Quality Manual-Blood Station PDF

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Summary

A manual for blood station managers....

Description

QUALITY MANUAL Version 1.0 DR. EUTIQUIO LL. ATANACIO JR. MEMORIAL HOSPITAL INC. BLOOD STATION DEPARTMENT F. Timbol Street, San Nicolas, Concepcion, Tarlac Danilo M. Atanacio, MD Tel. No. 923-0240

Written by

Reviewed by

Authorized by

Justine D. Malonzo, RMT

Hans Gabriel F. Atanacio, RMT

Dr. Catherine A Turla

Date: August 1, 2016

Date: August 1, 2016

Date: August 1, 2016

i.

Table of Contents

i. Table of Contents.....................................................................................................................2 1. Introduction to the Quality Manual........................................................................................4 1.1 Overview of the organization......................................................................................................................................... 4 1.2 Mission statement........................................................................................................................................................... 4 1.3 Vision statement............................................................................................................................................................. 4

Quality Manual

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1.4 Objectives....................................................................................................................................................................... 4 1.5 Scope.............................................................................................................................................................................. 4

2. Quality Policy.........................................................................................................................5 3. Organization............................................................................................................................6 3.1 Organization policy........................................................................................................................................................ 6 3.2 Conflict of interest.......................................................................................................................................................... 6 3.3 Organization chart.......................................................................................................................................................... 6 3.4 Internal communication.................................................................................................................................................. 7 3.5 Personnel responsibilities............................................................................................................................................... 8

4. Facilities and Safety................................................................................................................9 4.1 Policy............................................................................................................................................................................. 9 4.2 Facilities......................................................................................................................................................................... 9 4.3 Security.......................................................................................................................................................................... 9 4.4 Working environment................................................................................................................................................... 10 4.5 Waste disposal.............................................................................................................................................................. 10

5. Equipment.............................................................................................................................11 5.1 Policy............................................................................................................................................................................ 11 5.2 Selection of equipment................................................................................................................................................. 11 5.3 Installation and Acceptance Criteria............................................................................................................................. 11 5.4 Equipment Inventory and master file............................................................................................................................ 11 5.5 Validation..................................................................................................................................................................... 12 5.6 Preventive maintenance and repair............................................................................................................................... 12 5.7 Decommissioning......................................................................................................................................................... 12

6. Purchasing and Inventory.....................................................................................................13 6.1 Policy........................................................................................................................................................................... 13 6.2 Reagents and consumables management...................................................................................................................... 13 6.3 Selection and evaluation of providers........................................................................................................................... 13 6.4 Procurement................................................................................................................................................................. 14 6.4.1 Equipment procurement....................................................................................................................................... 14 6.4.2 Reagents, consumables and materials................................................................................................................... 14 6.5 Stock management and inventory................................................................................................................................. 15 6.6 Referral laboratories / subcontracting........................................................................................................................... 15

7. Process Management............................................................................................................16 7.1 Policy........................................................................................................................................................................... 16 7.2 Sample management..................................................................................................................................................... 17 7.2.1 Specimen collection and transport........................................................................................................................ 17 7.2.2 Specimen/sample receiving.................................................................................................................................. 17 7.2.3. Specimen/sample handling, preparation and storage........................................................................................... 17 7.3 Method validation......................................................................................................................................................... 17 7.4 List of examinations..................................................................................................................................................... 18 7.5 Quality Control............................................................................................................................................................. 19 7.6 Reporting...................................................................................................................................................................... 19 7.7 Sample retention and disposal...................................................................................................................................... 19

8. Assessments..........................................................................................................................20 8.1 Policy........................................................................................................................................................................... 20 8.2 Internal assessments..................................................................................................................................................... 20 8.2.1 Internal Audits...................................................................................................................................................... 20 8.2.2 Review and follow up of corrective actions..........................................................................................................20 8.2.3 Quality indicators................................................................................................................................................. 20 8.2.4 Staff suggestions..................................................................................................................................................20 8.2.5 Review of requests, methods and sampling requirements.....................................................................................20 8.3 External assessments....................................................................................................................................................21 8.3.1 External Quality Assessment/ Proficiency testing................................................................................................21 8.3.2 Customer feedback............................................................................................................................................... 21 8.3.3 External audits...................................................................................................................................................... 21

9. Personnel...............................................................................................................................22 9.1 Policy........................................................................................................................................................................... 22 9.2 Recruitment.................................................................................................................................................................. 22 9.3 Personnel file / health file............................................................................................................................................. 22 9.4 Integration and clearance..............................................................................................................................................22

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9.5 Training........................................................................................................................................................................ 23 9.6 Staff competency.......................................................................................................................................................... 23 9.7 Personnel performance appraisal..................................................................................................................................23 9.8 Continuous education................................................................................................................................................... 23 9.9 Non-permanent personnel............................................................................................................................................. 23

