Infection Control Measures in Blood Banks

Learning objectives:

To recognize

1-The main elements of blood safety basics.

2- Standards for blood banks and blood transfusion services.

3-Infection control measures at ambulance setting.

4-Corona virus guidance in blood and plasma facilities.

Introduction

Blood banks are an important component of the healthcare system of a country, saving
lives and improving the health of patients through the provision of blood. According to the
World Health Organization (WHO), each year approximately 112.5 million blood donations are
collected globally.

Blood-borne pathogens, particularly hepatitis C (HCV), hepatitis B (HBV) and human

immunodeficiency virus (HIV), are an important concern in blood banks where unsafe blood
banking practices can lead to the spread of such infections. According to WHO the prevalence
rates of HCV, HBV and HIV collectively range from 0.02%, 0.03%, 0.003% in high-income
countries to 1.03%, 1.08% and 3.7%, respectively in low-income countries among blood donors.
These blood donors can serve as the source of infection for blood recipients, hence screening of
blood for such infections and removal of infected blood from the supply is important. Blood
collected aseptically from the donor, properly screened and stored and aseptically transfused to a
compatible recipient constitutes a safe blood supply.

In addition to preventing the transfusion of transmitted infections (transmission of

infection to blood recipients), blood banks must also adhere to other infection control standards
in order to prevent the spread of blood-borne infections. Effective policies to ensure that staff
working in blood banks do not acquire infection, and to safely dispose of waste generated in a
blood bank, are critical to control the spread of blood-borne infections to patients, staff and the
community at large.
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Blood Safety Basics

According to CDC, any blood borne pathogen has the potential to be transmitted by
blood transfusion. Transfusion-transmitted infections (TTIs) are infections resulting from the
introduction of a pathogen into a person through blood transfusion. A wide variety of organisms,
including bacteria, viruses, prions, and parasites can be transmitted through blood transfusions.

Criteria for transfusion transmission of viruses and other infectious agents:

1. There must be an asymptomatic, viremic phase in the blood donor.
2. Virus viability must be maintained during storage.
3. There must be a seronegative recipient population.
4. The agent must be capable of inducing disease.

I. Bacterial contamination of blood products:

Bacterial contamination of blood products, especially in platelets that are stored at room
temperature, is the most common infectious risk of blood transfusion, occurring in approximately
1 in every 2,000-2,500 platelet transfusions. the sources of infection are mainly donor
bacteremia, contamination during whole blood collection, contamination of the collection
pack. Transfusion-transmitted sepsis, while less common, can cause severe illness and death.
Improved donor screening as well as improved methods of collection, handling, and storing of
blood products has decreased bacterial contamination in recent years.

• Gram-positive bacteria

Normally found on skin, such as Staphylococcus epidermidis or Staphylococcus aureus.

They are the most common bacterial contaminants of blood products. This type of
contamination is thought to occur when the bacteria on a donor’s skin is passed into the
collected blood through the collection needle.

• Gram-negative bacteria

They are part of the normal flora in the gastrointestinal tract. These bacteria can move
from a person’s gastrointestinal tract to their bloodstream, causing infections of varying
severity. Contamination of blood products with gram-negative bacteria is thought to
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 occur when blood is collected from donors who have bacteria in their bloodstream but do
not have symptoms of an infection. Examples include Acinetobacter, Klebsiella, and
Escherichia coli. Some gram-negative bacteria are resistant to multiple drugs and are
increasingly resistant to many available antibiotics.

Other bacterial infections include Anaplasmosis, Brucellosis, Ehrlichiosis.

II. Parasitic diseases:

Transmission of parasitic infections through blood transfusion is rare. To help minimize

the risk of transfusion-transmitted illnesses, including parasitic infections, donors are asked
questions to assist in determining if they are in good health. To reduce the risk of transmitting
specific infections (e.g., Malaria, Babesia, Leishmania), donors are asked about recent travel to
areas where these specific infections are more common.

III. Viral diseases:

Like bacteria and parasites, viruses that are blood-borne can be transmitted by blood
transfusion. Donors are asked questions about their social behavior and health history to help
minimize the risk of transfusion-transmitted viral diseases. Examples of viral diseases that can be
transmitted through transfusion as HBV, HCV, HIV, Chikungunya virus, Dengue fever, Yellow
fever virus, West Nile virus, and human T-lymphotropic virus (HTLV).

