Laboratory Quality Management System Certificate Program

Laboratory Quality Management SystemCertificate ProgramCase Study Slides

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QSE Organization and Management Lesson

Case Study: New Analyzer ABC (OR-1)

3

QSE Organization

and Leadership

RequirementApplication to Analyzer ABC

Quality Policy Adding the new analyzer has been determined to enhance customer

service.

The new analyzer will be implemented by following all applicable

requirements and the laboratory’s QMS policies, processes, and

procedures.

Scope of Services The new analyzer is being added because of increasing requests for

these types of examinations and will reduce the need for referral of

these examinations to another laboratory.

The new analyzer will be added to the laboratory’s existing automated

testing section.

Abbreviations: QMS, quality management system; QSE, quality system essential.


4

QSE Organization

and Leadership

RequirementApplication to Analyzer ABC

Legal identity Laboratory management has determined that addition of the new analyzer does not

affect its licensure.

Roles and

Responsibilities for

QMS activities

Analyzer ABC will be incorporated into the laboratory’s Automated Testing section. The

automated testing section manager will oversee the new analyzer implementation.

Selected testing personnel will:

• Receive training from the manufacturer.

• Conduct the instrument verification studies (ie, performance qualification [PQ]).

• Train other personnel who will operate the analyzer.

• Assess initial personnel competence.

The quality manager will review the PQ for completeness.

The laboratory director will review all installation qualification (IQ), operational

qualification (OQ), and PQ documents and records and document approval.

Abbreviations: IQ, installation qualification; OQ, operational qualification; PQ, performance qualification; QSE, quality system essential.


5

QSE Organization

and Leadership

Requirement Application to Analyzer ABC

Quality manual The automated testing section supervisor will use the quality manual

QSE policies and processes as an outline for a project management

checklist for implementing the new analyzer.

All applicable QSE processes and procedures will be followed to

ensure that all applicable regulatory and accreditation requirements

are met .

Abbreviation: QSE, quality system essential.


6

QSE Organization

and Leadership

Requirement

Application to Analyzer ABC

Resource allocation:

Facility

Personnel

Equipment

Information Technology

Materials

Specialty expertise

Purchased services

Adequate and appropriate space and environmental support has been secured for the

new analyzer.

The routine work performed by the two senior testing personnel selected for this project

will be covered by other personnel and any needed overtime hours.

The new analyzer is fully funded from the capital budget.

Budget is secured for the instrument interface to the LIS.

Purchasing orders for reagents, controls, calibrators, and other needed disposables have

been prepared, approved, and initiated.

None needed for this project.

An equipment service contract has been signed with the manufacturer.



7

QSE Organization

and Leadership

Requirement


Quality Planning:

Goals and Quality

Objectives

This project supports Laboratory Goal #1: Improve practitioner satisfaction with

laboratory services.

Objectives:

1. The ABC analyzer will be fully functional for patient testing by the end of the third

quarter.

2. All approved related process, procedure, and form documents will be in the

document management system four weeks before patient testing commences to allow

for training and competence assessment.

3. Training of assigned personnel and their initial competence assessment will be

completed before patient testing commences.

4. At least 90% of specimens will meet or exceed the preset turnaround time in the first

three months of testing.

Quality Plan The laboratory will use the requirements in the 12 QSEs as an outline for the “Quality

Plan to Implement Analyzer ABC.” This quality plan will serve as the project management

tool for keeping the implementation on time within the established budget.



8

QSE Organization

and Leadership

Requirement


Management review Results from the four objectives for this project will be included in

the next two quarterly management review meetings.

Communication plan The Communication Plan template for this project has been

completed and includes:

• Project goal(s).

• Key messages.

• Audience.

• Deliverable format.

• Frequency.

• Owner.

• Due date.


QSE Customer Focus Lesson

Case Study: New Analyzer ABC (CF-1)

10

QSE Customer

Focus

Requirement


Identifying customers The automated testing section supervisor worked with the quality manager to

identify customers affected by the new analyzer ABC.

• External customers: Physicians, patients, patient care professionals, and

accrediting organizations

• Internal customers: Laboratory personnel, including phlebotomists,

specimen processors, and testing personnel

Identifying

expectations

The automated testing section supervisor worked with the quality manager to

identify customer expectations for the new analyzer ABC.

• External customers: Improved testing TAT and accuracy of results

• Internal customers: Increased process efficiency (eg, use of small sample

volumes, faster sample throughput, interface to the computerized

information system)

Abbreviations: QSE, quality system essential; TAT, turnaround time10


11

QSE Customer

Focus

Requirement


Evaluating

capability

The quality manager worked with the automated testing section supervisor to evaluate

the new analyzer ABC’s capability to meet external and internal customer expectations.

Meeting

customer

expectations

The automated testing section supervisor worked with the quality manager to review the

identified external and internal customer expectations and determined that all were

realistic, with the exception of a 15-minute turnaround time TAT for stat Analyte-X

examinations.

The laboratory director met with the patient care professionals in the specialties that

commonly order Analyte-X to explain the limitations of analyzer ABC. Everyone agreed to

accept a TAT of 20 minutes.

The laboratory director sent an e-mail to all patient care professionals communicating the

outcome of the laboratory’s assessment of analyzer ABC capabilities, which included a

listing of expected TATs.

