SMILE Johns Hopkins University Baltimore, MD USA Guidelines for Developing a Quality Management Plan

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1 Guidelines for Developing a Quality Management Plan Author: Jaclyn Madden Document Number: Doc Peggy Coulter Effective Date: 30-Jul-08 Review: Date of last review: 30-Jul-08 Reviewed by: Penny Stevens Erin Gover Background In order to ensure the safety of patients and laboratory personnel and to ensure that accurate results are obtained and reported, the laboratory needs to maintain quality throughout its pre-analytical, analytical, and post-analytical path of workflow. A Quality Management Plan provides the infrastructure for maintaining quality in the laboratory. The Quality Management approach included in these guidelines is based on the 12 Quality System Essentials (QSE) model developed by CLSI/NCCLS (refer to CLSI/NCCLS documents GP26-A3, HS1-A2, and GP22-A2) and is mostly consistent with ISO standards (refer to ISO 15189). The 12 QSEs represent the most fundamental elements for maintaining quality, safety, and efficiency throughout the laboratory s path of workflow. Description of the 12 QSEs: QSE 1 - Documents and Records: This QSE describes the processes for creating standardized documents and records and maintaining documents and records so that they are up-to-date and accurate, readily accessible by laboratory staff, and protected from damage, deterioration, and unauthorized use. QSE 2 Organization: A strong commitment from top-level managers is essential for the success of the overall laboratory quality program. This QSE describes how the organizational structure and quality management system ensure that customers needs and regulatory requirements are met. QSE 3 Personnel: The most important of the laboratory s resources is its personnel. This QSE describes how personnel are managed and provided with the tools needed to perform testing so that accurate and reliable test results are obtained. QSE 4 Equipment: This QSE describes how equipment is selected, installed, identified, validated/verified, and maintained in order to ensure personnel safety and specimen and testing result integrity. QSE 5 Purchasing & Inventory: Availability of dependable and reliable test kits and supplies is essential. This QSE describes how reagents and supplies are procured, distributed, and managed. Doc Guidelines for Developing a Quality Management Plan Version 1.0 Page 1 of 4

2 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. Doc Guidelines for Developing a Quality Management Plan Version 1.0 Page 2 of 4

3 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 CLSI. Laboratory Design; Approved Guideline Second Edition. CLSI document GP18-A2. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; CLSI. Laboratory Documents: Development and Control; Approved Guideline Fifth Edition. CLSI document GP2-A5. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; Doc Guidelines for Developing a Quality Management Plan Version 1.0 Page 3 of 4

4 4. CLSI. Management of Nonconforming Laboratory Events; Approved Guideline. CLSI document GP32-A. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; ISO. Medical laboratories Particular requirements for quality and competence. EN/ISO Geneva: International Organization for Standardization; NCCLS. Application of a Quality Management System Model for Laboratory Services Approved Guideline Third Edition. NCCLS document GP26-A3. Wayne, Pennsylvania: NCCLS; NCCLS. A Quality Management System Model for Health Care; Approved Guideline Second Edition. NCCLS document HS1-A2. Wayne, Pennsylvania: NCCLS; NCCLS. Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline Second Edition. NCCLS document GP22- A2. Wayne, Pennsylvania: NCCLS; NCCLS. Clinical Laboratory Safety; Approved Guideline Second Edition. NCCLS document GP17-A2. Wayne, Pennsylvania: NCCLS; NCCLS. Selecting and Evaluating a Referral Laboratory; Approved Guideline. NCCLS document GP9-A. Wayne, Pennsylvania: NCCLS; NCCLS. Training and Competence Assessment; Approved Guideline Second Edition. NCCLS document GP21-A2. Wayne, Pennsylvania: NCCLS; Doc Guidelines for Developing a Quality Management Plan Version 1.0 Page 4 of 4

5 QSE 1: Documents and Records - Policy Documents and Records Policy Policy Number Doc1.0-14AppA Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility 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. This policy provides direction for the processes and procedures to effectively manage the laboratory s documents and records. 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 Records Storage Supporting 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. 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 are created, modified, stored, archived, and destroyed in a way that facilitates retrieval, prevents damage and unauthorized use, and maintains patient confidentiality. 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. 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

