center should ensure prevention of distribution, release, delivery, and
infusion or unintended usage of plasma products or services which do not conform to the requirements
determined.
9-1-3 Plasmapheresis production center must have a process for determining production, quarantine, retrieval
and recall of plasma and non-conforming and report these to the Drug Office.
9-1-4. Documents related to this lack of compliance and subsequent measures must be kept for 50 years.
9-2. Non-conforming plasma products which have been released
Plasma products which have been found to be non-conforming after release should be evaluated to determine
the effect of non-compliance on the quality of product. In cases that the quality of the product is affects, this
non-compliance should be reported immediately to the customer and the Drug Office. The documents of this
non-compliance and the actions made should be kept.
10. Accidents and severe adverse reactions:
10-1. Standard written instructions to take action against any adverse reaction and non-compliance must be
prepared in advance and these reactions and the actions made must be reported according to the specific
requirements.
10-2. Adverse reactions due to plasma donation must be evaluated, studied, documented and kept and reported
to the Drug Office.
10-3. Any serious adverse event including accidents and mistakes or errors associated with collecting, testing,
processing, storage and shipment of plasma along with severe adverse reactions, which have been observed
that may affect the quality and safety of plasma, should be followed and reported to the Drug Office.
11. Evaluations:
Plasmapheresis production center must have policies, processes and procedures to ensure that interior
assessment of performance and quality of systems are done in timed intervals.
11-1. Managing the results of evaluations
The results of interior and exterior evaluations should be revised by a person who is responsible for the
evaluation.
11-2. When a corrective action is made, it should be evaluated according to the standards of process
improvement through corrective and preventive measures.
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11-3. The results of internal and external evaluations, along with corrective and preventive measures, should
be reviewed by executive management.
12. Processes improvement through corrective and preventive measures:
Plasmapheresis production center must have policies, processes and procedures for data collection, analysis
and follow-up of corrective and preventive actions.
12-1. The process of corrective measures should include:
- Documentation relating to mistakes and accidents and reporting accidents, lack of conformity, and
complaints.
- Evaluation the reason of lack of conformity related to plasma products, sensitive materials and services.
- Investigating customers’ complaints
- Determining the type of corrective action needed to remove the lack of compliance, accidents, errors and
events.
- Evaluation to ensure that corrective action has been made and has been effective.
12-2. The process of preventive measures should include:
12-2-1. Revision of appropriate data references including evaluation results, the results of efficiency test,
quality control documents, and customers’ complaints to detect the potential causes of non-compliance
12-2-2. Determining the steps needed to address potential problems that require preventive measures.
12-2-3. Starting preventive actions and applying controls to ensure its effectiveness.
12-3. Quality Monitoring:
Plasmapheresis production center must have a process for evaluation the information related to qualitative
indices in a timed interval.
13. Facilities and safety:
Plasmapheresis production center should have policies, processes and procedures to ensure safety and suitable
conditions of workplace.
13-1. Plasmapheresis production center should have defined practical plans to minimize the environmental
hazards on health and safety of employees, donors and volunteers. There should be units, work environment
and appropriate equipment to maintain safety of the processes.
13-2. Plasmapheresis production center should have a process for biologic, chemical, and radiation safety,
where applicable, and a process for supervision and monitoring as well as training and compliance with terms
and regulations.
13-3. Plasmapheresis production center should transport and dispose plasma derivative products in a way to
minimize the potential contact with infectious agents.
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13-4. Waste and sewage of the center should be disposed of without any adverse effects on humans and
environment.
14. Traceability:
14-1. The trace of any donation from donor in plasmapheresis center to final product should be clear and
detectable.
14-2. An efficient system should be established to ensure traceability of plasma. Traceability should be done
regarding all healthy donors, laboratory diagnostic methods and in whole process of record keeping and
labeling processes.
14-3. All necessary measures to ensure that plasma collection, testing, storage and distribution is traceable
from donor to recipient and reverse should be taken.
14-4. Data and necessary information for complete tracking should be kept at least for 50 years.
14-5. It is desirable that in different plasmapheresis centers, a common system to be used in tracking of
donors.
15. Reporting to the Ministry of Health:
In addition to immediate reporting of events and severe adverse reactions, aberrations and non-compliance
cases which may affect quality, the following items should be reported to the Drug Office and Health Deputy
of the Ministry of Health:
1. The total number of donors
2. The total number of donations
3. The number of used and non-used donations
4. Maintenance place
5. The prevalence and range of transmissible infectious markers by plasma in donors
6. The number of returned products and non-conforming products
7. The number and type of severe adverse events and reactions and description of the measures taken
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Chapter 2
Donor and Healthy Plasma
1. Donor Health Maintenance Criteria:
On the day of plasma donation before blood sampling, the medical history of the donor should be evaluated
and the donor should be examined to ensure that plasma donation is not dangerous for the donor. The center
should have a process for management and assessment of received information from a third person about
suitability of donor in specific situations.
1-1. Donor Weight and Age:
Donor should weight at least 50 Kg less than 50 years old.
1-2. Plasmapheresis Frequency and its Permitted Volume:
1-2-1. Continuous plasma donor is a donor who donates plasma more than once in every four weeks.
