guidelines for developing a quality management...

SMILE Johns Hopkins University

Baltimore, MD USA

Doc1.0-14 Guidelines for Developing a Quality Management Plan

Version 1.0 of 4

Guidelines for Developing a Quality Management Plan Author: Jaclyn Madden

Peggy Coulter

Document Number: Doc1.0-14

Effective Date: 30-Jul-08

Review: Date of last review: 30-Jul-08

Reviewed by: Penny Stevens

Erin Gover

Background

In order to ensure the safety of patients and laboratory personnel and to ensure that accurate results are obtained and reported, the laboratory needs to maintain quality throughout its pre-analytical, analytical, and post-analytical path of workflow. A Quality Management Plan provides the infrastructure for maintaining quality in the laboratory.

The Quality Management approach included in these guidelines is based on the 12 Quality System Essentials (QSE) model developed by CLSI/NCCLS (refer to CLSI/NCCLS documents GP26-A3, HS1-A2, and GP22-A2) and is mostly consistent with ISO standards (refer to ISO 15189). The 12 QSEs represent the most fundamental elements for maintaining quality, safety, and efficiency throughout the laboratory’s path of workflow.

Description of the 12 QSEs:

• QSE 1 - Documents and Records: This QSE describes the processes for creating standardized documents and records and maintaining documents and records so that they are up-to-date and accurate, readily accessible by laboratory staff, and protected from damage, deterioration, and unauthorized use.

• QSE 2 – Organization: A strong commitment from top-level managers is essential for the success of the overall laboratory quality program. This QSE describes how the organizational structure and quality management system ensure that customers’ needs and regulatory requirements are met.

• QSE 3 – Personnel: The most important of the laboratory’s resources is its personnel. This QSE describes how personnel are managed and provided with the tools needed to perform testing so that accurate and reliable test results are obtained.

• QSE 4 – Equipment: This QSE describes how equipment is selected, installed, identified, validated/verified, and maintained in order to ensure personnel safety and specimen and testing result integrity.

• QSE 5 – Purchasing & Inventory: Availability of dependable and reliable test kits and supplies is essential. This QSE describes how reagents and supplies are procured, distributed, and managed.

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• QSE 6 – Process Control: This QSE describes the activities and techniques that are carried out to ensure that the testing procedures are correctly performed, the environment is suitable for reliable testing, and the testing methods work as expected to produce accurate and reliable results.

• QSE 7 – Information Management: This QSE describes how patient-related and testing information are managed in order to maintain the accuracy, reliability, confidentiality, and accessibility of the data.

• QSE 8 – Occurrence Management: This QSE describes how nonconforming events (occurrences) are detected, investigated, resolved, and tracked.

• QSE 9 – Assessment: This QSE describes the internal and external assessments that are conducted to evaluate the effectiveness of the laboratory’s quality management system.

• QSE 10 – Process Improvement: This QSE describes elements of a process improvement program that identifies and addresses opportunities for improvement and problems that impact patient care.

• QSE 11 – Customer Service: This QSE describes how the laboratory assesses and addresses its ability to meet the needs of internal and external customers.

• QSE 12 – Facilities & Safety: This QSE describes how the physical space of the laboratory is maintained in a manner that ensures efficient workflow, accurate test results, and personnel safety. It describes how the laboratory supplies the materials and training necessary to ensure the safety of all personnel.

Purpose

This document provides guidance for developing a Quality Management Plan for a laboratory. The policies, processes, and procedures outlined in these guidelines are only suggestions. Each individual laboratory is responsible for developing a Quality Management Plan that is consistent with its path of workflow, needs and responsibilities, protocols specific to the laboratory, and any organizational, accreditation, governmental, or other regulations with which it must comply.

Terms

Document - For these guidelines, the term document will refer to any written policy, process, procedure, form, or job aid.

Facility: For the purpose of these guidelines, the term facility will refer to the laboratory’s parent organization, including, but not limited to, hospitals, universities, or other institutions.

Policy Documents - Provide a statement of the intent and direction for accomplishing tasks.

Process Documents – Depict/describe how related activities are sequenced across time.


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Procedure Documents – Present step-by-step instructions that a single individual needs to take to successfully complete one activity in a process.

Record – Laboratory records may be paper or electronic. Laboratory records include, but are not limited to: examination requisitions; worksheets and instrument printouts; quality control results and actions taken; external quality assessment (proficiency testing); equipment calibration and maintenance; examination method verification; software verification; blood donation and transfusion; patient examination reports; staff training and competence; internal and external audits and inspections; and occurrence, nonconformance, and complaint records and actions taken.

Policies and Processes

The policies and processes related to each QSE are described in Appendices A-L.

Appendices A. QSE 1 – Documents and Records

B. QSE 2 – Organization

C. QSE 3 – Personnel

D. QSE 4 – Equipment

E. QSE 5 – Purchasing and Inventory

F. QSE 6 – Process Control

G. QSE 7 – Information Management

H. QSE 8 – Occurrence Management

I. QSE 9 – Assessment

J. QSE 10 – Process Improvement

K. QSE 11 – Customer Service

L. QSE 12 – Facilities and Safety

References 1. Berte, L. A World Wide Approach to Laboratory Quality Management – Session

1. Teleconference sponsored by ASCP on 06-Dec-2005.

2. CLSI. Laboratory Design; Approved Guideline – Second Edition. CLSI document GP18-A2. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; 2007.

3. CLSI. Laboratory Documents: Development and Control; Approved Guideline – Fifth Edition. CLSI document GP2-A5. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; 2006.


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4. CLSI. Management of Nonconforming Laboratory Events; Approved Guideline. CLSI document GP32-A. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; 2007.

5. ISO. Medical laboratories – Particular requirements for quality and competence. EN/ISO15189. Geneva: International Organization for Standardization; 2003.

6. NCCLS. Application of a Quality Management System Model for Laboratory Services – Approved Guideline – Third Edition. NCCLS document GP26-A3. Wayne, Pennsylvania: NCCLS; 2004.

7. NCCLS. A Quality Management System Model for Health Care; Approved Guideline – Second Edition. NCCLS document HS1-A2. Wayne, Pennsylvania: NCCLS; 2004.

8. NCCLS. Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline – Second Edition. NCCLS document GP22-A2. Wayne, Pennsylvania: NCCLS; 2004.

9. NCCLS. Clinical Laboratory Safety; Approved Guideline – Second Edition. NCCLS document GP17-A2. Wayne, Pennsylvania: NCCLS; 2004.

10. NCCLS. Selecting and Evaluating a Referral Laboratory; Approved Guideline. NCCLS document GP9-A. Wayne, Pennsylvania: NCCLS; 1998.

11. NCCLS. Training and Competence Assessment; Approved Guideline – Second Edition. NCCLS document GP21-A2. Wayne, Pennsylvania: NCCLS; 2004.


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QSE 1: Documents and Records - Policy

Documents and Records Policy

Policy Number Doc1.0-14AppA

Effective Date 30-Jul-08

Approval Signature: Laboratory Director

Review Cycle 1 year

Supersedes New

Policy The laboratory has a process for documenting the management’s instructions to staff about the laboratory’s work, what to do, how to do it, and how to maintain the records of what happened when work was done.

Purpose This policy provides direction for the processes and procedures to effectively manage the laboratory’s documents and records.

Responsibility The Laboratory Director is responsible for reviewing/approving all documents before implementation and on an annual basis.

The Quality Manager is responsible for establishing and maintaining the document control system.

The Laboratory Supervisor/Lead Technologists are responsible for authoring, modifying, distributing, and retaining documents, forms, and records as needed.

Laboratory Staff are responsible for following document control policies and procedures as necessary to complete their work.

Documents The laboratory has a document control system to ensure that all documents in use are written in the approved format, reflect the current version, and are reviewed and approved by the laboratory director at least annually.