6 New Document Creation, Review, and Approval- Process Process for Creating, Reviewing, and Approving New Documents Need for new document is identified Document Change Request Form is completed and approved Any Staff Member Writing Policy, Process, Procedure, and Form Documents Any Staff Member Supervisor Writing Policy, Process, Procedure, and Form Documents Document Change Request Form New document is drafted Assigned Author Writing Policy, Process, Procedure, and Form Documents Independent review and verification are performed Review and approval signatures are obtained Document is entered into Master List and assigned a unique identifier A Master File is created for the document Working copies of the document are distributed as needed Assigned Staff Reviewer Supervisor Reviewing and Verifying New or Changed Documents Reviewing and Verifying New or Changed Documents Document Control Document Master List Document Control Master File Supervisor Staff notification is made Supervisor Staff is trained in use of new document, and document is implemented Supervisor Document Control Notifying Staff of Document Changes Notifying Staff of Document Changes Staff Training Doc1.0-14AppA QSE 1- Documents and Records Version#: 1.0 Page 2 of 6

7 Revision of Existing Documents/Forms- Process Process for Revising Existing Documents/Forms Need for change to existing (previously approved) document is identified Any Staff Member Editing Documents Document Change Request Form Document Change Request Form is completed and approved Any Staff Member Editing Documents Document Change Request Form Changes needed to related documents are identified and Document Change Request Forms are completed Current document version is retrieved from master file Current document version is edited Independent review and verification are performed Review and approval signatures obtained The old version of the document is retired and archived in the Master File. The new version is retained in the Master File. Assigned Staff Assigned Author Editing Documents Document Change Request Form Document Control Editing Documents Assigned Author Editing Documents Assigned Staff Reviewer 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 Document Control Document Master List All working copies of old Document Control version are replaced with new Destruction of version. Discontinued working Documents copies are destroyed Staff notification is made Staff is trained in use of new document, and document is implemented Notifying Staff of Document Changes Notifying Staff of Document Changes Staff Training Doc1.0-14AppA QSE 1- Documents and Records Version#: 1.0 Page 3 of 6

8 Process for Document Control Document Control - Process Each document is uniquely identified to ensure traceability throughout the document life cycle Document is entered on the Document Master List A Master File containing master copies of current and previous document versions is created for each document Master List is used to identify locations of working copies of documents Working copies of the document are made from the master copy and distributed Discontinued working copies are destroyed Documents are reviewed and signed (at least annually) Document Control Document Control Document Master List Document Control Master File Archiving Retired SOPs Document Control Document Master List Supervisor Document Control Document Control Document Destruction Supervisor Document Control Document Review Document Review Schedule Doc1.0-14AppA QSE 1- Documents and Records Version#: 1.0 Page 4 of 6

9 Records Review, Retention, Storage, Retrieval, and Destruction - Process Process for Reviewing, Retaining, Storing, Retrieving, and Destroying Records Records are created Any Staff Member Associated Preanalytic SOPs Associated Analytic SOPs Associated Postanalytic SOPs Records are listed in a Records Index Records are reviewed according to established schedules Records are labeled, stored, and archived Records are scheduled for destruction. Documentation of destruction is maintained Maintaining Laboratory Records Supervisor Supervisor Any Staff Member Supervisor Maintaining Laboratory Records Storing Laboratory Records Record Retention Record Retention Destruction of Records Doc1.0-14AppA QSE 1- Documents and Records Version#: 1.0 Page 5 of 6

10 Process for Modifying Records Modify Records - Process The need for a change to a record is identified 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 Any Staff Member Associated Preanalytic SOPs Associated Analytic SOPs Associated Post- Analytic SOPs Modifying Records Assigned Staff Modifying Records Member Supervisor Assigned Staff Modifying Records Member Supervisor Patient Care Providers Assigned Staff Member Modifying Records Storing Laboratory Records Record Retention Doc1.0-14AppA QSE 1- Documents and Records Version#: 1.0 Page 6 of 6

