D.14 Pathology and Laboratory Medicine Policy Manual 36C24423R0132.pdf

Pathology & Laboratory

Medicine Policy Manual

Veteran Affairs Medical Center Lebanon, PA

Approved by Medical Staff Executive Board September 2021

TABLE OF CONTENTS

Section 1: PROVIDER ORDER ENTRY

1.1. Purpose

1.2. Introduction

1.3. Policy

1.4. Procedure

Section 2: REPORTING OF CRITICAL RESULTS

2.1. Purpose

2.2. Policy

2.3. Definitions

2.4. Procedures

2.5. Anatomic Pathology Result Call List

2.6. Critical Life-Threatening Lab Result Call List

2.7. Urgent Non-Life-Threatening Lab Result Call List

Section 3: TRANSFUSION SERVICES

3.1. Purpose

3.2. Policy

3.3. Procurement

3.4. Wastage

3.5 Responsibilities……………………………………………………………………...10

3.6. General Procedures

3.7. Blood/Blood Component Transfusion Requests……………………………..13

3.8. Administration of Blood

3.9. Indications for Transfusion

3.10. Blood/Blood Product Transfusions

3.11. Transfusion Complications

3.12. Blood and Blood Component Procurement

3.13 Storage of Blood

3.14. Issue of Blood

3.15. Inventory Control

3.16. Blood Bank Records

3.17. Reports

3.18. Transfusion Committee Blood Usage Review

3.19. Miscellaneous……………………………………………………………………..28

Section 4: STANDARDIZED SURGICAL BLOOD BANK ORDERS

4.1. Purpose

4.2. Policy

4.3. Definitions

4.4. Procedure

4.5. Responsibilities

Section 5: AUTOPSY POLICY AND PROCEDURE

5.1. Introduction

5.2. Policy

5.3. Procedure

Section 6: ANCILLARY TESTING PROGRAM POLICY

6.1. Purpose

6.2. Policy

6.3. Approved Ancillary Testing

6.4. Oversight

6.5. Definitions

6.6. Procedures

6.7. Authorization and Implementation

6.8. Program Responsibilities – Specific

APPENDIX A: GUIDELINES FOR ORDERING BLOOD FOR ELECTIVE SURGERIES

APPENDIX B: BLOOD USAGE REVIEW

Blood Utilization Statistical Report Form

APPENDIX C: BLOOD UTILIZATION REVIEW MONITORING PROCESS

APPENDIX D: GUIDELINES FOR PERFORMING POST-MORTEM

EXAMINATION ON FORMER PRISONERS OF WAR (POWs)

APPENDIX E: GUIDELINES FOR ORGAN OR BODY DONATION AND

FOR OBTAINING AUTOPSY PERMISSION

REVISIONS

Section 1: PROVIDER ORDER ENTRY

1.1. Purpose: To provide guidelines for the entry of laboratory orders into the computerized medical record system.

1.2. Introduction: The computerized medical record enhances medical information sharing by improving clarity and speed of processing of medical record information.

Direct entry of orders into the computerized medical record system by licensed providers is meant to reduce the risk of erroneous order entry.

1.3. Policy: It is the policy of this medical center to require provider entry of laboratory orders into the computerized medical record. In the circumstances outlined by this policy, registered nurses may enter laboratory orders into the computerized record.

1.4. Procedure: In keeping with standard medical practice and the policies of Veterans Health Administration (VHA), licensed providers request laboratory testing in the computerized medical record, providing the collection date and time.

a. The Laboratory staff will honor a provider’s order for a laboratory test for 120 days prior to and/or 60 days following the patient visit, except for international normalized ratio (INR) and drug levels.

b. Orders for INR testing will be honored as defined by the facility’s anticoagulation policy, seven days prior and seven days following the visit.

c. If a lab order is not acted upon within 180 days of the specified collection date and time, it will lapse and no longer be displayed as a pending order. If a patient presents to the Outpatient Draw Station beyond the designated “windows” as described above (before or after), the Outpatient Draw Station will notify the patient’s provider and request that new orders be written before specimens are collected. Under no circumstances will the Outpatient Draw Station enter orders on behalf of the provider.

d. Due to the six-month grace period for lab orders, providers should carefully review the pending orders when entering new lab orders to avoid duplication. Providers should be aware that some orders, (e.g., “comprehensive metabolic panel”) will include several other tests, (e.g., liver function tests, electrolytes, etc.).

e. For laboratory orders with timing in relation to nursing procedures, the providers may write a “free text nursing order” to allow registered nurses (RNs) to enter the electronic laboratory order “per policy” based on the time that the associated procedure is performed. Examples:

(1) “Trough drug levels” when timing is dependent on medication administration. The provider writes a free text order for the nurse to enter trough level laboratory test orders based on that patient’s medication administration time. The nurse enters the order according to the exact time of medication administration and marks the order “per policy.”

