www.aabb.org

Top 10 AABB Nonconformances: Avoid the Pitfalls

Judy Sullivan, MS, MT(ASCP)SBB

HAABB Fall Meeting

2011

www.aabb.org

Introduction

Your Performance Review

AABB Assessment Objective

Most Common Nonconformances/Objective Evidence

Avoiding the Pitfalls

Root Cause Analysis

Summary

www.aabb.org

Performance Review

Overall the blood banking industry is doing well embracing quality concepts

Facilities are recognizing benefits from implementation of quality systems

Follow through with root cause analysis is important

There is always room for improvement

www.aabb.org

Assessment Objective

To verify conformance with stated accreditation requirements BB/TS Standards, 27th edition

Immunohematology Reference Laboratory Standards, 7th

edition

Cellular Therapy Standards, 5th edition

Perioperative Standards, 4th

edition

Relationship Testing, 9th

edition

Molecular Testing 1st edition

www.aabb.org

Common Nonconformances BB/TS 25th Edition

0

20

40

60

80

100

120

Number

Standard

Common Non-Conformances 25th Edition

www.aabb.org

Common Nonconformances BB/TS 26th Edition

www.aabb.org

1. Organization

1.3 Quality and operational policies, processes and procedures shall be developedin writingand followed

Processes are not written

SOPs are not followed as written

www.aabb.org

1. Organization

1.4 shall have emergency operation policies, processes and procedures to respond to the effects of disasters

Emergency plans do not include what to do if you have an internal disaster

Where does the blood bank move if the primary location is inoperable?

www.aabb.org

1. Organization

1.5 shall have a process for personnel to anonymously communicate concerns about quality. Personnel shall be given the option to communicate such concerns either to their facilitys executive management, AABB, or both. AABBs contact information shall be readily available to all personnel

Communication of concerns to AABB is not part of facilitys process

www.aabb.org

2. Resources

2.1.3 Competence Evaluations of competence shall be performed at specified intervals.

No annual competency assessment performed

Competency assessment not done twice in the first year

Competency assessment does not include all CLIA elements

www.aabb.org

42 CFR 493.1451(b)(8)Competency Elements

Direct observations Patient testing Instrument maintenance/function checks

Monitoring recording and reporting of test results

Review of QC records, PT results and PM records

Assessment of test performance (PT, etc.) Assessment of problem solving skills

www.aabb.org

3. Equipment

3.0 shall identify equipment that is critical

3.5 process for scheduled monitoring and maintenance of equipment

No record of what equipment is considered critical

Do not follow manufacturers instructions

No evidence of follow up

www.aabb.org

3. Equipment

3.8 Warming devices

Blood bank takes no responsibility for blood warmers

Documentation of PM incomplete

www.aabb.org

5. Process Control

5.0 Process Control shall have policies and validated processes and procedures that ensure the quality

5.1.1 shall have a process to develop new processes and procedures or change existing ones

No documentation of process validation

Incomplete documentation of changes made to existing processes

CC process not followed

www.aabb.org

5. Process Control

5.1.2 Proficiency Testing shall participate in a proficiency testing program, if available, for CLIA regulated testing performed by the facility

There is no process to determine if PT is performed for each CLIA regulated test

www.aabb.org

5. Process Control

5.1.3 A program of quality control shall be established Results shall be reviewed and corrective action taken

Review of QC results is not always done in a timely manner or at all

Corrective action for out of range results is not always documented

www.aabb.org

5. Process Control

5.1.4 All materials shall be stored and used in accordance with manufacturers written instructions.

Storage of reagents (2-8C)

Failure to follow manufacturers instructions

www.aabb.org

5.1.5.1 Bacterial Detection

The BBTS shall have methods to limit and to detect or inactivate bacteria in all platelet components.