11 QSE 2: Organizational Structure - Policy Organizational Structure Policy Number Doc1.0-14AppB Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility The laboratory complies with all external requirements and has an organizational structure that ensures quality and meets customer needs. 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. 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 Chart of Laboratory Organization Referral Laboratories Supporting Documents The laboratory quality management system will be developed and linked with other facility quality management systems. A chart of the organizational structure of the administration and staff of the laboratory will be maintained. A chart identifying all Referral Laboratories is maintained. 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

12 Implementing a Laboratory Quality Management System Process Process for Implementing a Laboratory Quality Management System A Quality Manager is designated Internal and external customers needs are identified The resources needed to meet those needs are identified and obtained Policies for each QSE are developed and integrated into a Quality Manual The processes and procedures needed to implement each policy are developed The principles in the Quality Manual are communicated to all personnel Laboratory leadership reviews the Laboratory Quality Management System at least annually Laboratory leadership works with other departments to coordinate the laboratory quality system with other facility quality management systems Human Resources Management Management Personnel Processes/ Resource Allocation Management Management Facility Executive Management Personnel Training Other Departments Quality Management Doc1.0-14AppB QSE 2- Organization Version#: 1.0 Page 2 of 4

13 Organizational Chart Development and Maintenance - Process Process for Organizational Chart Development and Maintenance The laboratory administration is identified The levels of authority and responsibility for all personnel are defined The chain of command (reporting relationships among personnel) is identified An organizational chart (organogram) is published Executive Management Executive Management Executive Management Executive Management Developing and Maintaining the Organizational Chart Developing and Maintaining the Organizational Chart Developing and Maintaining the Organizational Chart Developing and Maintaining the Organizational Chart Doc1.0-14AppB QSE 2- Organization Version#: 1.0 Page 3 of 4

14 Identification of Referral Laboratories - Process Process for Identification of Referral Laboratories 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 Use of Referral Laboratories Testing Menu Review of Physician Order History Use of Referral Laboratories Referral Laboratory Testing Menus Chart of Referral Laboratories Doc1.0-14AppB QSE 2- Organization Version#: 1.0 Page 4 of 4

15 QSE 3: Personnel - Policy Personnel Policy Policy Number Doc1.0-14AppC Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility Job Descriptions Personnel Qualifications Orientation and Training Competency Continuing Education Supporting Documents 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. This policy provides direction for the processes and procedures to effectively manage the laboratory s personnel. 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 qualifications are specified in job descriptions for each laboratory position. Certification and education records are maintained for all members of the laboratory administration and staff. Employees are oriented to the organization and trained in each duty as assigned. Employees are assessed for competency twice the first year and then annually in their job duties as assigned. Opportunities are provided for continuing education and professional development. Continuing education activities are documented by employees. The following processes support this policy: Maintaining Adequate Staff Resources Job Descriptions Personnel Qualifications Employee Orientation and Training Assessing Employee Competency Continuing Education Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 1 of 7

16 Maintaining Adequate Staff Resources - Process Process for Maintaining Adequate Staff Resources Review of laboratory workload and personnel resources is conducted Need for additional staffing is identified New laboratory staff are recruited and hired Supervisor Supervisor Human Resources Supervisor Allocation of Staffing Resources Review of Laboratory Workload Allocation of Staffing Resources Allocation of Staffing Resources Human Resources Policies and Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 2 of 7

17 Process for Job Descriptions Job Descriptions - Process Job qualification requirements are established and documented Laboratory staffing needs are assessed Laboratory duties are assigned by position Job descriptions are developed and maintained so as to reflect qualification requirements and current job duties Staff familiarity with job description and job-related duties is documented Copies of job descriptions are maintained as part of the laboratory personnel file Human Resources Human Resources Policies and Review of Laboratory Workload Review of Laboratory Workload Staffing Chart Human Resources Human Resources Employee Human Resources Policies and Human Resources Policies and Job Descriptions Personnel Files Job Descriptions Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 3 of 7

18 Personnel Qualifications - Process Process for Documenting Personnel Qualifications Proof of licensure, certification, and education records are maintained in the personnel file for all members of laboratory administration and staff Current Curriculum Vitae (CV) are on file for Laboratory Director and Management Human Resources Human Resources Policies and Personnel Files Human Resources Human Resources Policies and Personnel Files Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 4 of 7