(2) In programs utilizing patient urine drug screens, the provider may order urine drug screens whenever necessary as a free text order. The personnel responsible for monitoring the patients’ compliance can enter the specific order when specimens are obtained in accordance with the program policy.

f. Nursing protocols: Nurses may enter laboratory orders per policy into the computerized medical record as long as the orders are in accordance with an established protocol approved by the Lebanon Veterans Affairs Medical Center (VAMC) Medical Staff Executive Board, and Nurse Practice Council, (e.g., Heparin protocol).

g. Provider text orders for these special situations noted above are to be entered into the computerized medical record by the provider. In general, verbal orders are discouraged except in cases of emergency.

h. Review of outside pathological material: When patients are to receive treatment at the Lebanon VAMC based on tissue samples obtained elsewhere (either at another VA facility or non-VA facility), Lebanon VAMC pathologists must review and issue a report on the slides of all specimens obtained outside the local VA so that the diagnosis can be confirmed. Any treatment or procedure on the patient should not be performed until confirmation of the diagnosis has been obtained. The patient's clinical provider is responsible to request and obtain the outside tissue slides. It is not the Lebanon VAMC Pathology and Laboratory Medicine Service’s (P&LMS) responsibility to request the outside pathological material. The patient's clinical provider will follow local procedures to request "Release of Information" (i.e., the tissue slides) from the other VA or non-VA source of the patient's tissue slides. The outside tissue slides should be sent to the Lebanon VAMC P&LMS with an SF 515 completed by the patient's clinical physician for accessioning, examination, and reporting in as timely a manner as possible (VHA Handbook 1106.01, January 2016, p 57; MCP 713-03).

Section 2: REPORTING OF CRITICAL RESULTS

2.1. Purpose: To establish procedures for the communication of critical laboratory test results to practitioners at this medical center.

2.2. Policy: It is the policy of this medical center that critical life-threatening laboratory test results will be communicated to the ordering practitioner within a timeframe that allows prompt attention and appropriate action. Critical life-threatening test results must be communicated telephonically, directly speaking to the ordering practitioner within 60 minutes of their discovery. If the ordering practitioner is not available, the critical life-threatening test result will be directly communicated to the provider’s surrogate. Suitable surrogates include the ordering provider’s supervisor or preceptor, or another provider who can take further appropriate therapeutic action. If efforts to directly contact the ordering provider or the surrogate are unsuccessful, a call cascade protocol will be followed. The technologist will document the result read-back in the patient’s electronic record.

2.3. Definitions

a. Abnormal test results: Abnormal test results are the results that fall outside a specified normal reference range, are unexpected, or could indicate the presence of disease. An abnormal test may or may not require action and therapeutic intervention, depending on the clinical context. There are three types of abnormal test results that require action or therapeutic intervention:

(1) Critical life-threatening: Any diagnostic finding which must be acted upon by the ordering provider or their designee immediately or within a short window of time and could result in severe morbidity or mortality if left untreated (e.g., critically elevated potassium).

(2) Urgent non-life-threatening: Any diagnostic finding which must be acted upon by the ordering provider or their designee within a relatively urgent timeframe (as clinically indicated to ensure timely, appropriate, and effective therapeutic action) (e.g., possible malignancy). Urgent non-life-threatening results will be called to the ordering provider or the designee as soon as possible, but not necessarily within 60 minutes.

(3) Clinically significant: A diagnostic finding in an immediate or urgent timeframe (e.g., high cholesterol).

b. Ordering provider: A practitioner who is privileged to enter and sign orders for specific tests.

c. Supervisor/preceptor: A licensed provider who supervises the ordering of tests by residents or by other ordering providers acting under a scope of practice.

2.4. Procedures

a. The Chief of Staff will:

(1) Ensure that a system for communication of critical life-threatening results is in place at their facility, including notification of surrogate providers in the event that the ordering provider is not available. The system may include communication via phone, pager, or instant message.

(2) Ensure that periodic process/outcome tracking monitors are in place to monitor timeliness of result communication and follow-up clinical action to document adherence to VHA and local policies

(3) Review these monitors of test result communication and resolve process deficiencies with Care Line Managers and Service Chiefs

b. The Chief, Pathology and Laboratory Medicine will:

(1) Recommend to the ordering provider additional tests that should be included in the local policy

(2) Ensure that test results are “verified” in the Laboratory Information System (LIS) in a timely manner

(3) Ensure that Laboratory Technologists adhere to local policy for the reporting of test results and document the transmission of critical life-threatening results in Veterans Information Systems and Technology Architecture (VISTA) to include at a minimum:

(a) Date and time of communication of critical life-threatening test results

(b) Name of provider to whom the results were given

(c) The “read-back” of the critical life-threatening test result by the provider including confirmation that the information read-back was correct

(d) Initials of the Laboratory Technologist who communicated the test results

(4) Work with the Chief of Staff or the Chief of Clinical Support to identify and resolve process deficiencies

(5) Review this policy for appropriateness with input from the ordering providers

c. The Clinical Care Line Managers/Service Chiefs are responsible for establishing a chain of responsibility for receipt of critical life-threatening and abnormal test results.

d. The ordering providers will:

(1) Take responsibility for results of any orders that have been placed

(2) Document changes in treatment plans in response to critical test results in the medical record

2.5. Anatomic Pathology Result Call List

a. Frozen section diagnosis and permanent findings are significantly different

b. New malignancy except squamous and basal cell carcinomas of the skin

c. Any infectious organism seen on a body fluid smear

d. Major discrepancy in diagnosis on a second review

2.6. Critical Life-Threatening Lab Result Call List

TEST & UNITS RESULT

LOWER THAN:

RESULT HIGHER

THAN:

Absolute Neutrophil Count cells/mcL 500 -

APTT seconds - 120

Calcium mg/ml 6.5 12

CO2 mmol/L 15 40

Creatinine mg/ml - 3

Digoxin ng/ml - 1.7

Gentamycin mcg/ml - Random and Trough 2.0

Glucose mg/ml 50 400

Hemoglobin g/dl 8 18

Lithium mmol/L - 1.5

Magnesium mg/ml 1 4.5 pCO2 mm/Hg 30 50 pH 7.30 7.50

Phenobarbital mcg/ml - 40

Phenytoin mcg/ml - 25

Phosphorus mg/ml 1.8 6

Platelets k/uL 30 750

PO2 mm/Hg 55

Potassium mmol/L 3 5.8

PT INR - 4.5

Sodium mmol/L 125 150

Theophylline mcg/ml - 20

Troponin ng/ml - 0.03

Vancomycin mcg/ml - Trough 20

WBC k/uL - 30

2.7 Urgent Non-Life-Threatening Lab Result Call List

TEST RESULT

CSF Culture Positive

Blood Culture Positive

MRSA Positive

C Diff Positive

Rapid HIV/HIV Positive

VRE Positive

AFB Positive

KPC Positive

CRE Positive

ESBL Positive

Shiga Toxin (Ecoli 0157) Positive

Legionella Urine Antigen Positive

Legionella Culture Positive

SARS-CoV-2 Positive

Blasts on peripheral blood smear Present

Section 3: TRANSFUSION SERVICES

3.1. Purpose: To outline the policy, procedure, and responsibility of personnel concerned with transfusion services in this medical center. This manual does not contain all the information and details concerning the Department of Veterans Affairs (VA) blood transfusion program; for further details, reference is made to VHA Handbook 1106.01, dated January 29, 2016. Additional references include Medical Center Policy (MCP) 713-01, Transfusion Utilization Committee Policy and MCP 713-02, Transfusion Policy.

3.2. Policy: Pathology and Laboratory Medicine will provide suitable blood, blood components and derivatives to meet the transfusion needs of patients being treated in this VA facility.

3.3. Procurement: Blood and blood components will be obtained from voluntary donors. This goal will be achieved through arrangements listed below:

a. From a local blood distribution center in accordance with a centrally developed contract

b. Exchange of blood with a blood bank registered with and/or licensed by the Bureau of Biologics, Food and Drug Administration (FDA). Appropriate records of all such exchanges are maintained in Pathology and Laboratory Medicine to ensure an equitable arrangement and periodic settling of accounts.

3.4. Wastage:

a. Red blood cell unit wastage defined as units discarded prior to their expiration dates because of, but not limited to, handling and storage errors such as breakage, failure to return unused units before their temperature exceeded allowable limits, etc, will be kept at/below 0.5% (Arch Pathol Lab Med, 2002, 126, 150-156).

b. Inventory outdates defined as any discarded expired unit and unused thawed fresh frozen plasma (FFP) will be minimized by:

(1) Inventory control and releasing unused crossmatched blood after three days

(2) Returning short dated red blood cell units to the distributor

(3) The patient’s physician following established criteria (lab results) for transfusing blood and blood products

c. Quarterly reports from the Transfusion Utilization Committee (TUC) including utilization percentages will be submitted to the Medical Staff Executive Board by the TUC Chairperson.

3.5. Responsibilities

a. The Medical Center Director will:

(1) Ensure current registration of the Blood Bank with FDA, Department of Health and Human Services

(2) Appoint a Transfusion Officer who will be directly responsible to the Chief of Staff, who in turn, will be responsible to the Director for the proper operation of the transfusion program

b. The designated Transfusion Officer will provide data and assistance as necessary to the Medical Staff Executive Board, through the Chairperson, relative to its review of transfusion service activities. His/her other responsibilities will include:

(1) Ensuring that all personnel who may in any way participate in the transfusion program are periodically indoctrinated with respect to their individual responsibilities in the program, as well as in the methods and practices required by VHA. Since the transfusion policies in non-VA hospitals may not be identical with those in VA Medical Centers, particular attention will be given to personnel new to VA and outside personnel who provide coverage.

(2) Participating actively in investigation of all transfusion complications, including cases of suspected bloodborne pathogens (e.g., hepatitis and human immunodeficiency virus [HIV])

(3) Initiating, when indicated, an electronic Joint Patient Safety Report (JPSR)

c. The TUC meets quarterly and will review transfusion practices and problems.

Written minutes will be prepared after each meeting and forwarded to the Medical Staff Executive Board. The committee will review the transfusion service report to assess transfusion reactions, to evaluate blood utilization, and to make recommendations regarding specific improvements in the transfusion service. If additional information is required, Pathology and Laboratory Medicine’s copies of current blood transfusion record form (BTRF), supplemented by reference to the patient’s medical record can be utilized. Special attention will be directed to all cases of suspected transfusion acquired diseases including hepatitis and HIV. In all instances of suspected hepatitis or HIV resulting from transfusion, the donor source(s) will be notified. The committee will review, at least quarterly, the quality indicators of blood utilization (C:T ratio, the rate of RBC unit expiration, and the rate of RBC wastage).

d. The Laboratory Manager is responsible for the professional laboratory aspects of the facility blood transfusion program, including the proper storage and issue of blood and blood components, inventory management, and for assuring that essential blood bank services will be available at all times. The Chief, Pathology and Laboratory Medicine, is responsible for the oversight of the laboratory aspects of the blood transfusion process including proper typing and grouping of donor and recipient blood and compatibility testing. Appropriate functions may be delegated to those laboratory personnel who are competent in blood bank procedures. The Laboratory Manager will cooperate with the Transfusion Officer in investigating transfusion complications. There are situations in which delay in transfusion may jeopardize the patient unduly. Such deviation from routine procedures carries a medical and legal risk and the potentially deleterious effects of such deviation must be weighed against the therapeutic effect.