Abbreviations: QSE, quality system essential; TAT, turnaround time.11


12

QSE Customer

Focus

Requirement


Measuring

external

customer

satisfaction

The automated testing section supervisor selected four analytes for monitoring daily TATs that

provided a good representation of overall instrument performance in meeting the external

customer expectations.

During the quarterly management review meeting, the quality manager reported to laboratory

leadership that TATs met expectations 80% of the time the first week and then have been stable

at above the target of 95% during the past three months.

Results of quarterly practitioner survey demonstrated an improvement in satisfaction with test

TAT.

Measuring

personnel

satisfaction

The automated testing section supervisor held short daily meetings during analyzer ABC

implementation to identify and resolve any operational issues in a timely manner. After 10 days,

personnel determined that the daily meetings were no longer needed, and the regular weekly

meeting was reinstated.



13

QSE Customer

Focus

Requirement


Recording

complaints

During the first week of analyzer ABC implementation, three customer complaints regarding

delayed TAT were recorded in the computerized quality incident reporting system. The quality

manager notified the automated testing section supervisor of each complaint when received.

The automated testing section supervisor worked with the testing personnel to resolve process

issues that were creating the delay. They decided to relocate a centrifuge used specifically for

specimens labeled stat. This action was recorded.

Managing

complaints

The customers received communication from the automated testing section supervisor that

action had been taken.

The quality manager monitored all complaints associated with analyzer ABC implementation and

determined that performance stabilized within one week after moving the centrifuge.

Ongoing monitoring of analyzer ABC TATs are reported in the quarterly management reviews by

the quality manager.


QSE Facilities and Safety Lesson

Case Study: New Analyzer ABC (FS-1)

15

QSE Facilities

and Safety

Management

Requirement


Facility design and

modification

In preparing for the new analyzer, the automated testing section

supervisor assessed and determined:

• Although no additional storage space was needed, the allocated

space for the analyzer and related work needed some renovation.

• No modifications would be needed to workflow of specimens and

personnel.

• There was no need for architectural and structural changes for energy

sources, ventilation, water, waste disposal, and utilities.

• There was no concern for any cross-contamination between work

cells.


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16

QSE Facilities

and Safety

Management

Requirement


Access The new analyzer was installed in a room that opens to a hallway

to which nonlaboratory personnel currently have access.

As a result, the automated testing section supervisor developed and

implemented:

• Criteria for authorization (ie, who will be allowed admittance)

• A process for authorizing admittance

• A key-card access control device

Access was given to authorized testing personnel who were identified

in accordance with the laboratory’s policy.


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17

QSE Facilities

and Safety

Management

Requirement


Facilities use and

maintenance

The new analyzer is sensitive to environmental conditions and the

examination process requires that reagents and specimens are stored at

different temperatures.

The automated testing section supervisor:

• Verified there was adequate and appropriate storage for reagents,

supplies, and specimens

• Implemented processes and procedures for:

- Housekeeping (ie, cleaning the work area).

- Monitoring, recording, and controlling the environmental.

conditions for reagents, supplies, and specimen storage.


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18

QSE Facilities and

Safety

Management

Requirement


Communications

system

The new analyzer will be installed in a room separate from the main

laboratory due to the sensitivity of the examinations it performs.

The automated testing section supervisor determined that the

laboratory will continue using the existing system of posting analyzer-

specific messages in a shift log for the analyzer.

Bulletin boards and e-mails will continue to be used for routine

communication.

The existing emergency telephone calling protocol will also be used.


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19

QSE Facilities

and Safety

Management

Requirement


Safety programs The automated testing section supervisor reviewed the safety

implications of new analyzer ABC for each of the laboratory’s safety

programs:

• Biosafety: Standard precautions apply.

• Chemical Hygiene Plan: The SDSs for each reagent were reviewed.

• Occupational Health: The organization’s program applies.

• Hazardous Waste Management: The new reagents can be disposed of

into the regular waste stream.

• Fire Prevention: The analyzer uses standard electrical current and

poses no fire risks different from other analyzers.

• Emergency Management: The organization’s program applies.

• Training: The laboratory’s safety training program applies.

Abbreviation: QSE, quality system essential; SDS, safety data sheet.19

QSE Personnel Management Lesson

Case Study: New Analyzer ABC (PE-1)

21

QSE Personnel

Management

Requirement


Job qualifications A new job title is not needed for the new analyzer; however, one new

person will be hired for performing examinations on this analyzer.

The automated testing section supervisor reviewed the existing job

description to verify that it covered current personnel and the new

person who will operate the new analyzer.

The existing job description includes specific sections for:

• Qualifications for this job for previous education, training, and skills.

• Key duties and responsibilities.

• Work conditions.

• Reporting relationships.

Abbreviation: QSE, quality system essential.21


22

QSE Personnel

Management

Requirement


Orientation of new

personnel to the

organization and

laboratory

Adding the new analyzer has resulted in one new person being hired in

the laboratory’s automated testing section.

The section manager will ensure that the new person:

• Is registered with human resources.

• Is welcomed to the organization and laboratory.

• Attends the organization’s general orientation session.

• Receives an orientation to the laboratory as a whole.

• Receives a detailed orientation to the automated testing section.

• Has records of completion of all orientation programs.



