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Policy and Procedure For Retention of Records: Page 1 - Blood Service Facility

This document outlines the policy and procedures for retention of records at the Blood Service Facility of Bangued Christian Hospital. It specifies the minimum time periods that different types of records must be retained, ranging from one year to 50 years depending on the content. Records relating to donor blood samples must be kept for one year, while documentation of adverse recipient events or quality assurance reports require retention for five years. Records pertaining to donations, transfusions, and product distribution must be maintained for 50 years. The policy aims to ensure records are available upon request and properly stored for the specified time periods according to regulatory standards.

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Darren Cariño
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132 views

Policy and Procedure For Retention of Records: Page 1 - Blood Service Facility

This document outlines the policy and procedures for retention of records at the Blood Service Facility of Bangued Christian Hospital. It specifies the minimum time periods that different types of records must be retained, ranging from one year to 50 years depending on the content. Records relating to donor blood samples must be kept for one year, while documentation of adverse recipient events or quality assurance reports require retention for five years. Records pertaining to donations, transfusions, and product distribution must be maintained for 50 years. The policy aims to ensure records are available upon request and properly stored for the specified time periods according to regulatory standards.

Uploaded by

Darren Cariño
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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POLICY AND PROCEDURE FOR RETENTION OF

RECORDS
Page 1 - Blood Service Facility
Issued: 01/28/2021

Overview
Records and documents are required to be available upon request, easily located and retained for a
specified amount of time. The amount of time retained is dependent on the type of information
contained in the documentation.

Policy
1. The Blood Service Facility of Bangued Christian Hospital shall retain documents and records
according to standards on blood and blood components.

2. The following documents shall be retained for one year:


2.1. The date, time and the phlebotomist’s identification when a recipient blood sample was
drawn; and,
2.2. Packing/shipping documentation, related to the transport, when shipping blood
components or blood products from Blood Service Facility to a facility and from a facility to a
facility.

3. The following documentation shall be retained for three years:


3.1. Validation of computer systems, including:
3.1.1. Description of computer system;
3.1.2. Any changes made to the system as a result of validation;
3.1.3. Training records of computer system manager and users; and
3.1.4. The validation plan and all results for the computer system’s elements,
including:
 Application programs;
 Technical environment;
 Data conversion;
 System parameters when configured for use;
 Operating procedures for the computer system;
 Operating procedures in the event of system failure;
 Personnel training material;
 System recovery; and
 Complete production system.
3.2. Calibration and performance verification of critical equipment.
Note: If equipment manufacturer’s instructions suggest a longer retention period
than three years, retain records in accordance with manufacturer’s instructions.

4. The following records shall be retained for five years:


4.1. Adverse events of recipients;
4.2. Storage temperatures of blood components and blood products;
4.3. Complaints about products;
4.4. Quality assurance reports and internal audit records; and
4.5. Quality control testing of blood components, reagents, equipment and proficiency testing
surveys, including:
4.5.1. Dates;
4.5.2. Testing performed;
4.5.3. Results observed;
4.5.4. Interpretations;
4.5.5. Individuals performing the tests; and,
4.5.6. Any appropriate corrective action.

5. Documentation shall be retained for ten years regarding:


POLICY AND PROCEDURE FOR RETENTION OF
RECORDS
Page 2 - Blood Service Facility
Issued: 01/28/2021

5.1. Investigations and reports related to the safety of a blood component or blood product in
the following recipient events:
5.1.1. Errors and accidents that could lead to serious adverse reactions; and
5.1.2. Unexpected or serious adverse events;
5.2. A lookback or traceback process;
5.3. Final disposition for autologous blood components, including recipient identification;
5.4. Qualifications, training, and the competency of each individual who performs any of the
following activities:
5.4.1. Preparation of blood components;
5.4.2. Testing and labelling of blood components;
5.4.3. Storage, packing, and transportation;
5.4.4. Requests, pre-transfusion testing, selection of components, and criteria for
acceptance;
5.4.5. Transfusion;
5.4.6. BSF responsibilities regarding blood products used in the facility;
Note: This item refers only to blood products located in the BSF.

5.4.7. Home transfusion;


5.4.8. Adverse event monitoring and corrective action; and,
5.4.9. Removal of unsafe blood components and blood products from inventory.

6. The following must be retained for 50 years:


6.1. Donation codes;
6.2. The record of issue of blood components and blood products for transfusion;
6.3. The record of transfusion of blood components and blood products;
6.4. Final disposition for transfused blood components and blood products, including recipient
identification; and,
6.5. Records relating to the distribution from the Blood Bank to BSF of Bangued Christian
Hospital, and transfer between other BSFs, including exceptional distribution and any recalls.

Adopted:

JULIETA JOY B. FIGUERAS, MD, MHA


Medical Director, Bangued Christian Hospital

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