You Too Can Be a Superhero: Internal Audits to the Rescue! · 2020. 9. 14. · Failure to follow SOP Verification of information No verification of the interpretation of crossmatch

You Too Can Be a Superhero:Internal Audits to the Rescue

J. Wade Atkins

MS, MT(ASCP) SBB

CQA(ASQ)

National Institutes of Health

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FACULTY DISCLOSURE

Nothing financially to disclose

My comments today are my own

They are not official positions of the US Government, DHHS, NIH,

the Clinical Center or DTM

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OBJECTIVES

Describe systems and associated findings commonly

cited during assessments

Identify activities that blood bankers can perform

during INTERNAL audits to identify areas of

noncompliance.

Develop processes to manage findings, resolve

problems, and ensure successful assessments.

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THEY HAVE TO FIND SOMETHING!DON’T THEY?

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COMMON

FINDINGS

Policies, Processes &

Procedures

- meet the standards

- are followed

Competency

Equipment

Document Control

WHAT IS AN

AUDIT?

A planned, independent, and documented assessment to determine whether agreed upon requirements are met.

A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

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WHAT IS AN

AUDIT?

Independent review or investigation to assess adequacy of compliance with and adherence to:

Contracts and licensing requirements

Baselines

Codes

Effectiveness of implementation

Established procedures

Instructions

Procedures

Software requirements

Specifications

Standards11

…...no they DON’T!

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THEY HAVE TO FIND SOMETHING….

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ORGANIZATION

BB/TS Standard

STD: 1.3 PPP

Requires: PPP to be

developed, written down,

implemented, and followed

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FREQUENT CITATIONS

PPP doesn’t exist

PPP not in writing

Failure to follow the approved version

Deficient documentation of current review

A form exists, but no process or procedure to address it

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AUDITOR TO THE RESCUE!

Review 1/12 of SOPs each month

Direct Observation of staff performing process

Look at the Standards

“Policy”, “Process”, “Procedure”

Look at your quality plan

“We have a process for…”

Have a process (in writing!) to review changes to Standards

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PERSONNEL - COMPETENCE

BB/TS Standard

STD: 2.1.3 and 2.1.3.1

Requires: evaluation of competence

performed before independent

performance of assigned activities and

at specified intervals

Tests and critical tasks

CLIA

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FREQUENT CITATIONS

Tasks are not defined, focus seems to be on testing personnel

only

Incomplete list of trained personnel

Incomplete documentation of competency

Separate documentation of training and initial competency

assessment

Failure to include all six CLIA elements for all tests performed

Failure to document delegation of management tasks (LD, TS

(TC), GS)

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AUDITOR TO THE RESCUE! Review processes and procedures and identify key, critical

tasks and create acceptable performance criteria

Identify Subject Matter experts to assist with evaluations

Have employee assist in the recordkeeping.

Assess 1/12 of the listed activities per month. Can be done

during a one on one employee-supervisor session

(remember to have praise sessions too not just discipline

meetings)

Define a manageable policy and practice

Documentation: Watch your dates!

If unsatisfactory staff performance (2.1.5.1) then remove

from duty until remediation and successful assessments are

documented

Don’t forget about PT results if used as part of

competency assessment

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EQUIPMENT – PREVENTIVE

MAINTENANCEBB/TS Standard

STD: 3.5

Requires: A process for scheduled monitoring and maintenance of equipment

At a minimum in accordance with manufacturer’s written instruction

To include

Frequency

Methods

Acceptance criteria

Actions for unsatisfactory results20

FREQUENT CITATIONS

Incomplete documentation that repairs are adequate and documented by qualified individuals before equipment is returned to service

Preventive maintenance not performed on time

Incomplete documentation by performing company representative or missing signatures

Manufacturer’s instructions not followed

Blood warmer PM not monitored

Reports not available

Pass/Fail

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Operations and Quality Staff review documentation of vendor or staff qualification before initiating repairs and then also all documentation (GDP met?) before returning equipment to service

Track deficiencies and then hold the vendor responsible for performance (consider evaluation of breech of contract)

Read the manufacturer’s manual!

