MEDICAL STAFF
POLICY & PROCEDURE
TITLE:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
MS-26
Effective Date: 01/11
POLICY:
It is the policy of the medical staff at Southeast Alabama Medical Center to transfuse only leukoreduced
blood products.
Criteria for the transfusion of blood products are reviewed by the Blood Utilization Subcommittee
annually.
PURPOSE:
To provide appropriate criteria for blood products and for the initiation of blood/blood product transfusion
and to outline the notification process for those patients who may potentially received contaminated blood
products.
PROCEDURE:
Criteria for the transfusion of blood products are as follows:
(A)
BLOOD PRODUCT TRANSFUSION CRITERIA
(1)
Criteria for All Blood Products
(a) Evidence of informed consent is required on all blood products;
(b) Documentation of necessity for transfusion should be placed on the chart; and
(c) At least one or more of the usage criteria must be met prior to the initiation of a
blood/blood product transfusion.
(2)
Evaluation of the Appropriateness of Transfusions
(a)
Audits regarding the appropriateness of transfusions shall be initially
performed by the Quality Management Department and are reported to the
physicians of the Transfusion Service and the Blood Utilization
Subcommittee.
(1)
Audit performance criteria, as listed under Outcome for each
transfused component, will be reviewed to assess whether practice
conforms to stated criteria.
(2)
Criteria are used to identify the circumstances in which a
transfusion can be approved by the Quality Management
Department as justifiable, without need for further justification.
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
(a)
These explicit criteria, such as laboratory data and other
easily measured data , shall not be used solely as
transfusion indications, but shall be used initially in the
review process.
(1)
(b)
(c)
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Such explicit criteria are established by the
Transfusion Service Medical Director and are
approved by the Blood Utilization
Subcommittee.
Implicit criteria, which are less easily measured and
involve individual judgment, such as medical history and
clinic subspecialty assessment, are used in final audit
reviews by the medical director of the Transfusion
Service and/or the Blood Utilization Subcommittee
members.
These individual assessments shall be reported to the
Blood Utilization Committee.
(3) Corrective Actions
(a)
(4)
Criteria for Transfusion
(a)
(5)
When possible inappropriate practice is identified, the Transfusion Service Medical
Director will forward the case to Quality Management. See the policy entitled
“Performance Improvement /Peer Review/Variance Procedure” in the Medical Staff
Policy and Procedure manual for details of the review process.
Every indication for the use of blood products cannot be anticipated. These
guidelines will not override physician judgment and the blood products will
be released in response to physician orders. However, transfusion outside
these guidelines shall be carefully peer reviewed to assure appropriate use.
Packed Cells Transfusion
(a)
Patients (including post-operative) should be transfused RBCs only if the
Hgb falls to 7g/dL to keep it between 7-9 g/dL (restrictive transfusion
approach).
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
(1) Exceptions include:
(a) active coronary ischemia. In general, patients with acute coronary
syndrome should be transfused if Hgb falls to 8g/dl to keep it
between 8-10 g/dl.
(b) oncology patients. Transfusion is acceptable when Hgb/Hct
fall below 10 g/dl/ 30%.
(c) ongoing blood loss.(Active bleeding with loss of greater
than 15% of the patient’s volume (along with
crystalloids and synthetic colloids.) This would correspond to
a recorded volume lost of 10 ml per kg of body weight (e.g. 700 ml
blood loss within 4 hours in a 70 kg patient).
(d) evidence of hypoperfusion, as documented by systolic <90mm/Hg
and/or orthostatic hypotension.
(e) severe sepsis and septic shock. Transfusion is justified to maintain
Hct > 30%.
(f) symptomatic chronic anemia:
(1)
Irreversible transfusion dependent bone marrow
syndromes.
(2)
Ongoing resting tachycardia (>110 per minute)
not explained by other causes in a patient with
a Hgb less than 10 g/dL.
(g) transfusion or exchange transfusion for severe sickle
syndromes.
(h) patients under going hemodialysis. Transfusion is justified if the
Hgb is <8 or Hct is <24.
(2)
RBCs should be ordered as single units for most inpatient
indications (transfuse and re-assess strategy) except for ongoing
blood loss with hemodynamic instability.
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MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
(6)
Washed Red Blood Cells- requests for washed red blood cells must be
initiated by the ordering physician
(a)
(b)
Must meet established criteria for red blood cells, and one of the
following:
(1)
A history of IgA deficiency.
(2)
A severe allergic transfusion reaction such as laryngeal
edema, bronchospasms or persistent uticaria.
Transfusion Medicine physicians will prospectively review initial
requests for washed red blood cells if the request does not meet
the above criteria.
