October 2, 2000 - pSMILE · Web viewQuality Manual Table of Contents Page 1. Introduction 4 2. Terms and Definitions 5 3. Purpose 5 4. Policy 5 5. Scope and Responsibilities 6 6

SMILEJohns Hopkins University

Baltimore, MD USA

Quality Manual Template

Author(s), Name & Title

Jaclyn Madden, M.S. Document Number

Effective Date

International Laboratory QA/QC Coordinator, SMILE

Doc10-15 22-Aug-08

Review by Heidi Hanes Review date 10-Feb-20

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE

Approved By

Name, Title Signature Date

SMILE 22-Aug-08

SOP Annual Review

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Penny Stevens 22-Aug-08

Revision History

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Quality Manual

Table of Contents Page1. Introduction 42. Terms and Definitions 53. Purpose 54. Policy 55. Scope and Responsibilities 66. Procedures for the Quality System Essentials 6

6.1 Documents and Records 66.2 Organizational Structure 86.3 Personnel 96.4 Equipment 106.5 Purchasing and Inventory 116.6 Process Control 126.7 Information Management 136.8 Occurrence Management 146.9 Assessment 156.10 Process Improvement 166.11 Customer Service 176.12 Facilities and Safety 18

7. Appendices 198. References 20



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1. IntroductionIn 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. The Quality Management Plan described in this Quality Manual provides the infrastructure for maintaining quality in the laboratory.

1.1 Description of the 12 QSEsThe Quality Management approach included in this Quality Manual 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.

1.1.1 Documents and Records: This QSE describes the processes for creating and maintaining standardized 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.

1.1.2 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 customer’ needs and regulatory requirements are met.

1.1.3 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.

1.1.4 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.

1.1.5 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.

1.1.6 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.

1.1.7 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.

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

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



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

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

1.1.12 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.

2. Terms and Definitions2.1 Document: The term document will refer to any written policy, process, procedure,

form, or job aid.

2.2 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.

2.3 Referral Laboratory: Also known as a reference or backup laboratory.

2.4 OFI: Opportunities for Improvement

2.5 Internal Customers: Includes all laboratory personnel.

2.6 External Customers: Includes anyone to whom the laboratory provides services. This includes the patient and his/her relatives, the patient caregivers, the ordering physician, network personnel, and others.

2.7 Occurrence: An occurrence is a nonconforming event.

2.8 Include any other terms as necessary.

3. Purpose

The purpose of this Quality Manual is to describe the procedures necessary to ensure total quality in the laboratory in all pre-analytical, analytical, and post-analytical activities throughout its path of workflow.

4. PolicyThe management of Laboratory Name is committed to providing laboratory testing services in accordance with the principles of good clinical laboratory practices. The management is also committed to providing accurate, reliable, and timely laboratory results. Management periodically reviews the performance of the Quality Management System and quality objectives to ensure their effectiveness and relevance. It is the responsibility of all laboratory personnel to familiarize themselves with the requirements of the Quality Management System and to



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implement the relevant policies and procedures in all pre-analytical, analytical, and post-analytical work processes.

5. Scope and ResponsibilitiesThis Quality Manual applies to all management and personnel of Laboratory Name.

5.1 The Laboratory Director is responsible for to be determined by the laboratory.5.2 The Laboratory Supervisor is responsible for to be determined by the labora-

tory.5.3 The Quality Manager is responsible for to be determined by the laboratory.5.4 The Lead Technologist is responsible for to be determined by the laboratory.5.5 The personnel of Laboratory Name are responsible for to be determined by

the laboratory. Further define personnel positions as needed for your labora-tory.

6. Procedures for the Quality System Essentials:

Note: The following is a template that can be used to describe instructions for all aspects of a Quality Management System. If this template is used, revise each requirement to include detailed, laboratory-specific instructions or include references to other procedures that provide the required detail.