IV. Prion diseases:

Prion diseases or transmissible spongiform encephalopathies (TSEs) are a family of rare,

progressive neurodegenerative disorders that affect both humans and animals. The causative
agent of TSEs is believed to be a prion. A prion is an abnormal, transmissible agent that can
induce abnormal folding of normal cellular prion proteins in the brain, leading to brain damage
and the characteristic signs and symptoms of the disease. Prion diseases are usually rapidly
progressive and always fatal. Like viruses, bacteria, and parasites, prions are bloodborne and
may be transmitted by blood transfusion as Variant Creutzfeldt-Jakob Disease (vCJD).

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 Standards for Blood Banks & Blood Transfusion Services

General Guidelines

✓ The blood bank or blood transfusion service should have its own constitution, which
defines the responsibility and authority of the management.

✓ The blood bank should function under the direction of a licensed physician qualified by
training and by experience as Transfusion Medicine Specialist (medical officer, blood
bank) who should be responsible for all medical, technical and administrative services.

✓ Blood bank should comply with laid-down standards in drugs and cosmetic rules in
recruitment and selection of blood donors, collection, processing, storage and
distribution.

✓ All blood banks should have their own quality policy and prepare a quality manual that
addresses the systems in use.

✓ Each blood bank should maintain a detailed standard operating procedure manual, as well
as records (forms, registers, labels) in a prescribed format prescribed by drugs and
cosmetic rules.

✓ Suitable space, environment and equipment should be available to maintain safe and
acceptable standards of housekeeping. The records of calibration, maintenance and
validation of equipment should be maintained.

✓ All materials for blood collection and transfusion should be sterile, pyrogen free and
disposable and should be stored in an air-conditioned area.

✓ All containers and anticoagulants used for storage, preservation of blood and blood
components and required reagents used for testing of blood samples should meet the
standards of the American Association of Blood Banks (AABB).

✓ The blood banks and transfusion services should aim to accept blood from only voluntary
non-remunerated safe blood donors and to do away with the high-risk donors and blood
sellers.

✓ Standard precautions (HH, PPE, sharp management ,..).

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 Donor Selection

Blood should be accepted only from voluntary, non-remunerated, low risk, safe and
healthy donors. Efforts should be directed towards encouraging and retaining adequate numbers
of repeat donors. Donors should be appropriately recognized and felicitated for their
contribution. The blood bank should educate donors prior to collection of blood regarding the
risk of transfusion transmissible infections.

Criteria for selection of donors

The following guidelines should be observed to determine that the blood donation will
not be detrimental to the donors/recipients.

• Physical examination: A medical officer should certify the donor fit for blood donation.

• General appearance: The prospective donor should appear to be in good health.

• Age: Donors should be between the age of 18 and 65 years.

• Hemoglobin or packed cell volume (Hematocrit): The hemoglobin should be not less
than 12.0 gm/dl or the packed cell volume should be not less than 36%.

• Weight: Blood collection from donors weighing 45-55 Kg should be 350 ml blood and
from those weighing 55 Kg and above should be 450 ml.

• Blood pressure: The systolic blood pressure should be between 100 and 160 mm of
mercury and the diastolic pressure should be between 60-90 mm of mercury.

• Temperature: Temperature should not exceed 37.5°C.

• Pulse: Pulse should be between 60 to 100 beats per minute and regular.

• Donor skin: The skin at the venipuncture site should be free of any skin lesion or scar
indicative of addiction to narcotics or infection as well as marks of repeat venipuncture.

• Examination of respiratory system, cardiovascular system and abdomen should be

carried out if necessary.

• Pregnancy: Prospective donor should not be accepted during period of pregnancy and till
12 months after full term delivery and also during lactation. Donors who have abortions

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 should be deferred till 6 months after 2nd and 3rd trimester abortion. Menstruation should
not be a cause for deferral.

• N.B Any donor who appears to be under the influence of alcohol or any drug abuse and
who does not appear to be providing reliable answers to questions on their medical
history should not be accepted.

Requirement of consent
Prior to blood donation, the consent of the donor should be obtained in writing with
donor's signature or thumb impression after the procedure is explained and the donor is informed
regarding testing of blood for all mandatory tests for safety of recipients. The donor should have
an opportunity to ask questions and refuse consent.

Collection of Blood from Donors

− Blood should be collected only by a licensed blood bank.