19 Employee Orientation and Training- Process Process for Employee Orientation and Training 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 Employee Human Resources Supervisor Employee Supervisor Employee Human Resources Supervisor Facility Policy and New Employee Orientation Procedure New Employee Orientation Procedure New Employee Training schedule Job-specific Training Standard Operating (as applicable) Facility Policy and New Employee Orientation Procedure Job-specific Training Personnel File Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 5 of 7

20 Assessing Employee Competency- Process Process for Assessing Employee Competency 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 Employee Employee Employee Supervisor Employee Supervisor Supervisor New Employee Training Schedule Standard Operating (as applicable) Employee Competency New Employee Training Schedule Standard Operating (as applicable) Employee Competency Standard Operating (as applicable) Employee Competency Annual Performance Review Standard Operating (as applicable) Employee Competency Annual Performance Review Employee Competency Annual Performance Review Personnel Files Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 6 of 7

21 Tracking Continuing Education - Process Process for Tracking Continuing Education 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 Employee reads professional educational material Continuing education documentation is maintained as part of laboratory personnel file Human Resources Employee Supervisor Employee Supervisor Employee Supervisor Human Resources Policies and Facility Policy and Documenting Continuing Education Educational Leave Request Form Documenting Continuing Education Documenting Continuing Education Documenting Continuing Education Personnel Files Doc1.0-14AppC QSE 3- Personnel Version#: 1.0 Page 7 of 7

22 QSE 4: Equipment - Policy Equipment Policy Policy Number Doc1.0-14AppD Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility Equipment Selection, Acquisition, Installation, and Inventory Validation Studies Method Comparison Carryover Maintenance, Calibration, Use, Troubleshooting, Service, Repair, and Records Retiring Instruments Supporting Documents The laboratory keeps detailed records on each piece of equipment that is critical in the processes across the laboratory s path of workflow. This policy provides direction for the processes and procedures to effectively manage the laboratory s equipment. 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. The laboratory acquires and installs the equipment needed for producing quality results. An inventory of all laboratory equipment is maintained. 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). When more than one method or instrument is used to conduct the same test, the methods or instruments are compared semi-annually. Studies are performed to show non-fda approved instruments or test systems do not have any carryover. 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. The laboratory retires instruments that are no longer in use and has procedures for storage of retired instruments and their records. 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

23 Equipment Acquisition - Process Process for Equipment Selection, Acquisition, Installation, Identification, and Inventory 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 New equipment is installed by manufacturer or approved representative Equipment is assigned a unique identifier Equipment is included in an inventory All instructions and documentation related to an instrument are kept in an equipment manual specific to that piece of equipment Finance Department Purchasing Department Manufacturer/ Representative Testing Turn Around Times Equipment Inventory Specific Equipment Service and Maintenance Records Requesting Bids from Suppliers Test-Specific Equipment Selection Finance Department Policies and 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 Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 2 of 9

24 Instrument Validation Studies - Process Process for Instrument Validation Studies New instrument validation studies are performed, documented, and evaluated for approval inhouse Annual or as needed validation studies are performed, documented, and evaluated for approval When equipment is removed from the laboratory or is serviced/repaired, performance is validated before use in patient testing s s s Instrument-Specific Validation Section- Specific Validation Instrument-Specific Validation Section- Specific Validation Instrument-Specific Validation Section- Specific Validation Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 3 of 9

25 Process for Method Comparisons Method Comparisons - Process 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 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 Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 4 of 9

26 Process for Carryover Studies Carryover- Process New instrument carryover studies are performed, documented, and evaluated for approval Additional instrument carryover studies are performed, documented, and evaluated for approval as needed s s Instrument-Specific Carryover Study Instrument-Specific Carryover Study Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 5 of 9

27 Instrument and Equipment Preventive/Corrective Maintenance - Process Process for Instrument and Equipment Preventive/Corrective Maintenance Instrument and/or equipment maintenance is performed on a daily, weekly, monthly, quarterly, semi-annual, or annual schedule Maintenance, service, or repair is performed on instruments or equipment at times other than scheduled All maintenance, service, and repair activities are documented and maintained in the equipment manual Documentation is reviewed at least monthly Technologists/ Technicians Technologists/ Technicians Instrument Manufacturer Service Personnel Facility Engineering Department Service Personnel Technologists/Technicians Equipment-Specific Manufacturer s Equipment Manual Maintenance Schedule Equipment-Specific Manufacturer s Equipment Manual Emergency Service Requests Requesting Service or Repair from Facility Engineering Department Maintenance, Service, and Repair Records Equipment-Specific Equipment-Specific Maintenance, Service, and Repair Records Maintenance Schedule Review and Storage of Laboratory Records Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 6 of 9