1-2-2. Plasmapheresis sessions should not be more than two times per week and have less than 48 hours
between two sessions. Generally, plasmapheresis should not be more than 24 times in a year.
1-2-3. In automated plasmapheresis, at any time during the process, the blood volume extracted should not be
more than 500 mL whole blood (without anticoagulant or 10.5 mL/Kg with consideration of sample volume)
unless with the diagnosis of physician in conditions in which the donor’s weight is 80 Kg or more.
It should be mentioned that even at this weight no more than 600 mL of whole blood in each session or more
than 1200 whole blood (without anticoagulant) in a two-day period should be extracted. (In each session, two
plamapheresis processes are done and totally about 500 mL of plasma is collected)
1-2-4. In automated plasmapheresis, the whole blood volume without anticoagulant during the process in a 7day period should not exceed 2000 mL and in each session of plasmapheresis should not exceed 650 mL
unless the weight of the donor is 80 Kg or more. Even at this weight, the whole blood volume without
anticoagulant should not exceed 2400 mL.
1-2-5. Only normal saline 0.9% (with approval of the Iran Ministry of Health and Medical Education) should
be used as intravenous replacement fluid.
1-2-6. Each donor should not donate more than 12 liters of plasma during one year.
1-3. Blood Pressure:
Only donors, who have systolic blood pressure of more than 180 mmHg and diastolic pressure of more than
100 mmHg, after evaluation by the medical director, should be accepted.
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1-4. Pulse Rate:
Pulse rate should not show any cardiac pathologic irregularity and should be between 50 and 100 beats per
minute (bpm). Donors whose pulse rate is higher than 100 bpm only can be accepted after assessment by
medical director. Donors whose pulse rate is lower than 50 bpm should only be accepted under the supervision
of medical director and if they belong to sportive groups. 1-5. 1-5. Hemoglobin or Hematocrit:
Hemoglobin or hematocrit should be determined before blood donation.
1-5-1 - Hemoglobin level should not be less than 13 g/dL. Hematocrit as a substitute to hemoglobin should not
be less than 40%. The blood obtained from earlobe should not be used for this purpose.
1-5-2. The maximum acceptable level of hemoglobin should be determined by each center.
1-6. Disease States:
Donors with cardiac, hepatic or pulmonary diseases or with history of malignancy or abnormal bleeding
should be deferred from donation unless it becomes clear by medical director that they are suitable for blood
donation.
1-7. Drug Therapy:
Donors who are taking medication should be considered regarding the suitability for blood donation.
2. Criteria to ensure plasma health and consumer protection
On the day of plasma donation and before blood taking, medical history of donor should be evaluated and
donor should be examined in order to prevent donation from a person who has signs of transmissible diseases
and also other conditions which may endanger suitability of blood and its products. The center should have a
process for information management received from third person about suitability of donor. Donors should be
healthy in their appearance. Performing medical examinations, interview and filling out questionnaire in
addition to screening laboratory tests is necessary.
2-1. Donor Identification
Private plasmapheresis production center should verify the identity of donor including personal information,
address, and signature and confirm them with previous archived documents.
Medical history and healthiness of donor is received via filling out a questionnaire and personal interview by a
qualified person. Gathered information should include those which help diagnose and screen cases if donation
endanger their and other’s healthiness.
2-2. Temperature
Oral temperature of donors should not be higher than 37.5° C (99.5° F) or its equivalent.
2-3. High-risk Behaviors
2-3-1. Alcohol abuse:
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If there is evidence of alcohol intoxication or alcohol dependency, the donor should be deferred from donating
plasma.
2-3-2. Site of blood sampling:
Skin of blood taking site must be free of any lesions.
2-3-3. Intravenous drugs:
Both arms of donor should be examined regarding intravenous drug abuse. If there is evidence of injection
marks on the arms or other signs suggestive of intravenous drug abuse, donor should be deferred from
donating for infinite time. Donor should not have used in the past any syringe for intravenous drugs except for
those prescribed by physician.
2-3-4. Sexually Transmitted Diseases (STD):
History of syphilis, gonorrhea, or their treatment, positive screening or reactive test result for syphilis and lack
of a confirmatory negative test leads to prohibition of donor from donating plasma for infinite time (due to the
probability of existence of AIDS simultaneously).
2-4. Transfusion of Blood, Blood Products or other Human Tissues
2-4-1. Donors with family history of Creutzfeldt–Jakob disease (CJD) or history of receiving tissue or tissue
derivatives which can be possible source for CJD (such as dura matter, human-derived hypophysial growth
hormone, etc) should be deferred from donating plasma for unlimited time.
2-4-2. Donors who have received blood or blood products during the preceding 12 months should be deferred
from donating plasma.
2-4-3. Donors who have received human tissues or blood derivatives which are known sources of blood-borne
pathogens should be deferred from donating plasma.
2-5. Vaccination and Immunization
Persons who have been vaccinated or immunized should be deferred from donating plasma for time intervals
indicated in the following Table.
