SMILE Johns Hopkins University Baltimore, MD USA
Guidelines for Developing a Quality Management Plan Author: Jaclyn Madden Peggy Coulter Review:
Document Number:
Doc1.0-14 Doc10-14
Effective Date:
30-Jul-08
Date of last review:
30-Jul-08 27 July 2010
Reviewed by:
Penny Stevens Heidi Hanes 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.
Doc1.0-14 Guidelines for Developing a Quality Management Plan Version 1.0
Page 1 of 4
SMILE Johns Hopkins University Baltimore, MD USA
•
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.
Doc1.0-14 Guidelines for Developing a Quality Management Plan Version 1.0
Page 2 of 4
SMILE Johns Hopkins University Baltimore, MD USA
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. Doc1.0-14 Guidelines for Developing a Quality Management Plan Version 1.0
Page 3 of 4
SMILE Johns Hopkins University Baltimore, MD USA
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 GP22A2. 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.
Doc1.0-14 Guidelines for Developing a Quality Management Plan Version 1.0
Page 4 of 4
SMILE Johns Hopkins University Baltimore, MD USA
QSE 1: Documents and Records - Policy Documents and Records Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppA
Effective Date
30-Jul-08
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
SMILE Johns Hopkins University Baltimore, MD USA
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
•
Document Change Request Form is completed and approved
• • •
•
•
Any Staff Member Quality Manager Laboratory Supervisor Laboratory Director
New document is drafted
•
Assigned Author
•
Independent review and verification are performed
•
Assigned Staff Reviewer
•
Review and approval signatures are obtained
• •
•
• •
Laboratory Director Laboratory Supervisor Quality Manager Quality Manager
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 Laboratory Supervisor Lead Technologist
•
Notifying Staff of Document Changes
•
Notifying Staff of Document Changes Staff Training Procedures
Document is entered into Master List and assigned a unique identifier
Staff is trained in use of new document, and document is implemented
• • •
Doc1.0-14AppA QSE 1- Documents and Records
Version#: 1.0
•
• •
•
Writing Policy, Process, Procedure, and Form Documents Writing Policy, Process, Procedure, and Form Documents Document Change Request Form Writing Policy, Process, Procedure, and Form Documents Reviewing and Verifying New or Changed Documents Reviewing and Verifying New or Changed Documents Document Control Document Master List
Page 2 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Revision of Existing Documents/Forms- Process Process for Revising Existing Documents/Forms What Happens
Who’s Responsible
Procedures •
Editing Documents
•
Document Change Request Form
Any Staff Member
•
Editing Documents
•
Laboratory Director
•
Document Change Request Form
Changes needed to related documents are identified and Document Change Request Forms are completed
• •
Assigned Staff Quality Manager
•
Editing Documents
•
Document Change Request Form
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 Quality Manager
•
Reviewing and Verifying New or Changed Documents Reviewing and Verifying New or Changed Documents Document Control Master File Archiving Retired SOPs
Master List is updated
•
Quality Manager
All working copies of old version are replaced with new version. Discontinued working copies are destroyed
• •
Quality Manager Laboratory Supervisor
• • • •
Document Control Document Master List Document Control Destruction of Documents
Staff notification is made
• • • •
Laboratory Supervisor Lead Technologist Laboratory Supervisor Lead Technologist
•
Notifying Staff of Document Changes Notifying Staff of Document Changes Staff Training Procedures
Need for change to existing (previously approved) document is identified
•
Document Change Request Form is completed and approved
•
The old version of the document is retired and archived in the Master File. The new version is retained in the Master File.
Staff is trained in use of new document, and document is implemented
Any Staff Member
Doc1.0-14AppA QSE 1- Documents and Records
Version#: 1.0
• • •
• •
Page 3 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Document Control - Process Process for Document Control What Happens
Who’s Responsible
Procedures
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
•
Quality Manager
• •
A Master File containing master copies of current and previous document versions is created for each document
•
Quality Manager
• • •
Document Control Document Master List Document Control Master File Archiving Retired SOPs
Master List is used to identify locations of working copies of documents
•
Quality Manager
• •
Document Control Document Master List
Working copies of the document are made from the master copy and distributed
• •
Quality Manager Laboratory Supervisor
•
Document Control
Discontinued working copies are destroyed
•
Quality Manager
• •
Documents are reviewed and signed (at least annually)
• •
Quality Manager Laboratory Supervisor Laboratory Director
• • •
Document Control Document Destruction Document Control Document Review Document Review Schedule
•
Doc1.0-14AppA QSE 1- Documents and Records
Version#: 1.0
Page 4 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Records Review, Retention, Storage, Retrieval, and Destruction - Process Process for Reviewing, Retaining, Storing, Retrieving, and Destroying Records What Happens Records are created
Who’s Responsible •
Any Staff Member
Procedures • • •
Associated Preanalytic SOPs Associated Analytic SOPs Associated Postanalytic SOPs Maintaining Laboratory Records
Records are listed in a Records Index
•
Quality Manager
•
Records are reviewed according to established schedules
•
Laboratory Supervisor Quality Manager Laboratory Director Laboratory Supervisor Quality Manager Any Staff Member
•
Maintaining Laboratory Records
•
Storing Laboratory Records Record Retention
Laboratory Supervisor Quality Manager
• •
Records are labeled, stored, and archived
• • • • •
Records are scheduled for destruction. Documentation of destruction is maintained
• •
Doc1.0-14AppA QSE 1- Documents and Records
Version#: 1.0
•
Record Retention Destruction of Records
Page 5 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Modify Records - Process Process for Modifying Records What Happens The need for a change to a record is identified
Who’s Responsible •
Any Staff Member
Procedures •
• •
Associated Preanalytic SOPs Associated Analytic SOPs Associated PostAnalytic SOPs Modifying Records Modifying Records
•
Modifying Records
• •
Modifying Records Storing Laboratory Records Record Retention
• •
Modification of record is made
• • •
Laboratory management and other appropriate individuals are notified of changes to records. Notification is documented
Copies of the original record, modified record, and notification documentation are maintained
•
Assigned Staff Member Quality Manager Laboratory Supervisor Assigned Staff Member
•
Quality Manager
•
Laboratory Supervisor
•
Patient Care Providers
•
Assigned Staff Member Quality Manager
•
Doc1.0-14AppA QSE 1- Documents and Records
•
Version#: 1.0
Page 6 of 6
SMILE Johns Hopkins University Baltimore, MD USA
QSE 2: Organizational Structure - Policy Organizational Structure Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppB
Effective Date
30-Jul-08
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.
Supporting Documents
The following processes support this policy: •
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
SMILE Johns Hopkins University Baltimore, MD USA
Implementing a Laboratory Quality Management System – Process Process for Implementing a Laboratory Quality Management System What Happens
Who’s Responsible
A Quality Manager is designated
•
Laboratory Director
•
Human Resources
Internal and external customers’ needs are identified
•
Quality Manager
•
Laboratory Management
The resources needed to meet those needs are identified and obtained
•
Procedures •
Personnel Processes/Procedures
•
Quality Management
Quality Manager
•
Resource Allocation
•
Laboratory Management
•
Quality Management
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
•
Quality Management
•
Laboratory Supervisor
•
Personnel Training Procedures
Laboratory leadership reviews the Laboratory Quality Management System at least annually
•
Quality Manager
•
Quality Management
•
Laboratory Management
•
Laboratory Director
Laboratory leadership works with other departments to coordinate the laboratory quality system with other facility quality management systems
•
Laboratory Management
•
Quality Management
•
Laboratory Director
•
•
Facility Executive Management
Other Departments’ Quality Management Procedures
Doc1.0-14AppB QSE 2- Organization
Version#: 1.0
Page 2 of 4
SMILE Johns Hopkins University Baltimore, MD USA
Organizational Chart Development and Maintenance - Process Process for Organizational Chart Development and Maintenance
What Happens
Who’s Responsible •
Executive Management
•
Laboratory Director
The levels of authority and responsibility for all personnel are defined
•
Executive Management
•
Laboratory Director
The chain of command (reporting relationships among personnel) is identified
•
Executive Management
•
Laboratory Director
An organizational chart (organogram) is published
•
Executive Management
•
Laboratory Director
The laboratory administration is identified
Doc1.0-14AppB QSE 2- Organization
Version#: 1.0
Procedures •
Developing and Maintaining the Organizational Chart
•
Developing and Maintaining the Organizational Chart
•
Developing and Maintaining the Organizational Chart
•
Developing and Maintaining the Organizational Chart
Page 3 of 4
SMILE Johns Hopkins University Baltimore, MD USA
Identification of Referral Laboratories - Process Process for Identification of Referral Laboratories
What Happens The need for referral laboratories is assessed
Referral laboratory’s capabilities are assessed
A list of Referral Laboratories and the tests that they conduct is maintained
Doc1.0-14AppB QSE 2- Organization
Who’s Responsible •
•
•
Laboratory Supervisor
Laboratory Supervisor
Laboratory Supervisor
Version#: 1.0
Procedures •
Use of Referral Laboratories
•
Laboratory Testing Menu
•
Review of Physician Order History
•
Use of Referral Laboratories
•
Referral Laboratory Testing Menus
•
Chart of Referral Laboratories
Page 4 of 4
SMILE Johns Hopkins University Baltimore, MD USA
QSE 3: Personnel - Policy Personnel Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppC
Effective Date
30-Jul-08
Review Cycle
1 year
Supersedes
New
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.