The physician ordering the transfusion of blood or blood components has the responsibility for requesting and/or accepting the consequences of deviation from routine procedures. Medical Technologists will ensure that transfusion orders are completed timely as requested by the provider. Technologists will not delay issuance of appropriate blood or components under any circumstances.

e. The physician concerned with a blood transfusion is not in any way relieved from his/her responsibility, administrative or legal, by the appointment of a Transfusion Officer.

f. The Associate Chief of Staff for Nursing and Chief of Education will be responsible for the education and training of the registered nurse staff regarding blood transfusions.

3.6. General Procedures

a. A current manual of laboratory procedures is maintained in the Blood Bank. The procedures will be in accordance with the current edition of Standards for Blood Bank and Transfusion Services, published by the American Association of Blood Banks (AABB). The AABB Technical Manual will also be available, and necessary records will be maintained on file in the Blood Bank.

b. Routine compatibility testing will not be initiated until the VISTA Blood Establishment Computer Software (VBECS) order is received. Verbal requests for blood will not constitute the proper authority, except under emergency circumstances.

c. The Laboratory Manager will enforce the guidelines established by Occupational Safety and Health Administration (OSHA) to promote the safety of Laboratory personnel. The clinical manager will assure that infection control practices will be adhered to at all times and that aseptic techniques will be used.

d. There will be a positive verification of the identity of the prospective recipient prior to collecting the pre-transfusion blood specimen. This will be carried out by reading/scanning the wristband for the name, Social Security number (SSN), and by asking the patient to give his/her name and full SSN. This information will be compared with the order printed from Computerized Patient Record System (CPRS). Two qualified persons, who have positive knowledge of the patient’s identity, will make the verification and sign the order sheet. The individual securing the specimen will authenticate it by labeling the specimen with the unique blood bank number. Once all information compares 100%, a unique blood bank band will be applied to the patient at bedside providing an additional identification number that cannot be duplicated. The band will include patient name, full SSN, unique blood bank number, and date, time, and initials of collection.

e. A pre-transfusion sample of the recipient’s blood is stored between 2 and 8° C and retained for ten days after administration of the unit of blood. This tube will be used only for delayed transfusion reaction workups.

f. When multiple transfusions are planned over a period of several days, a sample of the recipient’s blood will be obtained every three days. This sample will be used for compatibility tests to identify unexpected antibodies, which may have resulted from previous transfusion or pregnancies.

g. Blood will not be warmed toward body temperature prior to administration except under special circumstances. Administration of warmed blood for any reason shall be in accordance with indications given in the current AABB Standards for Blood Banks and Transfusion Service: Warming devices must not raise the temperature of blood above 42° C; devices should have a visible thermometer and an audible alarm. Blood warmers are maintained by the Biomed Department.

h. No drugs or solutions will be added to the blood or injected through the walls of intravenous (IV) administration sets before or during transfusion. Only 0.9% normal saline, FFP, or 5% albumin (and no other medications or fluids) shall be infused through the same intravenous line while the blood products are being transfused.

i. Following completion of all transfusions, the empty blood containers must be discarded in red-bag trash for incineration. The BTRF will be completed manually and returned to the Blood Bank during the following circumstances:

(1) Transfusion reaction investigation: In situations where a transfusion reaction has been called or the complete container has not been infused, the blood container and donor tag, along with tubing and additional solutions, must be returned to the Blood Bank along with a copy of the completed BTRF.

(2) Emergency release

(3) CPRS is down

(4) Blood issued to Operating Room (OR)/Ambulatory Surgery Unit (ASU)/Post Anesthesia Care Unit (PACU) staff will document vitals in Picis and paper BTRF. The

OR/ASU/PACU staff will make a copy of the BTRF. Original form is placed in patient’s chart, then scanned. The copy is sent to the Blood Bank for review.

(5) Blood administered to a patient during transfer to another medical facility.

j. Segments from donor bags are retained in the Blood Bank for at least an additional ten days under refrigeration.

3.7. Blood/Blood Component Transfusion Requests

a. ABO/Rh typing of donor red cell products will be verified upon receipt at this institution according to established AABB policy. Recipient blood is typed for ABO and D antigens. ABO/Rh typing antibody screening and compatibility testing will be determined in accordance with methods recommended in the current edition of Standards for Blood Bank and Transfusion Services, and Technical Manual published by the AABB. Compatibility testing will be performed prior to each routine transfusion.