Vaccination and immunization
Exemption
period
Toxoids or killed viral, bacterial, rickettsial vaccines or synthetic if donor is
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No exemption
asymptomatic and does not have fever including:
Anthrax
Whooping cough
Cholera
Plague
Diphtheria
Pneumococcal polysacharride
Hepatitis A
Polio (injection)
Hepatitis B
Rabies (lack of confrontation)
Influenza
Rocky Mountain Spotted Fever
Lyme’s disease
Tetanus
Parathyphoid
Thyphoid (injection)
Live attenuated bacterial or viral vaccines including
measles, polio (oral), yellow fever, mumps, thyphoid fever (oral)
Live attenuated bacterial or viral vaccines including
rubella (German measles) and varicella zoster
Others include:
Hepatitis B Immunoglobulin
Unapproved vaccines
Immunization for rabies if done after animal bite/scratch or other causes of
exposure to infected animals
2 weeks
4 weeks
12 months
2-6. Infectious Diseases
Donors must be free of documented infectious diseases which are transmitted by blood (to be clarified by
examinations and history taking).
2-6-1. Unlimited Exemption
Donors with history of each of the following should be deferred from plasma donation for unlimited time:
2-6-1-1. History of viral hepatitis after age of 11 years or having confirmed positive HBsAg test,
2-6-1-2. History of clinical or laboratory evidence suggestive of hepatitis C virus (HCV) or Human Immune
Deficiency Virus (HIV) infection at the moment or in the past,
2-6-1-3. Those who have been deferred from blood donation according to the terms and recommendations of
Iran Blood Transfusion Organization or the Iran Ministry of Health and Medical Education,
2-6-1-4. Those who have donated one unit of blood or blood products and have caused clinical or laboratory
findings of hepatitis or HIV related to blood transfusion in recipient and the recipient had not received other
blood products that may cause these findings,
2-6-1-5. Those who are at risk for getting HIV infection and have high-risk behaviors for transmission of HIV
and their examination results indicate HIV infection should be deferred from donating plasma according to
Iran Blood Transfusion Organization and Iran Ministry of Health and Medical Education.
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2-6-3-1. Immigrants, refugees and foreign nationals and those who have traveled to areas where disease
epidemiology in these areas is not clear fro the Ministry of Health and Medical Education should be deferred
from donating plasma.
2-6-3-2. Those who have been resident of one of the North American countries, Canada or Europe as of 1980
are considered as exempted.
(Other high-risk areas regarding other diseases should be determined by each center).
2-6-2. Temporary Exemption
If donors have one of the following criteria during the last 12 months should be deferred from donating plasma
for one year:
2-6-2-1. Tattooing, phlebotomy, acupuncture, electrolysis and other similar cases
2-6-2-2. Mucosal membrane contact with blood
2-6-2-3. Non-sterile perforation of donor’s skin with devices contaminated with blood or other body fluids.
2-6-2-4. Living with or having sexual contact with symptomatic persons (based on clinical or laboratory
findings) regarding viral hepatitis or confirmed positive hepatitis B surface antigen (HBsAg) test.
2-6-2-5. Sexual contact with a person who has HIV infection or is at high risk for getting HIV infection
(according to current recommendations of Iran Blood Transfusion Organization or the Ministry of Health and
Medical Education),
2-6-2-7. Being detained in prison for more than 72 hours.
2-6-2-8. Sexual contact with HCV-positive patients who had overt clinical hepatitis within the past 12 months
3. Providing Information to Donor:
3-1. Donor Education
Educational materials about blood, process of blood transfusion, blood elements, apheresis donation, benefits
of blood transfusion for patients as well as the hazards of infectious diseases transmission by blood and
symptoms and signs of AIDS should be provided to all donors. Before plasma donation, donors should give
written confirmation that they have read and understood educational materials and have had chance to ask
questions and that the materials have been understandable for them. If donors believe that their blood is not
suitable for donation, they should be aware of importance of plasma donation refusing.
Also, donors should be educated regarding necessity of physical examination, medical history, healthiness of
donor, testing of donated blood, self restriction, temporary suspension and permanent exemption. The reason
that why donor can not participate in donation, if there are hazards for recipients, should also be explained for
donors. Prohibition of unauthorized disclosure of donor’s identity, information about competence of donor and
the results of laboratory tests performed, information about this matter that donor have the right to change
17
his/her idea before plasma donating or refusing to continue the process, the reasons that why donors should
inform the center about any event that can affect suitability of the donated plasma, all should be explained for
donors.
3-2. Informed Consent
Informed consent before the donation should be obtained from plasma donors. The steps of plasma donation
should be explained for donor in a way that would be understandable for him/her. Explanation should include
information about the important hazards in plasma donation steps and tests done for decreasing the risk of
transmission of infectious diseases to recipient. Donor should have feasibility of asking questions and not
accepting informed consent.
3-2-1. Donor should be informed about conditions in which some laboratory tests about transmission of
infectious diseases are not performed.
3-2-2. Documents of informed consent should be kept.
3-3. Plasma Unit Elimination (Self-elimination, confidential)
If there is any possibility for donor to declare that collected plasma should not be used for refining, donor
should be certain that the blood will be tested and any positive test result will be reported to him/her. If there is
possibility of plasma self-elimination by donor, this action should be considered as confidential.
