Salwa Hindawi

Salwa HindawiMSc, FRCPath, CTMAssociate Professor in HaematologyDirector of Blood Transfusion ServicesKAUH, JeddahSaudi Arabia

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Introduction

Accreditation is a non-governmental, voluntary process

that evaluates institutions, agencies, and educational

programs.

Most of the accreditation programs develop and reviews

quality standards and guidance to ensure that quality

and its Quality System Essentials (QSEs) cover the entire

spectrum of the clinical laboratory services.

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Introduction

Quality means Fitness for a purpose

Purpose is A safe transfusion

To ensures maximum safety for donors, recipient, and

staff.

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Introduction

Quality Management Program

Quality Programs: encompass quality control (QC),

Quality assurance (QA), and quality improvement into

a broad-based program that ensures application of

quality principles throughout the operational areas of a

laboratory.

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What is Quality Control?

-Process or system for monitoring the quality of

laboratory testing.

- Quality Control is used to monitor both the precision

and the accuracy of the assay in order to provide

reliable results.

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Accuracy and Precision

The degree of fluctuation in the measurements is

indicative of the “precision” of the assay.

The closeness of measurements to the true value is

indicative of the “accuracy” of the assay.

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Precise and inaccuratePrecise and accurate

Precision and Accuracy

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Imprecise and inaccurate

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Quality assurance

Activities involving quality planning, control,

assessment, reporting, and improvement necessary to

ensure that a product or service meets defined quality

standards and requirements.

Patient receive blood that meets the required

specifications.

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The Quality Assurance Cycle

•Data and Lab

Management

•Safety

•Customer

Service

Patient/Client Prep

Sample Collection

Sample Receipt

and Accessioning

Sample TransportQuality Control

Record Keeping

ReportingPersonnel Competency

Test Evaluations

Testing

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Definition

Accreditation is an external review of quality with four

principal components :

It is based on written and published standards

Reviews are conducted by professional peers

The accreditation process is administered by an

independent body

The aim of accreditation is to encourage

organizational development.

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Definition A method to improve quality.

The health care provider undergoes a survey process by a team of health care professionals from an accrediting agency.

Accreditation is a process in which certification of competency, authority, or credibility is presented.Organizations

ISO, CAP, AABB, Local (CBAHI)

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What is a standard

Standards are evidence based, unambiguous requirements that

provide the basis for an accreditation program

Standards are required goals, not methods

Standards are minimal requirements that may be exceeded in

practice

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Standards & Guidance

Standards and guidance

A Standard is a GOAL

Guidance contains methods of meeting that goal (how)

Assessors assess against STANDARDS only! Did the

facility meet the goal?

“Shall” is a standard; “should” is guidance

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Systems Approach

Reviews objective evidence

Demonstrates operations over a period of time, not a point in

time

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Why Accreditation

It provides a structured evaluation by peers

It evaluates compliance with Standards

It delivers staff education and helps achieve the next level of proficiency

It enhances readiness to deal with changes and challenges to public health

It serves as a valuable tool to improve

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Concept of Accreditation

To Improve quality of our services and increase safety

of our Customers.

To ensure a safe environment, and continually work

to reduce risks to patients and staff.

To improve staff performance.

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Purpose of Assessment

To determine compliance with established Standards

Peer review

Education

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The Key to maintaining Licensing and

Accreditation

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Therefore need to

Make sure QMS is fit for purpose

Keep up to date with regulatory requirements and

guidance

Make use of Benchmarking and learn from others

Audit the system

Continuous review of QMS

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Most of the accreditation programs develop and

reviews quality standards and guidance to ensure

that quality and its Quality System Essentials (QSEs)

cover the entire spectrum of the clinical laboratory

services.

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Elements of Quality System Essentials:

Organization

Human Resources

Equipment

Supplier and Customer Issues

Process Control

Documents & Records

Deviations, Non-conformances, and Complications

Assessments: Internal & External

Process Improvement

Laboratory Safety

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HealthCare Organizations

Citizens

Scope of the Accreditation System

Hospitals & Clinics and

Physicians

Healthy Population(potential donors)

Patients

Blood Center & Transfusion Service

1. Organization2. Resources3. Equipment4. Supplier &

Customer Issues

5. Process Control

Collection & Production of Components

Transfusion Service Activities

Donor Recruitment

DonorAwareness

6. Documents & Records

7. Deviations 8. Assessments9. Process

Improvement10.Facilities & Safety

Unit for Transfusion

Quality Management Systems Foundation

TransfusionCommittee

Technical Standards

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Organization

-Each Laboratory can define its structure in any format that suits its operations.

-The Laboratory mission or vision statement should show support of its quality functions.

-There should be an active participation by the management in the review and approval of quality and technical policies, processes, and procedures.

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Organizational Chart

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Human Resources

The Clinical Laboratory should have highly qualified

personnel who have appropriate education, training, and

experience to ensure competent performance of assigned

duties.

It include:

-Job Description

-Orientation Program

-Competency Program

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Competency Program

Competency Program include:

-Written evaluations.

-Direct observation of test procedures

-Review of work records or reports

-samples Testing of unknown.