23

QSE Personnel

Management

Requirement


Personnel training The new person will receive training on the laboratory’s:

• QMS.

• Computer systems.

• Safety programs.

• Government reporting requirements.

Job-specific training cannot be conducted until after the new analyzer

has been verified as operating per intended use (QSE Process

Management).

After the analyzer process and procedure documents are developed

(QSE Documents and Records), the new analyzer training will take

place.

Abbreviation: QMS, quality management system; QSE, quality system essential.23


24

QSE Personnel

Management

Requirement


Competence

assessment

The automated testing section supervisor has determined that:

• The new person will need initial competence assessment on all assigned examination processes

and procedures.

• All personnel who will work on the new analyzer will also need initial competence assessment.

• All personnel will need ongoing competence assessment in all assigned examination processes

and procedures.

Initial analyzer ABC competence assessment will take place after instrument verification and

training, and before beginning examinations on patient samples.

Ongoing competence assessment will include direct observations, written assessments, and

records reviews.

Records will be maintained of all assessments.



25

QSE Personnel

Management

Requirement


Continuing

education and

professional

development

After several months of operating the new analyzer, the senior testing person is

informed by the technical service engineer that the manufacturer is offering a two-

day advanced troubleshooting and maintenance course in another city.

Based on the laboratory’s continuing education and professional development

program, the automated testing section supervisor will:

• Determine whether the request meets criteria and qualifies for support.

• Communicate the support the laboratory will provide in meeting the person’s

application to attend this program.

• Request a record of attendance at and completion of the continuing education

course. Possible ask the person to summarize the key issues for other personnel.

• Maintain the record in the person’s file.


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26

QSE Personnel

Management

Requirement


Performance

evaluation

At the end of the new person’s probation period, an evaluation of his

performance in operating the new analyzer is conducted.

Based on the organization’s formal performance evaluation program,

the automated testing section supervisor:

• Schedules the meeting.

• Obtains objective input from peers and laboratory customers on his

performance.

• Obtains feedback from team members on his performance.

• Provides constructive comments on his performance.

• Sets performance objectives for the remainder of the year.

• Makes and maintains a record of the performance evaluation.



27

QSE Personnel

Management

Requirement


End of

employment

The new employee is not a good fit with the laboratory and organization and

the decision has been made to release him from employment.

Based on the organization’s end of employment policies, processes, and

procedures, the automated testing section supervisor:

• Conducted an exit interview.

• Withdrew the person’s access to confidential information, information

systems, and the facility.

• Obtained return of a locker key and other materials belonging to the

laboratory and organization.

• Completed all forms associated with the termination.

• Maintained records of the termination.



28

QSE Personnel

Management

Requirement


Personnel files The automated testing section supervisor maintains a checklist to verify that all the

following necessary records are maintained in each person’s file:

• Current and previous versions of the job description

• Formal education and experience

• Professional certification(s), licensure, or registration, as needed or required

• Training records (job, laboratory, and external)

• Competence assessments

• Continuing education and professional development

• Performance evaluations

• Incident and accident reports

• Health records

• Dates of employment

• Personal identification (eg, signatures, initials, codes)

• End of employment records


QSE Supplier and Inventory Management Lesson

Case Study: New Analyzer ABC (SI-1)

30

QSE Supplier and

Inventory

Management

Requirements


Selection and

qualification based on

ability to meet

laboratory

expectations

The automated testing section supervisor, the laboratory director,

and selected testing personnel prepared a list of criteria that the

new analyzer would have to meet. Potential vendors with

established QMSs were chosen for evaluation.

With the help of the organization’s materials management

department, a template of criteria with ranked weighting was

prepared and applied to three potential suppliers. Discussions were

held with representatives from each supplier. One supplier was

chosen.

Abbreviation: QMS, quality management system; QSE, quality system essential.

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31

QSE Supplier and

Inventory

Management

Requirements


Processes for creating,

reviewing, and

amending purchasing

agreements

The automated testing section supervisor worked with the organization’s

materials management department and the appropriate suppliers to set up

the procurement agreements for all needed reagents, calibration materials,

controls, and other materials for performing examinations on analyzer ABC.

The laboratory has amended its agreement with its current referral

laboratory to refer examinations, as needed.

In the future, the laboratory might consider offering this specialized testing

to outreach clients. If that happens, special agreements for outreach

customers to purchase these examinations will be prepared.



32

QSE Supplier and

Inventory

Management

Requirements


Evaluating suppliers,

contractors, referral

laboratories, and

consultants

At three months and six months the automated testing section

supervisor plans to evaluate the suppliers of reagents, calibration

materials, controls, other supplies related to performing

examinations on analyzer ABC.

Referral laboratory and consultant performance will also be

reviewed.

If the six-month evaluation is still favorable, then the next

evaluation will be made when the contracts are due for renewal at

one year from initiation.



33

QSE Supplier and

Inventory

Management

Requirements


Receiving materials

and verifying

performance

All purchased materials are first received at the organization’s receiving dock

where the shipping container’s contents are matched to a purchase order. The

materials management department and the laboratory already have a process for

sending all received materials quickly to the laboratory, where the laboratory’s

receiving clerk checks the accuracy of shipping container contents and checks for

any damage, leakage, or contamination. The materials are then stored in a

segregated area until verified for use.