3-4. Recommendations prior to plasma donation
Donor should be informed about actions which must be done before plasma donation such as:
1. Donor should take a bath the night before donation
2. Non-stimulant drinks should be consumed frequently and it is better to avoid eating egg and fatty foods
during the 24-hour period prior to plasma donation.
3-5. Recommendations after plasmapheresis
Donors should be aware of cares after plasmapheresis.
3-6. Reporting test results
Medical director should establish tools required to inform donor about any medical issue revealed during
evaluations performed before plasmapheresis or in laboratory tests. Appropriate education and consultation or
referral to medical centers should be provided.
3-7. Information about donors after plasma donation
The center should have a process for management of important information about plasma donation which
receives from donor or a third person about eligibility of donor
4. Donor Care:
Plasmapheresis production center should have a process for prevention and treatment of adverse reactions in
18
donors. Donor should be cared carefully during plasmapheresis. Necessary equipment, medical emergency
devices with necessary tools should be accessible. Details should be documented donor should be
acknowledged in terms of personal medical care.
4-1. Before starting plasmapheresis, vital signs of donor (Supervision on Plasmapheresis Form) should be
documented and physician permits the process of plasmapheresis.
4-2. In general, all donors must be checked in terms of heart rate, blood pressure, respiratory rate, heart and
lung auscultation, body temperature at starting point and at the end of each process and “Supervision on
Plasmapheresis Form” should be completed.
4-3. Process duration and the time of start, finish, blood volume and amount of collected plasma and possible
complications of “Supervision on Plasmapheresis Form” should be filled out.
4-4. Lost red blood cells during the process which include collected blood samples for laboratory tests should
not exceed 25 mL per week or 200 mL in each 8-week period. If we can not return red blood cells to donor
after process, blood donation or plasmapheresis should be delayed until 8 weeks later.
4-5. before obtaining the second unit of whole blood in intermittent automated plasmapheresis, all red blood
cells collected from the first blood taking should be returned to donor and this time should not last more than
1.5 hours after starting of blood taking.
5. Requirements which should be considered about plasma
5-1. Method:
Methods should include criteria and doses of related factors (accessory) used and instructions used for
prevention and treatment of reactions in donors. The following documents must be kept:
Identity of donor, the results of test which assess donor, consumed anticoagulants, procedure duration, plasma
product volume, drugs used, disposable equipment number series and replacement fluids and any reaction
happened and the method of their treatment.
5-1-1. All actions related to prepare of plasma products should be done by automated plasmapheresis
machines.
5-2. Documents about decrease in total volume of red blood cells should be kept in order to determine that
decrease in red blood cells in 8-week period and the last 12 months will not exceed permitted red blood cell
decrease.
5-3. Medical director of plasmapheresis center should be responsible for plasmapheresis process (including
determining suitability of donor, blood taking, and preparation of plasma derivative products) for automated
plasmapheresis.
5-4. Sterility of the process should be preserved by using aseptic methods and solutions and sterile equipment
19
free of pyrogen materials during preparation of plasma derived products. It is better to use equipment capable
of transporting plasmapheresis products without breaking seal (closed system). If possible, it is better to use
disposable tools.
5-5. In case of using sterile connector machine for connecting two compatible tubing, a closed system is
created and the following should be considered:
5-5-1. The connecting welding created during the preparation process using the sterile connector must be
checked to be complete.
5-5-2. if the integrity of welding is complete, product can be kept until the expiration date of the first pack or
until the time determined by Blood Transfusion Organization.
5-5-3. If the integrity of welding is not complete, the product of system is considered as open and can not be
used.
5-5-4. Documents related to plasma product identification numbers, manufacturing series, software and
consumable materials should be kept.
5-6. For pooled products, the producer organization should maintain identification documents of collecting
center and identification number of any unit contained in pooled product.
5-7. In cases of plasma donation and preparation of FFP by automated plasmapheresis method, the time from
blood taking to freezing plasma should last less than 4 hours (considering transport time to putting in freezer).
After separation of plasma and its preparation by automated plasmapheresis devices, it should be put in
alcohol tank with temperature of - 30° C or below (plasma number should be determined proportional to
alcohol tanks) or (less than 10 units of plasma) can be put in rapid freezers with temperature of - 70° C or
below and also freezer blast can be used. Plasma dishes should be protected by polyethylene cover to prevent
chemical changes.
5-7-1. If after separation using rapid freezing devices, plasma freezes and its temperature reaches to - 30° C in
less than 1 hour and then kept at - 30° C or below, rapid freezing has been done desirably.
5-7-2. All steps of freezing should be validated for each plasma unit and it should be clear that plasma is kept
at what temperature, time duration, and by which device and the form of plasma products freezing should be
documented and kept.
5-7-3. If we can not freeze plasma according to the above mentioned methods in a desirable temperature, the
characteristics of plasma should be changed and the label should be stuck onto it.
8. Environment and Equipment:
5-8-1. The structure of environment and equipment should be possible to keep them clean. Walls and floor of
plasma collecting place should be washable and have ample light.
20
5-8-2. Arrangements should be considered for those who are not authorized can not enter the environment.
The operating room should not be used as crossing place for personnel of the center.
5-8-3. Plasmapheresis unit should be completely isolated from other units and donors should go under
plasmapheresis in an environment which is isolated from waiting rooms and other places.