6.1 Documents and Records 6.1.1 Creating and Implementing New Documents:

6.1.1.1 The need for a new document is identified and documented.

6.1.1.2 The new document is drafted.

6.1.1.3 The document is reviewed and approved by the Laboratory Director or designee before it is implemented.

6.1.1.4 The new document is assigned a unique identification number and entered onto the Document Master List.

6.1.1.5 A Master File is created for the new document. The master copy of the document is retained in this file.

6.1.1.6 Working copies of the document are made from the master copy and distributed. A log is kept to track where working copies are distributed.

6.1.1.7 Staff are notified of the new document and trained as necessary. They review and sign the document before using it.

6.1.2 Revising Existing Documents: 6.1.2.1 The need for a change to an existing document is identified and

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6.1.2.2 Changes to related documents are identified and requested.

6.1.2.3 The document is edited.

6.1.2.4 The new version of the document is reviewed and approved. The laboratory director or designee signs the new version before it is implemented.

6.1.2.5 The Document Master List is updated.

6.1.2.6 The Master File is updated. The master copy of the obsolete version is marked as retired and filed. Working copies of the obsolete version are retrieved and destroyed.

6.1.2.7 Working copies of the new version are made from the new master copy and distributed as necessary.

6.1.2.8 Staff are notified of changes to the document and trained as necessary. Staff review and sign the document before they use it.

6.1.3 Document Control:6.1.3.1 Each document is uniquely identified to ensure its traceability

throughout the document life cycle.

6.1.3.2 Information for each document is entered on the Document Master List. The information is updated when there are changes to version numbers or when a document is retired.

6.1.3.3 A Master File is maintained for each document. The Master File includes the master copy of the current and all previous versions of a document.

6.1.3.4 Working copies of documents are made from the master copy only. All working copies are maintained in a controlled manner such that there is a method for tracking the location of all working copies to ensure that only the most current version of a document is in use. Working copies are destroyed in a controlled manner.

6.1.3.5 Retention times for all retired documents are established. There is a method for storing retired documents.

6.1.3.6 The laboratory director or designee reviews and signs each current document at least annually.

6.1.3.7 There is a method for documenting staff’s knowledge of document content.

6.1.4 Reviewing, Retaining, Storing, Retrieving, and Destroying Records: 6.1.4.1 Records are created. Records include the name of the individual

creating the record and the date it was created.

6.1.4.2 Records are listed in a Records Index.

6.1.4.3 Records are reviewed and signed by the laboratory director or designee on a regular schedule (at least monthly).



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6.1.4.4 Records are labeled and stored in a manner that maintains patient confidentiality, ensures only authorized individuals have access, and maintains the physical integrity of the record.

6.1.4.5 Retention times for records are established. Destruction of records is documented.

6.1.5 Modifying Records: 6.1.5.1 The need for a change to a record is identified.

6.1.5.2 Record is modified.

6.1.5.3 Appropriate individuals are notified of the modification, including laboratory management and the ordering physician/other patient caregiver.

6.1.5.4 Modification of records is documented. Documentation should include the original record, the modified record, the individual who modified the record, the date of the modification, and the notification information.

6.2 Organizational Structure6.2.1 Implementing a Laboratory Quality Management System

6.2.1.1 A Quality Manager is designated.

6.2.1.2 Internal and external customers’ needs are identified. Resources are allocated for meeting those needs.

6.2.1.3 A Quality Manual is developed. All necessary policies, processes, and procedures are identified and developed. Information in the Quality Manual is communicated to all personnel. The Laboratory Director or designee reviews the Quality Manual and other policies, processes, and procedures prior to implementation and at least annually thereafter.

6.2.1.4 The Quality Management System is reviewed at least annually.

6.2.1.5 Laboratory leadership works with leadership of other departments to coordinate the laboratory quality management system with other facility/institution quality management systems.