− Blood should be drawn from the donor by a qualified physician or under his/her supervision
by assistants trained in the procedure. A physician should be present on the premises when
the blood is being collected.
− Blood donors are asked a set of standard questions prior to donating blood to assist in
determining if they are in good health and free of any diseases that could be transmitted by
blood transfusion. If the donor’s answers indicate they are not well or are at risk for having a
disease transmissible by blood transfusion, they are not allowed to donate blood.
− The blood donor area should be clean, congenial, comfortable and conveniently
approachable. As the temperatures vary widely in different seasons, it is mandatory to have
air-conditioned rooms to make the donor comfortable and to minimize chances of
contamination.
− A strict standardized procedure should be in use to achieve surgical cleanliness for preparing
venipuncture site to provide maximum possible assurance of sterile product.
− Blood should be collected by single venipuncture and flow of blood should be continuous.
− The blood bags for collection of blood should be sterile, pyrogen free and disposable, with a
closed system of collection as per standards provided by AABB.

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− Multiple interconnected plastic bags should be used for blood component preparation
(closed system).
− Venting of any container should be done under laminar airflow bench and such container
should be used within 24 hours. To avoid venting in case of pediatric use, multiple inter-
connected closed containers should be used.
− The anticoagulant solution should be sterile and pyrogen free.

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 Screening Donated Blood according to CDC

➢ If the donor is eligible to donate, the donated blood is tested for blood type (ABO group) and
Rh type (positive or negative). This is to make sure that patients receive blood that matches
their blood type.
➢ Before transfusion, the donor and blood unit are also tested for certain additional proteins
(antibodies) that may cause adverse reactions in a person receiving a blood transfusion.
➢ All blood for transfusion is tested for evidence of certain infectious disease pathogens, such
as HBV, HCV, and HIV. The tests used to screen donated blood are listed below:

Infectious Disease Pathogen Laboratory Tests Used Frequency of Tests

− Hepatitis B surface antigen
(HBsAg) assay
− Total antibody to hepatitis
Hepatitis B virus (HBV) B core antigen (anti-HBc) Every donation
assay
− Nucleic acid testing for
HBV
− Antibody to hepatitis C
virus (anti-HCV) assay
(CLIA).
− Nucleic acid testing for
Hepatitis C virus (HCV) Every donation
HCV
− Enzyme-Linked
Immunosorbent Assay
(ELISA) for HCV
− Antibodies to HIV-1 and
Human Immunodeficiency HIV-2 assay
Every donation
virus (HIV) Types 1 and 2 − Nucleic acid testing for
HIV-1
Human T-Lymphotropic Virus Antibodies to HTLV types I
Every donation
Types I and II (HTLV) and II assay
Anti-treponemal antibody
Treponema pallidum (syphilis) Every donation
detection
West Nile virus (WNV) Nucleic acid testing for WNV Every donation
Trypanosoma cruzi (Chagas
Anti-T. cruzi assay All first-time donors tested
disease)
Performed on some donations
Cytomegalovirus (CMV) Anti-CMV assay
for special needs recipients
Nucleic acid
Performed on donations
Babesia test Babesia species and
in Babesia-endemic regions
antibody for B. microti
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Proposed strategies to reduce transfusion-associated septic risk:

• Reducing risk of blood product contamination by:

− Improved donor screening.
− Improved venipuncture site disinfection.
− Removal of first aliquot of donor blood.
• Optimizing blood component processing and storage:
− Optimize storage temperature.
− Limit storage time.
− Universal leukocyte reduction.
• Reduce recipient exposure to blood donors:
− Optimize transfusion indications.
− Reduce transfusion triggers for RBCs and platelets.
− Increase use of apheresis-derived products.
• Pretransfusion bacterial detection:
− Visual inspection of components before issue.
− Direct staining for bacteria.
− Bacterial ribosomal assays.
− Assays for bacterial endotoxin.
− Nucleic acid testing for bacterial DNA.
− Measure CO2 production and O2 consumption by bacteria.
− Direct bacterial culture (manual or automated).

Storage and Transportation of Blood and Its Components:

a) Refrigerators and freezers for storage:

A designated area should be used for storage to limit deterioration and prevent
damage to materials in process and final products. The access to such areas should be
controlled. Refrigerators or freezers in which blood and blood components are stored
should be used for storage of blood, blood components and blood samples only and not
for any other items.
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 All reagents should be stored in separate refrigerators in specific laboratories.
Blood bank refrigerator/walk-in-cooler should have an inside temperature of 4°C ± 2°C
and should have a system to monitor temperature continuously or at least the temperature
should be recorded every 4 hours. An alarm system and a provision for alternate power
supply should be available.