Procedures All procedures used in the laboratory will be documented, reviewed, and signed by the Laboratory Director or designee prior to implementation and at least annually thereafter.

Records Records are created, modified, stored, archived, and destroyed in a way that facilitates retrieval, prevents damage and unauthorized use, and maintains patient confidentiality.

Storage All laboratory records, inclusive of requisitions, patient results, and QC, QA, and maintenance logs, will be retained for at least five years following the date of application to the FDA.

Supporting Documents

The following processes support this policy:

• New Document Creation, Review, and Approval • Revision of Approved Existing Documents • Document Control • Records Review, Retention, Storage, Retrieval, and Destruction • Records Modification

Doc1.0-14AppA QSE 1- Documents and Records Version#: 1.0 Page 1 of 6


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New Document Creation, Review, and Approval- Process

Process for Creating, Reviewing, and Approving New Documents

What Happens Who’s Responsible Procedures

Need for new document is identified

• Any Staff Member • Writing Policy, Process, Procedure, and Form Documents

Document Change Request Form is completed and approved

• Any Staff Member • Quality Manager • Laboratory

Supervisor • Laboratory Director

• Writing Policy, Process, Procedure, and Form Documents

• Document Change Request Form

New document is drafted

• Assigned Author • Writing Policy,

Process, Procedure, and Form Documents

Independent review and verification are performed

• Assigned Staff Reviewer

• Reviewing and Verifying New or Changed Documents

Review and approval signatures are obtained

• Laboratory Director • Laboratory

Supervisor • Quality Manager


Document is entered into Master List and assigned a unique identifier

• Quality Manager • Document Control • Document Master

List A Master File is created for the document

• Quality Manager • Document Control • Master File

Working copies of the document are distributed as needed

• Quality Manager • Laboratory

Supervisor

• Document Control

Staff notification is made • Laboratory Supervisor

• Lead Technologist

• Notifying Staff of Document Changes

Staff is trained in use of new document, and document is implemented

• Laboratory Supervisor



• Staff Training Procedures



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Revision of Existing Documents/Forms- Process Process for Revising Existing Documents/Forms


Need for change to existing (previously approved) document is identified

• Any Staff Member • Editing Documents


Document Change Request Form is completed and approved

• Any Staff Member

• Laboratory Director

• Editing Documents


Changes needed to related documents are identified and Document Change Request Forms are completed

• Assigned Staff • Quality Manager

• Editing Documents


Current document version is retrieved from master file

• Assigned Author • Quality Manager

• Document Control • Editing Documents

Current document version is edited

• Assigned Author • Editing Documents

Independent review and verification are performed

• Assigned Staff Reviewer


Review and approval signatures obtained

• Laboratory Director • Laboratory Supervisor • Quality Manager


The old version of the document is retired and archived in the Master File. The new version is retained in the Master File.

• Quality Manager • Document Control • Master File • Archiving Retired

SOPs

Master List is updated • Quality Manager • Document Control • Document Master List

All working copies of old version are replaced with new version. Discontinued working copies are destroyed

• Quality Manager • Laboratory Supervisor

• Document Control • Destruction of

Documents

Staff notification is made • Laboratory Supervisor • Lead Technologist


Staff is trained in use of new document, and document is implemented

• Laboratory Supervisor • Lead Technologist


• Staff Training Procedures



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Document Control - Process Process for Document Control


Each document is uniquely identified to ensure traceability throughout the document life cycle

• Quality Manager • Document Control

Document is entered on the Document Master List


List A Master File containing master copies of current and previous document versions is created for each document

• Quality Manager • Document Control • Master File • Archiving Retired

SOPs

Master List is used to identify locations of working copies of documents


List Working copies of the document are made from the master copy and distributed


Supervisor

• Document Control

Discontinued working copies are destroyed

• Quality Manager • Document Control • Document

Destruction Documents are reviewed and signed (at least annually)


Supervisor • Laboratory Director

• Document Control • Document Review • Document Review

Schedule



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Records Review, Retention, Storage, Retrieval, and Destruction - Process Process for Reviewing, Retaining, Storing, Retrieving, and Destroying Records


Records are created • Any Staff Member • Associated Pre-analytic SOPs

• Associated Analytic SOPs

• Associated Post-analytic SOPs

Records are listed in a Records Index

• Quality Manager • Maintaining Laboratory Records

Records are reviewed according to established schedules


• Quality Manager • Laboratory Director

• Maintaining Laboratory Records

Records are labeled, stored, and archived


• Quality Manager • Any Staff Member

• Storing Laboratory Records

• Record Retention

Records are scheduled for destruction. Documentation of destruction is maintained


• Quality Manager

• Record Retention • Destruction of

Records



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Modify Records - Process Process for Modifying Records


The need for a change to a record is identified

• Any Staff Member • Associated Pre-analytic SOPs

• Associated Analytic SOPs

• Associated Post-Analytic SOPs

• Modifying Records Modification of record is made

• Assigned Staff Member


Supervisor

• Modifying Records

Laboratory management and other appropriate individuals are notified of changes to records. Notification is documented


• Quality Manager


• Patient Care Providers

• Modifying Records

Copies of the original record, modified record, and notification documentation are maintained


• Quality Manager

• Modifying Records • Storing Laboratory

Records • Record Retention


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QSE 2: Organizational Structure - Policy

Organizational Structure

Policy Number Doc1.0-14AppB



Review Cycle 1 year

Supersedes New

Policy The laboratory complies with all external requirements and has an organizational structure that ensures quality and meets customer needs.

Purpose This policy provides the effective demonstration of the laboratory’s structure and quality management system as it is coordinated with other facility quality management programs.

Responsibility The Laboratory Medical Director is responsible for the allocation of resources so that strategic plans can be executed.

The Laboratory Supervisor is responsible for maintaining the organizational chart.

The Quality Manager is responsible for developing the laboratory quality management system and coordinating it with other facility quality management programs.

Quality Management System

The laboratory quality management system will be developed and linked with other facility quality management systems.

Chart of Laboratory Organization

A chart of the organizational structure of the administration and staff of the laboratory will be maintained.

Referral Laboratories A chart identifying all Referral Laboratories is maintained.



• Implementing a Laboratory Quality Management System

• Organizational Chart Development and Maintenance

• Identification of Referral Laboratories

Doc1.0-14AppB QSE 2- Organization Version#: 1.0 Page 1 of 4


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Implementing a Laboratory Quality Management System – Process Process for Implementing a Laboratory Quality Management System


A Quality Manager is designated


• Human Resources

• Personnel Processes/Procedures

Internal and external customers’ needs are identified

• Quality Manager

• Laboratory Management

• Quality Management

The resources needed to meet those needs are identified and obtained

• Quality Manager


• Resource Allocation


Policies for each QSE are developed and integrated into a Quality Manual

• Quality Manager • Quality Management

The processes and procedures needed to implement each policy are developed

• Quality Manager • Quality Management

The principles in the Quality Manual are communicated to all personnel

• Quality Manager



• Personnel Training Procedures

Laboratory leadership reviews the Laboratory Quality Management System at least annually

• Quality Manager




Laboratory leadership works with other departments to coordinate the laboratory quality system with other facility quality management systems



• Facility Executive Management


• Other Departments’ Quality Management Procedures



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Organizational Chart Development and Maintenance - Process Process for Organizational Chart Development and Maintenance


The laboratory administration is identified

• Executive Management


• Developing and Maintaining the Organizational Chart

The levels of authority and responsibility for all personnel are defined




The chain of command (reporting relationships among personnel) is identified




An organizational chart (organogram) is published






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Identification of Referral Laboratories - Process

Process for Identification of Referral Laboratories


The need for referral laboratories is assessed

• Laboratory Supervisor • Use of Referral Laboratories

• Laboratory Testing Menu

• Review of Physician Order History

Referral laboratory’s capabilities are assessed


• Referral Laboratory Testing Menus

A list of Referral Laboratories and the tests that they conduct is maintained

• Laboratory Supervisor • Chart of Referral Laboratories


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QSE 3: Personnel - Policy

Policy The laboratory collaborates with the Human Resources Department to hire qualified personnel and ensure that they have and can demonstrate the knowledge and skills necessary to perform their duties.