Reagents and Sera used for ABO Rh typing and antibody screening will be tested the day of use.

b. The need for emergency blood transfusion may not allow for routine compatibility testing. In such situations, the Blood Bank Technologist will issue red cell product following the emergency release procedure in “live” VBECS. The requesting physician assumes responsibility and will be required to complete an “Emergency Transfusion Request Form” (BB 595-267).

c. Recipients will receive blood of the same ABO and Rh type whenever possible or ABO compatible.

d. To assure availability of product, red cell transfusion requests should be initiated during regular working hours, and at least 24 hours in advance of need.

e. Please submit Blood Bank requests during regular working hours, and at least 24 hours in advance of scheduled surgery. To guarantee the availability of appropriate donor blood, ambulatory patients should be typed and screened at the time of the preoperative visit. In lieu of performing a complete crossmatch on all surgical cases, a standardized surgical blood order schedule has been compiled to indicate procedures where a type and screen should be performed (Appendix A). If blood is then required during surgery, a crossmatch can be performed using the current specimen within 90 minutes. If ABO history has previously been established, an electronic crossmatch may be performed within 15 minutes of notification. Recipient with identified antibodies shall have 2 units of antigen negative, crossmatched blood set up prior to the scheduled surgery.

f. Special components shall be ordered by recipient’s physician and should be available within 24- 48 hours depending on supplier availability. Special components include, but are not limited to, irradiated components, cryoprecipitate, and washed red blood cells.

(1) Leukocyte-reduced components are the standard of care for the Lebanon VAMC.

Leukocyte-reduced components are indicated to decrease the frequency of recurrent febrile non-hemolytic transfusion reactions. Leukocyte-reduced components have also been shown to reduce the risk of transfusion transmitted cytomegalovirus (CMV) and to reduce the incidence of human leukocyte antigens (HLA) alloimmunization.

(2) CMV-seronegative blood: CMV-seronegative recipients of allogenic progenitor cell transplants, patients with congenital immunodeficiencies, patients with HIV infection, CMV seronegative recipients of solid organ transplant from a seronegative donor, and CMV seronegative patients undergoing chemotherapy that results in a severe neutropenia.

(3) Irradiated cellular blood components are indicated for use in: Patients that are at risk for Transfusion Associated Graft Versus Host Disease, patients with congenital immunodeficiencies, patients undergoing progenitor cell transplantation, either autologous or allogenic, patients receiving HLA matched cellular components, recipients receiving directed donation red blood cells from first-degree relatives, and patients with Hodgkin’s disease, immunocompromised recipients, transfused patients receiving purine analogues (fludarabine, cladribine) or certain other biological immunodulators (alemtuzumab, anti-thymocyte globulin).

(4) Washed components may be used to reduce exposure to plasma proteins, acellular constituents or additives. It is indicated to reduce exposure to antibodies targeting known recipient antigens (such as from an Apheresis Platelet) or to remove constituents that predispose patients to significant or repeated transfusion reactions (e.g., the removal of IgA-containing plasma in providing transfusion support for an IgA-deficient recipient or in rare recipients experiencing anaphylactoid/anaphylactic reactions to other plasma components.

3.8. Administration of Blood

a. The administration of blood components may be initiated only after consent is obtained from the patient or legal representative (see VHA Handbook 1004.01 Informed Consent for Clinical Treatments and Procedures). Prior to transfusion, information inclusive of benefits and associated risks must be reviewed with the patient by the provider. “Patient Information for Blood Transfusion” sheets are provided to all patients.

Following review, VA Form 10-0431b “Consent/Refusal for Blood and/or Blood Products” or iMedConsent must be signed by the patient (or legal representative) and maintained in the patient’s medical record.

b. Patients receiving blood component transfusions in conjunction with operative or invasive procedures will not need to sign additional consent for blood component transfusions. These patients (or legal representatives) need only sign VA Form 10-10431a “Consent for Clinical Treatment/Procedure” or iMedConsent.

c. Before starting a transfusion, the transfusionist with a second verifier will confirm the patient’s identity by having the patient verbally state his/her full name and full SSN and verify that the full name and full SSN are identical to what is listed on the hospital wristband, unique blood bank armband, the BTRF, the Caution Tag, and on the necessary transfusion order. Two qualified persons will make certain the recipient is the person named on the Caution Tag, which is attached to the container of blood, and on the BTRF. Both will verify the information on the Blood Product, BTRF, and Caution Tag for the following:

(1) ABO & Rh group of patient

(2) ABO & Rh group of donor

(3) Compatibility test

(4) Donor number of the unit and expiration date

(5) Name and SSN of the recipient

(6) Match the unique blood bank number on BTRF, the blood bank armband, and the “Caution Tag”

(7) The type of blood product and the special transfusion requirements listed are consistent with the transfusion order.

d. Prior to transfusion, the transfusionist and the second verifier must confirm that the necessary transfusion order and the signed consent are in the medical record. This will be documented by the transfusionist in the verification section of CPRS Nursing Blood Administration Note (595-DT-493). The BTRF will be completed in writing when it must be returned to the Blood Bank.

e. Qualified verifiers include physicians, physician assistants, nurse practitioners, registered nurses, or nurse anesthetists. Prior to transfusion, the transfusionist and the second verifier must confirm that the necessary transfusion order and the signed consent are in the medical record. This will be documented by the transfusionist in the verification section of CPRS Nursing Blood Administration Note (595-DT-493). The BTRF will be completed in writing when it must be returned to the Blood Bank.

f. The responsibility for starting blood transfusions, other blood products, and IV fluids, which have been ordered by the patient’s provider, may be delegated to clinical staff deemed competent to receive blood products or clinical staff that have been deemed competent to administer intravenous therapy (see MCP 713-02, Transfusion Policy).

g. The physician will assume responsibility for all blood products transfused to patients under his/her care. The transfusionist will observe the patient at frequent intervals during transfusion and will notify the physician immediately of any untoward reactions the patient shows. In the event of a reaction, the physician will be responsible for ordering the transfusion reaction workup in CPRS. For an uneventful transfusion, the transfusionist will complete the CPRS Nursing Blood Administration Note (595-DT-493).