Deep freezer should have inside temperature of -30°C or -80°C having

temperature indicator/recording facility with alarm system and provision for alternate
power supply. Platelet incubator with agitator should have inside temperature of 22°C ±
2°C having temperature indicator/recording facility with alarm system and provision for
alternate power supply.

Adequate alternate storage facility and written display of instructions to maintain

the blood and components in the event of failure of power or equipment should be
provided in the area of preservation. The alarm of all storage equipment should signal in
an area that has adequate personnel coverage round the clock to ensure immediate
corrective action.

b) Transportation

Whole blood, red cell concentrate, should be transported in a manner that will
maintain a maximum temperature of 10°C ± 2°C. Platelet/ granulocyte concentrate stored
and transported at 22°C ± 2°C. Components stored frozen should be transported in a
manner to maintain them frozen. When these are issued for transfusion, these should be
thawed at 37°C prior to issue. The temperature during transport should be monitored.

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 Infection Control Guidelines at Ambulance Setting

A. General infection control considerations

Many patients have an unknown medical history. It is therefore important that personal
contact with patients be compatible with the health and safety of patients and staff. Staff must
keep all cuts, abrasions and open skin lesions covered with a waterproof dressing. All incidences
of accidental contamination, either from an open cut, abrasion, needle stick injury, or through
mucus membrane contact must be reported and needle stick and accident forms completed.
Blood and body fluids must be handled with the aim of minimizing contact with skin or mucus
membranes. Normal accepted hygiene precautions, of washing hands after contact with EVERY
patient should be always observed.

B. Ventilation requirements

− The ventilation of an ambulance is critical for the safety and health of members operating
inside the vehicle. Fresh air intake should be located towards the front of the vehicle to
afford maximum intake of fresh air. Exhaust vents should be located in the upper rear of
the vehicle.
− All seats, mounted cushions, cots, floors, counters, shelves, bulkheads, and container
linings must be made of or covered by non-absorbent, washable material. These surface
materials should be inert to detergents, solutions, and solvents, for disinfecting and
cleaning.

C. Management of sharps

− Sharps are defined as any article that can cut or puncture the skin by having a fine edge or
point. (e.g. needles, glass ampoules).
− When using sharps, it is the personal responsibility of staff using those sharps to dispose
of them safely in the sharp’s container provided.
− Staff must not leave sharps for other personnel to dispose of.
− Unsheathed sharps must never be carried in hands or pockets.
− Sharps must not be passed from hand to hand.
− Recapping of needles should never be attempted.

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 − Used needles should not be removed from the syringe unless a specific clinical procedure
requires it.

D. Standard precautions.

CDC Guidance for Blood and Plasma Facilities during COVID Epidemic

Hygiene

− Adhere to Respiratory Hygiene/Cough Etiquette and Standard Precautions

− Follow Routine Hand Hygiene Practices

Environmental controls

− Clean and disinfect environmental surfaces in accordance with standard facility protocols
after each donor has vacated the station and before setting up for arrival of a new donor at
that station.
− Ensure that environmental cleaning and disinfection procedures are followed consistently
and correctly by applying an EPA-registered, hospital-grade disinfectant to frequently
touched surfaces or objects for appropriate contact times as indicated on the product’s
label.

Physical Space
− Arrange seating for prospective donors in the waiting area at least 6 feet apart.
− Arrange seating for prospective donors in the waiting area at least 6 feet apart prior to
implementing donor questionnaire.
− Adjust the physical configuration of the donor cots during blood collection, so that
donors are at least 6 feet apart.

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Worker exposure

• Facility staff
− Assess yourself each day before leaving for work for symptoms consistent with COVID-
19.
− If experiencing COVID-19-like symptoms, remain at home and contact the established
point of contact (public health authorities or their facility’s occupational health program)
for medical evaluation prior to returning to work.
− If symptoms develop while at work, cease collection facility activities, notify supervisor,
minimize contact with others in facility, and go home promptly.

• Facility administrators
− Evaluate staff, volunteers, and prospective donors for COVID-19-like symptoms as they
enter the collection site.
− Ask individuals with COVID-19-like symptoms to leave to reduce the risk of viral
transmission.

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