10. Customer Focus..................................................................................................................24 10.1 Policy......................................................................................................................................................................... 24 10.2 Customers satisfaction measurement.......................................................................................................................... 24 10.3 Claims management...................................................................................................................................................24

11. Nonconforming Event Management...................................................................................25 11.1 Policy.......................................................................................................................................................................... 25 11.2 Corrective Actions...................................................................................................................................................... 25

12. Continual Improvement......................................................................................................25 12.1 Policy......................................................................................................................................................................... 25 12.2 Quality indicators....................................................................................................................................................... 25 12.3 Management review................................................................................................................................................... 26 12.4 Preventive action........................................................................................................................................................ 26

13. Documents and Records.....................................................................................................27 13.1 Policy......................................................................................................................................................................... 27 13.2 Documentation management...................................................................................................................................... 27 13.3 Documents and records control.................................................................................................................................. 28 13.4 Archiving.................................................................................................................................................................... 28 13.5 Review of contracts.................................................................................................................................................... 28

14. Information Management...................................................................................................28 14.1 Policy......................................................................................................................................................................... 28 14.2 Information system - Security..................................................................................................................................... 28 14.3 Confidentiality............................................................................................................................................................29

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DR. EUTIQUIO LL. ATANACIO JR. MEMORIAL HOSPITAL INC. BLOOD STATION DEPARTMENT

Version 1.0

August 1, 2016

1. Introduction to the Quality Manual 1.1 Overview of the organization As part of the diagnostic services, the Dr. Eutiquio LL. Atanacio Memorial Hospital Inc., Blood Station Department conducts Pre-analytical, Analytical, and Post-Analytical procedures on all blood units and other blood products received by the department personnel for the benefit of the patient and population. The department has adopted a quality management system for the purpose of the effective and efficient use of its resources. All employees are committed to the culture of quality. All staff shares responsibility for identifying nonconformities or opportunities for improvement, recording these instances so that corrective or preventive actions can be taken to ensure the department meets the needs of its customers. 1.2 Mission statement Our mission is to provide fully integrated and comprehensive blood station services, able to handle, do tests as ordered by the physician or other qualified professional upon their respective request to all kinds of blood products. 1.3 Vision statement The Dr. Eutiquio LL. Atanacio Memorial Hospital Inc., Blood Station Department is envisioned as the leading provider of customized health information services that utilizes innovative, state-of-the-art technologies for the communities in which we serve. 1.4 Objectives Our objectives are to produce accurate, reliable and timely analyses' results, achieve and maintain an effective quality management system and ensure compliance with relevant statutory and safety requirements. 1.5 Scope This quality manual describes the quality management system of the Dr. Eutiquio LL. Atanacio Memorial Hospital Inc., Blood Station Department. Its scope is for: 

Internal use - to communicate to staff the department’s quality policy and quality objectives, to make the staff familiar with the processes used to achieve compliance with quality requirements. This should facilitate the implementation of the quality management system as well as ensure its maintenance and required updates during altering circumstances. This should also allow effective communication and control of quality related activities and a documented base for quality system audits.

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External use - to inform the Dr. Eutiquio LL. Atanacio Memorial Hospital Inc., Blood Station Department’s external partners about its quality policy as well as its implemented quality management system and measures of compliance with quality. Quality Manual

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DR. EUTIQUIO LL. ATANACIO JR. MEMORIAL HOSPITAL INC. BLOOD STATION DEPARTMENT

Version 1.0

August 1, 2016

2. Quality Policy The Dr. Eutiquio LL. Atanacio Jr. Memorial Hospital Inc., a DOH – accredited secondary hospital is committed to the delivery of globally competitive, accessible and affordable healthcare services in Central Luzon through an effective quality management system. The DEAMHI continually improves its quality of service in accordance with regulatory, statutory and industry requirements.

Danilo M. Atanacio, MD. Medical Director

Catherine A. Turla, MD. Hospital Administrator

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DR. EUTIQUIO LL. ATANACIO JR. MEMORIAL HOSPITAL INC.

Version 1.0

BLOOD STATION DEPARTMENT

August 1, 2016

3. Organization 3.1 Organization policy The Pathologist, Chief Medical Technologist, Quality Manager and/or Staff Medical Technologist have the authority, competence and responsibility for the services provided. Quality management ensures the following:  There are no activities that could compromise the department’s performance;  There are appropriate procedures to ensure ethical respect of patient samples and confidentiality of patient information;  Duties and responsibilities of laboratory personnel are defined;  Appropriate communication is established within the laboratory;  A quality manager is designated. 3.2 Conflict of inte...