Supporting Documents
The following processes support this policy: • • • • • •
Doc1.0-14AppC QSE 3- Personnel
Maintaining Adequate Staff Resources Job Descriptions Personnel Qualifications Employee Orientation and Training Assessing Employee Competency Continuing Education Version#: 1.0
Page 1 of 7
SMILE Johns Hopkins University Baltimore, MD USA
Maintaining Adequate Staff Resources - Process Process for Maintaining Adequate Staff Resources What Happens
Who’s Responsible
Procedures
Review of laboratory workload and personnel resources is conducted
•
Laboratory Director
•
•
Laboratory Supervisor
Allocation of Staffing Resources
•
Review of Laboratory Workload
Need for additional staffing is identified
•
Laboratory Director
•
•
Laboratory Supervisor
Allocation of Staffing Resources
New laboratory staff are recruited and hired
•
Human Resources
•
•
Laboratory Supervisor
Allocation of Staffing Resources
•
Human Resources Policies and Procedures
Doc1.0-14AppC QSE 3- Personnel
Version#: 1.0
Page 2 of 7
SMILE Johns Hopkins University Baltimore, MD USA
Job Descriptions - Process Process for Job Descriptions
What Happens
Who’s Responsible
Job qualification requirements are established and documented
•
Laboratory Director
•
Human Resources
Laboratory staffing needs are assessed
•
Laboratory duties are assigned by position
Procedures •
Human Resources Policies and Procedures
•
Review of Laboratory Workload
Laboratory Supervisor
•
Review of Laboratory Workload
•
Laboratory Supervisor
•
Staffing Chart
Job descriptions are developed and maintained so as to reflect qualification requirements and current job duties
•
Human Resources
•
•
Laboratory Supervisor
Human Resources Policies and Procedures
Staff familiarity with job description and job-related duties is documented
•
Human Resources
•
•
Laboratory Supervisor
Human Resources Policies and Procedures
•
Laboratory Employee
•
Job Descriptions
•
Laboratory Supervisor
•
Personnel Files
•
Job Descriptions
Copies of job descriptions are maintained as part of the laboratory personnel file
Doc1.0-14AppC QSE 3- Personnel
Version#: 1.0
Page 3 of 7
SMILE Johns Hopkins University Baltimore, MD USA
Personnel Qualifications - Process Process for Documenting Personnel Qualifications What Happens
Who’s Responsible
Proof of licensure, certification, and education records are maintained in the personnel file for all members of laboratory administration and staff
•
Current Curriculum Vitae (CV) are on file for Laboratory Director and Management
•
Doc1.0-14AppC QSE 3- Personnel
Human Resources
Human Resources
Version#: 1.0
Procedures •
Human Resources Policies and Procedures
•
Personnel Files
•
Human Resources Policies and Procedures
•
Personnel Files
Page 4 of 7
SMILE Johns Hopkins University Baltimore, MD USA
Employee Orientation and Training- Process Process for Employee Orientation and Training What Happens Employee attends facility orientation session
Employee receives laboratory orientation
Employee is trained for duties as assigned
Documentation of orientation and training is maintained as part of laboratory personnel file
Doc1.0-14AppC QSE 3- Personnel
Who’s Responsible
Procedures
•
Laboratory Employee
•
Facility Policy and Procedures
•
Human Resources
•
New Employee Orientation Procedure
•
Quality Manager
•
•
Laboratory Supervisor
New Employee Orientation Procedure
•
Laboratory Employee
•
Laboratory Supervisor
•
New Employee Training schedule
•
Lead Technologist
•
•
Quality Manager
Job-specific Training Procedures
•
Laboratory Employee
•
Standard Operating Procedures (as applicable)
•
Human Resources
•
•
Lead Technologist
Facility Policy and Procedures
•
Quality Manager
•
New Employee Orientation Procedure
•
Laboratory Supervisor
•
Job-specific Training Procedures
•
Personnel File
Version#: 1.0
Page 5 of 7
SMILE Johns Hopkins University Baltimore, MD USA
Assessing Employee Competency- Process Process for Assessing Employee Competency What Happens Employee demonstrates initial posttraining-specific competency
Employee demonstrates competency at end of 3 month probation period
Employee competency is reviewed and documented at least annually
Corrective actions are initiated and documented in response to any competency failures
Documentation is maintained as part of laboratory personnel file
Doc1.0-14AppC QSE 3- Personnel
Who’s Responsible
Procedures
•
Laboratory Employee
•
New Employee Training Schedule
•
Lead Technologist
•
•
Quality Manager
Standard Operating Procedures (as applicable)
•
Employee Competency
•
Laboratory Employee
•
New Employee Training Schedule
•
Lead Technologist
•
•
Quality Manager
Standard Operating Procedures (as applicable)
•
Employee Competency
•
Standard Operating Procedures (as applicable)
•
Employee Competency
•
Laboratory Employee
•
Lead Technologist
•
Quality Manager
•
Laboratory Supervisor
•
Annual Performance Review
•
Laboratory Employee
•
•
Lead Technologist
Standard Operating Procedures (as applicable)
•
Quality Manager
•
Employee Competency
•
Laboratory Supervisor
•
Annual Performance Review
•
Quality Manager
•
•
Laboratory Supervisor
Employee Competency
•
Annual Performance Review
•
Personnel Files
Version#: 1.0
Page 6 of 7
SMILE Johns Hopkins University Baltimore, MD USA
Tracking Continuing Education - Process Process for Tracking Continuing Education What Happens Opportunities for personnel to participate in and document professional growth and development exist Employee attends facility and laboratory training update sessions
Employee attends training session offsite
Who’s Responsible •
Human Resources
•
Lead Technologist
•
Quality Manager
• •
Procedures •
Human Resources Policies and Procedures
Quality Manager
•
Laboratory Employee
Facility Policy and Procedures
•
Documenting Continuing Education
•
Laboratory Supervisor
•
Quality Manager
•
•
Laboratory Employee
Educational Leave Request Form
•
Documenting Continuing Education
•
Documenting Continuing Education
•
Laboratory Supervisor
Employee reads professional educational material
•
Quality Manager
•
Laboratory Employee
Continuing education documentation is maintained as part of laboratory personnel file
•
Quality Manager
•
•
Laboratory Supervisor
Documenting Continuing Education
•
Personnel Files
Doc1.0-14AppC QSE 3- Personnel
Version#: 1.0
Page 7 of 7
SMILE Johns Hopkins University Baltimore, MD USA
QSE 4: Equipment - Policy Equipment Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppD
Effective Date
30-Jul-08
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
SMILE Johns Hopkins University Baltimore, MD USA
Equipment Acquisition - Process Process for Equipment Selection, Acquisition, Installation, Identification, and Inventory What Happens Decision is made to purchase new equipment or replace equipment in use
Research is performed for available instrumentation
Equipment justification is performed
Equipment purchase request is completed and approved
Who’s Responsible •
Laboratory Director
•
Laboratory Supervisor
•
Lead Technologist
•
Laboratory Director
•
Laboratory Supervisor
•
Lead Technologist
•
Laboratory Director
•
Laboratory Supervisor
•
Finance Department
•
Laboratory Supervisor
•
Purchasing Department
•
Laboratory Supervisor
•
Lead Technologist
•
Quality Manager
•
Manufacturer/ Representative
Equipment is assigned a unique identifier
•
Laboratory Supervisor
•
Lead Technologist
Equipment is included in an inventory
•
Laboratory Supervisor
•
Lead Technologist
All instructions and documentation related to an instrument are kept in an equipment manual specific to that piece of equipment
•
Laboratory Supervisor
•
Lead Technologist
•
Quality Manager
•
Technicians/Technologists
New equipment is installed by manufacturer or approved representative
Doc1.0-14AppD QSE 4- Equipment
Version#: 1.0
Procedures •
Laboratory Testing Turn Around Times
•
Equipment Inventory
•
Specific Equipment Service and Maintenance Records
•