28 Process for Calibration Calibration- Process 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 Manufacturer s Equipment Manual Calibration Procedure Instrument/Equipment- Specific Manufacturer s Equipment Manual Calibration Procedure Instrument/Equipment- Specific Manufacturer s Equipment Manual Calibration Procedure Instrument/Equipment Specific - Review and Storage of Laboratory Records Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 7 of 9

29 Troubleshooting and Corrective Actions- Process Process for Troubleshooting and Corrective Actions 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 Technologists/Technicians Technologists/Technicians Technologist/Technicians Instrument/Laboratory Section-Specific Manufacturer s Manuals Instrument/Laboratory Section-Specific Manufacturer s Manuals Documenting Problems and Corrective Actions Instrument/Laboratory Section-Specific Manufacturer s Manuals Documenting Problems and Corrective Actions Documenting Problems and Corrective Actions Review and Storage of Laboratory Records Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 8 of 9

30 Process for Retiring Instruments Retiring Instruments - Process New instrument validation studies are completed Retired instrument is cleaned and decontaminated for storage Instrument is packed and removed for storage Instrument records are stored indefinitely (or as otherwise directed) after retirement Facility Maintenance Department Facility Engineering Department Technical SOPs Instrument-Specific Validation Retiring Laboratory Instruments/Equipment Equipment Decontamination Retiring Laboratory Instruments/Equipment Retiring and Archiving Laboratory Records Retiring Laboratory Instruments/Equipment Doc1.0-14AppD QSE 4- Equipment Version#: 1.0 Page 9 of 9

31 QSE 5: Purchasing and Inventory - Policy Purchasing and Inventory Policy Policy Number Doc1.0-14AppE Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility Selection and Use of Referral Laboratory Services Vendor Selection Purchasing Supplies and Reagents Receiving, Inspecting, Storing, and Managing Supplies and Reagents. Supporting Documents The laboratory purchases and maintains an inventory of equipment, supplies, and reagents used in the path of the laboratory workflow. This policy provides direction for the processes and procedures to effectively work with the Purchasing Department to manage purchase and inventory processes. 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. The laboratory has an established procedure for evaluating and selecting referral laboratories. The laboratory has a system for selecting vendors of equipment, supplies, and services. The laboratory works with the Purchasing Department to purchase supplies and reagents. The laboratory has processes and procedures for receiving, inspecting, storing, and managing the inventory of supplies and reagents used in the path of workflow. The following processes support this policy: Use of Referral Laboratory Services Identifying and Selecting Vendors Purchasing Supplies and Reagents Handling Supplies and Reagents Doc1.0-14AppE QSE 5- Purchasing and Inventory Version#: 1.0 Page 1 of 5

32 Use of Referral Laboratory Services - Process Process for Use of Referral Laboratory Services The laboratory has processes for evaluating and selecting referral laboratories 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 The laboratory maintains a listing of all referral laboratories it uses The laboratory maintains a log of all samples sent out to referral laboratories and a record of all tests conducted on each 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 Purchasing Department Referral Laboratory Representatives Use of Referral Laboratories Referral Laboratory Test Menu Test Menu Use of Referral Laboratories Purchasing Department Referral Laboratory Representatives Use of Referral Laboratories Completing Purchase Orders Use of Referral Laboratories Use of Referral Laboratories Specimen Tracking and Handling Use of Referral Laboratories Result Reporting Doc1.0-14AppE QSE 5- Purchasing and Inventory Version#: 1.0 Page 2 of 5