6.2.2 Organizational Chart: 6.2.2.1 Laboratory administration is identified.

6.2.2.2 Levels of authority and responsibility for all laboratory personnel are identified.

6.2.2.3 The laboratory reporting chain of command is identified and communicated to all personnel.

6.2.2.4 The organizational chart (organogram) is published and maintained.



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6.2.3 Identifying Referral Laboratories: 6.2.3.1 The need for referral laboratories is assessed.

6.2.3.2 Referral laboratory capabilities and performance are assessed.

6.2.3.3 A list of suitable referral laboratories and their test menus is maintained.

6.3 Personnel6.3.1 Maintaining Adequate Staff Resources:

6.3.1.1 The laboratory’s staffing needs are assessed/identified.

6.3.1.2 Personnel are recruited and hired to fulfill those needs.

6.3.2 Job Descriptions: 6.3.2.1 Job qualification requirements and duties are determined and

documented.

6.3.2.2 Job descriptions are developed and maintained so as to reflect these qualification requirements and duties.

6.3.2.3 Personnel are familiarized with their job descriptions.

6.3.2.4 Job descriptions are signed by applicable staff and documented in personnel files.

6.3.3 Documenting Personnel Qualifications: 6.3.3.1 Proof of licensure, certification, education records, and Curriculum

Vitae are maintained in personnel files.

6.3.4 Employee Orientation and Training: 6.3.4.1 New employees are oriented to the facility/institution.

6.3.4.2 New employees are oriented to the laboratory.

6.3.4.3 Personnel are trained for their duties.

6.3.4.4 Documentation of orientation and training is maintained in personnel files.

6.3.5 Employee Competency Assessments: 6.3.5.1 Methods for competency training are documented.

6.3.5.2 Frequency of competency assessments is documented.

6.3.5.3 Competency performance is assessed as scheduled (i.e. following initial training, at the end of the three month probation period, and annually thereafter) and documented in personnel files.

6.3.5.4 Competency failures/deficiencies are addressed. Corrective and/or preventive actions are documented in personnel files.



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6.3.6 Continuing Education: 6.3.6.1 Continuing education requirements are documented and

communicated to all personnel.

6.3.6.2 Opportunities for continuing education are available for personnel.

6.3.6.3 Completed continuing education is documented in personnel files.

6.4 Equipment6.4.1 Equipment Selection, Acquisition, Installation, Identification, and

Inventory: 6.4.1.1 The need for new equipment is assessed.

6.4.1.2 Potential new equipment is evaluated.

6.4.1.3 New equipment is purchased and installed.

6.4.1.4 Equipment is assigned a unique identifier and included in an equipment inventory.

6.4.1.5 Documentation related to each piece of equipment is maintained in an equipment manual/file.

6.4.2 Instrument Validation Studies: 6.4.2.1 Validation study requirements are defined.

6.4.2.2 Validation studies are performed on new instruments prior to implementing the instrument for patient testing, annually, or as needed.

6.4.2.3 Before implementation, the laboratory director approves new methods based on validation results.

6.4.2.4 Documentation of results of all validation studies is maintained.

6.4.3 Method Comparison Studies: 6.4.3.1 When two instruments/methods are used for the same testing,

comparison studies are conducted at least once every six months.

6.4.3.2 Comparison studies are statistically evaluated and approved by the laboratory director. Documentation is maintained.

6.4.4 Carryover Studies: 6.4.4.1 Carryover study requirements are determined for each test method.

6.4.4.2 Schedules for instrument carryover studies are determined.

6.4.4.3 Carryover studies are performed and documented as scheduled.



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6.4.5 Preventive Maintenance: 6.4.5.1 A schedule for instrument/equipment preventive maintenance is

determined for each piece of equipment.

6.4.5.2 Instrument maintenance is conducted and documented.

6.4.5.3 Laboratory management reviews documentation of preventive maintenance at least monthly.

6.4.6 Calibration: 6.4.6.1 Manufacturers’ recommendations are used to develop calibration

schedules and plans.