The laboratory has a process for verifying that reagents, calibration materials,

controls, and materials critical to examinations function as expected before use

in specimen examinations. Records are kept of these verifications.



34

QSE Supplier and

Inventory

Management

Requirements


Storing and handling

laboratory materials

The laboratory’s automated testing section maintains separate areas

in storage refrigerators for unverified and verified reagents,

calibration materials, and controls, segregated by analyzer, and

maintains records of refrigerator temperatures. All other materials

are stored according to manufacturer’s recommendations.


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35

QSE Supplier and

Inventory

Management

Requirements


Using, evaluating, and

maintaining inventory

of laboratory reagents

and materials

The automated testing section supervisor used the 5S method to

reorganize her section’s assigned storage and refrigerator space to

make room for all of analyzer ABC’s reagents and materials. The 5S

method was also applied to the workspaces around analyzer ABC.

The supervisor and personnel designed Kanban cards for each

reagent and material. The cards were placed at the point where

restock or reorder is needed. Personnel have remarked that it is

much easier to find materials and ensure enough are on hand. They

are committed to supporting 5S in the workspace areas.


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36

QSE Supplier and

Inventory

Management

Requirements


Tracing critical

materials

The automated testing section supervisor and “super users” identified all the

critical reagents and other materials associated with the new analyzer.

They ensured that all procedures contained instructions for capturing

information for tracing of equipment, reagents, materials, and personnel.

They verified the availability of a thermometer traceable to a national

standard to calibrate the thermometers in the storage refrigerators,

freezers, and work area.


QSE Equipment Management Lesson

Case Study: New Analyzer ABC (EQ-1)

38

QSE Equipment

Management

Requirement


Selection

and procurement

As a result of the decision to expand the test menu offerings, the

laboratory has decided to add a new type of analyzer.

The laboratory director and automated testing section supervisor:

• Identified necessary functional specifications.

• Identified facility, environment, and engineering requirements.

• Compared suppliers’ information about the analyzer’s functional

specifications and capabilities.

• Assessed and compared procurement alternatives.

• Contacted other users about the equipment and options being

considered.

• Recorded results of the selection and procurement processes.



39

QSE Equipment

Management

Requirement


Equipment

qualification

The automated testing section supervisor is responsible for ensuring that all of

the following actions have been completed before patient specimens are

accepted for examination on new analyzer ABC:

• Assignment of a unique identifier on receipt

• Securing approval of the manufacturer’s IQ, both pre- and postinstallation

• Completion of the OQ and securing approval

• Development, acceptance, completion, and securing approvals of the PQ plan

and results

• Collection of all documents for the new equipment; eg, operator’s manual,

parts lists, qualification records

• Training and initial competence assessment plans for authorized operators

• Creation and retention of all records of the equipment qualification

Abbreviation: IQ, installation qualification; OQ, operational qualification; PQ, performance qualification; QSE, quality system essential.


40

QSE Equipment

Management

Requirement


Calibration program The automated testing section supervisor and assigned personnel did all

of the following tasks:

• Prepared a calibration schedule for the new analyzer based on the

manufacturer’s recommendations and accreditation requirements

• Assigned responsibility for calibration to designated personnel

• Determined the traceability of calibration materials

• Developed instructions for calibrations, including analysis of results,

and action taken, where needed

• Developed forms to record calibration, where needed

• Maintained complete records of calibrations and calibration

verifications performed on the analyzer



41

QSE Equipment

Management

Requirement


Maintenance

program

According to the operator’s manual, the new analyzer needs daily, monthly,

quarterly, and annual maintenance. The automated testing section supervisor

decided that monthly and quarterly maintenance will be done by assigned

testing personnel; however, annual maintenance will be performed by the

manufacturer, according to the service contract.

The automated testing section supervisor also:

• Used the instrument’s inherent computerization to record daily maintenance.

• Used the manufacturer’s instructions and forms to perform and record

monthly and quarterly maintenance.

• Reviewed the service contract to verify that it included the manufacturer’s

specified annual maintenance.

• Verified presence of complete records of all maintenance performed.



42

QSE Equipment

Management

Requirement


Decommission and

final disposition

Analyzer ABC is new to the laboratory and will not replace any previous

version of equipment. However, in preparing the space for the new

analyzer, the automated testing section supervisor found some old

equipment under the counter and on some shelves that is no longer

being used.

The supervisor decommissioned the equipment by:• Removing it from inadvertent access by personnel.

• Recording the date of decommission in each equipment’s master file.

• Decontaminating any equipment that had come into contact with biohazard

materials.

• Determining that there was no confidential information to remove.

• Arranging to sell the old equipment.

• Completing the equipment records with the dates of decommission and sale, and

final disposition of “sold to…”



43

QSE Equipment

Management

Requirement


Equipment files

and records

The automated testing section supervisor created a new file folder for analyzer ABC,

where she has stored the following records as they were created:

• Records of acquisition and receipt

• IQ, OQ, and PQ records that confirmed the new analyzer’s suitability for use

• Calibration records, including analysis of data obtained from calibrations and

calibration verifications, and any follow-up actions taken for unexpected or

outlying results

• Maintenance records and follow-up actions

• Records of service and repair performed

She also created a problem log that will be kept next to the new analyzer, where

problems can be recorded as they occur with extra space to record actions taken.