33 Identifying and Selecting Vendors - Process Process for Identifying and Selecting Vendors for Supplies and Reagents Inventory lists are created from equipment/methods in use Possible vendors are identified and evaluated Test-Specific SOPs Purchasing Department Vendors are selected s Purchasing Department Test Menu Equipment-Specific Operating Manuals Purchasing Department Policies and List of Approved Vendors Purchasing Department Policies and List of Approved Vendors Doc1.0-14AppE QSE 5- Purchasing and Inventory Version#: 1.0 Page 3 of 5

34 Purchasing Supplies and Reagents - Process Process for Purchasing Supplies and Reagents Need for purchase of supplies or reagents is identified using inventory lists Purchase order is completed Purchase order is submitted and processed Supply Manager Supply Manager Supply Manager Purchasing Department Inventory of Supplies and Reagents Inventory of Supplies and Reagents Completing Purchase Orders Completing Purchase Orders Purchasing Department Inventory of Supplies and Reagents Doc1.0-14AppE QSE 5- Purchasing and Inventory Version#: 1.0 Page 4 of 5

35 Handling Supplies and Reagents- Process Process for Handling Supplies and Reagents Supplies and reagents are received in the facility Supplies and reagents are received in the laboratory Received supplies/reagents are documented on inventory 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 Facility Receiving Department Supply Manager Supply Manager Supply Manager Supply Manager Supply Manager Supply Manager Facility Receiving Department Receiving Supplies and Reagents in the Laboratory Receiving Supplies and Reagents in the Laboratory Inventory of Supplies/Reagents Receiving Supplies and Reagents in the Laboratory Quality Control of Supplies and Reagents Parallel Testing Receiving Supplies and Reagents in the Laboratory Quality Control of Supplies and Reagents Receiving Supplies and Reagents in the Laboratory Inventory of Supplies/Reagents Receiving Supplies and Reagents in the Laboratory Inventory of Supplies/Reagents Test-Specific SOPs Doc1.0-14AppE QSE 5- Purchasing and Inventory Version#: 1.0 Page 5 of 5

36 QSE 6: Process Control - Policy Process Control Policy Policy Number Doc1.0-14AppF Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility Process Identification and Validation Specimen Management Method Verification/Validation Internal Quality Control Supporting Documents The laboratory documents and validates all processes in the pre-analytic, analytic, and post-analytic activities path of workflow. 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. 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. The laboratory documents and validates all processes in the path of workflow prior to implementation. Specimen handling processes in pre-analytic, analytic, and post-analytic activities are designed and validated to ensure they work as intended. 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. Process and statistical measurements are made to identify random and special causes of process variations. The following processes support this policy: Process Identification and Validation Specimen Management Method Verification/Validation Internal Quality Control Doc1.0-14AppF QSE 6- Process Control Version#: 1.0 Page 1 of 6

37 Process Identification and Validation - Process Process for Process Identification and Validation The laboratory identifies and documents all processes in the path of workflow and for each QSE 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 s s s s 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 Doc1.0-14AppF QSE 6- Process Control Version#: 1.0 Page 2 of 6

38 Specimen Management - Process Process for Specimen Management The laboratory establishes written policies and procedures for specimen submission, handling, and referral The laboratory receives a written or electronic request for patient testing from an authorized person The laboratory ensures the specimens meet established written requirements Specimens are processed and stored prior to testing procedures Specimens are tested following analyte-specific SOPs s Patient Physicians Specimen Processors Specimen Tracking and Handling Specimen Tracking and Handling Specimen Processors Specimen Tracking and Handling Specimen Processors Technicians/Technologist Test-Specific SOPs Specimen Tracking and Handling Test-Specific SOPs Technicians/Technologist Specimen Tracking and Handling Test-Specific SOPs Specimens are stored after testing Technicians/Technologist Specimen Tracking and Handling The laboratory establishes and follows written policies and procedures for ongoing mechanisms to monitor, assess, and correct problems identified in specimen management Manager s Technicians/Technologist Test-Specific SOPs Specimen Tracking and Handling Test-Specific SOPs Quality Management Doc1.0-14AppF QSE 6- Process Control Version#: 1.0 Page 3 of 6