6.4.6.2 Calibration is conducted and documented as scheduled or for troubleshooting purposes.

6.4.6.3 Calibration records for each piece of equipment are reviewed by laboratory management as scheduled.

6.4.7 Equipment-Related Troubleshooting and Corrective Actions: 6.4.7.1 Troubleshooting schemes are developed, implemented, and

documented.

6.4.7.2 Corrective actions are documented.

6.4.7.3 Documentation is reviewed by laboratory management and filed.

6.4.8 Retiring Instruments: 6.4.8.1 The instrument is cleaned, decontaminated, packed, and removed

for shipment or storage.

6.4.8.2 Records from retired instruments are maintained and stored.

6.5 Purchasing and Inventory6.5.1 Use of Referral Laboratory Services:

6.5.1.1 Referral laboratories are evaluated and selected for their ability to meet regulatory and testing requirements.

6.5.1.2 The laboratory enters into contracts with referral laboratories.

6.5.1.3 The laboratory tracks samples sent to referral laboratories.

6.5.1.4 The laboratory reports results from referral laboratories. All required elements are listed on the result reports.

6.5.2 Identifying and Selecting Vendors for Supplies and Reagents: 6.5.2.1 The supplies and reagents needed are determined using the

inventory list.

6.5.2.2 The ability of vendors to meet inventory needs is evaluated.

6.5.2.3 Vendors are selected for all supplies and reagents.



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6.5.3 Purchasing Supplies and Reagents: 6.5.3.1 An inventory of all supplies and reagents is maintained.

6.5.3.2 Order needs are identified using the inventory list.

6.5.3.3 Purchase orders are completed.

6.5.4 Handling Supplies and Reagents: 6.5.4.1 Supplies and reagents are received in the laboratory.

6.5.4.2 Receipt is documented on the inventory.

6.5.4.3 Acceptability of reagents and supplies is determined and documented.

6.5.4.4 There are documented procedures for handling unacceptable reagents and supplies.

6.5.4.5 Acceptable reagents/supplies are labeled, stored, and put into use.

6.6 Process Control6.6.1 Process Identification and Validation:

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

6.6.1.2 Processes are validated prior to implementation.

6.6.1.3 Problems with processes are identified, and processes are revised to correct problems.

6.6.2 Specimen Management:6.6.2.1 Specimens are submitted, handled, and referred for additional

testing.

6.6.2.2 Tests are requested. Documentation of requests is maintained.

6.6.2.3 Specimen acceptability is determined, and unacceptable specimens are handled.

6.6.2.4 Specimens are processed, stored, and tested.

6.6.3 Method Validation/Verification, Reportable Ranges, and Reference Intervals: 6.6.3.1 All methods are validated/verified prior to implementation. This

includes accuracy, precision, linearity (analytic measurement range), sensitivity (lower detection limit), analytic interferences (specificity), reference intervals, and critical values.

6.6.3.2 Validation/verification studies are documented and approved by the laboratory director prior to implementing the method..



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6.6.4 Internal Quality Control: 6.6.4.1 Internal quality control procedures exist for all analytic procedures.

6.6.4.2 Control materials are selected, obtained, and stored.

6.6.4.3 Acceptability criteria is established and documented.

6.6.4.4 Control materials are tested, and results are documented, monitored, and evaluated for acceptability.

6.6.4.5 Corrective actions are performed and documented for any out of range results.

6.7 Information Management6.7.1 Patient Confidentiality:

6.7.1.1 Patient confidentiality is maintained.

6.7.1.2 Access to patient information is controlled.

6.7.2 Accessing and Using Electronic Information: 6.7.2.1 The computer system facilities meet environmental conditions and

safeguards for ensuring proper system operations.