5-8-4. It is necessary to provide entertaining facilities for donor to prevent donor from sleeping (If donor
sleeps there is likely that needle moves inside the vessel and therefore nurse should be careful).
5-8-5. Plasma storage environment should not be accessible by unauthorized people and its door must be
locked.
5-8-6. New equipment before usage and also during usage should be evaluated.
5-8-7. Work environment and employee safety such as how to dress, hand hygiene, how to deal with blood and
plasma and their vaccination, should be according to the standards of Health and Safety Unit of Blood
Transfusion Organization.
5-8-8. For each 10 active beds in each room, a trolley with all necessary facilities (including cardiac
resuscitation equipment, intravenous solutions (crystalloid), syringes, alcohol, cotton, drugs needed for
resuscitation) should be provided. Distance between two beds should be enough to allow putting automated
plasmapheresis machine base and nurse and physician can pass between them.
5-8-9. Computer system of plasmapheresis unit should not be accessible for all people in order to prevent
accessing data by unauthorized people.
5-8-9-1. There should be secondary methods called “back up” methods to protect and prevent deletion of
information from computers.
6. Storage devices
Plasmapheresis production center should consider some places for storage of plasma derivative products.
These sites should be designed to prevent damage or destruction of products. The way to access to these sites
and allowance to use the stored products should be defined.
6-1. Plasma, donated samples or related reagents and laboratory equipment should be kept in complete
isolation in determined places.
6-2. All freezing equipment must be equipped with ventilation for air circulation or have design to permit
maintaining appropriate temperature all over it.
6-3. Plasma products must be kept in temperatures proven to preserve the products safe. This temperature for
FFP is - 30°C or below.
6-3-1. Refrigerators and freezers should have a system for continuous monitoring of temperature and its
recording every 4 hours. If the products are kept in open places, the environment temperature should be
21
documented every 4 hours.
6-4. Refrigerators and freezers must have warning systems.
6-4-1. Warning systems should be set up in a way that activate before inappropriate temperature occurs for
blood products and provides suitable action.
6-4-2. Warning system (flashing lights or sound) must act in a place that covers enough number of personnel
to ensure urgent corrective action.
6-4-3. Warning system in liquid nitrogen freezers must activate at unacceptable levels of liquid nitrogen.
6-5. Processes in terms of maintaining and preservation of plasma in the limit of permitted temperatures
should be provided and include instructions that upon warning (light or noise), electric power interruption or
other problems can be followed.
6-6. Activating of warning system should be a start point for investigation and immediate evaluation and
corrective action.
7. Shipment and transportation:
7-1. Only plasma samples can be sent to refinery that are kept in quarantine and repeated test has been done on
donor (Retested donor) (According to explanations of Retested Donor Section).
7-2. Plasma and products should be transported in a way that prevents their damage.
7-3. Temperature for transportation of FFP should be -20°C or below.
7-4. Plasma should be inspected before transportation to refinery and if there is abnormal appearance, the
product should not be transported (In another word, it should be transported if met the required specific
criteria).
7-5. Using forms filled out during the process, any given path from a donor in plasmapheresis center to
finished product and the reverse path should be detectable.
7-6. At the time of plasma shipment to quarantine department, the related form should be completed and
signed.
8. Receipt
At the time of receiving of plasma and important materials, each container should be inspected to ensure that it
is not defective and that its label is complete and legible. Documents that describe plasma, receipt date,
producer and expiration date should be kept.
8-1. Upon receiving unapproved and non-conforming plasma (emergency or specific discharge), the receiver
should:
1) keep receiving and non-conformity documents
2) Keep this product in a separated place
22
9. Expiration:
Expiration date should be determined in accordance with the last day that plasma product seems useful for
regular objectives of refinery.
23
Chapter 3
Experts Involved in Plasmapheresis
3-1. Medical director of plasmapheresis production center should be responsible for plasmapheresis (including
determination of suitable donors, blood collection, preparation process plasma products) to be automated
plasmapheresis.
3-2. Person responsible for plasmapheresis section (medical director of the center or his/her successor) must
supervise on all steps and if the quality is not sufficient should intervene.
3-3. Other employees must have university educations at the level of Master and higher in medical sciences
and have a good knowledge of plasmapheresis and before and during work they participate at educational
courses and have necessary skills. The staff who will do plasmapheresis with automated machine should have
at least degree of master in nursing from accredited domestic or international universities and have learned the
method of dealing with plasmapheresis machine and have related certifications as well as attending at
continued medical education programs.
3-4. In addition to current control on all plasma products, responsible person for quality control should
evaluate at least 1% of plasmapheresis products qualitatively according to plasma quality control guidelines
and report the results to the manager of center.
3-5. It is necessary that the number of personnel follows the following Table and up to 20 plasma donors in
each working shift there should be a physician. If the responsible physician is absent, the successor physician
should be present. He/she should also attend required educational courses.
Number of personnel based on number of beds (donors) in plasmapheresis production unit
Number of active beds
Number of employees
4
1 nurse
20
1 physician
3-5-1. If the bed arrangement and the monitor of devices are in such a way that nurse can observe more than 2
beds, more bed numbers are also acceptable.