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Equipments

Approved supplier by:

-FDA, CE and ISO 9000 should be the source of equipment and reagents.

-Validation, calibration, and maintenance should be established for all equipments.

-All records of maintenance, repairs, or calibrations should be kept and reviewed periodically.

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Supplier & Customer Issues

The Laboratory should use the following criteria to rate

supplier performance :

-Quality of products of materials provided

-Delivery performance

-Service provided

-Maintenance

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process control

Elements of a process control system:

Development and use of standard operating procedures

(SOPs).

Processes to validate or control change to policies,

processes, or procedures.

Monitoring of quality control policies, processes and

procedures.

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Documents and Records

The laboratory should have a process to ensure that

documents (policies, process, and procedures) are

identified, approved by medical director, implemented, and

retained.

Forms should be controlled, and the records (completed

forms) stored and archived in a defined manner

Master List

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Deviations, Nonconformance, and

Complications

-The laboratory should have a process in place to capture and

assess incidents, errors, and accidents occurrences.

-Staff should be encouraged to report any concerns about

breakdowns or potential problems.

-The reports should be submitted directly to QA coordinator.

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Assessments: Internal and External

Internal Assessments

May include routine, scheduled system checks (also called

quality indicators), audits, and other findings initiated by

the facility.

External Assessments

Include inspections, surveys, some audits, etc, performed by

facilities not affiliated with organization, such as FDA, CAP

and AABB.

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Process Improvement

-Follow-up of findings from external assessments, reviews,

and inspections, as well as occurrence reporting provide

mechanisms for continued improvement.

-A summary of error and accident records provides an

overview of operations and may identify processes and

procedures that need clarification and personnel who need

retraining.

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Laboratories Safety

Safety Procedures must be in place and should cover:

Biologic Safety Radiation SafetyChemical SafetyDisaster Plan

Staff should be trained on all aspects related to safety

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Accreditation Process

It is a process of peer review by experts to

ensure the compliance of practice with the

recognized standards.

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Accreditation Process

Application

Pre-assessment

Assessment

Corrective actions

Decision on Accreditation

Re-assessment

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How Is a Survey for Accreditation Is Processed

The organization applies to the accrediting body.

Agreement is established.

Standards are provided to the organization.

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The Process Starts With

Six months prior to expiration of accreditation FDVR (Facility Data Verification Record) is sent to facility to update or confirm information

Assessors are assigned

Facility is provided with opportunity to accept or decline the team

Facility submits pre-assessment materials upon acceptance of team

Team lead sets assessment date, but does not notify the facility.

Unannounced visits began 1/1/07.

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How Is a Survey Conducted

A team surveys the institution through:

Review of required documents (policies & procedures)

Review of documents implementation:

Charts

Control sheets

Employees’ file

Interviews with staff and patients

Environmental rounds

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How Is a Survey Conducted

Conclusions and reports are provided at the end of survey .

Nonconformance or deficiencies is to be included in the report.

Action plan to be initiated by the facility for improvement.

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Failure to Meet Requirements

Nonconformance or Deficiency

A policy/process/procedure not defined or documented

More than one lack of implementation event

Requires the facility to submit a written plan of corrective

action

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Nonconformance / Deficiency

Must be linked to a requirement in the Standards or check

list.

Evaluate conformance or compliance to the intent of the

requirement.

Based upon objective evidence, not assessor opinion

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Summary Session

Meeting with key facility representatives

Assessment objective restated (to verify conformance to the requirements)

Facility accomplishments acknowledged

Requirement restated and nonconformance described (if NC exists)

Facility’s understanding of the issue(s) being presented verified

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Corrective Action Plan

Due date for action plan is 30 days from assessment date

Corrective action plan must include

Root cause analysis to identify possible system failure

Planned, scheduled events to resolve failures

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Final Steps

Facility response reviewed by two technical specialists in the AABB office; both must deem it acceptable

Educational support offered/provided

Additional information requested as necessary

Upon approval, accreditation documents sent to facility

Re-assessed every 2 years

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Staying Ready for Future Assessments

Implementation and monitoring of Corrective Action Plan.

Internal Assessments

Process Improvement

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Benefits of Accreditation

• To ensure the quality of health care through the

application of quality concepts.

• To foster a culture of patient safety and minimize the

risk of medical errors.

• To achieve optimum organizational results with

available resources.

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Benefits of Accreditation

• Provides assurance that Laboratory and Blood Bank is

operating to a prescribed level of technical competency

that meets Regulatory requirements.

• Increases public confidence in accuracy of Laboratory

results on which decisions can be made.

• it provides continuous learning and professional

development of all the staff.

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Outcome of a Local Experience

• Increase awareness among staff about importance of quality for safe practice.

• Educational Opportunities (ASCP, SBB).

• Help in change of attitude and increase self confidence among staff.

• Build trust between customer and BTS staff.

• Encourage team work.

• Continuous improvement to the quality of our services.

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Accreditation requirements are not just a burden, but are a framework that labs can use to ensure best practices.

Accreditation helps the institution to know its strengths, weaknesses and opportunities through an informed review process.

It helps Identify internal areas of planning and resource allocation.

Our goal should be continuous Quality Improvement through Accreditation Process.

Conclusions

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