Purpose This policy provides direction for the processes and procedures to effectively manage the laboratory’s personnel.

Responsibility The Human Resources Department is responsible for the employment advertising, applicant screening, employee record maintenance, and Facility Orientation of new employees.

The Laboratory Director is responsible for the hiring selection process of Laboratory Supervisors.

The Laboratory Supervisor is responsible for interviews, hiring selection process, department orientation, and performance reviews of all staff reporting to this position.

The Lead Technologists are responsible for job-specific training and competency, shift scheduling, and contributing to the performance reviews of staff reporting to this position.

The Quality Manager is responsible for assisting with training of new employees.

Job Descriptions Job qualifications are specified in job descriptions for each laboratory position.

Personnel Qualifications

Certification and education records are maintained for all members of the laboratory administration and staff.

Orientation and Training

Employees are oriented to the organization and trained in each duty as assigned.

Competency Employees are assessed for competency twice the first year and then annually in their job duties as assigned.

Continuing Education Opportunities are provided for continuing education and professional development. Continuing education activities are documented by employees.



• Maintaining Adequate Staff Resources • Job Descriptions • Personnel Qualifications • Employee Orientation and Training • Assessing Employee Competency • Continuing Education

Personnel Policy

Policy Number Doc1.0-14AppC



Review Cycle 1 year

Supersedes New

Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 1 of 7


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Maintaining Adequate Staff Resources - Process Process for Maintaining Adequate Staff Resources


Review of laboratory workload and personnel resources is conducted



• Allocation of Staffing Resources

• Review of Laboratory Workload

Need for additional staffing is identified




New laboratory staff are recruited and hired

• Human Resources



• Human Resources Policies and Procedures



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Job Descriptions - Process Process for Job Descriptions


Job qualification requirements are established and documented


• Human Resources


• Review of Laboratory Workload

Laboratory staffing needs are assessed

• Laboratory Supervisor • Review of Laboratory Workload

Laboratory duties are assigned by position

• Laboratory Supervisor • Staffing Chart

Job descriptions are developed and maintained so as to reflect qualification requirements and current job duties

• Human Resources



Staff familiarity with job description and job-related duties is documented

• Human Resources


• Laboratory Employee


• Job Descriptions

Copies of job descriptions are maintained as part of the laboratory personnel file

• Laboratory Supervisor • Personnel Files

• Job Descriptions



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Personnel Qualifications - Process

Process for Documenting Personnel Qualifications


Proof of licensure, certification, and education records are maintained in the personnel file for all members of laboratory administration and staff

• Human Resources • Human Resources Policies and Procedures

• Personnel Files

Current Curriculum Vitae (CV) are on file for Laboratory Director and Management

• Human Resources • Human Resources Policies and Procedures

• Personnel Files



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Employee Orientation and Training- Process

Process for Employee Orientation and Training


Employee attends facility orientation session


• Human Resources

• Facility Policy and Procedures

• New Employee Orientation Procedure

Employee receives laboratory orientation

• Quality Manager




Employee is trained for duties as assigned



• Quality Manager


• New Employee Training schedule

• Job-specific Training Procedures

• Standard Operating Procedures (as applicable)

Documentation of orientation and training is maintained as part of laboratory personnel file

• Human Resources


• Quality Manager




• Job-specific Training Procedures

• Personnel File



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Assessing Employee Competency- Process Process for Assessing Employee Competency


Employee demonstrates initial post-training-specific competency



• Quality Manager

• New Employee Training Schedule


• Employee Competency

Employee demonstrates competency at end of 3 month probation period



• Quality Manager

• New Employee Training Schedule



Employee competency is reviewed and documented at least annually



• Quality Manager




• Annual Performance Review

Corrective actions are initiated and documented in response to any competency failures



• Quality Manager





Documentation is maintained as part of laboratory personnel file

• Quality Manager




• Personnel Files



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Tracking Continuing Education - Process Process for Tracking Continuing Education


Opportunities for personnel to participate in and document professional growth and development exist

• Human Resources


• Quality Manager


Employee attends facility and laboratory training update sessions

• Quality Manager




• Documenting Continuing Education

Employee attends training session offsite

• Quality Manager



• Educational Leave Request Form


Employee reads professional educational material

• Quality Manager



Continuing education documentation is maintained as part of laboratory personnel file

• Quality Manager



• Personnel Files


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QSE 4: Equipment - Policy

Equipment Policy

Policy Number Doc1.0-14AppD



Review Cycle 1 year

Supersedes New

Policy The laboratory keeps detailed records on each piece of equipment that is critical in the processes across the laboratory’s path of workflow.

Purpose This policy provides direction for the processes and procedures to effectively manage the laboratory’s equipment.

Responsibility The Laboratory Director is responsible for laboratory acquisition decisions, implementing an instrument verification and maintenance program, and documentation review.

The Purchasing Department is responsible for the actual purchasing process associated with instrument purchases.

The Laboratory Supervisor is responsible for instrument justification and comparative analyses.

The Lead Technologists and Quality Manager are responsible for the validation, maintenance and repair once the instruments are on-site.

Equipment Selection, Acquisition, Installation, and Inventory

The laboratory acquires and installs the equipment needed for producing quality results. An inventory of all laboratory equipment is maintained.

Validation Studies Validation studies are performed and documented as required on laboratory instrumentation to include accuracy, precision, linearity, reportable ranges, reportable reference ranges, sensitivity (as needed) and specificity (as needed).

Method Comparison When more than one method or instrument is used to conduct the same test, the methods or instruments are compared semi-annually.

Carryover Studies are performed to show non-FDA approved instruments or test systems do not have any carryover.

Maintenance, Calibration, Use, Troubleshooting, Service, Repair, and Records

Each instrument in use has a separate manual which includes all instructions and documentation generated during the life of the instrument indefinitely or as otherwise directed.

Retiring Instruments The laboratory retires instruments that are no longer in use and has procedures for storage of retired instruments and their records.

Supporting Documents The following processes support this policy: • Equipment Acquisition, Installation, Identification, and Inventory • Instrument Validation Studies • Method Comparisons • Carryover Studies • Instrument and Equipment Preventative/Corrective Maintenance • Troubleshooting and Corrective Actions • Retiring Instruments

Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 1 of 9


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Equipment Acquisition - Process Process for Equipment Selection, Acquisition, Installation, Identification, and Inventory


Decision is made to purchase new equipment or replace equipment in use




• Laboratory Testing Turn Around Times

• Equipment Inventory

• Specific Equipment Service and Maintenance Records

Research is performed for available instrumentation




• Requesting Bids from Suppliers

• Test-Specific Procedures

• Equipment Selection

Equipment justification is performed



• Finance Department

• Finance Department Policies and Procedures

Equipment purchase request is completed and approved


• Purchasing Department

• Completing a Purchase Request Form

• Equipment Acquisition

New equipment is installed by manufacturer or approved representative



• Quality Manager

• Manufacturer/ Representative

• Manufacturers’ Equipment Manuals

• Installing New Laboratory Equipment

Equipment is assigned a unique identifier



• Equipment Identification

Equipment is included in an inventory



• Equipment Inventory

All instructions and documentation related to an instrument are kept in an equipment manual specific to that piece of equipment



• Quality Manager

• Technicians/Technologists

• Documenting Equipment-Related Activities

• Equipment-Related Records



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Instrument Validation Studies - Process Process for Instrument Validation Studies


New instrument validation studies are performed, documented, and evaluated for approval in-house