Abbreviation: IQ, installation qualification; OQ, operational qualification; PQ, performance qualification; QSE, quality system essential.

QSE Process Management Lesson

Case Study: New Analyzer ABC (PM-1)

45

QSE Process

Management

Requirements


Analysis, design, and

documentation of the

laboratory’s path of

workflow and QSE

activities

The automated testing section supervisor and the new analyzer ABC

“super users” reviewed the generic Analyzer Setup and Run process

flow chart and found it applicable without modification.

The boxes in the flow chart identified the specific procedures

needed. Relevant instructions were identified in the operator’s

manual and package inserts. Laboratory-specific information was

incorporated into approved procedure templates.

The laboratory’s quality team had already identified and developed

QSE processes and procedures when they prepared the laboratory’s

quality manual.



46

QSE Process

Management

Requirements


Process validation or

verification

The laboratory is going to implement analyzer ABC and its examination

methods with no modifications; therefore, the analyzer and the examinations

only need to be verified as meeting the manufacturer’s performance

specifications. However, the preexamination and postexamination processes,

as they apply to the orders and specimens for examinations on analyzer ABC,

and the review, verification, and release of results obtained and archiving of

examined specimens need to be validated. Measurement uncertainties for the

quantitative methods was determined.

The automated testing section supervisor served as the team lead, with the

chosen “super users” as team members. The laboratory director was actively

involved in reviewing and approving all parts of the validation and verification

plans and the results obtained from each plan.



47

QSE Process

Management

Requirements


Process monitoring and

control

The automated testing section supervisor has implemented the following controls

and monitoring for new analyzer ABC:

• Weekly review of maintenance and calibration results

• Recording of temperatures for all temperature-dependent equipment that

supports the examinations and weekly review of the records

• Active review of QC results and the effectiveness of the QC plan

• Periodic use of purchased external control materials

• Standing requirement for lot-to-lot results comparisons before implementing

lot changes

• Tracking and review of PT results across time

• Regular review of analyzer ABC troubleshooting log and any related NCEs

• Monitoring of whether quality objectives continue to be met

• Periodic internal audits through observations and records reviews

Abbreviation: NCE, nonconforming event; PT, proficiency testing; QC, quality control; QSE, quality system essential.


48

QSE Process

Management

Requirements


Process change

management

When any changes that affect analyzer ABC are identified, the

automated testing section supervisor intends to use the total

process control model and the QSE change management checklist to

ensure that all necessary change activities are conducted.



49

QSE Process

Management

Requirements


Risk management The automated test section supervisor used the Automated Analyzer

Set-Up and Run process flowchart to perform a risk analysis for new

analyzer ABC.

The same flowchart had been used many times previously to assess

risks for automated testing, so many risks common to automated

testing had already been identified and mitigated.

Only risks unique to the new analyzer were considered and action

taken to reduce or eliminate the risk or mitigate it to remove or

reduce failure cost.

Abbreviations: QSE, quality system essential.

QSE Documents and Records Management Lesson

Case Study: New Analyzer ABC (DR-1)

51

QSE Document

and Records

Management

Requirements


Document

identification

and control

Documents that will be used for new analyzer ABC were identified during QSE

Process Management and include the process flow chart and all related

procedures for setting up and performing examinations on analyzer ABC.

Each document has the document type in its title:

– Analyzer ABC Setup and Run Process (flow chart)

– Analyzer ABC Quality Control Schedule and Procedure

– Analyzer ABC Maintenance Form

Because they are all new, each document is version “v1.”

Each document will be entered into the laboratory’s electronic document

management system.



52

QSE Document

and Records

Management

Requirements


Creation, review,

and approval of

new documents

The automated testing section supervisor delegated the creation of new analyzer ABC documents to the

two “super-users.” The writers used the laboratory’s preestablished process, procedure, and form

templates for document development.

Review of the draft documents was assigned to new and veteran automated testing section personnel to

get a broad review perspective. Feedback was received and the documents were edited to the

reviewers’ satisfaction.

The laboratory director reviewed the final version-1 (v1) documents and signed her approval. The

automated testing section supervisor and the quality manager also approved the documents.

During the time that the laboratory’s document control coordinator was finalizing the status of the

documents in the document control system, the "super-users" began using the approved documents to

train the automated testing section personnel who will operate the new analyzer. Following personnel

training and initial competence assessment, the analyzer, personnel, and documents will be ready to

initiate patient examinations.



53

QSE Document

and Records

Management

Requirements


Making changes to

documents

During the first month of analyzer ABC operation, it was noted that a “v1” procedure

needed some new information provided by the manufacturer. The laboratory’s document

management form was used to request the change and explain why it was needed.

The change was verified that the procedure still works as intended. It was determined that

no other analyzer ABC documents were affected by this change.

The revised procedure was approved by the laboratory director and the automated testing

section supervisor. Procedure “v2” was released in the electronic document management

system.

The master copies of both v1 and now v2 are retained in the procedure’s master file for

the required retention period.



54

QSE Document

and Records

Management

Requirements


Periodic review of

documents

The automated testing section supervisor has set a review date for analyzer ABC

documents as being one calendar year from the implementation date.