39 Method Verification/Validation, Reportable Ranges, and Reference Intervals - Process Process for Method Verification/Validation, Reportable Ranges, and Reference Intervals The laboratory verifies/validates all methodology prior to implementing testing The laboratory establishes/verifies reportable ranges and biological reference intervals prior to implementing testing Verification/Validation Test-Specific SOPs Establishing Reportable Ranges Establishing Reference Intervals Test-Specific SOPs Doc1.0-14AppF QSE 6- Process Control Version#: 1.0 Page 4 of 6

40 Internal Quality Control - Process Process for Internal Quality Control Internal Quality Control Policy is established Control materials are selected and obtained for all analytic procedures Control materials are stored for all analytic procedures Control materials are tested and results documented as described in Test- Specific SOPs Quantitative Control values are monitored for acceptability following pre-established acceptability criteria (such as Westgard rules where applicable) Qualitative Control values are monitored for acceptability following pre-established acceptability criteria Corrective actions are completed and documented for all QC failures QC issues are discussed at monthly Quality Assurance Meetings Purchasing Department Supply Manger Team Quality Control Quality Control Test-Specific SOPs Hospital Purchasing Department Policies and Inventory of Reagents Inventory of Reagents Test-Specific SOPs Test-Specific SOPs Quality Control Quality Control Test-Specific SOPs Quality Control Test-Specific SOPs Quality Control Test-Specific SOPs Corrective Action Logs Quality Control Doc1.0-14AppF QSE 6- Process Control Version#: 1.0 Page 5 of 6

41 QSE 7: Information Management - Policy Information management Policy Policy Number Doc1.0-14AppG Effective Date 30-Jul-08 Approval Signature: Laboratory Director Review Cycle 1 year Supersedes New Policy Purpose Responsibility Patient Confidentiality Electronic Information Accessibility and Usage Reporting of Results Results Modification Reporting Delays Result Reporting Changes Data Integrity and Storage Supporting Documents 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. Processes are designed to ensure that patient information is kept private and confidential. Electronic data is retrievable only to authorized personnel Results are reported correctly and within established turnaround times. 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. Delays in testing or reporting results are relayed to key persons. Changes in test methodology or reference ranges are communicated to the ordering staff and/or associated study administrators. Data is stored and used in a manner that maintains the integrity of electronic and paper-based data. 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

42 Process for Patient Confidentiality Patient Confidentiality - Process A policy regarding patient confidentiality and restriction of access to patient information is established A system is in place to limit access to places where patient information is stored, including paperbased records and electronic data bases Employees attend required orientation sessions regarding patient confidentiality Employees sign confidentiality pledge Requests for patient information are handled in a manner that ensures patient confidentiality and provides information only to approved individuals Facility Committee on Patient Confidentiality Facility Committee on Patient Confidentiality Medical Records Department Information Technology (IT) Department Human Resources Human Resources Patient Confidentiality Procedure Facility Patient Confidentiality Procedure Patient Confidentiality Procedure Facility Patient Confidentiality Procedure Medical Records IT Confidentiality Procedure Patient Confidentiality Patient Confidentiality Patient Confidentiality Procedure Managing Requests for Patient Information Doc1.0-14AppG QSE 7- Information Management Version#: 1.0 Page 2 of 8

43 Accessing and Using Electronic Information- Process Process for Accessing and Using Electronic Information The computer system facilities meet environmental conditions and safeguards for proper system operations The computer systems meet laboratory accreditation and regulatory requirements Preventive maintenance is conducted on computer systems Disaster recovery plans, including alternative plans for downtime of computer system, are documented and practiced for backup of information are in place Changes to existing programs or validation of new programs is communicated Authorized personnel are trained in the use of electronic data management systems Security and access are restricted to authorized personnel based on job requirements and functions An audit trail is available to identify any individual who has accessed, entered, or modified data Information Technology (IT) Department Facilities Management IT Department IT Department Facilities Management Plans IT Department Accreditation and Regulatory Requirements IT Department IT Department IT Department Preventive Maintenance Records IT Department Disaster Recovery Plans Plan for Computer Downtime IT Department IT Department IT Department IT Department IT Department Information Technology Department IT Department Staff Notification Policy IT Department Training IT Department Computer Access and Security IT Policies and Computer Access and Security Doc1.0-14AppG QSE 7- Information Management Version#: 1.0 Page 3 of 8

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