• Lead Technologists

• Quality Manager


• Instrument-Specific Validation Procedures

• Laboratory Section-Specific Validation Procedures

Annual or as needed validation studies are performed, documented, and evaluated for approval



• Quality Manager




When equipment is removed from the laboratory or is serviced/repaired, performance is validated before use in patient testing



• Quality Manager






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Method Comparisons - Process Process for Method Comparisons


Two laboratory instruments or methods are used in testing of the same analytes


• Quality Manager


• Performing Comparison Studies

• Test-Specific SOPs

• Instrument-Specific User Manuals

Both manual and automated methods are used to result a laboratory analyte


• Quality Manager





A manual method is used to confirm an analyzer-generated result


• Quality Manager





An instrument/method comparison study is performed semi-annually


• Quality Manager







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Carryover- Process Process for Carryover Studies


New instrument carryover studies are performed, documented, and evaluated for approval



• Quality Manager


• Instrument-Specific Carryover Study Procedures

Additional instrument carryover studies are performed, documented, and evaluated for approval as needed



• Quality Manager


• Instrument-Specific Carryover Study Procedures



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Instrument and Equipment Preventive/Corrective Maintenance - Process Process for Instrument and Equipment Preventive/Corrective Maintenance


Instrument and/or equipment maintenance is performed on a daily, weekly, monthly, quarterly, semi-annual, or annual schedule


• Technologists/ Technicians

• Equipment-Specific Procedures

• Manufacturer’s Equipment Manual

• Maintenance Schedule

Maintenance, service, or repair is performed on instruments or equipment at times other than scheduled


• Technologists/ Technicians

• Instrument Manufacturer Service Personnel

• Facility Engineering Department Service Personnel



• Emergency Service Requests

• Requesting Service or Repair from Facility Engineering Department

All maintenance, service, and repair activities are documented and maintained in the equipment manual


• Technologists/Technicians

• Maintenance, Service, and Repair Records


Documentation is reviewed at least monthly

• Quality Manager



• Maintenance, Service, and Repair Records

• Maintenance Schedule

• Review and Storage of Laboratory Records



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Calibration- Process Process for Calibration


Calibration schedule is developed based on manufacturer’s recommendations



• Quality Manager


• Calibration Procedure

• Instrument/Equipment- Specific Procedures

Calibration is performed and documented at regularly scheduled intervals or as needed for troubleshooting


• Quality Manager




• Instrument/Equipment- Specific Procedures

Documentation is reviewed and filed

• Quality Manager




• Instrument/Equipment Specific Procedures-




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Troubleshooting and Corrective Actions- Process Process for Troubleshooting and Corrective Actions


Trouble-shooting and training schemes are developed


• Quality Manager



• Instrument/Laboratory Section-Specific Procedures

• Manufacturer’s Manuals

Problem is identified and documented

• Quality Manager





• Documenting Problems and Corrective Actions

Corrective Action is performed and documented

• Technologist/Technicians


• Quality Manager




Corrective Action documentation is reviewed and filed


• Quality Manager





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Retiring Instruments - Process Process for Retiring Instruments


New instrument validation studies are completed


• Quality Manager

• Technical SOPs


Retired instrument is cleaned and decontaminated for storage

• Quality Manager


• Retiring Laboratory Instruments/Equipment

• Equipment Decontamination

Instrument is packed and removed for storage

• Facility Maintenance Department

• Facility Engineering Department

• Quality Manager


Instrument records are stored indefinitely (or as otherwise directed) after retirement



• Quality Manager

• Retiring and Archiving Laboratory Records



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QSE 5: Purchasing and Inventory - Policy

Purchasing and Inventory Policy

Policy Number Doc1.0-14AppE



Review Cycle 1 year

Supersedes New

Policy The laboratory purchases and maintains an inventory of equipment, supplies, and reagents used in the path of the laboratory workflow.

Purpose This policy provides direction for the processes and procedures to effectively work with the Purchasing Department to manage purchase and inventory processes.

Responsibility The Purchasing Department is responsible for vendor payment and delivery arrangements.

The Laboratory Director reviews and approves contract of services to referral laboratories and other services or facilities.

The Laboratory Supervisor is responsible for vendor identification and selection and order processes.

The Lead Technologists are responsible for inventory maintenance.

The Laboratory Supply Manager is responsible for receiving and storage of inventory.

Selection and Use of Referral Laboratory Services

The laboratory has an established procedure for evaluating and selecting referral laboratories.

Vendor Selection The laboratory has a system for selecting vendors of equipment, supplies, and services.

Purchasing Supplies and Reagents

The laboratory works with the Purchasing Department to purchase supplies and reagents.

Receiving, Inspecting, Storing, and Managing Supplies and Reagents.

The laboratory has processes and procedures for receiving, inspecting, storing, and managing the inventory of supplies and reagents used in the path of workflow.


The following processes support this policy: • Use of Referral Laboratory Services • Identifying and Selecting Vendors • Purchasing Supplies and Reagents • Handling Supplies and Reagents

Doc1.0-14AppE QSE 5- Purchasing and Inventory Version#: 1.0 Page 1 of 5


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Use of Referral Laboratory Services - Process Process for Use of Referral Laboratory Services


The laboratory has processes for evaluating and selecting referral laboratories




• Referral Laboratory Representatives

• Use of Referral Laboratories

• Referral Laboratory Test Menu

• Laboratory Test Menu

The laboratory has processes to ensure that the referral laboratory’s performance meets all required regulations and standards.


The laboratory enters into contract with a referral laboratory




• Referral Laboratory Representatives


• Completing Purchase Orders

The laboratory maintains a listing of all referral laboratories it uses


The laboratory maintains a log of all samples sent out to referral laboratories and a record of all tests conducted on each




• Specimen Tracking and Handling

Result reports include the name and address of the referral laboratory and all of the essential elements of the referral laboratory’s report without alterations that may impact clinical interpretations




• Result Reporting



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Identifying and Selecting Vendors - Process Process for Identifying and Selecting Vendors for Supplies and Reagents


Inventory lists are created from equipment/methods in use

• Lead Technologist • Test-Specific SOPs

• Test Menu

• Equipment-Specific Operating Manuals

Possible vendors are identified and evaluated



• Purchasing Department Policies and Procedures

• List of Approved Vendors

Vendors are selected • Laboratory Supervisor

• Quality Manager



• Purchasing Department Policies and Procedures

• List of Approved Vendors



Baltimore, MD USA

Purchasing Supplies and Reagents - Process Process for Purchasing Supplies and Reagents


Need for purchase of supplies or reagents is identified using inventory lists


• Laboratory Supply Manager

• Inventory of Supplies and Reagents

Purchase order is completed





Purchase order is submitted and processed






• Purchasing Department Procedures




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Handling Supplies and Reagents- Process Process for Handling Supplies and Reagents


Supplies and reagents are received in the facility

• Facility Receiving Department

• Facility Receiving Department Procedures

Supplies and reagents are received in the laboratory

• Quality Manager


• Receiving Supplies and Reagents in the Laboratory

Received supplies/reagents are documented on inventory



• Inventory of Supplies/Reagents

Acceptability of reagents/supplies is determined


• Quality Manager




• Quality Control of Supplies and Reagents

• Parallel Testing

Unacceptable reagents/supplies are handled


• Quality Manager




• Quality Control of Supplies and Reagents

Acceptable supplies and reagents are labeled and stored for future use

• Quality Manager





Supplies and reagents are put in use

• Quality Manager







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QSE 6: Process Control - Policy

Process Control Policy

Policy Number Doc1.0-14AppF



Review Cycle 1 year

Supersedes New

Policy The laboratory documents and validates all processes in the pre-analytic, analytic, and post-analytic activities path of workflow.

Purpose This policy provides direction for the processes and procedures necessary to ensure that testing procedures are correctly performed, the environment is suitable for reliable testing, testing methods work as expected to yield reliable results, and governmental and other regulations are met. It also provides direction to effectively manage the laboratory’s processes such that all impacts of the changes on customers and other processes are considered and dealt with accordingly.