3-6. There should be no obscures about responsibilities of personnel in performing their duties.
3-7. Job description of employees and SOP of all steps in plasmapheresis should be accessible in written,
24
clear, and understandable way. (Control of vital signs, infusion of normal saline, awareness of any alteration in
general condition of donor and familiarity with adverse effects and completing required forms).
25
Chapter 4
Laboratory Tests
1. Tests Required for Plasma Donor
The pattern of performing laboratory tests and their intervals are defined in the following Table:
1-1. Be careful about the experiments that require to be repeated every four months; if the number of
plasmapheresis sessions exceeds 10, the test should be done. In another word, repetition of test is based on
doing every 4 months or per 10 plasmapheresis sessions (each one which occur earlier).
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Laboratory test
Acceptable
Test intervals
response
Blood group and Rh
Anti-HCV
Negative
In case of unacceptable
response in donor
Upon entry
Permanent exemption
Upon entry and each
Permanent exemption
time of
plasmapheresis
Anti-HIV I, II
Negative
Upon entry and each
Permanent exemption
time of
plasmapheresis
HBsAg
Negative
Upon entry and each
Permanent exemption
time of
plasmapheresis
RPR (rapid plasma
Negative
reagin)
Upon entry and each
Temporary exemption*
time of
plasmapheresis
Hb/Hct
Hb ≥ 13, Hct ≥ 40
Upon entry and each
Temporary exemption
time of
plasmapheresis
ALT (alanine
Less than 2 times
Upon entry and every
aminotransferase)
of the upper
4 months
Temporary exemption
reference limit
CBC (complete blood
Normal
count)
U/A (glucose and
Temporary exemption
4 months
Negative
protein in urine)
Total Plasma protein
Upon entry and every
Upon entry and every
Temporary exemption
4 months
≥ 6.0 g/100 mL
Upon entry and every
Temporary exemption
4 months
Albumin
≥ 4.0 g/100 mL
Upon entry and every
Temporary exemption
4 months
IgM titration
≥ 0.05 g/100 mL
Upon entry and every
4 months
27
Temporary exemption
IgG titration
< 2 g/100 mL, >
Upon entry and every
0.5
4 months
Temporary exemption
* In temporary exemption, donor will be given at least 1-2 months and then the desired test is performed and if
acceptable, other tests should also be done before plasmapheresis.
** If donor can not perform laboratory tests in 4 months, the maximum interval of 6 months is acceptable to
do tests. Otherwise, the person would be admitted as non-continuous donor.
Pattern of performing laboratory tests among continuous plasma donors
1-2. Plasma donors, even continuous or non-continuous, should be evaluated regarding ALT (It should not be
higher than 2 times of the upper limit of reference range).
1-3. Non-continuous donors in each session of donation should be evaluated as first donor with regard to
laboratory tests and in addition to the points about plasma donor, all the laboratory test mentioned in the above
Table should be done in each session.
1-4. All sent plasma to refinery should be tested regarding hepatitis C virus, hepatitis B virus, hepatitis A,
parvovirus B19, and HIV via minipod NAT test according to international standards.
1-5. All laboratory kits (particularly those related to screening of viral infectious agents) should have
permission from Iran Blood Transfusion Organization in addition to permits from the Ministry of Health and
Medical Education.
1-6. Pilot samples taken in each plasma donation should be tested and be consistent with the criteria of Iran
Blood Transfusion Organization.
1-7. If the tests are performed in plasmapheresis center, establishment license and its technical responsibility
should be done by Laboratory Affairs Office according to current regulations and the license to perform
screening tests should have been issued by Iran Blood Transfusion Organization. If the tests are performed in
other governmental or private laboratories, in addition to required licenses by Laboratory Affairs Office, the
center should have license to perform screening tests issued by Iran Blood Transfusion Organization.
1-8. Laboratories which have licenses and permits mentioned are not allowed to perform other diagnostic tests
under any title for donors.
2. Retested Donor:
28
All plasma donors should undergo once more all screening tests with time intervals of minimum of 3 months
and maximum of 6 months (or upon next plasma donation or just for testing). In other words, only plasma
products can be sent to refinery center that have been tested repeatedly for screening purposes regarding NAT,
RPR, HBsAg, anti-HIV-1/HIV-2, anti-HCV, ALT, hepatitis C, hepatitis B, hepatitis A, parvovirus B19, and
HIV.
2-1. If in the repeated screening test reactive result is observed, all previous plasma products of this specific
donor should be disposed and should not be sent and if this happens at any time this must be reported to
refinery center.
2-2. Plasmapheresis production center should set up look-back system.
2-3. Center should set up specific process for quarantine and clarifying condition of previously collected
plasma when screening test of a continuous donor shows positive/reactive test results regarding HBsAg, antiHCV, anti-HIV-1/HIV-2, ALT, and RPR.
3. Epidemiological studies:
The center should not collect plasma from population in which the prevalence of infectous diseases has been
shown to be high. Furthermore, it has been proposed not to collect plasma during epidemics of infectious
diseases, especially hepatitis A. Epidemiological evaluation should be done continuously in plasma/blood
collecting centers. Data should be reported as follows:
3-1. Incidence of donors whose tests have shown positive seroconversion and have been confirmed (in the
number of donors and number of items donated).