Requesting Bids from Suppliers
•
Test-Specific Procedures
•
Equipment Selection
•
Finance Department Policies and Procedures
•
Completing a Purchase Request Form
•
Equipment Acquisition
•
Manufacturers’ Equipment Manuals
•
Installing New Laboratory Equipment
•
Equipment Identification
•
Equipment Inventory
•
Documenting Equipment-Related Activities
•
Equipment-Related Records
Page 2 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Instrument Validation Studies - Process Process for Instrument Validation Studies What Happens
Who’s Responsible
New instrument validation studies are performed, documented, and evaluated for approval inhouse
•
Laboratory Director
•
Lead Technologists
•
Quality Manager
•
Technicians/Technologists
Annual or as needed validation studies are performed, documented, and evaluated for approval
•
Laboratory Director
•
Lead Technologists
•
Quality Manager
•
Technicians/Technologists
•
Laboratory Director
•
Lead Technologists
•
Quality Manager
•
Technicians/Technologists
When equipment is removed from the laboratory or is serviced/repaired, performance is validated before use in patient testing
Doc1.0-14AppD QSE 4- Equipment
Version#: 1.0
Procedures •
Instrument-Specific Validation Procedures
•
Laboratory SectionSpecific Validation Procedures
•
Instrument-Specific Validation Procedures
•
Laboratory SectionSpecific Validation Procedures
•
Instrument-Specific Validation Procedures
•
Laboratory SectionSpecific Validation Procedures
Page 3 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Method Comparisons - Process Process for Method Comparisons What Happens Two laboratory instruments or methods are used in testing of the same analytes
Both manual and automated methods are used to result a laboratory analyte
A manual method is used to confirm an analyzergenerated result
An instrument/method comparison study is performed semi-annually
Doc1.0-14AppD QSE 4- Equipment
Who’s Responsible •
Lead Technologist
•
Quality Manager
•
Technicians/Technologists
•
Lead Technologist
•
Quality Manager
•
Technicians/Technologists
•
Lead Technologist
•
Quality Manager
•
Technicians/Technologists
•
Lead Technologist
•
Quality Manager
•
Technicians/Technologists
Version#: 1.0
Procedures •
Performing Comparison Studies
•
Test-Specific SOPs
•
Instrument-Specific User Manuals
•
Performing Comparison Studies
•
Test-Specific SOPs
•
Instrument-Specific User Manuals
•
Performing Comparison Studies
•
Test-Specific SOPs
•
Instrument-Specific User Manuals
•
Performing Comparison Studies
•
Test-Specific SOPs
•
Instrument-Specific User Manuals
Page 4 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Carryover- Process Process for Carryover Studies What Happens New instrument carryover studies are performed, documented, and evaluated for approval
Additional instrument carryover studies are performed, documented, and evaluated for approval as needed
Doc1.0-14AppD QSE 4- Equipment
Who’s Responsible •
Laboratory Director
•
Lead Technologists
•
Quality Manager
•
Technicians/Technologists
•
Laboratory Director
•
Lead Technologists
•
Quality Manager
•
Technicians/Technologists
Version#: 1.0
Procedures •
Instrument-Specific Carryover Study Procedures
•
Instrument-Specific Carryover Study Procedures
Page 5 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Instrument and Equipment Preventive/Corrective Maintenance - Process Process for Instrument and Equipment Preventive/Corrective Maintenance What Happens
Who’s Responsible
Instrument and/or equipment maintenance is performed on a daily, weekly, monthly, quarterly, semi-annual, or annual schedule
•
Lead Technologist
•
Technologists/ Technicians
Maintenance, service, or repair is performed on instruments or equipment at times other than scheduled
•
Lead Technologist
•
Technologists/ Technicians
•
Instrument Manufacturer Service Personnel
•
Facility Engineering Department Service Personnel
All maintenance, service, and repair activities are documented and maintained in the equipment manual
•
Lead Technologist
•
Technologists/Technicians
Documentation is reviewed at least monthly
•
Quality Manager
•
Laboratory Director
Doc1.0-14AppD QSE 4- Equipment
Version#: 1.0
Procedures •
Equipment-Specific Procedures
•
Manufacturer’s Equipment Manual
•
Maintenance Schedule
•
Equipment-Specific Procedures
•
Manufacturer’s Equipment Manual
•
Emergency Service Requests
•
Requesting Service or Repair from Facility Engineering Department
•
Maintenance, Service, and Repair Records
•
Equipment-Specific Procedures
•
Equipment-Specific Procedures
•
Maintenance, Service, and Repair Records
•
Maintenance Schedule
•
Review and Storage of Laboratory Records
Page 6 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Calibration- Process Process for Calibration What Happens Calibration schedule is developed based on manufacturer’s recommendations
Calibration is performed and documented at regularly scheduled intervals or as needed for troubleshooting
Documentation is reviewed and filed
Doc1.0-14AppD QSE 4- Equipment
Who’s Responsible •
Laboratory Supervisor
•
Lead Technologist
•
Quality Manager
•
Lead Technologist
•
Quality Manager
•
Technicians/Technologists
•
Quality Manager
•
Laboratory Director
Version#: 1.0
Procedures •
Manufacturer’s Equipment Manual
•
Calibration Procedure
•
Instrument/EquipmentSpecific Procedures
•
Manufacturer’s Equipment Manual
•
Calibration Procedure
•
Instrument/EquipmentSpecific Procedures
•
Manufacturer’s Equipment Manual
•
Calibration Procedure
•
Instrument/Equipment Specific Procedures-
•
Review and Storage of Laboratory Records
Page 7 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Troubleshooting and Corrective Actions- Process Process for Troubleshooting and Corrective Actions What Happens Trouble-shooting and training schemes are developed
Problem is identified and documented
Corrective Action is performed and documented
Corrective Action documentation is reviewed and filed
Doc1.0-14AppD QSE 4- Equipment
Who’s Responsible •
Laboratory Supervisor
•
Quality Manager
•
Lead Technologist
•
Technologists/Technicians
•
Quality Manager
•
Lead Technologist
•
Technologists/Technicians
•
Technologist/Technicians
•
Lead Technologist
•
Quality Manager
•
Laboratory Director
•
Quality Manager
Version#: 1.0
Procedures •
Instrument/Laboratory Section-Specific Procedures
•
Manufacturer’s Manuals
•
Instrument/Laboratory Section-Specific Procedures
•
Manufacturer’s Manuals
•
Documenting Problems and Corrective Actions
•
Instrument/Laboratory Section-Specific Procedures
•
Manufacturer’s Manuals
•
Documenting Problems and Corrective Actions
•
Documenting Problems and Corrective Actions
•
Review and Storage of Laboratory Records
Page 8 of 9
SMILE Johns Hopkins University Baltimore, MD USA
Retiring Instruments - Process Process for Retiring Instruments What Happens
Who’s Responsible
Procedures
New instrument validation studies are completed
•
Lead Technologist
•
Technical SOPs
•
Quality Manager
•
Instrument-Specific Validation Procedures
Retired instrument is cleaned and decontaminated for storage
•
Quality Manager
•
•
Technicians/Technologists
Retiring Laboratory Instruments/Equipment
•
Equipment Decontamination
Instrument is packed and removed for storage
•
Facility Maintenance Department
•
Retiring Laboratory Instruments/Equipment
•
Facility Engineering Department
•
Quality Manager •
Retiring and Archiving Laboratory Records
•
Retiring Laboratory Instruments/Equipment
Instrument records are stored indefinitely (or as otherwise directed) after retirement
Doc1.0-14AppD QSE 4- Equipment
•
Laboratory Supervisor
•
Laboratory Director
•
Quality Manager
Version#: 1.0
Page 9 of 9
SMILE Johns Hopkins University Baltimore, MD USA
QSE 5: Purchasing and Inventory - Policy Purchasing and Inventory Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppE
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Use of Referral Laboratory Services - Process Process for Use of Referral Laboratory Services What Happens