6.7.2.2 Preventive maintenance for computer systems are conducted and documented.

6.7.2.3 Access to electronic information is restricted to authorized personnel.

6.7.2.4 There are plans for disaster recovery, downtime, and backup of information.

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

6.7.3 Reporting Results: 6.7.3.1 Results are reported to authorized recipients.

6.7.3.2 Panic values and population normal ranges are established and reported with results.

6.7.3.3 Ordering physicians and/or patient caregivers are notified of panic results. Notification is documented.

6.7.3.4 Reported results are monitored for accuracy.

6.7.3.5 Result reports are stored in a manner that limits access to authorized personnel only, maintains patient confidentiality, facilitates easy retrieval, and maintains data integrity.

6.7.4 Result Modification: 6.7.4.1 An incorrectly reported result is identified. The correct result is

documented.



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6.7.4.2 Laboratory management and the ordering physician and/or clinic are notified of the modified result. Notification is documented.

6.7.4.3 A revised report is generated. It should include the original result, the modified result, the name of the individual who modified the result, the date of the modification, and notification information (who made the notification, who was notified, and when).

6.7.5 Reporting Delays: 6.7.5.1 Delays resulting from reporting or equipment failures are monitored,

documented, reported to the ordering physician/patient caregiver, and communicated to appropriate DAIDS and network personnel.

6.7.6 Communicating Result Reporting Changes: 6.7.6.1 Changes in test methodology or reference ranges are communicated

to the ordering staff.

6.7.6.2 Changes in test methodology or reference ranges are communicated to associated study administrators.

6.7.6.3 Changes in test methodology or reference ranges are communicated to laboratory personnel.

6.7.7 Data Storage and Maintaining Data Integrity: 6.7.7.1 Data is labeled and stored in an area with controlled access and

appropriated environmental conditions.

6.7.7.2 Information is backed up.

6.7.7.3 Data integrity is verified after transmission and downtime.

6.7.7.4 Data integrity is verified by comparing it with the original input at defined intervals.

6.7.7.5 Calculations performed by the computer system are regularly verified.

6.7.7.6 Manual reports are regularly reviewed for correctness.

6.8 Occurrence Management6.8.1 Identifying and Documenting Occurrences:

6.8.1.1 The laboratory identifies and documents occurrences, including:

6.8.1.1.1 Complaints from internal and external customers.

6.8.1.1.2 Recalls or notifications of nonconformances related to materials, equipment, or software.

6.8.1.1.3 Nonconformances identified in internal or external audits.

6.8.1.1.4 QC, calibration, or EQA failures.

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6.8.1.2 Occurrence information is referred for remedial and corrective actions.

6.8.1.3 Occurrence information is referred for process improvement as necessary.

6.8.2 Remedial Actions and Investigation of Occurrences: 6.8.2.1 Remedial actions are initiated in response to any occurrences that

result in immediate impact on patient or personnel safety. Occurrences and remedial actions are documented.

6.8.2.2 Occurrences are investigated. Investigative steps are documented.

6.8.2.3 Additional corrective or preventive actions are performed and documented.

6.8.2.4 Referral for process improvement is made as necessary.

6.8.3 Analyzing Occurrence Information and Referral for Process Improvement: 6.8.3.1 Information regarding individual occurrences is tracked, categorized,

and organized in a manner that facilitates analysis of the collective data.

6.8.3.2 The collective data is analyzed at least monthly for trends in occurrence information.

6.8.3.3 Laboratory management reviews the occurrence data and allocates resources for root cause analysis and process improvement as necessary.

6.9 Assessment6.9.1 Internal Quality Indicator Surveillance:

6.9.1.1 Quality indicators are selected.

6.9.1.2 Data regarding quality indicators is collected and analyzed.

6.9.1.3 Quality indicator data is presented to laboratory management.

6.9.1.4 Follow-up actions are initiated.

6.9.2 Internal Audits: 6.9.2.1 Internal audits are conducted according to a regular schedule (at

least annually).

6.9.2.2 Internal audit findings are developed into a report that is submitted to laboratory management.

6.9.2.3 Follow-up actions are initiated.



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6.9.3 External Quality Assurance: 6.9.3.1 The laboratory participates in audits/assessments conducted by

external agencies. Information from audits is analyzed and submitted for managerial review. Follow-up actions are initiated as necessary.