During the year, document management forms were submitted requesting

changes to a few forms to make them more useful. Because the forms had been

reviewed in the document change process, the original annual review was not

also needed.

The new review date will be one year from the effective date of the changed

forms. However, the supervisor can still choose to review the forms on their

originally scheduled review date just to keep the review of all the analyzer ABC

documents at the same time.



55

QSE Document

and Records

Management

Requirements


Document

archiving, storage,

and retention

The automated testing section supervisor maintains designated file

cabinets in the secured document management space set aside for

the entire laboratory. The cabinets are clearly marked to indicate

where the current master files are stored, and which cabinets are

storing retired archived documents for the retention period.

Archived copies of reference documents received from outside

sources are also maintained in designated file cabinets for the

required retention period.



56

QSE Document

and Records

Management

Requirements


Records creation

and identification

The automated testing section supervisor identified all the records that

will be generated by the implementation of analyzer ABC and ensured

that there are instructions for how to enter information for every

record.

Records collection

and review

The automated testing section supervisor used the table on the

previous slide and added a third column to the right in which she

specified how frequently the records would be reviewed. She wants to

review QC and work results frequently to quickly catch and correct any

unfavorable trends that could affect the quality of the laboratory’s

examinations.

Abbreviation: QC, quality control; QSE, quality system essential.


57

QSE Document

and Records

Management

Requirements


Making changes to

records

The QSE Documents and Records Management section in the laboratory’s quality

manual contains the laboratory’s documented process for how changes are made for

all of the following, including new analyzer ABC.

• Paper internal records, such as worksheets and forms

• Electronic records of instrument maintenance, calibration, and QC results

• Paper-based laboratory results reports

• Electronic results reports in the Laboratory Information System (LIS).

In all cases, the processes and procedures retain the original information along with

the corrections.

Storage,

maintenance, and

retention of records

QC and patient examination results are stored in the laboratory’s LIS and its mirror-

system backup files. The automated testing section supervisor has labeled the

drawers on section file cabinets for storage of paper-based records. The records

retention schedule specifies the retentions periods of all records.

Abbreviation: LIS, laboratory information system; QC, quality control; QSE, quality system essential.


58

QSE Document

and Records

Management

Requirements


Process for security

and access of

records

The laboratory is in the process of validating a scanning device and its related

software so that scanned exact duplicate copies of paper-based laboratory records

can be stored electronically and retrieved as needed. The manufacturer was chosen

because of the software’s demonstrated ability to retrieve documents within the

required years of record retention. Records retained the the laboratory’s LIS are

accessible for the storage capacity of the system, which is several years.

Only authorized persons are given access to records stored outside the laboratory.

Process for records

destruction

The laboratory’s parent organization has a contract with a records incineration

company. The company produces a manifest of all the records boxes and media sent

to it and the date of destruction. The incineration process is completely automated

so that company workers do not have access to records box contents and

confidentiality is maintained.


QSE Information Management Lesson

Case Study: New Analyzer ABC (IM-1)

60

QSE Information

Management

Requirements


Planning for overall

information needs

The new analyzer was interfaced with the laboratory information system (LIS)

that provides specimen collection documents, assigns accession numbers on

received specimens, accepts result data from the analyzer, formats and sends

laboratory result reports, and prepares information for management reports.

Therefore, the automated testing section supervisor:

• Assessed information needs for the analyzer-LIS interface.

• Reviewed the examination request form and determined no revisions

were needed.

• Verified that autoverification criteria were developed and properly applied.

• Verified complete and accurate data capture and transfer from analyzer to

the LIS.

• Determined the report content and format on screens and on paper.

Abbreviations: LIS, laboratory information system; QSE, quality system essential.


61

QSE Information

Management

Requirements


Confidentiality of

information

There is an inquest into a patient’s death. The patient’s attending physician, the

patient’s family, and the coroner’s office have requested from laboratory

director the results of testing that had been performed on analyzer ABC.

Following the organization’s process for releasing results to external parties, the

automated testing section supervisor forwarded the results to the laboratory

director, who:

• Did not release results to the family, per the signed confidentiality

agreement.

• Verified that the coroner’s office submitted the required request form for

release of confidential information.

• Transferred the requested information to the organization’s legal office and

the coroner’s office according to the organization and laboratory’s established

processes and procedures.



62

QSE Information

Management

Requirements


Security for data

access

The new analyzer has an integrated information system that has

been interfaced with the LIMS. The laboratory is in the process of

interfacing the LIMS to the organization’s electronic health record

system (EHR).

In accordance with the organization’s information management

policies, processes, and procedures, the automated testing section

supervisor had the testing personnel sign a new confidentiality

agreement that specifies personnel will not have access to

nonlaboratory information in the EHR through the laboratory’s

interface.

Abbreviations: EHR, electronic health record; LIMS, laboratory information management system; QSE, quality system essential.


63

QSE Information

Management

Requirements


Integrity of data

transfers and

transmissions

New analyzer ABC has been interfaced with the LIMS.

To ensure the integrity of data transfer, the automated testing

section supervisor:

• Verified that all calculations performed by the analyzer’s software

are working correctly.

• Compared a sampling of results for each analyte across their

reportable ranges as they appear in the analyzer’s computer, to

the results transmitted from the analyzer to the LIMS.

• Created records of these reviews and verifications.