3-2. Prevalence of confirmed positive cases in new donors (includes all subjects who are tested for the first
time).
3-3. These reports should be part of the original file of plasma (Master file) and should be regularly updated.
3-4. Incidence and prevalence of infectious agents should be compared between different centers and also
between donors of blood in similar areas.
3-5. Violation rate in infectious indices at specific time intervals should be evaluated.
3-6. With observing major changes in difference of incidence and prevalence of infectious agents or violation
from infectious indices at specific time intervals appropriate strategies such as selecting donors more carefully,
additional criteria for exemption of donors and performing more screening tests for prevention of plasma
products contamination should be done.
3-7. For three viral infectious indices including Anti-HCV, HBsAg, and anti-HIV-1/HIV-2 epidemiological
analysis should be carried out and only confirmative positive test results (tests that have shown repeatedly
reactive screening test results and have at least one confirmatory positive result) should be reported.
29
4. Reporting Test Results to Donor:
Tests results which are reactive only after repeated dual testing and if positive result repeats after confirmatory
tests should be reported to donor.
4-1. Repeated dual test should be done on the primary sample with reactive test result.
4-2. Before asserting a positive test result to donor, a screening test on a sample which has been taken from
donor for second time should be done to ensure positive test result.
4-2-1. If the repeated test is negative, it should be interpreted and the possibility of primary pilots exchange
should be considered and all steps related to that series of samples tested should be evaluated and reported.
30
Chapter 5
Labeling
1. General requirements:
labeling process includes all steps to identify the primary unit of plasma product and to complete necessary
revisions and putting appropriate labels. Labeling process should include physical inspection of product in
terms of safety, integrity of plasma containers and normal appearance of product.
1-1. Labeling of plasma products containers should be done according to the latest international standard
edition for uniform blood labeling and blood products based on ISBT128. In the time period for change to
ISBT128, labeling according to uniform labeling guidelines is acceptable.
1-2. Major label and added parts
to the label should be stuck onto the plasma collection containers and must be legible clearly by eye and
reading machine. A single label of center can be used which contains practical information indicated in notes
2, 3, and 5 of this chapter. Changes or hand-written additions should be stable and legible and written by
water-proof ink.
1-3. Labeling process should include secondary controls to assure its correctness, expiration date and this
matter that product labels have been stuck onto containers.
1-4. if a product has been changed and a new label has been used, labeling process should include a method to
ensure accuracy of its contents, expiration date, and label of the product.
1-5. All changes which have been done to the label should be clarified and controlled.
1-6. If a product is changed and a new label is used, there should be a method to ensure the correctness of unit
number, expiration date and label of the product.
2. Unit Detection:
A numerical, combined number/letter, or barcode system should be applied to ensure detectability of each unit
of plasma production from origin until final place and provide repeated control documents for any specific unit
including investigation on adverse reactions.
2-1. Unique numerical, combined number/letter or barcode identification should be stuck in donor unit
(plasma collection). This number should not be distorted, changed or corrected in the following units.
31
2-2. If a center where pooling of plasma products is done or other transporting centers are involved they
should apply a numerical, combined number/letter or barcode system that shows the identification number of
producing unit.
2-3. There should be no more than two unique numerical, combined number/letter or barcode systems on any
plasma product container; one is for main collecting center and the other for transporting center. Therefore, it
might be necessary to cover or remove the identification number of intermediate center.
3. Labeling during collection or preparation of products:
During plasma collection, the label of plasma container should have at least the following information:
3-1. Name of the desired product
3-2. Numerical, numero-typo or barcode identification system representative of donor and donation
3-3. Name of anticoagulant
3-4. Approximate amount of plasma collected from donor
3-4-1. Approximate volume in container and pooled products
3-5. Precipitant agent, if applicable
3-6. Name of plasma collecting center or transformer center
4. Determining the suitability of product before labeling:
There should be a process to ensure that all characteristics of product and plasma and harvests and operations
before sticking final label have been done according to terms.
4-1. The criteria of test and acceptability should be defined and there must be reasons that all documents
related to tests and criteria of acceptability have been revised before sticking final label.
4-2. If there had been a donation, comparison should be done between current laboratory test results and the
latest documents. Ant incompatibility should be resolved before discharge.
4-3. Documents of donor should be revised before labeling process to ensure that plasma products of insuitable
donors have been quarantined and are not presented for transfer.
5. Final label prior to Distribution
Final label of plasma product should contain the following information (according to note 3 of this chapter):
5-1. Storage temperature
5-2. Expiration date (day) and if necessary expiration hours
5-3. Name of the center which has prepared the final product. For pooled products see note 5 of this chapter.
5-4. "Voluntary donation" and "compensated donation”, if applicable
5-5. On final plasma containers which are ready for shipment, label of “only for plasma refinery” should be
stuck
32
5-5-1. For specific plasma products, the characteristic of plasma should be added as well.