6.9.3.2 The laboratory participates in external proficiency testing (EQA) for all analytes tested. EQA results are analyzed and information is submitted for managerial review. Follow-up corrective/preventive actions are conducted as necessary.

6.9.4 External Benchmarks: 6.9.4.1 Quality indicators for external benchmarking are selected.

6.9.4.2 Performance data is collected.

6.9.4.3 Results are compared to external benchmarks and analyzed.

6.9.4.4 Information is presented for managerial review.

6.9.4.5 Follow-up actions are initiated as necessary.

6.9.5 Quality Assessment Report: 6.9.5.1 Data is collected from various sources, including quality indicator

surveillance, internal and external audits, EQA, external benchmark performance, occurrences, and internal/external customer suggestions and complaints.

6.9.5.2 Data is incorporated into a Quality Assessment Report.

6.9.5.3 The Quality Assessment Report is submitted to management for review. Management makes any necessary referrals for root cause analysis and process improvement.

6.10 Process Improvement6.10.1 Identifying Opportunities for Improvement:

6.10.1.1 Problems within processes and opportunities for improvement are identified and documented.

6.10.1.2 Problems within processes and opportunities for improvement are prioritized according to the level of impact on customer needs or patient care.

6.10.2 Root Cause Analysis and Corrective/Preventive Action Plans: 6.10.2.1 Problems and opportunities for improvement are addressed and

selected for additional analysis.

6.10.2.2 Root cause analysis is conducted.

6.10.2.3 Corrective and preventive action plans are developed and implemented.



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6.10.3 Quality Improvement Evaluation: 6.10.3.1 The laboratory evaluates the effectiveness of actions taken to

improve performance.

6.10.3.2 The laboratory conducts any additional follow-up actions resulting from the evaluation.

6.11 Customer Service6.11.1 Provision of Laboratory Services:

6.11.1.1 Contracts are developed and maintained with all customers.

6.11.1.2 The laboratory provides services to customers.

6.11.2 Identifying and Managing Customer Needs: 6.11.2.1 Internal and external customers and their needs are identified.

6.11.2.2 The need for new processes or changes to existing processes to meet customer needs is identified.

6.11.2.3 Referrals for process control and process improvement are made.

6.11.3 Managing Customer Complaints: 6.11.3.1 Internal and external customers submit complaints and

suggestions, including anonymous submissions.

6.11.3.2 Complaints/suggestions are received in the laboratory and documented.

6.11.3.3 Complaints/suggestions are addressed appropriately.

6.11.3.4 Feedback is provided to the customer regarding how the complaint/suggestion was addressed.

6.11.3.5 Complaints are tracked and analyzed. Referrals are made for process improvement as necessary.

6.11.4 Monitoring Customer Satisfaction: 6.11.4.1 Customer satisfaction is evaluated by the laboratory.

6.11.4.2 Customer satisfaction surveys are conducted and collected.

6.11.4.3 Information from customer satisfaction surveys or other evaluations is analyzed.

6.11.4.4 Referrals are made for process improvement as necessary.



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6.12 Facilities and Safety6.12.1 Laboratory Design:

6.12.1.1 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.

6.12.1.2 The laboratory is designed to meet governmental, accreditation, and organizational requirements.

6.12.1.3 The laboratory work process is designed for efficiency and ergonomics.

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

6.12.1.5 Supplies, reagents, and samples are stored in a manner that maintains their integrity.

6.12.1.6 Access to the laboratory is restricted, and information regarding safety hazards is communicated on entrances to the laboratory.

