N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-2.6 - Collection and handling of blood for subsequent allogeneic or autogeneic transfusion
(a)
Phlebotomy apparatus and blood containers shall be clean, pyrogen-free and
sterile. Anticoagulants shall be placed in containers prior to
sterilization.
(b) Phlebotomy sites
shall be prepared by a procedure found by the department to meet medical
standards generally accepted in New York State.
(c) Blood collection systems shall meet the
following minimum requirements:
(1) Blood
shall be collected under aseptic conditions using an approved closed system or
a vented system if adequately protected against contamination.
(2) Anticoagulant solutions shall be sterile
and pyrogen-free F.D.A.-approved formulae such as anticoagulant citrate
dextrose (ACD) (21-day storage), citrate phosphate dextrose (CPD) (21-day
storage), trisodium citrate (48-hour storage), heparin (48-hour storage),
citrate phosphate dextrose adenine-1 (CPDA-1) (35-day storage), and other safe
and effective formulae and storage periods, of such length as to assure the
blood's continued effectiveness for transfusion and retention of its safety,
purity and potency, as approved by the department, may be employed.
(3) Labeling requirements.
(i) For allogeneic collection, the container
and the attached pilot blood specimens shall be legibly labeled at the time of
collection with the associated unit's identification code. The container label
shall indicate the date of expiration. As soon as available, the results of ABO
and Rh grouping tests shall be affixed to the component containers.
(ii) With the exception of units collected in
an operating room which never leave the immediate proximity of the patient, for
autogeneic collection, the following information shall appear on a label or tag
attached to the blood container:
(a) the
identification of the collecting facility;
(b) the patient's name and if available, the
name of the hospital where the patient is to be transfused and the patient's
hospital registration number or, if unavailable, social security number, birth
date or similar identifying information. This tag shall be removed if the unit
is subsequently used for allogeneic transfusion;
(c) ABO and Rh group;
(d) date of expiration;
(e) if the unit does not qualify for
allogeneic transfusion, a prominent label to read " For autologous use only" or
similar wording;
(f) an autogeneic
unit from a donor who has tested positive or reactive on any of the tests
required in section
58-2.3(a)
of this Subpart within the previous 30 days shall be labeled as a biohazard
unless confirmatory testing has been negative. The exterior of the shipping
container shall not contain any information identifying the donor;
and
(g) a label bearing the donor
classification statement "Autologous donor" shall be permanently affixed to the
unit.
(d) Blood in transit shall be refrigerated at
one to 10 degrees Celsius, preferably at four to six degrees Celsius, with the
exception of units from which platelets will be separated, which may be stored
at room temperature.
(e)
Labeling requirements.
(1) For
allogeneic collection, the container and the attached pilot blood specimens
shall be legibly labeled at the time of collection with the associated unit's
identification code. The container label shall indicate the date of expiration.
As soon as available, the results of ABO and Rh grouping tests shall be affixed
to component containers.
(2) With
the exception of units collected in an operating room which never leave the
immediate proximity of the patient, for autogeneic collection, the following
information shall appear on a label or tag attached to the blood container:
(i) the identification of the collecting
facility;
(ii) the patient's name
and if available, the name of the hospital or limited transfusion service where
the patient is to be transfused and the patient's birth date or identifier.
This tag shall be removed if the unit is subsequently used for allogeneic
transfusion;
(iii) ABO and Rh
group;
(iv) date of
expiration;
(v) if the unit does
not qualify for allogeneic transfusion, a prominent label to read "For
autologous use only" or similar wording;
(vi) an autogeneic unit from a donor who has
tested positive or reactive on any of the tests required in section
58-2.3(a)
of this Subpart, with the exception of anti-HBc, within the previous 30 days
shall be labeled as a biohazard unless confirmatory testing has been negative.
The exterior of the shipping container shall not contain any information
identifying the donor; and
(vii) a
label bearing the donor classification statement "Autologous donor" shall be
permanently affixed to the unit.
(f) The blood shall be collected in the
manner appropriate for the container employed. Following collection, the
container shall be sealed securely. If a container is opened or entered in any
way, the blood component must be transfused within 24 hours or discarded,
unless a sterile connecting device which maintains a functionally closed system
has been utilized for entry.
(g)
Until issued, whole blood and red cell components shall be stored continuously
in a refrigerator either with a fan for circulating air, or of a capacity and
design to ensure that the proper temperature is maintained throughout, and
equipped with automatic temperature recording and an audible alarm. Periodic
verification of alarm function, in accordance with the manufacturer's
recommendations, shall be documented. Storage shall be at one to six degrees
Celsius. No items other than specimens, tissue, or reagents shall be stored in
a refrigerator in which whole blood and red blood cell components are stored.