Responsibility The Laboratory Director is responsible for ensuring process control is monitored for customer satisfaction.

The Laboratory Supervisor is responsible for the development and validation of specimen handling processes.

The Lead Technologists and Quality Manager are responsible for documenting and monitoring internal quality control.

Process Identification and Validation

The laboratory documents and validates all processes in the path of workflow prior to implementation.

Specimen Management

Specimen handling processes in pre-analytic, analytic, and post-analytic activities are designed and validated to ensure they work as intended.

Method Verification/Validation

All pre-analytic, analytic, and post-analytic activities utilize methods that have been verified or validated and have established and verified reportable ranges and reference intervals.

Internal Quality Control

Process and statistical measurements are made to identify random and special causes of process variations.


The following processes support this policy: • Process Identification and Validation • Specimen Management • Method Verification/Validation • Internal Quality Control

Doc1.0-14AppF QSE 6- Process Control Version#: 1.0 Page 1 of 6


Baltimore, MD USA

Process Identification and Validation - Process Process for Process Identification and Validation


The laboratory identifies and documents all processes in the path of workflow and for each QSE

• Laboratory Supervisor • Lead Technologists • Quality Manager

• Process Identification, Documentation, and Validation



The laboratory performs validation of all processes prior to implementation to ensure that they work as intended

• Laboratory Director • Laboratory Supervisor • Lead Technologists • Quality Manager




The laboratory identifies and documents any problems or deficiencies in the processes based on validation activities

• Laboratory Director • Laboratory Supervisor • Lead Technologists • Quality Manager




The laboratory revises any processes as necessary to correct problems or deficiencies

• Laboratory Supervisor • Lead Technologists • Quality Manager






Baltimore, MD USA

Specimen Management - Process Process for Specimen Management


The laboratory establishes written policies and procedures for specimen submission, handling, and referral

• Laboratory Supervisor • Lead Technologists • Laboratory Director


The laboratory receives a written or electronic request for patient testing from an authorized person

• Patient Physicians • Specimen Processors


The laboratory ensures the specimens meet established written requirements

• Specimen Processors • Specimen Tracking and Handling


Specimens are processed and stored prior to testing procedures

• Specimen Processors • Technicians/Technologist



Specimens are tested following analyte-specific SOPs

• Technicians/Technologist • Specimen Tracking and Handling


Specimens are stored after testing • Technicians/Technologist • Specimen Tracking and Handling


The laboratory establishes and follows written policies and procedures for ongoing mechanisms to monitor, assess, and correct problems identified in specimen management

• Quality Manager • Laboratory Manager • Lead Technologists • Technicians/Technologist






Baltimore, MD USA

Method Verification/Validation, Reportable Ranges, and Reference Intervals - Process

Process for Method Verification/Validation, Reportable Ranges, and Reference Intervals


The laboratory verifies/validates all methodology prior to implementing testing


• Quality Manager



• Verification/Validation Procedures


The laboratory establishes/verifies reportable ranges and biological reference intervals prior to implementing testing


• Quality Manager



• Establishing Reportable Ranges

• Establishing Reference Intervals




Baltimore, MD USA

Internal Quality Control - Process Process for Internal Quality Control


Internal Quality Control Policy is established


• Quality Manager

• Laboratory Quality Control

Control materials are selected and obtained for all analytic procedures


• Quality Manager




• Hospital Purchasing Department Policies and Procedures

• Inventory of Reagents

Control materials are stored for all analytic procedures


• Laboratory Supply Manger

• Inventory of Reagents


Control materials are tested and results documented as described in Test-Specific SOPs


• Quality Manager



Quantitative Control values are monitored for acceptability following pre-established acceptability criteria (such as Westgard rules where applicable)

• Quality Manager






Qualitative Control values are monitored for acceptability following pre-established acceptability criteria

• Quality Manager






Corrective actions are completed and documented for all QC failures

• Quality Manager






• Corrective Action Logs

QC issues are discussed at monthly Quality Assurance Meetings


• Quality Manager

• Quality Management Team





Baltimore, MD USA

QSE 7: Information Management - Policy

Policy The laboratory controls how patient and laboratory information is received, accessed, transmitted, and stored in both paper-based and electronic information systems.

Purpose This policy provides direction for the processes and procedures to effectively manage laboratory-generated information.

Responsibility The Laboratory Medical Director is responsible for turn around time decisions.

The Laboratory Supervisor is responsible for adherence to patient confidentiality and review of laboratory results.

The Lead Technologists and Quality Manager are responsible for review of laboratory results.

Information Technology is responsible for technological processes in the management of electronic information.

Patient Confidentiality Processes are designed to ensure that patient information is kept private and confidential.

Electronic Information Accessibility and Usage

Electronic data is retrievable only to authorized personnel

Reporting of Results Results are reported correctly and within established turnaround times.

Results Modification Any results changed or modified are documented to show both the original and modified results, reason for change, name of person notified, and date and time of notification.

Reporting Delays Delays in testing or reporting results are relayed to key persons.

Result Reporting Changes

Changes in test methodology or reference ranges are communicated to the ordering staff and/or associated study administrators.

Data Integrity and Storage

Data is stored and used in a manner that maintains the integrity of electronic and paper-based data.

Supporting Documents The following processes support this policy: • Patient Confidentiality • Accessing and Using Electronic Information • Reporting of Results • Results Modification • Reporting Delays • Result Reporting Changes • Data Storage and Maintaining Data Integrity

Information management Policy

Policy Number Doc1.0-14AppG



Review Cycle 1 year

Supersedes New

Doc1.0-14AppG QSE 7- Information Management Version#: 1.0 Page 1 of 8


Baltimore, MD USA

Patient Confidentiality - Process Process for Patient Confidentiality

What Happens Who’s Responsible Procedures A policy regarding patient confidentiality and restriction of access to patient information is established


• Facility Committee on Patient Confidentiality

• Laboratory Patient Confidentiality Procedure

• Facility Patient Confidentiality Procedure

A system is in place to limit access to places where patient information is stored, including paper-based records and electronic data bases



• Facility Committee on Patient Confidentiality

• Medical Records Department

• Information Technology (IT) Department


• Facility Patient Confidentiality Procedure

• Medical Records Procedures

• IT Confidentiality Procedure

Employees attend required orientation sessions regarding patient confidentiality

• Human Resources



• Patient Confidentiality

Employees sign confidentiality pledge

• Human Resources



• Patient Confidentiality

Requests for patient information are handled in a manner that ensures patient confidentiality and provides information only to approved individuals




• Managing Requests for Patient Information



Baltimore, MD USA

Accessing and Using Electronic Information- Process Process for Accessing and Using Electronic Information

What Happens Who’s Responsible Procedures The computer system facilities meet environmental conditions and safeguards for proper system operations

• Information Technology (IT) Department

• Facilities Management

• IT Department Procedures

• Facilities Management Plans

The computer systems meet laboratory accreditation and regulatory requirements

• IT Department




• Laboratory Accreditation and Regulatory Requirements

Preventive maintenance is conducted on computer systems

• IT Department • IT Department Procedures

• Preventive Maintenance Records

Disaster recovery plans, including alternative plans for downtime of computer system, are documented and practiced

• IT Department




• Disaster Recovery Plans

• Plan for Computer Downtime

Procedures for backup of information are in place


Changes to existing programs or validation of new programs is communicated

• IT Department



• Staff Notification Policy

Authorized personnel are trained in the use of electronic data management systems

• IT Department



• Training Procedures

Security and access are restricted to authorized personnel based on job requirements and functions

• IT Department





• Computer Access and Security

An audit trail is available to identify any individual who has accessed, entered, or modified data


• Information Technology Department

• IT Policies and Procedures

• Computer Access and Security



Baltimore, MD USA

Reporting of Results- Process Process for Reporting of Results

What Happens Who’s Responsible Procedures A procedure for reporting results is written and implemented


• Quality Manager


• Reporting Results

• Laboratory Section-Specific SOPs

Panic levels and population normal ranges are established and methods for reporting them are written and implemented


• Quality Manager



• Chart of Analyte Panic Levels

• Population Normal Ranges


Results reports, including population normal ranges and laboratory information, are generated





Reported results are compared to the bench worksheet and/or instrument printout to detect discrepancies

• Quality Manager





Patient caregivers are notified of panic results




• Chart of Analyte Panic Levels

• Notification of Results

Results reports are stored according to laboratory and/or facility policy



• Quality Manager





Baltimore, MD USA

Result Modification - Process Process for Result Modification

What Happens Who’s Responsible Procedures An incorrectly reported result is identified


• Quality Manager


• Patient Caregiver


• Result Modification

Correct result is entered and a copy of the modified report is initialed by the reporting technician/ technologist and the Laboratory Supervisor




• Quality Manager



The ordering physician or clinic is notified of the result modification. Notification is documented.