6. Pooled products
6-1. Label of pooled products should be according to requirements of C4/000 contain additional following
information:
6-1-1. Name of pooled product
6-1-2. Final volume of pooled product
6-1-3. Name of the center which has produced pooled product
6-1-4. Unique numerical or numero-typo identification of pooled product
6-2. The following information must be specified on the label or is attached appendix:
6-2-1. Number of units in pooled product.
6-2-2. The following information should be available in producing centers:
6-2-2-2. Identification number of each unit in pooled product
6-2-2-3. Identification collecting center of each unit pooled
33
Chapter 6
Records and Documents
A. Center Documentations
Plasmapheresis production center should ensure identification, gathering, listing, archiving, maintaining and
transferring documents according to the following standards:
1-1. Documents must be complete and can be retrieved appropriately at any specific time and should be
protected from damage or accidental changes.
1-1-1. Copy: before disposal of original documents, the center should have a process to copy documents.
Copying documents should be in a way that will be identical to original and this issue should be conformed.
The copies should be legible, complete, and accessible.
1-2. A system to prevent unauthorized access and assurance of confidentiality of records should be set up and
followed.
1-3. Recording system should make it possible that each unit of plasma products would be detectable from the
source (donor or blood taking unit) to the final place. Also, documents used for specific products and
assessment of adverse reactions in donors should be revised.
1-3-1. System must ensure that identifiers of donors are unique.
1-4. Result of any test should be recorded immediately and final interpretation should be documented upon
completion of tests.
1-5. Computer Systems
Private plasmapheresis production center should have a process for supporting start of new software, hardware
or data bank according to requirements of these standards.
5-1-1. When a computer system is used, a valid process for keeping following records should be available:
5-1-1-1. Application development of software, hardware, and data bank if they are operated,
5-1-1-2. Numerical display of system version, if possible, by mentioning the exact date of their use,
5-1-1-3. Operation validation (software, hardware, data bank) of system including risk assessment,
5-1-1-4. Installation and performance of system and evaluation of efficiency after installation,
5-1-1-5. Job training and continuing staff competence,
5-1-1-6. Surveillance and monitoring of data integrity for critical and important elements of information,
5-1-1-7. Rules, and maintenance methods and system operation,
34
5-1-2. Processes should include technical details in an understandable language for users.
5-1-3. There should be a system for displaying and confirmation of information before their final acceptance
(when information are added or corrected).
5-1-4. Center should have an alternative system to ensure continuation of work when computer data and
related tasks are not accessible.
5-1-4-1. Alternative systems should be tested regularly.
5-1-5. Changes in systems must be licensed and controlled. All changes must be validated before operation.
5-1-6. There should be a process in place to perform daily back-up for all important information.
5-1-7. Methods to ensure recovery and usability of information should be available.
5-1-8. Back-up data should be stored at off-site location.
1-6. There should be methods for identification of individuals who participate at every important steps of
collection, product preparation, required tests and shipment of plasma harvests.
2. Record keeping
2-1. Unlimited keeping
Records which should be kept for 50 years and in this time period can be retrieved include the following:
2-1-1. Donor records:
2-1-1-1. Identification information of donor (including address), previous medical records, physical
examination, informed consent and interpretations of laboratory indices which are done in order to determine
the eligibility of donor for current or following plasma donations.
2-1-1-2. Plasma products received from external sources including numerical, combined numerical/letter,
barcode of blood unit and characteristics of blood taking center. However, data from an intermediate
organization can be used if this organization has kept unit number and identification number of plasma
producing center.
2-1-1-3. Information for identification of organization where any step of plasma production is done.
2-1-1-4. Final keeping place of any plasma product unit,
2-1-1-5. Informing donors who have permanent exemption,
2-1-1-6. Documents of donors who have been exempted permanently or are under supervision for protecting
recipient,
2-1-1-7. Look back information (look back) to the corresponding centers in the Ministry of Health and
Medical Education and the Iranian Blood Transfusion Organization
2-1-1-8. Documents to detect previous blood taking, proper evidence of previous quarantine of products,
informing refinery and final spot or usage of products which are identified by potential laboratory tests,
35
2-1-2. Reports and Documents:
Names and signatures, or identification code, or first name and surname initials and exact dates of application
of people who are authorized to insert their first/last name initials and revision of reports and documents.
2-2. Keeping for at least five years
Documents which should be kept for minimum of 5 years include:
2-2-1. Donor records:
2-2-1-1. ABO group and Rh type of donor.
2-2-1-2. Difficulty in determining blood group,
2-2-1-3. Severe adverse reactions to donating plasma,
2-2-1-4. Clinical evidence of apheresis method
2-2-1-5. Inspection documents of plasma products before discharge and delivery
2-2. Other documents:
2-2-2-1. All left methods, manuals and journals.
2-2-2-2. storage temperatures and the results of inspection of plasma products,
2-2-2-3. Product control tests, reagents and equipment and efficiency tests (including date, performed tests, the
results observed, interpretation, characteristics of staff who perform tests, any corrective action made),
2-2-2-4. Documentations of required conditions, training, and eligibility of personnel,
2-2-2-5. Audition documents of quality system and internal self-evaluation.
2-3. Temporary keeping
Documents of donors who are exempted from donating temporarily should be kept for required time for
exemption. Also, interpretations of eligibility tests or before screening should be kept.
36