6.12.1.7 Laboratory cleanliness is maintained.

6.12.1.8 Renovations to the laboratory are conducted in a manner that meets the above requirements.

6.12.1.9 The laboratory is routinely inspected for safety, cleanliness, and comfort. Any deficiencies are addressed.

6.12.2 Safety Procedures, Records, and Audits: 6.12.2.1 There is a laboratory-specific safety manual available to staff at all

times. Staff are familiarized with the content of the manual. The manual is reviewed for relevance and content by the laboratory director or designee at least annually.

6.12.2.2 There is a list of emergency phone numbers and contacts available in the laboratory.

6.12.2.3 A documented chemical hygiene plan is available to staff at all times.

6.12.2.4 Current MSDS for all chemicals in the laboratory are available to staff at all times. MSDS are reviewed annually for content and relevance.

6.12.2.5 Hazardous waste materials are stored and disposed of in a manner that is compliant with all local and governmental regulations.

6.12.2.6 Staff can obtain emergency medical treatment. Staff are familiarized with instructions for how to obtain medical treatment.

6.12.2.7 Safety-related records and safety incident reports are documented and reviewed. Follow-up actions are taken as necessary.



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6.12.2.8 An internal safety inspection is conducted at least annually. Follow-up actions are performed as necessary.

6.12.3 Safety Training: 6.12.3.1 All personnel read and document understanding of the safety

manual and other job-related safety documents.

6.12.3.2 New employees are trained in safety procedures and requirements at hire. Safety training includes, but is not limited to, universal and standard precautions, blood-borne pathogens, and fire safety.

6.12.3.3 All personnel receive safety training at least annually. Safety training includes, but is not limited to, universal and standard precautions, blood-borne pathogens, and fire safety.

6.12.3.4 All personnel are familiarized with emergency preparedness plans. Drills are conducted regularly.

6.12.3.5 Safety training and competency are documented in personnel files.

6.12.4 Safety Equipment Availability and Use: 6.12.4.1 Personal Protective Equipment (PPE) including, but not limited to,

gloves, gowns, and face shields is available for all personnel. All personnel are trained in the proper use of PPE.

6.12.4.2 All staff are familiarized with the location of First Aid supplies and the procedures for obtaining emergency medical care in the laboratory.

6.12.4.3 All personnel are familiarized with the location and correct use of safety equipment. Safety equipment includes, but is not limited to, eye wash stations, safety showers, and fire extinguishers.

6.12.4.4 Preventive maintenance and function checks are performed on all safety equipment. Maintenance and checks are documented.

6.12.4.5 Hazardous materials are properly labeled. There are documented safety instructions for handling and storing hazardous materials.

7. Appendices:

List and attach any appendices applicable to your Quality Manual. Some examples of appendices that may or may not be included in your manual are listed below. Other documents may be necessary for your procedures. SMILE can provide examples of these appendices upon request.

7.1 Document Change Request Form

7.2 Document Master List Template

7.3 Signature Page Template



Baltimore, MD USA

7.4 Organogram

7.5 Job Descriptions

7.6 Orientation Checklist and Documentation Form

7.7 Training Documentation Form

7.8 Competency Assessment Documentation Form

7.9 Continuing Education Documentation Form

7.10 Equipment Inventory Template

7.11 Preventive Maintenance and Calibration Documentation Templates

7.12 Supply/Reagent Inventory Template

7.13 QC Testing Documentation Templates

7.14 Nonconformance Identification and Remedial Action Documentation Forms

7.15 Quality Indicator Performance Documentation Templates

7.16 Quality Assessment Report (QAR) Template

7.17 Opportunity for Improvement Identification and Tracking Forms

7.18 Root Cause Analysis Templates

7.19 Corrective/Preventive Action Plan Templates

7.20 Customer Satisfaction Survey

7.21 Customer Complaint Recording Forms

7.22 Safety Incident Documentation Forms

8. References1. Berte, L. A World Wide Approach to Laboratory Quality Management – Session 1.

Teleconference sponsored by ASCP.

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

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

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

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

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

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



Baltimore, MD USA

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

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

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

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

12. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory Accreditation Program; Laboratory General Checklist.