• Patient Caregiver



Modified reports, including original results, notification, and reason for change, are maintained

• Quality Manager





Modified results are documented under quality assurance monitoring

• Quality Manager • Result Modification




Baltimore, MD USA

Reporting Delays - Process Process for Reporting Delays

What Happens Who’s Responsible Procedures Delays related to result reporting or equipment failures are monitored and documented to help evaluate the overall effectiveness of the laboratory

• Quality Manager




• Test Turnaround Times


Results of tests that are delayed are relayed to key persons involved in patient care



• Patient Caregivers





Baltimore, MD USA

Result Reporting Changes - Process Process for Communicating Result Reporting Changes

What Happens Who’s Responsible Procedures Changes in test methodology and/or reference ranges are communicated to the ordering staff



• Patient Caregivers



• Laboratory Communication Procedures

Changes in test methodology and/or reference ranges are communicated to the associated study administrators



• Study Personnel




Changes in test methodology and/or reference ranges are communicated to laboratory staff



• Laboratory Staff Members






Baltimore, MD USA


Data Storage and Maintaining Data Integrity - Process Process for Data Storage and Maintaining Data Integrity

What Happens Who’s Responsible Procedures Data is labeled and stored in an area with limited access and appropriate environmental conditions


• IT Department

• Data Storage and Accessibility


Procedures for backup of information are in place


Data integrity is verified after transmission and downtime


Data integrity is verified by comparing it with the original input at defined intervals to detect errors in data transmission, storage, and processing


• Quality Manager

• IT Department

• Verifying Data Integrity



Calculations performed on patient data by the computer system are periodically verified/reviewed and documented


• Quality Manager

• IT Department




Manual reports are periodically reviewed for correctness


• Quality Manager

• IT Department





Baltimore, MD USA

QSE 8: Occurrence Management - Policy

Occurrence Management Policy

Policy Number Doc1.0-14AppH



Review Cycle 1 year

Supersedes New

Policy The laboratory identifies, documents, and investigates occurrences (nonconformances); classifies, analyzes, and trends the information they represent; performs remedial/corrective actions; and identifies the need for root cause analysis and process improvement.

Purpose This policy provides direction for the processes and procedures to effectively detect and resolve problems and to classify problems so that corrective actions aimed at removing root causes and improving processes can be planned and implemented.

Responsibility The Laboratory Supervisor is responsible for problem resolution and investigations.

The Quality Manager and Quality Management Team are responsible for collecting and analyzing occurrence data.

The Lead Technologists are responsible for documentation of complaints and problem resolution.

Identifying Occurrences

The laboratory has a means to identify, document, investigate, and respond to complaints from internal/external customers; recalls of materials, equipment, or software; and other nonconforming events.

Investigation and Response to Occurrences

The laboratory has a procedure for identifying, documenting, and investigating occurrences and performing remedial and corrective actions in response to those nonconforming events.

Classifying and Analyzing Occurrence Information

The laboratory has a procedure for classifying and analyzing occurrences, including trending information, so that the portions of the path of workflow with the most important patient-related and costly problems can be identified, corrected, and referred for root cause analysis and process improvement.


The following processes support this policy: • Identifying and Documenting Occurrences • Remedial Actions and Investigation of Occurrences • Analyzing Occurrence Information and Referring for Root Cause

Analysis and Process Improvement

Doc1.0-14AppH QSE 8- Occurrence Management Version#: 1.0 Page 1 of 4


Baltimore, MD USA

Identifying and Documenting Occurrences - Process Process for Identifying and Documenting Occurrences


The laboratory identifies or receives complaints from internal and external customers

• Laboratory Supervisor • Quality Manager • Technicians/Technologists • External Customers

• Communication of Safety and Quality Concerns

The laboratory receives recalls or notification of nonconformances as related to materials, equipment, or software

• Laboratory Supervisor • Laboratory Supply Manager

• Inventory Management


A nonconforming event is identified from internal/external audits, QC/Calibration/EQA failures, or management reviews

• Laboratory Director • Laboratory Supervisor • Quality Manager • Technicians/Technologists

• Audit-Related SOPs

• EQA SOPs



The occurrence is documented on appropriate electronic or paper-based occurrence report form

• Laboratory Supervisor • Quality Manager • Technicians/Technologists


The form is submitted to the designated individual for further action, including remedial/corrective actions, root cause analysis, and process improvement




• Process Improvement

• Remedial and Corrective Actions



Baltimore, MD USA

Remedial Actions and Investigation of Occurrences - Process Process for Remedial Actions and Investigation of Occurrences


Immediate remedial actions are initiated to resolve any immediate concerns related to patient care



• Investigations of Occurrences


Remedial actions are documented on the occurrence report form





The occurrence is investigated and documentation is completed

• Laboratory Supervisor • Quality Manager • Quality Management Team



Additional corrective or preventive actions are completed and documented

• Laboratory Supervisor • Quality Manager • Quality Management Team• Technicians/Technologists



• Technical SOPs


Occurrence report form is submitted to designated individual for additional occurrence analysis






Baltimore, MD USA


Analyzing Occurrence Information and Process Improvement Referral - Process

Process for Analyzing Occurrence Information and Process Improvement Referral


Information regarding individual occurrences is entered into an electronic or paper-based database

• Quality Manager • Quality Management Team


• Occurrence Report Forms


• Occurrence Data Analysis


Occurrences are categorized, tracked, and organized in a manner to facilitate analysis of collective data





Database and occurrence report information are reviewed at regular intervals to identify trends in occurrence information





Management reviews data and allocates resources for root cause analysis and process improvement

• Quality Manager • Quality Management Team• Laboratory Management




• Allocation of Resources


Baltimore, MD USA

QSE 9: Assessment - Policy

Assessment Policy

Policy Number Doc1.0-14AppI



Review Cycle 1 year

Supersedes New

Policy The laboratory will undergo internal and external assessments to determine the effectiveness of the laboratory’s quality management system.

Purpose This policy provides direction for the processes and procedures to effectively manage Quality Assessment of the laboratory.

Responsibility The Laboratory Medical Director is responsible for reviewing the Quality Assessment Report.

The Quality Manager is responsible for developing and implementing a Quality Assessment Program.

The Laboratory Supervisor and Lead Technologists are responsible for carrying out the activities of the Quality Assessment Program.

Internal Quality Indicator Surveillance

The laboratory has procedures to identify the path of workflow and select and monitor quality indicators that measure the performance of processes.

Internal Audits Internal process audits are performed for both Quality System Essentials and operations on a predetermined schedule.

External Quality Assurance

Assessments provided by external organizations determine the laboratory’s performance based on regulatory, accreditation, and predetermined values.

External Benchmark Laboratory performance is compared to self and others for continuing improvement goals.