(7) CMV Negative Red Blood Cells- requests for CMV negative red blood cells
must be initiated by the ordering physician.
(a)
AABB recognizes leukoreduced RBCs and platelets as CMV-safe,
independent of the CMV antibody status of the donor. Although all
RBCs transfused at SAMC are leukoreduced, the following
indications warrant units from CMV-negative donors. However, if
the latter are not available, leukoreduced units may be substituted on
a case by case basis after discussion with the patient’s physician:
(1)
All candidates or recipients (both CMV positive and
negative) of lung or heart-lung transplant.
(2)
Infant less than 4 mos. old and/or infant with birth weight
<1500gms and mother is CMV neg.
(3)
Allogeneic CMV seronegative hematopoietic stem cell
transplant recipient with CMV seronegative donors.
(4)
Liver transplant patient <18 years of age, or any CMV
seronegative liver transplant recipient.
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MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
(b)
(8)
Transfusion Medicine physicians will prospectively review all
requests for CMV negative red blood cell orders if the request does
not meet the established criteria.
Irradiated Red Blood Cells- requests for irrradiated red blood cells must be
initiated by the ordering physician.
(a) Must meet established criteria for red blood cells, and
(1) Suspected or established DiGeorge’s syndrome.
(2) Infants with birth weight <1500 grams.
(3) Intrauterine transfusion or neonatal exchange transfusion.
(4) HLA-matched products and crossmatched platelets for
designated recipient.
(5) Recipients of donor units known to be from a blood relative.
(6) Patients who have undergone bone marrow transplantation or
peripheral blood progenitor cell transplantation.
(b) Transfusion Service physicians will prospectively review all requests
for irradiated red blood cells if the request does not meet the
established criteria.
(9)
Outcome of Red Blood Cell Transfusion
(a)
Hbg or Hct on chart within 24-48 hours of transfusion;
(b)
Elective surgeries, the post-op value is not higher than preoperative (excludes preoperative anemic patients);
(c)
No evidence of adverse reaction; or
(d)
No death within 72 hours of transfusion.
(10) Platelet Transfusion: Indications for platelet transfusion include:
(a)
Platelet count of <20,000/microliter or lower.
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MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
(b)
Platelet count of 50,000/microliter or lower in the presence of bleeding.
(c)
Platelet count of 100,000/microliter or lower and 12 hours pre or post
surgery or vaginal delivery.
(d)
After massive transfusion (10 or more RBC including autologous RBC
salvaged intraoperatively).
(e) Open heart surgery with bleeding episode.
(f) Dysfunctional platelets.
(g)
No further justification for platelet transfusion is required if one or more of the
above conditions are met. Platelet use not meeting these criteria will be reviewed.
(h) Relative Contraindications:
(1) Idiopathic Thrombocytopenic Purpura
(2) Thrombotic Thrombocytopenic Purpura
(3) Hemolytic-Uremic Syndrome
(4) Heparin-Induced Thrombocytopenia
(i)
Outcome of Platelet transfusion
(1) Platelet count before and within 2 hours after transfusion and
repeated in 24 hours;
(2) No evidence of adverse reaction; and
(3) No death within 72 hours.
(11) Fresh Frozen Plasma/Plasma frozen within 24 hrs of phlebotomy Transfusion
(a) Indications for use include:
(1)
Bleeding due to multiple factor deficiencies such as that of liver failure or
disseminated intravascular coagulation (DIC).
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MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
7
(2) Massive transfusion (10 or more units of RBCs in a 24-hour period).
(3) Treatment of congenital immunodeficiency.
(4) Plasma exchange for thrombotic thrombocytopenic purpura.
(5) To treat congenital coagulation factor deficiencies except von Willebrand’s disease for
which DDAVP, commercial concentrates or cryoprecipitate should be used; Factor VIII
disorders for which commercial Factor VIII concentrates should be used; Factor IX
disorders for which Factor IX concentrates should be used; Factor VII deficiency for
which Factor VIIa concentrates should be used; and hypofibrinogenemia for which
cryoprecipitate is indicated. Antithrombin III and activated protein C concentrates have
been approved and should be considered as an alternative to plasma. Factor XII
deficiency does not require plasma replacement.
The medical record (physician progress note within 24 hrs of the transfusion in question,
the physician admitting note written at the beginning of the current hospitalization, or the
physician progress note written at the beginning of a series of plasma transfusions)
should state that the patient that has deficiency of Factor II, V, X, XI, XIII, Antithrombin
III, protein C, protein S or plasminogen. Alternately, when such a note is not evident, a
laboratory report should show that <50% of the protein in question is present in the
patient’s plasma.