Who’s Responsible •
Laboratory Director
•
Laboratory Supervisor
•
Purchasing Department
• 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
Procedures •
Use of Referral Laboratories
•
Referral Laboratory Test Menu
Referral Laboratory Representatives
•
Laboratory Test Menu
•
Laboratory Supervisor
•
Use of Referral Laboratories
•
Laboratory Director
•
•
Laboratory Supervisor
Use of Referral Laboratories
•
Purchasing Department
•
Completing Purchase Orders
•
Referral Laboratory Representatives
The laboratory maintains a listing of all referral laboratories it uses
•
Laboratory Supervisor
•
Use of Referral Laboratories
The laboratory maintains a log of all samples sent out to referral laboratories and a record of all tests conducted on each
•
Laboratory Supervisor
•
•
Technicians/Technologists
Use of Referral Laboratories
•
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
•
Laboratory Supervisor
•
•
Technicians/Technologists
Use of Referral Laboratories
•
Result Reporting
The laboratory has processes for evaluating and selecting referral laboratories
Doc1.0-14AppE QSE 5- Purchasing and Inventory
Version#: 1.0
Page 2 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Identifying and Selecting Vendors - Process Process for Identifying and Selecting Vendors for Supplies and Reagents What Happens Inventory lists are created from equipment/methods in use
Possible vendors are identified and evaluated
Vendors are selected
Who’s Responsible •
Lead Technologist
•
Purchasing Department
•
Laboratory Supervisor
•
Laboratory Supervisor
•
Quality Manager
•
Lead Technologists
•
Purchasing Department
Doc1.0-14AppE QSE 5- Purchasing and Inventory
Version#: 1.0
Procedures •
Test-Specific SOPs
•
Test Menu
•
Equipment-Specific Operating Manuals
•
Purchasing Department Policies and Procedures
•
List of Approved Vendors
•
Purchasing Department Policies and Procedures
•
List of Approved Vendors
Page 3 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Purchasing Supplies and Reagents - Process Process for Purchasing Supplies and Reagents What Happens
Who’s Responsible
Need for purchase of supplies or reagents is identified using inventory lists
•
Lead Technologist
•
Laboratory Supply Manager
Purchase order is completed
• •
Purchase order is submitted and processed
Procedures •
Inventory of Supplies and Reagents
Lead Technologist
•
Laboratory Supply Manager
Inventory of Supplies and Reagents
•
Completing Purchase Orders
•
Laboratory Supervisor
•
•
Lead Technologist
Completing Purchase Orders
•
Laboratory Supply Manager
•
Purchasing Department Procedures
•
Purchasing Department
•
Inventory of Supplies and Reagents
Doc1.0-14AppE QSE 5- Purchasing and Inventory
Version#: 1.0
Page 4 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Handling Supplies and Reagents- Process Process for Handling Supplies and Reagents What Happens
Who’s Responsible
Procedures
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
•
•
Laboratory Supply Manager
Receiving Supplies and Reagents in the Laboratory
Received supplies/reagents are documented on inventory
•
Laboratory Supply Manager
•
Receiving Supplies and Reagents in the Laboratory
•
Inventory of Supplies/Reagents
•
Receiving Supplies and Reagents in the Laboratory
Acceptability of reagents/supplies is determined
Unacceptable reagents/supplies are handled
Acceptable supplies and reagents are labeled and stored for future use
Supplies and reagents are put in use
•
Laboratory Supervisor
•
Quality Manager
•
Laboratory Supply Manager
•
Quality Control of Supplies and Reagents
•
Technicians/Technologists
•
Parallel Testing
•
Laboratory Supervisor
•
•
Quality Manager
Receiving Supplies and Reagents in the Laboratory
•
Laboratory Supply Manager
•
Quality Control of Supplies and Reagents
•
Technicians/Technologists
•
Quality Manager
•
•
Laboratory Supply Manager
Receiving Supplies and Reagents in the Laboratory
•
Technicians/Technologists
•
Inventory of Supplies/Reagents
•
Quality Manager
•
•
Laboratory Supply Manager
Receiving Supplies and Reagents in the Laboratory
•
Technicians/Technologists
•
Inventory of Supplies/Reagents
•
Test-Specific SOPs
Doc1.0-14AppE QSE 5- Purchasing and Inventory
Version#: 1.0
Page 5 of 5
SMILE Johns Hopkins University Baltimore, MD USA
QSE 6: Process Control - Policy Process Control Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppF
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Process Identification and Validation - Process Process for Process Identification and Validation What Happens The laboratory identifies and documents all processes in the path of workflow and for each QSE
The laboratory performs validation of all processes prior to implementation to ensure that they work as intended
The laboratory identifies and documents any problems or deficiencies in the processes based on validation activities
The laboratory revises any processes as necessary to correct problems or deficiencies
Doc1.0-14AppF QSE 6- Process Control
Who’s Responsible • • •
• • • •
• • • •
• • •
Laboratory Supervisor Lead Technologists Quality Manager
Laboratory Director Laboratory Supervisor Lead Technologists Quality Manager
Laboratory Director Laboratory Supervisor Lead Technologists Quality Manager
Laboratory Supervisor Lead Technologists Quality Manager
Version#: 1.0
Procedures •
Process Identification, Documentation, and Validation
•
Specimen Tracking and Handling
•
Test-Specific SOPs
•
Process Identification, Documentation, and Validation
•
Specimen Tracking and Handling
•
Test-Specific SOPs
•
Process Identification, Documentation, and Validation
•
Specimen Tracking and Handling
•
Test-Specific SOPs
•
Process Identification, Documentation, and Validation
•
Specimen Tracking and Handling
•
Test-Specific SOPs
Page 2 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Specimen Management - Process Process for Specimen Management What Happens
Who’s Responsible
Procedures
The laboratory establishes written policies and procedures for specimen submission, handling, and referral
• • •
Laboratory Supervisor Lead Technologists Laboratory Director
•
Specimen Tracking and Handling
The laboratory receives a written or electronic request for patient testing from an authorized person
• •
Patient Physicians Specimen Processors
•
Specimen Tracking and Handling
The laboratory ensures the specimens meet established written requirements
•
Specimen Processors
•
Specimen Tracking and Handling
•
Test-Specific SOPs
Specimens are processed and stored prior to testing procedures
• •
Specimen Processors • Technicians/Technologist
Specimen Tracking and Handling
•
Test-Specific SOPs
Technicians/Technologist •
Specimen Tracking and Handling
•
Test-Specific SOPs
Technicians/Technologist •
Specimen Tracking and Handling
•
Test-Specific SOPs
Quality Manager • Laboratory Manager Lead Technologists • Technicians/Technologist •
Specimen Tracking and Handling
Specimens are tested following analyte-specific SOPs
Specimens are stored after testing
The laboratory establishes and follows written policies and procedures for ongoing mechanisms to monitor, assess, and correct problems identified in specimen management
Doc1.0-14AppF QSE 6- Process Control
•
•
• • • •
Version#: 1.0
Test-Specific SOPs Quality Management
Page 3 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Method Verification/Validation, Reportable Ranges, and Reference Intervals Process Process for Method Verification/Validation, Reportable Ranges, and Reference Intervals
What Happens The laboratory verifies/validates all methodology prior to implementing testing
The laboratory establishes/verifies reportable ranges and biological reference intervals prior to implementing testing
Who’s Responsible •
Laboratory Supervisor
•
Quality Manager
•
Technicians/Technologists
•
Laboratory Director
•