Quality Assessment Report

A quality report is prepared and presented to the Quality Assurance Team and Laboratory Management on a regular basis.


The following processes support this policy: • Internal Quality Indicator Surveillance • Internal Audits • External Quality Assurance • External Benchmarking • Quality Assessment Reports

Doc1.0-14AppI QSE 9- Assessment Version#: 1.0 Page 1 of 6


Baltimore, MD USA

Internal Quality Indicator Surveillance- Process Process for Internal Quality Indicator Surveillance


Path of workflow is identified

• Laboratory Director • Laboratory Supervisor • Lead Technologist • Quality Manager


• Section-Specific Testing Procedures

• Laboratory Test Menu Quality indicators are selected

• Laboratory Director • Laboratory Supervisor • Quality Manager • Quality Assessment Team


• Section-Specific Testing Procedures

• Laboratory Test Menu • Quality Management

Data from Quality Indicators is collected



Data from Quality Indicators is analyzed

• Quality Manager • Quality Assessment Team


Quality indicator data is presented to facility and laboratory management and follow-up actions are initiated


• Quality Management • Preparing a Quality

Assessment Report • Process Improvement



Baltimore, MD USA

Internal Audits - Process Process for Internal Audits


An internal audit schedule is determined

• Laboratory Director • Quality Assessment Team • Internal Audit Team

• Internal Audit Procedures

• Quality Management An internal audit is conducted

• Quality Assessment Team • Internal Audit Team


• Quality Management A report of internal audit findings is submitted and reviewed

• Laboratory Director • Quality Assessment Team • Internal Audit Team • Quality Manager



Assessment Report Follow-up actions are initiated



• Quality Management • Process Improvement



Baltimore, MD USA

External Quality Assurance- Process Process for External Quality Assurance


Laboratory participates in audits/assessments conducted by external agencies (including agencies for accreditation and licensure)

• Laboratory Director • Laboratory Supervisor • Quality Manager • Lead Technologists • Technicians/Technologists • Quality Assessment Team • Auditing Agency

• External Audit Procedures


Laboratory participates in external proficiency testing program for all analytes tested

• Laboratory Director • Laboratory Supervisor • Quality Manager • Lead Technologists • Technicians/Technologists • Quality Assessment Team • Proficiency Testing Provider

• External Proficiency Testing Procedures


Information from external audits and proficiency testing is analyzed




• Quality Management Report of external assessment is submitted and reviewed

• Laboratory Director • Quality Assessment Team • Quality Manager








• Quality Management • Laboratory Section-

Specific SOPs • Process Improvement



Baltimore, MD USA

External Benchmark - Process Process for External Benchmark


Quality Indicators are selected


• Quality Management • Specimen Tracking

and Handling Procedures


Data is collected for Quality Indicators



Performance on Quality Indicators is compared to an external benchmark

• Quality Manager • Quality Assessment Team

• Quality Management • External Benchmarks

Results of benchmark performance are analyzed and presented

• Laboratory Director • Quality Manager • Quality Assessment Team

• Quality Management • External Benchmarks • Preparing a Quality


• Laboratory Director • Laboratory Supervisor • Quality Manager • Quality Monitoring Team

• Quality Management • External Benchmarks • Laboratory Section-

Specific SOPs • Process Improvement



Baltimore, MD USA


Quality Assessment Report- Process Process for Quality Assessment Report


Quality Assessment Team collects data generated from quality indicator surveillance, internal audits, external audits and proficiency testing, benchmark performance, occurrences, customer suggestions/complaints and staff suggestions

• Laboratory Supervisor • Quality Manager • Quality Assessment Team


Assessment Report

Quality Assessment Team writes and submits to management a quality assessment report on at least an annual basis

• Quality Manager • Quality Assessment Team • Laboratory Management


Assessment Report

Management reviews data and allocates resources for process improvement

• Quality Manager • Quality Assessment Team • Laboratory Management

• Quality Management • Quality Assessment

Report • Process Improvement • Allocation of

Resources


Baltimore, MD USA

QSE 10: Process Improvement - Policy

Process Improvement Policy

Policy Number Doc1,0-14AppJ



Review Cycle 1 year

Supersedes New

Policy The laboratory participates in a defined process improvement program to identify and address problems that impact relevant areas and outcomes of patient care.

Purpose This policy provides direction for the processes and procedures to effectively identify and address potential problems or areas of improvement within the laboratory.

Responsibility The Laboratory Director is responsible for reviewing Quality Improvement activities.

The Laboratory Supervisor is responsible for documenting the data needed for monitoring performance.

The Quality Manager is responsible for the compilation and presentation of data for performance improvement.

The QA and Lead Technologists are responsible for carrying out the activities of the Performance Improvement program.

Participation in Process Improvement Activities

Opportunities for improvement (OFIs) are identified from several sources. Laboratory personnel participate in Quality Improvement activities that deal with relevant areas and outcomes of patient care.

Review of Processes for Preventive Actions

A mechanism is in place to review processes in order to identify and prevent possible nonconformances.

Corrective Actions A defined strategy is used for process improvement when errors are identified.

Evaluation of Effectiveness of Actions Taken

The laboratory evaluates the effectiveness of actions taken to improve performance.


The following processes support this policy: • Identifying Opportunities for Improvement • Quality Improvement • Quality Improvement Evaluation

Doc1.0-14AppJ QSE 10- Process Improvement Version#: 1.0 Page 1 of 4


Baltimore, MD USA

Identifying Opportunities for Improvement- Process Process for Identifying Opportunities for Improvement

What Happens Who’s Responsible Procedures Processes with significant problems and opportunities for improvement (OFI’s) are identified from several sources


• Quality Management Team


• Internal and External Audits and Assessments

• Quality Assessment Reports

• Quality Indicators

• Occurrence Reports


OFI’s are prioritized according to level of impact on customer needs and patient care

• Laboratory Director • Laboratory Supervisor • Quality Manager • Quality Management

Team





Baltimore, MD USA

Quality Improvement - Process Process for Quality Improvement

What Happens Who’s Responsible Procedures Process/opportunity for improvement to be addressed is selected

• Laboratory Director • Laboratory Supervisor • Quality Manager • Quality Management Team



A root cause is determined for the problem using an appropriate improvement process (such as Root Cause Analysis)




Corrective or Preventive Action Plans are generated and selected




• Corrective and Preventive Actions

The chosen plan is implemented

• Laboratory Supervisor • Quality Manager • Lead Technologist • Technicians/Technologists



• Corrective and Preventive Actions



Baltimore, MD USA


Quality Improvement Evaluation - Process Process for Quality Improvement Evaluation

What Happens Who’s Responsible Procedures The laboratory evaluates the effectiveness of actions taken to improve performance


Team

• Quality Management • Process Improvement

The laboratory takes additional action as necessary


Team




Baltimore, MD USA

QSE 11: Customer Service - Policy

Customer Service Policy

Policy Number Doc1.0-14AppK



Review Cycle 1 year

Supersedes New

Policy The laboratory has processes and procedures for both internal and external customer service.

Purpose This policy provides direction for the processes and procedures to effectively manage the laboratory’s customer service.

Responsibility The Laboratory Director is responsible for the identification of the customers.

The Laboratory Supervisor is responsible for providing services and feedback mechanisms to the customer.

The Quality Manager is responsible for monitoring customer service and satisfaction

The Lead Technologists are responsible for contributing to problem identification and resolution.

Provision of Laboratory Services

The laboratory has processes and procedures for initial and ongoing reviews of contracts to provide its medical laboratory services to other services or facilities.

Identification of Customers and Their Needs

The laboratory has identified internal and external customers and their needs and expectations and develops/changes processes in order to meet these needs.

Customer Feedback Mechanisms

The laboratory has systems for assessing customer satisfaction and managing complaints in order to identify processes that are causing problems for the customers and initiate responses.