3.9. Indications for Transfusion: The following guidelines are to be used in conjunction with the physician’s clinical judgment (see also Appendix B):

a. Packed red blood cells – Indications for transfusion: The AABB recommends a restrictive RBC transfusion threshold in which the transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients, rather than a liberal threshold when the hemoglobin level is 10 g/dL. For patients undergoing orthopedic surgery or cardiac surgery and those with preexisting cardiovascular disease, the AABB recommends a restrictive RBC transfusion threshold hemoglobin level of 8 g/dL. The restrictive hemoglobin transfusion threshold of 7 g/dL is likely comparable with 8 g/dL, but RCT (Randomized Controlled Trials) evidence is not available for all patient categories.

These recommendations apply to all but the following conditions for which the evidence is insufficient for any recommendation: acute coronary syndrome, severe thrombocytopenia (patients treated for hematological or oncological disorders who are at risk of bleeding), and chronic transfusion–dependent anemia.

b. Fresh frozen plasma – Indications for transfusion:

(1) Emergent reversal of warfarin with a major or intracranial hemorrhage, or urgent reversal of warfarin effect when 4 factor prothrombin complex concentrate is not available

(2) Massive transfusion, ≥1 blood volume

(3) Active bleeding or risk of bleeding due to deficiency of multiple coagulation factors

(4) Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome

c. Platelet pool & Acrodose – Indications for transfusion:

(1) The AABB recommends that platelets should be transfused prophylactically to reduce the risk for spontaneous bleeding in hospitalized adult patients with therapy-induced hypoproliferative thrombocytopenia. The AABB recommends transfusing hospitalized adult patients with a platelet count of 10 × 109 cells/L or less to reduce the risk for spontaneous bleeding. The AABB recommends transfusing up to a single apheresis unit or equivalent. Greater doses are not more effective, and lower doses equal to one half of a standard apheresis unit are equally effective.

(2) The AABB suggests prophylactic platelet transfusion for patients having elective central venous catheter placement with a platelet count less than 20 × 109 cells/L.

(3) The AABB suggests prophylactic platelet transfusion for patients having elective diagnostic lumbar puncture with a platelet count less than 50 × 109 cells/L.

(4) The AABB suggests prophylactic platelet transfusion for patients having major elective non-neuraxial surgery with a platelet count less than 50 × 109 cells/L.

(5) The AABB recommends against routine prophylactic platelet transfusion for patients who are nonthrombocytopenic and have cardiac surgery with cardiopulmonary bypass. The AABB suggests platelet transfusion for patients having bypass who exhibit perioperative bleeding with thrombocytopenia and/or evidence of platelet dysfunction.

d. Cryoprecipitate – Indications for transfusion:

(1) Prophylaxis in non-bleeding patient undergoing an invasive procedure who has congenital fibrinogen deficiency or Von Willebrand’s disease unresponsive to DDAVP (1-deamino-8-d-arginine vasopressin)

(2) Actively bleeding patient with factor VIII deficiency for Von Willebrand’s disease when specific factor concentrates are not available

(3) Prophylaxis before cardiac surgery

(4) Acquired hypofibrinogenemic conditions such as liver transplantation or postpartum hemorrhage

3.10. Blood/Blood Product Transfusions

a. All blood components and derivatives will be collected and prepared according to standards specified by current authorities, including the AABB and the FDA.

b. Most patients requiring transfusions can be treated effectively with red blood cells.

Red cell products must be stored in a monitored refrigerator with a temperature between 1 and 6° C. Segments of red cell products will be products will be tested to confirm the ABO Rh of the unit and stored in the Blood Bank at least ten days after the product is transfused.

c. The use of pooled plasma is not permitted; single-donor FFP is used for transfusion purposes. The A and B antibodies in the donor plasma must be compatible with the A and B antigens on the recipient’s red cells. Plasma will be known to be free of unexpected antibodies. Plasma from donors with blood group “AB” may be used in any emergency transfusions. Prior to administration, the plasma will be thawed in accordance with recommendations of the FDA and the AABB. Once thawed, FFP must be stored in a monitored refrigerator with a temperature between 1 and 6° C and used within 24 hours from time of thawing. Compatibility testing is not required; however, per policy, a type & screen and unique blood bank identification number are required.

d. Platelet transfusion, whenever possible, is ABO specific, but it is not absolutely required. Acrodose platelets will contain platelets pooled from individual donors.

Platelets require constant agitation and must remain in the Blood Bank until it is time to infuse the product. The laboratory must always keep 1 dose of platelets on hand to comply with Tier 2 Surgery service. Platelets require constant agitation and must remain in the Blood Bank until it is time to infuse the product. Platelets must be infused using a 170-micron filter. Compatibility testing is not required; however, per policy, a type & screen and unique blood bank identification number are required.

e. Cryoprecipitate transfusion, whenever possible, is ABO specific, but it is not absolutely required. Cryoprecipitate is not stored onsite and a minimum of two hours is required to obtain cryoprecipitate from an outside source. Cryoprecipitate is a frozen product and is only thawed when there is a written order to infuse. Frozen pooled cryoprecipitate will be thawed, and an expiration date of 24 hours will be applied.