Laboratory Supervisor
•
Quality Manager
•
Technicians/Technologists
•
Laboratory Director
Doc1.0-14AppF QSE 6- Process Control
Version#: 1.0
Procedures •
Verification/Validation Procedures
•
Test-Specific SOPs
•
Establishing Reportable Ranges
•
Establishing Reference Intervals
•
Test-Specific SOPs
Page 4 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Internal Quality Control - Process Process for Internal Quality Control What Happens
Who’s Responsible
Internal Quality Control Policy is established
•
Laboratory Director
•
Quality Manager
Control materials are selected and obtained for all analytic procedures
•
Procedures •
Laboratory Quality Control
Lead Technologist
•
Laboratory Quality Control
•
Quality Manager
•
Test-Specific SOPs
•
Purchasing Department
•
Hospital Purchasing Department Policies and Procedures
•
Inventory of Reagents
Control materials are stored for all analytic procedures
•
Lead Technologist
•
Inventory of Reagents
•
Laboratory Supply Manger
•
Test-Specific SOPs
Control materials are tested and results documented as described in TestSpecific SOPs
•
Lead Technologist
•
Test-Specific SOPs
•
Quality Manager
•
Laboratory Quality Control
Quantitative Control values are monitored for acceptability following pre-established acceptability criteria (such as Westgard rules where applicable)
•
Quality Manager
•
Laboratory Quality Control
•
Lead Technologist
•
Test-Specific SOPs
•
Technicians/Technologists
•
Laboratory Supervisor
Qualitative Control values are monitored for acceptability following pre-established acceptability criteria
•
Quality Manager
•
Laboratory Quality Control
•
Lead Technologist
•
Test-Specific SOPs
•
Technicians/Technologists
•
Laboratory Supervisor
Corrective actions are completed and documented for all QC failures
•
Quality Manager
•
Laboratory Quality Control
•
Lead Technologist
•
Test-Specific SOPs
•
Laboratory Supervisor
•
Corrective Action Logs
•
Technicians/Technologists
•
Laboratory Director
•
Laboratory Quality Control
•
Quality Manager
•
Quality Management
•
Quality Management Team
QC issues are discussed at monthly Quality Assurance Meetings
Doc1.0-14AppF QSE 6- Process Control
Version#: 1.0
Page 5 of 6
SMILE Johns Hopkins University Baltimore, MD USA
QSE 7: Information Management - Policy Information management Policy Approval Signature: Laboratory Director
Policy
Purpose Responsibility
Policy Number
Doc1.0-14AppG
Effective Date
30-Jul-08
Review Cycle
1 year
Supersedes
New
The laboratory controls how patient and laboratory information is received, accessed, transmitted, and stored in both paper-based and electronic information systems. This policy provides direction for the processes and procedures to effectively manage laboratory-generated information. 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
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 1 of 8
SMILE Johns Hopkins University 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
•
Laboratory Director
•
•
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 paperbased records and electronic data bases
•
Laboratory Director
•
•
Laboratory Supervisor
Laboratory Patient Confidentiality Procedure
•
Facility Committee on Patient Confidentiality
•
Facility Patient Confidentiality Procedure
•
Medical Records Department
•
Medical Records Procedures
•
Information Technology (IT) Department
•
IT Confidentiality Procedure
Employees attend required orientation sessions regarding patient confidentiality
•
Human Resources
•
Patient Confidentiality
•
Laboratory Supervisor
•
Technicians/Technologists
Employees sign confidentiality pledge
•
Human Resources
•
Patient Confidentiality
•
Laboratory Supervisor
•
Technicians/Technologists
•
Laboratory Supervisor
•
•
Technicians/Technologists
Laboratory Patient Confidentiality Procedure
•
Managing Requests for Patient Information
Requests for patient information are handled in a manner that ensures patient confidentiality and provides information only to approved individuals
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 2 of 8
SMILE Johns Hopkins University Baltimore, MD USA
Accessing and Using Electronic Information- Process Process for Accessing and Using Electronic Information What Happens
Who’s Responsible
Procedures •
IT Department Procedures
•
Facilities Management Plans
IT Department
•
IT Department Procedures
•
Laboratory Director
•
•
Laboratory Supervisor
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
•
IT Department Procedures
•
Laboratory Director
•
Disaster Recovery Plans
•
Laboratory Supervisor
•
Plan for Computer Downtime
Procedures for backup of information are in place
•
IT Department
•
IT Department Procedures
Changes to existing programs or validation of new programs is communicated
•
IT Department
•
IT Department Procedures
•
Laboratory Supervisor
•
Staff Notification Policy
Authorized personnel are trained in the use of electronic data management systems
•
IT Department
•
IT Department Procedures
•
Laboratory Supervisor
•
Training Procedures
Security and access are restricted to authorized personnel based on job requirements and functions
•
IT Department
•
IT Department Procedures
•
Laboratory Director
•
Computer Access and Security
•
Laboratory Supervisor
•
Technicians/Technologists
•
Laboratory Supervisor
•
IT Policies and Procedures
•
Information Technology Department
•
Computer Access and Security
The computer system facilities meet environmental conditions and safeguards for proper system operations
•
Information Technology (IT) Department
•
Facilities Management
The computer systems meet laboratory accreditation and regulatory requirements
•
An audit trail is available to identify any individual who has accessed, entered, or modified data
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 3 of 8
SMILE Johns Hopkins University Baltimore, MD USA
Reporting of Results- Process Process for Reporting of Results
What Happens A procedure for reporting results is written and implemented Panic levels and population normal ranges are established and methods for reporting them are written and implemented
Who’s Responsible
Procedures
•
Laboratory Director
•
Reporting Results
•
Quality Manager
•
•
Laboratory Supervisor
Laboratory SectionSpecific SOPs
•
Laboratory Director
•
Reporting Results
•
Quality Manager
•
•
Laboratory Supervisor
Chart of Analyte Panic Levels
•
Population Normal Ranges
•
Test-Specific SOPs
Results reports, including population normal ranges and laboratory information, are generated
•
Lead Technologist
•
Reporting Results
•
Technicians/Technologists
•
Laboratory SectionSpecific SOPs
Reported results are compared to the bench worksheet and/or instrument printout to detect discrepancies
•
Quality Manager
•
Reporting Results
•
Lead Technologist
•
Quality Management
•
Technicians/Technologists
Patient caregivers are notified of panic results
•
Lead Technologist
•
Reporting Results
•
Technicians/Technologists
•
Chart of Analyte Panic Levels
•
Notification of Results
Results reports are stored according to laboratory and/or facility policy
•
Lead Technologist
•
Reporting Results
•
Technicians/Technologists
•
•
Quality Manager
Maintaining Laboratory Records
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 4 of 8
SMILE Johns Hopkins University Baltimore, MD USA
Result Modification - Process Process for Result Modification
What Happens
Who’s Responsible
Procedures
•
Technicians/Technologists
•
Reporting Results
•
Quality Manager
•
Result Modification
•
Lead Technologist
•
Patient Caregiver
Correct result is entered and a copy of the modified report is initialed by the reporting technician/ technologist and the Laboratory Supervisor
•
Technicians/Technologists
•
Reporting Results
•
Laboratory Supervisor
•
Result Modification
•
Lead Technologist
•
Quality Manager
The ordering physician or clinic is notified of the result modification. Notification is documented.