Frequency of PM

Frequency of cleaning

Establish a schedule and follow it

Outlook reminders

Excel spreadsheet

Green: PM performed

Yellow: PM due

Red: PM overdue

Review records in a timely fashion

Delegate and hold staff responsible

Make friends with BioMed

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PROCESS CONTROL

BB/TS Standard

STD: 5.1.3 QC

Requires program to ensure that reagents, equipment, and methods perform as expected

When QC failures occur, evaluate the validity of test results and methods and acceptability of products or services

STD: 5.1.4

Reagents shall be stored and used in accordance with

manufacturer’s written instructions

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FREQUENT CITATIONS

Incomplete records

Missing results or interpretations

Review not performed in a timely

fashion

Failure to evaluate test results

Heat block temperatures

MTS incubators

Incomplete record keeping or documentation of investigations

Antigen typing

2 drops of antisera instead of 1

Low alarm set at 1.5C, reagents’ storage range 2-8C

Failure to record all phases of testing

Rh: Immediate spin, RT incubation

IAT: Coombs Control Cells

Failure to use heterozygous positive controls

Rh: Screening Cells I and II

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TIMELY review

Second person, same shift

Next shift

Monthly supervisor review

Review package inserts

Frequent, small sample size reviews of representative records

Treat each unexpected event as a deviation so that a thorough

investigation and CAPA can be implemented. Catch it early to

make it more manageable.

Evaluate test results

Units issued?

BPD? 25

PROCESS CONTROL

BB/TS Standard

STD: 5.28 Product Administration

Requires: Protocol for administration of blood and blood components

Verification of information after issue and immediately before transfusion

Positive identification of recipient

Observation of recipient for potential adverse events

Standard 7.4.1 Recognition and response to immediate transfusion reactions

Clerical check at bedside

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FREQUENT CITATIONS

Failure to follow SOP

Verification of information

No verification of the interpretation of crossmatch tests (issue

and/or bedside)

Identification of recipient

Removal of crossmatch tag

Timing of vital signs

Monitoring of recipient

No instructions for and/or documentation of bedside clerical

check when transfusion reaction suspected

Incomplete record keeping or documentation of investigations27


Work with nursing to develop an SOP nurses can follow

Educate, educate, educate

Frequent, small sample size reviews of representative records

Blood administration audits

Checklist specific to the SOP

Involve staff

All shifts

Communicate results!

Tracers?

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DOCUMENTS AND RECORDS

BB/TS Standard

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STD: 6.1.5

Requires: Use of only current and valid

documents

6.2 Records

Requires: Records to be

Complete

Legible and indelible

Created concurrently

Corrected properly

Retained

FREQUENT CITATIONS

Documents

SOPs not reviewed and signed off at expected intervals.

Knee-jerk nonconformance

Write an SOP

Overlapping SOPs

SOP fails to match practice

Conflicting SOPs

“Lip service” biennial review

reaction to Fail to review other SOPs

Records

Incomplete records and forms

(GDP errors)

Use of gel pens

Use of arrows for results

Overwrites

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Documents

Divide and conquer!

Electronic document control

Organize SOPs in a logical fashion

Work-flow or process driven

Use a different pair of eyes for review

“Authorized” individual

Use change control when adding an SOP

Other SOPs affected?

Records

BAN GEL PENS

Design forms for success

Instructions for completing on form

Space to record results

Colored areas: no result needed

Defined policy for error correction

Document errors and omissions as part of deviation management

Units issued?

BPD?

Timely review 32

DEVIATION MANAGEMENT

BB/TS Standard

STD: 7.0

Requires: PPP for capture, assessment,

investigation, and monitoring of deviations

Report of deviations to outside agencies

(Biological Product Deviation reporting)

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FREQUENT CITATIONS

Missing or incomplete documentation of a well executed investigation

prior to release of the product

Documentation, assessment, and investigation, but lack of monitoring

Failure to recognize and report BPDs to the FDA

Insufficient SOP to describe how to consistently perform and

document the investigation and outcomes

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What can be done: HIRE MORE STAFF ☺

Seriously, open an investigation as soon as possible

Alert all stakeholders of an event that requires investigation to safely proceed

Document findings, actions taken and reviews

Debrief

Focus on Process, not People

Make it non-punitive

Encourage staff to report

Was a test result or product affected?

Gain control!

Monitor

Classify

Is there a trend?

Evaluate every deviation as a potential BPD 36

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BBTS Standard 8.1

The results of internal and external

assessments shall be reviewed by

personnel having responsibility for the

area being assessed.

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CORRECTIVE &

PREVENTIVE ACTION

WHAT ELSE?

Evaluate to ensure that

corrective action taken

is EFFECTIVE

Ensure that the results of

the internal audit and

corrective & preventive

action is reviewed by

executive management (& keep a record of that!)

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SESSION NUMBER:

4803