• Maintained these records.

Abbreviations: LIMS, laboratory information management system; QSE, quality system essential.


64

QSE Information

Management

Requirements


Protection of

information availability

during computer

downtime

After two months of operating the new analyzer, the LIMS experienced an

unplanned downtime of several hours.

The automated testing section supervisor did all of the following:

• Communicated the situation to personnel and outreach clients

• Initiated the unplanned downtime process and procedures to get patient test

results and reports to practitioners

• Met with information technology personnel while the cause was being

determined

• Accessed archived data as needed

• Verified data integrity across the interface when the LIMS became operable

• Reinstated the standard operating processes and procedures

• Communicated to personnel and clients when the situation was resolved

• Documented all actions taken and maintained the records

Abbreviations: LIMS, laboratory information management system; QSE, quality system essential.

QSE Nonconforming Event Management Lesson

Case Study: New Analyzer ABC (NC-1)

66

QSE

Nonconforming

Event Management

Requirements


Process to identify,

report, and record NCEs

All personnel received refresher training on detecting and reporting

NCEs involving the new analyzer.

Examples include:

• Failures in quality control (QC) or calibration

• Failures in instrument performance

• Problems with reagents or materials

• Corrections to released results and reports

• Complaints about turnaround times, results, or reports

Abbreviations: NCE, nonconforming event; QC, quality control; QSE, quality system essential.


67

QSE

Nonconforming

Event Management

Requirements


Processes to investigate

and take appropriate

action on NCEs and

complaints

Testing personnel noticed that some of the blood specimens submitted for

analysis were in the wrong collection tube types.

This should have been caught and corrected at the laboratory specimen

receiving area. The testing person completed an NCE report and submitted it

to the automated testing section supervisor, who followed up with an

investigation.

As a short-term correction, a memo was sent to specimen receiving

personnel reminding them of the correct tube type, until a more in-depth

investigation could be completed as to the underlying reason(s) why the

wrong tube types were used for specimen collection.

Abbreviations: NCE, nonconforming event; QSE, quality system essential.


68

QSE

Nonconforming

Event Management

Requirements


Processes for:• Recalls of

manufacturer’s

materials, equipment,

or software

• Recalls of the

laboratory’s

nonconforming products

or services

• Reporting defective

medical devices

The automated testing section supervisor will follow, when needed,

the organization and laboratory’s established processes for recalls

of manufacturer’s products. This involves recalling laboratory

products related to the new analyzer and reporting any analyzer

defects to the manufacturer and as required, to any other

organization.



69

QSE

Nonconforming

Event Management

Requirements


Process for

classification, analysis,

and presentation of

data and information

After a three-month data collection period, the automated testing

section supervisor analyzed all NCEs arising from the new analyzer.

A Pareto chart was chosen as the best tool for presenting the NCE

data because the most frequent problem would appear first on the

chart. The tallest bar on the chart came from numerous complaints

that turnaround time for examinations on this analyzer did not meet

customer expectations.

Abbreviations: NCE, nonconforming event; QSE, quality system essential.


70

QSE

Nonconforming

Event Management

Requirements


Process for identifying

underlying cause(s) of

process problems

The most frequent NCE was complaints that the laboratory did not meet the

turnaround time promised for the new analyzer’s examinations.

An RCA team was initiated to include persons who performed examinations

on the new analyzer. They identified that procedures for specimen handling

and transport were not as clearly documented in the laboratory’s guide to

services as they could be, resulting in rejected specimens. Customer

questions and concerns caused delays that resulted in extended turnaround

times.

The RCA team revised the problematic procedures. A pilot test showed

better customer comprehension of the revised instructions.

Abbreviations: NCE, nonconforming event; QSE, quality system essential; RCA, root cause analysis.


71

QSE

Nonconforming

Event Management

Requirements


Process to report NCE

information for

management review

The automated testing section supervisor provided the Pareto chart

of the new analyzer’s NCEs for inclusion in the laboratory’s quarterly

quality report.

The results of the RCA and the process improvements made were

also provided for the quality report.

The Pareto chart made after the process improvements were

incorporated showed a much-diminished bar height for NCEs about

turnaround time.

Abbreviations: NCE, nonconforming event; QSE, quality system essential; RCA, root cause analysis.

QSE Assessments Lesson

Case Study: New Analyzer ABC (AS-1)

73

QSE Assessments

RequirementsApplication to Analyzer ABC

Implement processes

for selection,

enrollment, and

participation in

external laboratory

assessment

The laboratory already participates in a nationally mandated program of

external assessment to maintain its licensure, accreditation, and ability to

offer laboratory services. It also participates in a voluntary accreditation

assessment program.

The laboratory developed a flow chart of the external assessment process and

assigned responsibility for specific activities in this process to designated

laboratory management and technical personnel.

Laboratory management believes that when personnel follow all processes and

procedures as written and complete all required entries on forms and screens

for operating analyzer ABC, there should be no problems with providing

objective evidence of meeting the related accreditation requirements when

the assessors are present.



74

QSE Assessments


Implement processes

for selection,

enrollment, and

participation in

PT/EQA

The laboratory compared the list of analytes it is planning to offer on new analyzer ABC

with the list of analytes for which PT is required: all offered analytes will need PT.