•
Lead Technologist
•
Result Modification
•
Technicians/Technologists
•
Notification of Results
•
Patient Caregiver
Modified reports, including original results, notification, and reason for change, are maintained
•
Quality Manager
•
Result Modification
•
Lead Technologist
•
•
Technicians/Technologists
Maintaining Laboratory Records
Modified results are documented under quality assurance monitoring
•
Quality Manager
•
Result Modification
•
Quality Management
An incorrectly reported result is identified
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 5 of 8
SMILE Johns Hopkins University 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
•
Reporting Results
•
Lead Technologist
•
•
Technicians/Technologists
Test Turnaround Times
•
Quality Management
Results of tests that are delayed are relayed to key persons involved in patient care
•
Lead Technologist
•
Reporting Results
•
Technicians/Technologists
•
Notification of Results
•
Patient Caregivers
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 6 of 8
SMILE Johns Hopkins University Baltimore, MD USA
Result Reporting Changes - Process Process for Communicating Result Reporting Changes
What Happens
Who’s Responsible
Changes in test methodology and/or reference ranges are communicated to the ordering staff
•
Laboratory Supervisor
•
Laboratory Director
•
Patient Caregivers
Changes in test methodology and/or reference ranges are communicated to the associated study administrators
•
Laboratory Supervisor
•
Laboratory Director
•
Study Personnel
Changes in test methodology and/or reference ranges are communicated to laboratory staff
•
Laboratory Supervisor
•
Lead Technologist
•
Laboratory Staff Members
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Procedures •
Laboratory SectionSpecific SOPs
•
Reporting Results
•
Laboratory Communication Procedures
•
Laboratory SectionSpecific SOPs
•
Reporting Results
•
Laboratory Communication Procedures
•
Laboratory SectionSpecific SOPs
•
Reporting Results
•
Laboratory Communication Procedures
Page 7 of 8
SMILE Johns Hopkins University Baltimore, MD USA
Data Storage and Maintaining Data Integrity - Process Process for Data Storage and Maintaining Data Integrity What Happens
Who’s Responsible
Data is labeled and stored in an area with limited access and appropriate environmental conditions
•
Laboratory Supervisor
•
IT Department
Procedures for backup of information are in place
•
Data integrity is verified after transmission and downtime
Procedures •
Data Storage and Accessibility
•
IT Department Procedures
IT Department
•
IT Department Procedures
•
IT Department
•
IT Department Procedures
Data integrity is verified by comparing it with the original input at defined intervals to detect errors in data transmission, storage, and processing
•
Laboratory Supervisor
•
Verifying Data Integrity
•
Quality Manager
•
IT Department Procedures
•
IT Department
•
Quality Management
Calculations performed on patient data by the computer system are periodically verified/reviewed and documented
•
Laboratory Supervisor
•
Verifying Data Integrity
•
Quality Manager
•
IT Department Procedures
•
IT Department
•
Quality Management
Manual reports are periodically reviewed for correctness
•
Laboratory Supervisor
•
Verifying Data Integrity
•
Quality Manager
•
IT Department Procedures
•
IT Department
•
Quality Management
Doc1.0-14AppG QSE 7- Information Management
Version#: 1.0
Page 8 of 8
SMILE Johns Hopkins University Baltimore, MD USA
QSE 8: Occurrence Management - Policy Occurrence Management Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppH
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Identifying and Documenting Occurrences - Process Process for Identifying and Documenting Occurrences What Happens
Who’s Responsible
Procedures
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
•
Communication of Safety and Quality Concerns
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
•
Quality Management
•
Communication of Safety and Quality Concerns
The occurrence is documented on appropriate electronic or paper-based occurrence report form
• • •
Laboratory Supervisor Quality Manager Technicians/Technologists
•
Communication of Safety and Quality Concerns
The form is submitted to the designated individual for further action, including remedial/corrective actions, root cause analysis, and process improvement
• • •
Laboratory Supervisor Quality Manager Technicians/Technologists
•
Communication of Safety and Quality Concerns
•
Quality Management
•
Process Improvement
•
Remedial and Corrective Actions
Doc1.0-14AppH QSE 8- Occurrence Management
Version#: 1.0
Page 2 of 4
SMILE Johns Hopkins University Baltimore, MD USA
Remedial Actions and Investigation of Occurrences - Process Process for Remedial Actions and Investigation of Occurrences What Happens Immediate remedial actions are initiated to resolve any immediate concerns related to patient care
Remedial actions are documented on the occurrence report form
Who’s Responsible • • •
• • •
Laboratory Supervisor Quality Manager Technicians/Technologists
Laboratory Supervisor Quality Manager Technicians/Technologists
Procedures •
Communication of Safety and Quality Concerns
•
Investigations of Occurrences
•
Remedial and Corrective Actions
•
Investigations of Occurrences
•
Quality Management
•
Remedial and Corrective Actions
The occurrence is investigated and documentation is completed
• • •
Laboratory Supervisor Quality Manager Quality Management Team
•
Investigations of Occurrences
•
Quality Management
Additional corrective or preventive actions are completed and documented
• • • •
Laboratory Supervisor Quality Manager Quality Management Team Technicians/Technologists
•
Investigations of Occurrences
•
Quality Management
•
Technical SOPs
•
Remedial and Corrective Actions
•
Quality Management
•
Process Improvement
Occurrence report form is submitted to designated individual for additional occurrence analysis
• • •
Doc1.0-14AppH QSE 8- Occurrence Management
Laboratory Supervisor Quality Manager Quality Management Team
Version#: 1.0
Page 3 of 4
SMILE Johns Hopkins University Baltimore, MD USA
Analyzing Occurrence Information and Process Improvement Referral Process Process for Analyzing Occurrence Information and Process Improvement Referral What Happens Information regarding individual occurrences is entered into an electronic or paper-based database
Who’s Responsible • •
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
• • •
Doc1.0-14AppH QSE 8- Occurrence Management
Quality Manager Quality Management Team
Quality Manager Quality Management Team
Quality Manager Quality Management Team
Quality Manager Quality Management Team Laboratory Management
Version#: 1.0
Procedures •
Communication of Safety and Quality Concerns
•
Occurrence Report Forms
•
Quality Management
•
Occurrence Data Analysis
•
Process Improvement
•
Occurrence Data Analysis
•
Quality Management
•
Process Improvement
•
Occurrence Data Analysis
•
Quality Management
•
Process Improvement
•
Quality Management
•
Occurrence Data Analysis
•
Process Improvement
•
Allocation of Resources
Page 4 of 4
SMILE Johns Hopkins University Baltimore, MD USA
QSE 9: Assessment - Policy Assessment Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppI
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Internal Quality Indicator Surveillance- Process Process for Internal Quality Indicator Surveillance What Happens
Who’s Responsible • • • •
Laboratory Director Laboratory Supervisor Lead Technologist Quality Manager
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team
Data from Quality Indicators is collected
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team
Data from Quality Indicators is analyzed
• •
Quality indicator data is presented to facility and laboratory management and follow-up actions are initiated
• • • •
Path of workflow is identified
Quality indicators are selected
Doc1.0-14AppI QSE 9- Assessment
Procedures •
• • •
Specimen Tracking and Handling Section-Specific Testing Procedures Laboratory Test Menu Specimen Tracking and Handling Section-Specific Testing Procedures Laboratory Test Menu Quality Management Quality Management
Quality Manager Quality Assessment Team
•
Quality Management
Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team
• •
Quality Management Preparing a Quality Assessment Report Process Improvement
Version#: 1.0
• • • •
•
Page 2 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Internal Audits - Process Process for Internal Audits What Happens
Who’s Responsible • • • • •
Laboratory Director Quality Assessment Team Internal Audit Team Quality Assessment Team Internal Audit Team
A report of internal audit findings is submitted and reviewed
• • • •
Laboratory Director Quality Assessment Team Internal Audit Team Quality Manager
Follow-up actions are initiated
• • •
Laboratory Director Laboratory Supervisor Quality Manager
An internal audit schedule is determined An internal audit is conducted
Doc1.0-14AppI QSE 9- Assessment
Version#: 1.0
Procedures • • • • • • • • • •
Internal Audit Procedures Quality Management Internal Audit Procedures Quality Management Internal Audit Procedures Quality Management Preparing a Quality Assessment Report Internal Audit Procedures Quality Management Process Improvement
Page 3 of 6
SMILE Johns Hopkins University Baltimore, MD USA
External Quality Assurance- Process Process for External Quality Assurance What Happens Laboratory participates in audits/assessments conducted by external agencies (including agencies for accreditation and licensure) Laboratory participates in external proficiency testing program for all analytes tested
Information from external audits and proficiency testing is analyzed
Report of external assessment is submitted and reviewed
Who’s Responsible • • • • • • • • • • • • • • • • • •
Laboratory Director Laboratory Supervisor Quality Manager Lead Technologists Technicians/Technologists Quality Assessment Team Auditing Agency Laboratory Director Laboratory Supervisor Quality Manager Lead Technologists Technicians/Technologists Quality Assessment Team Proficiency Testing Provider Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team