5.1.5.1.1 Detection methods shall either be approved by the FDA or validated to provide sensitivity equivalent to FDA-approved methods.

www.aabb.org

Evidence of Implementation

Culture-based detection method Other FDA approved detection method (ex: Verax) Validated detection method

Validation to be evaluated by AABB

Viral/bacterial inactivation method (International: variance required)

NOT Acceptable pH Glucose Swirling

www.aabb.org

Labeling

5.1.6.3.1 The labeling process shall include a second check to ensure that the correct unit number, ABO/Rh and expiration datehave been affixed

The labeling process does not include a documented second check

www.aabb.org

5.1.6.3.1 ISBT 128

Labeling of blood and component containers shall be in conformance with the most recent version of the US Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT 128.

AT A MINIMUM: Facility does not have have validated processes in place to receive and modify units labeled in ISBT 128 in emergency situations

www.aabb.org

5.15 Crossmatch

5.15.1 Serological Crossmatch Before issue, a sample of the recipients serum or plasma shall be crossmatched against a sample of donor cells from an integrally attached Whole Blood or Red Blood Cell segment. The crossmatch shall use methods that demonstrate ABO incompatibility and clinically significant antibodies to red cell antigens and shall include an antiglobulin test.

www.aabb.org

5.15 Crossmatch

5.15.1.1 If no clinically significant antibodies were detected in Std 5.13.3 (unexpected red cell antibodies) and there is no record of previous detection of such antibodies, at a minimum, detection of ABO incompatibility shall be performed.

www.aabb.org

5.15 Crossmatch

5.15.2 Computer Crossmatch

If a computer system is used to detect ABO incompatibility, the following requirements shall be met

www.aabb.org

Evidence of Implementation

Patients with no abs or history of abs

IS crossmatch OR

Computer crossmatch

Patients with absor history of abs

IS crossmatch AND

AHG crossmatch

www.aabb.org

6. Documents and Records

6.0 shall have policies, processes and procedures to ensure that documents are identified, reviewed, approved, and retained

Processes and procedures for document control are not complete

Reviews are incomplete or not timely

www.aabb.org

6. Documents and Records

6.1.1 A master list of documents..

6.1.4 Annual review and approval

6.1.5 Use of only current and valid documents

No list of forms, labels

No review or authorized individual not delegated

Using outdated references or no process for review of current references

www.aabb.org

6. Documents and Records

6.2.1 Records shall be complete, retrievable in a period of time appropriate to the circumstances

Records have been reviewed but data is missing

Records are maintained outside the blood bank and cannot be retrieved

www.aabb.org

Avoiding the Pitfalls

Be prepared!

4 month implementation period prior to effective date of Standards

Use the crosswalk to identify new and revised standards

Revise policies, processes, and procedures

www.aabb.org

Use the Data You Have

Analysis of occurrence reports

Findings from quality indicators

Reports of customer complaints

External assessment report findings

Review of selected processes (internal audits)

www.aabb.org

What to Audit

Blood Banks and Transfusion Services, 27th Edition 8.0 Assessments: Internal and External

The blood bank or transfusion service shall have policies, processes, and procedures to ensure that internal and external assessments of operations and quality systems are scheduled and conducted.

www.aabb.org

Operations vs Quality Systems

Operations Quality control

Preventive maintenance

Storage devices

Testing

Blood administration

Quality Systems Training

Competency

Agreements

Change control

Document control

Process improvement

www.aabb.org

Process Audit

Can be used to assess both quality and operations in one audit

www.aabb.org

Process Audits

Examples available in the Commendable Practices Library

Standards and Accreditation> Accreditation Member Tools> Commendable Practices > 8.0 Internal and External Assessments

www.aabb.org

Assessment Tools

Process audits wont capture all 10 QSEs

Use of assessment tools for audits provides a comprehensive self-assessment

www.aabb.org

Assessment Tools

AABB Web site

Standards and Accreditation> Accreditation Member Tools > Facilities

Available in Word format

www.aabb.org

Assessment Tool

Accreditation Requirement

Sample Assessment Questions

Evidence of Compliance

1.3 Policies, Processes, and

Procedures

Quality and operational policies, processes, and procedures shall be developed and implemented to ensure that the requirements of these BB/TS Standards are satisfied. All such policies, processes, and procedures shall be in writing or captured electronically and shall be followed.