The laboratory compared the analytes it is planning to offer on the new analyzer ABC to

the list of available PT enrollments offered by its primary PT provider: most but not all

analytes are available. PT challenges for all but one of the analytes can be secured from

a secondary PT provider.

The laboratory contacted both PT providers, completed their respective application

processes, and paid the required fees. The automated testing section supervisor and

quality manager added the new PT challenges to the master PT schedule that rotates

such testing across all testing personnel on all shifts where examinations are performed.

The first set of PT challenge samples is scheduled to arrive so that examinations can be

performed during the PQ process on the analyzer and the PT results received within the

first quarter of actual patient testing.

Abbreviations: EQA, external quality assurance; PT, proficiency testing; QSE, quality system essential.


75

QSE Assessments


Implement any

needed alternative

assessment processes

for examination

method performance

The automated testing section supervisor determined that there is one analyte

for which no PT is available from an established provider. Therefore the

laboratory will need to implement an alternative assessment method for that

analyte.

The laboratory has chosen to share previously examined samples with another

laboratory that has the same analyzer ABC and is performing the same

analyte.

The laboratories have agreed to share samples at least three times each year

on or about the same schedule as for the PT performed on the other analytes

on the analyzer ABC.

The automated testing section supervisor wrote a procedure for how the

alternative assessment by shared samples will be handled.

Abbreviations: PT, proficiency testing; QSE, quality system essential.


76

QSE Assessments


Implement a

laboratory internal

audit program and

perform audits

The laboratory’s quality manager prepared a schedule for auditing the processes

and documents for the new analyzer ABC. It was determined that, considering the

newness of the analyzer, records and process audits would be performed quarterly

during the first year of operation.

Persons who perform testing on other automated analyzers were chosen as auditors

and given auditor training and audit practice.

Audits were conducted according to the audit schedule.

Auditors prepared reports in the laboratory’s standard audit report form.

The laboratory quality manager included a summary of the audit findings in the

quality report for management review.



77

QSE Assessments


Identify and monitor

laboratory quality

indicators

The automated testing section supervisor and the quality manager

have identified quality indicators for the new analyzer ABC that cover

the entire path of workflow.

Preexamination • Examination request accuracy

• Adequacy of received specimens

Examination • Incomplete test runs (from technical failures)

• Invalid test runs (from QC and calibrator failures)

Postexamination • Turnaround time from specimen receipt in the

laboratory to results release

• Corrected reports

Quality indicator data will be graphically presented using tools similar

to those for other selected examinations.

Abbreviations: QC, quality control; QSE, quality system essential.


78

QSE Assessments


Compare your

laboratory’s

performance to

other laboratories

The automated testing section supervisor decided the following:

For preexamination comparison, this laboratory will compare its examination

order accuracy and specimen acceptability data to those in published studies

conducted by a laboratory accreditation organization.

Examination comparison to other laboratories will be accomplished through

participation in PT and alternative PT programs, and submission of the new

analyzer’s QC data to the QC materials manufacturer’s review program.

For postexamination comparison, the laboratory will compare its turnaround

time and corrected report data to those in published studies conducted by a

laboratory accreditation organization, because these examinations were not

done previously in this laboratory.

Abbreviations: PT, proficiency testing; QSE, quality system essential.


79

QSE Assessments


Assess utilization of

blood components,

where applicable

The new analyzer ABC is not related to blood utilization in any

way.

However, the laboratory does provide transfusion services and the

transfusion service medical director and supervisor are actively

involved in collecting and analyzing blood use and transfusion

service practice data. Information gathered is provided for blood

utilization review and there is active participation in the blood

utilization review committee’s activities. The transfusion service is

accredited through the hospital’s accreditation organization.


QSE Continual Improvement Lesson

Case Study: New Analyzer ABC (CI-1)

81

QSE Continual

Improvement

Requirements


Participating in quality

improvement activities

at the organizational

level

The automated testing section supervisor prepares a storyboard for

the hospital-wide Quality Fair that explains the entire acquisition

and implementation process of the new analyzer ABC.

The supervisor highlights how the TAT was monitored daily. The

supervisor includes graphs that showed the TAT delay in the initial

week with adjustments to laboratory processes that stabilized the

TAT by the third week to achieve what was promised.

Abbreviations: QSE, quality system essential; TAT, turnaround time.

Case Study: New Analyzer ABC (CI-2)

82

QSE Continual

Improvement

Requirements


Using a defined CI strategy:

1. Identifying opportunities

for improvement

2. Selecting an opportunity

3. Generating solution(s)

4. Implementing solution(s)

5. Evaluating effect of

solution(s)

6. Integrating and sustaining

improvement(s)

1. During management review of performance metrics, a negative trending of

unacceptable STAT potassium TATs was noted.

2. The management team tasked the quality manager with leading a team to

improve STAT potassium TATs.

3. The team worked with emergency department phlebotomists to identify

where improvements to the blood collection and handling processes could

be made.

4. The phlebotomists conducted a small test of change, implementing the top

five solutions.

5. TATs following the implemented solutions were evaluated, with significant

improvement noted.

6. Changes were implemented with the entire phlebotomy team. TATs

continued to be monitored to ensure improvements were sustained.

Abbreviations: CI, continual improvement; QSE, quality system essential; TAT, turnaround time.

Thank you!