(6)
To treat acquired coagulation problems including, but not limited to, liver disease,
vitamin K deficiency, or warfarin (coumadin, coumarin) effect as mentioned in the
physician progress notes written within 24 hrs of the transfusion in question, in the
physician admitting note at the beginning of the current hospitalization, or in physician
progress notes written at the beginning of a series of plasma infusions.
Patients with these conditions should exhibit prolonged partial thromboplastin time
and/or prothrombin time using current normals PLUS either the presence of overt
hemorrhage or mention of plans to perform an invasive procedure within 12 hrs. The
interval of > 12 hrs would permit an attempt to correct the clotting abnormalities with
vitamin K therapy, so that plasma may not be needed.
(7) Use of FFP for other indications will be reviewed.
(8) Plasma should not be used as a colloid volume expander in adults in the absence
of other indications.
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
8
(9) Plasma replacement should not be guided solely by coagulation screening tests
such as Prothrombin Time (PT) and Partial Thromboplastin Time (PTT). If considered
with other factors, FFP is generally not indicated unless INR> 1.9 or PTT exceeds the
upper limit of the normal range.
(a) Abnormal PT and PTT should be followed up by tests to determine the
specific cause of the prolonged clotting times.
(10) Outcomes of Fresh Frozen Plasma transfusion
(a)
Protime, PTT or factor assay done before and within 24 hours after
transfusion.
(b) No evidence of adverse reaction; and
(c) No death within 72 hours.
(12) Cryoprecipitate Transfusion
(a)
Cryoprecipitate is generally given to replace fibrinogen or Factor XIII. Because
purified preparations are now available, it should no longer be used to treat Factor
VIII deficiency or von Willebrand’s disease. No further justification for
cryoprecipitate transfusions is required if one or more of the following can be found in
the medical record:
(1) To treat congenital or acquired hypofibrinogenemia as indicated either by the
diagnosis of hypofibrinogenemia, afibrinogenemia or dysfibrinogenemia
recorded in the medial record or by a plasma fibrinogen level < 100 mg/dl
(measured within 24 hours before the transfusion) as might occur in disseminated
intravascular coagulation or fibrinolysis.
(2) To treat congenital or acquired Factor XIII deficiency as indicated by the
diagnosis as stated in the medical record or by a laboratory report indicating
abnormal Factor XIII activity (measured within 24 hours before the transfusion).
(3) To treat active bleeding in a patient with the diagnosis of uremia, renal failure or
with a blood urea nitrogen (BUN) > 50 mg/dl or serum Creatinine > 4.0 mg/dl
(measured within 24 hours before the transfusion). A trial of DDAVP therapy is
preferred prior to cryoprecipitate.
(4) Fibrin glue.
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
(5)
Outcome of Cryoprecipitate Transfusion
(a)
(B)
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No evidence of bleeding
LOOKBACK FOR PATIENT WHO HAS RECEIVED POTENTIALLY
CONTAMINATED BLOOD PRODUCTS
(1) Policy:
On notification by our blood source provider and Transfusion Service that a
patient has received potentially contaminated blood products, the office of the
Risk Manager/Medical Director will notify the patient’s physician. Within
the next eight weeks, three attempts will be made to notify the patient or his/her
legal representative of the need to be evaluated.
(2) Procedure:
(a)
Notification of the physician:
Physician: On notification by our blood source provider that a donor
has tested repeatedly reactive for HCV, HIV-1, HIV-2, HTLV-I or HTLVII, the office of the Risk Manager/Medical Director will inform the
patient's physician of the information by telephone and certified letter.
(b) Notification of the recipient:
Recipient: A certified letter signed by the Risk Manager/Medical Director
and Medical Director of the Laboratory Medicine Department will be
forwarded to the recipient or his/her legal representative, informing
him/her of the need for testing and counseling. If no receipt of the letter is
confirmed, additional letters will be forwarded (for a total of three letters
within eight weeks) to the recipient's last known address. (if information is
obtained revealing a change of address, the process will be repeated.)
1. Notification to legal representative or relative: If the recipient
had been adjudged incompetent by a state court, the notice will
be forwarded to the designated legal representative. In
HIV/HTLV lookbacks, if the recipient is deceased, the notice
will be forwarded to recipient’s legal representative or relative,
if known.
Documentation should address the reasons for notification of a
legal representative or relative.
Letter Format: The following letter formats will be utilized.