Transfuse thawed cryoprecipitate using a 170 micron filter. Compatibility testing is not required; however, per policy, a type & screen and unique blood bank identification number are required.

f. Rate of administration: The rate of flow of a transfusion can be controlled by a clamp on the administration set or an infusion pump, adjusted according to the recommendation of the patient’s physician. For elective transfusions, the rate is usually set so that the transfusion of 1 unit of red cells is accomplished within two hours but must not exceed four hours from the time it is removed from the Blood Bank. In patients with shock due to blood loss, or actively losing blood, a much faster rate of administration may be used. Special care is needed for elderly patients, cardiac and pulmonary disease patients, debilitated patients, and patients with severe chronic anemia. These patients are particularly susceptible to circulatory overload due to the increase in their blood volume resulting from the transfusion. They are normally given red blood cells, transfused at a slow rate as determined by the attending physician (1-4 ml per minute). In addition, frequent surveillance is needed during and after the transfusion to detect symptoms of circulatory overload.

g. If blood flows more slowly than is desired, the filter or IV catheter may be obstructed, or the product may simply be too viscous for rapid flow through the administration set. To correct the problem:

(1) Elevate the blood container to increase gravitational pull

(2) Consider performing new venipuncture with larger-bore IV if blood is infusing through a catheter smaller than 18G

(3) Examine the filter of the administration set for excessive debris. Change the administration set if necessary.

(4) If red blood cells are flowing too slowly, and there is an order permitting addition of normal strength saline (NSS) at keep vein open (KVO) rate, then infuse NSS at KVO rate. Infuse red blood cells through the NSS “Y” site of the IV line.

3.11. Transfusion Complications

a. In the event of a suspected transfusion reaction, the following actions are to be taken/initiated:

(1) Discontinue the blood component transfusion. Keep the intravenous line open as ordered.

(2) Notify the attending physician, resident, or hospitalist if the attending physician or resident is not immediately available

(3) Examination of the patient by the physician is required

(4) Upon determination by the physician that a transfusion reaction is suspected, the physician will order the transfusion reaction workup in CPRS

(5) Pathology & Laboratory Medicine Blood Bank section will be notified immediately following the physician’s determination of a suspected reaction

(6) A transfusion reaction workup will be initiated. The Blood Bank Technologist will verify all of the patient and unit information with the nurse. A new specimen is collected following Blood Bank specimen collection guidelines and a new unique blood bank armband is placed on the patient. Additional blood specimens are collected for testing.

Collection of the first voided urine may be necessary. The blood component container, including the recipient set and the completed BTRF copy, will be returned to the Blood Bank immediately.

b. Symptoms noted immediately or shortly after the transfusion is begun may include any of the following: Hives, chills, 1°C (2°F) increase in body temperature, palpitation, chest pain, flank pain, shortness of breath, headache, flushing, or even loss of consciousness. In severe reactions, these symptoms may be accompanied by shock, oliguria, hematuria, bronchospasm, respiratory arrest, and a bleeding diathesis.

c. Types of reactions:

(1) Allergic - Characterized by the appearance of hives and itching (urticaria) or a diffuse rash and responds to anti-allergic medications

(2) Febrile (non-hemolytic) - Chills and fever associated with blood transfusion may be reactions to normal donor blood. These reactions may be treated and sometimes prevented by antipyretic drugs. Keeping the patient warm may also help. In patients who have repeated febrile reactions, transfusion of leukocyte-poor red cells may be tried.

(3) Transfusion Acquired Circulatory overload - Difficulty in breathing with cyanosis, coughing, and frothy sputum. Treatment for heart failure may be required.

(4) Contaminated blood - Chills, extremely high fever, generalized aches and pains, erythema, and early onset of rapid hypotension with shock

(5) Hemolytic - Fever, headache, chest or back pain, dyspnea, vomiting, and often shock. In an anesthetized patient, reaction may be suspected by an unexplained increase in pulse rate or untoward oozing from the surgical wound. Hemoglobinemia and hemoglobinuria may occur promptly. Severely affected patient may have complete renal shutdown.

(6) Delayed hemolytic - Rare; may produce complex effects identifiable by appropriate but often difficult evaluation procedures

(7) Delayed effects - Viral hepatitis, syphilis, malaria, acquired immune deficiency syndrome (AIDS), and other diseases

(8) Transfusion-related acute lung injury (TRALI). A special investigation of the affected patient must be conducted by the Lab Medical Director, Transfusion Officer, and the attending physician prior to alerting the blood distributor (Central Pennsylvania Blood Bank [CPBB]) of the possible diagnosis of TRALI. The distributor takes responsibility for the investigation, testing, and final diagnosis of TRALI. Procedures are available in the Blood Bank. NOTE: The distributor does not accept female donors for FFP or plasma since multiparous females have been implicated as the possible cause of donor-related TRALI.