• • •
Laboratory Director Quality Assessment Team Quality Manager
Procedures • •
• •
• • • • • • •
Follow-up actions are initiated
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team
• • • • •
Doc1.0-14AppI QSE 9- Assessment
Version#: 1.0
External Audit Procedures Quality Management
External Proficiency Testing Procedures Quality Management
External Audit Procedures External Proficiency Testing Procedures Quality Management External Audit Procedures External Proficiency Testing Procedures Quality Management Preparing a Quality Assessment Report External Audit Procedures External Proficiency Testing Procedures Quality Management Laboratory SectionSpecific SOPs Process Improvement
Page 4 of 6
SMILE Johns Hopkins University Baltimore, MD USA
External Benchmark - Process Process for External Benchmark What Happens
Who’s Responsible
Procedures
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team
• •
• • • • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Assessment Team Quality Manager Quality Assessment Team
•
Quality Management Specimen Tracking and Handling Procedures Laboratory SectionSpecific SOPs Quality Management
• •
Quality Management External Benchmarks
Results of benchmark performance are analyzed and presented
• • •
Laboratory Director Quality Manager Quality Assessment Team
• • •
Follow-up actions are initiated
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Monitoring Team
• • •
Quality Management External Benchmarks Preparing a Quality Assessment Report Quality Management External Benchmarks Laboratory SectionSpecific SOPs Process Improvement
Quality Indicators are selected
Data is collected for Quality Indicators
Performance on Quality Indicators is compared to an external benchmark
Doc1.0-14AppI QSE 9- Assessment
Version#: 1.0
•
•
Page 5 of 6
SMILE Johns Hopkins University Baltimore, MD USA
Quality Assessment Report- Process Process for Quality Assessment Report What Happens
Who’s Responsible
Procedures
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
• •
Quality Management Preparing a Quality 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
• •
Quality Management Preparing a Quality Assessment Report
Quality Manager Quality Assessment Team Laboratory Management
• •
Quality Management Quality Assessment Report Process Improvement Allocation of Resources
Management reviews data and allocates resources for process improvement
Doc1.0-14AppI QSE 9- Assessment
• • •
Version#: 1.0
• •
Page 6 of 6
SMILE Johns Hopkins University Baltimore, MD USA
QSE 10: Process Improvement - Policy Process Improvement Policy Approval Signature: Laboratory Director
Policy Number
Doc1,0-14AppJ
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Identifying Opportunities for Improvement- Process Process for Identifying Opportunities for Improvement
What Happens Processes with significant problems and opportunities for improvement (OFI’s) are identified from several sources
OFI’s are prioritized according to level of impact on customer needs and patient care
Who’s Responsible
Procedures
• • •
Laboratory Director Laboratory Supervisor Quality Manager
•
Communication of Safety and Quality Concerns
•
Quality Management Team
•
Internal and External Audits and Assessments
•
Quality Assessment Reports
•
Quality Indicators
•
Occurrence Reports
•
Process Improvement
•
Quality Management
•
Process Improvement
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Management Team
Doc1.0-14AppJ QSE 10- Process Improvement
Version#: 1.0
Page 2 of 4
SMILE Johns Hopkins University 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
•
Quality Management
•
Process Improvement
A root cause is determined for the problem using an appropriate improvement process (such as Root Cause Analysis)
• • •
Laboratory Supervisor Quality Manager Quality Management Team
•
Quality Management
•
Process Improvement
Corrective or Preventive Action Plans are generated and selected
• • •
Laboratory Supervisor Quality Manager Quality Management Team
•
Quality Management
•
Process Improvement
•
Corrective and Preventive Actions
•
Quality Management
•
Process Improvement
•
Corrective and Preventive Actions
The chosen plan is implemented
• • • •
Laboratory Supervisor Quality Manager Lead Technologist Technicians/Technologists
Doc1.0-14AppJ QSE 10- Process Improvement
Version#: 1.0
Page 3 of 4
SMILE Johns Hopkins University 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
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Management Team
• •
Quality Management Process Improvement
The laboratory takes additional action as necessary
• • • •
Laboratory Director Laboratory Supervisor Quality Manager Quality Management Team
•
Quality Management
•
Process Improvement
Doc1.0-14AppJ QSE 10- Process Improvement
Version#: 1.0
Page 4 of 4
SMILE Johns Hopkins University Baltimore, MD USA
QSE 11: Customer Service - Policy Customer Service Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppK
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Provision of Laboratory Services - Process Process for Provision of Laboratory Services What Happens
Who’s Responsible
Procedures
The laboratory enters into contracts with entities receiving laboratory services.
•
Laboratory Director
•
•
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
•
Laboratory Director
•
•
Management for Recipients of Services
Provision of Laboratory Services
•
Service Contracts
The laboratory has the capabilities and resources to meet the requirements
•
Laboratory Director
•
•
Laboratory Supervisor
Provision of Laboratory Services
•
Service Contracts
•
Test-Specific SOPs
•
Test Menu
Amendments or changes to contract provisions are discussed and documented
•
Laboratory Director
•
•
Management for Recipients of Services
Provision of Laboratory Services
•
Service Contracts
Any deviations from the contract are reported to the clients
•
Laboratory Director
•
•
Management for Recipients of Services
Provision of Laboratory Services
•
Service Contracts
Doc1.0-14AppK QSE 11- Customer Service
Version#: 1.0
Page 2 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Identifying and Managing Customer Needs - Process Process for Identifying and Managing Customer Needs
What Happens
Who’s Responsible
The laboratory identifies internal and external customers
•
Laboratory Director
•
Laboratory Supervisor
The needs and expectations of internal and external customers are identified
•
Laboratory Director
•
Laboratory Supervisor
•
Quality Manager
•
The need for new processes or changes to existing processes in order to meet customer needs is determined Referrals for Process Control and Process Improvement are made
Doc1.0-14AppK QSE 11- Customer Service
Procedures •
Customer Service
•
Customer Service
Laboratory Director
•
Quality Management
•
Laboratory Supervisor
•
Customer Service
•
Quality Manager
•
Laboratory Director
•
Quality Management
•
Laboratory Supervisor
•
Customer Service
•
•
Process Improvement
Quality Manager
Version#: 1.0
Page 3 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Managing Customer Complaints - Process Process for Managing Customer Complaints
What Happens
Who’s Responsible
Methods for external customers to submit concerns or suggestions (including anonymous submission) are developed and implemented
•
Laboratory Director
•
Laboratory Supervisor
•
Quality Manager
•
Technicians/Technologists
A policy is developed and implemented whereby internal customers can submit concerns and suggestions anonymously and without fear of reprisal
•
Laboratory Director
•
Laboratory Supervisor
•
Quality Manager
•
Technicians/Technologists
Customer complaints are received and documented in the laboratory
•
Laboratory Director
•
Laboratory Supervisor
•
Quality Manager
•
Technicians/Technologists
•
Laboratory Supervisor
•
Quality Manager
•
Corrective actions are initiated and documented in response to complaints
Customer is provided with feedback regarding response to complaint
Complaints are tracked and analyzed
Referrals are made for process improvement as needed
Procedures •
Communication of Safety and Quality Concerns
•
Customer Service
•
Communication of Safety and Quality Concerns
•
Customer Service
•
Communication of Safety and Quality Concerns
•
Customer Service
•
Communication of Safety and Quality Concerns
Technicians/Technologists
•
Customer Service
•
Laboratory Supervisor
•
•
Quality Manager
Communication of Safety and Quality Concerns
•
Customer Service
•
Communication of Safety and Quality Concerns
•
Quality Management
•
Process Improvement Quality Management Process Improvement
•
Quality Manager
•
Laboratory Supervisor
•
•
Quality Manager
•
Doc1.0-14AppK QSE 11- Customer Service
Version#: 1.0
Page 4 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Monitoring Customer Satisfaction - Process Process for Monitoring Customer Satisfaction
What Happens
Who’s Responsible
Approval is obtained for conducting satisfaction surveys and surveys are created for internal and external customers Satisfaction surveys are conducted and collected
Information from satisfaction surveys is analyzed
•
Laboratory Director
•
Customer Service
•
Laboratory Supervisor
•
Customer Satisfaction Surveys
•
Quality Manager
•
Laboratory Supervisor
•
Customer Service
•
Customer Satisfaction Surveys
•
Customer Service
•
Customer Satisfaction Surveys
•
Quality Management
•
Quality Manager
•
Internal and External Customers
•
Laboratory Supervisor
•
Results are submitted for management review and referred for process improvement as needed
Doc1.0-14AppK QSE 11- Customer Service
Procedures
Quality Manager
•
Laboratory Management
•
Customer Service
•
•
Quality Management
Quality Manager
•
Process Improvement
Version#: 1.0
Page 5 of 5
SMILE Johns Hopkins University Baltimore, MD USA
QSE 12: Facilities and Safety - Policy Facilities and Safety Policy Approval Signature: Laboratory Director
Policy Number
Doc1.0-14AppL
Effective Date
30-Jul-08
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.