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
10
Date, 200_
RE:
CONFIDENTIAL NOTIFICATION OF POTENTIAL BLOOD PRODUCT
CONTAMINATION FOR HIV-1, HIV-2 AND HTLV-I OR HTLV-II
Dear ___:
Following an investigation conducted by our blood source provider, it has come to our
attention that at the time of donation, the blood product(s) you received on (date) was/were tested
and found to be negative, or not tested due to lack of test procedure, for HIV-1, HIV-2 and
HTLV-I or HTLV-II. However the donor of that/those components) now has developed a
positive test result for
________________.________ _________
Because it is our duty to inform anyone who may have been infected in order to prevent the
spread of such infection, we urge you to do the following:
1)
Arrange immediately to have a screening test for
. At our request, we
can perform this test for you and your spouse/partner at no charge. Contact our
staff (334) 793-8705 and we will arrange the screening test at our facility or assist
you in making arrangements to have the test performed at no charge at the nearest
healthcare facility.
2)
Contact your physician for counseling, or we can, at your request arrange for
counseling at an outreach program through our Social Services Department.
We realize that this information is unsettling and we apologize for its necessity. Please be
assured that this matter will be treated in a confidential manner by our facility; however, we are
obligated to communicate with your attending physician. We urge you to contact us if you have
any questions or need assistance.
Sincerely,
C. Wayne Hannah, M.D., J.D.
Risk Manager
Mark E. Shertzer, M.D.
Medical Director, Laboratory Medicine
XC:
Dr.
.
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
11
Date, 200_
RE: CONFIDENTIAL NOTIFICATION OF POTENTIAL BLOOD PRODUCT
CONTAMINATION FOR HEPATITIS C – RECIPIENT’S LETTER
Dear
A nationwide effort is underway to identify people who may have been infected with the
hepatitis C virus (HCV). One of the ways that HCV has been transmitted is through a blood
transfusion. Our records show that you received blood that may have been infectious for HCV.
This is not HIV, the virus that causes AIDS. HCV causes a liver disease called Hepatitis C.
You should get tested for hepatitis C. Most persons who get hepatitis C carry the virus for the
rest of their lives. Most of these persons have some liver damage but many do not yet feel sick
from the disease. Of every 100 persons infected with HCV, about 15 persons will develop
cirrhosis (scarring) of the liver which can lead to liver failure. This can take many years to
develop. It is important that you get tested for hepatitis C so you can be checked for liver disease
and get treatment, if indicated, and in addition, learn how to help protect your liver by avoiding
substances that can further cause harm, such as alcohol and certain medicines. If you have
hepatitis C, it is important that you learn what actions you can take to avoid spreading this
disease to others. We can provide testing for you at no charge. To arrange for testing, contact
our staff at (334) 793-8705 and we can arrange the screening test at our facility or assist you in
making arrangements to have the test performed at the nearest healthcare facility. We can also
arrange for any counseling, as indicated, after testing. You may desire to contact your
personal physician for this testing and any subsequent counseling.
Please contact us if you have any questions or need assistance.
Sincerely,
C. Wayne Hannah, M.D., J.D.
Risk Manager
Mark E. Shertzer, M.D.
Medical Director, Laboratory Medicine
Date, 200_
MEDICAL STAFF POLICY:
BLOOD OR BLOOD PRODUCTS TRANSFUSIONS
RE:
12
CONFIDENTIAL NOTIFICATION OF POTENTIAL BLOOD PRODUCT CONTAMINATION
FOR HEPATITIS C – PHYSICIAN’S LETTER
Dear
The Food and Drug Administration (FDA) is requiring the notification of persons who received
blood or blood products that were potentially contaminated with hepatitis C virus (HCV). Our
records show that the above listed patient was in your care recently (may not have been at the
time of the transfusion.)
We are in the process of notifying this patient, so he/she can obtain testing, counseling, and if
indicated, possible treatment. Should the patient contact you, please provide this care for
him/her or refer him/her to another physician that you may feel will be appropriate.
The donor at the time of this donation tested negative for hepatitis C virus (HCV).
However at a subsequent donation the donor tested positive for hepatitis C virus (HCV).
HCV testing for this patient can be performed at no cost by our facility. Contact our staff at
334-793-8705 to arrange for testing.
Please call if you have any questions or need assistance.
Sincerely,
C. Wayne Hannah, M.D., J.D.
Risk Manager
Mark E. Shertzer, M.D.
Medical Director, Laboratory Medicine
Date adopted by the Quality/Risk Management Committee
Date adopted by the Medical Executive Committee
Houston County Health Care Authority
Reviewed/Revised:
Date approved by the Medical Executive Committee
Date approved by the Houston County Healthcare Authority
Reviewed/Revised:
January 25, 2000
February 8, 2000
February 29, 2000
January 21, 2003
February 11, 2003
February 25, 2003
January 10, 2006
December, 2008
March 22, 2011
September 19, 2011