(9) Anaphylactic Reactions - hypotension, tachycardia, nausea, vomiting and/or diarrhea, abdominal pain, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasms and/or laryngospasm are rare but dangerous complications requiring immediate treatment with epinephrine and supportive care. While these reactions have been reported in Ig A-deficient patients with anti-Ig A antibodies and patients with haptoglobin deficiency, most reactions are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause.

d. Transfusion complications will be investigated by the patient’s physician, the Chief, Pathology and Laboratory Medicine, and/or the Transfusion Officer. The findings and conclusions will be electronically documented promptly in the patient’s clinical record using CPRS. In addition, a JPSR will be initiated for any transfusion error jeopardizing the patient’s life. A report of the findings, conclusions, actions taken in the investigation, and clinical follow up by the Transfusion Utilization Committee will be made to the Medical Staff Executive Board. FDA will be notified as required.

e. Procedures for investigation of a transfusion reaction will be in accordance with those recommended in current editions of Standards for Blood Bank and Transfusion Services and the Technical Manual, published by the AABB. If bacterial contamination is suspected as being the cause of the transfusion reaction, investigation of the source of the contamination will be initiated and the extent of special precautions will be determined by the Chief, Pathology and Laboratory Medicine and/or Transfusion Officer in cooperation with the infection control activity of the Medical Staff Executive Board.

f. Cases of actual or suspected transfusion transmitted disease such as hepatitis or HIV, thought to be related to blood transfusion, will be referred for investigation and appropriate action to the Chief, Pathology and Laboratory Medicine, the Transfusion Officer, and the Medical Staff Executive Board.

g. When a complication of blood collection or transfusion is confirmed to be fatal, the fatality program contact within the FDA Division of Inspections and Surveillance must be notified by the VA Regional Commissioner by telephone (240-402-9160) or email:

fatalities2@fda.hhs.gov as soon as possible. Within seven days after fatality, a written report of investigation must be submitted to U.S. Food and Drug Administration, Center for Biologics Evaluation and Research Document Control Center, 10903 New Hampshire Avenue, WO71, G112, Silver Spring, MD 20993-0002. FDA/CBER, Director, Office of Compliance and Biologics Quality, Attn: Fatality Program Manager (HFM-650), Division of Inspections and Surveillance, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. The FDA report should include the following information:

(1) Date and time of the notification

(2) Your name, title, telephone number, fax number, and email address

(3) Your facility’s name, mailing address, and FDA registration number

(4) Age and sex of the deceased

(5) Transfusion date(s)

(6) Blood/Blood Component(s) and unit number(s) of the product(s) that may be Implicated

(7) Brief description of events that led to the fatality - include underlying medical condition or disease and circumstances necessitating this hospitalization, reason for transfusion, how the patient initially responded to the transfusion, any medical intervention taken or response to the reaction, and time from initiating the transfusion to patient’s death.

(8) If an autopsy was or will be performed

3.12. Blood and Blood Component Procurement

a. Routine: The Blood Bank Technologist will conduct a daily inventory of blood products stored in the Blood Bank. Replacement orders along with special orders will be placed with the contracted blood distribution center around 0800.

b. Emergency: If an emergency occurs, the Blood Bank Technologist will procure blood products from the contracted blood distribution center following established guidelines posted in the Blood Bank. When possible, the contracted blood distribution center courier will deliver blood products. Emergency procedures should be used rarely and only after judicious consideration. While blood product is in transit, procedures necessary for crossmatch will be initiated. MCP 713-05 addresses inventory shortages.

c. FFP: A supply of FFP is kept onsite. Prior to use, the Blood Bank Technologist will thaw the FFP according to current editions of Standards for Blood Banks and Transfusion Services and the Technical Manual, published by the AABB. The FFP should be infused within 4 hours from time of thaw for maximum benefit but must be infused within 24 hours. Thawed FFP is stored in the Blood Bank at 1-6° C until infusion.

Thawed FFP not transfused within 24 hours is discarded.

d. Platelet Apheresis and Acrodose: The Laboratory must always keep 1 dose of platelets on hand to comply with Tier 2 Surgery service. Procurement of the product requires at least two hours’ notice. With rare exceptions, platelet procurement requires a written order to infuse the product upon arrival. The product must be infused using 170 to 260 micron filter obtained from the Blood Bank. Platelets not transfused are discarded.

3.13. Storage of Blood

a. Blood for transfusion is stored centrally in the authorized refrigerator in the Blood Bank section of Pathology and Laboratory Medicine and is maintained at a temperature between 1 and 6° C. This refrigerator is connected with the facility’s emergency power and is equipped with the following:

(1) Fan to ensure adequate circulation of air

(2) Recording thermometer connected with a special sensor immersed in a container with 150 ml of product simulated solution (1:10 ratio of glycerin to water)

(3) Automatic alarm that is visible, audible, and centrally alarmed

(4) or Automatic temperature recorder/tracking system

b. In the event of the Blood Bank refrigerator failure, the following instructions are to be followed:

(1) In the event of refrigerator malfunction, the Blood Bank Technologist will follow established guidelines in the Blood Bank to assure proper storage of blood products

(2) When the refrigerator temperature is outside of range, the audible alarm will sound. Laboratory staff will receive an e-mail notification from TempTrak within 15 minutes of the identified failure. Staff will acknowledge the notification and monitor for correction. If the temperature does not correct, staff are required to correct the problem or move the blood inventory to the refrigerator in the Surgical Building 104.

c. The only subsidiary refrigerator authorized for use is located in the Surgical Building 104. This refrigerator is temperature monitored and maintained in the same way as the Blood Bank refrigerator in Pathology and Laboratory Medicine.

d. The interior of a blood storage refrigerator will be scrupulously clean. Adequate lighting is provided to facilitate inspection of donor blood.

e. Space is designated within the refrigerator for separation of homologous, autologous, and directed uncrossmatched blood; homologous, autologous, and directed crossmatched blood, and quarantined blood (for rejection or discarding).

f. Blood is stored in the original…