Temperature records shall be available for inspection for at least five years.
Autogeneic units shall be stored in a separate, specifically designated portion
of the refrigerator.
(h) Until
issued, cryoprecipitate, fresh frozen plasma, FP24, and cryoprecipitate-poor
plasma shall be stored continuously at a temperature not higher than minus 18
degrees Celsius for up to one year or, with F.D.A. approval, at a temperature
not higher than minus 65 degrees Celsius for up to seven years, in a freezer
equipped with automatic temperature recording and an audible alarm. Periodic
verification of alarm function, in accordance with the manufacturer's
recommendations, shall be documented. Such frozen components shall not be
relabeled as different components and released for transfusion, but may be used
for fractionation into derivatives. After thawing, plasma shall be transfused
immediately or stored at one to six degrees Celsius. Cryoprecipitate intended
for factor VIII replacement shall be transfused within six hours after thawing.
Freezer temperature records shall be available for inspection for at least five
years.
(i) Until issued, platelets
shall be stored at 20 to 24 degrees Celsius and shall be continuously rotated
on a rotator designed for such use. Temperature records shall be available for
inspection for at least five years.
(j) Until issued, frozen red blood cells
shall be stored at a temperature not higher than minus 65 degrees Celsius in a
freezer equipped with automatic temperature recording and audible alarm, or in
liquid nitrogen. Liquid nitrogen levels must be mechanically or visually
monitored daily. Periodic verification of alarm function, in accordance with
the manufacturer's recommendations, shall be documented. Storage time shall not
exceed 10 years. Freezer temperature or liquid nitrogen level records shall be
available for inspection for at least five years. After thawing, red blood
cells shall be transfused or refrozen within 24 hours or discarded, unless
deglycerolized using a closed system that allows a 14-day expiration date, as
approved by the F.D.A. If a refrozen unit is subsequently rethawed and
deglycerolized, a notation indicating such previous thawing and deglycerolizing
shall be made on a label or tag attached to the blood unit, or on accompanying
paperwork.
(k) Whenever blood is
irradiated, a protocol for such irradiation, approved by the director of
transfusion services or the director of the blood bank, must be followed.
Maintenance and operation of blood irradiators must conform to the
manufacturer's instructions. Whenever irradiation of blood is medically
indicated because of a blood relationship between donor and recipient, such
irradiation shall be performed by the blood bank collecting the blood unless
the hospital notifies in writing the facility collecting the blood that the
hospital will be responsible for irradiation in which case such blood shall be
identified as requiring irradiation on a tag or paperwork accompanying the
units. Blood that has been irradiated shall be identified as "Irradiated" on a
label or tag attached to the unit.
(l) Fresh frozen plasma, cryoprecipitate,
FP24 and frozen red blood cells shall be thawed only in a water bath at a
temperature not exceeding 38 degrees Celsius, with entry ports protected from
water contamination by positioning or a protective overwrap, or in another
device specially designed for such thawing. If a water bath is used for
thawing, its temperature shall be recorded each day of such use. Temperature
records shall be available for inspection for at least five years. Maintenance
and operation of all equipment for processing or preparation of blood
components shall conform to the manufacturer's instructions and shall follow a
protocol approved by the director of transfusion services.
(m) Except for blood recovered
intraoperatively or postoperatively, or collected for use in a reinfusion
procedure, all blood intended for transfusion shall, upon collection, become
the responsibility of the blood collection service. Disposition of blood
collected by phlebotomy shall be at the discretion of the director of the
collection service until the blood is transferred to a transfusion service, at
which time its disposition shall be at the discretion of the director of
transfusion services. The director of the blood bank shall ensure that during
any transport blood is packed and handled appropriately, and only by authorized
individuals. No directed or autogeneic blood unit or component shall be
transported to a transfusion service unless the director of the receiving
transfusion service or his/her designee has authorized such transport. A
transfusion service which has granted standing authorization for receipt of
blood shall be given specific notice prior to each shipment. Disposition of
blood recovered intraoperatively or postoperatively shall be at the discretion
of the intraoperative or postoperative blood collection service, unless the
blood is transferred to the hospital blood bank for storage, at which time its
disposition shall be at the discretion of the director of transfusion services.
Blood banks shall not release blood or blood components intended for
transfusion to any site or entity in New York State not holding a department
permit as a collection service or transfusion service, or approved by the
department as a limited transfusion service or an ambulance transfusion
service.
(n) The premises,
equipment, procedure manuals, records, circulars of information, and all blood,
blood components and derivatives shall be available for inspection, review and
approval by the department during normal business hours.
Notes
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