Referral for Process Improvement

Information from customer complaints and satisfaction surveys are analyzed and identified problems are referred for process improvement.


The following processes support this policy: • Provision of Laboratory Services • Identifying and Managing Customer Needs • Managing Customer Complaints • Monitoring Customer Satisfaction

Doc1.0-14AppK QSE 11- Customer Service Version#: 1.0 Page 1 of 5


Baltimore, MD USA

Provision of Laboratory Services - Process Process for Provision of Laboratory Services


The laboratory enters into contracts with entities receiving laboratory services.


• Management for Recipients of Services

• Provision of Laboratory Services

• Service Contracts

The requirements for the laboratory’s services are defined, documented, and understood by all recipients of the laboratory’s services





The laboratory has the capabilities and resources to meet the requirements






• Test Menu

Amendments or changes to contract provisions are discussed and documented





Any deviations from the contract are reported to the clients







Baltimore, MD USA

Identifying and Managing Customer Needs - Process Process for Identifying and Managing Customer Needs

What Happens Who’s Responsible Procedures The laboratory identifies internal and external customers



• Customer Service

The needs and expectations of internal and external customers are identified



• Quality Manager


The need for new processes or changes to existing processes in order to meet customer needs is determined



• Quality Manager



Referrals for Process Control and Process Improvement are made



• Quality Manager






Baltimore, MD USA

Managing Customer Complaints - Process Process for Managing Customer Complaints

What Happens Who’s Responsible Procedures Methods for external customers to submit concerns or suggestions (including anonymous submission) are developed and implemented



• Quality Manager




A policy is developed and implemented whereby internal customers can submit concerns and suggestions anonymously and without fear of reprisal



• Quality Manager




Customer complaints are received and documented in the laboratory



• Quality Manager




Corrective actions are initiated and documented in response to complaints


• Quality Manager




Customer is provided with feedback regarding response to complaint


• Quality Manager



Complaints are tracked and analyzed

• Quality Manager • Communication of Safety and Quality Concerns



Referrals are made for process improvement as needed


• Quality Manager





Baltimore, MD USA


Monitoring Customer Satisfaction - Process Process for Monitoring Customer Satisfaction

What Happens Who’s Responsible Procedures Approval is obtained for conducting satisfaction surveys and surveys are created for internal and external customers



• Quality Manager


• Customer Satisfaction Surveys

Satisfaction surveys are conducted and collected


• Quality Manager

• Internal and External Customers



Information from satisfaction surveys is analyzed


• Quality Manager




Results are submitted for management review and referred for process improvement as needed


• Quality Manager





Baltimore, MD USA

QSE 12: Facilities and Safety - Policy

Facilities and Safety Policy

Policy Number Doc1.0-14AppL



Review Cycle 1 year

Supersedes New

Policy The laboratory facilities are designed, renovated, used, and maintained to meet all applicable requirements for safety, efficiency, and ergonomics. Laboratory practices ensure the safety of all employees and visitors.

Purpose This policy provides direction for the processes and procedures to effectively manage the laboratory’s facilities and safety practices.

Responsibility The Laboratory Medical Director is responsible for working with the parent organization to obtain optimal facilities and for laboratory safety.

The Laboratory Supervisor is responsible for communicating the needs of the laboratory through workflow analysis and for providing a safe workplace for all laboratory personnel.

The Laboratory Safety Officer is responsible for providing guidance to laboratory management and staff regarding safety issues and responsibilities.

The Lead Technologists are responsible for training and adherence of staff to safety policies

Facilities management is responsible for the general maintenance of the facility.

Facility Space Allocation, Design, and Renovation

The laboratory work areas are designed such that the workload can be performed without compromising the quality of work or the safety of personnel or patients.

Personnel Safety The laboratory provides a safe working environment and opportunities for each employee to comply with safety requirements by providing training and appropriate personal protective and other safety equipment.

Facility Maintenance The facility is routinely inspected and maintained as a safe and comfortable workspace.


The following processes support this policy: • Laboratory Design • Safety Procedures, Records, and Audits • Safety Training • Safety Equipment Availability and Use

Doc1.0-14AppL QSE 12- Facilities and Safety Version#: 1.0 Page 1 of 5


Baltimore, MD USA

Laboratory Design - Process Process for Laboratory Design


The laboratory work areas are designed to be sufficient in size, comfortable for work processes, ergonomically correct, and suitable for protection against chemical or biological hazards


• Laboratory Safety Officer

• Facility Policies and Procedures

• Laboratory Design

• CLSI Document GP18 – Laboratory Design

Renovation of the laboratory is performed as needed to maintain safe and ergonomic practices





Governmental, accreditation, and organizational requirements are met for current laboratory needs





• Governmental, Accreditation, and Organizational Requirement Checklists

The laboratory work process is designed for best flow and ergonomics




Laboratory-specific environmental requirements are met for energy sources, water, lighting, ventilation, temperature and humidity control, noise control, and waste disposal






• Hazardous Waste Management

• CLSI Document GP-18 – Laboratory Design

Storage areas for materials, reagents and consumables are defined, secure, and adequate for maintaining their integrity and uninterrupted supply to the laboratory




• Supply and Reagent Inventory


Access to the laboratory is controlled and signs are present indicating the types of hazards present within the laboratory






• Safety Manual

The facility is routinely inspected and maintained as a safe, clean, and comfortable workspace.




• Facilities Management Policies and Procedures



Baltimore, MD USA

Safety Procedures, Records, and Audits – Process Process for Safety Procedures, Records, and Audits

What Happens Who’s Responsible Procedures A laboratory-specific safety manual is available in all work areas, read by all new employees, and reviewed and updated by laboratory management at least annually





• Laboratory Safety Manual

• Safety Training

A documented chemical hygiene plan and MSDS are available to laboratory personnel at all times. These are reviewed annually.





• Chemical Hygiene Plan

• MSDS

There is a documented plan for storage and disposal of hazardous waste materials



• Hazardous Waste Management

Processes are in place to ensure a safe and secure environment and emergency treatment is available for personal injuries



• Emergency Service Providers


• Emergency Service Contact Information

All safety-related records (including employee injury records, personnel training records, employee reports of hazards, hazardous waste disposal records) are maintained and reviewed




The laboratory conducts an internal safety inspection at least annually





• Safety Inspections



Baltimore, MD USA

Safety Training - Process Process for Safety Training

What Happens Who’s Responsible Procedures Personnel read and document understanding of the Safety Manual and other job-related safety SOPs at initial hiring and when changes are made to the documents





• Chemical Hygiene Plan

• MSDS

• Safety-Related SOPs

New employees participate in orientation safety training (including fire safety, chemical safety, infection control, blood-borne pathogens, universal and standard precautions, appropriate use of PPE)




• New Employee Orientation

• Safety Training

All employees participate in safety training at least annually




• Safety Training

Evacuation, fire, or other emergency drills are practiced on each shift at least annually




• Personnel Competency

• Safety Training

Documentation of safety-related training and competency is maintained for all personnel



• Personnel Training Documentation



Baltimore, MD USA


Safety Equipment Availability and Use- Process

Process for Safety Equipment Availability and Use

What Happens Who’s Responsible Procedures Personal Protective Equipment (PPE) is available to and used appropriately by all laboratory personnel





• Use of PPE

• Reagent and Supply Inventory

First Aid supplies and procedures for obtaining emergency care are available




• First Aid and Emergency Medical Contacts and Procedures

Eye wash stations are available and tested at least weekly



• Safety Manual


Safety showers are available and tested at least annually



• Safety Manual


Fire extinguishers are available and checked at least monthly by laboratory staff. They are checked professionally at least annually



• Fire Safety Professionals

• Safety Manual

• Fire Safety

All chemicals and biological materials are labeled correctly, including any relevant hazard labels or safety instructions



• Safety Manual

• MSDS

All chemical and biological hazards are stored appropriately



• Safety Manual

• MSDS