What is the process to ensure that the requirements of AABB Standards and of regulatory agencies are incorporated into your documents and practices?

www.aabb.org

What Next?

Corrective Action

Root Cause Analysis

Process Improvement

www.aabb.org

Corrective Action Plans

Restatement of nonconformance and objective evidence

Remedial action

Root cause analysis

System improvement

www.aabb.org

Corrective Action Plans

Remedial Action

Immediate

Corrects specific incidence of nonconformance

Band-aid

www.aabb.org

Corrective Action Plans

Root Cause Analysis

Identification of the underlying factors causing the problem

Eliminates being blindsided by the same problem

Resolve not Re-Solve

www.aabb.org

Root Cause Analysis Is NOT

A restatement of the objective evidence

Objective evidence: No process exists for evaluating the competency of testing personnel.

Root cause analysis: We never developed a process for evaluating the competency of testing personnel.

Why???

www.aabb.org

Root Cause Analysis Is NOT

Meant to be applied to each piece of objective evidence

LOOK AT THE

BIG PICTURE

www.aabb.org

Look for Common Threads

Is it a document development issue?

Is there a problem with the review process?

Is it a document control issue?

Is there a problem with the training process?

WHY??

www.aabb.org

Is It Worth It?

A systematic approach to problem-solving takes time & resources

Minor problems dont warrant RCA

Use RCA on problems that you perceive as important; those in which the cause (or causes) is not obvious

www.aabb.org

What to Correct?

Goal of Corrective Action: to prevent the reoccurrence of the same or similar situation

Is there enough information? Is the information accurate? Determine steps to be taken to correct

the problems identified in root cause analysis

Is the planned corrective action is relevant to the problem?

www.aabb.org

Corrective Action Plans

System Improvements Description of the action taken to prevent recurrence of same or similar nonconformance

Timeline for the completion of the action

Individuals responsible for overseeing the completion of the action

www.aabb.org

System Improvements

Keep it simple

Keep it practical

Involve other people

What is the impact of the improvement on other parts of the system?

www.aabb.org

How Do I Know

It Worked??

www.aabb.org

Plan for Monitoring CA

Monitoring the effectiveness of CA is critical for ensuring that the causative factors of the incident have been identified and corrected

Indicator tracking

Error tracking

Direct observation

Paperwork review

Focused audits

Combination of these

www.aabb.org

Establishing Reasonable Timelines

Short term: time to verify that the CA is being applied properly

Long term: evaluation after CA has been integrated into the process

Employee retraining: evaluation to measure retention of information

www.aabb.org

Analyze This

Analyze information obtained from observation, data collection, audit, etc.

Is the data showing that the corrective action actually corrected the problem?

If so

www.aabb.org

Long Range Evaluation

Plan for a future re-audit to assess what happens over a period of time

What is the impact on other processes of any changes that were made in response to the incident?

www.aabb.org

Analyze That

If not

Why not?

Where do you go from here if the corrective action didnt work?

www.aabb.org

Unsuccessful Corrective Action

Was something missed in the original root cause analysis?

Retrace steps

Perform follow up interviews

Was the wrong factor corrected?

Training vs. attitude

SOP vs. reagents

www.aabb.org

Unsuccessful Corrective Action

Was the wrong part of the process identified as needing change?

Was another part of the process also a factor, but overlooked?

Was more than one change implemented at a time?

www.aabb.org

Additional Resources

www.aabb.org

AABB Assessment Tools

Commendable Practices Library

Facility Guide Through the Assessment Process

AABB Community

www.aabb.org

Additional Resources

AABB Department of Accreditation and Quality

301-215-6492

accreditation@aabb.org

www.aabb.org

Summary Examples of most common

nonconformances

Common thread in all areas is process control

There should be a process to review new standards and determine compliance prior to implementation

Corrective action and root cause

Keep up the good work!

www.aabb.org

Thank You!

Questions?