Supporting Documents
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
SMILE Johns Hopkins University Baltimore, MD USA
Laboratory Design - Process Process for Laboratory Design What Happens
Who’s Responsible
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 Director
•
Laboratory Safety Officer
Renovation of the laboratory is performed as needed to maintain safe and ergonomic practices
•
Laboratory Director
•
Laboratory Safety Officer
Governmental, accreditation, and organizational requirements are met for current laboratory needs
•
Procedures •
Facility Policies and Procedures
•
Laboratory Design
•
CLSI Document GP18 – Laboratory Design
•
Facility Policies and Procedures
•
Laboratory Design
Laboratory Director
•
Laboratory Design
•
Laboratory Supervisor
•
•
Laboratory Safety Officer
Governmental, Accreditation, and Organizational Requirement Checklists
The laboratory work process is designed for best flow and ergonomics
•
Laboratory Supervisor
•
Laboratory Design
•
Laboratory Safety Officer
Laboratory-specific environmental requirements are met for energy sources, water, lighting, ventilation, temperature and humidity control, noise control, and waste disposal
•
Laboratory Director
•
Laboratory Design
•
Laboratory Supervisor
•
•
Laboratory Safety Officer
Hazardous Waste Management
•
Facilities 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
•
Laboratory Director
•
•
Laboratory Supervisor
Supply and Reagent Inventory
•
Laboratory Safety Officer
•
Laboratory Design
Access to the laboratory is controlled and signs are present indicating the types of hazards present within the laboratory
•
Laboratory Director
•
Laboratory Design
•
Laboratory Supervisor
•
•
Laboratory Safety Officer
Facility Policies and Procedures
•
Safety Manual
•
Facilities Management Policies and Procedures
The facility is routinely inspected and maintained as a safe, clean, and comfortable workspace.
Doc1.0-14AppL QSE 12- Facilities and Safety
•
Laboratory Director
•
Laboratory Safety Officer
•
Facilities Management Version#: 1.0
Page 2 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Safety Procedures, Records, and Audits – Process Process for Safety Procedures, Records, and Audits
What Happens
Who’s Responsible
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 Director
•
Laboratory Supervisor
•
Laboratory Safety Officer
•
Technologists/Technicians
A documented chemical hygiene plan and MSDS are available to laboratory personnel at all times. These are reviewed annually.
•
Laboratory Director
•
Laboratory Supervisor
•
Laboratory Safety Officer
There is a documented plan for storage and disposal of hazardous waste materials
•
Laboratory Supervisor
•
Laboratory Safety Officer
Processes are in place to ensure a safe and secure environment and emergency treatment is available for personal injuries
•
Laboratory Supervisor
•
Laboratory Safety Officer
•
Emergency Service Providers
All safety-related records (including employee injury records, personnel training records, employee reports of hazards, hazardous waste disposal records) are maintained and reviewed
•
Laboratory Supervisor
•
Laboratory Safety Officer
The laboratory conducts an internal safety inspection at least annually
•
Laboratory Director
•
Laboratory Supervisor
•
Laboratory Safety Officer
Doc1.0-14AppL QSE 12- Facilities and Safety
Version#: 1.0
Procedures •
Laboratory Safety Manual
•
Safety Training
•
Laboratory Safety Manual
•
Chemical Hygiene Plan
•
MSDS
•
Hazardous Waste Management
•
Laboratory Safety Manual
•
Emergency Service Contact Information
•
Laboratory Safety Manual
•
Laboratory Safety Manual
•
Safety Inspections
Page 3 of 5
SMILE Johns Hopkins University Baltimore, MD USA
Safety Training - Process Process for Safety Training What Happens
Who’s Responsible
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
•
Laboratory Supervisor
•
Laboratory Safety Officer
•
Technologists/Technicians
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)
•
Laboratory Supervisor
•
Laboratory Safety Officer
•
Technologists/Technicians
All employees participate in safety training at least annually
•
Laboratory Supervisor
•
Laboratory Safety Officer
•
Technologists/Technicians
Evacuation, fire, or other emergency drills are practiced on each shift at least annually
•
Laboratory Supervisor
•
Laboratory Safety Officer
•
Technicians/Technologists
Documentation of safetyrelated training and competency is maintained for all personnel
•
Laboratory Supervisor
•
Laboratory Safety Officer
Doc1.0-14AppL QSE 12- Facilities and Safety
Version#: 1.0
Procedures •
Laboratory Safety Manual
•
Chemical Hygiene Plan
•
MSDS
•
Safety-Related SOPs
•
New Employee Orientation
•
Safety Training
•
Safety Training
•
Personnel Competency
•
Safety Training
•
Personnel Training Documentation
Page 4 of 5
SMILE Johns Hopkins University 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
•
Laboratory Director
•
Use of PPE
•
Laboratory Supervisor
•
•
Laboratory Safety Officer
Reagent and Supply Inventory
•
Technologists/Technicians
First Aid supplies and procedures for obtaining emergency care are available
•
Laboratory Supervisor
•
•
Laboratory Safety Officer
Reagent and Supply Inventory
•
First Aid and Emergency Medical Contacts and Procedures
Eye wash stations are available and tested at least weekly
•
Laboratory Supervisor
•
Safety Manual
•
Laboratory Safety Officer
•
Reagent and Supply Inventory
Safety showers are available and tested at least annually
•
Laboratory Supervisor
•
Safety Manual
•
Laboratory Safety Officer
•
Reagent and Supply Inventory
Fire extinguishers are available and checked at least monthly by laboratory staff. They are checked professionally at least annually
•
Laboratory Supervisor
•
Safety Manual
•
Laboratory Safety Officer
•
Fire Safety
•
Fire Safety Professionals
All chemicals and biological materials are labeled correctly, including any relevant hazard labels or safety instructions
•
Laboratory Supervisor
•
Safety Manual
•
Laboratory Safety Officer
•
MSDS
All chemical and biological hazards are stored appropriately
•
Laboratory Supervisor
•
Safety Manual
•
Laboratory Safety Officer
•
MSDS
Doc1.0-14AppL QSE 12- Facilities and Safety
Version#: 1.0
Page 5 of 5
